Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing. (b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company. (c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company. (d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820. (e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions. (f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy. (g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law. (h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial. (i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws. (j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program (k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable. (l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws. (n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 3 contracts
Samples: Acquisition Agreement, Acquisition Agreement, Acquisition Agreement
Regulatory Matters. (a) The Company Product has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force been researched, developed, tested, manufactured, supplied, promoted, distributed, marketed, commercialized, stored and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in partsold, as a result applicable, by Seller and, to Seller’s Knowledge, by each other Person on behalf of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDASeller, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with (i) all applicable Laws and any other letters, notices (ii) all Permits. The Product is not adulterated or guidances issued by misbranded within the meaning of the FDA Act or any Governmental Authority which regulates the sale similar governmental act or Law of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(db) The manufacture Seller has made available to Purchaser complete and correct copies of (i) each NDA submitted by or on behalf of Seller to the products FDA with respect to the Product; (ii) all other material document, correspondence, filing or other communication submitted to a Governmental or Regulatory Authority or the Department of Justice by or on behalf of Seller or received from a Governmental or Regulatory Authority or the Company is being conducted Department of Justice by or on behalf of Seller, in compliance in each case, with respect to the Product or the Acquired Assets; (iii) all material respects scientific, clinical and safety data of Seller with current “good manufacturing practices,” as defined respect to the Product; and (iv) all audit reports performed by the FDA, including, as applicable, the FDASeller or on its behalf to assess Seller’s “Quality System Regulation” set forth in 21 C.F.R. Part 820compliance with applicable Health Laws.
(ec) The Company Seller has not received, nor with respect to the Product is and has there any pending or outstanding: (i) Form 483 observations, FDA warning letters or post-sale warnings or other regulatory warning letters or sanctions; (ii) inspectional observations or establishment inspection reports reciting penalties for corrective or remedial action or requiring corrective action plans; (iii) field notifications or alerts; (iv) import alerts, holds or detentions; or (v) other documents that, in the case of each of the preceding clauses (i) through (iv), have been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered received by Seller from the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports or Regulatory Authority relating to product corrections the Product, or to Seller’s Knowledge, any facility in which the Product is manufactured, packaged or stored, and removals that assert ongoing material lack of compliance with any such Laws by Seller.
(including FDA requirements set forth d) Seller is not in 21 C.F.R. Part 806violation of, and, to Seller’s Knowledge, Seller is not the subject of, any pending investigation by a Governmental or Regulatory Authority regarding activities prohibited under, the U.S. Anti-Kickback Act (42 U.S.C. § 1320a-7b(b), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803et seq.), Adverse Experiencesthe U.S. Xxxxx Law (42 U.S.C. § 1395nn), Serious Adverse Eventsthe U.S. False Claims Act (31 U.S.C. § 3729, Serious Injurieset seq.), incidents the Trade Agreements Act (19 U.S.C. §§2501-2581) or near-incidents any other Laws governing participation in United States healthcare programs, or any comparable state or foreign Laws. There are no lawsuits, actions or proceedings pending or, to Seller’s Knowledge, threatened in writing against Seller that would reasonably be expected to result in the exclusion of Seller from any third party payment program in which they participate.
(e) Seller has not received any written notice from the FDA or any other Governmental or Regulatory Authority that it has commenced, and product malfunctionsto Seller’s Knowledge neither the FDA nor any other Governmental or Regulatory Authority has threatened to commence, any action to withdraw its approval or request the recall of the Product, or commenced, or to Seller’s Knowledge threatened to commence, any action to enjoin production at any facility at which the Product is manufactured.
(f) None Seller has not, and to Seller’s Knowledge, no director, officer, employee or agent of Seller has, committed an act, made a statement, or failed to make a statement, that would reasonably be expected to provide a basis for any Governmental or Regulatory Authority to invoke the Company orFDA policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy, in each case as related to the Product or the Acquired Assets. Seller, and, to the Knowledge Seller’s Knowledge, no director, officer, employee or agent of the CompanySeller, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct for which has resulted or could result in debarment or disqualification similar punishment is mandated or permitted by the FDA 21 U.S.C. § 335a(a) or any other Governmental Authoritysimilar Laws or authorized by 21 U.S.C. § 335a(b) or any similar Laws. Seller has not, and there are no proceedings pending orand, to the Knowledge Seller’s Knowledge, no director, officer, employee or agent of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners Seller has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted convicted of any crime or engaged in compliance any conduct for which such Person could be excluded from participating in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her health care programs under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violationsamended, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach similar Laws.
(ng) To The annual Prescription Drug User Fees for the extent Product due for all time periods prior to the Company provides reimbursement coding or billing advice regarding products offered for sale Closing have been timely paid by the Company and procedures related thereto, such advice is and has been true and complete Seller in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsfull when due.
Appears in 3 contracts
Samples: Asset Purchase Agreement (Midatech Pharma PLC), Asset Purchase Agreement (Galena Biopharma, Inc.), Asset Purchase Agreement (Galena Biopharma, Inc.)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued Except as would not be material to the Company Group, taken as a whole: (i) the Company Products are in full force and effect, compliance with all current applicable Device Regulatory Laws; (ii) each member of the Company Group is in compliance in with all material respects withapplicable Device Regulatory Laws relating to the sourcing, procurement, and is not in default in any material respect 30 under (the import of raw materials for the Company Products and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permitmethods and materials used in, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole facilities and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectivelycontrols used for, the “Company Regulatory Filings”) design, manufacture, processing, packaging, labeling, storage, distribution, export, and holds all rightimport, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to useif applicable, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any Products; (iii) each member of the Company Group has received confirmation from the Notified Body that a formal application for conformity assessment of the Company Products has been accepted and that the Company Products may continue to be placed on the market of the European Union countries until December 31, 2028; and (iv) since January 1, 2021, all such raw materials and all Company Products have been sourced, procured, processed, manufactured, packaged, labeled, stored, handled, distributed, exported, and imported, if applicable, by the Company Group in compliance with all applicable Device Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingLaws.
(b) Except as set forth would not be material to the Company Group, taken as a whole: (i) all preclinical and clinical investigations sponsored by or on Section 4.13(b) behalf of a member of the Company Disclosure ScheduleGroup with respect to any Company Product are being, and since January 1, 2021, have been, conducted in compliance with applicable Device Regulatory Laws, including Good Clinical Practices and Good Laboratory Practices requirements, and federal and state Laws restricting the use and disclosure of individually identifiable health information; and (ii) each member of the Company Group complies with, and since January 1, 2021, has complied with, all requirements under the Laws relating to monitoring and reporting of adverse events during clinical trials.
(c) No action has been taken by any Governmental Authority or is in the process of being taken that would slow, halt or enjoin the development, manufacturing, or marketing of the Company Products or the operation of the business of the Company Group or subject the development, manufacturing, or marketing of the Company Products or a member of the Company to regulatory enforcement action.
(d) Except as would not be material to the Company Group, taken as a whole, since January 1, 20072021, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product the members of the Company Group have maintained records relating to the development, manufacture, testing, storage, handling, labeling, packaging, sale, marketing, promotion, distribution, import or product candidate export of the Company.
(c) The Company is Products in material compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdictionDevice Regulatory Laws. There are no pending or, Except as would not be material to the Knowledge of the CompanyCompany Group, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Companytaken as a whole, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates each member of the Company against any Person that manufactures any componentGroup and each of their respective contractors and agents have submitted to FDA, ingredientNotified Bodies and all other applicable regulatory authorities, institutional review boards, or material used in manufacturing the products or the product candidates of the Company pursuant to a developmentaccreditation bodies, commercializationall required supplemental applications, manufacturing510(k) premarket notifications, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologicCE Mark applications, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, includingpre-market approval applications and de novo classification requests, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820notices, filings and annual or other reports and information.
(e) The Except as would not be material to the Company is Group, taken as a whole, since January 1, 2021, all manufacturing operations for the Company Products conducted by or on behalf of a member of the Company Group have been and has been are being conducted in compliance in all material respects with all Laws requiring the maintenance or submission QSR and any similar requirements of reports or records under requirements administered by the FDA or FDA, Notified Bodies and any other Governmental AuthorityCompany Product regulatory authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.the Company Products are not adulterated within the meaning of
(f) None Except as would not be material to the Company Group, taken as a whole, no member of the Company Group or, to the Knowledge of the Company, any director, officer, employee, contractor or agent of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None a member of the Company Group is the subject of any pending Action or, to the Knowledge of the Company, any ongoing investigation or inquiry, or has received any notice of any actual investigation, inquiry, for-cause inspection or audit or other Action by a Governmental Authority regarding a violation of a Device Regulatory Law, including FDA pursuant to its Collaborative Partners “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar Governmental Authority pursuant to any similar policy, or concerning allegations of a violation by a member of the Company Group or any director, officers, employees, contractors or agents of a member of the Company Group of any Device Regulatory Laws, nor has a member of the Company Group or, to the Knowledge of the Company, any director, officer, employee, contractor or agent of a member of the Company Group committed any act, or made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” the FDA Application Integrity Policy or for any other similar Governmental Authority to invoke a similar policy or a violation of a Device Regulatory Law. Except as would not be material to the Company Group, taken as a whole, no member of the Company Group and no director, officer, employee, contractor or agent of a member of the Company Group has violated any Device Regulatory Law nor knowingly made any false statements on, or omissions from, any notifications, applications, approvals, reports and other submissions to a Governmental Authority relating to any Company Product or has voluntarily disclosed any violations of Device Regulatory Laws related to any Company Product. Except as would not be material to the Company Group, taken as a whole, no member of the Company Group, nor any director, officer, employee, contractor or agent of a member of the Company Group, has been convicted of any crime or engaged in any other conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar policyLaw, or authorized by 21 U.S.C. § 335a(b) or any similar Law.
(g) There have been no Serious Adverse EventsExcept as would not be material to the Company Group, Serious Injuries or MDR Reportable Events associated with the use taken as a whole, (including in clinical trialsi) of the products each member of the Company Group, and each Company Product being manufactured, marketed, or product candidates distributed, is in compliance in all respects with the regulations for medical device reporting set forth in 21 C.F.R. Part 803, and reports of corrections and removal under 21 C.F.R. Part 806, and any similar Law; (ii) since January 1, 2021, each member of the Company that have not been reported Group has promoted, marketed, and continues to promote and market Company Products only for uses cleared or approved for such Company Product by the FDA or other Governmental Authority; and (iii) no litigation or Governmental Authority enforcement action or investigation is pending or threatened with respect to the FDA in accordance Company Group or its members’ compliance with applicable Lawthe requirements under Device Regulatory Laws, or the Company Group or its members’ promotional practices.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf no member of the Company by any Group and no director, officer, employee, contractor or agent of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf a member of the Company Group, has been terminated investigated for, charged with or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge convicted of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officerProgram-related offense, directoror convicted of, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) charged with or investigated for a violation of the Companyfederal or state Law related to fraud, northeft, to the Knowledge embezzlement, breach of the Companyfiduciary responsibility, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) financial misconduct, obstruction of the Company: (i) an investigation of controlled substances, or has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws(nor is any such debarment, exclusion or suspension pending), or been subject to any Order or consent decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority except, in each case of this Section 3.22(h), as would not be material to the Company Group, taken as a whole.
Appears in 3 contracts
Samples: Merger Agreement (Nordson Corp), Merger Agreement (Nordson Corp), Merger Agreement (Nordson Corp)
Regulatory Matters. (a) The Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company has Material Adverse Effect, (i) each of the Company and the Company Subsidiaries holds all Permits required by Company Permits, including (x) all permits, licenses, franchises, approvals, clearances. registrations, and authorizations under the FDA to conduct the Business United States Food, Drug and Cosmetic Act of 1938, as amended (the “FDA FDCA”), the Public Health Service Act, as amended (the “PHSA”), the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, and data protection laws, and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Company Products (any such Governmental Entity or Notified Body, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company or any Company Subsidiary as currently conducted or as planned to be conducted (the “Company Regulatory Permits”). All of the FDA ; (ii) all such Company Regulatory Permits held by or issued to the Company are valid and in full force and effect, ; and (iii) the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving terms of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingPermits.
(b) Except as set forth on Section 4.13(b) would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, the businesses of each of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the and each Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There Subsidiary are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care ProgramFDCA; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”)PHSA; (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs Medicare and non-procurement programsMedicaid statutes and related state or local statutes; (iv) to the Knowledge any comparable foreign Laws for any of the Company, is the target or subject foregoing applicable in jurisdictions in which material quantities of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offenseof the Company Products or Company Product candidates are manufactured or sold; or (v) is currently charged with federal, state or convicted of any provincial criminal offense relating to or civil healthcare Laws (including the delivery of an item or service under any Federal Health Care Program
federal Anti-Kickback Statute (k) The Company reasonably believes that it has the requisite know-how and processes to42 U.S.C. §1320a-7(b)), subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 3729 et seq.1320a-7h).
(m) To the Knowledge of the Company, the Company is exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 19951996 (42 U.S.C. §1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAAHITECH Act”), and any comparable federal, state, provincial or local healthcare Laws in the regulations contained United States or in 45 C.F.R. Parts 160 jurisdictions in which material quantities of any of the Company Products or Company Product candidates are manufactured or sold); (vi) all applicable foreign, federal, state, and 164provincial Laws pertaining to privacy, data protection, and information security, including receiving all HIPAA and HITECH provisions pertaining to privacy, information security, and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any notices applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (viii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Company Healthcare and Data Protection Laws”). Since January 1, 2012, neither the Company nor any Company Subsidiary has received any written notification or communication from any Company Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights relating Rights, the Centers for Medicare and Medicaid Services, the FTC, and the Department of Health and Human Services, of noncompliance by, or liability of Company or the Company Subsidiaries under, any Company Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, the Company and the Company Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Company or any Company Subsidiary is a party to any such violationsmaterial corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any comparable state Governmental Entity.
(d) All pre-clinical and clinical investigations in respect of a Company Product or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Product candidate conducted or sponsored by each of the Company has been and the Company Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 58, 312, 314, 320, 812 and 820 Subpart C of the Code of Federal Regulations, (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(e) Since January 1, 2012, neither the Company nor any Company Subsidiary has received any written notice from the FDA or the European Medicines Agency (the “EMA”) or any foreign agency or Notified Body with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of the Company Products or Company Product candidates which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Company Regulatory Permits or of any application for marketing approval or clearance already granted or currently pending before the FDA or such other Company Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Company Regulatory Agency by the Company and the Company Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects with on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012 neither the Company nor any Company Subsidiaries, nor, to the knowledge of the Company, any officer, employee, agent or distributor of the Company or any of the Company Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Company Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Company Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of the Company or any of the Company Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Company Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Company Material Adverse Effect. Neither the Company nor any of the Company Subsidiaries, nor, to the knowledge of the Company, any officer, employee, agent or distributor of the Company or any of the Company Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Company Products or Company Product candidates are sold or intended by the Company to be sold. Since January 1, 2012, neither the Company nor any of the Company Subsidiaries, nor, to the knowledge of the Company, any officer, employee, agent or distributor of the Company or any of the Company Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal and state data breach Lawshealth care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Company Healthcare Law or program.
(ng) To As to each Company Product or Company Product candidate subject to the extent FDCA, PHSA or the regulations of the FDA promulgated thereunder or any similar applicable Law in any foreign jurisdiction in which material quantities of any of the Company provides reimbursement coding Products or billing advice regarding products offered for sale Company Product candidates are sold or intended by the Company and procedures related thereto, such advice to be sold that is and or has been true developed, manufactured, tested, distributed or marketed by or on behalf of the Company or any of the Company Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, each such Company Product or Company Product candidate is being or has been developed, manufactured, stored, distributed and complete in all material respects and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of the Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in all each case alleging any violation applicable to any Company Product or Company Product candidate by the Company or any of the Company Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, since January 1, 2012, neither the Company nor any of the Company Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, correction, removal, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Company Product. To the knowledge of Company, there are no facts which are reasonably likely to cause, and the Company has not received any written notice from the FDA or any other Company Regulatory Agency regarding (i) the recall, removal, correction, market withdrawal or replacement of any Company Product sold or intended to be sold by the Company or a Company Subsidiary (other than recalls, removals, corrections, market withdrawals or replacements that are not material respects with to the payment requirements Company or the Company Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of Medicare and any such Company Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Company Products, or (iv) a material negative change in reimbursement status of a Company Product.
(i) Except as would not reasonably be expected to have a Company Material Adverse Effect, neither the Company nor any Company Subsidiary has experienced any security breach or other Federal Health Care Program Lawsincident resulting in the unauthorized access, use, or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law.
(j) Notwithstanding anything contained in this Section 3.13, no representation or warranty shall be deemed to be made in this Section 3.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 3 contracts
Samples: Merger Agreement (Allergan Inc), Merger Agreement (Warner Chilcott LTD), Merger Agreement (Actavis PLC)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference Neither Parent nor Merger Subs nor any of the Company Regulatory FilingsParent’s or Merger Subs’ personnel, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings Representatives or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners controlled Affiliates has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA FDA, the EMA or any other Governmental Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any such similar policies set forth in any applicable Laws. None of the Parent or Merger Subs or, to Parent’s or Merger Subs’ Knowledge, any of their officers, directors, Representatives or other Governmental Authority of Parent’s or Merger Subs’ personnel, has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to invoke result, in debarment or exclusion under applicable Laws, including, without limitation, 21 U.S.C. Section 335a and 42 U.S.C. Section 1320a-7. To Parent’s and Merger Subs’ Knowledge, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion of Parent or Merger Subs are pending or threatened, against Parent or Merger Subs or any similar policyof their officers, directors, Representatives or other personnel.
(gb) There have been no Serious Adverse Events, Serious Injuries Parent’s product candidates for human use or MDR Reportable Events associated with the anticipated to be for human use (including in clinical trialsthe “Parent Product Candidates”) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted developed, tested, labeled, manufactured, stored, imported, exported and distributed, as applicable, in compliance in all material respects with the FDCA and applicable implementing regulations issued by the FDA and applicable Laws and applicable implementing regulation issued by the EM and any other applicable Governmental Authorities, including, as applicable, those Laws relating to the FDA’s current good manufacturing practices, good laboratory practices, good clinical practices, investigational use and applications to market a new pharmaceutical product and, to the Knowledge of Parent without investigation, all Laws referred to in EudraLex Volume 10 (Guidelines for Clinical Trials).
(c) To the extent required by applicable Laws, all clinical studies, preclinical studies and tests conducted by or on behalf of Parent have been, and if still pending are being, conducted in material compliance with the research protocols submitted to the FDA or other Governmental Authority, good laboratory practices, good clinical practices, and all applicable Laws, including, as applicablebut not limited to, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including FDCA and the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions Laws of the Federal FoodEMA and, Drug to Parent’s Knowledge, all clinical studies and Cosmetic Act preclinical studies and its tests conducted by or on behalf of Parent have been or, if pending, are being conducted in material compliance, to the extent applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 with such practices and 812, and comparable Laws of any other Governmental AuthorityLaws. No clinical trial study conducted by the Company or, to the Knowledge of the Company, or on behalf of the Company Parent has been terminated or suspended prior to completion for safety completion. None of the FDA, EMA or non- compliance reasons, and neither the FDA nor any other applicable Governmental Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over over, a clinical study conducted by or participated in any such clinical trial on behalf of Parent has initiatedcommenced, or, to the Knowledge of the CompanyParent’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay terminate or suspendsuspend or refuse to commence, any such proposed or ongoing clinical trial, investigation or study conducted or proposed to disqualify, restrict be conducted by or debar any clinical investigator or other person or entity involved in any such clinical trialon behalf of Parent.
(id) Neither the Company nor Parent is not subject to any officer, director, managing employee (as those terms are defined investigation that is pending and of which Parent has been notified in 42 C.F.R. § 1001.1001) of the Company, norwriting or, to the Knowledge of the CompanyParent’s Knowledge, any agent (as such term is defined which has been threatened, in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: each case by (i) has been debarred, excluded the FDA or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating Inspector General or Department of Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the Federal False Claims Act (31 U.S.C. §3729.
(e) Parent has not submitted any claim for payment to any such violationsgovernment healthcare program in connection with any referrals related to any of the Parent Product Candidates that violated in any material respect any applicable self-referral law, including the Federal Ethics in Patient Referrals Act, 42 U.S.C. §1395nn, or any comparable applicable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsself-referral law.
(nf) To All manufacturing operations conducted by or for the benefit of Parent with respect to the Parent Product Candidates have been and are being conducted in material compliance with applicable Laws, including, to the extent applicable, the Company provides reimbursement coding or billing advice regarding products offered for sale provisions of the FDA’s current good manufacturing practice regulations, and the respective counterparts thereof promulgated by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare EMA and other Governmental Authorities in countries outside the United States. Parent has not recalled any Parent Product Candidates and no Governmental Authority has suspended or otherwise restricted the manufacture of any of the Parent Product Candidates. Parent has not received any written notice that the FDA, EMA or any other Governmental Authority, any relevant institutional review board, independent ethics committee or any other similar body has initiated, or threatened to initiate, any action to suspend or otherwise restrict the manufacture of any of the Parent Product Candidates.
(g) Parent has not submitted any claim for payment to any government healthcare program related to any of the Parent Product Candidates in material violation of any laws relating to false claims or fraud, including the Federal Health Care Program LawsFalse Claim Act, 31 U.S.C. § 3729, or any applicable state false claim or fraud law.
Appears in 3 contracts
Samples: Merger Agreement (Cyclo Therapeutics, Inc.), Merger Agreement (Rafael Holdings, Inc.), Merger Agreement (Cyclo Therapeutics, Inc.)
Regulatory Matters. (a) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all Permits required by permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to conduct the Business be conducted (the “FDA Parent Regulatory Permits”). All of the FDA ; (ii) all such Parent Regulatory Permits held by or issued to the Company are valid and in full force and effect, the Company ; and (iii) Parent is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving terms of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company all Parent Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingPermits.
(b) Except as set forth on Section 4.13(bwould not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the Company Disclosure Scheduleforegoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, since state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 20072012, there neither Parent nor any of the Parent Subsidiaries has not been received any voluntarily written notification or involuntarily initiatedcommunication from any Parent Regulatory Agency, conductedincluding the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or issued recallliability of Parent or the Parent Subsidiaries under, market withdrawalany Parent Healthcare and Data Protection Laws, safety alertexcept where such noncompliance or liability would not reasonably be expected to have, warningindividually or in the aggregate, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companya Parent Material Adverse Effect.
(c) The Company is Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects with all applicable Laws and any other letters, notices on the date filed (or guidances issued were corrected in or supplemented by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionsubsequent filing). Since January 1, 2007 there have been no written notices2012, reportsneither Parent nor any of the Parent Subsidiaries, warning lettersnor, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company knowledge of Parent, any officer, employee, agent or the products distributor of Parent or product candidates any of the Company Parent Subsidiaries, has made an untrue statement of a material fact or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard fraudulent statement to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental AuthorityParent Regulatory Agency, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by be disclosed to the FDA or any other Governmental AuthorityParent Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make a statement, in each such case, related to the business of Parent or any statement that of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Parent Regulatory Agency to invoke any similar policy.
(g) There , except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have been no Serious a Parent Material Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) Effect. Neither Parent nor any of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyParent Subsidiaries, nor, to the Knowledge knowledge of the CompanyParent, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) agent or distributor of Parent or any of the CompanyParent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the Knowledge knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the CompanyParent Subsidiaries, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, suspended or excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him government health care program or her convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; similar Parent Healthcare Law or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableprogram.
(lg) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the Knowledge knowledge of the CompanyParent, there are no pending facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or threatened filings against any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of an action relating to any such Parent Products, (iii) a termination or suspension of the Company under any federal manufacturing, marketing, or state whistleblower statutedistribution of such Parent Products, including under the False Claims Act or (iv) a material negative change in reimbursement status of 1863 (31 U.S.C. § 3729 et seq.)a Parent Product.
(mi) To the Knowledge Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the CompanyParent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, the Company use or disclosure of data or information that is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating linked to any such violations, reasonably identifiable person or any comparable state other data protected under applicable Law. Parent or local Laws. The Company Merger Sub is not a “covered entity” business associate, as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsthe HIPAA regulations at 45 C.F.R. § 160.103.
(nj) To the extent the Company provides reimbursement coding Notwithstanding anything contained in this Section 4.13, no representation or billing advice regarding products offered for sale by the Company and procedures related theretowarranty shall be deemed to be made in this Section 4.13 in respect of environmental, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program LawsTax, employee benefits or labor Law matters.
Appears in 3 contracts
Samples: Merger Agreement (Warner Chilcott LTD), Merger Agreement (Allergan Inc), Merger Agreement (Actavis PLC)
Regulatory Matters. (a) The Except (x) as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company has Material Adverse Effect or (y) that, individually or in the aggregate, as of the date of this Agreement, would not reasonably be expected to prevent, materially delay or materially impair the ability of the Company to perform its obligations under this Agreement or to consummate the Mergers, (i) each of the Company and its Subsidiaries holds (A) all Permits required by authorizations under the FDA to conduct the Business U.S. Food, Drug, and Cosmetic Act of 1938 (the “FDA FDCA”), the U.S. Public Health Service Act (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and (B) authorizations of any applicable Governmental Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Company Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or any of its Subsidiaries as currently conducted (the “Company Regulatory Permits”); (ii) all such Company Regulatory Permits are valid and in full force and effect; and (iii) the Company and its Subsidiaries are in compliance with the terms of all Company Regulatory Permits. All of the FDA Company Regulatory Permits held by or issued to the Company are in full force and effect, except where the failure to be in full force and effect (A) has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or (B) as of the date of this Agreement, individually or in the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of the Company is to perform its obligations under this Agreement or to consummate the Mergers.
(b) Neither the Company nor any of its Subsidiaries are party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Company Regulatory Agency.
(c) All pre-clinical and clinical investigations in respect of a Company Product conducted or sponsored by the Company or any of its Subsidiaries are being, and since January 1, 2019 have been, conducted in compliance with all Applicable Laws administered or issued by the applicable Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in all material respects withTitle 21 parts 50, 54, 56, 312, 314 and is 320 of the Code of Federal Regulations and (ii) any Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that has not had and would not reasonably be expected to have, individually or in default the aggregate, a Company Material Adverse Effect.
(d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, during the period beginning on January 1, 2019 and ending on the date of this Agreement, neither the Company nor any material respect 30 under of its Subsidiaries has received any written notice from the FDA or the European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of the Company Products that would reasonably be expected to lead to the Knowledge of the Companydenial, no event which with the giving of notice or lapse of timelimitation, revocation, or both, would become a default under), each such Permit, and none rescission of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, Permits or of any of application for marketing approval currently pending before the Know-How contained in any of the FDA or such other Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingAgency.
(be) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since Since January 1, 20072019, there has not been all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of other Company Regulatory Agency by the Company and its Subsidiaries have been so filed, maintained or product candidate of furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the Company.
(c) The aggregate, a Company is in compliance Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete in all material respects with all applicable Laws and any other letters, notices on the date filed (or guidances issued were corrected in or supplemented by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionsubsequent filing). Since January 1, 2007 there have been no written notices2019, reportsneither the Company nor any of its Subsidiaries, warning lettersnor, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company knowledge of the Company, any officer, employee, agent or the products or product candidates distributor of the Company or any subpoenas of its Subsidiaries, has made an untrue statement of a material fact or investigative demands a fraudulent statement to the FDA or any other written inquiries that would reasonably Company Regulatory Agency, failed to disclose a material fact required to be interpreted as raising disclosed to the FDA or any other Company Regulatory Agency, or committed an act, made a compliance concern sent statement, or delivered by any Governmental Authority with regard failed to any product make a statement, in each such case, related to the business of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative PartnersSubsidiaries, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by that, at the FDA or any other Governmental Authoritytime such disclosure was made, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Company Regulatory Agency to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries except for any act or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company statement or product candidates of the Company that have not been reported failure to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board make a statement that has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Except as has not had jurisdiction over and would not reasonably be expected to have, individually or participated in any such clinical trial has initiatedthe aggregate, ora Company Material Adverse Effect, to the Knowledge of the Companysince January 1, threatened to initiate2019, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Companyits Subsidiaries, nor, to the Knowledge knowledge of the Company, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of the Company or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is a party to, mandated by 21 U.S.C. § 335a(a) or bound by, any order, individual integrity agreement, corporate integrity agreement similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other formal jurisdictions in which material quantities of any of the Company Products are sold or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
intended by the Company to be sold; and (jii) Neither neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Companyits Subsidiaries, nor, to the Knowledge knowledge of the Company, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of the Company: (i) Company or any of its Subsidiaries, has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 19351935 or any similar Applicable Law or program.
(f) Except as has not had and would not reasonably be expected to have, codified at Title 42individually or in the aggregate, Chapter 7a Company Material Adverse Effect, as to each Company Product subject to the FDCA and the regulations of the United States Code (FDA promulgated thereunder or any similar Applicable Law in any foreign jurisdiction in which material quantities of any of the “Social Security Act”); (iii) Company Products are sold or intended by the Company or any of its Subsidiaries to be sold that is currently listed or has been developed, manufactured, tested, distributed or marketed by or on behalf of the General Services Administration published list Company or any of parties excluded from federal procurement programs its Subsidiaries, each such Company Product is being or has been developed, manufactured, stored, distributed and non-procurement programs; (iv) marketed in compliance with all Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the Knowledge knowledge of the Company, is threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Company Product by the target Company or subject any of its Subsidiaries of any current investigation by a Governmental Authority relating Applicable Law, except as has not had and would not reasonably be expected to any Federal Health Care Program-related offense; have, individually or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableaggregate, a Company Material Adverse Effect.
(lg) To Except as has not had and would not reasonably be expected to have, individually or in the Knowledge aggregate, a Company Material Adverse Effect, (i) during the period beginning on January 1, 2019 and ending on the date of this Agreement, neither the Company nor any of its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Company Product and (ii) to the knowledge of the Company, there are no pending or threatened filings against neither the Company nor any of an action relating its Subsidiaries has received, any written notice from the FDA or any other Company Regulatory Agency during the period beginning on January 1, 2019 and ending on the date of this Agreement regarding (A) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by the Company or its Subsidiaries (other than recalls, withdrawals or replacements that are not material to the Company under and its Subsidiaries, taken as a whole), (B) a material change in the marketing classification or a material change in the labeling of any federal such Company Products, (C) a termination or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge suspension of the Companymanufacturing, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”)marketing, or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department distribution of Health and Human Services Office of Civil Rights relating to any such violationsCompany Products, or any comparable state or local Laws. The (D) a material negative change in reimbursement status of a Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsProduct.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 3 contracts
Samples: Merger Agreement (Astrazeneca PLC), Merger Agreement (Alexion Pharmaceuticals, Inc.), Merger Agreement (Alexion Pharmaceuticals, Inc.)
Regulatory Matters. (a) The Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect or that, individually or in the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of the Company has to perform its obligations under this Agreement or to consummate the Mergers, (i) each of Parent and its Subsidiaries holds (A) all Permits required by authorizations under the FDCA, the PHSA, and the regulations of the FDA to conduct promulgated thereunder, and (B) authorizations of any applicable Governmental Authority that are concerned with the Business quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Parent Products (any such Governmental Authority, a “Parent Regulatory Agency”) necessary for the lawful operation of the businesses of Parent or any of its Subsidiaries as currently conducted (the “FDA Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent and its Subsidiaries are in compliance with the terms of all Parent Regulatory Permits. All of the FDA Parent Regulatory Permits held by or issued to the Company are in full force and effect, except where the Company is failure to be in compliance in all material respects withfull force and effect (A) has not had, and is would not reasonably be expected to have, individually or in default the aggregate, a Parent Material Adverse Effect or (B) individually or in any material respect 30 the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of Parent to perform its obligations under this Agreement or to consummate the Mergers (and to in the Knowledge case of this clause (B), as of the Company, no event which with the giving date of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Neither Parent nor any of its Subsidiaries are party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any Parent Regulatory Agency that have had or would reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) All pre-clinical and clinical investigations in respect of a Parent Product conducted or sponsored by Parent or any of its Subsidiaries are being, and since January 1, 2019 have been, conducted in compliance with all Applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(d) Except as set forth has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, during the period beginning on Section 4.13(b) January 1, 2019 and ending on the date of this Agreement, neither Parent nor any of its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of the Company Disclosure ScheduleParent Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Parent Regulatory Permits or of any application for marketing approval currently pending before the FDA or such other Parent Regulatory Agency.
(e) Since January 1, 2019, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, since January 1, 20072019, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(ci) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, neither Parent nor any of its Collaborative Partners, agents or subcontractors Subsidiaries has been debarred or convicted of any crime or engaged in any conduct for which has resulted debarment is mandated by 21 U.S.C. § 335a(a) any similar Applicable Law or could result in debarment or disqualification authorized by the FDA 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other Governmental Authority, and there are no proceedings pending or, to the Knowledge jurisdictions in which material quantities of any of the Company, threatened that reasonably might Parent Products are sold or intended by Parent to be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, sold; and (ii) neither Parent nor any of its Collaborative Partners Subsidiaries has committed been excluded from participation in any act, made federal health care program or convicted of any statement crime or failed to make engaged in any statement that would conduct for which such Person could reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated be excluded from participating in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target 1935 or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; similar Applicable Law or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableprogram.
(lf) To Except as has not had and would not reasonably be expected to have, individually or in the Knowledge aggregate, a Parent Material Adverse Effect, as to each Parent Product subject to the FDCA and the regulations of the Company, there are no pending FDA promulgated thereunder or threatened filings against the Company any similar Applicable Law in any foreign jurisdiction in which material quantities of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the CompanyParent Products are sold that is or has been developed, the Company is not under investigation manufactured, tested, distributed or marketed by any Governmental Authority for a violation or on behalf of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, Parent or any comparable state of its Subsidiaries, each such Parent Product is being or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been developed, manufactured, stored, distributed and marketed in compliance in all material respects with federal and state data breach LawsApplicable Law.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 3 contracts
Samples: Merger Agreement (Astrazeneca PLC), Merger Agreement (Alexion Pharmaceuticals, Inc.), Merger Agreement (Alexion Pharmaceuticals, Inc.)
Regulatory Matters. (a) The Each of the Company has all and the Company Subsidiaries holds, and is operating in material compliance with, such Company Permits of the United States Food and Drug Administration (“FDA”) or any other applicable U.S. or foreign drug regulatory authority (collectively with the FDA, “Regulatory Authorities”) required by for the FDA to conduct the Business of its business as currently conducted (collectively, the “FDA Regulatory Permits”). All Each of the FDA Permits held by or issued Company and the Company Subsidiaries has fulfilled and performed all of its material obligations with respect to the Regulatory Permits, and no event has occurred which would allow, with or without notice or lapse of time, revocation or termination thereof or would result in any other material impairment of the rights of the holder of any Regulatory Permit, except where the failure to so fulfill or perform, or the occurrence of such event, would not have a Company are in full force and effect, Material Adverse Effect. Except to the extent disclosed on Section 3.28(a) of the Company Disclosure Schedule, each of the Company and the Company Subsidiaries has operated and currently is in compliance in all material respects with, with applicable statutes and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice implementing regulations administered or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated enforced by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and or any other Regulatory Authority, except where the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued failure to the so comply would not have a Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingMaterial Adverse Effect.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since Since January 1, 20072005, there has not been any voluntarily all of Company’s and the Company Subsidiaries’ Pharmaceutical Products that are subject to the jurisdiction of the FDA or involuntarily initiatedother Regulatory Authorities in other jurisdictions are being manufactured, conductedimported, or issued recallexported, market withdrawalprocessed, safety alertdeveloped, warninglabeled, “dear doctor” letterstored, market correctiontested, or investigator notice relating marketed, promoted, detailed and distributed by or, to an alleged material lack the knowledge of safety or efficacy of any product the Company, on behalf of the Company or product candidate of the Company.
(c) The Company is Subsidiaries in compliance in all material respects with all applicable Laws requirements under any Regulatory Permit or Laws, including applicable statutes and any other letters, notices implementing regulations administered or guidances issued enforced by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products other Regulatory Authority, including those relating to investigational use, premarket approval and applications or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, abbreviated applications to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to market a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionnew Pharmaceutical Product. Since January 1, 2007 there have been no written notices2005, reportsall material applications, warning letterssubmissions, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to information and data utilized by the Company or the products Company’s Subsidiaries as the basis for, or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered submitted by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge knowledge of the Company, on behalf of the Company by or the Company’s Subsidiaries in connection with, any of its Collaborative Partners, are beingand all requests for a Regulatory Permit relating to the Company or any Company Subsidiary, and at all times have beenits respective business and Pharmaceutical Products, conducted in compliance when submitted to the FDA or other Regulatory Authority, were true and correct in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Regulatory Authority.
(c) Since January 1, 2005, all preclinical studies and clinical trials, and other studies and tests conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary have been, and if still pending are being, conducted in material compliance with all applicable Laws, including, as applicablebut not limited to, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 5858 and 312. Except to the extent disclosed on Section 3.28(c) of the Company Disclosure Schedule, 312 and 812since January 1, and comparable Laws of any other Governmental Authority. No 2005, no clinical trial conducted by the Company or, to the Knowledge knowledge of the Company, on behalf of the Company or any Company Subsidiary has been terminated or suspended prior to completion for safety or non- compliance other non-business reasons, and neither the FDA nor any other Governmental applicable Regulatory Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over or participated in any such over, a clinical trial conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary has initiatedcommenced, or, to the Knowledge knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trialinvestigation conducted by or, to the knowledge of the Company, on behalf of the Company or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialCompany Subsidiary.
(id) Neither Except as set forth in Section 3.28(d) of the Company Disclosure Schedule, since January 1, 2005, neither the Company nor any officerCompany Subsidiary has had any Pharmaceutical Product or manufacturing site (whether Company-owned or that of a contract manufacturer for Pharmaceutical Products) subject to a Regulatory Authority (including FDA) shutdown or import or export prohibition, directornor received any FDA Form 483 or other Regulatory Authority written notice of material inspectional observations, managing employee “warning letters,” “untitled letters” or written requests to make material changes, in each case as it applies to the Pharmaceutical Products or any of the Company’s manufacturing processes or procedures that if not complied with would have a Company Material Adverse Effect.
(as those terms are defined in 42 C.F.R. § 1001.1001e) To the knowledge of the Company, norSection 3.28(e) of the Company Disclosure Schedule sets forth a list of all recalls, field notifications, market withdrawals or replacements, written warnings, “dear doctor” letters, investigator notices, safety alerts, post-approval “serious adverse event” reports or other material written notice of action relating to an alleged lack of safety or regulatory compliance of the Pharmaceutical Products issued by the Company and/or any Company Subsidiary since January 1, 2005 (“Safety Notices”). To the Company’s knowledge, and except as disclosed in any item reference in Section 3.28(e) of the Company Disclosure Schedule, there are no facts that would be reasonably likely to result in (A) a material Safety Notice with respect to the Pharmaceutical Products, or (B) a material change in the labeling of any of the Pharmaceutical Products.
(f) Since January 1, 2005, all manufacturing operations conducted by or, to the Knowledge knowledge of the Company, for the benefit of the Company or any Company Subsidiary have been conducted in material compliance with applicable Laws, including the provisions of the FDA’s current good manufacturing practice regulations at 21 C.F.R. Parts 210-211 for Pharmaceutical Products sold in the United States, and the respective counterparts thereof promulgated by Regulatory Authorities in countries outside the United States, except where the failure to so comply would not have a Company Material Adverse Effect.
(g) Since January 1, 2005, neither the Company, nor any Company Subsidiary, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, or similar policies, set forth in any applicable Laws. Since January 1, 2005, none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any agent of their respective officers or key employees has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under applicable Law, including, without limitation, 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment are pending, and the Company has not received written notice that any such claims, actions, proceedings or investigations are threatened against the Company, the Company Subsidiaries, or any of their respective officers or key employees.
(as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)h) Each of the Company is a party toand the Company Subsidiaries, and to the knowledge of the Company its respective directors, officers, employees, and agents (while acting in such capacity) is, and at all times has been, in material compliance with all health care Laws applicable to the Company or bound byany Company Subsidiary or by which any or their respective properties, any orderbusinesses, individual integrity agreement, corporate integrity agreement products or other formal assets is bound or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officeraffected, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, norincluding, to the Knowledge of extent applicable, the Companyfederal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), any agent the Anti-Inducement Law (as such term is defined in 42 C.F.R. U.S.C. § 1001.1001(a)(1)(ii1320a-7a(a)(5)) of ), the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. §§ 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 19951996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic exclusion laws (42 U.S.C. § 1320a-7), the Food Drug and Clinical Health Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Medicare Program (Title XVIII of the Social Security Act), the Medicaid Program (Title XIX of the Social Security Act), the regulations promulgated pursuant to such Laws, requirements of the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, requirements of Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) state pharmaceutical assistance programs and regulations under such Laws (collectively, “HIPAAHealth Care Laws”). Since January 1, 2005, none of the Company or any Company Subsidiary has received any written notification, correspondence or any other written or communication from any Governmental Authority, including, without limitation, the regulations contained in 45 C.F.R. Parts 160 FDA, the Centers for Medicare and 164Medicaid Services, including receiving any notices from and the United States Department of Health and Human Services Office of Civil Rights relating to any such violationsInspector General, of potential or actual material non-compliance by, or liability of, the Company or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Subsidiary, under any Health Care Laws.
(ni) To the extent None of the Company provides reimbursement coding or billing advice regarding products offered for sale any Company Subsidiary is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or other similar written agreements, in each case, entered into with or imposed by the Company and procedures related theretoany Regulatory Authority, other than any such advice is and agreement, decree or order that has been true and complete previously disclosed in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsany Other Filing.
Appears in 2 contracts
Samples: Merger Agreement (Imclone Systems Inc), Merger Agreement (Lilly Eli & Co)
Regulatory Matters. (a) The Company has all Except as would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect and except with respect to Permits required by under applicable Environmental Laws (which are addressed exclusively in Section 7.20), (i) Utah and the Utah Subsidiaries have obtained all of the Permits necessary under applicable Laws for Utah and the Utah Subsidiaries to own, lease and operate their assets in the manner in which they are now owned, leased and operated and to conduct their businesses as now conducted, including (A) all authorizations and approvals under the FDCA (including Sections 505, 510(k) and 515 thereof), the PHSA and the regulations of the FDA to conduct promulgated thereunder and (B) authorizations of any applicable Governmental Authority that are concerned with the Business quality, identity, strength, purity, safety, efficacy, testing, manufacturing, marketing, distribution, sale, storage, pricing, import or export of the Utah Products (any such Governmental Authority, a “Utah Regulatory Agency”), in each case necessary for the lawful operation of the businesses of Utah and its Subsidiaries in each jurisdiction in which such Person operates (the “FDA Utah Regulatory Permits”). All of the FDA ; (ii) all such Utah Regulatory Permits held by or issued to the Company are valid and in full force and effect, the Company ; and (iii) Utah is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving terms of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company all Utah Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingPermits.
(b) Except as would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect, the businesses of each of Utah and each Utah Subsidiary are being conducted in compliance with, and such Persons have appropriate internal controls that are reasonably designed to ensure compliance with, all applicable Laws, including (i) the FDCA (including all applicable registration and listing requirements set forth on Section 4.13(b) in Sections 505 and 510 of the Company Disclosure ScheduleFDCA and 21 C.F.R. Parts 207 and 807); (ii) the PHSA; (iii) the Prescription Drug Marketing Act, since as amended; (iv) federal Medicare and Medicaid statutes and related state or local statutes; (v) the Patient Protection and Affordable Care Act, as amended (including the Biologics Price Competition and Innovation Act); (vi) the Veterans Health Care Act; (vii) the Physician Payments Sunshine Act; (viii) the Federal Trade Commission Act, as applicable; (ix) provincial formulary and drug pricing statutes; (x) any comparable foreign Laws for any of the foregoing; (xi) the federal Anti-Kickback Statute, as amended (42 U.S.C. § 1320a-7(b)), Xxxxx Law (42 U.S.C. §1395nn), False Claims Act, as amended (42 U.S.C. § 1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, state prescription drug marketing laws, and any comparable federal, state, provincial or local Laws; (xii) state or provincial licensing, disclosure and reporting requirements; (xiii) Laws with respect to the protection of personally identifiable information collected or maintained by or on behalf of Utah or the Utah Subsidiaries; (xiv) all applicable Laws analogous to the foregoing in states and all other jurisdictions in which Utah or any Utah Subsidiary operates or sells or distributes a Utah Product or Utah Product candidate; and (xv) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Utah Healthcare Laws”). Since January 1, 20072017, there neither Utah nor any Utah Subsidiary has not been received any voluntarily written notification or involuntarily initiatedcommunication from any Utah Regulatory Agency, conductedincluding the FDA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services or any other “notified body” or corresponding Governmental Authority in any jurisdiction, of noncompliance by, or issued recallliability of Utah or any Utah Subsidiaries under, market withdrawalany Utah Healthcare Laws, safety alertexcept where such noncompliance or liability would not reasonably be expected to have, warningindividually or in the aggregate, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companya Utah Material Adverse Effect.
(c) The Company Neither Utah nor any of the Utah Subsidiaries is in compliance in all material respects subject to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements or consent decrees with all applicable Laws and or imposed by any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending orUtah Regulatory Agency and, to the Knowledge knowledge of Utah, (i) the Company, threatened regulatory Actions imposition of any such agreement or decree is not currently pending and (other than non-material routine ii) no Utah Entity has received written notice that the imposition of any such agreement or periodic inspections decree is currently contemplated or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Companyproposed.
(d) The manufacture Except, in each case, for such matters that would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect, all pre-clinical and clinical investigations conducted or sponsored by each of Utah and the products of the Company is Utah Subsidiaries are being conducted in compliance with all applicable Utah Healthcare Laws, including (i) FDA standards for conducting non-clinical laboratory studies contained in all material respects with current “Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for good manufacturing practices,” clinical practice requirements (GCPs) and clinical study submissions, including as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in Title 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts parts 50, 54, 56, 58312, 312 314, 320, 812 and 812814 of the Code of Federal Regulations, (iii) 42 U.S.C. 282(j), (iv) any comparable foreign Laws for any of the foregoing or other Laws regulating the conduct of pre-clinical and comparable clinical investigations and (v) federal, state and provincial Laws restricting the collection, use and disclosure of any other Governmental Authorityindividually identifiable health information and personal information. No Except, in each case, for such matters that would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect, since January 1, 2017: (i) no clinical trial conducted by the Company or, to the Knowledge of the Company, or on behalf of the Company Utah or any Utah Subsidiary has been terminated terminated, materially delayed or suspended prior to completion for safety or non- compliance reasons, completion; and (ii) neither the FDA nor any other applicable Governmental Authority, clinical investigator Authority or institutional review board that has or has had jurisdiction over or participated in any such a clinical trial conducted by or on behalf of Utah or any Utah Subsidiary has initiatedcommenced, or, to the Knowledge knowledge of the CompanyUtah, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such proposed or ongoing clinical trial, investigation conducted or proposed to disqualify, restrict be conducted by or debar on behalf of Utah or any clinical investigator or other person or entity involved in any such clinical trialUtah Subsidiary.
(ie) Neither the Company Since January 1, 2017, neither Utah nor any officerUtah Subsidiary has received any written notice from the FDA (including any inspection reports on Form 483, directorFDA warning letters or FDA untitled letters) or the EMA or any other Utah Regulatory Agency with jurisdiction over the development, managing employee marketing, labelling, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, suspension or revocation of any application or grant for marketing approval or clearance with respect to any Utah Product currently pending before or previously approved or cleared by the FDA, the EMA or such other Utah Regulatory Agency, except, in each case, for such matters that would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect.
(as those terms are defined f) Since January 1, 2017, all reports, documents, claims, permits, adverse event reports, notices and biological license, device or drug applications required to be filed, maintained or furnished to the FDA or any other Utah Regulatory Agency by Utah and the Utah Subsidiaries have been so filed, maintained or furnished in 42 C.F.R. § 1001.1001) of a timely manner, except where failure to file, maintain or furnish such reports, documents, claims, permits, notices or applications would not reasonably be expected to have, individually or in the Companyaggregate, a Utah Material Adverse Effect. All such reports, documents, claims, permits, notices and applications were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Neither Utah nor any Utah Subsidiary, nor, to the Knowledge knowledge of the CompanyUtah, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of Utah or any Utah Subsidiary, has made an untrue statement of a material fact or a fraudulent statement to the Company is FDA or any other Utah Regulatory Agency, failed to disclose a party tomaterial fact required to be disclosed to the FDA or any other Utah Regulatory Agency, or bound bycommitted an act, made a statement, or failed to make a statement, in each such case, related to the business of Utah and its Subsidiaries, that, at the time of such disclosure, act or failure, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with Utah Regulatory Agency to invoke any Governmental Authority concerning compliance with Federal Health Care Program Lawssimilar policy.
(jg) Neither the Company Utah nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyUtah Subsidiary, nor, to the Knowledge knowledge of the CompanyUtah, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of the Company: Utah or any Utah Subsidiary, has been (i) disqualified, suspended or debarred for any purpose, or received written notice of action or threat of action with respect to debarment under the provisions of 21 U.S.C. § 335a or any equivalent provisions in any other jurisdiction; (ii) excluded under 42 U.S.C. Section 1320a-7 or otherwise from participation in the Medicare program, any state Medicaid program or any other federal healthcare program; or (iii) formally charged with or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law, except in each case as would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect. Neither Utah nor any Utah Subsidiary, nor, to the knowledge of Utah, any officer, employee, agent or distributor of Utah or any Utah Subsidiary, has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; similar Law or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableprogram.
(lh) As to each Utah Product or Utah Product candidate subject to the FDCA, the PHSA, the regulations of the FDA promulgated thereunder or similar Law in any foreign jurisdiction that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Utah or any of the Utah Subsidiaries, except as would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect, each such Utah Product or Utah Product candidate is being or has been developed, manufactured, tested, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labelling, advertising, storing, promotion, import/export, distribution, provision of samples (PDMA), record keeping, reporting and security. There is no investigation, action or proceeding pending or, to the knowledge of Utah, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation of any Law applicable to any Utah Product or Utah Product candidate by Utah or any of the Utah Subsidiaries, except as would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect.
(i) Since January 1, 2017, no Utah Entity has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall or any field corrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Utah Product, in each case which has not been publicly disclosed by the applicable Utah Regulatory Agency, or is currently considering initiating, conducting or issuing any recall of any Utah Product, in each case except as would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect. To the Knowledge knowledge of the CompanyUtah, there are no pending facts which would reasonably be expected to cause, and no Utah Entity has received since January 1, 2017 any written notice from the FDA or threatened filings against any other Utah Regulatory Agency regarding, (i) the Company recall, market withdrawal or replacement of an action relating any Utah Product sold or intended to be sold by Utah or the Company under Utah Subsidiaries, (ii) a change in the marketing classification or a material change in the labelling of any federal such Utah Products, (iii) a termination, enjoinment or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge suspension of the Companymanufacturing, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”)marketing, or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department distribution of Health and Human Services Office of Civil Rights relating to any such violationsUtah Products, or any comparable state (iv) a negative change in reimbursement status of a Utah Product, that in each case, would reasonably be expected to have, individually or local Laws. The Company is not in the aggregate, a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsUtah Material Adverse Effect.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Business Combination Agreement (Mylan N.V.), Business Combination Agreement (Pfizer Inc)
Regulatory Matters. (a) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and its Subsidiaries holds (A) all Permits required by authorizations and certifications applicable to its activities, products and functions, including, where applicable, those under the FDCA, the PHSA, and the regulations and requirements of the FDA to conduct promulgated thereunder, including good laboratory, clinical, and manufacturing practices regulations, as well as ISO certifications and standards for healthcare and related data including ISO31000, ISO14155, ISO13485, ISO9001 and ISO 27001, and (B) authorizations of any applicable Governmental Authority that are concerned with the Business quality, functionality, identity, strength, purity, safety, efficacy, manufacturing, testing, processing, research, packaging, labelling, storage, transport, marketing, distribution, sale, pricing, import or export of any of the Parent Drug Product Candidates (any such Governmental Authority, an “Parent Regulatory Agency”), necessary for the lawful activities and operations of the businesses of Parent or any of its Subsidiaries as currently conducted or as previously conducted during the period beginning on the Reference Date and ending on the date of this Agreement (collectively all such authorizations in (A) and (B) are referred hereafter as, the “FDA Parent Regulatory Permits”). All of the FDA ; (ii) all such Parent Regulatory Permits held by or issued to the Company are in each case valid and in full force and effect, effect (subject to the Company is Bankruptcy and Equity Exceptions to the extent applicable thereto); and (iii) Parent and its Subsidiaries are in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving terms of notice or lapse of time, or both, would become a default under), each all such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Parent Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingPermits.
(b) Except as set forth on Section 4.13(b) As of the Company Disclosure Scheduledate hereof, since January 1neither Parent nor any of its Subsidiaries (i) are party to any material corporate integrity agreements, 2007monitoring agreements, there consent decrees, settlement orders, reduced or special licensing measures, warnings notices, enhanced monitoring or audits, deficiency notices or similar agreements, notices or measures with or imposed by any Parent Regulatory Agency or (ii) has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy knowledge (including as a result of any product of communication from the Company FDA) that a material Parent Regulatory Permit or product candidate of the Companyapplication for a material Parent Regulatory Permit is invalid or will be or has been suspended, rejected, cancelled, terminated or granted in a scope narrower than applied for.
(c) The Company is All pre-clinical and clinical investigations in respect of a Parent Drug Product Candidate conducted or sponsored by Parent or any of its Subsidiaries are being, and since the Reference Date have been, conducted in compliance in all material respects with all applicable Applicable Laws and any other letters, notices administered or guidances issued by the applicable Parent Regulatory Agencies, including (i) standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials promogulated by the FDA, and as contained in Title 21 parts 50, 54, 56, 310, 312, 314, 320, and 600 of the Code of Federal Regulations, applicable research protocols, institutional review board or other ethics committee requirements, and federal and state legal requirements, and (ii) any Applicable Laws governing, relating to, or restricting the collection, processing, use and disclosure of individually identifiable information, health information, human biological samples and genetic information, and personal information, except, in each case, for such noncompliance that has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Neither Parent nor any of its Subsidiaries has received any written notices, correspondence, or other communication from the FDA or any other similar Governmental Authority which regulates or any ethics committee recommending or requiring the sale of pharmaceutical products or biologicaltermination, device or regenerative medicine products in any jurisdiction. There are no pending orsuspension, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredientclinical hold, or material used in manufacturing the products modification of any ongoing or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning lettersplanned clinical trials conducted by, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Companyon behalf of, Parent.
(d) The manufacture Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, during the period beginning on the Reference Date and ending on the date of this Agreement, neither Parent nor any of its Subsidiaries has received any written notice from the FDA or any foreign agency with jurisdiction over the design, development, testing, marketing, labeling, sale, use handling and control, functionality, safety, efficacy, reliability, distribution, storage, transport, packaging, processing, or manufacturing of Parent Drug Product Candidates that would reasonably be expected to lead to the denial, suspension, limitation, revocation, or rescission of any of the products Parent Regulatory Permits or of any self-certification or application for marketing approval currently pending before the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820FDA or such other Parent Regulatory Agency.
(e) The Company is Except as has not had and has been would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, Parent and its respective directors, officers, employees and, to the knowledge of Parent, its other agents (while acting in such capacity) are, and since the Reference Date have been, in compliance in all material respects with all Applicable Laws requiring relating to controlled substances or the maintenance manufacturing, testing, processing, supplying, distributing, transporting, labeling, packaging, dispensing, using, reporting, storing, disposing, importing, exporting, controlling, wholesaling, brokering or submission trading of reports controlled substances, including the federal Controlled Substances Act (21 U.S.C. §§ 801 et seq.), and the regulations promulgated pursuant thereto, and any other similar local, state, or records foreign laws, including all necessary registration, recordkeeping, reporting, security and storage requirements. Since the Reference Date to the date hereof, Parent has not received any correspondence or any other written communication from any Governmental Authority, including the Drug Enforcement Administration and local, state or foreign regulatory and law enforcement authorities, of potential or actual non-compliance by, or liability of, Parent under requirements administered by any Applicable Law relating to controlled substances.
(f) Since the Reference Date, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Governmental AuthorityParent Regulatory Agency by Parent and its Subsidiaries have been so filed, includingmaintained or furnished, for avoidance except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were true, accurate and complete in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since the Reference Date, neither Parent nor any of doubtits Subsidiaries, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company ornor, to the Knowledge knowledge of the CompanyParent, any officer, employee, agent or contractor of Parent or any of its Collaborative PartnersSubsidiaries, agents has made an untrue statement of a material fact or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by a fraudulent statement to the FDA or any other Governmental AuthorityParent Regulatory Agency, and there are no proceedings pending or, failed to the Knowledge of the Company, threatened that reasonably might disclose a material fact required to be expected disclosed to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company orParent Regulatory Agency, to the Knowledge of the Company, any of its Collaborative Partners has or committed any an act, made any statement a statement, or failed to make a statement, in each such case, related to the business of Parent or any statement that of its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority Parent Regulatory Agency to invoke any similar policy.
, except for any act or statement or failure to make a statement that has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, since the Reference Date, (gi) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by neither Parent nor any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanySubsidiaries, nor, to the Knowledge knowledge of the CompanyParent, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined agent or contractor of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in 42 C.F.R. any conduct for which debarment is mandated by 21 U.S.C. § 1001.1001335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which any of the CompanyParent Drug Product Candidates are tested, manufactured, marketed, distributed, or sold or where Parent has publicly announced an intention to sell an Parent Drug Product Candidate; and (ii) neither Parent nor any of its Subsidiaries, nor, to the Knowledge knowledge of the CompanyParent, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or contractor of the Company: (i) Parent or any of its Subsidiaries, has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against itfederal health care program or convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program, him health or her buying procurement program, pricing or reimbursement scheme under Section 1128A 1128 of the Social Security Act of 19351935 or any similar program, codified at Title 42including any conduct that would constitute non-compliance with the Federal Anti-Kickback Statute, Chapter 7Federal False Claims Act, or their respective state equivalents.
(g) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, as to each Parent Drug Product Candidate subject to the FDCA and the regulations of the United States Code FDA promulgated thereunder or any similar Applicable Law in any applicable jurisdiction, each such Parent Drug Product Candidate is being or has been designed, developed, manufactured, stored, distributed and marketed in compliance with all Applicable Laws, including those relating to investigational use, marketing approval, current good clinical practices and good manufacturing practices, packaging, functionality, labeling and product claims, advertising, record keeping, reporting, and security. There are no Proceedings pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Platform or Parent Drug Product Candidate by Parent or any of its Subsidiaries of any Applicable Law, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(h) Except as has not had and would not reasonably be expected to have, individually or in the “Social Security Act”); aggregate, a Parent Material Adverse Effect, (iiii) is currently listed during the period beginning on the General Services Administration published list Reference Date and ending on the date of parties excluded from federal procurement programs this Agreement, neither Parent nor any of its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market suspension, withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, functionality, efficacy or regulatory compliance of any Parent Drug Product Candidate and non-procurement programs; (ivii) to the Knowledge knowledge of Parent, neither Parent nor any of its Subsidiaries has received, any written notice from the FDA or any other Parent Regulatory Agency during the period beginning on the Reference Date and ending on the date of this Agreement regarding (A) the recall, market withdrawal or replacement of any Parent Drug Product Candidate (other than recalls, withdrawals or replacements that are not material to Parent and its Subsidiaries, taken as a whole), (B) a material change in the marketing classification or a material change in the labeling of any such Parent Drug Product Candidates, (C) a termination or suspension of the Companymanufacturing, is the target marketing, testing, or subject distribution of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; such Parent Drug Product Candidates, or (vD) is currently charged with or convicted of any criminal offense relating to the delivery a material negative change in reimbursement status of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableParent Drug Product Candidate.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Transaction Agreement (Exscientia PLC), Transaction Agreement (Recursion Pharmaceuticals, Inc.)
Regulatory Matters. (a) The Company has all Permits required All existing Registrations held by the FDA to conduct the Business (the “FDA Permits”). All Seller as of the FDA Permits held by or issued to the Company date of this Agreement are set forth in Schedule 1.1(k) and are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company Seller is the sole and exclusive owner of the FDA Registrations. To the Knowledge of Seller, the Applicable Permits and included in the associated filings and applications with Purchased Assets constitute all of the FDApermits, including approvals, licenses, franchises or authorizations from any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or applicable Governmental Authority held by Seller, that are used exclusively for the Product or issued to the Company (collectively, Business in the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingTerritory.
(b) To Seller's Knowledge, the Distribution of the Product by Seller in the Territory has been conducted in material compliance with the Registrations and all applicable Laws, including the Act and the PDMA.
(c) Seller has not received any written notice or, to Seller's Knowledge, other notice of proceedings from any applicable Governmental Authority alleging that the Product or any of the Purchased Assets or the ownership, Manufacturing or Distribution is in violation of any applicable Law during the period between June 7, 2002 and the Execution Date, or at any time prior to the Execution Date to the extent still active or pending, including (i) any FDA Form 483's with respect to the Product that would have a Material Adverse Effect; (ii) any FDA Notices of Adverse Findings with respect to the Product; or (iii) any warning letters from the FDA or any other applicable Governmental Authority with respect to the Product.
(d) Except as set forth could not have a Material Adverse Effect on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007Business, there has not been any voluntarily or involuntarily initiated, conducted, or issued occurrence of any product recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, withdrawal or investigator notice relating to an alleged material lack lot replacement conducted by or on behalf of safety or efficacy of any product of Seller concerning the Company or product candidate of Product in the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company United States or any product candidate recall, market withdrawal or lot replacement conducted by or on behalf of any entity as a result of any alleged defect in the Company.
(d) Product in the United States during the period between [***] and the Execution Date, or at any time prior to the Execution Date to the extent still active or pending. The manufacture Product is approved for commercialization in the United States pursuant to 21 CFR 314 subpart H. To Seller's Knowledge, Seller has made available to Purchaser every complaint and notice of alleged defect or adverse reaction with respect to the products of Product in the Company is being conducted Territory that has been received in compliance in all material respects with current “good manufacturing practices,” as defined writing by Seller and its Affiliates or that has been orally transmitted to and recorded by Seller and its Affiliates, other than the FDA, including, as applicable, the FDA’s “Quality System Regulation” litigation set forth in 21 C.F.R. Part 820on Schedule 4.6.
(e) The Company NDA included in the Purchased Assets is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by only regulatory approval necessary from the FDA or any other Governmental Authority, including, for avoidance Seller to Distribute the Product and conduct the Business as conducted as of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsthe Execution Date.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents Seller has completed and filed all annual or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification other reports required by the FDA or any other Governmental Authorityin order to maintain the Registrations, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis except for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policymost recent filing not yet due.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trialsSchedule 4.10(g) of the products Seller Disclosure Schedule sets forth a complete list of the Company all post-marketing commitments as may be necessary or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company required by any of its Collaborative Partners, are being, applicable Governmental Authority to maintain the NDA and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense Registrations relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableProduct.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Asset Purchase and Sale Agreement (Prometheus Laboratories Inc), Asset Purchase and Sale Agreement (Prometheus Laboratories Inc)
Regulatory Matters. (a) (i) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All businesses of the FDA Permits held by or issued to the Company Borrowers have been and are in full force and effect, the Company is being conducted in compliance in all material respects withwith all applicable Law, including the Healthcare Laws, and is not in default in all Permits, (ii) each Product (whether manufactured by Accuray or any material respect 30 of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under (and contract to the Knowledge Accuray or any of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permitits Subsidiaries) has been, and none of such Permits will be terminated or impaired or become terminablecurrently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications compliance with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filingsapplicable Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and Document Controls under 21 CFR 820.40 and all Product specifications as established in company documentation, except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Credit Parties (other than immaterial consequences), (iii) each contract between Accuray and any of its Subsidiaries on the Know-How contained one hand, and any third party manufacturer on the other hand contain (and Accuray and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements, (iv) Accuray and its Subsidiaries are in compliance in all material respects with applicable Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (v) neither Accuray nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that Accuray, any such Subsidiary or any such Product was not in compliance in any of the Company Regulatory Filings material respect with any applicable Law or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingPermit.
(b) Except as set forth on Section 4.13(b) Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to Accuray or any of its Subsidiary is pending or, to the knowledge of the Company Disclosure ScheduleCredit Parties, since January 1threatened. None of Accuray or any of its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, 2007, there has not been any voluntarily or involuntarily initiated, conductedproblems, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, concerns regarding the quality or investigator notice relating to an alleged material lack of safety or efficacy of any product performance of the Company or product candidate of the CompanyProducts.
(c) The Company Accuray and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, and (ii) to carry on the business of Accuray and each of its Subsidiaries. All such Permits are valid and in full force and effect and Accuray and each Subsidiary is in compliance in all material respects with all applicable Laws terms and conditions of such Permits. None of Accuray or any other letters, notices or guidances issued by the FDA or Subsidiary has received any written notice from any Governmental Authority which regulates that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply testing and/or manufacturing of such Product should cease or other collaboration arrangement with that such Product should be withdrawn from the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Companymarketplace.
(d) The manufacture There have been no adverse clinical test results which have or could reasonably be expected to have a materially adverse impact on Accuray or any of the products of the Company is being conducted its Subsidiaries, and there have been no Product recalls or voluntary Product withdrawals from any market (other than specific and discrete batches or lots not made in compliance in all material respects conjunction with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820a larger recall).
(e) The Company is Neither Accuray nor any of its Subsidiaries have experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Accuray or any of its Subsidiaries in accordance with all specifications thereof and the required payments related thereto in any twelve (12) month period have decreased by more than twenty percent (20%) with respect to the quantities of such Product produced in the prior twelve (12) month period.
(f) There has been no material untrue statement of fact and no fraudulent statement made by Accuray or any of its Subsidiaries or any of their respective agents or representatives to the FDA, NRC, or any other Governmental Authority, and there has been no failure to disclose any material fact required to be disclosed to the FDA, NRC or any other Governmental Authority.
(g) To the best knowledge of the Credit Parties, no insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and treatments performed using the CyberKnife and TomoTherapy Products, or (ii) reduced the scope of coverage or the rate of reimbursement it provides for procedures and treatments performed using the CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to have a materially adverse impact on the revenues of Accuray and its Subsidiaries. None of Accuray or any of its Subsidiaries has been the subject of any “for cause” inspection, investigation or audit by any Governmental Authority in connection with any alleged improper activity.
(h) There is no arrangement relating to Accuray or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All xxxxxxxx by Accuray and each of its Subsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all Laws requiring applicable Law, including the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsHealthcare Laws.
(fi) None of the Company Accuray or any of its Subsidiaries, or, to the Knowledge knowledge of the CompanyCredit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Collaborative PartnersSubsidiaries has been convicted of, agents charged with or, to the knowledge of the Credit Parties, investigated for any federal or subcontractors state health program-related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Credit Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of Accuray or any of its Subsidiaries or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of any crime or engaged in any conduct which including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or could would reasonably be expected to result in a debarment or disqualification by exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Law. No debarment proceedings or investigations in respect of the FDA business of Accuray or any other Governmental Authority, and there of its Subsidiaries are no proceedings pending or, to the Knowledge knowledge of the CompanyCredit Parties, threatened that reasonably might be expected to result in criminal against Accuray or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed Subsidiaries or any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any individual who is an officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) or manager of the Company, nor, to the Knowledge Accuray or any of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Lawsits Subsidiaries.
(j) Neither the Company nor any officerAll studies, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs tests and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense preclinical and clinical trials conducted relating to the delivery Products, sponsored by Accuray or any of its Subsidiaries have been conducted, and are currently being conducted, in all material respects in accordance with all applicable Law and IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the extent required by applicable Law, Accuray and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an item IDE for the conduct of any clinical investigations conducted by or service under any Federal Health Care Programon behalf of Accuray or such Subsidiary, as applicable.
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge knowledge of the CompanyCredit Parties, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge none of the Companyclinical investigators in any clinical trial sponsored by Accuray or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violationsServices, or any comparable state Governmental Authority and, to the knowledge of the Credit Parties, no such disqualification, or local Lawsother sanction of any such clinical investigator is pending or threatened. The Company is not a “covered entity” as that term is defined None of Accuray or any of its Subsidiaries has received from the FDA or other applicable Governmental Authority any notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects connection with the payment requirements of Medicare and other Federal Health Care Program LawsProducts.
Appears in 2 contracts
Samples: Credit and Security Agreement (Accuray Inc), Credit and Security Agreement (Accuray Inc)
Regulatory Matters. (a) The Company has all Permits required by To the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effectCompany’s knowledge, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is its subsidiaries are in compliance in all material respects with all applicable Laws statutes, rules and regulations of the U.S. Food and Drug Administration and similar federal, state or local Governmental Entities (collectively, the “FDA”) and similar foreign Governmental Entities (“Foreign Authorities”) with respect to the sale, labeling, storing, testing, development, manufacture, packaging, distribution, or marketing of the products being distributed or developed by or on behalf of the Company and its subsidiaries. The Company has previously made available to Parent true and complete copies of all applications, approvals, clearances, registrations or licenses obtained by the Company or any of its subsidiaries from the FDA or Foreign Authorities, or required in connection with the conduct of the business of the Company and its subsidiaries as currently conducted and has made all such information available to Parent.
(b) The Company has made available to Parent true and correct copies of all material written communications, and material oral communications to the extent reduced to written form, between the Company and its subsidiaries, on the one hand, and the FDA or Foreign Authorities, on the other lettershand, notices in each case since January 1, 2002, with respect to the products being distributed or guidances issued developed by or on behalf of the Company and its subsidiaries (collectively, the “Regulatory Correspondence”). The Company shall promptly deliver to Parent copies of all Regulatory Correspondence received or reduced to written form from the date hereof through the Closing. Neither the Company nor any of its subsidiaries is in receipt of written notice of, or, to the Company’s knowledge, is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, compelled or voluntary recall, investigation, penalty for corrective or remedial action or other compliance or enforcement action, in each case relating to any products being distributed or developed by or on behalf of the Company or any of its subsidiaries or to the facilities in which any such products are manufactured, collected or handled, by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of Foreign Authorities.
(c) To the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company’s knowledge, there are no pending or threatened regulatory Actions (other than non-material routine actions, proceedings or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) enforcement actions by the FDA or Foreign Authorities which would prohibit or materially adversely impact the conduct of the business of the Company and its subsidiaries as currently conducted.
(d) Neither the Company nor any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in its subsidiaries has made any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning lettersmaterial false statements on, or untitled letters alleging omissions from, the applications, approvals, reports and other submissions to the FDA or asserting noncompliance in any material respect Foreign Authorities prepared or maintained to comply with any applicable Law the requirements of the FDA or Foreign Authorities relating to the Company Company, its subsidiaries or the products any product being distributed or product candidates developed by or on behalf of the Company or any subpoenas of its subsidiaries.
(e) Neither the Company nor any of its subsidiaries has received any notification, written or investigative demands oral, that remains unresolved, from FDA or other written inquiries Foreign Authorities indicating that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of its subsidiaries is misbranded or adulterated as defined in the CompanyU.S. Food, Drug & Cosmetic Act, 21 U.S.C. § 321, et seq., as amended, and the rules and regulations promulgated thereunder, or has violated in any similar respect the laws, rules or regulations of any Foreign Authority.
(df) The manufacture of the products No product of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and or any of its subsidiaries has been in compliance in all material respects with all Laws requiring recalled or withdrawn from the maintenance or submission market as a result of reports or records under requirements administered any action by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of Foreign Authority against the Company or any of its subsidiaries or, to the Knowledge Company’s knowledge, any licensee, distributor or marketer of any product of the Company, Company or any of its Collaborative Partnerssubsidiaries, agents whether in the United States or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of elsewhere.
(g) To the Company’s knowledge, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of neither the Company or, to the Knowledge of the Company, nor any of its Collaborative Partners subsidiaries has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) amendments thereto. None of the products Company, its subsidiaries and, to the Company’s knowledge, any manager, officer, employee or agent of the Company or product candidates any of the Company its subsidiaries has been convicted of any crime or engaged in any conduct that have not been reported would reasonably be expected to the FDA result in accordance with applicable Law(i) debarment under 21 U.S.C. § 335a or any similar Legal Requirement or (ii) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf The FDA complaint handling system of the Company and its subsidiaries has been made available for review by Parent and contains complete and correct information about all product defect claims and all products returned to the Company or any of its Collaborative Partnerssubsidiaries because of warranty or other problems. The records of the Company and its subsidiaries relating to credits and allowances made with respect to any product have been made available to Parent and, to the Company’s knowledge, are being, true and at all times have been, conducted in compliance correct in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authorityrespects. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of its subsidiaries maintains any records of warranty or other product defect claims other than the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws’s FDA complaint handling system.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Agreement and Plan of Reorganization (Hemosense Inc), Agreement and Plan of Reorganization (Inverness Medical Innovations Inc)
Regulatory Matters. (a) The Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company has Material Adverse Effect, (i) each of the Company and its Subsidiaries holds (A) all Permits required by authorizations under the FDA to conduct the Business United States Food, Drug and Cosmetic Act of 1938, as amended (the “FDA FDCA”), the Public Health Service Act, as amended (the “PHSA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, and (B) authorizations of any applicable Governmental Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Company Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company and each of its Subsidiaries as currently conducted (the “Company Regulatory Permits”); (ii) all such Company Regulatory Permits are valid and in full force and effect; and (iii) the Company and its Subsidiaries are in compliance with the terms of all Company Regulatory Permits. All of the FDA Company Regulatory Permits held by or issued to the Company are in full force and effect, except where the failure to be in full force and effect has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) Neither the Company is nor any of its Subsidiaries are party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Company Regulatory Agency.
(c) All pre-clinical and clinical investigations in respect of a Company Product or Company Product candidate conducted or sponsored by the Company or any of its Subsidiaries are being and, since January 1, 2017 have been, conducted in compliance with all Applicable Laws administered or issued by the applicable Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in all material respects withTitle 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, and is (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that has not had and would not reasonably be expected to have, individually or in default the aggregate, a Company Material Adverse Effect.
(d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, during the period beginning on January 1, 2017 and ending on the date hereof, neither the Company nor any material respect 30 under of its Subsidiaries has received any written notice from the FDA or the European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of the Company Products which would reasonably be expected to lead to the Knowledge of the Companydenial, no event which with the giving of notice or lapse of timelimitation, revocation, or both, would become a default under), each such Permit, and none rescission of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, Permits or of any of application for marketing approval currently pending before the Know-How contained in any of the FDA or such other Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingAgency.
(be) Except as set forth During the period beginning on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 20072017 and ending on the date hereof, there has not been all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of other Company Regulatory Agency by the Company and its Subsidiaries have been so filed, maintained or product candidate of furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the Company.
(c) The aggregate, a Company is in compliance Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete in all material respects with all applicable Laws and any other letters, notices on the date filed (or guidances issued were corrected in or supplemented by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionsubsequent filing). Since January 1, 2007 there have been no written notices2017, reportsneither the Company nor any of its Subsidiaries, warning lettersnor, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company knowledge of the Company, any officer, employee, agent or the products or product candidates distributor of the Company or any subpoenas of its Subsidiaries, has made an untrue statement of a material fact or investigative demands a fraudulent statement to the FDA or any other written inquiries that would reasonably Company Regulatory Agency, failed to disclose a material fact required to be interpreted as raising disclosed to the FDA or any other Company Regulatory Agency, or committed an act, made a compliance concern sent statement, or delivered by any Governmental Authority with regard failed to any product make a statement, in each such case, related to the business of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative PartnersSubsidiaries, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by that, at the FDA or any other Governmental Authoritytime such disclosure was made, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Company Regulatory Agency to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries except for any act or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company statement or product candidates of the Company that have not been reported failure to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board make a statement that has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Except as has not had jurisdiction over and would not reasonably be expected to have, individually or participated in any such clinical trial has initiatedthe aggregate, ora Company Material Adverse Effect, to the Knowledge of the Companysince January 1, threatened to initiate2017, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Companyits Subsidiaries, nor, to the Knowledge knowledge of the Company, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of the Company or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is a party to, mandated by 21 U.S.C. § 335a(a) or bound by, any order, individual integrity agreement, corporate integrity agreement similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other formal jurisdictions in which material quantities of any of the Company Products or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
Company Product candidates are sold or intended by the Company to be sold; and (jii) Neither neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Companyits Subsidiaries, nor, to the Knowledge knowledge of the Company, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of the Company: (i) Company or any of its Subsidiaries, has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7or any similar Applicable Law or program.
(f) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, as to each Company Product or Company Product candidate subject to the FDCA and the regulations of the United States Code (FDA promulgated thereunder or any similar Applicable Law in any foreign jurisdiction in which material quantities of any of the “Social Security Act”); (iii) Company Products or Company Product candidates are sold or intended by the Company or any of its Subsidiaries to be sold that is currently listed or has been developed, manufactured, tested, distributed or marketed by or on behalf of the General Services Administration published list Company or any of parties excluded from federal procurement programs its Subsidiaries, each such Company Product or Company Product candidate is being or has been developed, manufactured, stored, distributed and non-procurement programs; (iv) marketed in compliance with all Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the Knowledge knowledge of the Company, is threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Company Product or Company Product candidate by the target Company or subject any of its Subsidiaries of any current investigation by a Governmental Authority relating Applicable Law, except as has not had and would not reasonably be expected to any Federal Health Care Program-related offense; have, individually or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableaggregate, a Company Material Adverse Effect.
(lg) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, during the period beginning on January 1, 2017 and ending on the date hereof, neither the Company nor any of its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Company Product. To the Knowledge knowledge of the Company, there are no pending or threatened filings against facts as of the date hereof which are reasonably likely to cause, and neither the Company nor any of an action relating its Subsidiaries has received any written notice from the FDA or any other Company Regulatory Agency during the period beginning on January 1, 2017 and ending on the date hereof regarding, (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by the Company or its Subsidiaries (other than recalls, withdrawals or replacements that are not material to the Company under and its Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any federal such Company Products, (iii) a termination or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge suspension of the Companymanufacturing, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”)marketing, or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department distribution of Health and Human Services Office of Civil Rights relating to any such violationsCompany Products, or any comparable state or local Laws. The (iv) a material negative change in reimbursement status of a Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsProduct.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Bristol Myers Squibb Co), Merger Agreement (Celgene Corp /De/)
Regulatory Matters. (a) The Neither the Company nor any of its Affiliates nor any predecessor thereof has all Permits required by received any oral or written communication (including any Warning Letter, Courtesy Letter, untitled letter conveying adverse inspectional observations, Form 483 or similar notices) from any Governmental Authority, including but not limited to the FDA to conduct or FTC, or from any counterpart regulatory authorities in the Business (European Union, or any other country, regarding the “FDA Permits”). All of Company’s currently marketed products, or regarding claims that are currently being made for the FDA Permits held by or issued to the Company are in full force and effectCompany’s currently marketed products, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the CompanyCompany and its Affiliates, there is no event which with the giving of notice action or lapse of time, proceeding pending or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any of its Subsidiaries or Affiliates is not currently in compliance with any and all applicable Laws implemented by the FDA or FTC, or any counterpart regulatory exclusivities) associated with each such authorities in the European Union or any other country, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Regulatory FilingMaterial Adverse Effect. There are no pending voluntary or involuntary market withdrawals, field corrective actions (including recalls), destruction orders, seizures or other regulatory enforcement actions related to any product that have had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) Except as set forth on Section 4.13(b) The Company has, prior to the execution of this Agreement, made available to Parent copies of any and all documents in its or its Subsidiaries’ possession that are material to assessing the Company Disclosure ScheduleCompany’s or any of its Subsidiaries’ material compliance with the Federal Food, since January 1Drug, 2007and Cosmetic Act, there has not been any voluntarily or involuntarily initiated, conductedFederal Trade Commission Act, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, the International Standards Organization and their respective implementing regulations or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) other similar regulations in any applicable jurisdiction. The Company is and its Subsidiaries are in compliance in all material respects with all applicable Laws requirements of the Federal Food, Drug, and any other lettersCosmetic Act and the Federal Trade Commission Act and the regulations promulgated thereunder (collectively, notices or guidances issued the “FDA Requirements”).
(c) To the extent currently required, all manufacturing, including testing, by the FDA Company and its Subsidiaries have been conducted in all material respects in compliance with applicable good manufacturing practices, and good laboratory practices as set forth by the FDA.
(d) The Company and its Subsidiaries have not filed any biologics license applications, new drug applications, medical device premarket notifications or applications and neither the Company nor its Subsidiaries market any biologic, drug or medical device products. None of the Company, any of its Subsidiaries or any Governmental Authority which regulates the sale of pharmaceutical products their respective officers or biological, device or regenerative medicine products in any jurisdiction. There are no pending employees or, to the Knowledge of the Company, threatened regulatory Actions (other than non-agents has made an untrue statement of a material routine or periodic inspections or reviews) against the Company, and fact to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates Office of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product Inspector General of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services or failed to disclose a material fact required to be disclosed to the FDA, FTC or the Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsthe Inspector General.
(ne) To the extent Company’s Knowledge, as of the Company provides reimbursement coding date hereof, there are no facts or billing advice regarding products offered for sale by circumstances that would render unlikely the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in Company’s compliance in all material respects with the payment requirements of Medicare Dietary Supplement and other Federal Health Care Program LawsNonprescription Drug Consumer Protection Act (due to be effective on December 22, 2007), in the form in which that Act currently exists, or the regulations for Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (21 C.F.R. Part 111), as to which compliance is required by June 25, 2009.
Appears in 2 contracts
Samples: Merger Agreement (Plethico Pharmaceuticals Ltd.), Merger Agreement (Nutra Acquisition CO Inc.)
Regulatory Matters. (ai) The Each of the Company and its Subsidiaries has all Permits required by the FDA Licenses necessary to conduct its business as presently conducted, including all such Licenses of the Business United States Food and Drug Administration (the “FDA PermitsFDA”). All of the FDA Permits held by ) or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under other applicable U.S. or foreign drug regulatory authority (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications collectively with the FDA, including any biologics license application, new drug application, 510(kthe “Regulatory Authorities”) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued necessary to the Company conduct its business as presently conducted (collectively, the “Regulatory Licenses”), except those Licenses the absence of which, individually or in the aggregate with other such absences, would not reasonably be expected to have a Company Regulatory Filings”) Material Adverse Effect and holds all rightwould not reasonably be expected to prevent, title and interest in and to all Company Regulatory Filings free and clear materially delay or materially impair the consummation of the transactions contemplated hereby. There has not occurred any revocation or termination of any Encumbrance (other than Permitted Encumbrances). The Company has not granted Regulatory License, or any third party any right or license to use, access or reference any material impairment of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate its Subsidiaries under any Regulatory License, except for any such revocation, termination or impairment that, individually or in the aggregate with other such revocations, terminations and impairments, would not reasonably be expected to have a Company Material Adverse Effect. Each of the Company.
(c) The Company is and its Subsidiaries has operated in compliance in all material respects with all applicable Laws and any other letters, notices administered or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered enforced by the FDA or any other Governmental Regulatory Authority, includingexcept where the failure so to comply, for avoidance of doubtindividually or in the aggregate with other such failures, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would not reasonably be expected to provide have a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Company Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policyAdverse Effect.
(gii) There have been no Serious Adverse EventsSince January 1, Serious Injuries or MDR Reportable Events associated with the use (including in 2009, all preclinical studies and clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical other studies and clinical research being tests conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries have been and, if still pending, are being conducted in compliance with all applicable Laws (including those pertaining to Good Laboratory Practice and Good Clinical Practice contained in 21 C.F.R. Part 58 and Part 312 and all applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54 and 56), except for noncompliances that, individually or in the aggregate with other such noncompliances, would not reasonably be expected to have a Company Material Adverse Effect. Since January 1, 2009, except for such exceptions that, individually or in the aggregate with other such exceptions, would not reasonably be expected to have a Company Material Adverse Effect, no clinical trial conducted by or, to the knowledge of the executive officers of the Company, on behalf of the Company or its Subsidiaries has been terminated or suspended prior to completion for safety or non- compliance other non-business reasons, and neither the FDA nor any other Governmental applicable Regulatory Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over or participated in any such over, a clinical trial conducted by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries has initiatedcommenced, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trialinvestigation conducted by or, to the Knowledge of the Company, on behalf of the Company or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialits Subsidiaries.
(iiii) Neither Since January 1, 2009, (A) neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, its Subsidiaries nor, to the Knowledge of the Company, any agent (as of their officers, directors, employees or agents has been convicted of any crime or engaged in any conduct that in any such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party tocase has resulted, or bound byis reasonably likely to result, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
in debarment under 21 U.S.C. Section 335a and (jB) Neither neither the Company nor any officer, director, managing of its Subsidiaries has hired any employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, norunder debarment or used a vendor that, to the Knowledge of the Company, employed any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her person under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; debarment.
(iv) The Company has made available to the Knowledge Parent complete and correct copies of each Investigational New Drug Application, each similar state or foreign regulatory filing made on behalf of the CompanyCompany or its Subsidiaries, is including all related supplements, amendments and annual reports, and all correspondence between the target or subject Company and any of its Affiliates on one hand and any current investigation by a Governmental Regulatory Authority relating to any Federal Health Care Program-related offense; or on the other hand.
(v) is currently charged with or convicted of any criminal offense relating Since January 1, 2009 to the delivery date of an item this Agreement, each medicinal or service under any Federal Health Care Program
(k) The Company reasonably believes pharmaceutical product that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related theretoresearched, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.developed, manufactured, labeled, supplied, promoted, co-promoted, co-developed, co-marketed,
Appears in 2 contracts
Samples: Merger Agreement (Shire PLC), Merger Agreement (Dyax Corp)
Regulatory Matters. (a) The Company has and each of its Subsidiaries are, and since January 1, 2020 have been, in compliance in all Permits required respects with all applicable Laws, including the FDCA and any other similar Laws administered or promulgated by the FDA or other comparable Governmental Entity, except for any noncompliance, either individually or in the aggregate, which would not be material to the Company. To the Company’s Knowledge, no investigation, inspection, claim, suit, proceeding, audit or other action by any Governmental Entity is pending or threatened against the Company or any of its Subsidiaries.
(b) There is no agreement, judgment, injunction, order or decree binding upon the Company or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company or any of its Subsidiaries, any acquisition of material property by the Company or any of its Subsidiaries or the conduct of business by the Business Company or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(c) The Company and its Subsidiaries have at all times since January 1, 2020 held and have operated in compliance with all Governmental Authorizations that are necessary for the conduct of business of the Company and its Subsidiaries as currently being conducted (the “FDA Company Permits”), except where such failures to hold or remain so in compliance would not, either individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. All of the FDA such Company Permits held by or issued to the Company are valid and are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and will continue to the Knowledge be so upon consummation of the CompanyContemplated Transactions, no event which with except as would not, either individually or in the giving of notice or lapse of timeaggregate, reasonably be expected to have a Company Material Adverse Effect. No notice, filing, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, other Consent is required as a result of the transaction contemplated by this AgreementContemplated Transactions under any material Company Permit. Section 3.16(c) of the Company Disclosure Schedule identifies each Company Permit. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds its Subsidiaries hold all right, title and interest in and to all the Company Regulatory Filings Permits free and clear of any Encumbrance (other than Permitted Encumbrances)Lien. All fees and charges with respect to such Company Permits, as of the date hereof, have been paid in full and all filing, reporting and maintenance obligations have been completely and timely satisfied, except as would not, either individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company has not granted any third party any right or license to use, access or reference any and each of its Subsidiaries are in material compliance with the terms of the Company Regulatory FilingsPermits. To the Company’s Knowledge, includingno Legal Proceeding is pending or threatened, without limitationwhich seeks to revoke, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedulelimit, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conductedsuspend, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of materially modify any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyPermit.
(d) The manufacture To the Company’s Knowledge, there are no proceedings pending or threatened with respect to an alleged material violation by the Company or any of its Subsidiaries of the products FDCA or any other similar Law administered or promulgated by any comparable Governmental Entity. Neither the Company, any of its Subsidiaries nor to the Company’s Knowledge, any Person providing services to the Company is being conducted in compliance in all material respects or any of its Subsidiaries with respect to the Company’s current products or product candidates (the “good manufacturing practices,” as defined by the FDACompany Products”) has received any written notice, includingincluding any warning letter, as applicableuntitled letter, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance FDA Form-483, written notice of other adverse finding, or submission notice of reports deficiency or records under requirements administered by violation, or similar written communication from the FDA or any other Governmental AuthorityEntity alleging that the Company or its Subsidiaries, includingtheir respective operations, for avoidance or the Company Products are in material violation of doubtany applicable Law or Company Permit.
(e) As required under applicable Law or pursuant to a Governmental Authorization, records the Company and reports relating its Subsidiaries have maintained, filed, or furnished to product corrections the applicable Governmental Entities or Person all filings, documents, claims, reports, notices, and removals other submissions (including FDA requirements set forth in 21 C.F.R. Part 806the “Reports”), MDRs (including FDA requirements set forth required to be maintained, filed, or furnished on a timely basis, and, at the time of maintenance, filing, or furnishing all such Reports were complete and accurate when submitted, or were subsequently updated, changed, corrected, or modified, except where the failures to so maintain, file, furnish, update, change, correct or modify would not, either individually or in 21 C.F.R. Part 803)the aggregate, reasonably be expected to have a Company Material Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsEffect.
(f) None of the Company or, to the Knowledge of Neither the Company, its Subsidiaries, nor to the Company’s Knowledge, any Person providing services to the Company or its Subsidiaries has made an untrue statement of its Collaborative Partners, agents a material fact or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by fraudulent statement to the FDA or any other a Governmental AuthorityEntity, and there are no proceedings pending or, failed to the Knowledge of the Company, threatened that reasonably might disclose a material fact required to be expected disclosed to result in criminal or civil liability or debarment or disqualification by the FDA or any other a Governmental Authority. None of the Company orEntity, to the Knowledge of the Companyor made a statement, any of its Collaborative Partners has committed any act, made any statement or failed to make any a statement that that, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the “FDA Ethics Policy”). Neither the Company, its Subsidiaries, nor to the Company’s Knowledge, any Person providing services to the Company or its Subsidiaries has ever been investigated by the FDA or other Governmental Entity for data or healthcare program fraud. Neither the Company, its Subsidiaries, nor to the Company’s Knowledge, any Person providing services to the Company or its Subsidiaries is the subject of any pending or, to the Company’s Knowledge, threatened investigation pursuant to the FDA Ethics Policy, or resulting from any other Governmental Authority to invoke any similar policyuntrue or false statement or omission.
(g) There have been no Serious Adverse EventsNeither the Company, Serious Injuries or MDR Reportable Events associated with its Subsidiaries, nor, to the use (including in clinical trials) of the products of Company’s Knowledge, any Person providing services to the Company or product candidates its Subsidiaries, nor their respective officers, directors, partners, employees, or agents have been:
(i) debarred or suspended pursuant to 21 U.S.C. § 335a;
(ii) excluded under 42 U.S.C. § 1320a-7 or any similar law, rule or regulation of any Governmental Entity;
(iii) excluded, debarred, suspended or deemed ineligible to participate in federal procurement and non-procurement programs, including those produced by the Company U.S. General Services Administration;
(iv) charged, named in a complaint, convicted, or otherwise found liable in any Legal Proceeding that have not been reported to falls within the FDA in accordance with ambit of 21 U.S.C. § 331, 21 U.S.C. § 333, 21 U.S.C. § 334, 21 U.S.C. § 300x, 00 X.X.X. § 000x, 00 X.X.X. § 0000x - 7, 31 U.S.C. §§ 3729 – 3733, 42 U.S.C. § 1320a-7a, or any other applicable Law;
(v) disqualified or deemed ineligible pursuant to 21 C.F.R. Parts 312, 511, or 812, or otherwise restricted, in whole or in part, or subject to an assurance; or
(vi) had a pending Legal Proceeding, or otherwise received any written notice from any Governmental Entity or any Person threatening, investigating, or pursuing (i)-(v) above.
(h) To the Knowledge of the CompanyAll clinical, all studies, tests, pre-clinical and preclinical other studies and clinical research being tests conducted by the Company, and to the Knowledge of the Company, or on behalf of of, or sponsored by, the Company by or any of its Collaborative PartnersSubsidiaries, or in which the Company or any of its Subsidiaries or the Company Products have participated were and, if still pending, are being, and at all times have been, being conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice Laws and regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized enforced by the FDAFDA or any comparable Governmental Entity, including the ICH Tripartite Guideline for Good Clinical Practicewithout limitation, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 58 and 812, and comparable Laws of any other Governmental Authority312. No clinical trial conducted by the Company or, to the Knowledge of To the Company’s Knowledge, on behalf there are no other studies, the results of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order onwhich are inconsistent with, or otherwise terminatecall into question, materially delay or suspend, the results of any such ongoing clinical trialstudies or tests conducted by or on behalf of, or sponsored by, the Company or any of its Subsidiaries, or in which the Company or any of its Subsidiaries or the Company Products. The Company has not received written notice of any complaints, information, or adverse drug experience reports related to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical triala Company Product that would reasonably be expected to have a Company Material Adverse Effect.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, norits Subsidiaries, nor to the Knowledge of the CompanyParent’s Knowledge, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating Person providing services to the Company under or its Subsidiaries has received any federal written notice, correspondence, or state whistleblower statuteother written communications from the FDA, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Companyany other Governmental Entity, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act Institutional Review Board (“HIPAAIRB”), or other Person or board responsible for the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving oversight or conduct of any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violationsstudy conducted by or on behalf of, or sponsored by, the Company or any comparable state of its Subsidiaries, or local Lawsin which the Company or any of the Company Products are participating, requiring or threatening the termination, hold, material adverse modification or suspension of any clinical study that is being or is proposed to be conducted. The All clinical studies conducted or sponsored by or on behalf of the Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance were and, if still pending, are being conducted in all material respects in accordance with federal all applicable Laws, the protocols, procedures and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered controls designed and approved for sale by the Company and procedures related theretosuch studies, such advice is and has been true and complete in all material respects and in compliance in all material respects accordance with the payment requirements any requirement of Medicare and an IRB or other Federal Health Care Program LawsPerson or board responsible for review of such studies.
Appears in 2 contracts
Samples: Merger Agreement (Advaxis, Inc.), Merger Agreement (Advaxis, Inc.)
Regulatory Matters. (a) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds all Parent Permits required by and clearances, including (x) all permits, licenses, franchises, approvals, registrations, authorizations and clearances under the FDCA, the PHSA, and the regulations of the FDA to conduct promulgated thereunder and (y) authorizations of any applicable Governmental Entity that are concerned with the Business quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries (the “FDA Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits. All of the FDA Parent Regulatory Permits held by or issued to the Company are in full force and effect, except where the Company is failure to be in compliance in all material respects withfull force and effect would not reasonably be expected to have, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole individually or in partthe aggregate, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingParent Material Adverse Effect.
(b) Except as set forth on Section 4.13(bwould not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) provincial formulary and drug pricing statutes; (v) any comparable foreign Laws for any of the Company Disclosure Scheduleforegoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by Parent to be sold; (vi) federal, since state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Xxxxx Law (42 U.S.C. §1395nn), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et. seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local healthcare Laws); (vii) state or provincial licensing, disclosure and reporting requirements; and (viii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare Laws”). Since January 1, 20072011, there neither Parent nor any of the Parent Subsidiaries has not been received any voluntarily written notification or involuntarily initiatedcommunication from any Parent Regulatory Agency, conductedincluding the FDA, the Drug Enforcement Administration, the United Stated States Department of Justice (including any United States Attorney’s Office), the Office of Inspector General of the Department of Health and Human Services, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services, of noncompliance by, or issued recallliability of Parent or the Parent Subsidiaries under, market withdrawalany Parent Healthcare Laws, safety alertexcept where such noncompliance or liability would not reasonably be expected to have, warningindividually or in the aggregate, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companya Parent Material Adverse Effect.
(c) The Company is Parent and the Parent Subsidiaries are not party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries, not to include investigator initiated studies, are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 58, 312, 314, 320, and 812 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs or medical devices which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2011, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects with all applicable Laws and any other letters, notices on the date filed (or guidances issued were corrected in or supplemented by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionsubsequent filing). Since January 1, 2007 there have been no written notices2011, reportsneither Parent nor any of the Parent Subsidiaries, warning lettersnor, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company knowledge of Parent, any officer, employee, agent or the products distributor of Parent or product candidates any of the Company Parent Subsidiaries, has made an untrue statement of a material fact or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard fraudulent statement to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental AuthorityParent Regulatory Agency, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by be disclosed to the FDA or any other Governmental AuthorityParent Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make a statement, in each such case, related to the business of Parent or any statement that of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Parent Regulatory Agency to invoke any similar policy.
(g) There , except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have been no Serious a Parent Material Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) Effect. Neither Parent nor any of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyParent Subsidiaries, nor, to the Knowledge knowledge of the CompanyParent, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) agent or distributor of Parent or any of the CompanyParent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the Knowledge knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the CompanyParent Subsidiaries, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; similar Parent Healthcare Law or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableprogram.
(lg) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product, other than notices or actions that are not material to Parent or the Parent Subsidiaries, taken as a whole. To the Knowledge knowledge of the CompanyParent, there are no pending facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or threatened filings against any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material adverse change in the labeling of an action relating to any such Parent Products, (iii) a termination or suspension of the Company under any federal manufacturing, marketing, or state whistleblower statutedistribution of such Parent Products, including under the False Claims Act or (iv) a material negative change in reimbursement status of 1863 (31 U.S.C. § 3729 et seq.)a Parent Product.
(mi) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations Notwithstanding anything contained in 45 C.F.R. Parts 160 and 164this Section 4.13, including receiving any notices from the United States Department no representation or warranty shall be deemed to be made in this Section 4.13 in respect of Health and Human Services Office of Civil Rights relating to any such violationsenvironmental, Tax, employee benefits or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawslabor Law matters.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Mallinckrodt PLC), Merger Agreement (Questcor Pharmaceuticals Inc)
Regulatory Matters. (ai) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, an Actavis Material Adverse Effect, (i) each of Actavis and the Actavis Subsidiaries holds all Actavis Permits required by and Clearances, including (x) all authorizations under the FDCA, the PHSA, and the regulations of the FDA to conduct promulgated thereunder, and (y) authorizations of any applicable Relevant Authority that are concerned with the Business quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of the Actavis Products (any such Relevant Authority, a “Actavis Regulatory Agency”) necessary for the lawful operating of the businesses of Actavis or any of the Actavis Subsidiaries (the “FDA Actavis Regulatory Permits”); (ii) all such Actavis Regulatory Permits are valid and in full force and effect; and (iii) Actavis is in compliance with the terms of all Actavis Regulatory Permits. All of the FDA Actavis Regulatory Permits held by or issued to the Company are in full force and effect, except where the Company is failure to be in full force and effect would not reasonably be expected to have, individually or in the aggregate, an Actavis Material Adverse Effect.
(ii) Except as would not, individually or in the aggregate, reasonably be expected to have an Actavis Material Adverse Effect, the businesses of each of Actavis and the Actavis Subsidiaries are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes; (iv) provincial formulary and drug pricing statutes; (v) any comparable foreign Laws for any of the foregoing; (vi) federal, state or provincial criminal or civil Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), Stark Law (42 U.S.C. §1395nn), False Claims Act (42 U.S.C. §1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et. seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local Laws); (vii) state or provincial licensing, disclosure and reporting requirements; and (viii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Actavis Healthcare Laws”). Since January 1, 2011, neither Actavis nor any of the Actavis Subsidiaries has received any written notification or communication from any Actavis Regulatory Agency, including without limitation the FDA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services, of noncompliance by, or liability of Actavis or the Actavis Subsidiaries under, any Actavis Healthcare Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, an Actavis Material Adverse Effect.
(iii) Actavis and the Actavis Subsidiaries are not party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Actavis Regulatory Agency.
(iv) All pre-clinical and clinical investigations conducted or sponsored by each of Actavis and the Actavis Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Warner Chilcott Regulatory Agencies, including without limitation (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (iii) federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have an Actavis Material Adverse Effect.
(v) Since January 1, 2011, neither Actavis nor any of the Actavis Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the marketing, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial of any application for marketing approval currently pending before the FDA or such other Actavis Regulatory Agency.
(vi) Since January 1, 2011, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Actavis Regulatory Agency by Actavis and the Actavis Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits and notices would not reasonably be expected to have, individually or in the aggregate, an Actavis Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects with, and is not on the date filed (or were corrected in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become supplemented by a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrancessubsequent filing). The Company has not granted any third party any right or license to use, access or reference Neither Actavis nor any of the Company Regulatory FilingsActavis Subsidiaries, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending ornor, to the Knowledge of the CompanyActavis, threatened regulatory Actions (other than non-material routine any officer, employee, agent or periodic inspections distributor of Actavis or reviews) against the Company, and to the Knowledge any of the CompanyActavis Subsidiaries, there are no pending has made an untrue statement of a material fact or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining a fraudulent statement to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental AuthorityActavis Regulatory Agency, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by be disclosed to the FDA or any other Governmental AuthorityActavis Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make a statement, in each such case, related to the business of Actavis or any statement that of the Actavis Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Actavis Regulatory Agency to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) . Neither Actavis nor any of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyActavis Subsidiaries, nor, to the Knowledge of the CompanyActavis, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) agent or distributor of Actavis or any of the CompanyActavis Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. Neither Actavis nor any of the Actavis Subsidiaries, nor, to the Knowledge of the CompanyActavis, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of Actavis or any of the Company: (i) Actavis Subsidiaries, has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7, or any similar Law or program.
(vii) As to each Actavis Product or Actavis Product candidate subject to the FDCA and the regulations of the United States Code (FDA promulgated thereunder or similar Law in any foreign jurisdiction that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Actavis or any of the “Social Security Act”); (iii) Actavis Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have an Actavis Material Adverse Effect, each such Actavis Product or Actavis Product candidate is currently listed on the General Services Administration published list of parties excluded from federal procurement programs being or has been developed, manufactured, stored, distributed and non-procurement programs; (iv) marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the Knowledge of Actavis, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Actavis Product or Actavis Product candidate by Actavis or any of the Company, is the target or subject Actavis Subsidiaries of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; Law, except as would not, individually or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableaggregate, reasonably be expected to have an Actavis Material Adverse Effect.
(lviii) Since January 1, 2011, each of Actavis and the Actavis Subsidiaries have neither voluntarily nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Actavis Product. To the Knowledge of the CompanyActavis, there are no pending facts which are reasonably likely to cause, and Actavis has not received any written notice from the FDA or threatened filings against any other Actavis Regulatory Agency regarding (i) the Company recall, market withdrawal or replacement of any Warner Chilcott Product sold or intended to be sold by Actavis or the Actavis Subsidiaries, (ii) a change in the marketing classification or a material change in the labeling of any such Actavis Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Actavis Products, or (iv) a negative change in reimbursement status of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.)Actavis Product.
(mix) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”Notwithstanding anything contained in this Clause 6.2(m), no representation or the regulations contained warranty shall be deemed to be made in 45 C.F.R. Parts 160 and 164this Clause 6.2(m) in respect of environmental, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, employee benefits or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawslabour Law matters.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Transaction Agreement (Actavis, Inc.), Transaction Agreement (Warner Chilcott PLC)
Regulatory Matters. Except as would not reasonably be expected to have, individually or in the aggregate, a Seller Material Adverse Effect or be material to the MRT Program, taken as a whole, and in each case solely with respect to the MRT Program:
(a) The Company Seller Parent and each of its Subsidiaries is developing, testing, labeling, packaging, manufacturing, marketing, distributing, and storing, and at all times has all Permits required by developed, tested, labeled, packaged, manufactured, marketed, distributed, and stored the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued product(s) and product candidate(s) relating to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is MRT Program in compliance in all material respects with (i) the FDC Act, (ii) the medicinal products laws of the European Union and applicable implementing regulations and guidelines issued by applicable Governmental Entities in the European Union, including the EMA, and (iii) any other applicable Governmental Entities in any other country where Seller Parent or any of its Subsidiaries has developed, tested, labeled, packaged, manufactured, distributed or stored any such product(s) and product candidate(s). Seller Parent and each of its Subsidiaries has complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) HIPAA and (ii) any applicable privacy Laws with respect to the product(s) and product candidate(s) relating to the MRT Program.
(b) All preclinical studies and other studies and tests of the product(s) and product candidate(s) relating to the MRT Program conducted by or on behalf of the Seller have been, and if still pending are being, conducted in material compliance, to the extent applicable, with good laboratory practices, good clinical practices and all applicable Laws, including the FDC Act and the respective counterparts thereof outside the United States.
(c) All documents filed by Seller Parent or any other letters, notices or guidances issued by of its Subsidiaries with the FDA or any other Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, Entity with respect to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviewsproduct(s) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviewsproduct candidate(s) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company MRT Program, or the products manufacturing, handling, storage or shipment of such product(s) or product candidates candidate(s), were, at the time of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Companyfiling, true, complete and accurate in all material respects.
(d) With respect to the product(s) or product candidate(s) relating to the MRT Program, the Seller has not received any written notice of FDA regulatory actions against Seller Parent or any of its Subsidiaries, including notice of adverse findings, regulatory, untitled or warning letters or mandatory recalls, or any other notice from any governmental entity alleging or asserting material noncompliance with any Law. Neither Seller Parent, its Subsidiaries nor their respective suppliers or contract manufacturers have received an FDA Form 483 or any other written notice from a Governmental Entity of inspectional observations related to or affecting the product(s) and product candidate(s) relating to the MRT Program, which has not been closed out by the FDA or the relevant Governmental Entity.
(e) The manufacture Seller and each of the products Selling Subsidiaries has filed with the FDA and any other applicable Governmental Entity all notices, registration applications, order forms, reports, supplemental applications and annual or other reports or documents, including adverse experience reports, that are required by Law and material to the continued development or handling of the Company product(s) and product candidate(s) relating to the MRT Program.
(f) Neither Seller Parent nor any of its Subsidiaries have received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit or, to the Seller’s Knowledge, investigation from the FDA or any other Governmental Entity alleging that any operation or activity of Seller Parent or any of its Subsidiaries in connection with the MRT Program is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined violation of the FDC Act or the respective counterparts thereof promulgated by applicable state Governmental Entities or Governmental Entities outside the FDAUnited States, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is medicinal products and has been in compliance in all material respects with all medical device Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company European Union. No civil, criminal or administrative action, suit, demand, claim, complaint, hearing, proceeding or, to the Knowledge of Seller’s Knowledge, investigation for which the Company, any of its Collaborative Partners, agents or subcontractors Seller has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings received written notice is pending or, to the Knowledge of the CompanySeller’s Knowledge, threatened against Seller Parent or any of its Subsidiaries in connection with the MRT Program. To the Seller’s Knowledge, there has not been any material violation of any laws by Seller Parent or any of its Subsidiaries in its product development efforts, submissions or reports to any Governmental Entity in connection with the MRT Program that could reasonably might be expected to result in criminal require investigation, corrective action or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, enforcement action.
(g) With respect to the Knowledge of the CompanyMRT Program, (i) neither Seller Parent nor any of its Collaborative Partners has Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority such similar policies set forth in any applicable Laws and (ii) neither the Seller nor, to invoke the Seller’s Knowledge, any similar policy.
(g) There have of its officers, employees or agents, has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment or exclusion under applicable Law, including 21 U.S.C. Section 335a. To the Seller’s Knowledge, no Serious Adverse Eventsclaims, Serious Injuries actions, proceedings or MDR Reportable Events associated investigations with respect to the use (including MRT Program that would reasonably be expected to result in clinical trials) such a material debarment or exclusion of the products Seller or any of the Company Selling Subsidiaries are pending or product candidates threatened against the Seller or any of the Company that have not been reported to the FDA in accordance with applicable LawSelling Subsidiaries or any of their respective officers, employees or agents.
(h) To Neither the Knowledge Seller nor or any of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanySelling Subsidiaries, nor, to the Knowledge Seller’s Knowledge, any officer or employee of the Company, Seller or any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company Selling Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is a party tomandated by 21 U.S.C. § 335a(a) or any similar Laws or authorized by 21 U.S.C. § 335a(b) or any similar Laws with respect to the MRT Program. Neither the Seller nor, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanySelling Subsidiaries, nor, to the Knowledge Seller’s Knowledge, any officer or employee of the Company, Seller or any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) Selling Subsidiaries, has been debarred, excluded convicted of any crime or suspended from participation engaged in any conduct with respect to the MRT Program for which such Person or entity could be excluded from participating in the Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her healthcare programs under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7, or any similar Laws. Neither the Seller nor any of the United States Code (the “Social Security Act”); (iii) Selling Subsidiaries is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with respect to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged MRT Program with or convicted of imposed by any criminal offense relating to the delivery of an item or service under any Federal Health Care ProgramGovernmental Entity.
(ki) The Company reasonably believes that it has the requisite know-how and processes to, Neither Seller Parent nor any of its Subsidiaries is subject to any required regulatory approvalsinvestigation related to any MRT Product or the MRT Program that is pending and of which Seller Parent or any of its Subsidiaries has been notified in writing or, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal Seller’s Knowledge, which has been threatened in writing, in each case by (i) the FDA or state whistleblower statute, including under (ii) the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating Inspector General or Department of Justice pursuant to any such violations, the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b) (known as the “Anti-Kickback Statute”) or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsthe Federal False Claims Act (31 U.S.C. §3729).
(nj) To Notwithstanding anything herein to the extent contrary, the Company provides reimbursement coding or billing advice regarding products offered for sale by representations and warranties set forth in this Section 2.9 are the Company only representations and procedures related thereto, such advice is warranties of the Seller and has been true and complete in all material respects and in compliance in all material respects the Selling Subsidiaries with the payment requirements of Medicare and other Federal Health Care Program Lawsrespect to regulatory matters.
Appears in 2 contracts
Samples: Asset Purchase Agreement (Translate Bio, Inc.), Asset Purchase Agreement (Translate Bio, Inc.)
Regulatory Matters. (a) The Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company has Material Adverse Effect, (i) each of the Company and the Company Subsidiaries holds all Permits required by Company Permits, including (x) all permits, licenses, franchises, approvals, registrations, authorizations and clearances under the FDA to conduct the Business United States Food, Drug and Cosmetic Act of 1938, as amended (the “FDA FDCA”), the Public Health Service Act, as amended (the “PHSA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, and (y) authorizations of any applicable Governmental Entity that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Company Products (any such Governmental Entity, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company or any Company Subsidiary (the “Company Regulatory Permits”); (ii) all such Company Regulatory Permits are valid and in full force and effect; and (iii) the Company is in compliance with the terms of all Company Regulatory Permits. All of the FDA Company Regulatory Permits held by or issued to the Company are in full force and effect, except where the Company is failure to be in compliance in all material respects withfull force and effect would not reasonably be expected to have, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole individually or in partthe aggregate, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingMaterial Adverse Effect.
(b) Except as set forth on Section 4.13(b) would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, the businesses of each of the Company Disclosure Scheduleand each Company Subsidiary are being conducted in compliance with all applicable Laws, since including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) provincial formulary and drug pricing statutes; (v) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Company Products or Company Product candidates are sold or intended by the Company to be sold; (vi) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Xxxxx Law (42 U.S.C. §1395nn), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local Laws); (vii) state or provincial licensing, disclosure and reporting requirements; and (viii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Company Healthcare Laws”). Since January 1, 20072011, there neither the Company nor any Company Subsidiary has not been received any voluntarily written notification or involuntarily initiatedcommunication from any Company Regulatory Agency, conductedincluding the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the Office of Inspector General of the Department of Health and Human Services, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services, of noncompliance by, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, liability of Company or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company Subsidiaries under, any Company Healthcare Laws, except where such noncompliance or product candidate of liability would not reasonably be expected to have, individually or in the Companyaggregate, a Company Material Adverse Effect.
(c) The Company is and the Company Subsidiaries are not party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Company Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Company Product or Company Product candidate conducted or sponsored by each of the Company and the Company Subsidiaries, not to include investigator initiated studies, are being conducted in compliance with all applicable Laws administered or issued by the applicable Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 58, 312, 314 320, and 812 of the Code of Federal Regulations, (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(e) Since January 1, 2011, neither the Company nor any Company Subsidiary has received any written notice from the FDA or the European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs or medical devices which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Company Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Company Regulatory Agency.
(f) Since January 1, 2011, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Company Regulatory Agency by the Company and the Company Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects with all applicable Laws and any other letters, notices on the date filed (or guidances issued were corrected in or supplemented by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionsubsequent filing). Since January 1, 2007 there have been no written notices2011 neither the Company nor any Company Subsidiaries, reportsnor, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company knowledge of the Company, any officer, employee, agent or the products or product candidates distributor of the Company or any subpoenas of the Company Subsidiaries, has made an untrue statement of a material fact or investigative demands a fraudulent statement to the FDA or any other written inquiries that would reasonably Company Regulatory Agency, failed to disclose a material fact required to be interpreted as raising disclosed to the FDA or any other Company Regulatory Agency, or committed an act, made a compliance concern sent statement, or delivered by any Governmental Authority with regard failed to any product make a statement, in each such case, related to the business of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by Subsidiaries, that, at the FDAtime such disclosure was made, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Company Regulatory Agency to invoke any similar policy.
(g) There , except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have been no Serious a Company Material Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental AuthorityEffect. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyCompany Subsidiaries, nor, to the Knowledge knowledge of the Company, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of the Company or any of the Company Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is a party tomandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Company Products or Company Product candidates are sold or intended by the Company to be sold. Since January 1, or bound by2011, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyCompany Subsidiaries, nor, to the Knowledge knowledge of the Company, any officer, employee, agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) or distributor of the Company: (i) Company or any of the Company Subsidiaries, has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7, or any similar Company Healthcare Law or program.
(g) As to each Company Product or Company Product candidate subject to the FDCA and the regulations of the United States Code (FDA promulgated thereunder or any similar applicable Law in any foreign jurisdiction in which material quantities of any of the “Social Security Act”); (iii) Company Products or Company Product candidates are sold or intended by the Company to be sold that is currently listed or has been developed, manufactured, tested, distributed or marketed by or on behalf of the General Services Administration published list Company or any of parties excluded from federal procurement programs the Company Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, each such Company Product or Company Product candidate is being or has been developed, manufactured, stored, distributed and non-procurement programs; (iv) marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the Knowledge knowledge of the Company, is threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Company Product or Company Product candidate by the target Company or subject any of the Company Subsidiaries of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; Law, except as would not, individually or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableaggregate, reasonably be expected to have a Company Material Adverse Effect.
(lh) Since January 1, 2011, neither the Company nor any of the Company Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Company Product, other than notices or actions that are not material to the Company or the Company Subsidiaries, taken as a whole. To the Knowledge knowledge of the Company, there are no pending or threatened filings against facts which are reasonably likely to cause, and the Company has not received any written notice from the FDA or any other Company Regulatory Agency regarding (i) the recall, market withdrawal or replacement of an action relating any Company Product sold or intended to be sold by the Company or a Company Subsidiary (other than recalls, withdrawals or replacements that are not material to the Company under or the Company Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material adverse change in the labeling of any federal such Company Products, (iii) a termination or state whistleblower statutesuspension of the manufacturing, including under the False Claims Act marketing, or distribution of 1863 such Company Products, or (31 U.S.C. § 3729 et seq.)iv) a material negative change in reimbursement status of a Company Product.
(mi) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations Notwithstanding anything contained in 45 C.F.R. Parts 160 and 164this Section 3.13, including receiving any notices from the United States Department no representation or warranty shall be deemed to be made in this Section 3.13 in respect of Health and Human Services Office of Civil Rights relating to any such violationsenvironmental, Tax, employee benefits or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawslabor Law matters.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Questcor Pharmaceuticals Inc), Merger Agreement (Mallinckrodt PLC)
Regulatory Matters. (a) The Since January 1, 1996 through the date hereof (i) there have been no written notices, citations or decisions by any governmental or regulatory body that any product produced, manufactured, marketed or distributed at any time by the Company has all Permits required or any Company subsidiary (the "PARENT PRODUCTS") is defective or fails to meet any applicable standards promulgated by any such governmental or regulatory body, or any other governmental or regulatory body, agency or office of any other jurisdiction to which the Company or any of its subsidiaries is subject, (ii) there have been no recalls, field notifications or seizures ordered or threatened by the FDA or any other comparable governmental or regulatory body with respect to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any Parent Production and (iii) none of the Know30- Parent or the Parent subsidiaries have received any warning letter, Section 305 notices from the FDA or so-How contained in any called Section 483 notices of the Company Regulatory Filings adverse observations (or rights (including any comparable notices from such other governmental or regulatory exclusivities) associated with each such Company Regulatory Filingbodies).
(b) Except as set forth on Section 4.13(bwould not, individually or in the aggregate, have a Parent Material Adverse Effect, with respect to each Parent Product: (i) the Parent and its subsidiaries have obtained all applicable Licenses to permit the manufacturing, distribution, sale (including reimbursement and pricing), marketing, export, import or human research (including clinical and non-clinical trials) of such Product and (ii) Parent and its subsidiaries are in full compliance with all terms and conditions of each License in each country in which such Parent Product is marketed, and with all requirements pertaining to the Company Disclosure Schedulemanufacturing (including current good manufacturing practices), since January 1marketing, 2007export, there has import or human research (including good laboratory practices and clinical and non-clinical trials) of such Parent Product which is not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating required to an alleged material lack be the subject of safety or efficacy of any product of the Company or product candidate of the Companya License.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, impediments to issuance of any Parent FDA premarket approval application ("PMA") as to which Parent has received an approvable letter from the Knowledge of the Company, threatened regulatory Actions (FDA other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” those set forth in 21 C.F.R. Part 820.
(e) The Company any so-called Section 483 Notices described in the Parent Disclosure Schedule, and Parent is and has been in compliance in all material respects with all Laws requiring the maintenance or submission not aware of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating reason why it will be unable to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, address to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, FDA's satisfaction all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations observations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsNotices.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Autonomous Technologies Corp), Merger Agreement (Summit Technology Inc)
Regulatory Matters. (a) The Company Except as would not, individually or in the aggregate, reasonably be expected to be material to the business of the Acquired Companies, taken as a whole: (i) the Acquired Companies own, possess or validly have the right to use all permits required to research, develop, manufacture, market, commercialize, distribute and sell its products; (ii) all products of the Acquired Companies are and, since January 1, 2019, have been researched, developed, manufactured and marketed in accordance with applicable specifications, Permits and applicable Laws, including GMPs, GLPs, GCPs, GDPs and GVPs; (iii) since January 1, 2019, (A) no product of the Acquired Companies or manufacturing site has all Permits required shut down, been subject to any import or export prohibition, received any FDA Form 483 or other Governmental Body notice of inspectional observations, “warning letters,” “untitled letters” or requests or requirements to make changes to any product of the Acquired Companies or any manufacturing operations for any product of the Acquired Companies and (B) there have been no recalls, field notifications, field corrections, warnings, “dear doctor” letters, investigator notices, safety alerts or other written notices of action issued by a Governmental Body or the FDA Acquired Companies relating to conduct an alleged lack of safety, efficacy, or regulatory compliance of any product of the Business Acquired Companies (the collectively, “FDA PermitsSafety Notices”). All of the FDA Permits held by or issued to the Each Acquired Company are in full force and effect, the Company is in compliance has complied in all material respects withwith its obligations to make filings, declarations, listings, registrations, reports or submissions with the applicable regulatory authorities (including the FDA and is the DEA or any other Governmental Body performing functions similar to those performed by the FDA and the DEA) relating to Acquired Company drug products, including but not limited to adverse event reports. Except as would not reasonably be expected, individually or in default in any the aggregate, to be material respect 30 under (and to the Knowledge business of the CompanyAcquired Companies, taken as a whole, no event which written deficiencies have been asserted by any applicable Governmental Body with the giving of notice respect to any such filings, declarations, listing, registrations, reports or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filingsubmissions.
(b) Except as set forth on Section 4.13(b) would not reasonably be expected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a whole, no Acquired Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating (i) made an untrue statement of a material fact statement to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologicalBody, device or regenerative medicine products in any jurisdiction. There are no pending or, (ii) failed to the Knowledge of the Company, threatened regulatory Actions (other than non-disclose a material routine or periodic inspections or reviews) against the Company, and fact required to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining be disclosed to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(diii) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or committed any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement statement, that would reasonably be expected to provide (in any such case) establishes a reasonable basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) Gratuities Final Policy. As of the products of Agreement Date, the Company or product candidates of is not the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws subject of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, pending or, to the Knowledge of the Company, threatened investigation by the FDA pursuant to initiateits Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, Acquired Companies nor, to the Knowledge of the Company, any agent officers, directors, employees, agents or clinical investigators of any of the Acquired Companies or, to the Acquired Companies’ Knowledge, anyone acting on behalf of the Acquired Companies, is, has been, or is threatened in writing to be: (i) excluded, debarred, suspended or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs (as such that term is defined in 42 C.F.R. U.S.C. § 1001.1001(a)(1)(ii1320a- 7b(f)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii“Excluded”)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had convicted of a civil monetary penalty assessed against it, him crime for which a Person or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”)entity can be debarred or Excluded; (iii) is currently listed on the General Services Administration Administrative published list of parties excluded from federal procurement programs and non-procurement programs; programs or (iv) party to a corporate integrity agreement with the Office of Inspector General of the United States Department of Health and Human Services or otherwise has any continuing reporting obligations pursuant to any deferred prosecution or settlement with any Governmental Authority. To the Acquired Companies’ Knowledge, there are no facts or circumstances reasonably likely to result in such a debarment or exclusion with respect to its business.
(c) Except as would not reasonably be expected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a whole, the Acquired Companies are in compliance and, since January 1, 2019, have been in compliance with all Healthcare Laws applicable to the operation of its business as currently conducted. As of the Agreement Date, to the Knowledge of the CompanyCompany no enforcement, regulatory or administrative proceeding is pending, and no such enforcement, regulatory or administrative proceeding has been threatened in writing, against the target Company under the Healthcare Laws, other than any such proceeding that would not reasonably be expected, individually or subject in the aggregate, to be material to the business of the Acquired Companies, taken as a whole. None of the Acquired Companies has received any written notice, warning letter, or similar written communication that (A) alleges a material violation of, or asserts a material failure to comply with, any applicable Healthcare Law, or (B) imposes a written obligation to undertake, or to bear all or any portion of the cost of, any remedial action of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viablenature.
(ld) Since January 1, 2019 , the Company and its Subsidiaries have performed periodic audits of all manufacturing sites that supply regulatory starting materials, drug substances, drug product intermediates, drug products or finished products to the Company or the Subsidiaries to the extent permitted by any Contract relating to such manufacturing site or required by applicable Healthcare Law. To the Knowledge of the Company, there are no pending written findings deemed critical by the auditor or threatened filings against the Company of an action relating to the Company under any federal inspector resulting from such audits or state whistleblower statuteinspections since January 1, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) 2019 that have not been remediated in all material respects. To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined manufacturing site has performed in HIPAAall material respects all tasks required by such written remediation plans. The Company has been in compliance in made available to Parent complete and accurate copies of all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding reports from all regulatory audits or billing advice regarding products offered for sale inspections conducted since January 1, 2019 by the Company and procedures related theretoits Subsidiaries or, such advice is to the extent in the possession or control of the Company and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsits Subsidiaries, by their Representatives or any Governmental Bodies.
Appears in 2 contracts
Samples: Merger Agreement (Biodelivery Sciences International Inc), Merger Agreement (Collegium Pharmaceutical, Inc)
Regulatory Matters. (a) The Except as would not reasonably be expected to have, individually or in the aggregate, a Company has Material Adverse Effect, each of the Company and its Subsidiaries holds or is in the process of acquiring (A) all Permits required by authorizations under the FDA to conduct the Business U.S. Food, Drug, and Cosmetic Act of 1938 (the “FDA FDCA”), and the applicable regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, (B) all authorizations under the U.S. Federal Insecticide, Fungicide and Rodenticide Act of 1910 (the “FIFRA”), the U.S. Food Quality Protection Act of 1996 (the “FQPA”) and the applicable regulations of the U.S. Environmental Protection Agency (the “EPA”) promulgated thereunder and (C) authorizations of the FDA, U.S. Department of Agriculture (“USDA”) and any other applicable Governmental Entity that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Company Products (any such Governmental Entity, a “Company Regulatory Agency”), in each case, that is necessary for the lawful operation of the businesses of the Company or any of its Subsidiaries as currently conducted (the “Company Regulatory Permits”). All of Except as would not reasonably be expected to have, individually or in the FDA aggregate, a Company Material Adverse Effect, all such Company Regulatory Permits held by or issued to the Company are valid and in full force and effect, effect and the Company is and its Subsidiaries are in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving terms of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingPermits.
(b) Except as set forth on Section 4.13(b) would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, each of the Company Disclosure Scheduleand its Subsidiaries is in compliance with all regulations and requirements of the FDA, USDA, EPA and other Company Regulatory Agencies, including any applicable Good Manufacturing Practices, Hazard Analysis Critical Control Point (HACCP) requirements, labeling requirements, testing requirements and protocols, shipping requirements, record keeping and reporting requirements, monitoring requirements, packaging or repackaging requirements, laboratory controls, storage and warehousing procedures and marketing restrictions. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 20072019, there has not all Company Products have been any voluntarily or involuntarily initiatedproduced, conducteddistributed, or issued recalllabeled, market withdrawalmarketed and sold, safety alertand all raw materials and ingredients in such products have been procured, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Applicable Laws governing the procurement, production, distribution, labeling and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products such products, raw materials or biologicalingredients. Except as would not reasonably be expected to have, device individually or regenerative medicine products in any jurisdiction. There are no pending orthe aggregate, to the Knowledge of the Companya Company Material Adverse Effect, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since since January 1, 2007 2019, there have been no recalls, withdrawals or suspensions with respect to any Company Products produced, distributed, labeled, marketed or sold by the Company or any of its Subsidiaries. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2019, neither the Company nor any of its Subsidiaries has received any written noticesnotice of or otherwise is aware of, reportsany Company Regulatory Agency untitled letters, warning letters, notices of warning or untitled letters alleging withholding, suspension or asserting noncompliance withdrawal of inspection, seizure, criminal referral or other similar federal, state or private enforcement actions with respect to such Company Products. Except as would not reasonably be expected to have, individually or in any material respect with any applicable Law relating to the aggregate, a Company Material Adverse Effect, since January 1, 2019, neither the Company nor any of its Subsidiaries is subject (or the products or product candidates of the Company or has been subject) to any subpoenas or investigative demands adverse inspection finding, recall, investigation, penalty assessment, audit or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined enforcement action by the FDA, includingUSDA, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820EPA and other Company Regulatory Agencies.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(ic) Neither the Company nor any officerof its Subsidiaries is party to any corporate integrity agreements, directormonitoring agreements, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Companyconsent decrees, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party tosettlement orders, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged similar agreements with or convicted of imposed by any criminal offense relating Company Regulatory Agency, except as would not reasonably be expected to the delivery of an item have, individually or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableaggregate, a Company Material Adverse Effect.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Bioceres Crop Solutions Corp.), Merger Agreement (Marrone Bio Innovations Inc)
Regulatory Matters. (a) The Company has Borrower and its Subsidiaries have conducted and currently conduct their business in compliance with all applicable U.S. federal, state, local or foreign laws, statutes, ordinances, rules, regulations, judgments, orders, injunctions, decrees, arbitration awards and Key Permits required issued by the FDA to conduct the Business any Governmental Authority (the collectively, “FDA PermitsLaws”). All , except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(i) Borrower LDTs were researched, developed, designed, and validated in compliance with all applicable Laws, including the FDCA, CLIA, Privacy Laws and state laws, and have been and continue to be performed, marketed, and conducted in compliance with all applicable Laws, including the FDCA, FTC Act, CLIA, Privacy Laws and state laws, including the laws of New York, except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(ii) Borrower Medical Devices have been and are being researched, developed, designed, investigated, manufactured, marketed, and distributed in compliance with all applicable Laws, including the FDCA, the FTC Act, Privacy Laws and state laws, except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(iii) The cord blood collection and storage activities of the FDA Permits held by or issued to the Company Borrower and its Subsidiaries have been and are in full force being marketed, performed, and effect, the Company is otherwise offered in compliance in all material respects withwith all applicable Laws, including the FDCA and applicable FDA regulations (including 21 C.F.R. 1271), and is not in default in any material respect 30 under constitute private storage (storage by and to the Knowledge on behalf of the Company, no event which with the giving of notice a donor or lapse of time, or both, would become a default underdonor’s family members), each such Permitexcept where the failure to do so, and none of such Permits will be terminated or impaired or become terminable, in whole individually or in partthe aggregate, as could not reasonably be expected to result in a result of the transaction contemplated by this AgreementMaterial Adverse Effect. The Company is the sole Borrower and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest its Subsidiaries do not engage in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filingpublic cord blood storage.
(b) Except as set forth on Section 4.13(bSchedule 6.18(b) or as otherwise disclosed to the Lender, (i) to the Borrower’s knowledge, no investigation by any Governmental Authority with respect to the Borrower is pending or threatened, and (ii) the Borrower has not received any written communication from any Person (including any Governmental Authority) alleging any noncompliance with any applicable laws or any written communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Company Disclosure ScheduleProducts, since January 1in each case, 2007, there has not been any voluntarily to the extent such investigation or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating noncompliance could reasonably be expected to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companyresult in a Material Adverse Effect.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices All manufacturing facilities owned or guidances issued operated by the FDA Borrower or any Governmental Authority which regulates of its Subsidiaries, or to Borrower’s knowledge used in the sale production of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions Product (other than non-Products in development), are and have been operated in material routine or periodic inspections or reviews) against the Company, compliance with cGMPs and all other applicable laws. The FDA has not issued to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredientBorrower, or material used in manufacturing the products or the product candidates of the Company pursuant to a developmentBorrower’s knowledge any other Person, commercializationany Form 483, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning lettersWarning Letter, or untitled letters alleging letter with respect to any such facility, or asserting noncompliance in otherwise alleged of Borrower, or to Borrower’s knowledge of any other Person, any material respect non-compliance with any applicable Law relating to cGMPs. All manufacturing facilities owned or operated by the Company or the products or product candidates of the Company Borrower or any subpoenas or investigative demands or of its Subsidiaries are operated in material compliance with other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Companyapplicable federal, state and local laws.
(d) The manufacture Except as set forth on Schedule 6.18(d) or as otherwise disclosed to the Lender, (i) the Borrower has made available to Lender lists and copies, if requested, of all Key Permits and written correspondence submitted to or received from FDA, CMS, or other Governmental Authority (including minutes and official contact reports relating to any written communications with any Governmental Authority) in the Borrower’s possession or control, and (ii) to the Borrower’s knowledge, there has been no untrue statement of fact and no fraudulent statement made by the Borrower, any of the products Subsidiaries or any of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by their respective agents or representatives to the FDA, includingCMS, as applicableor any other Governmental Authority, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and there has been in compliance in all material respects with all Laws requiring no failure by the maintenance Borrower or submission of reports or records under requirements administered by its Subsidiaries to disclose any fact required to be disclosed to the FDA or any other Governmental Authority, includingin each case, for avoidance of doubtexcept where the failure to do so, records and reports relating individually or in the aggregate, could not reasonably be expected to product corrections and removals result in a Material Adverse Effect.
(including FDA requirements e) Except as set forth in 21 C.F.R. Part 806)Schedule 6.18(e) or as otherwise disclosed to the Lender, MDRs (including FDA requirements set forth no right of the Borrower to receive reimbursements pursuant to any government program or private program has ever been terminated or otherwise materially adversely affected as a result of any investigation or enforcement action, whether by any Governmental Authority or other Third Party, and to the Borrower’s knowledge, the Borrower has not been subject of any inspection, investigation, or audit, by any Governmental Authority in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsconnection with any alleged improper activity.
(f) None To Borrower’s knowledge, there is no arrangement relating to the Borrower providing for any rebates, kickbacks or other forms of compensation that are unlawful to be paid to any Person in return for the referral of business or for the arrangement for recommendation of such referrals. To the Borrower’s knowledge, all xxxxxxxx by the Borrower for its services have been true and correct (other than any inadvertent errors corrected in the ordinary course of business) and, to the Borrower’s knowledge, are in compliance with all applicable laws, including the Federal False Claims Act or any applicable state false claim or fraud law except where such failure, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(g) Except as set forth on Schedule 6.18(g), or as otherwise disclosed to the Lender, the Borrower has not, and to the knowledge of the Company Borrower, no officer, director, employee or agent of the Borrower has, (i) been convicted of, charged with, or to the Borrower’s knowledge, investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in any such program; or within the past five (5) years, has been convicted of, charged with or, to the Knowledge Borrower’s knowledge, investigated for a violation of the CompanyLaws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of its Collaborative Partnersfiduciary responsibility, agents financial misconduct, obstruction of an investigation or subcontractors has controlled substances; (ii) been convicted of any crime or engaged in any conduct which that has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that would reasonably might be expected to result in criminal or civil liability or debarment or disqualification by exclusion under 21 U.S.C. § 335a, Section 1128 of the FDA Social Security Act or any other Governmental Authority. None of the Company orsimilar applicable law, and no such debarment or exclusion proceedings or investigations are pending or to the Knowledge of Borrower’s knowledge, threatened against the Company, Borrower or any of its Collaborative Partners has committed any actofficers, made any statement directors, managers, employees or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Lawagents.
(h) To the Knowledge of the CompanyExcept as set forth on Schedule 6.18(h), all studies, tests, tests and preclinical and clinical research being trials conducted by the Company, and relating to the Knowledge of the CompanyProducts, by or on behalf of the Company by any Borrower and the Subsidiaries and, to the knowledge of its Collaborative Partnersthe Borrower, are beingtheir respective licensees, licensors and Third Party services providers and consultants, have been conducted, and at all times have beenare currently being conducted, conducted in compliance in all material respects respects, in accordance with all applicable Laws, includingprocedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules and regulations. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Lender as requested by it. To the extent required by applicable law, the Borrower has obtained all necessary Regulatory Authorizations material to the conduct of its business, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug such business and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialdistribution is currently being carried out.
(i) Neither The transactions contemplated by the Company nor Loan Documents (or contemplated by the conditions to effectiveness of any officer, director, managing employee Loan Document) will not impair the Borrower’s or any of its Subsidiaries’ ownership of or rights under (as those terms are defined in 42 C.F.R. § 1001.1001) of or the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement license or other formal or informal agreement with right to use, as the case may be) any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense Regulatory Authorizations relating to the delivery of an item or service under Products in any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viablematerial manner.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Credit Agreement (Natera, Inc.), Credit Agreement (Natera, Inc.)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All activities of the FDA Permits held by or issued to the Company are in full force and effectCompany, the Company is Subsidiary are now, and since January 1, 2020, have been, in compliance in all material respects withwith all applicable Health Care Laws except where such non-compliance would not reasonably be expected to have, and is not individually or in default in the aggregate, a Company Material Adverse Effect. Since January 1, 2020, neither the Company nor the Company Subsidiary has received any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of written notice or lapse other written communication alleging any violation of timeany applicable Health Care Laws with respect to such activities or has received any warning letters or untitled letters, or bothexcept where such non-compliance would not reasonably be expected to have, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole individually or in part, as the aggregate a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingMaterial Adverse Effect.
(b) Except as set forth on Section 4.13(b) To the knowledge of the Company Disclosure ScheduleCompany, since January 1, 20072020, there each Company Product is being or has not been any voluntarily developed, manufactured, tested, distributed or involuntarily initiated, conducted, marketed by or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product on behalf of the Company or product candidate the Company Subsidiary in compliance with all applicable Health Care Laws, including all requirements relating to research, investigational use, development, security, manufacture, sale, packaging, labeling, storing, testing, distribution, record-keeping, reporting, import, export, marketing, and promotion, except where such non-compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Since January 1, 2020, neither the Company nor the Company Subsidiary has received any unresolved (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to any Company Product or any manufacturing processes or procedures related to any Company Product due to allegations of material noncompliance with applicable Laws or Company Permits, or (v) other similar written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Health Care Laws or Company Permits with respect to any Company Product.
(c) All animal studies or other preclinical tests performed in connection with or as the basis for any Company Permit required by applicable Health Care Laws for the Company Products have been conducted in all material respects in accordance with applicable Good Laboratory Practice requirements contained in 21 CFR Part 58. Neither the Company nor the Company Subsidiary has received any written notice or, to the knowledge of the Company, any other written communication from a Governmental Entity requiring the termination or suspension or material modification of any preclinical study with respect to any Company Product.
(d) Accurate and complete copies of all material reports with respect to material human clinical trials that relate to the Company Products have been provided or made available to Parent. The Company has heretofore provided or made available to Parent all material correspondence between the Company or the Company Subsidiaries, on the one hand, and the FDA and other Governmental Entities, on the other hand, regarding such clinical trials.
(e) All clinical trials conducted by or on behalf of the Company or the Company Subsidiary have been, and are being, conducted in material compliance with the Health Care Laws. Since January 1, 2020, neither the Company nor the Company Subsidiary has received any written notice from the FDA, any institutional review board, or any domestic or foreign Governmental Entity that the FDA, any Institutional Review Board, or Governmental Entity, has initiated, or, to the knowledge of the Company, threatened to initiate, any clinical hold or other similar action to suspend any ongoing clinical trial sponsored by or on behalf of Company, or any action to suspend or terminate any active Investigational New Drug Application (“IND”) sponsored by or on behalf of the Company.
(cf) The As it relates to any clinical trial conducted by or on behalf of the Company is or the Company Subsidiary (with respect to the applicable Company Products) in connection with or as the basis for any submission to the FDA or other comparable Governmental Entity, filed under an IND, or other foreign equivalent or that the Company anticipates will be submitted to the FDA or other comparable Governmental Entity, (i) all such clinical trials have been properly registered in compliance with all applicable Health Care Laws, except where such failure to comply would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect and (ii) the results of all such clinical trials have been disclosed in all material respects in accordance with all applicable Laws and any other lettersHealth Care Laws, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge each case including section 402 of the CompanyPHSA, threatened regulatory Actions except where such failure to comply would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(other than non-material routine or periodic inspections or reviewsg) against the CompanyThere is not and since January 1, 2020, there has not been, and to the Knowledge Company’s knowledge, there is no threat by any Governmental Entity or clinical investigators of, any return or defect of any Company Product proposed to be used during a clinical investigation, nor has the Company issued any replacements, safety alerts or any other written notice to an investigator or Governmental Entity asserting a lack of safety or regulatory compliance with respect to any Company Product used in or to be used during a clinical investigation, and to the Company’s knowledge, there are no pending facts that would be reasonably likely to result in the foregoing, except where such failure to comply would not reasonably be expected to have, individually or threatened regulatory Actions in the aggregate, a Company Material Adverse Effect.
(other than non-material routine or periodic inspections or reviewsh) pertaining to the products or product candidates of Neither the Company against any Person that manufactures any component, ingredientnor the Company Subsidiary is, or material used in manufacturing the products has been since January 1, 2020, a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply similar agreement with or other collaboration arrangement with the Company (“Collaborative Partners”) imposed by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Entity.
(i) Since January 1, 2007 there have been no written notices2020, reports, warning lettersneither the Company nor the Company Subsidiary, or untitled letters alleging any officer, director, managing employee or asserting noncompliance in any material respect with any applicable Law relating to agents of the Company or the products Company Subsidiary (as those terms are defined in 42 C.F.R. § 1001.1001): (i) has (A) been placed under or product candidates of the Company otherwise made subject to or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(dB) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy.
; (gii) There have has been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) convicted of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge Company’s knowledge, is under investigation for any offense related to any Bribery Legislation or Sanctions Laws; (iii) has been charged with or convicted of any criminal offense relating to the delivery of an item or service under Medicare, Medicaid, TRICARE or any similar government health care program (collectively, “Federal Health Care Programs”) (in the case of the Company’s managing employees and agents, on behalf of the Company representation and warranty in this clause (iii) is only being made to the Company’s knowledge); (iv) has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated excluded from participation in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
or is currently listed on the U.S. Department of Health Office of Inspector General’s List of Excluded Individuals/Entities; (j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (iv) has been debarredsubject to, excluded or suspended convicted of any crime that would reasonably be expected to result in, debarment, exclusion, or suspension from participation in any Federal Health Care Program, or otherwise under 21 U.S.C. Section 335a or any similar Law; (iivi) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935Act, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”)Code; (iiivii) has been excluded, suspended, debarred, or is otherwise ineligible to participate federal procurement or non-procurement programs, or is currently listed on the United States General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (ivviii) has been or are currently the subject of a proceeding that could lead to the Knowledge their becoming a debarred individual or debarred entity under Section 306 of the CompanyFDCA; (ix) is on any of the FDA Clinical Investigator enforcement lists (including without limitation, the Disqualified/Totally Restricted List, the Restricted List, the Adequate Assurance List) or is subject to an ongoing disqualification proceeding as defined by the FDA; or (x) is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Indivior PLC), Merger Agreement (Indivior PLC)
Regulatory Matters. (a) The Company has all Permits required Each of the products currently marketed by ANI or any of its Subsidiaries and each of the FDA to conduct products under development by ANI or any of its Subsidiaries is identified in Section 3.16(a) of the Business ANI Disclosure Schedule (the “ANI Products”). Except as set forth in Section 3.16(a) of the ANI Disclosure Schedule, ANI and the ANI Subsidiaries hold all material licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all required authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”) and the regulations of the FDA promulgated thereunder, and any other Government Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the ANI Products (any such Government Authority, an “ANI Regulatory Agency”) required for the lawful operation of the businesses of ANI and the ANI Subsidiaries (the “ANI Permits”), except, in each case, as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on ANI. All Except as set forth in Section 3.16(a) of the FDA ANI Disclosure Schedule all such ANI Permits held by or issued to the Company are valid and in full force and effect, the Company is . Except as set forth in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge Section 3.16(a) of the CompanyANI Disclosure Schedule, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such ANI Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction transactions contemplated by this Agreement. The Company is ANI and the ANI Subsidiaries are the sole and exclusive owner of the FDA ANI Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, abbreviated new drug application, drug master files, biologics master files, master files for devices, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to ANI and the Company ANI Subsidiaries (collectively, the “Company ANI Regulatory Filings”) and holds hold all right, title and interest in and to all Company ANI Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances)Lien. The Company has ANI and the ANI Subsidiaries have not granted any third party any right or license to use, access or reference any of the Company ANI Regulatory Filings, including, without limitation, including any of the Knowknow-How how contained in any of the Company ANI Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company ANI Regulatory Filing.
(b) Except as set forth on in Section 4.13(b3.16(b) of the Company ANI Disclosure Schedule, since January 1, 20072010, there has not occurred any breach or violation of, default (with or without notice or lapse of time or both) under or event giving rise to any right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any ANI Permit. Except as set forth in Section 3.16(b) of the ANI Disclosure Schedule, ANI and the ANI Subsidiaries are in compliance in all material respects with the terms of all ANI Permits, and no event has occurred and no facts or circumstances exist that, to the knowledge of ANI, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any material ANI Permit.
(c) Except as set forth in Section 3.16(c) of the ANI Disclosure Schedule, since January 1, 2010, all material applications, submissions, information and data used by ANI or the ANI Subsidiaries as the basis for, or submitted by or, to the knowledge of ANI, on behalf of ANI or the ANI Subsidiaries in connection with, any and all requests for ANI Permits when submitted to the FDA or other ANI Regulatory Agency, were, to ANI’s knowledge, accurate and complete in all material respects as of the date of submission, and any updates, changes, corrections or modifications to such applications, submissions, information and data required under Applicable Law have been submitted to the FDA or other ANI Regulatory Agency.
(d) Since January 1, 2010, neither ANI nor any of the ANI Subsidiaries has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other ANI Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or similar policies under Applicable Law. Except as set forth in Section 3.16(d) of the ANI Disclosure Schedule, neither ANI nor any of its ANI Subsidiaries nor, to the knowledge of ANI, any agent, subcontractor, director, officer, employee or other Person associated with or acting on behalf of ANI has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Government Authority, and there are no proceedings pending or threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Government Authority.
(e) Neither ANI nor any of the ANI Subsidiaries nor, to the knowledge of ANI, any director, officer, agent, employee or other Person associated with or acting on behalf of ANI or any of the ANI Subsidiaries has: (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), or any similar Applicable Law; or (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment. There are no pending or, to the knowledge of ANI, threatened filings against ANI or any ANI Subsidiary of an action relating to the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)).
(f) Since January 1, 2010, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, field notification, field correction, market withdrawalwithdrawal or replacement, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the CompanyANI Product.
(cg) The Company is Except as set forth in Section 3.16(g) of the ANI Disclosure Schedule, ANI and its Subsidiaries are in compliance in all material respects with all applicable Applicable Laws and any other letters, notices or guidances guidance issued by the FDA or any Governmental Government Authority which regulates regulate the sale clinical investigation, manufacture, sale, promotion, sampling and distribution of pharmaceutical products or biological, or device or regenerative medicine products in any jurisdiction. ANI has at all times and is currently distributing, marketing, promoting, labeling and selling its products in accordance with the FDCA and Prescription Drug Marketing Act of 1987. There are no pending or, to the Knowledge knowledge of the CompanyANI, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending ANI or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionits Subsidiaries. Since January 1, 2007 2010 there have been no written notices, reports, FDA Form 483 observations that have not been disclosed by ANI, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Applicable Law relating to the Company ANI or the products any ANI Subsidiary or product candidates of the Company any ANI Product or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Government Authority with regard to any product of the Company or any product candidate of the CompanyANI Product.
(dh) The manufacture of the products of the Company ANI Products is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the . ANI has been in material compliance with FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820registration and listing requirements to the extent required by FDA.
(ei) The Company is ANI and has its Subsidiaries are and have been in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Government Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, and Serious Injuries, incidents or near-incidents and product malfunctions.
(f. Except as set forth in Section 3.16(i) None of the Company orANI Disclosure Schedule, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Events or Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company any ANI Products that have not been reported to the FDA in accordance with applicable Applicable Law.
(hj) To the Knowledge knowledge of the CompanyANI, all studies, tests, and preclinical and clinical research being conducted by the CompanyANI and ANI Subsidiaries, and to the Knowledge knowledge of the CompanyANI, on behalf of the Company by any of its Collaborative PartnersANI and ANI Subsidiaries, are being, and at all times have been, conducted in compliance in all material respects with all applicable Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws laws of any other Governmental Government Authority. No clinical trial conducted by the Company ANI or any ANI Subsidiary or, to the Knowledge knowledge of the CompanyANI, on behalf of the Company ANI or any ANI Subsidiary has been terminated or suspended prior to completion for safety or non- non-compliance reasons, and neither the FDA nor any other Governmental Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge knowledge of the CompanyANI, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person Person or entity involved in any such clinical trial.
(ik) Neither the Company ANI nor any ANI Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyANI or any ANI Subsidiary, nor, to the Knowledge knowledge of the CompanyANI, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company ANI or any ANI Subsidiary is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, monitoring agreement, consent decree, settlement order, deferred prosecution agreement or other formal or informal agreement with any Governmental Government Authority concerning compliance with the laws governing any “Federal Health Care Program Laws.
Program” (jwhich means Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act) and any other state or federal health care program). ANI meets all the requirements of participation and payment of Medicare, Medicaid, and any other governmental health care programs and third party payment programs to the extent in which it participates (collectively, “Programs”). There is no action pending, received or, to ANI’s knowledge, threatened against ANI which relates in any way to a violation of any health care laws or which could result in the imposition penalties against or the exclusion of ANI from participation in any Programs. Neither the Company ANI nor any ANI Subsidiary nor officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation have engaged in any Federal Health Care activities which are cause for civil penalties or mandatory or permissive exclusion from any Program; (ii) has had a civil monetary penalty assessed against it. To ANI’s knowledge, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line there is no longer viable.
(l) To the Knowledge of the Companypending, there are no pending proposed or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state final Medicare national or local Lawscoverage determination that, if finalized, would restrict coverage for ANI’s Products. The Company ANI has not established any reimbursement support program, such that payment for ANI product is contingent upon a purchaser’s receipt of payment from a third party payer. ANI does not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement furnish any coverage, coding or billing advice to any health care professionals regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements off-label indications of Medicare and other Federal Health Care Program LawsANI products.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Biosante Pharmaceuticals Inc), Merger Agreement (Biosante Pharmaceuticals Inc)
Regulatory Matters. (a) The (i) With respect to each product that is, directly or indirectly, being distributed for commercial sale by the Company has or any of the Company Subsidiaries (the "Products"): (1) the Company and the Company Subsidiaries have obtained all Permits applicable approvals, clearances, authorizations, licenses and registrations required by Governmental Entities to permit the FDA to conduct the Business manufacture, distribution, sale (the “FDA Permits”including reimbursement and pricing). All , marketing or human research and development of the FDA Permits held by or issued to such Product (collectively, "Approvals"); (2) the Company are in full force and effect, the Company is Subsidiaries are in compliance in all material respects with, with all terms and conditions of each Approval in each country in which such Product is not in default in any material respect 30 under marketed; (and to 3) the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is Subsidiaries are in compliance in all material respects with all applicable Laws requirements (as set forth in relevant statutes and any other lettersregulations) regarding registration, notices licensure or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products notification for each site (in any jurisdiction. There are no pending orcountry) at which such Product is manufactured, processed, packed, held for distribution or from which it is distributed; (4) to the Knowledge extent such Product is intended for export from the United States, the Company and the Company Subsidiaries are in compliance in all material respects with either all United States Food and Drug Administration ("FDA") requirements for marketing or 21 U.S.C. §381(e) or 382; and (5) none of the Company, threatened regulatory Actions the Company Subsidiaries or any officer or employee of the Company or the Company Subsidiaries is under investigation or has been debarred pursuant to 21 U.S.C. §335a; (other than non-material routine ii) all manufacturing operations performed by or periodic inspections or reviews) against for the CompanyCompany and the Company Subsidiaries are being, and to the Knowledge of the CompanyCompany have been, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to conducted in full compliance with current good manufacturing practices, including, but not limited to, the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in good manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) practice regulations and guidance issued by the FDA and counterpart requirements in the European Union and other countries;
(iii) all nonclinical laboratory studies, as described in 21 C.F.R. §58.3(d), conducted or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to sponsored by the Company or the products or product candidates Company Subsidiaries are being, and to the Knowledge of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being have been, conducted in full compliance in all material respects with current “the good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” laboratory practice regulations set forth in 21 C.F.R. Part 82058 and counterpart requirements in the European Union and other countries; (iv) all clinical studies of Products, as described in 21 C.F.R. §50.3(c), sponsored by the Company or the Company Subsidiaries are being, and to the Knowledge of the Company have been, conducted in full compliance with 21 C.F.R. §§812,50, 54 and 56; and (v) the Company and the Company Subsidiaries are in full compliance with the adverse event reporting requirements for devices in 21 C.F.R. Parts 812 and 803; except, in the case of subsections (i) through (iv) above, for any such failures to obtain or instances of noncompliance which, individually or in the aggregate, would not have a Company Material Adverse Effect. Without limiting the generality of the foregoing definition of "Approvals", such definition shall specifically include, with respect to the United States, product license applications, premarket approval applications under Section 515 of the FDCA, premarket notifications under Section 510(k) of the FDCA, investigational device exemptions, and product export applications issued by the FDA, as well as registrations issued by the Department of Justice.
(eb) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to To the Knowledge of the Company, none of the Company or the Company Subsidiaries nor any of its Collaborative Partnerstheir officers, employees or agents has made any untrue statement of a material fact or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by fraudulent statement to the FDA or any other Governmental Authorityforeign equivalent, and there are no proceedings pending or, failed to the Knowledge of the Company, threatened that reasonably might disclose a fact required to be expected disclosed to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company orforeign equivalent, to the Knowledge of the Company, any of its Collaborative Partners has or committed any act, made any statement statement, or failed to make any statement statement, that would reasonably be expected to provide a basis for the FDA and any foreign equivalent to invoke its policy with respect to “respecting, "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations ," set forth in 21 C.F.R. Part 5856 Fed. Reg. 46191 (September 10, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.1991).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (I Stat Corporation /De/), Merger Agreement (I Stat Corporation /De/)
Regulatory Matters. (a) The Company has and the Company Subsidiaries hold all Permits required by material licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all authorizations under the FDA to conduct the Business Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDA FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”) and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, and any other Government Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the Company’s current or under-development products (any such Government Authority, a “Company Regulatory Agency”) required for the lawful operation of the businesses of the Company and the Company Subsidiaries (the “Company Permits”), except, in each case, as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All of the FDA such Company Permits held by or issued to the Company are valid and in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none . None of such Company Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction transactions contemplated by this Agreement. The Company is and the Company Subsidiaries are the sole and exclusive owner of the FDA Company Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company and the Company Subsidiaries (collectively, the “Company Regulatory Filings”) and holds hold all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances)encumbrance. The Company has and the Company Subsidiaries have not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Knowknow-How how contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except Since January 1, 2008, there has not occurred any breach or violation of, default (with or without notice or lapse of time or both) under or event giving rise to any right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any Company Permit, except as set forth would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. The Company and the Company Subsidiaries are in compliance in all material respects with the terms of all Company Permits, and no event has occurred and no facts or circumstances exist that, to the knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Company Permit.
(c) Since January 1, 2008, all material applications, submissions, information and data utilized by the Company or the Company Subsidiaries as the basis for, or submitted by or, to the knowledge of the Company, on Section 4.13(b) behalf of the Company Disclosure Scheduleor the Company Subsidiaries in connection with, since any and all requests for Company Permits when submitted to the FDA or other Company Regulatory Agency, were, to the Company’s knowledge, accurate and complete in all material respects as of the date of submission, and any updates, changes, corrections or modifications to such applications, submissions, information and data required under Applicable Law have been submitted to the FDA or other Company Regulatory Agency.
(d) Since January 1, 20072008, neither the Company nor any of the Company Subsidiaries has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or similar policies under Applicable Law. Neither the Company’s nor any of the Company Subsidiaries’ agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Government Authority, and there are no proceedings pending or threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Government Authority.
(e) Neither the Company nor any of the Company Subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee or other Person associated with or acting on behalf of the Company or any of the Company Subsidiaries has: (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), or any similar Applicable Law; or (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment.
(f) Since January 1, 2008, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(cg) The Company is and its Subsidiaries are in compliance in all material respects with all applicable Applicable Laws and any other letters, notices or guidances guidance issued by the FDA or any Governmental Government Authority which regulates regulate the sale of pharmaceutical products or biological, or device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending Company or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionits Subsidiaries. Since January 1, 2007 2008 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Applicable Law relating to the Company or any Company Subsidiary or the products or product candidates of the Company or any Company Subsidiary or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Government Authority with regard to any product of the Company or any product candidate of the CompanyCompany or any Company Subsidiary.
(dh) The manufacture of the products of the Company or any Company Subsidiary is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(ei) The Company is and has its Subsidiaries are and have been in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Government Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, and Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Events or Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company or any Company Subsidiary that have not been reported to the FDA in accordance with applicable Applicable Law.
(hj) To the Knowledge knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the CompanyCompany and Company Subsidiaries, and to the Knowledge knowledge of the Company, on behalf of the Company by any of its Collaborative Partnersand Company Subsidiaries, are being, and at all times have been, conducted in compliance incompliance in all material respects with all applicable Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws laws of any other Governmental Government Authority. No clinical trial conducted by the Company or any Company Subsidiary or, to the Knowledge knowledge of the Company, on behalf of the Company or any Company Subsidiary has been terminated or suspended prior to completion for safety or non- non-compliance reasons, and neither the FDA nor any other Governmental Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person Person or entity involved in any such clinical trial.
(ik) Neither the Company nor any Company Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyCompany or Company Subsidiary, nor, to the Knowledge knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company or any Company Subsidiary is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Government Authority concerning compliance with the laws governing Federal Health Care Program LawsPrograms.
(jl) Neither the Company nor any Company Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyCompany or any Company Subsidiary, nor, to the Knowledge knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the CompanyCompany or any Company Subsidiary: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified 1935,codified at Title 4200, Chapter 7Xxxxxxx 0, of the United States xx xxx Xxxxxx Xxxxxx Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge knowledge of the Company, is the target or subject of any current investigation by a Governmental Government Authority relating to any Federal Health Care Program-Program related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(lm) To the Knowledge knowledge of the Company, there are no pending or threatened filings against the Company or any Company Subsidiary of an action relating to the Company or any Company Subsidiary under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(mn) To the Knowledge knowledge of the Company, neither the Company nor any Company Subsidiary is not under investigation by any Governmental Government Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Lawslaws. The Neither the Company is not a nor any Company Subsidiaries are “covered entityentities” as that term is defined in HIPAA. The Company has and the Company Subsidiaries have been in compliance in all material respects with federal and state data breach Lawslaws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Synageva Biopharma Corp.), Merger Agreement (Trimeris Inc)
Regulatory Matters. (a) The Except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole, to the knowledge of the Company, each of the Company and its subsidiaries (or their respective agents) has all Permits required by licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and has submitted notices to, all Governmental Authorities that are concerned with the FDA to conduct quality, identity, strength, purity, safety, efficacy, use, manufacturing, advertising, distribution and sale of the Business Company Products (any such Governmental Authority, a “Company Regulatory Agency”), including, but not limited to, all authorizations and registrations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDA FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, the Federal Controlled Substances Act of 1970 and the regulations of the U.S. Drug Enforcement Administration (the “DEA”) promulgated thereunder and all state controlled substance Laws and regulations, in each case to the extent necessary for the Company or any such subsidiary to own, lease and operate its properties or other assets and to carry on and operate its respective businesses as currently conducted (the “Company Permits”). All of Except as would not, individually or in the FDA Permits held by or issued aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole, all such Company Permits are valid and in full force and effect. Since January 1, 2012, there has occurred no violation by the Company is in compliance in all material respects withor its subsidiaries of, and is not in default in any material respect 30 under (and with or without notice or lapse of time or both) by the Company or its subsidiaries under, or, to the Knowledge knowledge of the Company, no event which giving to others any right of termination, amendment or cancellation of, with the giving of or without notice or lapse of time, time or both, would become a default under), each such any Company Permit, and none of such Permits will be terminated or impaired or become terminableexcept as would not, in whole individually or in partthe aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a result whole. Except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole, the Company and each of its subsidiaries are in compliance with the transaction contemplated by this Agreement. The terms of all Company is the sole and exclusive owner of the FDA Permits and the associated filings consummation of the Merger, in and applications with of itself, will not cause the FDA, including revocation or cancellation of any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued Company Permit pursuant to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear terms of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingPermit.
(b) Except Since January 1, 2012, except as set forth on Section 4.13(b) would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole, all of the Company Disclosure ScheduleProducts that are subject to the jurisdiction of the FDA, since January 1DEA or any other Company Regulatory Agency are being manufactured, 2007imported, there has not been any voluntarily or involuntarily initiatedexported, conductedprocessed, or issued recalldeveloped, market withdrawallabeled, safety alertstored, warningtested, “dear doctor” lettermarketed, market correctionadvertised, or investigator notice relating promoted, detailed and distributed by or, to an alleged material lack the knowledge of safety or efficacy of any product the Company, on behalf of the Company or product candidate of its subsidiaries in compliance with all applicable requirements under any Company Permit or Laws administered or enforced by the CompanyFDA, DEA or other Company Regulatory Agency, including those relating to investigational use, premarket approval and applications or abbreviated applications to market a new Company Product.
(c) The Since January 1, 2012, all preclinical studies and clinical trials, and other studies and tests conducted by or, to the knowledge of the Company, on behalf of the Company is or any of its subsidiaries have been, and if still pending are being, conducted in compliance in all material respects with all applicable Laws Laws, including, but not limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, except for such noncompliance as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. Since January 1, 2012, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole, no clinical trial conducted by or, to the knowledge of the Company, on behalf of the Company or any of its subsidiaries has been terminated or suspended prior to completion for safety or other non-business reasons, and neither the FDA nor any other lettersapplicable Company Regulatory Agency, notices clinical investigator that has participated or guidances issued is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to the FDA knowledge of the Company, on behalf of the Company or any Governmental Authority which regulates of its subsidiaries has commenced, or, to the sale knowledge of pharmaceutical products the Company, threatened to initiate, any action to place a clinical hold order on, or biologicalotherwise terminate, device delay or regenerative medicine products suspend, any ongoing clinical investigation conducted by or, to the knowledge of the Company, on behalf of the Company or any of its subsidiaries.
(d) Since January 1, 2012 through the date hereof, neither the Company nor any of its subsidiaries has received any FDA “warning letters” with respect to the Company Products or any of the Company’s manufacturing or distribution processes or procedures.
(e) As of the date hereof, none of the Company or any of its subsidiaries, nor to the knowledge of the Company any contract manufacturer with respect to the Company Products, is subject to an unresolved Company Regulatory Agency shutdown or import or export prohibition, FDA Form 483 or other Company Regulatory Agency written notice of material inspectional observations, “warning letters,” “untitled letters” or written requests to make material changes, in each case as it applies to the Company Products or any jurisdictionof the Company’s manufacturing or distribution processes or procedures, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole.
(f) The current manufacturing operations conducted by or, to the knowledge of the Company, on behalf of the Company or any of its subsidiaries is conducted in compliance with applicable Laws, including the provisions of the FDA’s current good manufacturing practice regulations at 21 C.F.R. Parts 210-211 and 820 for Company Products sold in the United States, and the respective counterparts thereof promulgated by Company Regulatory Agencies in countries outside the United States, except where the failure to so comply would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. There As of the date hereof, there are no pending or, to the Knowledge knowledge of the Company, threatened regulatory Actions (other than non-material routine actions or periodic inspections proceedings by the FDA, DEA or reviews) against any applicable foreign equivalent which would reasonably be expected to prohibit or materially impede the Companysale of any Company Product currently manufactured and/or sold by the Company or any of its subsidiaries into any market except as would not, and individually or in the aggregate, reasonably be expected to be materially adverse to the Knowledge Company and its subsidiaries, taken as a whole.
(g) Since January 1, 2012, to the knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of neither the Company, nor any of its Collaborative Partnerssubsidiaries, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, or for similar policies, set forth in any other Governmental Authority applicable Laws, except as would not, individually or in the aggregate, reasonably be expected to invoke be materially adverse to the Company and its subsidiaries, taken as a whole. Since January 1, 2012, none of the Company, its subsidiaries or, to the knowledge of the Company, any of their respective officers or key employees has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under 21 U.S.C. Section 335a or any similar policy.
(g) There have been no Serious Adverse Eventsapplicable Law except as would not, Serious Injuries individually or MDR Reportable Events associated with in the use (including in clinical trials) aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. As of the products date hereof, no Actions against the Company, its subsidiaries, or, to the knowledge of the Company Company, any of their respective officers or product candidates key employees that would reasonably be expected to result in such a material debarment are pending, and as of the date hereof the Company has not received written notice that have not been reported any such Actions are threatened except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the FDA in accordance with applicable LawCompany and its subsidiaries, taken as a whole.
(h) To the Knowledge knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf each of the Company by and its subsidiaries, and each of their respective directors, officers, employees and authorized agents (while acting in such capacity) is, and since January 1, 2012 has been, in compliance with all Health Care Laws applicable to the Company or any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Lawssubsidiaries, including, as to the extent applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), good clinical practicesthe Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. §§ 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 19951996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic exclusion Laws (42 U.S.C. § 1320a-7), the Food Drug and Clinical Health Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Controlled Substances Act (21 U.S.C. §§ 801 et seq), the Medicare Program (Title XVIII of the Social Security Act), the Medicaid Program (Title XIX of the Social Security Act), the regulations promulgated pursuant to such Laws, requirements of the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, requirements of Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126), state pharmaceutical assistance programs and regulations under such Laws (collectively, “HIPAAHealth Care Laws”), except for non-compliance that would not, individually or in the regulations contained aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. Since January 1, 2012 through the date hereof, except as would not, individually or in 45 C.F.R. Parts 160 the aggregate, reasonably be expected to be materially adverse to the Company and 164its subsidiaries, including receiving taken as a whole, none of the Company or any notices of its subsidiaries has received any written notification, written correspondence or any other written communication from any Governmental Authority, including, without limitation, the United States FDA, the DEA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of Civil Rights relating to any such violationsInspector General, specifically alleging non-compliance by, or liability of, the Company or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach of its subsidiaries under any Health Care Laws.
(ni) To As of the extent date hereof, none of the Company provides reimbursement coding or billing advice regarding products offered for sale any of its subsidiaries is a party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or other similar written agreements, in each case, entered into with or imposed by any Company Regulatory Agency, other than any such agreement, decree or order that has been previously disclosed in any filing with a Company Regulatory Agency.
(j) As of the date hereof, neither the Company nor any of its subsidiaries has received any written notice from the FDA, DEA or any other Governmental Authority that it has commenced, or threatened to initiate, any action to withdraw approval, place sales, pricing or marketing restrictions on or request the recall of any Company Product, or that it has commenced, or threatened to initiate, any action to enjoin or place restrictions on the production of any Company Products except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and procedures related theretoits subsidiaries, such advice is and taken as a whole.
(k) As to the Company Products for which a biological license application, new drug application, abbreviated new drug application, investigational new drug application, 510(k) clearance, premarket approval application, investigational device exemption, or similar state or foreign regulatory application has been approved, the Company and its subsidiaries are in compliance with 21 U.S.C. §§ 355, 360, 360e, Section 351 of the PHSA or 21 C.F.R. Parts 312, 314, 600, 601, 812 or 814 et seq., respectively, and all applicable similar state and foreign regulatory requirements of any Governmental Authority, and all terms and conditions of such licenses or applications, except for any such failure or failures to be in compliance that would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. As to each drug for which the Company has sales, the Company and any relevant subsidiary of the Company, and the officers, employees or agents of the Company and any subsidiary of the Company, have included in the application for such drug, where required, the certification described in 21 U.S.C. § 335a(k)(1) and the list described in 21 U.S.C. § 335a(k)(2) and each such certification and list was true and complete when made except as would not, individually or in all material respects the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. In addition, the Company and each of its subsidiaries is in compliance with all applicable registration and listing requirements set forth in all material respects with 21 U.S.C. § 360 and 21 C.F.R. Parts 207 and 807, except for failures to so comply that have not had, and would not, individually or in the payment requirements of Medicare aggregate, reasonably be expected to be materially adverse to the Company and other Federal Health Care Program Lawsits subsidiaries, taken as a whole.
Appears in 2 contracts
Samples: Merger Agreement (Hospira Inc), Merger Agreement (Pfizer Inc)
Regulatory Matters. (a) The Except as would not reasonably be expected to have, individually or in the aggregate, a Company has Material Adverse Effect, (i) the Company and its Subsidiaries have obtained all Permits (including, for the avoidance of doubt, all establishment registrations, device listings and 510(k) clearances (or their foreign equivalents)) required by any Health Authority to permit the FDA to conduct the Business of their respective businesses as currently conducted, (the “FDA Permits”). All ii) all of the FDA such Permits held by or issued to the Company are in full force and effect, (iii) the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, Permit and (iv) none of such Permits will shall be terminated or impaired or become terminable, in whole or in part, as a result of the transaction transactions contemplated by this Agreement. The Company is Agreement or the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingTransaction Documents.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices2011, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge none of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending Subsidiaries or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge knowledge of the Company, any of their respective directors, officers, employees or Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Company and its Collaborative Partners has Subsidiaries) have (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Health Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Health Authority, or (iii) committed any other act, made any statement or failed to make any statement statement, that would reasonably be expected to provide (in any such case) establishes a reasonable basis for the FDA to invoke its the policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Fraud Policy”) or for any other Governmental Health Authority to invoke any a similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of policy that may be applicable to the Company or product candidates any of the Company that have not been reported to the FDA its Subsidiaries in accordance with applicable Law.
(h) To the Knowledge another jurisdiction. None of the Company, all studiesany of its Subsidiaries or, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge knowledge of the Company, on behalf any of their respective directors, officers, employees or Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Company and its Subsidiaries) are the subject of any pending or, to the Company’s knowledge, threatened investigation by the FDA under the FDA Fraud Policy, or the subject of any similar investigation by any other Health Authority.
(c) Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2011, the Company and each of its Subsidiaries and, to the knowledge of the Company, each Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company by any of and its Collaborative PartnersSubsidiaries), are being, and at all times have been, conducted has been in compliance in all material respects with all applicable Health Laws, including, as applicable, good including those relating to laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions developed tests. None of the Federal FoodCompany, Drug and Cosmetic Act and any of its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company Subsidiaries or, to the Knowledge knowledge of the Company, on behalf of any Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company has been terminated and its Subsidiaries) (i) have received any written notice or suspended prior other written communication from any Health Authority (including a warning, untitled or notice of violation letter or Form FDA-483) alleging any violation of any Health Law, including any failure to completion for safety or non- maintain systems and programs adequate to ensure compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in with any such clinical trial has initiatedHealth Laws, oror contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any product subject to any Health Law, or (ii) are subject to any enforcement, regulatory or administrative proceedings against or affecting the Company relating to or arising under any Health Law and, to the Knowledge knowledge of the Company, threatened to initiateno such enforcement, any action to place a clinical hold order on, regulatory or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialadministrative proceeding has been threatened.
(id) Neither The Company and its Subsidiaries have filed with the applicable Health Authority all required and material Filings, including adverse event reports. All such Filings were in material compliance with Applicable Law when filed, and no deficiencies have been asserted in writing by any applicable Health Authority with respect to any such Filings.
(e) None of the Company nor or any officerof its Subsidiaries, directorany of their respective officers, directors or managing employee employees (as those such terms are defined in 42 C.F.R. § 1001.1001) of the Company, noror, to the Knowledge knowledge of the Company, any other Company Service Provider or agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)1001.1001) of the Company is a party toor any of its Subsidiaries has been disqualified, debarred or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with deregistered by any Governmental Authority concerning compliance with Federal Health Care Program LawsAuthority.
(jf) Neither As of the date hereof, neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, its Subsidiaries have received any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded written coverage or suspended reimbursement decision from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him commercial third-party payor or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viablegovernment payor.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Transaction Agreement, Transaction Agreement (Foundation Medicine, Inc.)
Regulatory Matters. (a) The At all times since January 1, 2016, (i) the Company has developed, tested, manufactured, labeled, marketed, promoted and stored, as applicable, each of the Company Products, and, (ii) to the Company’s Knowledge, all Permits required Company vendors have marketed and promoted each of the Company Products, in compliance with the Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations enforced by the FDA to conduct the Business U.S. Food and Drug Administration (the “FDA PermitsFDA”). All , Public Health Service Act of the FDA Permits held by or issued to the Company are in full force and effect1944, the Company is in compliance in all material respects withas amended (“PHSA”), and is not in default in any material respect 30 under (and and, to the Knowledge of the Company, no event which with comparable applicable Laws outside of the giving United States, including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices, as applicable, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. During the three (3) years prior to the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of other communication from the FDA Permits and or any other Governmental Authority alleging any violation of any Law with respect to such activities or any FDA “warning letters” with respect to any Company Product or any manufacturing, promotional, marketing or distribution processes or procedures. There are no existing conditions at the associated filings and applications with the FDACompany or any of its Subsidiaries or, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any Knowledge of the Company Regulatory Filings, including, without limitation, any as of the Know-How contained date of this Agreement, at any contract manufacturer with respect to any Company Product, that would result in a Governmental Authority shutdown or import or export prohibition, Form FDA 483 or other written notice of material inspectional observations, “warning letters,” “untitled letters” or written requests to make material changes with respect to any Company Product including the design, manufacture or distribution of Company Products, or the way in which the Company Regulatory Filings Products are marketed or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filingpromoted, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. All deficiencies and non-conformities discovered during internal and external audits and inspections have been corrected and resolved in all material respects.
(b) Except Since January 1, 2016, the Company does not and has not marketed Company Products using verbiage prohibited by Law, outside of the scope of indications, or for indications other than those permitted by the Law or by policy or guidance of any Governmental Authority, except as set forth on Section 4.13(bwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. During the three (3) years prior to the date of this Agreement, none of the Company Disclosure Schedulenor any of its Subsidiaries or, since January 1to the Knowledge of the Company as of the date of this Agreement, 2007any contract manufacturer with respect to any Company Product, there has not been received any voluntarily notices, information request letters, correspondence, orders or involuntarily initiatedother communications from the FDA or any other Governmental Authority issuing, conducted, requiring or issued causing any recall, seizure, detention, market withdrawalwithdrawal or replacement, safety alert, warning, “dear doctor” letter, market correction, investigator notice or investigator other notice relating to an alleged material lack of safety or efficacy of or manufacturing deficiencies of any product Company Product, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. None of the Company or product candidate nor any of its Subsidiaries or, to the Knowledge of the Company as of the date of this Agreement, any contract manufacturer with respect to any Company Product, has taken any such action voluntarily. To the Company’s Knowledge, there have been no Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of any Company Product that have not been reported to the FDA or any other applicable Governmental Authority in accordance with an applicable Law.
(c) The All preclinical studies and clinical trials conducted by or on behalf of the Company is or any of its Subsidiaries have been conducted in material compliance in all material respects with all applicable Laws and material Laws, including submission of all required applications (e.g., Investigational New Drug Application). As of the date of this Agreement, no clinical trial conducted by or on behalf of the Company or any of its Subsidiaries has been terminated or suspended prior to completion primarily for safety or other non-business reasons. As of the date of this Agreement, neither the FDA nor any other lettersapplicable Governmental Authority, notices clinical investigator who has participated or guidances issued is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the FDA Company or any Governmental Authority which regulates of its Subsidiaries has commenced, or, to the sale Knowledge of pharmaceutical products the Company as of the date of this Agreement, threatened to initiate, any action to place a clinical hold order on, or biologicalotherwise terminate or suspend, device any ongoing clinical investigation conducted by or regenerative medicine products in on behalf of the Company or any jurisdictionof its Subsidiaries. There are no pending or, to the Knowledge of the CompanyCompany as of the date of this Agreement, threatened regulatory Actions (other than non-material routine actions or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered proceedings by the FDA or any other Governmental AuthorityAuthority seeking to (or that would reasonably be expected to) prohibit or impede the sale of any Company Product into any market. The Company has made available to Parent accurate and complete copies of the material reports and material correspondence with Governmental Authorities with respect to preclinical and clinical trials, includingstudies or tests conducted by or on behalf of the Company or any of its Subsidiaries, for avoidance or with respect to any Company Product, that are listed in Section 4.18(c) of doubtthe Company Disclosure Letter and as of the date of this Agreement, records and there are no other such reports relating or correspondence with Governmental Authorities that would reasonably be expected to product corrections and removals (including FDA requirements set forth have, individually or in 21 C.F.R. Part 806)the aggregate, MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), a Material Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsEffect.
(fd) None of the Company or, to To the Knowledge of the CompanyCompany as of the date of this Agreement, none of the Company nor any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA Subsidiaries or any other Governmental Authoritycontract manufacturer with respect to any Company Product, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, or for similar policies, set forth in any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products Laws. None of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by nor any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company Subsidiaries or, to the Knowledge of the CompanyCompany as of the date of this Agreement, on behalf any of their respective officers or key employees, or any contract manufacturer with respect to any Company Product, has been convicted of any crime that has resulted, or would reasonably be expected to result, in debarment under 21 U.S.C. § 335a or any similar applicable Law. There is no pending legal proceeding (or to the Knowledge of the Company has been terminated as of the date of this Agreement, threatened legal proceeding) against the Company or suspended prior to completion for safety any of its Subsidiaries, or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator of their respective officers or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiatedkey employees, or, to the Knowledge of the Company, threatened to initiateCompany as of the date of this Agreement, any action contract manufacturer with respect to place any Company Product, that would reasonably be expected to result in such a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialmaterial debarment.
(ie) Neither None of the Company nor any officerof its Subsidiaries is a party to any corporate integrity agreement, directormonitoring agreement, managing employee (as those terms are defined deferred prosecution agreement, consent decree, settlement order, or other similar agreement, in 42 C.F.R. § 1001.1001) of the Companyeach case, norentered into with or imposed by any Governmental Authority, and, to the Knowledge of the Company, any agent (Company as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company date of this Agreement, no such action is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Lawspending.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Smith & Nephew PLC), Merger Agreement (Osiris Therapeutics, Inc.)
Regulatory Matters. (a) The Company has and each of its Subsidiaries hold (i) all Permits required material approvals, authorizations, certificates and licenses issued by the FDA State Regulators that are required for Company and each of its Subsidiaries to conduct the Business its business as presently conducted and (ii) all other material regulatory permits, approvals, licenses and other authorizations, including franchises, ordinances and other agreements granting access to public rights of way, issued or granted to Company or any of its Subsidiaries by a Governmental Entity that are required for Company and each of its Subsidiaries to conduct its business, as presently conducted (clause (i) and (ii) collectively, the “FDA PermitsCompany Licenses”). All of .
(b) Each Company License is valid and in full force and effect and has not been suspended, revoked, canceled or adversely modified, except where the FDA Permits held by or issued failure to the Company are be in full force and effect, or the suspension, revocation, cancellation or modification of which would not reasonably be expected to result in, individually or in the aggregate, a Company Material Adverse Effect. No Company License is subject to (i) any conditions or requirements that have not been imposed generally upon licenses in compliance the same service, unless such conditions or requirements would not reasonably be expected to result in, individually or in all material respects withthe aggregate, and is a Company Material Adverse Effect, or (ii) any pending regulatory proceeding or judicial review before a Governmental Entity, unless such pending regulatory proceeding or judicial review would not reasonably be expected to result in, individually or in default in any material respect 30 under (and to the aggregate, a Company Material Adverse Effect. To the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has been no event, condition or circumstance that would preclude any Company License from being renewed in the ordinary course (to the extent that such Company License is renewable by its terms), except where the failure to be renewed would not been any voluntarily reasonably be expected to result in, individually or involuntarily initiatedin the aggregate, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the a Company or product candidate of the CompanyMaterial Adverse Effect.
(c) The licensee of each Company License is in compliance in with each Company License and has fulfilled and performed all material respects of its obligations with respect thereto, including all applicable Laws reports, notifications and any other letters, notices or guidances issued applications required by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologicalrules, device or regenerative medicine products in any jurisdiction. There are no pending orregulations, to the Knowledge policies, instructions and orders of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the CompanyState Regulators, and the payment of all regulatory fees and contributions, except (i) for exemptions, waivers or similar concessions or allowances and (ii) where such failure to the Knowledge of the Companybe in compliance, there are no pending fulfill or threatened regulatory Actions (other than non-material routine perform its obligations or periodic inspections pay such fees or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that contributions would not reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal in, individually or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableaggregate, a Company Material Adverse Effect.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Merger Agreement (Glowpoint, Inc.), Merger Agreement (Glowpoint, Inc.)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of Borrowers’ and their Subsidiaries’ material Products and material Regulatory Required Permits are listed on Schedule 4.17 on the FDA Closing Date. With respect to each Product, (i) the Borrowers and their Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits held needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or issued on behalf of Borrower, in each case except where the failure to obtain such Regulatory Required Permits could not reasonably be expected to have a Material Adverse Effect and (ii) such Product is being tested, manufactured, marketed or sold, as the case may be, by Borrowers (or to the Company are in full force and effectBorrowers’ knowledge, the Company is by any applicable third parties) in compliance with all applicable Laws and Regulatory Required Permits in all material respects with, and is each case except where the failure to do so could not in default in any material respect 30 under (and reasonably be expected to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become have a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingMaterial Adverse Effect.
(b) Except as set forth on Section 4.13(b) None of the Company Disclosure Schedule, since January 1, 2007, there has not been Borrowers or any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy Subsidiary thereof are in violation of any product of the Company or product candidate of the CompanyHealthcare Law, except where any such violation would not reasonably be expected to have a Material Adverse Effect.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA No Borrower or any Governmental Authority which regulates the sale of pharmaceutical products or biologicalSubsidiary thereof receives any material payments directly (including through any third party payment processor) from Medicare, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredientMedicaid, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyTRICARE.
(d) The manufacture To the Borrowers’ knowledge (after reasonable inquiry), none of the products Borrowers or their Subsidiaries’ officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the Company is being conducted in compliance in all FDA or failed to disclose a material respects with current “good manufacturing practices,” as defined by fact required to be disclosed to the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that would could reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or for any other Governmental Authority to invoke any similar policyset forth in 56 Fed. Regulation 46191 (September 10, 1991).
(ge) There have been no Serious Except as would not reasonably be expected to result in a Material Adverse EventsEffect, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: each Product (i) has been debarredand/or shall be manufactured, excluded or suspended from participation imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in any Federal Health Care Program; accordance with all applicable Permits and Laws, and (ii) has had a civil monetary penalty assessed against itbeen and/or shall be manufactured in accordance with Good Manufacturing Practices.
(f) No Borrower, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Companynor any Subsidiary thereof, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvalsproceeding, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Companysuit or, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statuteBorrower’s knowledge, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation federal, state, local or foreign government or quasi-governmental body, agency, board or authority or any other administrative or investigative body (including the Office of the Health Insurance Portability and Accountability Act Inspector General of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office Services),which could reasonably be expected to result in the revocation, transfer, surrender, suspension of Civil Rights relating to any such violations, material Permits of Borrower or any comparable state Subsidiary thereof or local Laws. The Company is not otherwise be expected to result in a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsMaterial Adverse Effect.
(ng) To As of the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related theretoClosing Date, such advice is and has there have been true and complete in all no material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program LawsRegulatory Reporting Events.
Appears in 2 contracts
Samples: Credit and Security Agreement (Treace Medical Concepts, Inc.), Credit and Security Agreement (Term Loan) (Treace Medical Concepts, Inc.)
Regulatory Matters. (ai) The Neither the Company nor any of its Subsidiaries, all or part of whose rates or services are regulated by a Governmental Entity, (A) has all Permits required by rates which have been or are being collected subject to refund, pending final resolution of any suit, action or proceeding pending before a Governmental Entity or on appeal in a court of competent jurisdiction, or (B) is a party to any suit, action or proceeding before a Governmental Entity or on appeal from orders of a Governmental Entity, in each case, which have had or would reasonably be expected to have, individually or in the FDA aggregate, a Material Adverse Effect or would reasonably be expected to conduct prevent, materially delay or impair the Business (the “FDA Permits”). All ability of the FDA Permits held by Company to consummate the Merger or issued comply with its obligations under this Agreement.
(ii) With respect to the Company are in full force and effectFCC Private Licenses, (A) neither the Company nor any of its Subsidiaries is in compliance in all material respects with, “red light” status under the rules and is not in default in any material respect 30 under (and to the Knowledge policies of the CompanyFCC, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and (B) none of such Permits the FCC Private Licenses is used to provide commercial interconnected voice or data service and (C) none of the FCC Private Licenses was acquired by competitive bidding. Neither the Company nor any of its Subsidiaries holds any FCC-issued authorizations other than the FCC Private Licenses. Except as would not have and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, none of the FCC Private Licenses will be terminated or terminated, impaired or become terminable, in whole or in part, solely as a result of the transaction Merger and the other transactions contemplated by this Agreement. The Company is , so long as the sole and exclusive owner of FCC has, prior to the FDA Permits and Closing, approved the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory FCC Form 603 application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) applications pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale FCC Private Licenses filed by the Company and procedures related thereto, such advice is and has been true and complete Ultimate Parent in all material respects and in compliance in all material respects connection with the payment requirements of Medicare Merger and the other Federal Health Care Program Lawstransactions contemplated by this Agreement.
Appears in 2 contracts
Samples: Merger Agreement (Transcanada Corp), Merger Agreement (Columbia Pipeline Group, Inc.)
Regulatory Matters. (ai) The (A) Each of the Company has and its Subsidiaries holds all Permits required by material authorizations under the FDCA, the PHSA, and the regulations of the FDA to conduct promulgated thereunder, the Business Food and Drugs Act, the CDSA, and the regulations of Health Canada promulgated thereunder, the requirements of the European Medicines Agency and any other Governmental Entity that regulates the quality, identity, strength, purity, safety, efficacy, manufacturing, distribution, sale, import or export of the Company Products (any such Governmental Entity, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company or any of its Subsidiaries as currently conducted and the testing, manufacturing, sale or distribution, as applicable, of each of the Company Products (the “FDA Company Regulatory Permits”). All of the FDA ) and (B) all such Company Regulatory Permits held by or issued to the Company are valid and in full force and effect. Since January 1, 2011, there has not occurred any violation of, default under, or event giving any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Regulatory Permit, that would prohibit or impede the sale of any Company Product currently manufactured and/or sold by the Company is in compliance in all material respects withor any of its Subsidiaries into any market. Since January 1, and is not in default in any material respect 30 under (and 2011, no event has occurred that, to the Knowledge knowledge of the Company, no event which with would reasonably be expected to result in a penalty under or the giving of notice revocation, cancellation, non-renewal or lapse of timeadverse modification of, or both, would become a default under), each such any Company Regulatory Permit, except as has not had and none of such Permits will would not reasonably be terminated or impaired or become terminableexpected to have, in whole individually or in partthe aggregate, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingMaterial Adverse Effect.
(bii) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since Since January 1, 20072011, there has not been any voluntarily to the knowledge of the Company, all pre-clinical and clinical investigations conducted or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product sponsored by each of the Company or product candidate any of the Company.
(c) The Company is its Subsidiaries have been and, if still pending, are being conducted in compliance in all material respects with all applicable Laws and any other letters, notices administered or guidances issued by the applicable Company Regulatory Agency, including (A) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (B) FDA regulations for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (C) Division 5 of the Food and Drug Regulations regarding Drugs for Clinical Trials Involving Human Subjects, and (D) material Laws restricting the collection, use and disclosure of individually identifiable health information and personal information.
(iii) Since January 1, 2011, none of the Company or any of its Subsidiaries has received any material written information from the FDA or any Governmental Authority other Company Regulatory Agency which regulates would reasonably be expected to lead to the sale denial of pharmaceutical products any application for marketing approval currently pending before the FDA or biologicalany other Company Regulatory Agency.
(iv) All material reports, device documents, claims, permits and notices required to be filed, maintained or regenerative medicine products furnished to the FDA or any other Company Regulatory Agency by the Company or any of its Subsidiaries have been so filed, maintained or furnished. To the knowledge of the Company, all such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). None of the Company or any jurisdiction. There are no pending of its Subsidiaries or, to the Knowledge knowledge of the Company, any officer, employee, agent or distributor of the Company or any of its Subsidiaries is the subject of any pending, or, to the knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge investigation in respect of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered Products by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, Regulatory Agency pursuant to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its FDA’s policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events. Neither the Company nor any of its Subsidiaries, Serious Injuries or MDR Reportable Events associated with nor, to the use (including in clinical trials) knowledge of the products Company, any officer, employee, agent or distributor of the Company or product candidates any of its Subsidiaries, has been convicted of any crime or engaged in any conduct that could result in a material debarment mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. None of the Company that have not been reported or any of its Subsidiaries or, to the FDA in accordance with applicable Law.
(h) To the Knowledge knowledge of the Company, all studiesany officer, testsemployee, and preclinical and clinical research being conducted by agent or distributor of the CompanyCompany or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that could result in a material exclusion from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, and to as amended, or any similar Law or program.
(v) To the Knowledge knowledge of the Company, on behalf the development, manufacture, testing, distribution, and marketing of the each Company by any of its Collaborative PartnersProduct or, are as applicable, Company Product candidate that is or since January 1, 2011 has been developed, manufactured, tested, distributed or marketed is being, and at all times have since January 1, 2011 has been, conducted in compliance in all material respects with all applicable Lawsthe FDCA and the regulations of the FDA promulgated thereunder, includingthe Food and Drugs Act, as applicablethe CDSA and the regulations of Health Canada promulgated thereunder, or any similar Law in any foreign jurisdiction including those relating to investigational use, premarket clearance or marketing approval, good laboratory practice regulations set forth in 21 C.F.R. Part 58manufacturing practices, good clinical practices, as defined good laboratory practices, labeling, advertising, record keeping and filing of reports. There is no action or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company proceeding pending or, to the Knowledge knowledge of the Company, on behalf threatened by any Company Regulatory Agency, including any prosecution, injunction, seizure, civil fine, suspension or recall, in each case alleging any violation applicable to any Company Product or Company Product candidate by the Company or any of its Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to be material to the Company or any of its Subsidiaries.
(vi) Since January 1, 2011, each of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and its Subsidiaries have neither the FDA voluntarily nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has involuntarily initiated, orconducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Company Product. To the Knowledge knowledge of the Company, there are no facts which are reasonably likely to cause (A) the recall, market withdrawal or replacement of any Company Product sold by the Company or any of its Subsidiaries, (B) a material change in the labeling of any such Company Products, or (C) a termination or suspension of the marketing of such Company Products.
(vii) Since January 1, 2011, neither the Company nor any of its Subsidiaries has received any written notice that the FDA, Health Canada or any other Company Regulatory Agency has commenced, or threatened to initiate, any action to place a clinical hold order on, enjoin manufacture or otherwise terminate, materially delay distribution of any Company Product sold by the Company or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialof its Subsidiaries.
(iviii) Neither Since January 1, 2011, none of the Company nor or any officerof its Subsidiaries has received any written notice from the FDA, directorHealth Canada or any other Company Regulatory Agency alleging material violations of advertising or marketing Laws with respect to a Company Product or a material negative change in reimbursement status of a Company Product.
(ix) Except as would not, managing employee (as those terms are defined individually or in 42 C.F.R. § 1001.1001) the aggregate, reasonably be expected to have a Company Material Adverse Effect, to the knowledge of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the no Company is a party to, Product manufactured or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale distributed by the Company and procedures related thereto, such advice or any of its Subsidiaries is and has been true and complete in all material respects and in compliance in all material respects with (A) adulterated within the payment requirements meaning of Medicare and other Federal Health Care Program Laws21 U.S.C. § 351 (or any similar Law) or (B) misbranded within the meaning of 21 U.S.C. § 352 (or any similar Law).
Appears in 2 contracts
Samples: Merger Agreement (Medicis Pharmaceutical Corp), Merger Agreement (Valeant Pharmaceuticals International, Inc.)
Regulatory Matters. Each Company shall cause (a)
(i) The Company has Broker-Dealers to take all Permits required by reasonable action to maintain all rights, privileges, broker-dealer licenses and memberships, broker-dealer registrations necessary or desirable in the FDA to normal conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effectits business, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminableexcept, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending orcase, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and extent that failure to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that do so would not reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None a Material Adverse Effect, (ii) each Broker-Dealer to comply with all material rules and regulations of the Company orSEC and FINRA applicable to it (including such rules and regulations dealing with net capital requirements) and, to the Knowledge extent applicable to any Broker-Dealer, all similar, equivalent or comparable foreign statutes, rules, regulations and other regulatory requirements, except, in each case, where the failure to so comply would not reasonably be expected to result in a Material Adverse Effect , (iii) all Broker-Dealers to deliver after the end of each fiscal quarter of each fiscal year of the Borrower or promptly after the date such information is filed with the SEC, a copy of each Broker-Dealer's Financial and Operational Combined Uniform Single Report filed with the SEC for such fiscal quarter and (iv) all Broker-Dealers to promptly deliver copies of each notice or other correspondence received from the SEC (or comparable agency in any applicable non-U.S. jurisdiction) concerning any investigation by such agency regarding financial or other operational results of any Company, any of its Collaborative Partners has committed any actin each case which are reasonably likely to be determined adversely and which if determined adversely, made any statement or failed to make any statement that would reasonably be expected to provide result in a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, BriberyAdverse Effect , and Illegal Gratuities” (b) (i) all of its Investment Adviser Companies to take all reasonable action to maintain all rights, privileges and investment adviser registrations necessary or for any other Governmental Authority desirable in the normal conduct of its business, except, in each case, to invoke any similar policy.
the extent that failure to do so would not reasonably be expected to result in a Material Adverse Effect , (gii) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated all of its Investment Adviser Companies to comply with the use (including in clinical trials) all material rules and regulations of the products of the Company or product candidates of the Company that have not been reported SEC applicable to it and, to the FDA in accordance with extent applicable Law.
(h) To the Knowledge of the to any Investment Adviser Company, all studiessimilar, testsequivalent or comparable foreign statutes, rules, regulations, and preclinical and clinical research being conducted by other regulatory requirements, except, in each case, where the Companyfailure to so comply would not reasonably be expected to result in a Material Adverse Effect, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on unless previously delivered, all of its Investment Adviser Companies to promptly deliver copies of each notice or other correspondence received from the General Services Administration published list of parties excluded from federal procurement programs and SEC (or comparable agency in any applicable non-procurement programs; (ivU.S. jurisdiction) to the Knowledge concerning any investigation by such agency regarding financial or other operational results of the any Investment Adviser Company, is the target or subject of any current investigation by in each case which are reasonably likely to be determined adversely and which if determined adversely, would reasonably be expected to result in a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableMaterial Adverse Effect.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: First Lien Term Loan Agreement, First Lien Term Loan Agreement
Regulatory Matters. (a) The All products and services of the Company or its Subsidiaries that are currently marketed or sold by or for the Company or its Subsidiaries or are currently under development or with respect to which the Company or any of its Subsidiaries has all Permits required by the FDA to conduct the Business provided any indemnity or a warranty (collectively, the “FDA PermitsCompany Products”). All of the FDA Permits held by or issued to the Company are ) have been in full force material compliance with all applicable Contract commitments, applicable Law, all applicable safety standards and effect, the Company is in compliance in all material respects withexpress and implied warranties, and is not in default in any material respect 30 under no Litigations are pending (and and, to the Knowledge of the Company, there is no event which with reasonable basis for any present or future Litigation against the Company or any of its Subsidiaries giving rise to any such liability). Since January 1, 2012, neither the Company nor any of notice or lapse its Subsidiaries has been notified in writing of timeany claims for (and, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result to the Knowledge of the transaction contemplated by this AgreementCompany, there are no threatened claims for) any extraordinary product returns, warranty obligations or product services relating to any Company Products. The Company is the sole and exclusive owner As of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Scheduledate hereof, since January 1, 20072011, there have been no FDA (or similar foreign Governmental Authority) ordered Recalls, or any seizures or adverse regulatory actions taken (or, to the Knowledge of the Company, threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any Company Products are produced, processed, packaged or stored, and since January 1, 2012, the Company has not been any not, either voluntarily or involuntarily initiatedat the request of any Governmental Authority, conductedinitiated or participated in any Recalls of any Company Product. There are no facts, circumstances or conditions that would reasonably be expected to form the basis for an enforcement action by the FDA or other Governmental Authority with respect to any action to withdraw or delay approval of, place restrictions on the production, clinical use or testing or sales or marketing of, or issued recallrequest the Recall of, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate any of the Companyits Subsidiaries that would have a Company Material Adverse Effect if successful.
(cb) The Without limiting Section 3.13(a) or other provisions of this Section 3.13, each of the Company is and its Subsidiaries is, and since January 1, 2012, has been, in compliance in all material respects with all health care Laws applicable to the Company and its Subsidiaries, or by which any property, product or other asset of the Company and its Subsidiaries is bound or affected, including, but not limited to, the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPAA”), all criminal Laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. §§ 286 and 287, and the health care fraud criminal provisions under HIPAA, the exclusion laws, Social Security Act § 1128 (42 U.S.C. § 1320a-7), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, and in each case the regulations promulgated thereunder, all other Laws relating to the development, billing, labeling, storage, testing, distribution or marketing of pharmaceutical products, and any state, local and foreign equivalents of any of the foregoing (collectively, “Health Care Laws”). Neither the Company nor any Subsidiary of the Company has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation or arbitration from any Governmental Authority alleging potential or actual material non-compliance by, or material liability of, the Company or any Subsidiary of the Company under any Health Care Laws.
(c) Each of the Company and its Subsidiaries holds all Permits from the FDA and any similar foreign Governmental Authorities required for the conduct of its business as currently conducted (collectively, the “Regulatory Permits”) and all such Regulatory Permits are valid and in full force and effect. Each of the Company and its Subsidiaries has fulfilled and performed all of its material obligations with respect to the Regulatory Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other lettersmaterial impairment of the rights of the holder of any Regulatory Permit. Each of the Company and its Subsidiaries has filed with the FDA and any similar foreign Governmental Authorities all material reports, notices documents, forms, notices, applications, records, claims, submissions, and supplements or guidances amendments thereto, including adverse event reports and all other submitted data relating to the Company’s and its Subsidiaries’ products, as required by any Health Care Law or Regulatory Permit, and all such reports, documents, forms, notices, applications, records, claims, submissions, and supplements or amendments were in all material respects complete, accurate and not misleading on the date filed (or were corrected or supplemented by a subsequent submission), and no written notice (or, to the Knowledge of the Company, any oral notice) of deficiencies which are material, individually or in the aggregate, has been issued or asserted by any applicable Governmental Authority with respect to any such reports, documents, forms, notices, applications, records, claims, submissions, or any supplements or amendments thereto.
(d) The Company and its Subsidiaries and their contract manufacturers are, and since January 1, 2012 have been, in material compliance with, and each Company Product regulated as a medical device or drug in current commercial distribution is designed, manufactured, prepared, assembled, packaged, labeled, stored, installed, serviced and processed in material compliance with, a recognized quality management system, including the Quality System Regulation set forth in 21 C.F.R. Part 820, the current Good Manufacturing Practice (GMP) regulation set forth in 21 C.F.R. Part 211, as applicable, and the provisions of any similar non-U.S. requirements, such as the EU Medical Device Directives, the EU Drug Directives and ISO 13485 and ISO 9000 series, as applicable.
(e) The Company and its Subsidiaries have obtained and currently hold in good standing all material approvals, registrations and authorizations from, and have maintained or procured all records, studies and other documentation needed to reasonably satisfy and demonstrate compliance with the requirements of, the FDA (and any similar foreign Governmental Authority) for the conduct of their business activities relating to the Company Products and for the sale and/or provision of the Company Products (as applicable).
(f) Neither the Company nor any of its Subsidiaries has made any material false statement in, or material omission from, the applications, approvals, reports or other submissions to the FDA or to any similar foreign Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of the FDA or any similar foreign Governmental Authority; provided that no representation or warranty is made by the Company herein to the extent that any such statement or omission was made by or in reliance on data or information provided by any third Person, including any contractor, investigator or researcher, engaged or retained by, or otherwise acting on behalf of, the Company or any of its Subsidiaries (any such Person, a “Section 3.13 Third Person”).
(g) To the Knowledge of the Company, no Section 3.13 Third Person has made any material false statement in, or material omission from, any report, study or other documentation prepared in conjunction with the applications, approvals, reports or records submitted to or prepared for the FDA or any similar foreign Governmental Authority.
(h) Neither the Company nor any of its Subsidiaries has received any written notice of any investigation by any Governmental Authority which regulates in respect of the sale promotion of pharmaceutical products “off-label” or biologicalsimilar use of the Company Products and there is no pending or, device to the Knowledge of the Company, threatened Litigation by any Governmental Authority with respect to the promotion of “off-label” or regenerative medicine products similar use of such products. To the Knowledge of the Company, no facts or circumstances exist that could reasonably support a material claim that the Company or any of its Subsidiaries has engaged in promotional activities that are in violation of any Law concerning “off-label” promotional activities, including any Health Care Law.
(i) Notwithstanding anything in this Agreement to the contrary, this Section 3.13 contains the sole and exclusive representations and warranties of the Company in any jurisdictionway relating to any FDA- or any similar foreign Governmental Authority-related safety, compliance or health matter, including compliance with Health Care Laws.
(j) To the Knowledge of the Company, the Company and its Subsidiaries have not used in any capacity the services of any individual or entity debarred or excluded, or which has engaged in any conduct that has resulted or would reasonably be expected to result in debarment or exclusion, under 21 U.S.C. § 335a(a), 42 U.S.C. § 1320a-7 or any equivalent or similar Laws.
(k) The clinical and pre-clinical studies conducted by or on behalf of or sponsored by the Company or a Subsidiary of the Company were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable Health Care Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act, its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and any foreign equivalents. Since January 1, 2012, neither the Company nor any Subsidiary of the Company has received any written notice or other correspondence from the FDA or any similar foreign Governmental Authority requiring the termination, suspension or material modification of any ongoing clinical or pre-clinical study. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine actions or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) proceedings by the FDA or any similar foreign Governmental Authority which regulates would prohibit or impede the potential future commercial sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental AuthoritySubsidiaries’ products. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending contracts, including settlements with Governmental Authorities, which would reasonably be expected to impose obligations for independent review and oversight of marketing and sales practices or threatened filings against limit in any material respect the ability of the Company or any of an action relating its Subsidiaries to develop, manufacture, market or sell any of the Company under any federal Company’s or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.)its Subsidiaries’ products.
(ml) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in made available to Purchaser prior to the date hereof true, correct and complete copies of (i) all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale filings made by the Company or any of its Subsidiaries with the FDA or any similar foreign Governmental Authority in its possession or control and procedures related thereto, such advice is and has been true and complete in (ii) all material respects and in compliance in all material respects correspondence with the payment requirements of Medicare FDA or any similar foreign Governmental Authority in its possession or control, in each case with regard to the Company’s and other Federal Health Care Program Lawsits Subsidiaries’ products.
Appears in 2 contracts
Samples: Stock Purchase Agreement, Stock Purchase Agreement (Mallinckrodt PLC)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued approved ANDAs and NDAs relating to the Company are Products and each such approved ANDA and NDA is valid, effective and in full force and effecteffect and there are no proceedings pending, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and or to the Knowledge knowledge of Seller, threatened which would reasonably be expected to result in the revocation, cancellation or suspension thereof. None of the Company, no event which with approved ANDAs or NDAs for the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner Products requires any further approval of the FDA Permits and or any other Government Agency for the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug purpose for which they currently are being manufactured or investigational device exemption application, comparable regulatory application or filing made or held sold by or issued on behalf of Seller. This Section 5.1(g)(a) does not apply to the Company (collectively, deregistration and related activities commenced in the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingUnited Kingdom.
(b) Except as set forth on Section 4.13(bThe Products now being distributed meet the requirements of applicable Regulatory Authority laws and regulations. With respect to the Products, Seller has made available to Purchaser copies of (i) of all material regulatory filings and Product Approvals, including applications for Product Approvals, and (ii) all serious adverse event reports and periodic adverse event reports that have been filed with the Company Disclosure Schedule, FDA since January 1, 20072005, there has not been including any voluntarily material correspondence or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating other material documents. Seller shall maintain and file with the FDA any customer complaints that are directed to an alleged material lack of safety or efficacy of the Seller for any product of Product sold prior to the Company or product candidate of the CompanyClosing Date.
(c) The Company is in compliance All regulatory materials submitted or filed by Seller with the FDA was, at the time of submission or filing, true, complete and accurate in all material respects with all applicable Laws respects, and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, serious adverse event information has come to the Knowledge attention of the Company, threatened regulatory Actions (other than non-material routine Seller or periodic inspections or reviews) against the Company, and its Affiliates that is materially different with respect to the Knowledge incidence, severity or nature of such serious adverse events than the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person information that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted was filed as raising a compliance concern sent or delivered by any Governmental Authority with regard safety updates to any product of the Company or any product candidate of the Companysuch regulatory submissions.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, Neither Seller nor any of its Collaborative PartnersAffiliates, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, nor any of its Collaborative Partners or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the FDA with respect to the development of Products, failed to disclose a material fact required to be disclosed to the FDA with respect to the development of the Products, or committed any an act, made any statement a statement, or failed to make any a statement with respect to the development of Products that would could reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or for set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any other Governmental Authority to invoke any similar policyamendments thereto.
(ge) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending known or threatened filings against the Company of an action relating pending, actions with respect to the Company under any federal Product withdrawals, field actions or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seqrecalls.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 2 contracts
Samples: Asset Sale and Purchase Agreement, Asset Sale and Purchase Agreement (Akorn Inc)
Regulatory Matters. (a) The Company has all Permits required by All activities of Issuer and its Subsidiaries that are subject to the FDA to conduct the Business (the “FDA Permits”). All jurisdiction of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of timecomparable Governmental Authority, or bothsubject to Health Care Laws, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not have been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is conducted in compliance in all material respects with all applicable Laws and requirements under all such Health Care Laws.
(b) Neither Issuer, any of its Subsidiaries nor, to Issuer’s Knowledge, any Third Party, has received notice or other letters, notices communication alleging a possible material violation by Issuer or guidances issued by the FDA or its Subsidiaries of any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. Health Care Law.
(c) There are no Actions pending or, to the Knowledge Issuer’s Knowledge, threatened, with respect to an actual or alleged violation by Issuer, any of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredientits Subsidiaries, or material used in manufacturing the products or the product candidates to Issuer’s Knowledge, any Third Party, of the Company pursuant any Health Care Law applicable to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA Issuer or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Companyits Subsidiaries.
(d) The manufacture To Issuer’s Knowledge, there is no information, condition, event, occurrence or circumstance that would reasonably be expected to adversely affect, in any material respect, the acceptance, obtaining or maintaining of any Product Registration for any of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820Products.
(e) The Company Issuer owns all Product Registrations with respect to the Products, and each of such Product Registrations is in full force and has been effect. All of the Products are being, and at all times have been, Exploited in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by for the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsapplicable Product Registrations.
(f) None Issuer has made available to Purchaser true, correct and complete copies of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by (A) all material filings with the FDA or equivalent Governmental Authority relating to any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the CompanyProducts, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by (B) all material correspondence and communications with the FDA or equivalent Governmental Authority relating to any of the Products and (C) all material data, information, results, analyses, trial protocols, publications, and reports relating to the safety and efficacy of the Products.
(g) Issuer has made available to Purchaser its current plan for development of all Products, including Issuer’s current plan for obtaining Product Registrations necessary to ultimately commercialize the Products.
(h) All applications, notifications, submissions, information, claims, reports and statistics and other data, utilized as the basis for, or submitted in connection with, any Product Registration for any Product, when submitted to the FDA or such other applicable Governmental Authority were true, correct and complete in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to the FDA or such other applicable Governmental Authority. None of the Company or, filings made by or on behalf of Issuer or any of its Subsidiaries with the FDA or an equivalent Governmental Authority relating to the Knowledge any of the CompanyProducts contained any untrue statement of a material fact or fraudulent statement or omitted any material fact necessary to make the statements therein not misleading.
(i) Neither Issuer, any of its Collaborative Partners Subsidiaries or any officer, director, employee or, to Issuer’s Knowledge, agent of Issuer or any of its Subsidiaries, or any Third Party, (A) has committed any act, or made any statement a statement, or failed to make any statement a statement, that would could reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its FDA’s policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Eventspolicy with respect to Issuer, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative PartnersSubsidiaries or any of their respective officers, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined directors or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
employees; (i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (iB) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under Medicare, Medicaid, TRICARE or any similar government health care program (collectively, “Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAAPrograms”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.;
Appears in 2 contracts
Samples: Stock Purchase Agreement (ONCOSEC MEDICAL Inc), Stock Purchase Agreement (ONCOSEC MEDICAL Inc)
Regulatory Matters. (a) The Company is developing, testing, labeling, packaging, manufacturing, distributing, and storing, and at all times since incorporation has all Permits required by developed, tested, labeled, packaged, manufactured, distributed, and stored the FDA to conduct the Business (the “FDA Permits”). All Product and each of the FDA Permits held by or issued to the Company are in full force and effect, the Company is Product Candidates in compliance in all material respects with, and is not in default in any material respect 30 under with (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of i) the FDA Permits Act and the associated filings applicable implementing regulations and applications with guidances issued by the FDA, including any biologics license applicationincluding, as applicable, those requirements relating to the FDA’s current good manufacturing practices, good laboratory practices, good clinical practices and investigational use, in each case, for a new drug applicationproduct, 510(k(ii) submissionthe Laws of the European Union and applicable implementing regulations and guidelines issued by applicable Governmental Entities in the European Union, premarket approvalincluding the EMA, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to and (iii) any other applicable Governmental Entities in any other country where the Company (collectivelyhas actually developed, tested, labeled, packaged, manufactured, distributed or stored the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear Product or any of any Encumbrance (other than Permitted Encumbrances)the Product Candidates. The Company has not granted received written notice of any third party pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or any right other Governmental Entity alleging that any operation or license to use, access or reference any activity of the Company Regulatory Filings, including, without limitation, any is in material violation of the Know-How contained in any of FDA Act or the Company Regulatory Filings respective counterparts thereof promulgated by applicable state Governmental Entities or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingGovernmental Entities outside the United States.
(b) Except as set forth on Section 4.13(bThe Company owns good title, free and clear of all Security Interests, to (i) the NDA for Minocin and (ii) the rights to reference the NDA for Minocin in seeking and obtaining Regulatory Approval for RPX-602 within and outside of the United States. The Company Disclosure Scheduleis not subject to any third party contractual obligation that prevents, since January 1, 2007, there has not been any voluntarily restricts or involuntarily initiated, conducted, adversely affects the Company from marketing Minocin within the United States or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, seeking Regulatory Approvals for or investigator notice relating to an alleged material lack of safety marketing RPX-602 within or efficacy of any product outside of the Company or product candidate of the CompanyUnited States.
(c) The Company is has made available to the Buyer, with respect to the Product and each of the Product Candidates, complete and correct copies, as of the date of this Agreement, of (i) in the case of the Product, all NDAs in its possession or of which it has Knowledge submitted to the FDA, (ii) all INDs or Clinical Trial Applications (“CTAs”) submitted to the FDA or to any other Governmental Entity, respectively, (iii) all XXXx submitted to the EMA and its respective counterparts in the European Union, (iv) all foreign counterparts to the NDAs, INDs, CTAs and XXXx (in any other country where the Company has undertaken any action to develop, test, label, manufacture, distribute or store the Product or any of the Product Candidates), (v) all supplements to and amendments of the items set forth in clauses (i) through (iv) and (vi) all material correspondence with the FDA or with any other Governmental Entity located in the United States or European Union with respect to the Product and each of the Product Candidates. All information, claims, reports, statistics, and other data and conclusions submitted by the Company in connection with the NDAs, the INDs, the CTAs and the XXXx and any foreign counterparts thereof and in all supplements to and amendments of the same were true, complete and correct in all material respects as of the applicable date of submission and were in compliance in all material respects with all applicable Laws as of the respective dates such filings were made.
(d) All preclinical studies and clinical trials, and other studies and tests of each of the Product Candidates conducted by or on behalf of the Company have been, and if still pending are being, conducted in material compliance, to the extent applicable, with the applicable protocol for such study or trial, good laboratory practices, good clinical practices and all applicable Laws, including the FDA Act and the respective counterparts thereof outside the United States, including, as applicable, the Laws of the European Union. To the Knowledge of the Company, all preclinical studies and clinical trials, and other studies and tests of the Product have been, and if still pending are being, conducted in material compliance, to the extent applicable, with the applicable protocol for such study or trial, good laboratory practices, good clinical practices and all applicable Laws, including the FDA Act. No clinical trial conducted by or on behalf of the Company has been terminated or suspended prior to scheduled completion, and neither the FDA nor any other lettersapplicable Governmental Entity, notices clinical investigator that has participated or guidances issued is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company has initiated, or, to the Company’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation of any of the Product Candidates conducted or proposed to be conducted by or on behalf of the Company. Neither the Company nor any of its Subsidiaries has received any written notice that the FDA or any other Governmental Entity has commenced, or, to the Company’s Knowledge, threatened in writing to initiate, any action to withdraw or suspend an IND, or commenced or, to the Company’s Knowledge threatened in writing to initiate, any action to enjoin production of the Product or any of the Product Candidates at any of its or its suppliers’ facilities. No clinical investigator who has conducted or, if still pending, is conducting any clinical trial sponsored by or on behalf of the Company has been disqualified from receiving investigational products by the FDA or any other Governmental Authority which regulates Entity or received any written notice from the sale FDA or any other Governmental Entity of pharmaceutical products or biological, device or regenerative medicine products in an intent to initiate such disqualification proceedings.
(e) The Company is not subject to any jurisdiction. There are no investigation that is pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, that is pending and to the Knowledge of the Company, there are no pending not served or threatened regulatory Actions or that has been threatened, in each case by (other than non-material routine or periodic inspections or reviewsi) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates (ii) the sale Department of pharmaceutical products Health and Human Services Office of Inspector General or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating Department of Justice pursuant to the Company U.S. Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b) or the products or product candidates of U.S. Federal False Claims Act (31 U.S.C. §3729) (known as the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company“Federal Civil False Claims Act”).
(df) The manufacture of Company has not submitted any claim for payment to any government healthcare program in connection with any referrals that violated any applicable self-referral Law, including the products of Federal Ethics in Patient Referrals Act, 42 U.S.C. §1395nn (known as the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDAXxxxx Law”), including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820or any applicable state self-referral Law.
(eg) The Company is and has been not submitted any claim for payment to any government healthcare program in compliance violation of any Laws relating to false claims or fraud, including the Federal Civil False Claim Act or any applicable state false claim or fraud Law.
(h) The Company has complied in all material respects with all Laws requiring applicable security and privacy standards regarding protected health information under (i) HIPAA and (ii) any applicable health privacy Laws.
(i) All manufacturing operations conducted for the maintenance benefit of the Company have been and are being conducted in material compliance with applicable Laws, including, to the extent applicable, the provisions of the FDA’s current good manufacturing practice regulations and the respective counterparts thereof promulgated by state Governmental Entities, or submission Governmental Entities in countries outside the United States. To the Company’s Knowledge, none of the Company’s suppliers or contract manufacturers has received an FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters” or “untitled letters”, in each case, related to or affecting the Product or any of the Product Candidates. The Company has made available to the Buyer copies of all material (i) reports of inspection observations, if any, relating to the Product or records under requirements administered any of the Product Candidates received by the Company or any of its Subsidiaries, (ii) establishment inspection reports relating to the Product or any of the Product Candidates received by the Company or any of its Subsidiaries, and (iii) warning letters relating to the Product or any of the Product Candidates received by the Company or any of its Subsidiaries, if any, as well as any other documents received by the Company or any of its Subsidiaries, or to its Knowledge, its suppliers or contract manufacturers from the FDA or any other applicable Governmental Authority, including, for avoidance of doubt, records and reports Entities relating to product corrections the Product or any of the Product Candidates or arising out of the development of the Product or any of the Product Candidates that assert past or ongoing lack of compliance with any applicable Laws by the Company or any of its Subsidiaries, and removals (including FDA requirements set forth in 21 C.F.R. Part 806)to its Knowledge, MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents its suppliers and contract manufacturers relating to clinical development of the Product or near-incidents and product malfunctionsany of the Product Candidates.
(fj) None Section 3.18(j) of the Company orDisclosure Schedule sets forth a list of (i) all Product or Product Candidate recalls, field notifications, investigator notices, safety alerts, “serious adverse event” reports or other notices of action relating to the Knowledge an alleged lack of the Company, any of its Collaborative Partners, agents safety or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification regulatory compliance issued by the FDA Company or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None contracting Persons acting on behalf of the Company or(“Safety Notices”), (ii) the dates such Safety Notices, if any, were resolved or closed, and (iii) to the Knowledge of the Company’s Knowledge, any of its Collaborative Partners material Product or Product Candidate complaints that are currently unresolved.
(k) The Company has not committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any such similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations policies set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other any applicable provisions Laws. None of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge Company’s Knowledge, any of its officers, key employees or agents, has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the Company’s Knowledge, on behalf no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion of the Company has been terminated are pending or suspended prior to completion for safety threatened against the Company or non- compliance reasonsany of its officers, and neither employees or agents. All documents filed by the Company or any of its Subsidiaries with the FDA nor or any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, Entity with respect to the Knowledge Product and any of the Company, threatened to initiate, any action to place a clinical hold order onProduct Candidates, or otherwise terminatethe manufacturing, handling, storage or shipment of the Product or any of the Product Candidates were, at the time of filing, true, complete and accurate in all material respects, no adverse event information has come to the attention of the Company or any of its Subsidiaries that is materially delay different in terms of the incidence, severity or suspend, nature of such adverse events than any which were filed as safety updates to the documents filed by the Company or any of its Subsidiaries with the FDA or any other Governmental Entity with respect to the Product and each of the Product Candidates and all written data summaries prepared by the Company or any of its Subsidiaries that were included in documents filed with the FDA or any other Governmental Entity with respect to the Product and each of the Product Candidates and that are based on clinical studies conducted or sponsored by the Company or any of its Subsidiaries accurately summarize in all material respects the corresponding raw data underlying such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialsummaries.
(il) The Company is not a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Governmental Entity.
(m) The Company has complied in all material respects with ICH-GCP guidelines in the management of the clinical data that has been presented to the Buyer.
(n) The Company has disclosed to the Buyer all material information known by the Company or any of its Subsidiaries with respect to the safety and efficacy of the Product and each of the Product Candidates from nonclinical and/or clinical studies.
(o) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of its Subsidiaries has received any written notice questioning the good standing with the FDA or any other Governmental Entity of any of the Company, nor, documents filed by the Company or any of its Subsidiaries with the FDA or any other Governmental Entity with respect to the Knowledge Product or any of the CompanyProduct Candidates or the manufacturing, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) handling, storage or shipment of the Company is a party to, Product or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAAProduct Candidates. The Company has been in compliance in made available to the Buyer complete and accurate copies of all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale documents filed by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects or any of its Subsidiaries with the payment requirements FDA or any other Governmental Entity with respect to the Product and each of Medicare the Product Candidates. The Company and its Subsidiaries have filed with the FDA and other Federal Health Care Program Lawsapplicable Governmental Entity all required notices, registration applications, order forms, reports, supplemental applications and annual or other reports or documents, including adverse experience reports, that are material to the continued development or handling of the Product or any of the Product Candidates.
Appears in 1 contract
Samples: Merger Agreement (Medicines Co /De)
Regulatory Matters. (a) The Each Subsidiary of the Company has all Permits required that generates, transmits, or distributes electric energy for sale is subject to regulation by FERC as a public utility under the FPA or as a public utility or public service company (or similar designation) by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreementrelevant state utility commission. The Company itself is a “holding company” under the sole and exclusive owner Public Utility Holding Company Act of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances)2005. The Company has not granted any third party any right or license to use, access or reference any Each Subsidiary of the Company Regulatory Filingsthat owns and operates natural gas pipe-lines and related facilities is not subject to, includingor is otherwise exempt from, without limitation, any regulation by FERC under the Natural Gas Act of 1938 and the Know-How contained in any Natural Gas Policy Act of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing1978.
(b) Except as set forth on Section 4.13(b) All filings required under Law to be made by the Company or any Subsidiary of the Company Disclosure Schedulewith FERC or any applicable state utility commissions, since January 1as the case may be, 2007have been timely made, there has including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and all such filings compiled, as of their respective dates, and currently comply, with all requirements of applicable Laws, except for filings the failure of which to make or the failure of which to make in compliance with all requirements of applicable Laws, have not been any voluntarily had or involuntarily initiatedwould not reasonably be expected to have, conductedindividually or in the aggregate, a Company Material Adverse Effect or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the a Company or product candidate of the CompanyImpairment Effect.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates Each Subsidiary of the Company against any Person that manufactures any componenthas all tariffs, ingredientservice agreements, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply rates or other collaboration arrangement Contracts on file with the Company (“Collaborative Partners”) by the FDA or any applicable Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating Entity required to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard legally entitled to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance operate its business and provide services in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
areas (ei) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating where it currently provides service to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authoritycustomers, and there are no proceedings pending or(ii) as identified in their respective tariffs, service agreements and other Contracts with its customers, except for failures to be so entitled, that, individually or in the Knowledge of the Companyaggregate, threatened that reasonably might be expected to result in criminal have not had or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would not reasonably be expected to provide have, individually or in the aggregate, a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Company Material Facts, Bribery, and Illegal Gratuities” Adverse Effect or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of a Company Impairment Effect. All charges by the Company or product candidates and the Subsidiaries of the Company that have not been reported to the FDA made for service and all related fees have been charged in accordance with applicable Law.
(h) To the Knowledge terms and conditions of the Company, all studies, tests, valid and preclinical effective tariffs or valid and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline enforceable agreements for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how tariff charges and processes to, are not subject to any required regulatory approvalsrefund, manufacture and market Dermagraft based on a new cell line except for failures to have made such charges or charged such fees that, individually or in the event that the current cell line is no longer viableaggregate, have not had or would not reasonably be expected to have a Company Material Adverse Effect or a Company Impairment Effect.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Merger Agreement (Avangrid, Inc.)
Regulatory Matters. (a) Since January 1, 2009, the Company has not received any written notices or statements from the United States Food and Drug Administration (the “FDA”), European Medicines Agency (the “EMEA”) or any other governmental agency, and otherwise has no knowledge, that any license, approval, permit or authorization to conduct any clinical trial of any product of the Company has been, will be or may be suspended, revoked, modified or limited, except as would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect.
(b) The Company has all Permits franchises, permits, licenses, and any similar authority, including without limitation all franchises, permits and licenses required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous materials, necessary for the conduct of its business as now being conducted by it and as currently proposed to conduct be conducted as disclosed in the Business SEC Reports, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect. The Company is not in violation of or default under any of such franchises, permits, licenses, or other similar authority, except where such violation or default would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect.
(c) In connection with the Company’s product candidates known as Marqibo, Alocrest, Brakiva and topical menadione (the “FDA PermitsInvestigational Products”). All , the Company has made available to the Lead Investor all (i) approved and pending new drug applications (including Section 505(b)(2) applications) and abbreviated new drug applications as of the FDA Permits held date hereof and (ii) all pre-clinical and clinical studies and trials and bioequivalence studies referenced in the Company’s investigational new drug applications, pending new drug applications (including Section 505(b)(2) applications) and abbreviated new drug applications previously or as of the date hereof currently undertaken or sponsored by the Company or issued any subsidiary of the Company. The Company has made available to the Lead Investor true, complete and accurate copies of all material data and reports with respect to such applications, studies and trials, and all other material information regarding the quality, efficacy and safety of the Investigational Products. The Company has made available to the Lead Investor all material correspondence and contact information between the Company, the FDA, EMEA and other Governmental Authorities regarding the Investigational Products, and, to the extent provided to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in or any material respect 30 under (and to the Knowledge subsidiary of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with material correspondence between the FDA, EMEA and other Governmental Authorities relating thereto, including but not limited to (1) reports of inspection observations from any biologics license applicationgovernmental authority related to manufacturing facilities where the Investigational Products are being manufactured, new drug applicationto the extent such report relates to a product, 510(k(2) submissionestablishment inspection reports from any Governmental Authority, premarket approvalto the extent such report relates to an Investigational Product, investigational new drug (3) any FDA Form 483s relating to the Investigational Products or investigational device exemption applicationany equivalent thereto from any Governmental Authority in any applicable jurisdiction, comparable (4) any minutes of meetings between the Company and FDA, EMEA or other governmental authorities regarding the Investigational Products and (5) any notice, warning letter, regulatory application letter, Section 305 notice, or filing made or held by or issued any other similar communication to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the subsidiaries stating that their businesses were or are in material violation of any law, clearance, Company Regulatory FilingsPermit, consent, guidance or guideline, or were or are the subject of any material pending or, to the knowledge of the Company, threatened Governmental Authority investigation, proceeding, review or inquiry.
(d) Except as would not result in a Material Adverse Effect, none of the Company, any of its subsidiaries or any officers or, to the Company’s knowledge, employees of the Company or any of its subsidiaries is currently, or has been convicted of any crime or been debarred pursuant to 21 U.S.C. Section 335a(a) or 21 U.S.C. Section 335a(b) or any similar law or to the Company’s knowledge, engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar law or authorized by 21 U.S.C. Section 335a(b), or been charged with or convicted under U.S. law for conduct relating to the development or approval, or otherwise relating to the regulation of any product that is a drug under the Generic Drug Enforcement Act of 1992, or any other relevant or analogous law in any applicable jurisdiction.
(e) None of the Company, any of its subsidiaries or any officers or, to the Company’s knowledge, employees of the Company or any of its subsidiaries is currently excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law, or otherwise made ineligible to participate in U.S. federal or state health care programs, or any other relevant or analogous law in any applicable jurisdictions or, to the Company’s knowledge, engaged in any conduct for which such person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law, or otherwise made ineligible to participate in U.S. federal or state health care programs, or any other relevant or analogous law in any applicable jurisdictions. Except as would not result in a Material Adverse Effect, none of the Company, any of its subsidiaries or any officers or, to the Company’s knowledge, employees of the Company or any of its subsidiaries is currently, or has violated or caused a violation of any federal or state health care fraud and abuse or false claims statute or regulation, including, without limitation, any the Medicare/Medicaid Anti-kickback provisions of the Know-How contained Social Security Act, 42 U.S.C. § 1320a-7b(b), and the relevant regulations in 42 C.F.R. Part 1001, or any other relevant or analogous law in any of applicable jurisdictions. Except as would not result in a Material Adverse Effect, neither the Company Regulatory Filings or rights (including nor any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedulesubsidiary, since January 1nor any officer, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending ornor, to the Knowledge of the Company’s knowledge, threatened regulatory Actions (other than non-material routine employee or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates agent acting on behalf of the Company or any subpoenas subsidiary, has, unless corrected in a subsequent statement, act or investigative demands disclosure made prior to the date hereof, made an untrue statement of a material fact or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard fraudulent statement to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by be disclosed to the FDA or any other Governmental Authority, and there are no proceedings pending oror committed an act, made a statement, or failed to make a statement that, at the Knowledge of the Companytime such disclosure was made, threatened that would reasonably might be expected to violate the FDA policy respecting “Fraud, Untrue Statements of Material Fact, Bribery, and Illegal Gratuities,” set forth in 56 Fed Reg. 46191 (September 10, 1991) or any similar policy or other relevant or analogous law in any applicable jurisdiction. Except as would not result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company ora Material Adverse Effect, to the Knowledge none of the Company, any of its Collaborative Partners has committed subsidiaries or any actofficers or, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “FraudCompany’s knowledge, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products employees of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partnerssubsidiaries has provided any false or fraudulent information to the Centers for Medicare & Medicaid Services, are beingany of its contractors, and at all times have beenor Part D prescription drug plans, conducted in compliance in all material respects with all applicable Lawsfor any purpose, including, as applicablebut not limited to, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws coverage of any other Governmental Authorityof its products or the setting of any reimbursement rates. No clinical trial conducted by the Company orExcept as would not result in a Material Adverse Effect, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge none of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of its subsidiaries or any officers or, to the Company’s knowledge, employees of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement of its subsidiaries has provided any false or other formal fraudulent information to any compendia that are used by any Federal healthcare program to establish coverage or informal agreement with payment for any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company’s products. Except as would not result in a Material Adverse Effect, nor, to the Knowledge none of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of its subsidiaries or any officers or, to the Company’s knowledge, employees of the Company or any of its subsidiaries has furnished any false or fraudulent reimbursement advice to any actual or potential customer, or has indicated how any actual or potential customer could profit from seeking reimbursement for any of the Company: (i) has been debarred’s products. Except as would not result in a Material Adverse Effect, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge each of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating its subsidiaries’ officers and, to the delivery Company’s knowledge, employees of an item the Company or service under any Federal Health Care Program
(k) The Company reasonably believes that it has of its subsidiaries, are all in material compliance with the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based PhRMA Code on a new cell line in the event that the current cell line is no longer viableInteractions with Healthcare Professionals.
(lf) To Except as would not result in a Material Adverse Effect, none of the Knowledge Investigational Products manufactured, tested, distributed, held and/or marketed by the Company or any of its subsidiaries has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise) since the date such product was acquired by the Company or one of its subsidiaries. Except as would not result in a Material Adverse Effect, no proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product or pre-market approvals or marketing authorizations of any such product are pending, or to the knowledge of the Company, there are no pending or threatened filings threatened, against the Company or any of an action relating to its subsidiaries, nor have any such proceedings been pending at any time since the date such product was acquired by the Company under any federal or state whistleblower statute, including under the False Claims Act one of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAAits subsidiaries. The Company has been in compliance in provided or made available to the Lead Investor all material respects with federal current U.S. annual periodic reports and state data breach Laws.
(n) To all information about adverse drug experiences obtained or otherwise received by the extent Company, in each case since December 31, 2006, from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific papers, relating to any product or, to the Company’s knowledge, Investigational Product manufactured, tested, distributed, held and/or marketed by the Company, any of its subsidiaries in the possession of the Company provides reimbursement coding or billing advice regarding products offered any of its subsidiaries, except for sale by the Company and procedures related thereto, such advice is and has been true and complete any adverse drug experiences or reports which would not result in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsa Material Adverse Effect.
Appears in 1 contract
Samples: Securities Purchase Agreement (Hana Biosciences Inc)
Regulatory Matters. (ai) The All of the Company’s operations have in the past three years complied and do comply in all material respects with the applicable requirements of the U.S. Food and Drug Administration (“FDA”) and Drug Enforcement Agency (“DEA”), (ii) the Company has all Permits material licenses and permits required by for manufacturing or placing the Company’s products on the market in the United States and no license or permit has been revoked or terminated, (iii) in the past three years, the Company has not received any written notice that it is subject to any pending or threatened civil, criminal or administrative action, suit or proceeding from the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued any similar Governmental Authority that is adverse to the Company including a consent decree, injunction, or suspension of manufacturing, (iv) all manufacturing facilities of the Company are operated in full force material compliance with the Federal Food, Drug, and effectCosmetic Act of 1938 (“FD&C Act”) and its implementing regulations, (v) the Company is in material compliance in with all material respects withapplicable requirements of the FDA and FD&C Act pertaining to registration, record-keeping, reporting, listing, labeling, advertising and promotion, pre- and post-marketing adverse event reporting, and is not manufacturing requirements, in default in any material respect 30 under (and each case to the Knowledge of extent applicable to the Company, no event which with and (vi) the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted in the past three years introduced into commercial distribution any third party any right or license to use, access or reference any of Company products that upon their shipment by the Company Regulatory Filings, including, without limitation, any of were adulterated or misbranded as defined by the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingFD&C Act.
(b) Except as set forth on Section 4.13(b) of In the Company Disclosure Schedulepast three years, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate none of the Company’s products has been recalled or subject to FDA or other Governmental Authority correction or removal requirements or other field action, and the Company has not received in the past three years written notice from the FDA or another Governmental Authority of any proceeding seeking a recall, correction, removal, other field action, or seizure of any products.
(c) The Company is in compliance in has made available to Buyer true, correct and complete copies of (i) all material respects customer complaints relating to any company Products and all MedWatch forms received by the Company or filed with the FDA during the past three years; (ii) all applicable Laws and any other warning letters, untitled letters, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs), or guidances issued by other material correspondence, including meeting minutes, relating to the Company’s products’ compliance with, and the Company’s compliance with, applicable Laws from the FDA or any other Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge and all of the Company, threatened regulatory Actions ’s written responses thereto in the past three years; and (other than non-material routine or periodic inspections or reviewsiii) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no all written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating audit reports issued to the Company or in the products or product candidates past three years pertaining to assessment of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered with current Good Manufacturing Practice (cGMP) requirements by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in material compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, Bribery and Illegal Gratuities,” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 5856 Fed. Reg. 46191 (Sept. 10, good clinical practices1991) and any similar laws, as defined rules, regulations or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authoritypolicies. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge knowledge of the Company, the Company is has not under investigation by made any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”)materially false statements on, or material omissions from, any notifications, reports and other submissions to the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, FDA or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawssimilar Governmental Authority.
(ne) To As of the extent date hereof, neither the Company provides reimbursement coding or billing advice regarding products offered for sale nor, to the knowledge of the Company, any individual employed by the Company and procedures related theretoCompany, such advice is and has been true and complete in all material respects and in compliance in all material respects with disqualified or debarred by the payment requirements FDA pursuant to the FD&C Act, or been convicted under U.S. Law for misconduct relating to the development, approval, marketing or sale of Medicare and other Federal Health Care Program Lawspharmaceutical products, including the products manufactured by the Company.
Appears in 1 contract
Samples: Membership Interest Purchase Agreement (Albany Molecular Research Inc)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued Except as would not be material to the Company Group, taken as a whole: (i) the Company Products are in full force and effect, compliance with all current applicable Device Regulatory Laws; (ii) each member of the Company Group is in compliance in with all material respects withapplicable Device Regulatory Laws relating to the sourcing, procurement, and is not in default in any material respect 30 under (the import of raw materials for the Company Products and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permitmethods and materials used in, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole facilities and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectivelycontrols used for, the “Company Regulatory Filings”) design, manufacture, processing, packaging, labeling, storage, distribution, export, and holds all rightimport, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to useif applicable, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any Products; (iii) each member of the Company Group has received confirmation from the Notified Body that a formal application for conformity assessment of the Company Products has been accepted and that the Company Products may continue to be placed on the market of the European Union countries until December 31, 2028; and (iv) since January 1, 2021, all such raw materials and all Company Products have been sourced, procured, processed, manufactured, packaged, labeled, stored, handled, distributed, exported, and imported, if applicable, by the Company Group in compliance with all applicable Device Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingLaws.
(b) Except as set forth would not be material to the Company Group, taken as a whole: (i) all preclinical and clinical investigations sponsored by or on Section 4.13(b) behalf of a member of the Company Disclosure ScheduleGroup with respect to any Company Product are being, and since January 1, 20072021, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance with applicable Device Regulatory Laws, including Good Clinical Practices and Good Laboratory Practices requirements, and federal and state Laws restricting the use and disclosure of individually identifiable health information; and (ii) each member of the Company Group complies with, and since January 1, 2021, has complied with, all requirements under the Laws relating to monitoring and reporting of adverse events during clinical trials.
(c) No action has been taken by any Governmental Authority or is in all the process of being taken that would slow, halt or enjoin the development, manufacturing, or marketing of the Company Products or the operation of the business of the Company Group or subject the development, manufacturing, or marketing of the Company Products or a member of the Company to regulatory enforcement action.
(d) Except as would not be material respects to the Company Group, taken as a whole, since January 1, 2021, the members of the Company Group have maintained records relating to the development, manufacture, testing, storage, handling, labeling, packaging, sale, marketing, promotion, distribution, import or export of the Company Products in material compliance with all applicable Device Regulatory Laws. Except as would not be material to the Company Group, includingtaken as a whole, each member of the Company Group and each of their respective contractors and agents have submitted to FDA, Notified Bodies and all other applicable regulatory authorities, institutional review boards, or accreditation bodies, all required supplemental applications, 510(k) premarket notifications, CE Mark applications, pre-market approval applications and de novo classification requests, as applicable, good laboratory practice regulations set forth notices, filings and annual or other reports and information.
(e) Except as would not be material to the Company Group, taken as a whole, since January 1, 2021, all manufacturing operations for the Company Products conducted by or on behalf of a member of the Company Group have been and are being conducted in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by compliance with the QSR and any similar requirements of the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, Notified Bodies and any other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812Company Product regulatory authority, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to Products are not adulterated within the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.meaning of
Appears in 1 contract
Samples: Merger Agreement (Atrion Corp)
Regulatory Matters. (ai) The Company has Asset Sellers and each of the Target Companies and the Target Subsidiaries are in compliance with all Permits required by applicable Laws of the United States and each foreign jurisdiction, including of the rules and regulations of the FDA and any governmental agency of any other country having jurisdiction of the Manufacturing Facilities or the manufacture, sale, labeling, storing, testing and distribution of the Products, as applicable (each, a “Regulatory Authority”), with respect to the manufacture, sale, labeling, storing, testing and distribution of the Products, except for such instances of noncompliance that would not, individually and in the aggregate, have a Material Adverse Effect. Each of the Target Companies and the Target Subsidiaries have all material permits, approvals, registrations and licenses related to the Manufacturing Facilities from the Regulatory Authorities to conduct the Business as currently conducted.
(the “FDA Permits”ii) Since January 1, 2003 (or its date of formation, if later). All , none of the FDA Permits held by Asset Sellers or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Target Companies or the Target Subsidiaries is in receipt of notice of, has been or is subject to, any adverse inspection, compelled or voluntary recall, investigation, penalty for corrective or remedial action or corrective action plan, in each case relating to the Products or the Manufacturing Facilities by the Regulatory FilingsAuthorities, includingincluding compliance with current good manufacturing practices as regulated and/or required by the Regulatory Authorities, without limitationexcept for such instances which would not, individually and in the aggregate, have a Material Adverse Effect.
(iii) As of the date of this Agreement, there are no pending actions, suits, proceedings, hearings, investigations, charges, claims, demands, notices or complaints by the Regulatory Authorities relating to the Manufacturing Facilities or the Products.
(iv) None of the Asset Sellers or any of the Know-How contained in any of Target Companies or the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure ScheduleTarget Subsidiaries has received, since January 1, 20072003 (or its date of formation, there has not been if later), any voluntarily written notification, that remains unresolved, from any Regulatory Authorities indicating that any Product is misbranded or involuntarily initiatedadulterated as defined in the FDA Act and the rules and regulations promulgated thereunder or any similar Law, conductedexcept for such instances which would not, or issued recallindividually and in the aggregate, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack have a Material Adverse Effect. The Asset Sellers and the Target Table of safety or efficacy of any product of Contents Companies and the Company or product candidate of Target Subsidiaries have properly handled and stored all Products included in the Company.
(c) The Company is Inventory in compliance in all material respects with all applicable Laws and any other letters, notices none of the Products included in the Inventory are misbranded or guidances issued by adulterated as defined in the FDA Act and the rules and regulations promulgated thereunder or any Governmental Authority similar Law, except for such instances which regulates would not, individually and in the sale of pharmaceutical products or biologicalaggregate, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to have a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyMaterial Adverse Effect.
(dv) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined This representation does not relate to Tax matters, employee benefit matters, environmental matters or labor matters, which are covered by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806Sections 4(i), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803n), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents (o) and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”p), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsrespectively.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company Except as has not been, and would not reasonably be expected to be, materially adverse to the Business, (i) Seller and all Permits Divesting Entities hold all Product Registrations, necessary for the lawful operation of the Business including all applicable authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the "FDCA"), and the regulations promulgated thereunder, and any other the Food and Drugs Act, as amended (the "Food and Drugs Act"), and any other authorization required by Governmental Authority that is concerned with the FDA to conduct the Business (the “FDA Permits”). All quality, identity, strength, purity, safety, efficacy, testing, manufacturing, sale or distribution, sale, import or export, as applicable, of each of the FDA Permits held by or issued to Products in the Company Territory (any such Governmental Authority, a "Regulatory Agency") and (ii) all such Product Registrations are valid and in full force and effect. Since ***, the Company is except as set forth in compliance in all material respects withSchedule 5.20(a), and is there has not in occurred any violation of, default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of or without notice or lapse of timetime or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, of any Product Registration, except as has not had and would become a default under), not reasonably be expected to be materially adverse to the Business. Seller and each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is Divesting Entities are in compliance in all material respects with the terms of all applicable Laws Product Registrations, and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending orevent has occurred that, to the Knowledge of the CompanySeller, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted expected to result in a penalty under or the revocation, cancellation, non-renewal or adverse modification of any Product Registration, except as raising a compliance concern sent or delivered by any Governmental Authority with regard has not been and would not reasonably be expected to any product of be materially adverse to the Company or any product candidate of the CompanyBusiness.
(db) The manufacture With respect to the Business, each of Seller and the products of the Company is being conducted Divesting Entities are in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, includingterms of the ***.
(c) Neither Seller nor any of the Divesting Entities has received any written information from the FDA which would reasonably be expected to lead to the denial of any application for marketing approval currently pending before the FDA relating to the Business.
(d) Seller and the Divesting Entities, as applicable, have completed and filed all reports, documents, claims, permits and notices required by any Regulatory Agency in order to maintain the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is Product Registrations, except where failure to file such reports would not have a Material Adverse Effect. To the Knowledge of Seller, all such reports, documents, claims, permits and has been in compliance notices were complete and accurate in all material respects with all Laws requiring on the maintenance date filed (or submission were corrected in or supplemented by a subsequent filing). With respect to the Business, neither Seller nor any of reports the Divesting Entities, nor any officer, employee, agent or records under requirements administered by distributor of Seller or any of the Divesting Entities, has made an untrue statement of a material fact or a fraudulent statement to the FDA failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ," set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA, or any other Governmental Authority Regulatory Agency to invoke any similar policy.
(g) There have been no Serious Adverse Events. With respect to the Business, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) neither Seller nor any of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the CompanyDivesting Entities, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) agent or distributor of Seller or any of the CompanyDivesting Entities, nor, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. With respect to the Knowledge Business, neither Seller nor any of the CompanyDivesting Entities, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) agent or distributor of Seller or any of the CompanyDivesting Entities, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded convicted of any crime or suspended from participation engaged in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7or any similar Law or program. No Regulatory Agency has commenced or, to Knowledge of Seller, threatened to initiate any action alleging any violations of any federal, state or local or any payor "fraud and abuse," consumer protection and false claims statutes and regulations or any pricing or rebate reporting requirements or to seek exclusion, whether voluntary or otherwise, of Seller, its employees, and/or Seller's Relevant Affiliates from participation in any federally or state-funded program. Neither Seller nor, to Knowledge of Seller, any employee of Seller or Divesting Entity, has received any written notice to such effect.
(e) Since ***, each of Seller and the United States Code Divesting Entities have neither voluntarily nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field alerts, field corrections, market withdrawal or replacement, safety alert, warning, "dear doctor" letter, investigator notice, safety alert, or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product. Each of Seller and the Divesting Entities are not aware of any facts which are reasonably likely to cause (i) the “Social Security Act”); recall, market withdrawal or replacement of any Product sold or intended to be sold by Seller or the Divesting Entities, (ii) a change in the marketing classification or a material change in the labeling of any such Products, or (iii) is currently listed on a termination or suspension of the General Services Administration published list marketing of parties excluded from federal procurement programs and such Products.
(f) Since ***, neither Seller nor any of the Divesting Entities has received any written notice that any Regulatory Agency has (i) commenced, or threatened to initiate, any action to request the recall of any Product sold or intended to be sold by Seller or the Divesting Entity, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Product sold or intended to be sold by Seller or the Divesting Entities or (iii) issued any demand letter, finding of deficiency or non-procurement programs; compliance or adverse inspection report in respect of any Product or the Business.
(ivg) Since ***, except as set forth on Schedule 5.20, neither Seller nor any of the Divesting Entities has received any warning letters from the FDA or any other Regulatory Agency regarding inappropriate advertising or marketing of a Product or any written notice of any actual or potential violation of law or regulation with respect to any Product or product candidate, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Business.
(h) Since ***, except as set forth on Schedule 5.20, there have been no audits, inspections, examinations or, to the Knowledge of the CompanySeller, is the target or subject investigations of any current investigation records by a Governmental Authority relating to any Federal Health Care Program-related offense; or (vother than in respect of Taxes) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), Business or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsPurchased Assets.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Asset Purchase Agreement (Valeant Pharmaceuticals International, Inc.)
Regulatory Matters. (a) The Company has To Sellers’ Knowledge, Sellers hold all Permits Product Registrations necessary for the lawful operation of the Business as currently conducted including all applicable authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended, and the regulations promulgated thereunder, the Food and Drug Act, as amended, and any other authorization required by a Governmental Authority in the FDA to conduct U.S. that is concerned with the Business quality, identity, strength, purity, safety, efficacy, testing, manufacturing, sale or distribution, sale, import or export, as applicable, of the Product (the any such Governmental Authority, a “FDA PermitsRegulatory Agency”). All of the FDA Permits held by or issued to the Company such Product Registrations and Governmental Authorizations are valid and in full force and effect. In the past three (3) years there has not occurred any violation of, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of or without notice or lapse of timetime or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to useProduct Registration, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating and would not reasonably be expected to an alleged material lack of safety or efficacy of any product of be materially adverse to the Company or product candidate of the Company.
(c) The Company is Business. Sellers are in compliance in all material respects with the terms of all applicable Laws Product Registrations, and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending orevent has occurred that, to the Knowledge of the CompanySellers’ Knowledge, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal a penalty under or civil liability the revocation, cancellation, non-renewal or debarment adverse modification of any Product Registration, except as would not be material with respect to the Purchased Assets.
(b) Sellers have made available to Purchaser complete and correct copies of all written information to the extent related to the Product and the Laser received by Sellers from any Regulatory Agency which would reasonably be expected to result in the revocation, cancellation, non-renewal or disqualification material modification of any Product Registration except as would not be material with respect to the Product, the Laser and the Purchased Assets.
(c) Sellers have completed and filed all material reports, documents, claims, permits and notices required by any Regulatory Agency in order to maintain the Product Registrations. To Sellers’ Knowledge, all such reports, documents, claims, permits and notices were complete and accurate in all respects on the date filed (or were corrected in or supplemented by a subsequent filing). With respect to the Purchased Assets, none of Sellers, their Affiliates or any of their officers or employees, and to Sellers’ Knowledge, none of Sellers’ agents or distributors, has made an untrue statement of a material fact or a fraudulent statement to the FDA, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA, or any other Governmental Authority Regulatory Agency to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported . With respect to the FDA in accordance with applicable Law.
(h) To the Knowledge Purchased Assets, none of the CompanySellers, all studies, tests, and preclinical and clinical research being conducted by the Companytheir Affiliates or any of their officers or employees, and to Sellers’ Knowledge, none of Sellers’ agents or distributors, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. With respect to the Knowledge Business, none of the CompanySellers, on behalf of the Company by their Affiliates or any of its Collaborative Partners, are beingor their officers or employees, and at all times have beento Sellers’ Knowledge, conducted in compliance in all material respects with all applicable Lawsnone of Sellers’ agents or distributors, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws has been convicted of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated crime or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated engaged in any conduct for which such clinical trial has initiated, or, to Person could be excluded from participating in the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her federal health care programs under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7or any similar Law or program. No Regulatory Agency has commenced or, to Sellers’ Knowledge, threatened to initiate any action alleging any violations of any federal, state or local or any payor “fraud and abuse,” consumer protection and false claims statutes and regulations or any pricing or rebate reporting requirements or to seek exclusion, whether voluntary or otherwise, of Sellers, their employees, and/or their Affiliates from participation in any federally or state-funded program. None of Sellers or, to Sellers’ Knowledge, any employee of any Seller, has received any written notice to such effect.
(d) In the United States Code past three (3) years, none of Sellers or any of their Affiliates has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field alerts, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert, or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of the “Social Security Act”); Product. No Seller is aware of any facts which are reasonably likely to cause (i) the recall, market withdrawal or replacement of Product or Lasers sold or intended to be sold by Seller or any of its Affiliates, (ii) a change in the marketing classification or a material change in the labeling of the Product, or (iii) is currently listed on a termination or suspension of the General Services Administration published list marketing of parties excluded from federal procurement programs and the Product or the Laser.
(e) In the past three (3) years, no Seller or, to Sellers’ Knowledge, any other Person has received any written notice that any Regulatory Agency has:
(i) commenced, or threatened to initiate, any action to request the recall of any Product or Laser sold by Sellers;
(ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Product or Laser sold or intended to be sold by Sellers; or
(iii) issued any demand letter, finding of deficiency or non-procurement programs; compliance or adverse inspection report (ivincluding any FDA Form 483s, FDA Notices of Adverse Findings, Untitled Letters, or Warning Letters) in respect of the Product or Laser.
(f) No Seller has received any written information from the FDA which would reasonably be expected to lead to the Knowledge denial of any application for marketing approval currently pending before the FDA relating to the Product or Laser.
(g) In the past three (3) years, no Seller has received any warning letters from the FDA or any other Regulatory Agency regarding inappropriate advertising or marketing of the Company, is the target Product or subject Laser or any written notice of any current investigation actual or potential violation of law or regulation with respect to the Product or Laser.
(h) In the past three (3) years, there have been no audits, inspections, examinations or, to Sellers’ Knowledge, investigations of records by a Governmental Authority relating to any Federal Health Care Program-related offense; or (vother than in respect of Taxes) is currently charged with or convicted of any criminal offense relating to the delivery of an item Products or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableLaser.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required FCC Licenses and PUC Authorizations held or managed by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company Restricted Companies are valid and in full force and effecteffect without conditions except for such conditions as are generally applicable to holders of FCC Licenses and such Authorizations or that, individually or in the Company is aggregate, could not reasonably be expected to result in compliance in all material respects witha Material Adverse Effect. No event (including the pendency of any petition to deny, informal objection, petition to revoke, or other complaint, investigation or proceeding before the FCC or any PUC) has occurred and is not continuing which could reasonably be expected to result in default in any material respect 30 under (and to the Knowledge forfeiture or the revocation, termination or adverse modification of, or of the CompanyRestricted Companies rights under, no event which any FCC License or PUC Authorization held or managed by a Restricted Company except (a) for modifications to any FCC Licenses in connection with the giving of notice Re-Banding Proceeding or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect. None of the Company Disclosure Schedule, since January 1, 2007, there Restricted Companies has not been any voluntarily reason to believe or involuntarily initiated, conducted, has any knowledge that the FCC Licenses and PUC Authorizations held or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating managed by the Restricted Companies that are material to an alleged material lack of safety or efficacy of any product the Mobile Communications Business of the Company Restricted Companies will not be renewed in the ordinary course, except for such non-renewals (a) in connection with the Re-Banding Proceeding or product candidate (b) that could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The current ownership and operation by each of the Company.
(c) The Company is in compliance in Restricted Companies of its Mobile Communications Business comply with the Communications Act of 1934, as amended, and all material respects with all applicable Laws rules, regulations and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge policies of the CompanyFCC, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, any PUC and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, includingexcept for such non-compliance that could not, for avoidance of doubtindividually or in the aggregate, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policyAdverse Effect.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All Section 3.24(a) of the FDA Permits held Company Disclosure Letter sets forth a true and complete list of each Permit received by (or issued to applied for by) the Company are or any of its Subsidiaries from the FCC, any State PUC, foreign regulatory authorities or other Governmental Authority to own or operate businesses regulated by Communications Laws. Except as set forth on Section 3.24(a) of the Company Disclosure Letter and except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, as of the date of this Agreement, each Permit is valid and in full force and effecteffect in accordance with its terms, and there is no outstanding written notice of cancellation, termination, modification, or notice of apparent liability or any written threatened cancellation, termination or modification in connection therewith nor are any of such Permits subject to any restrictions or conditions that limit the operations of the Company or any of its Subsidiaries (other than restrictions or conditions generally applicable to Permits of that type).
(b) Since January 1, 2014 through the date of this Agreement, and except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, the Company is and its Subsidiaries have taken all steps reasonably necessary to maintain and preserve the effectiveness of the Permits.
(c) Except as would not, individually or in compliance in all material respects withthe aggregate, and is not in default in any material respect 30 under (and reasonably be expected to have a Company Material Adverse Effect, as of the date of this Agreement, there are no existing or, to the Knowledge of the Company, threatened Legal Actions before any Governmental Authority, including the FCC and the State PUCs, regarding the Permits or the operations of the Company of any of its Subsidiaries (except Legal Action of general applicability to the industry and not specific to the Company or its Subsidiaries), that would reasonably be expected to result in the revocation, cancellation, suspension, nonrenewal, placement of material restrictions on, or material adverse modification of any of, the Permits that would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company is not aware of any fact relating to its or any of its Subsidiaries’ respective businesses, operations (including but not limited to operations in foreign jurisdictions), financial condition, direct or indirect foreign ownership or control, or legal status, including any officer’s, director’s or current employee’s status, that might reasonably be expected to impair the ability of the parties to this Agreement to obtain, on a timely basis, any authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority or third party necessary for the consummation of the transactions contemplated by this Agreement, or that might result in one or more material conditions being placed on any such authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority (including the FCC and any State PUC) or third party necessary for the consummation of the transactions contemplated by this Agreement.
(d) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, as of the date of this Agreement, to the Company’s Knowledge, no event which with the giving of has occurred that results in, or after notice or lapse of time, or both, would become a default under)reasonably be expected to result in the revocation, each such Permitcancellation, and none suspension, nonrenewal, placement of such Permits will be terminated restrictions on, or impaired or become terminable, in whole or in part, as a result material adverse modification of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Permits.
(e) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Regulatory FilingsMaterial Adverse Effect, includingto the Company’s Knowledge, without limitationthe Company’s Subsidiaries are not in violation of any Communications Laws. Except as would not, any of individually or in the Know-How contained in any aggregate, reasonably be expected to have a Company Material Adverse Effect, each of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company and its Subsidiaries is in compliance in all material respects with the Communications Laws applicable to, and the terms and conditions of, any Permit, and have all applicable Laws Permits from, have made all required filings with, and have made all required payments due to, all Governmental Authorities, including any other lettersstate regulatory authority, notices or guidances issued by the FDA or FCC and the Universal Service Administrative Company (in connection with any Governmental Authority which regulates the sale of pharmaceutical products or biologicalfederal Universal Service Fund assessments and contributions), device or regenerative medicine products in any jurisdiction. There are no pending or, required to the Knowledge conduct their respective businesses as presently conducted as of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviewsdate of this Agreement. Except as set forth in Section 3.24(e) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any componentDisclosure Letter, ingredientthere is not pending, or material used in manufacturing to the products or the product candidates of the Company pursuant to a developmentCompany’s Knowledge threatened, commercializationany audits, manufacturingexaminations, supply investigations, or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products proceedings in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged such filing and/or reporting requirements, in any conduct each case, which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported be material to the FDA in accordance with applicable LawCompany.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Merger Agreement (Inteliquent, Inc.)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All Section 3.24(a) of the FDA Permits held Company Disclosure Letter sets forth a true and complete list of each Permit received by (or issued to applied for by) the Company are or any of its Subsidiaries from the FCC, any State PUC, foreign regulatory authorities or other Governmental Authority to own or operate businesses regulated by Communications Laws. Except as set forth on Section 3.24(a) of the Company Disclosure Letter and except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, as of the date of this Agreement, each Permit is valid and in full force and effecteffect in accordance with its terms, and there is no outstanding written notice of cancellation, termination,modification, or notice of apparent liability or any written threatened cancellation, termination or modification in connection therewith nor are any of such Permits subject to any restrictions or conditions that limit the operations of the Company or any of its Subsidiaries (other than restrictions or conditions generally applicable to Permits of that type).
(b) Since January 1, 2014 through the date of this Agreement, and except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, the Company is and its Subsidiaries have taken all steps reasonablý necessary to maintain and preserve the effectiveness of the Permits.
(c) Except as would not, individually or in compliance in all material respects withthe aggregate, and is not in default in any material respect 30 under (and reasonably be expected to have a Company Material Adverse Effect, as of the date of this Agreement, there are no existing or, to the Knowledge of the Company, threatened Legal Actions before any Governmental Authority, including the FCC and the State PUCs, regarding the Permits or the operations of the Company of any of its Subsidiaries (except Legal Action of general applicability to the industry and not specific to the Company or its Subsidiaries), that would reasonably be expected to result in the revocation, cancellation, suspension, nonrenewal, placement of material restrictions on, or material adverse modification of any of, the Permits that would not, individuallyor in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company is not aware of any fact relating to its or any of its Subsidiaries' respective businesses, operations (including but not limited to operations in foreign jurisdictions),financial condition, direct or indirect foreign ownership or control, or legal status, **MSPSC Electronic Copy ** 2016-UA-225 Filed on 11/14/2016 ** including any officer's, director's or current employee's status, that might reasonably be expected to impair the ability of the parties to this Agreement to obtain, on a timely basis, any authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority or third party necessary for the consummation of the transactions contemplated by this Agreement, or that might result in one or more material conditions being placed on any such authorization, consent, Order, declaration or approval of, or ability to contract with, any GovernmentalAuthority (including the FCC and any State PUC) or third party necessary for the consummation of the transactions contemplated by this Agreement.
(d) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, as of the date of this Agreement, to the Company's Knowledge, no event which with the giving of has occurred that results in, or after notice or lapse of time, or both, would become a default under)reasonably be expected to result in the revocation, each such Permitcancellation, and none suspension, nonrenewal, placement of such Permits will be terminated restrictions on, or impaired or become terminable, in whole or in part, as a result material adverse modification of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Permits.
(e) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Regulatory FilingsMaterial Adverse Effect, includingto the Company's Knowledge, without limitationthe Company's Subsidiaries are not in violation of any Communications Laws. Except as would not, any of individually or in the Know-How contained in any aggregate, reasonably be expected to have a Company Material Adverse Effect, each of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company and its Subsidiaries is in compliance in all material respects with the Communications Laws applicable to, and the terms and conditions of, any Permit, and have all applicable Laws Permits from, have made all required filings with, and have made all required payments due to, all Governmental Authorities, including any other lettersstate regulatory authority, notices or guidances issued by the FDA or FCC and the Universal Service Administrative Company (in connection with any Governmental Authority which regulates the sale of pharmaceutical products or biologicalfederal Universal Service Fund assessments and contributions), device or regenerative medicine products in any jurisdiction. There are no pending or, required to the Knowledge conduct their respective businessesas presently conducted as of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviewsdate of this Agreement. Except as set forth in Section 3.24(e) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any componentDisclosure Letter, ingredientthere is not pending, or material used in manufacturing to the products or the product candidates of the Company pursuant to a developmentCompany's Knowledge threatened, commercializationany audits, manufacturingexaminations, supply investigations, or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products proceedings in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged such filing and/or reporting requirements, in any conduct each case, which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported be material to the FDA in accordance with applicable LawCompany.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Agreement and Plan of Merger
Regulatory Matters. (a) The Company has and each of its Subsidiaries possesses all Permits required by material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (“Regulatory Authorizations”) from the FDA to conduct the Business U.S. Food and Drug Administration (the “FDA PermitsFDA”). All of the FDA Permits held by or issued ) and all other applicable Governmental Bodies relating to the Company’s and each of its Subsidiaries’ products and product candidates (“Company Products”) or that are necessary for the Company or any of its Subsidiaries to conduct its business in all material respects as presently conducted. Except as would not reasonably be expected to have a Material Adverse Effect, (i) all such Regulatory Authorizations are (A) in full force and effect, (B) validly registered and on file with applicable Governmental Bodies and (C) in compliance with all formal filing and maintenance requirements and (ii) the Company is in compliance in and each of its Subsidiaries has fulfilled and performed all of its material respects withobligations with respect to such Regulatory Authorizations, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event has occurred which with the giving of allows, or after notice or lapse of timetime would allow, revocation or both, termination thereof. Except as would become a default under), each such Permit, and none of such Permits will not reasonably be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued expected to be material to the Company, (1) the Company and each of its Subsidiaries has filed, maintained or furnished to FDA or other applicable Governmental Bodies all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (collectively, the “Company Regulatory Filings”including all adverse event/experience reports) and holds (2) all right, title such submissions were complete and interest accurate and in and to all Company Regulatory Filings free and clear of any Encumbrance compliance with applicable Legal Requirements when filed (other than Permitted Encumbrancesor were corrected or completed in a subsequent filing). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedulewould not reasonably be expected to have a Material Adverse Effect, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of all preclinical and clinical investigations sponsored by the Company or product candidate any of its Subsidiaries are being conducted in material compliance with applicable Legal Requirements, rules, regulations and guidances, including Good Clinical Practices. Neither the FDA nor any other Governmental Body performing functions similar to those performed by the FDA has sent any written notices or other correspondence to the Company or any of its Subsidiaries with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. Neither the Company nor any of its Subsidiaries has received any written notifications from any institutional review board, ethics committee or safety monitoring committee raising any material issues that require or would require the termination, suspension or investigation of, or seeking to place a clinical hold order on or otherwise delay or materially restrict any, clinical studies proposed or currently conducted by, or on behalf of, the Company or any of its Subsidiaries, and, to knowledge of the Company, no such action has been threatened. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of and reasonably available to the Company or any of its Subsidiaries and all material written correspondence that exists as of the date of this Agreement between the Company or any of its Subsidiaries and the applicable Governmental Bodies, in each case with respect to any clinical studies proposed or currently conducted by, or on behalf of, the Company or any of its Subsidiaries.
(c) The To the knowledge of the Company, neither the Company is in compliance in all nor any of its Subsidiaries has (i) made an untrue statement of a material respects with all applicable Laws and any other letters, notices fact or guidances issued by fraudulent statement to the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologicalBody, device or regenerative medicine products in any jurisdiction. There are no pending or, (ii) failed to the Knowledge of the Company, threatened regulatory Actions (other than non-disclose a material routine or periodic inspections or reviews) against the Company, and fact required to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining be disclosed to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(diii) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or committed any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement statement, that would reasonably be expected to provide (in any such case) establishes a reasonable basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) Gratuities Final Policy. As of the products date of this Agreement, neither the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by nor any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by Subsidiaries is the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws subject of any other Governmental Authority. No clinical trial conducted by the Company pending or, to the Knowledge Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of the CompanyMaterial Facts, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasonsBribery, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Illegal Gratuities Final Policy. Neither the Company nor or any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, its Subsidiaries nor, to the Knowledge knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) officers, employees, agents or clinical investigators of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) its Subsidiaries has been debarred, excluded suspended or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with debarred or convicted of any criminal offense relating crime or engaged in any conduct that would reasonably be expected to the delivery of an item result in (A) debarment under 21 U.S.C. Section 335a or service any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viablesimilar Legal Requirement.
(ld) To the Knowledge of the CompanyExcept as would not reasonably be expected to have a Material Adverse Effect, there are no pending or threatened filings against the Company and each of an action relating its Subsidiaries is and since January 1, 2019, has been in compliance with all healthcare laws applicable to the Company under any federal or state whistleblower statuteoperation of its business as currently conducted, including under (i) any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
; (mii) To the Knowledge of the CompanyFederal Food, the Company is not under investigation by any Governmental Authority for a violation of Drug and Cosmetics Act (“FDCA”); (iii) the Health Insurance Portability and Accountability Act of 1995, as amended by 1996 and the Health Information and Technology for Economic and Clinical Health Act (collectively “HIPAA”); (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) Legal Requirements relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the regulations contained in 45 C.F.R. Parts 160 and 164foregoing, including receiving by the Company or any notices from of its Subsidiaries. Neither the United States Department Company nor any of Health and Human Services Office of Civil Rights relating its Subsidiaries is subject to any enforcement, regulatory or administrative proceedings regarding compliance with healthcare laws and, to the knowledge of the Company, no such violationsenforcement, regulatory or administrative proceeding has been threatened. To the knowledge of the Company, neither the Company nor any comparable state of its Subsidiaries has had any unauthorized use or local Laws. The Company is not a disclosure of “covered entityprotected health information” (as that such term is defined in used under HIPAA. The ) that would constitute a security incident or breach that would require the Company has been in compliance in all material respects with federal and state data breach Lawsto provide notice under HIPAA.
(ne) To the extent required by applicable Legal Requirements, all manufacturing operations conducted for the benefit of the Company provides reimbursement coding or billing advice regarding products offered for sale by with respect to any Company Product used in human clinical trials have been conducted in accordance with GMP Regulations, except where the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsfailure to comply would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Regulatory Matters. (a) Authorizations. The Company has holds all Permits required by Federal Communications Commission ("FCC"), state public utility commission ("PUC") and foreign regulatory authority permits, licenses, certificates, registrations and other similar authorizations necessary or appropriate for the FDA conduct of its business (collectively, the "Authorizations"), the lack of which would, individually or in the aggregate, reasonably be expected to conduct the Business (the “FDA Permits”)have a Material Adverse Effect. All The Company and its Subsidiaries have maintained and kept in force and effect, and have applied in a timely manner for renewal of all such Authorizations. Except as disclosed in Section 3.18(a) of the FDA Permits held by Disclosure Schedules, the Company and its Subsidiaries are in compliance with all such Authorizations and any terms and conditions thereto except such non-compliance as would not, individually or issued in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as disclosed in Section 3.18(a) of the Disclosure Schedules, each Authorization which is material to the business of the Company are is valid and in full force and effect, and the Company is and its Subsidiaries have not received notice from the FCC, any PUC, or any foreign regulatory authority of its intention to revoke, suspend, condition or fail to renew any such Authorization, which would, individually or in compliance the aggregate, reasonably be expected to have a Material Adverse Effect. Except as disclosed in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge Section 3.18(a) of the CompanyDisclosure Schedules, no event has occurred or facts and circumstances exist, which with the giving of notice allows or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA allow, or which after notice or lapse of time would allow or would reasonably be expected to invoke its policy with respect to “Fraudallow, Untrue Statements of Material Factsrevocation, Briberysuspension, and Illegal Gratuities” non-renewal or for termination or result in any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge material impairment of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by 's or its Subsidiaries' rights under any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, Authorizations to the Knowledge of the Companyextent that such revocation, on behalf of the Company has been terminated termination or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place impairment would have a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialMaterial Adverse Effect.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Securities Purchase Agreement (Skyterra Communications Inc)
Regulatory Matters. (a) The Company has With respect to each material Product, (i) the Credit Parties and their Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of the Credit Parties, and have provided Agent with all notices and other information required by Section 4.1, and (ii) such Product is being tested, manufactured, marketed or sold, as the FDA to conduct the Business case may be, by Credit Parties (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are Credit Parties’ knowledge, by any applicable third parties) in full force material compliance with all applicable Laws and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingRequired Permits.
(b) Except as set forth on Section 4.13(b) None of the Company Disclosure Schedule, since January 1, 2007, there has not been Credit Parties or any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy Subsidiary thereof are in violation of any product of the Company or product candidate of the CompanyHealthcare Law in any material respect.
(c) The Company is in compliance in all To the Credit Parties’ knowledge (after reasonable inquiry), none of the Credit Parties or their Subsidiaries’ officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material respects with all applicable Laws and any other letters, notices fact or guidances issued by fraudulent statement to the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, failed to the Knowledge of the Company, threatened regulatory Actions (other than non-disclose a material routine or periodic inspections or reviews) against the Company, and fact required to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining be disclosed to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that would could reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or for any other Governmental Authority to invoke any similar policyset forth in 56 Fed. Regulation 46191 (September 10, 1991).
(gd) There have been no Serious Except as would not reasonably be expected to result in a Material Adverse EventsEffect, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: each Product (i) has been debarredand/or shall be manufactured, excluded or suspended from participation imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service MidCap / Viewray / Credit, Security and Guaranty Agreement has been conducted in any Federal Health Care Programaccordance with all applicable Permits and Laws; and (ii) has had a civil monetary penalty assessed against itbeen and/or shall be manufactured in accordance with Good Manufacturing Practices.
(e) No Credit Party, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Companynor any Subsidiary thereof, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvalsproceeding, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Companysuit or, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statuteCredit Party’s knowledge, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation federal, state or local government or quasi-governmental body, agency, board or authority or any other administrative or investigative body (including the Office of the Health Insurance Portability and Accountability Act Inspector General of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating Services),which could reasonably be expected to any such violations, or any comparable state or local Laws. The Company is not result in a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsMaterial Adverse Effect.
(nf) To As of the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related theretoClosing Date, such advice is and has there have been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsno Regulatory Reporting Events.
Appears in 1 contract
Samples: Credit, Security and Guaranty Agreement (ViewRay, Inc.)
Regulatory Matters. (ai) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All Schedule 10.1(g) sets forth, as of the FDA Permits held by or issued to the Company are in full force and effectEffective Date, the Company is in compliance in a list of all material respects Regulatory Approvals granted to any Depomed Entity by, or application therefor pending with, any Governmental Authority to manufacture, have made, test, market, package, import, distribute, sell and is not commercialize the Products in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingTerritory.
(bii) Except All Products sold under the Regulatory Approvals are manufactured, marketed, distributed and sold in accordance with such Regulatory Approvals, including the specifications and standards contained therein, except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily and would not, individually or involuntarily initiatedin the aggregate, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating reasonably be expected to an alleged material lack of safety or efficacy of any product of be materially adverse to the Company or product candidate of the CompanyBusiness.
(ciii) The Company is in compliance in all material respects with all applicable Laws and With respect to the Business, neither any other lettersDepomed Entity, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending ornor, to the Knowledge of the CompanyDepomed, threatened regulatory Actions any officer, employee, or agent of any Depomed Entity, (other than non-A) has made an untrue statement of a material routine fact or periodic inspections or reviews) against the Company, and a fraudulent statement to the Knowledge of the CompanyFDA, there are no pending or threatened regulatory Actions (other than non-failed to disclose a material routine or periodic inspections or reviews) pertaining fact required to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant be disclosed to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Gratuities policy set forth in the FDA’s Compliance Policy Guide Sec. 120.100 (CPG 7150.09), or for (B) has been convicted of any other Governmental Authority crime or engaged in any conduct that would reasonably be expected to invoke result in debarment under 21 U.S.C. 335a or any similar policyLegal Requirement.
(giv) There have Since April 2, 2015, no Depomed Entity has (A) voluntarily nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field alerts, market withdrawal or replacement, safety alert, “dear doctor” letter, investigator notice, or other notice or action relating to an alleged lack of safety, or efficacy of any Product, Certain information in this document has been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated omitted and filed separately with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not Securities and Exchange Commission. Confidential treatment has been reported requested with respect to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, omitted portions marked [***]. and to the Knowledge of Depomed, there are no facts which are reasonably likely to cause (1) the Companyrecall, on behalf market withdrawal or replacement of any Product sold or intended to be sold by any Depomed Entity, (2) a change in the marketing classification or a material change in the labeling of any such Products or (3) a termination or suspension of the Company by marketing of such Products; or (B) received any of its Collaborative Partnerswritten notice that any Governmental Authority has (1) commenced, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order onrequest the recall or to enjoin the manufacture or distribution of any Product sold or intended to be sold by any Depomed Entity or (2) commenced, or otherwise terminate, materially delay or suspendthreatened to initiate, any such ongoing clinical trial, or action to disqualify, restrict or debar withdraw any clinical investigator or other person or entity involved in Regulatory Approvals issued relating to any such clinical trialProduct.
(iv) Neither Except for ordinary course inquiries or as set forth on Schedule 10.1(g)(v), since April 2, 2015, Depomed has not received, with respect to the Company nor Products marketed and sold in the Territory, any officerwritten notice or communications from any Governmental Authority alleging any safety or quality concerns with respect to any Product or noncompliance with any applicable Legal Requirements or Regulatory Approvals, directorexcept as would not, managing employee (as those terms are defined individually or in 42 C.F.R. § 1001.1001) the aggregate, reasonably be expected to be materially adverse to the operation of the Company, norBusiness. Depomed is not subject to any enforcement proceedings by the FDA related to the Products and, to the Knowledge of the CompanyDepomed, any agent (as no such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Lawsproceedings have been threatened.
(jvi) Neither All clinical trials and studies for the Company nor any officerProducts that have been or are being conducted by or on behalf of Depomed or its Affiliates, directorwere conducted, managing employee (as those terms and are defined being conducted, in 42 C.F.R. § 1001.1001) of the Companyall material respects in accordance with all applicable Legal Requirements, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal including Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) Legal Requirements. To the Knowledge of the CompanyDepomed, there are is no Legal Proceeding pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority to suspend, investigate or terminate any ongoing clinical trials or studies for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsProduct.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, (i) each of the Acquired Corporations holds all Governmental Authorizations under the FDCA (including Sections 510(k) and 515 thereof) and the MDD, and all Governmental Authorizations of any applicable Governmental Body that has regulatory authority over the testing, development, design, quality, identity, safety, efficacy, manufacturing, labeling, marketing, distribution, commercialization, sale, pricing, import or export of the Company has all Permits required by Products (any such Governmental Body, a “Company Regulatory Agency”) necessary for the FDA to conduct lawful operation of the Business businesses of the Acquired Corporations in each jurisdiction in which such Acquired Corporation operates (the “FDA Company Regulatory Permits”). All of the FDA ; (ii) all such Company Regulatory Permits held by or issued to the Company are valid and in full force and effect, ; and (iii) the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving terms of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreementall Company Regulatory Permits. The Company is Regulatory Permits cover the sole Company Products as they are currently being tested, manufactured, labeled, marketed, distributed, commercialized, sold, imported and exclusive owner exported. No changes have been made to any Company Product (or the manufacturing, testing, labeling or intended use of any Company Product) after the submission of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or other filing made for the relevant Company Regulatory Permits that would require a new Governmental Authorization, or held by a supplement or issued amendment to a Governmental Authorization, except those changes for which the Company subsequently obtained the required new Governmental Authorization (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrancesor supplement or amendment). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws had and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would not reasonably be interpreted as raising expected to have, individually or in the aggregate, a compliance concern sent or delivered by any Governmental Authority with regard to any product Material Adverse Effect, the businesses of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is each Acquired Corporation are being conducted in compliance in all material respects with, and have appropriate internal controls that are reasonably designed to ensure compliance with current “good manufacturing practices,” as defined by (i) the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals FDCA (including FDA all applicable registration and listing requirements set forth in Section 510 of the FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 806807), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal Medicare and Medicaid statutes and related state or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”)local statutes; (iii) is currently listed on any comparable foreign Legal Requirements for any of the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programsforegoing (including the MDD); (iv) to the Knowledge of the Companyfederal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or Sxxxx Law (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to42 U.S.C. §1395nn), subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 42 U.S.C. § 3729 et seq.1320a-7b(a).
(m) To the Knowledge of the Company), the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 19951996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local Legal Requirements; (v) state or provincial testing, manufacturing, distribution, commercialization, marketing, licensing, disclosure, gift ban, code of conduct and reporting requirements, including the Physician Payments Sunshine Act (42 C.F.R. Parts 402-403) and equivalent or related international or state reporting requirements; (vi) Legal Requirements with respect to the protection of personally identifiable information collected or maintained by or on behalf of each Acquired Corporation; and (vii) the rules and regulations promulgated pursuant to all such applicable Legal Requirements, each as amended from time to time (collectively, “HIPAACompany Healthcare Laws”). Since January 1, 2011, no Acquired Corporation has received any written notification or the regulations contained in 45 C.F.R. Parts 160 and 164communication from any Company Regulatory Agency, including receiving any notices from the United States FDA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office Services, MDD competent authority in any jurisdiction or any public or private entity designated by a Company Regulatory Agency for such purpose (“Notified Body”), of Civil Rights noncompliance by, or liability of the Acquired Corporation under, any Company Healthcare Laws, except where such noncompliance or liability has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(c) No Acquired Corporation is party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Company Regulatory Agency and, to the Company’s knowledge, no such action is currently contemplated, proposed or pending.
(d) All pre-clinical and clinical investigations conducted or sponsored by or on behalf of each Acquired Corporation, or, to the knowledge of the Company, used or intended to be used to support any filing or application for a Company Regulatory Permit, has been or is being conducted in compliance with all applicable Legal Requirements administered or issued by the applicable Company Regulatory Agencies, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials and the protection of human subjects, including without limitation, Title 21 parts 11, 50, 54, 56 and 812 of the Code of Federal Regulations, (iii) any comparable foreign Legal Requirements for any of the foregoing or other Legal Requirements (including state, provincial and local requirements) regulating the conduct of pre-clinical and clinical investigations and the protection of human subjects, (iv) federal, state and provincial Legal Requirements restricting the collection, use and disclosure of individually identifiable health information and personal information and (v) all directions, notices, approvals, and restrictions issued by the relevant institutional review board or ethics board, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Material Adverse Effect. To the knowledge of the Company, no investigator, employee or agent that has participated or is participating in any clinical investigation conducted or sponsored by or on behalf of an Acquired Corporation, or used or intended to be used to support any filing or application for a Company Regulatory Permit, is or has been disqualified or restricted by the FDA from receiving investigational drugs, biologics or devices or from conducting any clinical investigation that supports an application for a research or marketing permit; has entered into a restricted agreement with FDA; or is or has been subject to any comparable action by any other Governmental Body.
(e) Since January 1, 2011, no Acquired Corporation has been or is the subject of any 483 observations, warning letters, untitled letters, inspection or audit reports from any Notified Body or Company Regulatory Agency identifying any major or minor non-compliances, subpoenas, investigations, actions, demands or notices relating to any alleged non-compliance, which has had or would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect or to lead to the denial, suspension or revocation of any application or grant for marketing approval with respect to any material Company Product currently pending before or previously approved or cleared by the FDA or such violationsother Company Regulatory Agency. Since January 1, 2011, no Acquired Corporation has been subject to any adverse audit reports from any Notified Body or alleged non-compliance by its customers or other third parties with which it does business, except where such report or allegation of non-compliance has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(f) Since January 1, 2011, for each adverse event and device malfunction requiring the submission of a medical device report under 21 C.F.R. Part 803 (“MDR”), a medical device vigilance report under the MDD (“MDV”), or any comparable state other filing, submission, notice, or local Lawsreport to the FDA or any other Company Regulatory Agency, the Acquired Corporations have reported, filed, or submitted an MDR, MDV or other required filing, submission, notice or report in a timely manner, except where a failure to report, file, or submit has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance All such MDRs, MDVs and other filings, submissions, notices and reports were complete and accurate in all material respects on the date filed and, to the extent any material new or additional information was learned or obtained after filing, were corrected in or supplemented by a timely subsequent filing, to the extent required by applicable Legal Requirements. The Acquired Corporations have maintained and are maintaining all records, reports and other documentation required under the applicable Legal Requirements for product complaints and reports of adverse events and device malfunctions (including all required records and documentation related to MDR and MDV reporting), except where the failure to maintain such records, reports and other documentation has not had and would not reasonably be expected to result in, individually or in the aggregate, a material liability to the Acquired Corporations or otherwise interfere in any material respect with the conduct of their respective businesses as now being conducted. None of the Acquired Corporations, nor, to the knowledge of the Company, any officer, employee, agent or distributor of the Acquired Corporations, has made an untrue statement of a material fact, a material omission or a fraudulent statement to the FDA or any other Company Regulatory Agency, to an institutional review board or ethics board, or in any records or documentation prepared or maintained to comply with the applicable Legal Requirements; failed to disclose a material fact required to be disclosed to the FDA or any other Company Regulatory Agency; or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of the Acquired Corporations. None of the Acquired Corporations, nor, to the knowledge of the Company, any officer, employee, agent or distributor of the Acquired Corporations, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Legal Requirement or authorized by 21 U.S.C. § 335a(b) or any similar Legal Requirement. None of the Acquired Corporations, nor, to the knowledge of the Company, any officer, employee, agent or distributor of the Acquired Corporations, has been excluded from participation in any federal and state data breach Lawshealth care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program.
(ng) As to each Company Product or Company Product candidate subject to the FDCA or similar Legal Requirement in any foreign jurisdiction (including the MDD) that is or has been designed, developed, manufactured, processed, tested, packaged, labeled, stored, distributed or marketed by or on behalf of the Acquired Corporations, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each such Company Product or Company Product candidate is being or has been designed, developed, manufactured, processed, tested, packaged, labeled, stored, distributed and marketed in compliance with all applicable Legal Requirements, including (i) those relating to investigational use and marketing approval or clearance, (ii) the Quality System Regulation at 21 C.F.R. Part 820, ISO 13485 and any other requirements related to good manufacturing practices for medical devices, including those requirements applicable to purchase controls and supplier oversight, and (iii) the relevant state, local and provincial requirements. There is no action or proceeding pending or, to the knowledge of the Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Company Product or Company Product candidate by the Acquired Corporations of any Legal Requirement, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(h) Since January 1, 2011, each of the Acquired Corporations have neither voluntarily nor involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued any recall, removal, market withdrawal, replacement, field action, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients (including any action required to be reported or for which records must be maintained under 21 C.F.R. Part 806) relating to any Company Product (collectively, a “Recall”) or is currently considering initiating, conducting or issuing any Recall of any Company Product, except as (with respect to Recalls other than Class I Recalls) has not had and would not reasonably be expected to, individually or in the aggregate, result in a material liability to the Acquired Corporations or otherwise interfere in any material respect with the conduct of their respective businesses as now being conducted. To the extent knowledge of the Company, there are no facts which are reasonably likely to cause, and the Company provides reimbursement coding has not received since January 1, 2009 any written notice from the FDA or billing advice regarding products offered for sale any other Company Regulatory Agency regarding, (i) the Recall of any Company Product sold or intended to be sold by the Acquired Corporations, (ii) a change in the marketing classification or a material change in the labeling of any such Company and procedures related theretoProducts, (iii) a termination, enjoinment or suspension of the manufacturing, marketing, or distribution of such advice is and Company Products or (iv) a negative change in reimbursement status of a Company Product, that in each case, has been true and complete in all had or would reasonably be expected to have a material respects and in compliance in all material respects with impact on the payment requirements business of Medicare and other Federal Health Care Program Lawsthe Acquired Corporations.
Appears in 1 contract
Samples: Merger Agreement (Volcano Corp)
Regulatory Matters. (a) The Each of the Company and the Subsidiaries has obtained and currently possesses all material, necessary and applicable Permits required by any Governmental Authority, including the FDA to conduct the Business United States Food and Drug Administration (the “FDA PermitsFDA”). All ) or under the Customs & International Trade Laws to permit the design, development, pre clinical and clinical testing, manufacture, labeling, sale, import, export, distribution and promotion of the FDA Permits held by or issued to the Company are and Subsidiary products in full force and effectjurisdictions where they conduct such activities, the Company is in compliance in all material respects withexcept as has not had, and is would not in default in any material respect 30 under (and be reasonably be expected to the Knowledge of the Companyhave, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole individually or in partthe aggregate, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingMaterial Adverse Effect.
(b) Since January 1, 2010, each of the Company and the Subsidiaries has complied and remains in compliance with, and there are no material unresolved questions or claims concerning any liability of the Company or the Subsidiaries with respect to: (i) all applicable Laws, including the Customs & International Trade Laws and the Healthcare Regulatory Laws, and (ii) the terms and requirements of all necessary and applicable Permits required by any Governmental Authority to permit the design, development, pre clinical and clinical testing, manufacture, labeling, sale, import, export, distribution and promotion of the Company or Subsidiary products, except, in each case, where the failure to so comply would not reasonably be expected to have a Material Adverse Effect. There is no (i) civil, criminal, administrative or other action, suit, demand, claim, hearing, proceeding, notice or demand pending, received or, to the Company’s knowledge, threatened in writing or (ii) civil or criminal investigation, audit or inquiry pending, received or, to the Company’s knowledge, threatened, in each case against the Company or the Subsidiaries, or any of their directors, officers or employees which relates to a violation or alleged violation of the Customs & International Trade Laws or the Healthcare Regulatory Laws.
(c) Except as set forth on Section 4.13(b) Schedule 4.20(c), as of the Company Disclosure Schedule, since January 1, 2007date hereof, there has not have been any voluntarily or involuntarily initiatedno recalls, conductedfield notifications, injunctive actions, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, other written warnings or investigator notice relating to an alleged material lack of safety seizures ordered or efficacy of any product of the Company or product candidate of the Company.
adverse regulatory actions taken (c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”threatened) by the FDA or any other Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in with respect to any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or Subsidiary products, including any subpoenas facilities where any Company or investigative demands Subsidiary products are produced, processed, packaged or stored, and within the three (3) years preceding the date hereof neither the Company nor the Subsidiaries have, voluntarily nor at the request of any Governmental Authority, initiated or participated in a recall of any Company product or issued any written warning (other written inquiries than labeling changes that would reasonably be interpreted as raising a compliance concern sent were disclosed to or delivered approved by any Governmental Authority Authority) with regard to any product of the Company or any product candidate of the Companyrespect thereto.
(d) The manufacture Except as set forth on Schedule 4.20(d), All manufacturing operations of Company products by the Company or its Subsidiaries and, to the knowledge of the products Company, for the benefit of the Company and its Subsidiaries, have been since January 1, 2010, and are being, conducted in material compliance with FDA regulations governing current good manufacturing practices, including 21 C.F.R. Parts 210 and 211 and applicable guidance documents, and all applicable similar requirements in countries where such compliance is required.
(e) Except as set forth on Schedule 4.20(e), all preclinical and clinical trials being conducted by or on behalf of the Company that have been submitted to any appropriate Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Permit, are being or have been conducted in compliance in all material respects with the experimental protocols, procedures and controls required pursuant to applicable Laws, including current “good manufacturing practices,” clinical practices and the Health Insurance Portability and Accountability Act of 1996, as defined amended by the FDAHealth Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, includingand any applicable state privacy Laws. To the Company’s knowledge, as applicable, none of the FDA’s “Quality System Regulation” set forth clinical investigators participating in 21 C.F.R. Part 820.
(e) The Company is and trials has been or is disqualified, restricted from participating in compliance in all material respects with all Laws requiring the maintenance such trials or submission of reports or records under requirements administered otherwise sanctioned by the FDA or any other Governmental Authority. To the Company’s knowledge, including, for avoidance of doubt, records no Person involved in any preclinical and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of clinical investigations sponsored by the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct for which has resulted or could result in debarment or disqualification is mandated by the FDA 21 U.S.C. §335a(a) or any other Governmental Authority, similar Law or authorized by 21 U.S.C. §335a(b) or any similar Law and there are no proceedings pending or, to the Knowledge of the Company’s knowledge, threatened that might reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None The Company has not received any written notices, correspondence or other written communication from the FDA or any other Governmental Authority, or any institutional review board, requiring the termination, suspension or material modification of any preclinical or clinical trials conducted by, or on behalf of, the Company, or in which the Company has participated.
(f) Except as set forth on Schedule 4.20(f), no product liability claims have been asserted in writing against the Company or the Subsidiaries or, to the Knowledge knowledge of the Company, threatened in writing against the Company or the Subsidiaries relating to any of their products or product candidates developed, tested, manufactured, marketed, distributed or sold by the Company or the Subsidiaries. There is no judgment, order or decree outstanding against the Company or any of its Subsidiaries relating to product liability claims or assessments.
(g) During the last three (3) years, neither the Company nor the Subsidiaries has received any written notice that any products or materials imported by or on behalf of the Company of the Subsidiaries where the Company or the Subsidiaries is the importer of record, for which final liquidation has not yet occurred, is subject to or otherwise covered by an antidumping duty order or countervailing duty order that remains in effect or is subject to or otherwise covered by any pending antidumping or countervailing duty investigation by agencies of the United States government.
(h) Neither the Company nor any Subsidiary, nor any officer, director or employee of the Company or any Subsidiary, nor, to the knowledge of the Company, any agents, distributors, and other Persons (including each of their respective officers, directors, employees) acting for or on behalf of the Company or any Subsidiary (the “Relevant Persons”): (i) has been debarred or excluded from any government program related to Company or Subsidiary products; (ii) has been or is designated on any list of any U.S. Governmental Authority, including OFAC’s list of Specially Designated Nationals and Blocked Persons, Commerce’s Denied Persons List, the Commerce Entity List, and the U.S. Department of State’s (“State Department”) Debarred List; (iii) has directly or indirectly participated in any transaction involving such designated person or entity, or any country that is subject to U.S. sanctions administered by OFAC or any applicable U.N., E.U. or other international sanctions regime; (iv) has exported (including deemed exportation) or re-exported, directly or indirectly, any good, technology or services in violation of any applicable U.S. export control or economic sanctions laws, regulations or orders administered by OFAC, Commerce or the State Department; or (v) has directly or indirectly participated in any export, re-export or transaction connected with any purpose prohibited by U.S. export control and economic sanctions laws, including, without limitation, support for international terrorism and nuclear, chemical or biological weapons proliferation’s Debarred List.
(i) To the knowledge of the Company, no officer, employee or agent (in its Collaborative Partners capacity as agent) of the Company has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with such as FDA Compliance Policy Guide 120.100. To the use (including in clinical trials) knowledge of the products Company, neither the Company nor its Subsidiaries has used in any capacity the services of any individual or entity debarred under 21 U.S.C. § 335a(a) or any similar laws, rules or regulations in connection with a product of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasonsSubsidiaries, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Companyits Subsidiaries, nor, to the Knowledge knowledge of the Company, any agent of their respective directors, officers, agents (in the capacity as such term is defined agent) or employees, has engaged in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party toany conduct that has resulted, or bound bywould reasonably be expected to result, in debarment under 21 U.S.C. § 335a(a) or any ordersimilar laws, individual integrity agreement, corporate integrity agreement rules or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Lawsregulations.
(j) Neither None of the Company nor or any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanySubsidiaries is a party to any corporate integrity agreements, normonitoring agreements, to the Knowledge of the Companyconsent decrees, settlement orders, or other similar written agreements, in each case, entered into with or imposed by any agent (as Governmental Authority, other than any such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) agreement, decree or order that has been debarred, excluded or suspended from participation previously disclosed in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by other filing with a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care ProgramAuthority.
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to Notwithstanding any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge other provision of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Companythis Agreement, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability representations and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations warranties contained in 45 C.F.R. Parts 160 Section 4.20(a) through Section 4.20(j) (together with Section 4.03, Section 4.04 and 164, including receiving any notices from Section 4.09) constitute the United States Department sole and exclusive representations and warranties of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program LawsSubsidiaries relating to Laws relating to regulatory matters.
Appears in 1 contract
Regulatory Matters. (i) To its knowledge, all notices, supplemental applications and annual or other reports or documents, including adverse experience reports that are material to the conduct of the Business in the Territory as presently conducted have been filed with the relevant Governmental Authorities to the extent required under the Requirements of Laws, except to the extent failure to make such filings could not reasonably be expected to have a Material Adverse Effect with respect to the Business in the Territory as presently conducted.
(ii) Except as could not reasonably be expected to have a Material Adverse Effect on the Business in the Territory as presently conducted, neither WFHC nor its Affiliates has received: (a) The Company has all Permits required by the any FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued Form 483’s with respect to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
Product; (b) any FDA Notices of Adverse Findings with respect to the Product; or (c) any warning letters or other written correspondence from the FDA or any other Governmental Authority with respect to the Product during the one (1) year prior to this Agreement, or at any time prior to this Agreement to the extent still active or pending, in which the FDA or such other Governmental Authority asserted that the operations of WFHC were not in compliance with applicable Requirements of Laws, with respect to the Product in the United States. Except as set forth could not reasonably be expected to have a Material Adverse Effect on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007Business in the Territory as presently conducted, there has not been any voluntarily or involuntarily initiated, conducted, or issued occurrence of any product recall, market withdrawalwithdrawal or replacement, safety alert, warning, “dear doctor” letteror post-sale warning conducted by or on behalf of WFHC concerning the Product in the United States or any product recall, market correction, withdrawal or investigator notice relating to an alleged material lack replacement conducted by or on behalf of safety or efficacy WFHC as a result of any product alleged defect in the Product in the United States during the one (1) year prior to this Agreement, or, to WFHC’s knowledge, at any time prior to this Agreement to the extent still active or pending, and WFHC has made available to Shire every material complaint and notice of alleged defect or adverse reaction with respect to the Company Product that has been received in writing by WFHC and its Affiliates or product candidate of the Companythat has been orally transmitted to and recorded by WFHC and its Affiliates.
(ciii) The Company To WFHC’s knowledge, WFHC has fulfilled and performed its obligations under the Transferred Regulatory Documentation pertaining to the Product. To WFHC’s knowledge, no event has occurred or condition or state of facts exists which constitutes or, after notice or lapse of time or both, would constitute a breach or default or violation under any such Transferred Regulatory Documentation or which permits or, after notice or lapse of time or both, would permit revocation or termination of any such Transferred Regulatory Documentation, or which might adversely affect in any material respect the rights of WFHC under any Transferred Regulatory Documentation; provided, however, that a Phase IV regulatory study for the Product in the European Union is required. No written notice of cancellation, of default, of violation or of any material dispute concerning such Transferred Regulatory Documentation, or of any event, condition or state of facts described in compliance in all material respects with all applicable Laws and the preceding clause, has been received by, or is known to, WFHC.
(iv) None of WFHC, any other letters, notices or guidances issued by the FDA of its Affiliates or any Governmental Authority which regulates sublicensee have sold the sale Product in the Territory prior to the Effective Date.
(v) WFHC has made available to Shire copies of pharmaceutical products or biological, device or regenerative medicine products all Transferred Regulatory Documentation in any jurisdiction. WFHC’s physical possession except for Transferred Regulatory Documentation containing information that would not be reasonably be expected to have a Material Adverse Effect on the Business in the Territory as presently conducted.
(vi) There are no pending or, to the Knowledge applications filed by or on behalf of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement WFHC with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, respect to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged Product in any conduct country within the Territory for which Regulatory Documentation has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Lawissued.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: License and Supply Agreement (Women First Healthcare Inc)
Regulatory Matters. (a) The Each of the Company and its Subsidiaries (or their respective agents) has all Permits required by material licenses, permits, franchises, variances, registrations, exemptions, Orders and other governmental authorizations, consents, approvals and clearances, and has submitted notices to, all Governmental Authorities, including, but not limited to, all authorizations and registrations under the FDA to conduct the Business Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDA FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, the Federal Controlled Substances Act of 1970 and the regulations of the U.S. Drug Enforcement Administration (the “DEA”) promulgated thereunder and all state controlled substance Laws and regulations and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy, use, manufacturing, advertising, distribution and sale of the Company Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the Company or any such Subsidiary to own, lease and operate its properties or other assets and to carry on and operate its respective businesses as currently conducted (the “Company Permits”). All of , and, except as has not been and would not reasonably be expected to be, individually or in the FDA Permits held by or issued aggregate, material to the Company and its Subsidiaries, taken as a whole, all such Company Permits are valid, and in full force and effect. There has occurred no violation of, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of or without notice or lapse of timetime or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, would become a default under), each such any Company Permit, except as have not been and none of such Permits will would not reasonably be terminated or impaired or become terminableexpected to be, in whole individually or in partthe aggregate, material to the Company and its Subsidiaries, taken as a result of the transaction contemplated by this Agreementwhole. The Company is the sole and exclusive owner each of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is its Subsidiaries are in compliance in all material respects with the terms of all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions Company Permits.
(other than non-material routine or periodic inspections or reviewsb) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices2008, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates all of the Company or any subpoenas or investigative demands or other written inquiries Products that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard are subject to any product the jurisdiction of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA DEA or any other Governmental AuthorityCompany Regulatory Agency are being manufactured, includingimported, for avoidance of doubtexported, records processed, developed, labeled, stored, tested, marketed, advertised, promoted, detailed and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company distributed by or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of or its Collaborative Partners, are being, and at all times have been, conducted Subsidiaries in compliance in all material respects with all applicable requirements under any Company Permit or Laws, including applicable statutes and implementing regulations administered or enforced by the FDA, DEA or other Company Regulatory Agency, including those relating to investigational use, premarket approval and applications or abbreviated applications to market a new Company Product, or adopt or use a new Trademark.
(c) Since January 1, 2008, all preclinical studies and clinical trials, and other studies and tests conducted by or, to the Knowledge of the Company, on behalf of the Company or any of its Subsidiaries have been, and if still pending are being, conducted in compliance with all applicable Laws, including, as applicablebut not limited to, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 5858 and 312, 312 except where such noncompliance has not been and 812would not reasonably be expected to be, individually or in the aggregate, material to the Company and comparable Laws of any other Governmental Authorityits Subsidiaries, taken as a whole. No Since January 1, 2008, no clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company or any of its Subsidiaries has been terminated or suspended prior to completion for safety or non- compliance other non-business reasons, and neither the FDA nor any other Governmental Authorityapplicable Company Regulatory Agency, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over or participated in any such over, a clinical trial conducted by or, to the Knowledge of the Company, on behalf of the Company or any of its Subsidiaries has initiatedcommenced, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trialinvestigation conducted by or, to the Knowledge of the Company, on behalf of the Company or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialof its Subsidiaries.
(id) Neither Since January 1, 2008, neither the Company nor any officerof its Subsidiaries has had any Company Product or manufacturing site (whether Company-owned or that of a contract manufacturer for Company Products) subject to a Company Regulatory Agency (including FDA and DEA) shutdown or import or export prohibition, directornor received any FDA Form 483 or other Company Regulatory Agency written notice of material inspectional observations, managing employee “warning letters,” “untitled letters” or written requests to make material changes, in each case as it applies to the Company Products or any of the Company’s manufacturing or distribution processes or procedures that if not complied with has not, and would not reasonably be expected, individually or in the aggregate, to have a Company Material Adverse Effect.
(e) Section 4.21(e) of the Company Disclosure Schedule sets forth a list, as those terms are defined in 42 C.F.R. § 1001.1001of the date hereof, of all recalls, field notifications, market withdrawals or replacements, written warnings, “dear doctor” letters, investigator notices, safety alerts, post-approval “serious adverse event” reports or other material written notice of action relating to an alleged lack of safety or regulatory compliance of the Company Products issued by the Company and/or any of its Subsidiaries since January 1, 2008 (“Safety Notices”).
(f) Since January 1, 2008, all manufacturing operations conducted by or, to the Knowledge of the Company, norfor the benefit of the Company or any of its Subsidiaries have been conducted in material compliance with applicable Laws, including the provisions of the FDA’s current good manufacturing practice regulations at 21 C.F.R. Parts 210-211 for Company Products sold in the United States, and the respective counterparts thereof promulgated by Company Regulatory Agencies in countries outside the United States, except where the failure to so comply has not been, and would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole. There are no pending or, to the Knowledge of the Company, threatened actions or proceedings by the FDA, DEA or any applicable foreign equivalent which would prohibit or materially impede the sale of any product currently manufactured and/or sold by the Company or any of its Subsidiaries into any market.
(g) Since January 1, 2008, to the Knowledge of the Company, neither the Company, nor any of its Subsidiaries, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, or similar policies, set forth in any applicable Laws. Since January 1, 2008, none of the Company, its Subsidiaries or, to the Knowledge of the Company, any agent of their respective officers or key employees has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under applicable Law, including, without limitation, 21 U.S.C. Section 335a. No Actions that would reasonably be expected to result in such a material debarment are pending, and the Company has not received written notice that any such Actions are threatened against the Company, its Subsidiaries, or any of their respective officers or key employees.
(as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)h) Each of the Company and its Subsidiaries, and to the Knowledge of the Company its respective directors, officers, employees, and agents (while acting in such capacity) is, and at all times has been in compliance with all Health Care Laws applicable to the Company or any of its Subsidiaries or by which any or their respective properties, businesses, products or other assets is bound or affected, including, to the extent applicable, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), the exclusion Laws (42 U.S.C. § 1320a-7), the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Controlled Substances Act (21 U.S.C. §§ 801 et seq), the Medicare Program (Title XVIII of the Social Security Act), the Medicaid Program (Title XIX of the Social Security Act), the regulations promulgated pursuant to such Laws, requirements of the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, requirements of Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126), state pharmaceutical assistance programs and regulations under such Laws (collectively, “Health Care Laws”), except for non-compliance that has not been and would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole. Since January 1, 2008, none of the Company or any of its Subsidiaries has received any written notification, written correspondence or any other written communication from any Governmental Authority, including, without limitation, the FDA, the DEA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of Inspector General, specifically alleging material non-compliance by, or liability of, the Company or any of its Subsidiaries, under any Health Care Laws.
(i) None of the Company or any of its Subsidiaries is a party toto any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or bound byother similar written agreements, in each case, entered into with or imposed by any orderCompany Regulatory Agency, individual integrity other than any such agreement, corporate integrity agreement decree or order that has been previously disclosed in any other formal or informal agreement filing with any Governmental Authority concerning compliance with Federal Health Care Program Lawsa Company Regulatory Agency.
(j) Neither the Company nor any officerof its Subsidiaries has received any written notice from the FDA, directorDEA or any other Governmental Authority that it has commenced, managing employee or threatened to initiate, any action to withdraw approval, place sales or marketing restrictions on or request the recall of any Company Product, or that it has commenced, or threatened to initiate, any action to enjoin or place restrictions on the production of any Company Products.
(k) As to the Company Products for which a biological license application, new drug application, abbreviated new drug application, investigational new drug application or similar state or foreign regulatory application has been approved, the Company and its Subsidiaries are in compliance with 21 U.S.C. §§ 355, Section 351 of the PHSA or 21 C.F.R. Parts 312, 314, 600 or 601 et seq., respectively, and all applicable similar state and foreign regulatory requirements of any Governmental Authority, and all terms and conditions of such licenses or applications, except for any such failure or failures to be in compliance that have not been, and would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as those terms are defined in 42 C.F.R. § 1001.1001) a whole. As to each drug for which the Company has material sales, the Company and any relevant Subsidiary of the Company, norand the officers, to employees or agents of the Knowledge Company and any Subsidiary of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line have included in the event that application for such drug, where required, the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 certification described in 21 U.S.C. § 3729 et seq.).
(m335a(k)(1) To and the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability list described in 21 U.S.C. § 335a(k)(2) and Accountability Act of 1995, as amended by the Health Information Technology for Economic each such certification and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been list was true and complete in all material respects when made. In addition, the Company and each of its Subsidiaries is in compliance with all applicable registration and listing requirements set forth in all 21 U.S.C. § 360 and 21 C.F.R. Part 207, except for failures to so comply that have not been, and would not reasonably be expected to be, individually or in the aggregate, material respects to the Company and its Subsidiaries, taken as a whole.
(l) Notwithstanding any other provision of this Agreement, this Section 4.21 sets forth the sole and exclusive representations and warranties of the Company with respect to the payment requirements of Medicare and other Federal Health Care Program Lawsregulatory matters described in this Section 4.21.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All Schedule 6.13(a) contains a complete and correct list of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (Products and to the Knowledge of Seller any and all improvements thereto or line extensions thereof that have been researched, investigated, developed, manufactured, sold or are in the Companyprocess of being researched, no event which with the giving of notice investigated, developed, manufactured or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held sold by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear on behalf of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right Seller or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingCarnrick.
(b) Except as set forth on Section 4.13(b) Schedule 6.14(b), to the Knowledge of Seller, contains a complete and correct list of all NDA's and ANDA's related to the Company Disclosure SchedulePurchased Assets, since January 1, 2007, there Seller has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack provided Buyer with true and complete copies of safety or efficacy of any product of the Company or product candidate of the Companysuch filings.
(c) The Company is in compliance in all material respects To the Knowledge of Seller, with all applicable Laws and any other respect to the Purchased Assets, there have been no (i) product recalls, field corrective activity, warning letters, notices Notice of Adverse Finding letters, audit reports or guidances issued administrative actions by the FDA or any similar action by any other Governmental or Regulatory Authority which regulates or (ii) withdrawals or expected withdrawals.
(d) To the sale Knowledge of pharmaceutical products Seller all NDA's and ANDA's for the Products are currently effective and valid and have been validly issued. Neither the execution, delivery or biological, device performance of this Agreement nor the mere passage of time will have any effect on the continued validity or regenerative medicine products in any jurisdictionsufficiency of such filings. There are is no Action or Proceeding by any Governmental or Regulatory Authority pending or, to the Knowledge of the CompanySeller, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and with respect to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820Regulatory Documentation.
(e) The Company is To the Knowledge of Seller, neither Carnrick nor any of their employees has, with respect to the Purchased Assets or the business with respect thereto, (i) been disbarred or received notice of action or threat of action with respect to debarment under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335(a) and (b); (ii) been subject to any other FDA enforcement Action or Proceeding, or (iii) used in any capacity the services of any Person that has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA subject to debarment or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents enforcement action or near-incidents and product malfunctionsproceeding.
(f) None All of the Company orProducts included in the Inventory, and to the Seller's Knowledge all of the CompanyProducts manufactured by or on behalf of Carnrick, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Eventsmanufactured in accordance with FDA requirements and they (i) have been manufactured, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA held and shipped in accordance with applicable Law.
(h) To the Knowledge of the Company, GMPs and all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Programlaw; (ii) has had a civil monetary penalty assessed against ithave been manufactured, him or her under Section 1128A of held and shipped in accordance with the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”)Products' specifications; (iii) is currently listed on have not been adulterated or misbranded under the General Services Administration published list of parties excluded from U.S. federal procurement programs Food, Drug, and non-procurement programsCosmetic Act, as amended, or under any other applicable law; and (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viablemay be introduced into interstate commerce pursuant thereto.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company has With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits required by needed in connection with the FDA to conduct the Business (the “FDA Permits”). All testing, manufacture, marketing or sale of the FDA Permits held such Product as currently being conducted by or issued on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to the Company are in full force and effectBorrower’s actual knowledge, the Company is by any applicable third parties) in compliance in with all material respects with, applicable Healthcare Laws and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingRequired Permits.
(b) Except as set forth on Section 4.13(b) would not reasonably be expected to have a Material Adverse Effect, none of the Company Disclosure Schedule, since January 1, 2007, there has not been Borrowers or any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy Subsidiary thereof are in violation of any product of the Company or product candidate of the Companyapplicable Healthcare Law.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA No Borrower or any Governmental Authority which regulates the sale of pharmaceutical products or biologicalSubsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredientMedicaid, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyTRICARE.
(d) The manufacture To Borrower’s knowledge, none of the products Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the Company is being conducted in compliance in all FDA or failed to disclose a material respects with current “good manufacturing practices,” as defined by fact required to be disclosed to the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that would could reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 5856 Fed. Regulation 46191 (September 10, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.1991).
(me) To the Knowledge of the CompanyNo Borrower, the Company nor any Subsidiary thereof, is not under subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority for a violation Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of the Health Insurance Portability and Accountability Act any material Permits of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, Borrower or any comparable state or local Laws. The Company is not Subsidiary thereof, in each case, that would reasonably be expected to result in a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsMaterial Adverse Effect.
(nf) To As of the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related theretoClosing Date, such advice is and has there have been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsno Regulatory Reporting Events.
Appears in 1 contract
Samples: Credit and Security Agreement (Sight Sciences, Inc.)
Regulatory Matters. (a) The Except as would not reasonably be expected to, individually or in the aggregate, have a Company has all Permits required by the FDA to conduct the Business Material Adverse Effect, (the “FDA Permits”). All of the FDA Permits held by or issued to i) the Company are in full force and effect, the Company is in compliance in all material respects withSubsidiaries have filed, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which maintained or furnished with the giving of notice or lapse of timeapplicable regulatory authorities, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with including but not limited to the FDA, including any biologics license applicationPharmaceuticals and Medical Devices Agency (“PMDA”), new drug applicationand European Medicines Agency (“EMA”) all required filings, 510(k) submissiondeclarations, premarket approvallistings, investigational new drug or investigational device exemption applicationregistrations, comparable regulatory application or filing made or held by or issued to the Company reports, submissions, applications, amendments, modifications, supplements, notices, correspondence, and other documents (collectively, the collectively “Company Regulatory FilingsHealth Care Submissions”) and holds (ii) all right, title such Health Care Submissions were complete and interest accurate and in and to all Company Regulatory Filings free and clear of any Encumbrance compliance with applicable Laws when filed (other than Permitted Encumbrancesor were corrected or completed by a subsequent filing). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate None of the Company.
(c) The , any Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending Subsidiary or, to the Knowledge Company’s knowledge, any of the Company, threatened regulatory Actions (other than non-material routine their respective employees is or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company has been debarred pursuant to a development, commercialization, manufacturing, supply 21 U.S.C. Section 335a (a) or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionb). Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any Except as would not reasonably be expected to be material respect with any applicable Law relating to the Company or the products or product candidates of and the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted Subsidiaries, taken as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of whole, the Company or any product candidate of and the Company Subsidiaries have not, and, to the Company.
(d) The manufacture ’s knowledge, none of the products their respective representatives have, made any untrue statement of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance fact or submission of reports or records under requirements administered by fraudulent statement to the FDA or any other Governmental AuthorityEntity, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by be disclosed to the FDA or any other Governmental AuthorityEntity, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy.
(gc) There Except as would not reasonably be expected to, individually or in the aggregate, have been no Serious a Company Material Adverse EventsEffect, Serious Injuries (i) all Product Candidates under development by or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by or any of its Collaborative PartnersCompany Subsidiary have been researched, are beingdeveloped, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported, and at all times have been, conducted in compliance in all material respects with all applicable Laws, includingexported, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58compliance with applicable Drug Laws, good clinical practices, as defined or recognized by and without limiting the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions generality of the Federal Foodforegoing, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No (ii) all clinical trial trials conducted by the Company or, to the Knowledge of the Company, or on behalf of the Company has or any Company Subsidiary have been terminated or suspended prior to completion for safety or non- conducted in compliance reasonswith applicable protocols, procedures and neither the FDA nor any other applicable Drug Laws, (iii) no Governmental AuthorityEntity, clinical investigator or institutional review board that board, or ethics committee has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, commenced any action to place a clinical hold order on, or otherwise terminate, materially delay terminate or suspend, any such ongoing clinical trial, trial conducted by or to disqualify, restrict on behalf of the Company or debar any clinical investigator or other person or entity involved in any such clinical trial.
Company Subsidiary and (iiv) Neither neither the Company nor any officerCompany Subsidiary has received any written notice or communication alleging that the Company has violated or failed to comply with any applicable Drug Laws with respect to such clinical trials. Since January 1, director2016, managing employee neither the Company nor any Company Subsidiary has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Governmental Entity; or (B) except as would not reasonably be expected to be material to the Company and the Company Subsidiaries, taken as a whole, any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous notice from any other Governmental Entity.
(d) Since January 1, 2016, the Company and the Company Subsidiaries have been in compliance with, and have not been notified in writing by any Governmental Entity of any failure (or any investigation with respect thereto) by them or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, Drug Laws, including those terms Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, and including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements, and clinical trial disclosure requirements, in each case with respect to any Product Candidates of the Company or any Company Subsidiary, except for such failures or investigations which would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect.
(e) As of the date of this Agreement, (i) no Product Candidate manufactured, tested, distributed, or held by the Company or any Company Subsidiary has been recalled, withdrawn or suspended since January 1, 2016 and (ii) no Proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any Product Candidate are defined in 42 C.F.R. § 1001.1001) pending or, to the knowledge of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of threatened against the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program LawsCompany Subsidiary.
(jf) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) As of the Company, nor, to the Knowledge date of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Companythis Agreement: (i) has been debarred, excluded or suspended from participation in any Federal the Company and the Company Subsidiaries have provided to Parent complete and accurate copies of (A) all material Health Care ProgramSubmissions, including material correspondence with and from, and contact reports summarizing interactions with, the FDA, EMA, PMDA, and other regulatory authorities and (B) all case report forms received by the Company and the Company Subsidiaries prior to the date of this Agreement in respect of any patient adverse event, patient adverse drug reaction or other patient safety event in respect of the clinical trials of the Product Candidates; and (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge knowledge of the Company, there are no pending has not been any patient serious adverse event, patient serious adverse drug reaction, or threatened filings against the Company of an action relating other serious patient safety event related to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge use of the Company, the Company is Product Candidates that has not under investigation by any Governmental Authority for a violation of either been: (x) included or referenced in the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), Care Submissions or the regulations contained case report forms referred to in 45 C.F.R. Parts 160 clauses (A) and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, (B) above; or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(ny) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale otherwise disclosed by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsto Parent.
Appears in 1 contract
Samples: Merger Agreement (AveXis, Inc.)
Regulatory Matters. (a) The Section 4.14(a) of the Company Disclosure Letter sets forth a true and complete list, as of the Agreement Date, and the Company has made available to Parent true and complete copies of, all Permits required Regulatory Authorizations from the FDA and all material Regulatory Authorizations from any other applicable Regulatory Authorities held by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued Company relating to the Company are Products. Except as would not reasonably be expected to, individually or in full force and effectthe aggregate, result in a Company Material Adverse Effect, (x) the Company is in compliance in all material respects withhas filed, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which maintained or furnished with the giving of notice or lapse of timeapplicable Regulatory Authorities all required filings, or bothdeclarations, would become a default under)listings, each such Permitregistrations, submissions, amendments, modifications, notices and none of such Permits will be terminated or impaired or become terminableresponses to notices, in whole or in partapplications and supplemental applications, as a result of the transaction contemplated by this Agreement. The Company is the sole reports (including all adverse event/experience reports) and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company other information (collectively, the “Company Regulatory FilingsHealth Care Submissions”) and holds (y) all right, title such Health Care Submissions were complete and interest in accurate and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with applicable Health Laws when filed (or were corrected or completed in a subsequent filing).
(i) Since October 6, 2021, the Company and its subsidiaries have been in material compliance with all applicable Health Laws that affect the business, Company Products, properties, assets and activities of the Company or its subsidiaries; (ii) as of the Agreement Date, neither the Company nor its subsidiaries have received any written notice or other letters, notices or guidances issued by the FDA or communication from any Governmental Regulatory Authority which regulates the sale alleging any material violation of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There Health Law; and (iii) there are no pending orinvestigations, suits, claims, actions or proceedings pending, or to the Knowledge knowledge of the Company, threatened regulatory Actions (other than non-material routine against the Company or periodic inspections its subsidiaries with respect to the Company Products or reviews) against alleging any violation by the Company, and its subsidiaries or the Company Products of any such Health Law.
(c) Since October 6, 2021, to the Knowledge Company’s knowledge, all pre-clinical studies and clinical trials conducted with respect to the Company Products by or at the direction of the Company have been conducted in material compliance with applicable experimental protocols, procedures and controls, and all applicable Laws, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Health Laws governing the privacy of patient medical records and other personal information and data. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, neither the Company nor its subsidiaries have outstanding written notifications or other written communications from any institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Regulatory Authority in any jurisdiction, that requires or would require the termination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any clinical studies in which the Company or its subsidiaries have participated and, to the knowledge of the Company, there are no pending or such action has been threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Companyits subsidiaries.
(d) The Since October 6, 2021, to the Company’s knowledge, all manufacture of the products Company Product, including any clinical supplies used in any clinical trials, by or on behalf of the Company is being has been conducted in material compliance in all material respects with current the applicable specifications and requirements of applicable Health Laws. As of the Agreement Date, neither the Company nor, to the knowledge of the Company, any person acting on its behalf has, with respect to the Company Product, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority written notice of inspectional observations, “good manufacturing practiceswarning letters,” as defined by “untitled letters” or written requests or requirements to make any material change to the FDA, including, as applicable, Company Product or any of the FDACompany’s “Quality System Regulation” set forth processes or procedures or any similar correspondence from any Regulatory Authority in 21 C.F.R. Part 820respect to the Company or its business operations alleging or asserting noncompliance with any applicable Law or Regulatory Authorization.
(e) The None of the Company, its subsidiaries, or, to the knowledge of the Company, its officers, employees, or any clinical investigator acting for the Company is and has been in compliance in all (i) made an untrue statement of a material respects with all Laws requiring the maintenance fact or submission of reports or records under requirements administered by the FDA fraudulent statement to any Regulatory Authority or any other Governmental AuthorityEntity, including, for avoidance of doubt, records and reports relating (ii) failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to the Knowledge of the Company, be disclosed to any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA Regulatory Authority or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal Entity or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has (iii) committed any an act, made any statement a statement, or failed to make a statement, including with respect to any statement that scientific data or information, that, at the time such disclosure was made or failure to disclose occurred, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or for any other Governmental Regulatory Authority to invoke any similar policy.
(g) There have been no Serious Adverse Eventspolicy or any other statute or regulation regarding the communication or submission of false information to any applicable Regulatory Authority or Governmental Entity. The Company has not committed or engaged in any fraud or falsification or forgery of any research or development data, Serious Injuries report, studies or MDR Reportable Events associated with the use (including in clinical trials) publications of the products of the Company any document or product candidates of the Company that have not been reported statement voluntarily submitted or required to the FDA in accordance with applicable Law.
(h) To the Knowledge be submitted to any Regulatory Authority or any other Governmental Entity. None of the Company, all studiesits subsidiaries, testsor, and preclinical and clinical research being conducted by the Company, and to the Knowledge knowledge of the Company, on behalf of the Company by its officers, employees, or any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline investigator acting for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, is currently or has been convicted of any crime that has resulted in, or would reasonably be expected to result in, debarment pursuant to 21 U.S.C. Section 335a (a) or (b) or exclusion from participation in any federal health care program pursuant to 42 U.S.C. Section 1320a-7.
(f) No Company Product that is or has been manufactured, tested, distributed, held or marketed by or on behalf of the Company has been terminated recalled, withdrawn or suspended prior to completion for safety (whether voluntarily or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, otherwise) or, to the Knowledge Company’s knowledge, has been adulterated or misbranded. No Proceedings (whether complete or pending) seeking the recall, withdrawal, suspension or seizure of any such Company Product or pre-market approvals or marketing authorizations are pending or, to the knowledge of the Company, threatened against the Company. The Company has filed all annual and periodic reports, amendments and safety reports required for the Company Product required to initiate, be made to any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialRegulatory Authority.
(ig) Neither the Company nor any officer, director, managing employee (as those terms its subsidiaries are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, to any order, individual corporate integrity agreement, corporate integrity agreement monitoring agreement, consent decree, settlement order, or other formal or informal similar agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation imposed by any Governmental Regulatory Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsother Governmental Entity.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Neither the Company nor any of its Affiliates has received any oral or written communication (including any warning letter, untitled letter, Form 483s or similar notices) from the FDA or any counterpart regulatory authorities in the European Union, and to the Knowledge of the Company and its Affiliates, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any of its Subsidiaries is not currently in compliance with any and all Permits required applicable Laws implemented by the FDA FDA, the Drug Enforcement Administration, any counterpart regulatory authorities in the European Union or any other country, except as has not had and would not reasonably be expected to conduct have, individually or in the Business aggregate, a Company Material Adverse Effect. There are no pending voluntary or involuntary market withdrawals, field corrective actions (including recalls), destruction orders, seizures or other regulatory enforcement actions related to any product that have had or would reasonably be expected to have, individually or in the “FDA Permits”). All of the FDA Permits held by or issued to aggregate, a Company Material Adverse Effect.
(b) Neither the Company are nor any of its Affiliates has received any correspondence from the FDA, or a counterpart regulatory authority in full force and effectthe European Union, the Company is in compliance in all material respects withregarding, and is not in default in any material respect 30 under (and and, to the Knowledge of the Company, there is no event which with pending or threatened action or proceeding against, the giving Company or any of notice its Subsidiaries or lapse any of timetheir respective employees regarding any debarment action or investigation undertaken pursuant to the Generic Drug Enforcement Act of 1992 (21 U.S.C. Sections 335(a), (b) and (c)), or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner any similar regulation of the FDA Permits and the associated filings and applications with the FDA, including or any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear similar regulation of any Encumbrance (other than Permitted Encumbrances). The Company counterpart regulatory authority in the European Union, except for any action or proceeding that has not granted any third party any right had or license would not reasonably be expected to usehave, access individually or reference any of in the aggregate, a Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the CompanyMaterial Adverse Effect.
(c) The No data generated by the Company or any of its Affiliates with respect to its products that has been provided to its customers or otherwise made public is in compliance in all material respects with all applicable Laws and the subject of any regulatory or other lettersaction, notices either pending or guidances issued threatened, by the FDA or any other comparable Governmental Authority which regulates relating to the sale truthfulness or scientific adequacy of pharmaceutical products or biological, device or regenerative medicine products in such data.
(d) Neither the Company nor any jurisdiction. There are no of its Subsidiaries is subject to any pending or, to the Knowledge of the Company, threatened regulatory Actions threatened, investigation by (other than non-material routine or periodic inspections or reviewsi) against the CompanyFDA pursuant to its Fraud, Untrue, Material Facts, Bribery, and Illegal Gratuities Final Policy, (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Knowledge of the Company, there are no pending or threatened regulatory Actions Federal Anti-Kickback Statute (other than non-material routine or periodic inspections or reviews42 U.S.C. Section 1320a-7(b)) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates Civil False Claims Act (31 U.S.C. Section 3729 et seq.) or (iii) any equivalent statute or policy of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance country in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820European Union.
(e) The Company is has, prior to the execution of this Agreement, made available to Parent copies of any and has been all documents in its or its Subsidiaries’ possession that are material to assessing the Company’s or any of its Subsidiaries’ compliance with the Federal Food, Drug and Cosmetic Act or the International Standards Organization and their respective implementing regulations or any other similar regulations in any applicable jurisdiction.
(f) The Company and its Subsidiaries are in compliance in all material respects with all Laws requiring applicable requirements of the maintenance Act, the Public Health Service Act, and the regulations promulgated thereunder by the FDA (collectively, the “FDA Requirements”).
(g) Since January 1, 2002, neither the Company nor any of its Affiliates has received any notice or submission of reports or records under requirements administered by other communication from the FDA or any other Governmental Authority, including, for avoidance Authority alleging any current violation of doubt, records and reports relating to product corrections and removals (including the FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsRequirements.
(fh) None of All manufacturing, testing, research, and other scientific operations by the Company orand its Subsidiaries have been conducted in all material respects in compliance with good manufacturing practices, to good clinical practices and good laboratory practices as set forth by the Knowledge FDA.
(i) The Company and its Subsidiaries have not filed any biologics license applications. None of the Company, any of its Collaborative PartnersSubsidiaries or any of their respective officers or employees or, to the knowledge of the Company, agents has made an untrue statement of a material fact to the FDA or subcontractors other Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA or other Governmental Authority.
(j) None of the Company, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct for which has resulted or could result in debarment or disqualification is mandated by the FDA 21 U.S.C. Section 335a(a) or any other Governmental Authoritysimilar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law.
(k) The Company and its Subsidiaries are in compliance in all material respects with all Laws that apply to the Medicare and Medicaid Antikickback Act (42 U.S.C. § 1320a-7b(a)), the Civil False Claims Act (31 U.S.C. § 3729(a)), Sections 1128A, 1128B, and there are no proceedings pending or1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, 1395nn), the Health Care Fraud Act (18 U.S.C. § 1347), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1171-79), and the Criminal False Claims Act (18 U.S.C. § 287), as amended from time to time, as well as similar applicable state Laws.
(l) Section 4.18(l) of the Company Disclosure Schedule sets forth a true, correct and complete list of all INDs, NDAs, sNDAs, and other Drug Approval Applications filed with a Governmental Authority relating to the Key Products.
(m) Each of IND #67,482, IND #70,109, IND #70,863 and IND #73,167 has been issued in the name of the Company and, to the Knowledge of the Company, threatened constitutes all governmental approvals, permits and licenses required by the Company in connection with the performance of clinical trials concerning, respectively, NRP104 (ADHD), NRP104 (Cocaine), NRP290 and NRP409, as such clinical trials have been conducted by the Company as of the Effective Time.
(n) The Company and its Subsidiaries have complied in all material respects with all applicable Laws in connection with the preparation and submission to the FDA of IND #67,482, IND #70,109, IND #70,863 and IND #73,167 and each such IND is in effect.
(o) The Company or any Subsidiary of the Company has complied in all material respects with the requirements of filing with the applicable regulatory authority all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to IND #67482, IND #70,109, IND #70,863 and IND #73,167.
(p) In the course of the conduct of the development of any Key Product, the Company and its Subsidiaries have not used any employee or consultant that reasonably might be expected to result in criminal or civil liability or debarment or disqualification is debarred by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the CompanyCompany or its Affiliates, is the subject of debarment proceedings by the FDA.
(q) Neither the Company nor any of its Collaborative Partners Affiliates has committed received any actwritten notice from any Governmental Authority claiming that the research, made development, manufacture, and use of any statement Key Product by the Company or failed to make any statement of its Subsidiaries as of the Effective Time is not in compliance with all applicable Law and Permits, including the Act.
(r) Since January 1, 2002, no Governmental Authority has served notice on the Company or any of its Affiliates that would the Company Technology or any Key Product was or is in violation of any Law or the subject of any investigation.
(s) Since January 1, 2002, neither the Company nor any of its Affiliates has received written notice from any Governmental Authority that there are any circumstances currently existing that might reasonably be expected to provide a basis for lead to any loss or refusal to renew any material Permit relating to the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Company Technology or for any other Governmental Authority to invoke any similar policyKey Product.
(gt) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use No Governmental Authority (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company ) has commenced or, to the Knowledge of the CompanyCompany or its Affiliates, on behalf of threatened to initiate any formal action to reject or withdraw the Company has been terminated INDs or suspended prior to completion Drug Approval Applications for safety any Key Product, or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, commenced or, to the Knowledge of the CompanyCompany or its Affiliates, threatened to initiate, initiate any action to place a clinical hold order onenjoin production of any Key Product at any facility, nor has the Company or otherwise terminateany of its Affiliates received any notice to such effect since January 1, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial2002.
(iu) Neither the The Company nor has delivered or otherwise made available to Parent copies of all material (A) reports of FDA Form 483 inspection observations, (B) establishment inspection reports, (C) warning letters and (D) other documents that assert ongoing lack of compliance in any officer, director, managing employee material respect with any applicable Laws (as including those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyFDA), norin each case, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of extent received by the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with of its Affiliates from the FDA relating to any Governmental Authority concerning compliance with Federal Health Care Program LawsKey Product.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company and its Affiliates have delivered or made available to Parent any facts reasonably believes that it has believed in good faith to be material regarding: (A) preclinical and clinical study results and protocols for any Key Product; (B) any communications to or from the requisite know-how and processes to, subject FDA with respect to any required regulatory approvalsKey Product, manufacture IND, NDA, or sNDA submissions, and market Dermagraft based any FDA minutes of meetings and telephone conferences; (C) any FDA requests for data and studies on a new cell line in the event that the current cell line is no longer viableany Key Product; and (D) adverse drug experiences and other IND, NDA, or sNDA safety reports with respect to any Key Product.
(lw) To Except as pursuant to the disclosures described in Section 4.18(v), to the Knowledge of the Company, there are no pending safety or threatened filings against the Company of an action relating to the Company under any federal efficacy issues that would preclude regulatory approval or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices cause withdrawal from the United States Department market of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsNRP104.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Merger Agreement (Shire PLC)
Regulatory Matters. (ai) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Medtronic Material Adverse Effect, (i) each of Medtronic and the Medtronic Subsidiaries holds all Medtronic Permits required by and Clearances, including (x) all authorizations under the FDCA (including Section 510(k) thereof), the regulations of the FDA to conduct promulgated thereunder and the Business MDD, and (y) authorizations of any applicable Relevant Authority that are concerned with the quality, identity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of the Medtronic Products (any such Relevant Authority, a “Medtronic Regulatory Agency”) necessary for the lawful operation of the businesses of Medtronic or any of the Medtronic Subsidiaries in each jurisdiction in which such person operates (the “FDA Medtronic Regulatory Permits”); (ii) all such Medtronic Regulatory Permits are valid and in full force and effect; and (iii) Medtronic is in compliance with the terms of all Medtronic Regulatory Permits. All of the FDA Medtronic Regulatory Permits held by or issued to the Company are in full force and effect, except where the Company is failure to be in full force and effect has not had and would not reasonably be expected to have, individually or in the aggregate, a Medtronic Material Adverse Effect.
(ii) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Medtronic Material Adverse Effect, the businesses of each of Medtronic and the Medtronic Subsidiaries are being conducted in compliance in all material respects with, and is not such persons have appropriate internal controls that are reasonably designed to ensure compliance with, all applicable Laws, including (t) the FDCA (including all applicable registration and listing requirements set forth in default in Section 510 of the FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 807); (u) federal Medicare and Medicaid statutes; (v) any material comparable foreign Laws for any of the foregoing (including the MDD); (w) federal, state or provincial criminal or civil Laws (including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), Xxxxx Law (42 U.S.C. § 1395nn), False Claims Act (42 U.S.C. § 1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et. seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local Laws); (x) state or provincial licensing, disclosure and reporting requirements; (y) Laws with respect 30 under (and to the Knowledge protection of personally identifiable information collected or maintained by or on behalf of Covidien or Covidien’s Subsidiaries; and (z) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Medtronic Healthcare Laws”). Since December 31, 2011, neither Medtronic nor any of the CompanyMedtronic Subsidiaries has received any written notification or communication from any Medtronic Regulatory Agency, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with including without limitation the FDA, including the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services or any biologics license applicationother “notified body” or “competent authority” or corresponding Relevant Authority in any jurisdiction, new drug applicationof noncompliance by, 510(k) submissionor liability of Medtronic or the Medtronic Subsidiaries under, premarket approvalany Medtronic Healthcare Laws, investigational new drug except where such noncompliance or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company liability has not granted any third party any right had and would not reasonably be expected to have, individually or license to usein the aggregate, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filinga Medtronic Material Adverse Effect.
(biii) Except as set forth on Section 4.13(b) of Medtronic and the Company Disclosure ScheduleMedtronic Subsidiaries are not party to any corporate integrity agreements, since January 1deferred prosecution agreement, 2007monitoring agreements, there has not been any voluntarily or involuntarily initiatedconsent decrees, conductedsettlement orders, or issued recallsimilar agreements with or imposed by any Medtronic Regulatory Agency and, market withdrawalto Medtronic’s knowledge, safety alertno such action is currently contemplated, warning, “dear doctor” letter, market correction, proposed or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companypending.
(civ) The Company is All pre-clinical and clinical investigations conducted or sponsored by each of Medtronic and the Medtronic Subsidiaries are being conducted in compliance in all material respects with all applicable Laws administered or issued by the applicable Covidien Regulatory Agencies, including without limitation (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (iii) any comparable foreign Laws for any of the foregoing or other lettersLaws regulating the conduct of pre-clinical and clinical investigations and (iv) federal, notices state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or guidances issued in the aggregate, has not had and would not reasonably be expected to have a Medtronic Material Adverse Effect.
(v) Since December 31, 2011, neither Medtronic nor any of the Medtronic Subsidiaries has received any written notice from the FDA (including any inspection reports on Form 483) or any foreign agency with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of medical devices which would reasonably be expected to lead to the denial, suspension or revocation of any application or grant for marketing approval with respect to any material Medtronic Product currently pending before or previously approved or cleared by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (such other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyMedtronic Regulatory Agency.
(dvi) The manufacture of the products of the Company is being conducted in compliance in Since December 31, 2011, all material respects with current “good manufacturing practices,” as defined by the FDAreports, includingdocuments, as applicableclaims, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is permits, notices and has been in compliance in all material respects with all Laws requiring the maintenance MDRs required to be filed, maintained or submission of reports or records under requirements administered by furnished to the FDA or any other Governmental AuthorityMedtronic Regulatory Agency by Medtronic and the Medtronic Subsidiaries have been so filed, includingmaintained or furnished in a timely manner, for avoidance of doubtexcept where failure to file, records maintain or furnish such reports, documents, claims, permits, notices or MDRs has not had and reports relating would not reasonably be expected to product corrections have, individually or in the aggregate, a Medtronic Material Adverse Effect. All such reports, documents, claims, permits and removals notices were complete and accurate in all material respects on the date filed (including FDA requirements set forth or were corrected in 21 C.F.R. Part 806or supplemented by a subsequent filing), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None . Neither Medtronic nor any of the Company orMedtronic Subsidiaries, nor, to the Knowledge knowledge of Medtronic, any officer, employee, agent or distributor of Medtronic or any of the CompanyMedtronic Subsidiaries, any has made an untrue statement of its Collaborative Partners, agents a material fact or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by a fraudulent statement to the FDA or any other Governmental AuthorityMedtronic Regulatory Agency, and there are no proceedings pending or, failed to the Knowledge of the Company, threatened that reasonably might disclose a material fact required to be expected disclosed to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company orMedtronic Regulatory Agency, to the Knowledge of the Company, any of its Collaborative Partners has or committed any an act, made any statement a statement, or failed to make a statement, in each such case, related to the business of Medtronic or any statement that of the Medtronic Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Medtronic Regulatory Agency to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) . Neither Medtronic nor any of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyMedtronic Subsidiaries, nor, to the Knowledge knowledge of the CompanyMedtronic, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) agent or distributor of Medtronic or any of the CompanyMedtronic Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. Neither Medtronic nor any of the Medtronic Subsidiaries, nor, to the Knowledge knowledge of Medtronic, any officer, employee, agent or distributor of Medtronic or any of the CompanyMedtronic Subsidiaries, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; similar Law or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableprogram.
(lvii) As to each Medtronic Product or Medtronic Product candidate subject to the FDCA, the regulations of the FDA promulgated thereunder or similar Law in any foreign jurisdiction (including the MDD) that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Medtronic or any of the Medtronic Subsidiaries, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Medtronic Material Adverse Effect, each such Medtronic Product or Medtronic Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labelling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Medtronic, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Medtronic Product or Medtronic Product candidate by Medtronic or any of the Medtronic Subsidiaries of any Law, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Medtronic Material Adverse Effect.
(viii) Since December 31, 2011, each of Medtronic and the Medtronic Subsidiaries have neither voluntarily nor involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued any “Class I” recall or any material field corrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Medtronic Product or is currently considering initiating, conducting or issuing any “Class I” recall of any Medtronic Product. To the Knowledge knowledge of the CompanyMedtronic, there are no pending facts which are reasonably likely to cause, and Medtronic has not received since December 31, 2011 any written notice from the FDA or threatened filings against any other Medtronic Regulatory Agency regarding (i) the Company recall, market withdrawal or replacement of an action relating any Medtronic Product sold or intended to be sold by Medtronic or the Company under Medtronic Subsidiaries, (ii) a change in the marketing classification or a material change in the labelling of any federal such Medtronic Products, (iii) a termination, enjoinment or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge suspension of the Companymanufacturing, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”)marketing, or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department distribution of Health and Human Services Office of Civil Rights relating to any such violationsMedtronic Products, or any comparable state (iv) a negative change in reimbursement status of a Medtronic Product, that in each case, has had or local Laws. The Company is not would reasonably be expected to have a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal impact on the business of Medtronic and state data breach Lawsits Subsidiaries.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Transaction Agreement (Covidien PLC)
Regulatory Matters. (a) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Valeant Material Adverse Effect, (i) each of Valeant and the Valeant Subsidiaries holds all Permits required by Valeant Permits, including all authorizations under the FDCA, the PHSA, and the regulations of the FDA to conduct promulgated thereunder, the Business Food and Drugs Act, the CDSA and the regulations of Health Canada promulgated thereunder, and any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, distribution, sale, import or export of the Valeant Products (any such Governmental Entity, a “Valeant Regulatory Agency”) necessary for the lawful operating of the businesses of Valeant or any of the Valeant Subsidiaries and the testing, manufacturing, sale or distribution, as applicable, of each of the Valeant Products (the “FDA Valeant Regulatory Permits”). All of the FDA ) and (ii) all such Valeant Regulatory Permits held by or issued to the Company are valid and in full force and effect. Since January 1, 2009, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Valeant Regulatory Permit, except as has not had and would not reasonably be expected to have, individually or in the Company is aggregate, a Valeant Material Adverse Effect. Valeant and each of the Valeant Subsidiaries are in compliance in all material respects withwith the terms of all Valeant Regulatory Permits, and is not in default in any material respect 30 under (and no event has occurred that, to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or bothValeant, would become reasonably be expected to result in a default under)penalty under or the revocation, each such cancellation, non-renewal or adverse modification of any Valeant Regulatory Permit, except as has not had and none of such Permits will would not reasonably be terminated or impaired or become terminableexpected to have, in whole individually or in partthe aggregate, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingValeant Material Adverse Effect.
(b) Except as set forth on Section 4.13(bwould not, individually or in the aggregate, reasonably be expected to have a Valeant Material Adverse Effect, the businesses of each of Valeant and the Valeant Subsidiaries are being conducted in compliance with all applicable Laws, including (i) the FDCA, including the rules and regulations promulgated thereunder; (ii) federal Medicare and Medicaid statutes and related state or local statutes or regulations; (iii) the Food and Drugs Act and the CDSA, including the rules and regulations promulgated thereunder; (iv) provincial formulary and drug pricing statutes, including the rules and regulations promulgated thereunder; (v) any comparable foreign Laws for any of the Company Disclosure Scheduleforegoing; (vi) federal, since January 1state or provincial criminal or civil Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), 2007Xxxxx Law (42 U.S.C. §1395nn), there has not been False Claims Act (42 U.S.C. §1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et. seq. and any voluntarily comparable state, provincial or involuntarily initiatedlocal Laws) and (vii) state or provincial licensing, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companydisclosure and reporting requirements.
(c) The Company is All pre-clinical and clinical investigations conducted or sponsored by each of Valeant and the Valeant Subsidiaries are being conducted in compliance in all material respects with all applicable Laws and any other letters, notices administered or guidances issued by the applicable Regulatory Authorities, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (iii) Division 5 of the Food and Drug Regulations regarding Drugs for Clinical Trials Involving Human Subjects, and (iv) federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information.
(d) Neither Valeant nor any of the Valeant Subsidiaries has received any written information from the FDA, the EMEA or Health Canada or any Governmental Authority foreign agency with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of drugs which regulates would reasonably be expected to lead to the sale denial of pharmaceutical products any application for marketing approval currently pending before the FDA, Health Canada or biologicalsuch other Valeant Regulatory Agency.
(e) All material reports, device documents, claims, permits and notices required to be filed, maintained or regenerative medicine products furnished to the FDA, Health Canada or any other Valeant Regulatory Agency by Valeant and the Valeant Subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no liability exists with respect to such filing. Neither Valeant nor any jurisdiction. There are no pending orof the Valeant Subsidiaries, nor, to the Knowledge of the CompanyValeant, threatened regulatory Actions (other than non-material routine any officer, employee, agent or periodic inspections distributor of Valeant or reviews) against the Company, and to the Knowledge any of the CompanyValeant Subsidiaries, there are no pending has made an untrue statement of a material fact or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining a fraudulent statement to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA Health Canada or any other Governmental AuthorityValeant Regulatory Agency, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to be disclosed to the Knowledge of the CompanyFDA, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA Health Canada or any other Governmental AuthorityValeant Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA FDA, Health Canada or any other Valeant Regulatory Agency to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) . Neither Valeant nor any of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the CompanyValeant Subsidiaries, all studiesnor, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of Valeant, any officer, employee, agent or distributor of Valeant or any of the CompanyValeant Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. Neither Valeant nor any of the Valeant Subsidiaries, nor, to the Knowledge of Valeant, any officer, employee, agent or distributor of Valeant or any of the Valeant Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program.
(f) As to each Valeant Product or Valeant Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder, the Food and Drugs Act , the CDSA and the regulations of Health Canada promulgated thereunder, or similar Law in any foreign jurisdiction that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of the Company by Valeant or any of its Collaborative Partnersthe Valeant Subsidiaries, are beingeach such Valeant Product or Valeant Product candidate is being or has been developed, and at all times have beenmanufactured, conducted tested, distributed or marketed in compliance in all material respects with all applicable Lawsrequirements under the FDCA and the regulations of the FDA promulgated thereunder, includingthe Food and Drugs Act, as applicablethe CDSA and the regulations of Health Canada promulgated thereunder, and similar Laws in any foreign jurisdiction, including those relating to investigational use, premarket clearance or marketing approval, good laboratory practice regulations set forth in 21 C.F.R. Part 58manufacturing practices, good clinical practices, good laboratory practices, labeling, advertising, record keeping, filing of reports, and security. There is no action or proceeding pending or threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Valeant Product or Valeant Product candidate by Valeant or any of the Valeant Subsidiaries of any Law, except as defined would not, individually or recognized in the aggregate, reasonably be expected to have a Valeant Material Adverse Effect.
(g) Since January 1, 2009, each of Valeant and the Valeant Subsidiaries have neither voluntarily nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Valeant Product. Each of Valeant and the Valeant Subsidiaries are not aware of any facts which are reasonably likely to cause (i) the recall, market withdrawal or replacement of any Valeant Product sold or intended to be sold by Valeant or the Valeant Subsidiaries, (ii) a change in the marketing classification or a material change in the labeling of any such Valeant Products, or (iii) a termination or suspension of the marketing of such Valeant Products.
(h) To Valeant’s Knowledge, no data generated by Valeant or any of the Valeant Subsidiaries with respect to the Valeant Products that has been provided to its customers or otherwise made public or filed with a Valeant Regulatory Agency is the subject of any regulatory or other action, either pending or threatened, by any Valeant Regulatory Agency relating to the truthfulness or scientific adequacy of such data.
(i) Since January 1, 2009, neither Valeant nor any of the Valeant Subsidiaries has received any written notice that the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of Health Canada or any other Governmental Authority. No clinical trial conducted by the Company orValeant Regulatory Agency has (i) commenced, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order onrequest the recall of any product sold or intended to be sold by Valeant or the Valeant Subsidiaries, or otherwise terminate(ii) commenced, materially delay or suspendthreatened to initiate, any such ongoing clinical trial, action to enjoin manufacture or distribution of any product sold or intended to disqualify, restrict be sold by Valeant or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program LawsValeant Subsidiaries.
(j) Neither the Company Since January 1, 2009, neither Valeant nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyValeant Subsidiaries has received any written notice from the FDA, nor, to the Knowledge Health Canada or any other Valeant Regulatory Agency regarding inappropriate advertising or marketing of the Company, any agent (as such term is defined a Valeant Product or a negative change in 42 C.F.R. § 1001.1001(a)(1)(ii)) reimbursement status of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care ProgramValeant Product.
(k) The Company reasonably believes that it has the requisite know-how and processes toExcept as would not, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line individually or in the event that aggregate, reasonably be expected to have a Valeant Material Adverse Effect, no Valeant Product manufactured or distributed by Valeant or any of the current cell line Valeant Subsidiaries is no longer viable(i) adulterated within the meaning of 21 U.S.C. § 351 (or any similar Law), (ii) misbranded within the meaning of 21 U.S.C. § 352 (or any similar Law).
(l) To the Knowledge of the CompanyValeant, there all of its vendors are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal good manufacturing practice and state data breach Lawssimilar regulations promulgated by regulatory agencies with jurisdiction over Valeant’s vendors.
(nm) To This Section 4.17 does not apply to environmental matters, which are the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements subject of Medicare and other Federal Health Care Program LawsSection 4.13.
Appears in 1 contract
Samples: Merger Agreement (Valeant Pharmaceuticals International)
Regulatory Matters. (a) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, (i) each of Apple and its Subsidiaries holds (A) all Permits required by authorizations under the FDA to conduct the Business Federal Food, Drug, and Cosmetic Act of 1938 (the “FDA FDCA”) and all amendments thereto, the Public Health Service Act (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and (B) authorizations of any applicable Governmental Authority that are concerned with the research, quality, identity, strength, purity, safety, efficacy, manufacturing, packaging, labelling, storage, transport, marketing, distribution, sale, pricing, import or export of any of the Apple Products (any such Governmental Authority, a “Apple Regulatory Agency”) necessary for the lawful operation of the businesses of Apple or any of its Subsidiaries as currently conducted (the “Apple Regulatory Permits”). All of the FDA ; (ii) all such Apple Regulatory Permits held by or issued to the Company are valid and in full force and effect, the Company is ; and (iii) Apple and its Subsidiaries are in material compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving terms of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company all Apple Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingPermits.
(b) Except as set forth on Section 4.13(b) As of the Company Disclosure Scheduledate hereof, since January 1neither Apple nor any of its Subsidiaries (i) has entered into material corporate integrity agreements, 2007monitoring agreements, there has not been any voluntarily or involuntarily initiatedconsent decrees, conductedsettlement orders, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correctionsimilar agreements with or imposed by any Apple Regulatory Agency, or investigator (ii) has received written notice relating to from any Apple Regulatory Agency that alleges any material noncompliance or notifies the recipient that it is under investigation or the subject of an inquiry by any such Apple Regulatory Agency for alleged material lack of safety or efficacy of noncompliance with any product Applicable Law related to the operation of the Company or product candidate business of the CompanyApple.
(c) The Company is All pre-clinical and clinical investigations in respect of an Apple Product conducted or sponsored by Apple or any of its Subsidiaries for submission to an Apple Regulatory Agency are being, and have been, conducted in material compliance with all Applicable Laws administered or issued by the applicable Apple Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such material noncompliance that has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(d) Apple has submitted certain BLA filings to FDA in support of a marketing authorization approval for OLT-200, and Apple has not taken any action to withdraw these filings. Apple has not received any communication from FDA indicating that FDA has refused or will refuse to accept or file the BLA.
(e) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, during the period beginning on January 1, 2017 and ending on the date of this Agreement, neither Apple nor any of its Subsidiaries has received any written notice from the FDA or the European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, distribution, storage, transport, packaging or manufacturing of Apple Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Apple Regulatory Permits or of any application for marketing approval currently pending before the FDA or such other Apple Regulatory Agency.
(f) Since November 1, 2018 all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Apple Regulatory Agency by Apple and its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete in all material respects with all applicable Laws and any other letters, notices on the date filed (or guidances issued were corrected in or supplemented by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionsubsequent filing). Since January 1, 2007 there have been no written notices2017, reportsneither Apple nor any of its Subsidiaries, warning lettersnor, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company knowledge of Apple, any officer, employee, agent or the products or product candidates distributor of the Company Apple or any subpoenas of its Subsidiaries, has made an untrue statement of a material fact or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard fraudulent statement to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental AuthorityApple Regulatory Agency, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by be disclosed to the FDA or any other Governmental AuthorityApple Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make a statement, in each such case, related to the business of Apple or any statement that of its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Apple Regulatory Agency to invoke any similar policy.
, except for any act or statement or failure to make a statement that has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, (gi) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by neither Apple nor any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanySubsidiaries, nor, to the Knowledge knowledge of the CompanyApple, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined agent or distributor of Apple or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in 42 C.F.R. any conduct for which debarment is mandated by 21 U.S.C. § 1001.1001335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the CompanyApple Products are sold or where Apple has publicly announced an intention to sell an Apple Product; and (ii) neither Apple nor any of its Subsidiaries, nor, to the Knowledge knowledge of the CompanyApple, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) officer or employee of the Company: (i) Apple or any of its Subsidiaries, has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 19351935 or any similar program, codified at Title 42including any conduct that would constitute material non-compliance with the Federal Anti-Kickback Statute, Chapter 7Federal False Claims Act, or their respective state equivalents.
(g) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, as to each Apple Product subject to the FDCA and the regulations of the United States Code FDA promulgated thereunder or any similar Applicable Law in any foreign jurisdiction in which material quantities of any of the Apple Products are sold that has been researched, developed, manufactured, tested, distributed or marketed by or on behalf of Apple or any of its Subsidiaries, each such Apple Product is being or has been researched, developed, manufactured, stored, distributed and marketed in material compliance with all Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There are no Proceedings pending or, to the knowledge of Apple, threatened in writing, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Apple Product by Apple or any of its Subsidiaries of any Applicable Law, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(h) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, (i) neither Apple nor any of its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “Social Security Act”); dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory material compliance of any Apple Product and (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (ivii) to the Knowledge knowledge of Apple, neither Apple nor any of its Subsidiaries has received, any written notice from the FDA or any other Apple Regulatory Agency regarding (A) the recall, correction, market withdrawal, or replacement of any Apple Product sold (other than recalls, corrections, withdrawals, or replacements that are not material to Apple and its Subsidiaries, taken as a whole), (B) a material change in the marketing classification or a material change in the labeling of any such Apple Products, (C) a termination or suspension of the Companymanufacturing, is the target marketing, or subject distribution of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; such Apple Products, or (vD) is currently charged with or convicted of any criminal offense relating to the delivery a material negative change in reimbursement status of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableApple Product.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company Except as would not, individually or in the aggregate, reasonably be expected to be material to the business of the Acquired Companies, taken as a whole: (i) the Acquired Companies own, possess or validly have the right to use all permits required to research, develop, manufacture, market, commercialize, distribute and sell its products; (ii) all products of the Acquired Companies are and, since January 1, 2019, have been researched, developed, manufactured and marketed in accordance with applicable specifications, Permits and applicable Laws, including GMPs, GLPs, GCPs, GDPs and GVPs; (iii) since January 1, 2019, (A) no product of the Acquired Companies or manufacturing site has all Permits required shut down, been subject to any import or export prohibition, received any FDA Form 483 or other Governmental Body notice of inspectional observations, “warning letters,” “untitled letters” or requests or requirements to make changes to any product of the Acquired Companies or any manufacturing operations for any product of the Acquired Companies and (B) there have been no recalls, field notifications, field corrections, warnings, “dear doctor” letters, investigator notices, safety alerts or other written notices of action issued by a Governmental Body or the FDA Acquired Companies relating to conduct an alleged lack of safety, efficacy, or regulatory compliance of any product of the Business Acquired Companies (the collectively, “FDA PermitsSafety Notices”). All of the FDA Permits held by or issued to the Each Acquired Company are in full force and effect, the Company is in compliance has complied in all material respects withwith its obligations to make filings, declarations, listings, registrations, reports or submissions with the applicable regulatory authorities (including the FDA and is the DEA or any other Governmental Body performing functions similar to those performed by the FDA and the DEA) relating to Acquired Company drug products, including but not limited to adverse event reports. Except as would not reasonably be expected, individually or in default in any the aggregate, to be material respect 30 under (and to the Knowledge business of the CompanyAcquired Companies, taken as a whole, no event which written deficiencies have been asserted by any applicable Governmental Body with the giving of notice respect to any such filings, declarations, listing, registrations, reports or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filingsubmissions.
(b) Except as set forth on Section 4.13(b) would not reasonably be expected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a whole, no Acquired Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating (i) made an untrue statement of a material fact statement to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologicalBody, device or regenerative medicine products in any jurisdiction. There are no pending or, (ii) failed to the Knowledge of the Company, threatened regulatory Actions (other than non-disclose a material routine or periodic inspections or reviews) against the Company, and fact required to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining be disclosed to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(diii) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or committed any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement statement, that would reasonably be expected to provide (in any such case) establishes a reasonable basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) Gratuities Final Policy. As of the products of Agreement Date, the Company or product candidates of is not the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws subject of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, pending or, to the Knowledge of the Company, threatened investigation by the FDA pursuant to initiateits Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, Acquired Companies nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) officers, directors, employees, agents or clinical investigators of any of the Company is a party toAcquired Companies or, to the Acquired Companies’ Knowledge, anyone acting on behalf of the Acquired Companies, is, has been, or bound byis threatened in writing to be: (i) excluded, any orderdebarred, individual integrity agreementsuspended or otherwise
(c) Except as would not reasonably be expected, corporate integrity agreement individually or other formal or informal agreement with any Governmental Authority concerning in the aggregate, to be material to the business of the Acquired Companies, taken as a whole, the Acquired Companies are in compliance and, since January 1, 2019, have been in compliance with Federal Health Care Program Laws.
(j) Neither all Healthcare Laws applicable to the Company nor any officer, director, managing employee (operation of its business as those terms are defined in 42 C.F.R. § 1001.1001) currently conducted. As of the Company, norAgreement Date, to the Knowledge of the CompanyCompany no enforcement, regulatory or administrative proceeding is pending, and no such enforcement, regulatory or administrative proceeding has been threatened in writing, against the Company under the Healthcare Laws, other than any such proceeding that would not reasonably be expected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a whole. None of the Acquired Companies has received any written notice, warning letter, or similar written communication that (A) alleges a material violation of, or asserts a material failure to comply with, any agent applicable Healthcare Law, or (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)B) imposes a written obligation to undertake, or to bear all or any portion of the Company: (i) has been debarredcost of, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject remedial action of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viablenature.
(ld) Since January 1, 2019 , the Company and its Subsidiaries have performed periodic audits of all manufacturing sites that supply regulatory starting materials, drug substances, drug product intermediates, drug products or finished products to the Company or the Subsidiaries to the extent permitted by any Contract relating to such manufacturing site or required by applicable Healthcare Law. To the Knowledge of the Company, there are no pending written findings deemed critical by the auditor or threatened filings against the Company of an action relating to the Company under any federal inspector resulting from such audits or state whistleblower statuteinspections since January 1, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) 2019 that have not been remediated in all material respects. To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined manufacturing site has performed in HIPAAall material respects all tasks required by such written remediation plans. The Company has been in compliance in made available to Parent complete and accurate copies of all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding reports from all regulatory audits or billing advice regarding products offered for sale inspections conducted since January 1, 2019 by the Company and procedures related theretoits Subsidiaries or, such advice is to the extent in the possession or control of the Company and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsits Subsidiaries, by their Representatives or any Governmental Bodies.
Appears in 1 contract
Samples: Agreement and Plan of Merger (Biodelivery Sciences International Inc)
Regulatory Matters. (a) The Company has all Permits required Except as described in the Registration Statement and the Prospectus, the preclinical and clinical studies conducted by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued or, to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge knowledge of the Company, no event which with on behalf of or sponsored by the giving of notice Company or lapse of timeits subsidiaries, or bothin which the Company or its subsidiaries have participated, would become a default under), each such Permit, the results of which are referred to in the Registration Statement and none of such Permits will be terminated or impaired or become terminable, in whole or in partthe Prospectus, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company applicable (collectively, the “Company Studies”), were, and if still pending are, being conducted in all material respects in accordance with all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “Regulatory FilingsAuthorities”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has no knowledge of any other studies not granted any third party any right described in the Registration Statement and the Prospectus, the results of which are inconsistent with or license call into question the results described or referred to in the Registration Statement and the Prospectus. The Company and its subsidiaries are, and since May 1, 2018, have operated in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities and all other applicable federal, state or foreign health care laws and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, access or reference any of the Company Regulatory Filingsdistribution, includingmarketing, without limitationlabeling, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedulepromotion, since January 1sale, 2007offer for sale, there has not been any voluntarily or involuntarily initiatedstorage, conductedimport, export, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy disposal of any product of candidates under development by the Company or product candidate any of its subsidiaries (collectively, the Company.
(c) The “Health Care Laws”), except where such non-compliance would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company is in compliance in all material respects with all applicable Laws and nor any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending orits subsidiaries, to the Knowledge knowledge of the Company, threatened regulatory Actions (have received any written notices, correspondence or other than non-material routine communications from the Regulatory Authorities or periodic inspections any other governmental agency requiring or reviews) against threatening the Companytermination or suspension of any such Studies, and and, to the Knowledge knowledge of the Company, there are no pending reasonable grounds for the same. Except as would not, whether singly or threatened in the aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries has received any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining authority alleging that it is in violation of any Health Care Laws, and, to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate knowledge of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, includingno such claim, as applicableaction, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and suit, proceeding, hearing, enforcement, investigation, arbitration or other action has been in compliance in all material respects with all Laws requiring threatened. Neither the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental AuthorityCompany, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company orits subsidiaries nor, to the Knowledge knowledge of the Company, any of the Company’s or its Collaborative Partnerssubsidiaries’ officers, directors, employees, contractors or agents is a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or subcontractors has been convicted similar agreements with or imposed by any Regulatory Authority with respect to Health Care Laws. Neither the Company, any of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending orits subsidiaries nor, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge knowledge of the Company, any of the Company’s or its Collaborative Partners subsidiaries’ employees, officers, directors, contractors or agents has committed been excluded, suspended or debarred from participation in any actU.S. federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) or human clinical research or is subject to a governmental inquiry, made any statement investigation, proceeding or failed to make any statement other similar action that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraudresult in such debarment, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” suspension or for any other Governmental Authority to invoke any similar policyexclusion.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Open Market Sale Agreement (Ayala Pharmaceuticals, Inc.)
Regulatory Matters. (ai) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All businesses of the FDA Permits held by or issued to the Company Borrowers have been and are in full force and effect, the Company is being conducted in compliance in all material respects withwith all applicable Law, including the Healthcare Laws, and is not in default in all Permits, (ii) each Product (whether manufactured by Accuray or any material respect 30 of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under (and contract to the Knowledge Accuray or any of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permitits Subsidiaries) has been, and none of such Permits will be terminated or impaired or become terminablecurrently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications compliance with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filingsapplicable Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and Document Controls under 21 CFR 820.40 and all Product specifications as established in company documentation, except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Credit Parties (other than immaterial consequences), (iii) each contract between Accuray and any of its Subsidiaries on the Know-How contained one hand, and any third party manufacturer on the other hand contain (and Accuray and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements, (iv) Accuray and its Subsidiaries are in compliance in all material respects with applicable Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (v) neither Accuray nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that Accuray, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Law or any Permit.
2. Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to Accuray or any of its Subsidiary is pending or, to the knowledge of the Company Regulatory Filings Credit Parties, threatened. None of Accuray or rights (including any regulatory exclusivities) associated of its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with each such Company Regulatory Filingany Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products.
3. Accuray and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (bi) Except as set forth on Section 4.13(b) for the research and development and commercialization of the Company Disclosure ScheduleProducts, since January 1including, 2007without limitation, there has not been any voluntarily all Permits necessary in connection with testing, manufacturing, marketing or involuntarily initiatedselling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating and (ii) to an alleged material lack carry on the business of safety or efficacy Accuray and each of any product of the Company or product candidate of the Company.
(c) The Company its Subsidiaries. All such Permits are valid and in full force and effect and Accuray and each Subsidiary is in compliance in all material respects with all applicable Laws terms and conditions of such Permits. None of Accuray or any other letters, notices or guidances issued by the FDA or Subsidiary has received any written notice from any Governmental Authority which regulates that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the sale development, testing and/or manufacturing of pharmaceutical products such Product should cease or biological, device or regenerative medicine products in any jurisdictionthat such Product should be withdrawn from the marketplace.
4. There are have been no pending or, adverse clinical test results which have or could reasonably be expected to the Knowledge have a materially adverse impact on Accuray or any of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Companyits Subsidiaries, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written noticesProduct recalls or voluntary Product withdrawals from any market (other than specific and discrete batches or lots not made in conjunction with a larger recall).
5. Neither Accuray nor any of its Subsidiaries have experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Accuray or any of its Subsidiaries in accordance with all specifications thereof and the required payments related thereto in any twelve (12) month period have decreased by more than twenty percent (20%) with respect to the quantities of such Product produced in the prior twelve (12) month period.
6. There has been no material untrue statement of fact and no fraudulent statement made by Accuray or any of its Subsidiaries or any of their respective agents or representatives to the FDA, reports, warning lettersNRC, or untitled letters alleging or asserting noncompliance in any other Governmental Authority, and there has been no failure to disclose any material respect with any applicable Law relating fact required to be disclosed to the Company FDA, NRC or any other Governmental Authority.
7. To the best knowledge of the Credit Parties, no insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and treatments performed using the CyberKnife and TomoTherapy Products, or (ii) reduced the scope of coverage or the products or product candidates rate of reimbursement it provides for procedures and treatments performed using the Company CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to have a materially adverse impact on the revenues of Accuray and its Subsidiaries. None of Accuray or any subpoenas of its Subsidiaries has been the subject of any “for cause” inspection, investigation or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered audit by any Governmental Authority in connection with regard any alleged improper activity.
8. There is no arrangement relating to Accuray or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any product Person to induce, or in return for obtaining or the referral of business or for the Company or any product candidate arrangement for recommendation of the Company.
(d) The manufacture such referrals. All xxxxxxxx by Accuray and each of the products of the Company is being conducted in compliance its Subsidiaries for its services have been true and correct in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been are in compliance in all material respects with all Laws requiring applicable Law, including the maintenance or submission Healthcare Laws.
9. None of reports or records under requirements administered by the FDA Accuray or any other Governmental Authorityof its Subsidiaries, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge knowledge of the CompanyCredit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Collaborative PartnersSubsidiaries has been convicted of, agents charged with or, to the knowledge of the Credit Parties, investigated for any federal or subcontractors state health program-related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Credit Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of Accuray or any of its Subsidiaries or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of any crime or engaged in any conduct which including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or could would reasonably be expected to result in a debarment or disqualification by exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Law. No debarment proceedings or investigations in respect of the FDA business of Accuray or any other Governmental Authority, and there of its Subsidiaries are no proceedings pending or, to the Knowledge knowledge of the CompanyCredit Parties, threatened that reasonably might be expected to result in criminal against Accuray or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed Subsidiaries or any actindividual who is an officer, made director, employee or manager of Accuray or any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke of its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policySubsidiaries.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all 10. All studies, tests, tests and preclinical and clinical research being trials conducted by the Company, and relating to the Knowledge of the CompanyProducts, on behalf of the Company sponsored by Accuray or any of its Collaborative Partners, are beingSubsidiaries have been conducted, and at all times have beenare currently being conducted, conducted in compliance in all material respects in accordance with all applicable LawsLaw and IDEs, includingincluding procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the extent required by applicable Law, Accuray and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or on behalf of Accuray or such Subsidiary, as applicable.
11. To the knowledge of the Credit Parties, good laboratory practice regulations set forth none of the clinical investigators in 21 C.F.R. Part 58, good any clinical practices, as defined trial sponsored by Accuray or recognized any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violationsServices, or any comparable state Governmental Authority and, to the knowledge of the Credit Parties, no such disqualification, or local Lawsother sanction of any such clinical investigator is pending or threatened. The Company is not a “covered entity” as that term is defined None of Accuray or any of its Subsidiaries has received from the FDA or other applicable Governmental Authority any notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects connection with the payment requirements of Medicare and other Federal Health Care Program LawsProducts.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required is a savings and loan holding company supervised by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingFRB.
(b) Except as set forth on Section 4.13(b) The Bank is a federal savings bank supervised by the OCC. The deposit accounts of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued Bank are insured by the FDA FDIC to the fullest extent permitted by law. The Bank has paid or any Governmental Authority which regulates properly reserved or accrued for all current premiums and assessments with respect to such deposit insurance, all premiums and assessments required to be paid in connection therewith have been paid when due, and no proceedings for the sale termination of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There such insurance are no pending or, to the Knowledge Company’s Knowledge, threatened. The Bank received a rating of at least “satisfactory” in its most recent examination or interim review under the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyCommunity Reinvestment Act.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(ic) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term its Subsidiaries is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound bythe subject of, any cease-and-desist order, individual integrity consent order, written agreement, corporate integrity agreement order for civil money penalty, prompt corrective action directive, memorandum of understanding, supervisory letter, individual minimum capital requirement, operating agreement, or any other formal or informal agreement with enforcement action issued by, or entered into with, any Governmental Regulatory Authority. Except as set forth in Schedule 8.14, none of the Companies has made, adopted, or implemented any currently effective commitment, board resolution, policy, or procedure at the request or recommendation of any Regulatory Authority concerning that limits in any material respect the conduct of its business or that in any material manner relates to its capital adequacy, its payment of dividends or distribution of capital, its credit or risk management, its compliance with Federal Health Care Program Lawsprogram, its management, its growth, or its business.
(jd) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) Except for examinations of the CompanyCompanies conducted by their respective primary regulators in the ordinary course of business, norno Regulatory Authority has initiated or has pending any proceeding or, to the Knowledge Company’s Knowledge, any inquiry or investigation into the business or operations of the CompanyCompanies, any agent (as except where such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarredproceeding, excluded inquiry, or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against itinvestigation would not reasonably be likely to be, him either individually or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Companyaggregate, there are no pending or threatened filings against the Company of an action relating material to the Company under any federal and its Subsidiaries, taken as a whole. There is no unresolved violation, apparent violation, criticism, matter requiring attention, recommendation, or state whistleblower statuteexception cited, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Companymade, the Company is not under investigation or threatened by any Governmental Regulatory Authority for a violation in any report of examination, report of inspection, supervisory letter or other communication that would reasonably be likely to be, either individually or in the Health Insurance Portability and Accountability Act of 1995aggregate, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating material to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related theretoits Subsidiaries, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawstaken as a whole.
Appears in 1 contract
Samples: Merger Agreement (Bank Mutual Corp)
Regulatory Matters. (a) The Company is and has been in substantial compliance with all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued material Laws applicable to the Company are in full force Company’s products and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filingsactivities, including, without limitation, product design, development, testing, clinical trials, manufacturing, marketing, distribution, labeling, storage and transport, in all jurisdictions in which such acts or any of the Know-How contained in them occurred or are reasonably likely to occur or such products or any of the Company Regulatory Filings them have been or rights are likely to be sold or used (including any regulatory exclusivities) associated Laws administered by the United States Food and Drug Administration (“FDA”). The labeling claims and advertising and promotional claims made by the Company for any Company products are and have been in compliance with FDA approval for each such Company Regulatory Filingproduct in each jurisdiction where it is marketed in all material respects, and supported by proper research, development, design, testing, analysis and disclosure that conforms in all material respects with applicable Laws.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure ScheduleThe products, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate activities and facilities of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending oras well as, to the Knowledge of the Company, threatened its suppliers, distributors, contractors and other intermediaries, are and have been in substantial compliance with all applicable requirements of Clinical Laboratory Improvement Amendments (“CLIA”), the Public Health Service Act, the Federal Food, Drug, and Cosmetic Act (“FDCA”) and implementing FDA regulations, including, but not limited to, regulations relating to registration, listing, labeling, advertising and promotion, clinical studies and manufacturing requirements, all to the extent applicable to any of the Company’s products or services. The Company is not and has not been subject to any obligation or requirement arising under any consent decree, consent agreement, or warning letter issued by or entered into with the FDA or any other Governmental Authority or other notice, response or commitment made to the FDA or any other Governmental Authority.
(c) The Company has made available to Acquiror true, correct and complete copies of (i) all customer complaints relating to any Company products and all MedWatch forms received by the Company or filed with the FDA within the last three (3) years; (ii) all warning letters, untitled letters, regulatory Actions letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or other correspondence relating to any Company products and the Company’s compliance with Laws from the FDA or any other Governmental Authority and all of the Company’s responses thereto within the last three (3) years; (iii) a list of all Company Products marketed within the last three (3) years, each of which have been sold or distributed in material compliance with all applicable Laws; (iv) all correspondence, meeting minutes or related documents concerning material communications between FDA and the Company, including requests for information and responses thereto; (v) all written audit reports pertaining to assessment of compliance with Good Manufacturing Practice(GMP) requirements by the Company and their suppliers in the Company’s possession or reasonably accessible by the Company; and (vi) all product labeling and advertising currently in use or within the past three (3) years, including that posted on the Company’s website and in user manuals.
(d) Since January 1, 2011, no exemptions or approvals for any Company product have been subjected to reevaluation, revocation, rescission, withdrawal, modification, cancellation or suspension by the FDA or other Governmental Authority and no Company product has been discontinued (other than nonfor commercial or other business reasons), recalled or subject to a voluntary recall, field notification, field correction or removal or safety alert (whether voluntarily or otherwise), nor has the production of such products been enjoined,. Since January 1, 2011, no proceedings have occurred (whether completed or pending) seeking to recall, reclassify, re-material routine label, suspend, detain or periodic inspections or reviews) against the Company, and to seize any Company product. To the Knowledge of the Company, there are no pending facts which are reasonably likely to cause: (A) the recall, suspension, field notification, field correction or threatened regulatory Actions removal, reclassification, re-labeling, detention, seizure or safety alert of any Company product or any product intended to be sold by the Company; (other than non-B) a change in the marketing classification or approval or a material routine change in labeling of any such products; or periodic inspections (C) a termination or reviews) pertaining suspension of marketing of any such products, All Company products manufactured, distributed, or developed by the Company that are subject to the products or product candidates jurisdiction of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any comparable Governmental Authority which regulates are being and have been designed, researched, tested, manufactured, prepared, packed, assembled, packaged, labeled, stored, processed, distributed, and marketed in substantial compliance with all applicable Laws, requirements and implementing regulations thereunder; (ii) the sale of pharmaceutical products or biologicCompany is, device or regenerative medicine products in any jurisdiction. Since and at all times since January 1, 2007 there have been no 2011 has been, in substantial compliance with the written noticesprocedures, reportsrecord-keeping, warning lettersand FDA reporting requirements for pharmaceutical drug reporting and comparable requirements, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to where applicable, of other Governmental Authorities; and (iii) the Company or the has not introduced into commercial distribution any Company products or product candidates of which upon their shipment by the Company were adulterated or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” misbranded as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820FDCA.
(e) The All nonclinical, or pre-clinical, trials and clinical trials conducted by or on behalf of the Company is have been, and has been are being conducted in substantial compliance in with experimental protocols, procedures and controls pursuant to accepted professional scientific standards, such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) requirements and all material respects with all applicable Laws requiring relating thereto, including the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records FDCA and reports relating to product corrections and removals (including FDA requirements set forth in its applicable implementing regulations at 21 C.F.R. Part 806)Parts 50, MDRs (including FDA requirements set forth in 21 C.F.R. Part 803)54, Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents 56 and product malfunctions312.
(f) None of Neither the Company ornor, to the Knowledge of the Company, any of its Collaborative Partnersdirector, agents officer, employee or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authorityagent thereof, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or for as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of amendments thereto. Neither the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Companynor, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf any director, officer, employee or agent thereof, has engaged in any activity prohibited under U.S. federal or state criminal or civil health care laws (including without limitation the U.S. federal Anti-Kickback Statute, Sxxxx Law, False Claims Act, Health Insurance Portability and Accountability Act, Patient Protection and Affordable Care Act and any comparable state laws), or the regulations promulgated pursuant to such laws (each, a “Health Care Law”). There is no civil, criminal, administrative or other proceeding, notice or demand pending, received or, to the Knowledge of the Company, threatened against the Company by that relates to an alleged violation of any of its Collaborative PartnersHealth Care Law. Neither the Company nor, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by to the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions Knowledge of the Federal FoodCompany, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50any director, 54officer, 56employee or agent thereof, 58, 312 and 812, and comparable Laws has been convicted of any other Governmental Authoritycrime or engaged in any conduct for which debarment is mandated by 21 U.S.C. sec. No clinical trial conducted 335a(a) or any similar Law or authorized by 21 U.S.C. sec. 335a(b) or any similar Law. There are no consent decrees (including plea agreements) or similar actions to which the Company or, to the Knowledge of the Company, on behalf of the any director, officer, employee or agent thereof, are bound or which relate to Company has been terminated products. No claims, actions, proceedings or suspended prior investigations that could reasonably be expected to completion for safety result in such disqualification, debarment, penalty or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, exclusion are pending or, to the Knowledge of the Company, threatened to initiateagainst the Company or any of their collective officers, any action to place a clinical hold order onemployees or agents
(g) There are no investigations, audits, actions, inquiries or otherwise terminate, materially delay or suspend, any such ongoing clinical trialother proceedings pending, or to disqualifythe Knowledge of the Company threatened, restrict with respect to a violation by the Company of any Law that reasonably would be expected to result in administrative, civil, or debar any clinical investigator criminal liability, and there are no facts or circumstances existing that would reasonably be expected to serve as a basis for such an investigation, audit, action, inquiry or other person or entity involved in any such clinical trialproceeding.
(h) The Company is in substantial compliance with all applicable DEA and FDA import and export requirements, including, without limitation, import-for-export requirements, export notifications or authorizations and record keeping requirements, Schedule 2.26(h) sets forth a list of (i) Neither the Company nor any officerall recalls, directorfield notifications, managing employee field corrections or removals, corrective or preventive actions (CAPA) instituted as those terms are defined in 42 C.F.R. § 1001.1001) part of the Company’s GMP requirements, norimport alerts, detentions, seizures and safety alerts with respect to any Company products issued between January 1, 2011 and the date of this Agreement, and the dates, if any, such CAPA, recalls, field notifications, field corrections or removals, import alerts, detentions, seizures and safety alerts were resolved or closed, and (ii) to the Knowledge of the Company, any agent (complaint files with respect to any Company products that are open as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party todate of this Agreement. There are no outstanding recalls, field notifications, field corrections or bound byremovals, any orderimport alerts, individual integrity agreementdetentions, corporate integrity agreement seizures, safety alerts or other formal or informal agreement product complaints with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating respect to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating Company products, and to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending facts that would be reasonably likely to result in a product recall, field notification, field correction or threatened filings against the Company of an action relating to the Company under any federal removal, import alert, detention, seizure or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating safety alert with respect to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsproducts.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company has business of the Borrowers and their Subsidiaries is being conducted in compliance with (a) applicable requirements under the federal Communications Act of 1934, as amended, and with all Permits required by relevant rules, regulations and published policies of the FDA to conduct the Business Federal Communications Commission (the “FDA PermitsFCC”); and (b) any applicable state communications laws and regulations of a state public service commission or similar state governmental authority (“State PUC”) (collectively, the “Communications Laws”), except as would not have a Material Adverse Effect. The Borrowers and their Subsidiaries possess all registrations, licenses, authorizations, and certifications issued by the FCC and State PUCs necessary to conduct their respective businesses as currently conducted. All licenses and authorizations issued by the FCC and State PUCs required for the operations of the FDA Permits held by or issued to the Company Borrowers and their Subsidiaries are in full force and effect, effect (the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits “FCC Licenses” and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory FilingsState PUC Licenses”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) There is no condition, event or occurrence existing, nor, to the best of the Company Disclosure ScheduleBorrowers’ knowledge, since January 1is there any proceeding being conducted or threatened by any Governmental Authority, 2007which would reasonably be expected to cause the termination, there has not been any voluntarily or involuntarily initiatedsuspension, conductedcancellation, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correctionnonrenewal of any of the FCC Licenses or State Licenses, or investigator notice relating to an alleged material lack of safety or efficacy the imposition of any product penalty or fine by any Governmental Authority with respect to any of the Company FCC Licenses, State Licenses, the Borrowers or product candidate of the Companytheir Subsidiaries, in each case which would have a Material Adverse Effect.
(c) The Company There is in compliance in all material respects with all applicable Laws and any other lettersno (a) outstanding decree, notices decision, judgment, or guidances order that has been issued by the FDA FCC or State PUCs against the Borrowers, any Governmental Authority which regulates of their Subsidiaries, the sale FCC Licenses or the State Licenses or (b) notice of pharmaceutical products violation, order to show cause, complaint, investigation or biological, device other administrative or regenerative medicine products in any jurisdiction. There are no judicial proceeding pending or, to the Knowledge best of the CompanyBorrowers’ knowledge, threatened regulatory Actions (other than non-material routine by or periodic inspections before the FCC or reviews) State PUC against the CompanyBorrowers, and to any of their Subsidiaries, the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products FCC Licenses or the product candidates State PUC Licenses that, in the case of the Company pursuant to a developmenteach of (a) or (b) above, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would could reasonably be interpreted as raising expected to have a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyMaterial Adverse Effect.
(d) The manufacture of No consent, approval, authorization, order or waiver of, or filing with, the products of FCC or State PUCs is required under the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined Communications Laws to be obtained or made by the FDABorrowers or any of their Subsidiaries for the execution, including, as applicable, delivery and performance of this Agreement or the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820transactions contemplated herein and therein.
(e) The Company is Borrowers and has been in compliance in their Subsidiaries each have filed with the FCC and State PUCs all material respects with all Laws requiring the maintenance necessary reports, documents, instruments, information, or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating applications required to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, be filed pursuant to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental AuthorityCommunications Laws, and there are no proceedings pending or, have paid all fees required to be paid pursuant to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Communications Laws, including, except as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place would not have a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialMaterial Adverse Effect.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required Except for matters that, individually or in the aggregate, have not had and would not reasonably be expected to have a Parent Material Adverse Effect, there are no suits, arbitrations, legal or administrative or regulatory proceedings, charges, complaints or investigations by the FDA to conduct the Business U.S. Food and Drug Administration (the “FDA PermitsFDA”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, U.S. Department of Health and is not in default in any material respect 30 under Human Services (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under“HHS”), each such Permit, and none the U.S. Department of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectivelyJustice, the U.S. Federal Trade Commission (the “Company Regulatory FilingsFTC”), the U.S. Alcohol and Tobacco Tax and Trade Bureau (the “TTB”), the Department of Commerce (“DOC”), U.S. Customs and Border Protection (“CBP”) and holds all rightor any state, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right local or license to use, access non-U.S. regulatory agency or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no Entity pending or, to the Knowledge of the CompanyParent, threatened regulatory Actions against or relating to, directly or indirectly, Parent or the Parent Subsidiaries.
(other than non-b) Except for matters that, individually or in the aggregate, have not had and would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries nor any of their respective Affiliates or Representatives has made an untrue statement of material routine fact or periodic inspections or reviews) against the Company, and fraudulent statement to the Knowledge of FDA, the CompanyHHS, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of FTC, the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply TTB or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA applicable regulatory agencies or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company Entity or, to the Knowledge of Parent, failed to disclose a material fact required to be disclosed to such regulatory agency or any Governmental Entity or committed an act, made or failed to make a statement that could reasonably be expected to provide a basis for any of them to invoke the Companypolicy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or equivalent regulations.
(c) There are no unresolved reports, warning letters or other notifications or documents received by Parent or any Parent Subsidiary from or issued by the FDA, the HHS, the FTC, the TTB, the DOC, CBP or other Governmental Entity or applicable regulatory agencies that (i) indicate or suggest lack of compliance with applicable regulatory requirements by Parent, any Parent Subsidiary or any Person providing services for the benefit of Parent, any Parent Subsidiary or any of their respective Affiliates or Representatives in connection with the business of Parent and the Parent Subsidiaries which, if there were such lack of compliance, would, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, or (ii) commence or threaten to initiate any action to withdraw or terminate any Permit applicable to any activities or any studies being conducted by Parent or any Parent Subsidiary which, if any such Permits were withdrawn or terminated, would, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(d) Neither Parent nor any Parent Subsidiary nor, to the Knowledge of Parent, any of its Collaborative Partnerstheir respective Affiliates, agents Representatives or subcontractors other Persons providing services for their benefit has been debarred, or convicted of any crime or engaged in any conduct for which has resulted debarment is mandated by 21 U.S.C. Section 335a(a) or could result in debarment authorized by 21 U.S.C. Section 335a(b) or disqualification for which suspension is mandated by the FDA 21 U.S.C. Section 335a(g) or temporary denial of approval is authorized by 21 U.S.C. Section 335a(f) or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws standards of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialEntity.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (ai) The Company has made all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects withfilings under applicable insurance holding company statutes, and is not has received approvals of acquisition of control and/or affiliate transactions, in default each jurisdiction in which such filings or approvals are required, except where the failure to have made such filings or receive such approvals in any material respect 30 under (and to such jurisdiction would not result, individually or in the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminableaggregate, in whole or in part, as a result of the transaction contemplated by this AgreementMaterial Adverse Effect. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any Each of the Company Regulatory Filingsand its subsidiaries: (A) holds such permits, licenses, consents, exemptions, franchises, authorizations and other approvals from insurance departments and other governmental or regulatory authorities (each, an “Authorization”) (including, without limitation, any insurance licenses from the insurance regulatory agencies of the Knowvarious states or other jurisdictions where it conducts business (the “Insurance Licenses”)), and has made all filings with and notices to, all governmental or regulatory authorities and self-How contained regulatory organizations and all courts and other tribunals, as are necessary to own, lease, license and operate its respective properties and to conduct its business in the manner described in the Confidential Information Memorandum and the SEC Filings, except where the failure to have any Authorization or Insurance License or to make any such filing or notice would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, and (B) has fulfilled and performed all material obligations necessary to maintain such Authorizations and Insurance Licenses. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect (A) each such Authorization and Insurance License is valid and in full force and effect and each of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company and its Subsidiaries is in compliance in all material respects with all applicable Laws the terms and conditions thereof and with the rules and regulations of the authorities and governing bodies having jurisdiction with respect thereto; and (B) no event has occurred (including, without limitation, the receipt of any other lettersnotice from any authority or governing body, notices or guidances issued the execution, delivery and performance of this Agreement by the FDA or any Governmental Authority which regulates Sellers, the sale and delivery of pharmaceutical products the Series A Preferred Stock and the compliance by the Sellers with all of the provisions hereof and the consummation by the Sellers of the transactions contemplated in this Agreement) which allows or, after notice or biologicallapse of time of both, device would allow, revocation, suspension or regenerative medicine products termination of any such Authorization or Insurance License or results or, after notice or lapse of time or both, would result in any jurisdiction. There are no pending or, to the Knowledge impairment of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge rights of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted holder of any crime such Authorization or engaged Insurance License. Except as disclosed in the Confidential Information Memorandum and the SEC Filings, no insurance regulatory agency or body has issued any conduct order or decree impairing, restricting or prohibiting the payment of dividends of any Company Subsidiary to its respective parent which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide have, individually or in the aggregate, a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policyAdverse Effect.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(iii) Neither the Company nor any officerof its Insurance Subsidiaries is in violation of, directoror in default in the performance, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Companyobservance or fulfillment of, any agent (as such term is defined obligation, agreement, covenant or condition contained in 42 C.F.R. § 1001.1001(a)(1)(ii)) of reinsurance treaties, contracts, agreements and arrangements to which the Company or any of its Insurance Subsidiaries is a party party, except for such violations or defaults which would not reasonably be expected to, individually or bound byin the aggregate, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither result in a Material Adverse Effect; neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of its Insurance Subsidiaries has received any notice from any of the Companyother parties to such treaties, norcontracts, agreements or arrangements that such other party intends not to perform its obligations thereunder and none of them has any reason to believe that any of the other parties to such treaties, contracts, agreements or arrangements will be unable to perform its obligations thereunder, except to the Knowledge of the Company, any agent (as extent that such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company nonperformance would not reasonably believes that it has the requisite know-how and processes be expected to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line individually or in the event that the current cell line is no longer viableaggregate, result in a Material Adverse Effect.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Stock Purchase Agreement (Universal American Corp.)
Regulatory Matters. (a) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Biovail Material Adverse Effect, (i) each of Biovail and the Biovail Subsidiaries holds all Permits required by Biovail Permits, including all authorizations under the FDA to conduct the Business Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDA FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, the Food and Drugs Act, as amended (the “Food and Drugs Act”), the Controlled Drugs and Substances Act, as amended (the “CDSA”), and the regulations of Health Canada promulgated thereunder, and any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, distribution, sale, import or export of the Biovail Products (any such Governmental Entity, a “Biovail Regulatory Agency”) necessary for the lawful operating of the businesses of Biovail or any of the Biovail Subsidiaries and the testing, manufacturing, sale or distribution, as applicable, of each of the Biovail Products (the “Biovail Regulatory Permits”). All of the FDA ) and (ii) all such Biovail Regulatory Permits held by or issued to the Company are valid and in full force and effect. Since January 1, 2009, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Biovail Regulatory Permit, except as has not had and would not reasonably be expected to have, individually or in the Company is aggregate, a Biovail Material Adverse Effect. Biovail and each of the Biovail Subsidiaries are in compliance in all material respects withwith the terms of all Biovail Regulatory Permits, and is not in default in any material respect 30 under (and no event has occurred that, to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or bothBiovail, would become reasonably be expected to result in a default under)penalty under or the revocation, each such cancellation, non-renewal or adverse modification of any Biovail Regulatory Permit, except as has not had and none of such Permits will would not reasonably be terminated or impaired or become terminableexpected to have, in whole individually or in partthe aggregate, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingBiovail Material Adverse Effect.
(b) Except as set forth on Section 4.13(bwould not, individually or in the aggregate, reasonably be expected to have a Biovail Material Adverse Effect, the businesses of each of Biovail and the Biovail Subsidiaries are being conducted in compliance with all applicable Laws, including (i) the FDCA, including the rules and regulations promulgated thereunder; (ii) federal Medicare and Medicaid statutes and related state or local statutes or regulations; (iii) the Food and Drugs Act and the CDSA, including the rules and regulations promulgated thereunder; (iv) provincial formulary and drug pricing statutes, including the rules and regulations promulgated thereunder, (v) any comparable foreign Laws for any of the Company Disclosure Scheduleforegoing; (vi) federal, since January 1state or provincial criminal or civil Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), 2007Xxxxx Law (42 U.S.C. §1395nn), there has not been False Claims Act (42 U.S.C. §1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et. seq., and any voluntarily comparable state, provincial or involuntarily initiatedlocal Laws) and (vii) state or provincial licensing, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companydisclosure and reporting requirements.
(c) The Company is Each of Biovail and the Biovail Subsidiaries are in compliance in all material respects with the terms of the Corporate Integrity Agreement, dated September 11, 2009, between the Office of Inspector General of the Department of Health and Human Services and Biovail.
(d) All pre-clinical and clinical investigations conducted or sponsored by each of Biovail and the Biovail Subsidiaries are being conducted in compliance in all material respects with all applicable Laws and any other letters, notices administered or guidances issued by the applicable Regulatory Authorities, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (iii) Division 5 of the Food and Drug Regulations regarding Drugs for Clinical Trials Involving Human Subjects, and (iv) federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information.
(e) Neither Biovail nor any of the Biovail Subsidiaries has received any written information from the FDA, the European Medicines Agency (“EMEA”) or Health Canada or any Governmental Authority foreign agency with jurisdiction over the marketing, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which regulates would reasonably be expected to lead to the sale denial of pharmaceutical products any application for marketing approval currently pending before the FDA, Health Canada or biologicalsuch other Biovail Regulatory Agency.
(f) All material reports, device documents, claims, permits and notices required to be filed, maintained or regenerative medicine products furnished to the FDA, Health Canada or any other Biovail Regulatory Agency by Biovail and the Biovail Subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no liability exists with respect to such filing. Neither Biovail nor any jurisdiction. There are no pending orof the Biovail Subsidiaries, nor, to the Knowledge of the CompanyBiovail, threatened regulatory Actions (other than non-material routine any officer, employee, agent or periodic inspections distributor of Biovail or reviews) against the Company, and to the Knowledge any of the CompanyBiovail Subsidiaries, there are no pending has made an untrue statement of a material fact or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining a fraudulent statement to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA Health Canada or any other Governmental AuthorityBiovail Regulatory Agency, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to be disclosed to the Knowledge of the CompanyFDA, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA Health Canada or any other Governmental AuthorityBiovail Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA FDA, Health Canada or any other Biovail Regulatory Agency to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy. Neither Biovail nor any of the Biovail Subsidiaries, nor, to the Knowledge of Biovail, any officer, employee, agent or distributor of Biovail or any of the Biovail Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. Neither Biovail nor any of the Biovail Subsidiaries, nor, to the Knowledge of Biovail, any officer, employee, agent or distributor of Biovail or any of the Biovail Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program.
(g) There have been no Serious Adverse Events, Serious Injuries As to each Biovail Product or MDR Reportable Events associated with Biovail Product candidate subject to the use (including in clinical trials) FDCA and the regulations of the products FDA promulgated thereunder, the Food and Drugs Act, the CDSA and the regulations of the Company Health Canada promulgated thereunder, or product candidates of the Company similar Law in any foreign jurisdiction that have not is or has been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Companydeveloped, all studiesmanufactured, teststested, and preclinical and clinical research being conducted distributed or marketed by the Company, and to the Knowledge of the Company, or on behalf of the Company by Biovail or any of its Collaborative Partnersthe Biovail Subsidiaries, are beingeach such Biovail Product or Biovail Product candidate is being or has been developed, and at all times have beenmanufactured, conducted tested, distributed or marketed in compliance in all material respects with all applicable Lawsrequirements under the FDCA and the regulations of the FDA promulgated thereunder, includingthe Food and Drugs Act, as applicablethe CDSA and the regulations of Health Canada promulgated thereunder, and similar Laws in any foreign jurisdiction, including those relating to investigational use, premarket clearance or marketing approval, good laboratory practice regulations set forth in 21 C.F.R. Part 58manufacturing practices, good clinical practices, good laboratory practices, labeling, advertising, record keeping, filing of reports, and security. There is no action or proceeding pending or threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Biovail Product or Biovail Product candidate by Biovail or any of the Biovail Subsidiaries of any Law, except as defined would not, individually or recognized in the aggregate, reasonably be expected to have a Biovail Material Adverse Effect.
(h) Since January 1, 2009, each of Biovail and the Biovail Subsidiaries have neither voluntarily nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Biovail Product. Each of Biovail and the Biovail Subsidiaries are not aware of any facts which are reasonably likely to cause (i) the recall, market withdrawal or replacement of any Biovail Product sold or intended to be sold by Biovail or the Biovail Subsidiaries, (ii) a change in the marketing classification or a material change in the labeling of any such Biovail Products, or (iii) a termination or suspension of the marketing of such Biovail Products.
(i) To Biovail’s Knowledge, no data generated by Biovail or any of the Biovail Subsidiaries with respect to the Biovail Products that has been provided to its customers or otherwise made public or filed with a Biovail Regulatory Agency is the subject of any regulatory or other action, either pending or threatened, by any Biovail Regulatory Agency relating to the truthfulness or scientific adequacy of such data.
(j) Since January 1, 2009, neither Biovail nor any of the Biovail Subsidiaries has received any written notice that the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of Health Canada or any other Governmental Authority. No clinical trial conducted by the Company orBiovail Regulatory Agency has (i) commenced, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order onrequest the recall of any product sold or intended to be sold by Biovail or the Biovail Subsidiaries, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against itcommenced, him or her under Section 1128A of the Social Security Act of 1935threatened to initiate, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) any action to the Knowledge of the Company, is the target enjoin manufacture or subject distribution of any current investigation product sold or intended to be sold by a Governmental Authority relating to any Federal Health Care Program-related offense; Biovail or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care ProgramBiovail Subsidiaries.
(k) The Company reasonably believes that it Since January 1, 2009, neither Biovail nor any of the Biovail Subsidiaries has received any written notice from the requisite know-how and processes toFDA, subject to Health Canada or any required regulatory approvals, manufacture and market Dermagraft based on other Biovail Regulatory Agency regarding inappropriate advertising or marketing of a new cell line Biovail Product or a negative change in the event that the current cell line is no longer viablereimbursement status of a Biovail Product.
(l) To Except as would not, individually or in the Knowledge aggregate, reasonably be expected to have a Biovail Material Adverse Effect, no Biovail Product manufactured or distributed by Biovail or any of the Company, there are no pending or threatened filings against Biovail Subsidiaries is (i) adulterated within the Company meaning of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 21 U.S.C. § 3729 et seq.351 (or any similar Law), (ii) misbranded within the meaning of 21 U.S.C. § 352 (or any similar Law).
(m) To the Knowledge of the CompanyBiovail, the Company is not under investigation by any Governmental Authority for a violation all of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been its vendors are in compliance in all material respects with federal good manufacturing practice and state data breach Lawssimilar regulations promulgated by regulatory agencies with jurisdiction over Biovail’s vendors.
(n) To This Section 3.17 does not apply to environmental matters, which are the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements subject of Medicare and other Federal Health Care Program LawsSection 3.13.
Appears in 1 contract
Samples: Merger Agreement (Valeant Pharmaceuticals International)
Regulatory Matters. (ai) The Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole): (A) the Company and its Subsidiaries hold all Licenses under the Healthcare Laws (as defined below) that are necessary for the lawful operation of the business of the Company and its Subsidiaries in each jurisdiction in which the Company or any of its Subsidiaries operates, including the FDCA (including Section 510(k) thereof), and all Licenses of any applicable Governmental Entity that has all Permits required regulatory authority over the testing, development, design, quality, identity, safety, efficacy, manufacturing, labeling, marketing, distribution, commercialization, sale, pricing, import or export of the products sold by the FDA to conduct Company (“Company Products” and any such Governmental Entity, a “Regulatory Agency”), necessary for the Business lawful operation of the business of the Company or its Subsidiaries in each jurisdiction in which the Company or any of its Subsidiaries operates (the “FDA Regulatory Permits”). All of the FDA ; (B) all such Regulatory Permits held by or issued to the Company are valid and in full force and effect, ; and (C) the Company and its Subsidiaries are in compliance with the terms of all Regulatory Permits. There is no Proceeding to which the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no subject pending or, to the Knowledge of the Company, threatened regulatory Actions (in writing that would result in the termination, revocation, suspension or the imposition of a restriction on any such Regulatory Permit or the imposition of any fine, penalty or other than non-sanction for violation of any such Regulatory Permit, in each case, except as would not reasonably be expected to be, individually or in the aggregate, material routine or periodic inspections or reviews) against the Company, and to the Knowledge of Company and its Subsidiaries (taken as a whole).
(ii) Except as would not reasonably be expected to be, individually or in the Companyaggregate, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates Company and its Subsidiaries (taken as a whole), the business of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company and its Subsidiaries is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by with: (A) the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals FDCA (including FDA all applicable registration and listing requirements set forth in Section 510 of the FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 806807); (B) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010; (C) federal Medicare and Medicaid statutes and related state or local statutes; (D) the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), MDRs Xxxxx Law (including FDA requirements set forth in 21 C.F.R. Part 80342 U.S.C. § 1395nn), Adverse Experiencesthe federal False Claims Act (31 U.S.C. § 3729 et seq.), Serious Adverse Eventsthe Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), Serious Injuriesas amended by the Health Information Technology for Economic and Clinical Health Act, incidents and any comparable federal, state or near-incidents local Laws; (E) state testing, manufacturing, distribution, commercialization, marketing, licensing, disclosure, gift ban, code of conduct and product malfunctions.
reporting requirements, including the Physician Payments Sunshine Act (f42 U.S.C. § 1320a-7h) None of the Company or, and equivalent or related state reporting requirements; (F) applicable requirements under Data Protection Laws with respect to the Knowledge protection of Personal Information collected or maintained by or on behalf of the Company; (G) the Federal Trade Commission Act; (H) the rules and regulations promulgated pursuant to all such applicable Laws with respect to any of the foregoing, each as amended from time to time; (I) any comparable foreign Laws for any of the foregoing; and (J) any other Law that governs the healthcare industry, medical device industry or relationships among healthcare and/or medical device providers, suppliers, distributors, manufacturers and patients, as applicable (collectively, “Healthcare Laws”). Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole), there are no Proceedings or subpoenas against the Company or any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA Subsidiaries or any other director, officer or current employee of the foregoing pending by or before any Governmental Authority, and there are no proceedings pending Entity or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by writing against the FDA Company or any other Governmental Authority. None of its Subsidiaries or any director, officer or current employee of the foregoing by any Governmental Entity, in each case with respect to Healthcare Laws.
(iii) As of the date of this Agreement, neither the Company ornor any of its Subsidiaries (A) is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, certificate of compliance, consent decrees, settlement orders or similar material agreements with or imposed by any Governmental Entity, and, to the Knowledge of the Company, no such action is currently proposed to the Company and its Subsidiaries or pending with the Company and its Subsidiaries, (B) has any continuing material reporting obligations pursuant to any agreement contemplated by the foregoing clause (A) of this Section 5.5(e)(iii), (C) is or has been a defendant in any litigation arising out of or relating to the federal False Claims Act (31 U.S.C. § 3729 et seq.) or (D) has been served with or received a search warrant, subpoena or civil investigative demand from any Governmental Entity.
(iv) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole), (A) since the Applicable Date, all reports, claims, permits, adverse event reports, documents, notices, registrations, applications, responses, submissions, modifications, supplements and amendments required to be filed, maintained or furnished to the FDA or any other Regulatory Agency by the Company or any of its Collaborative Partners Subsidiaries have been so timely filed, maintained or furnished under such applicable legal requirements (“Healthcare Submissions”) and (B) all such Healthcare Submissions were compliant in all respects with applicable legal requirements at the time of filing (or were corrected in or supplemented by a subsequent filing).
(v) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole), from the Applicable Date to the date of this Agreement, to the Knowledge of the Company, neither the Company nor any of its Subsidiaries nor any officer or employee of the Company or any of its Subsidiaries, has made an untrue statement of material fact or a fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, or committed any an act, made any a statement or failed to make any statement that a statement, in each case, related to the business and which, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting the “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) policy of the products FDA set forth in 56 Fed. Reg. 46191 (September 10, 1991). From the Applicable Date to the date of this Agreement, neither the Company or product candidates nor any of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Companyits Subsidiaries nor, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, any officer or employee of the Company or any of its Subsidiaries, has been debarred or convicted of any crime. From the Applicable Date to the date of this Agreement, to the Knowledge of the Company, neither the Company nor any of its Subsidiaries nor any director, officer or employee of the Company or any of its Subsidiaries, has been excluded from participating in any federal health care program or convicted of any crime except, in each case, as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole).
(vi) All pre-clinical and clinical studies, tests or investigations conducted or sponsored by or on behalf of the Company by or any of its Collaborative Partners, Subsidiaries have been or are being, and at all times have been, being conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized Healthcare Laws and other requirements under the Healthcare Laws issued by the FDAapplicable Regulatory Agencies, including the ICH Tripartite Guideline for Good Laboratory Practices, Good Clinical PracticePractices, other applicable provisions FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials and the Federal Foodprotection of human subjects, Drug and Cosmetic Act and its applicable implementing regulations at including Title 21 C.F.R. Parts parts 11, 50, 54, 5656 and 812 of the Code of Federal Regulations and any comparable state and local legal requirements regulating the conduct of pre-clinical and clinical investigations and the protection of human subjects, 58except, 312 and 812in each case, and comparable Laws of any other Governmental Authority. No clinical trial conducted by as would not reasonably be expected to be, individually or in the aggregate, material to the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place its Subsidiaries (taken as a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialwhole).
(ivii) Neither Except as would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any officerof its Subsidiaries has received, directorsince the Applicable Date, managing employee (as those terms are defined any FDA Form 483 observations, notice of adverse finding, warning letters, notice of violation, inspection or audit reports from any Regulatory Agency identifying any non-compliances, subpoenas, investigations, actions, demands or notices relating to any alleged non-compliance, which would reasonably be expected to be, individually or in 42 C.F.R. § 1001.1001) of the Companyaggregate, nor, material to the Knowledge Company and its Subsidiaries (taken as a whole) or to lead to the denial, suspension or revocation of any License or grant for marketing approval with respect to any Company Product currently pending before or previously approved or cleared by the Company, any agent (as FDA or such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program LawsRegulatory Agency.
(jviii) Neither Since the Applicable Date, except as would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any officerSubsidiary has voluntarily or involuntarily initiated, directorconducted or issued, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Companycaused to be initiated, nor, to the Knowledge of the Companyconducted or issued, any agent recall, field corrective action, market withdrawal, seizure, suspension, replacement, safety alert, written warning, “dear doctor” letter, investigator notice to healthcare wholesalers, healthcare distributors, healthcare retailers, healthcare professionals or patients (as such term is defined in 42 including any action required to be reported or for which records must be maintained under 21 C.F.R. § 1001.1001(a)(1)(ii)Part 806) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; Company Product (collectively, a “Recall”) or, as of the date hereof, currently intends to initiate, conduct or issue any Recall of any Company Product. Except as would not reasonably be expected to be material to the Company and its Subsidiaries (taken as a whole), neither the Company nor any of its Subsidiaries has received any written notice from the FDA or any other Regulatory Agency regarding (x) any Recall of any Company Product or (vy) is currently charged with a change in the marketing status or convicted classification, or a material change in the labeling, of any criminal offense relating to such Company Product or (z) a negative change in the delivery reimbursement status of an item or service under any Federal Health Care Programa Company Product.
(kix) The Company and its Subsidiaries have instituted and maintain policies and procedures reasonably believes that it has designed to ensure the requisite know-how and processes tointegrity of data generated or used in any clinical trials or other studies related to the development, subject to any required regulatory approvalsuse, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge handling, safety, efficacy, reliability or manufacturing of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seqProducts.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds all Parent Permits required by and clearances, including (x) all authorizations under the FDCA, the PHSA, and the regulations of the FDA to conduct promulgated thereunder and (y) authorizations of any applicable Governmental Entity that are concerned with the Business quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries (the “FDA Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits. All of the FDA Parent Regulatory Permits held by or issued to the Company are in full force and effect, except where the Company is failure to be in compliance in all material respects withfull force and effect would not reasonably be expected to have, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole individually or in partthe aggregate, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingParent Material Adverse Effect.
(b) Except as set forth on Section 4.13(bwould not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) provincial formulary and drug pricing statutes; (v) any comparable foreign Laws for any of the Company Disclosure Scheduleforegoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold; (vi) federal, since state or provincial criminal or civil Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), Xxxxx Law (42 U.S.C. §1395nn), False Claims Act (42 U.S.C. §1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et. seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local Laws); (vii) state or provincial licensing, disclosure and reporting requirements; and (viii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare Laws”). Since January 1, 20072011, there neither Parent nor any of the Parent Subsidiaries has not been received any voluntarily written notification or involuntarily initiatedcommunication from any Parent Regulatory Agency, conductedincluding the FDA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services, of noncompliance by, or issued recallliability of Parent or the Parent Subsidiaries under, market withdrawalany Parent Healthcare Laws, safety alertexcept where such noncompliance or liability would not reasonably be expected to have, warningindividually or in the aggregate, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companya Parent Material Adverse Effect.
(c) The Company is Parent and the Parent Subsidiaries are not party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2011, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects with all applicable Laws and any other letters, notices on the date filed (or guidances issued were corrected in or supplemented by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdictionsubsequent filing). Since January 1, 2007 there have been no written notices2011, reportsneither Parent nor any of the Parent Subsidiaries, warning lettersnor, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company knowledge of Parent, any officer, employee, agent or the products distributor of Parent or product candidates any of the Company Parent Subsidiaries, has made an untrue statement of a material fact or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard fraudulent statement to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental AuthorityParent Regulatory Agency, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by be disclosed to the FDA or any other Governmental AuthorityParent Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make a statement, in each such case, related to the business of Parent or any statement that of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority Parent Regulatory Agency to invoke any similar policy.
(g) There , except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have been no Serious a Parent Material Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) Effect. Neither Parent nor any of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyParent Subsidiaries, nor, to the Knowledge knowledge of the CompanyParent, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, directoremployee, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) agent or distributor of Parent or any of the CompanyParent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the Knowledge knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the CompanyParent Subsidiaries, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him federal health care program or her convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42as amended, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; similar Law or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableprogram.
(lg) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product, other than notices or actions that are not material to Parent or the Parent Subsidiaries, taken as a whole. To the Knowledge knowledge of the CompanyParent, there are no pending facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or threatened filings against any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of an action relating to any such Parent Products, (iii) a termination or suspension of the Company under any federal manufacturing, marketing, or state whistleblower statutedistribution of such Parent Products, including under the False Claims Act or (iv) a material negative change in reimbursement status of 1863 (31 U.S.C. § 3729 et seq.)a Parent Product.
(mi) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations Notwithstanding anything contained in 45 C.F.R. Parts 160 and 164this Section 4.13, including receiving any notices from the United States Department no representation or warranty shall be deemed to be made in this Section 4.13 in respect of Health and Human Services Office of Civil Rights relating to any such violationsenvironmental, Tax, employee benefits or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawslabor Law matters.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Biovail Material Adverse Effect, (i) each of Biovail and the Biovail Subsidiaries holds all Permits required by Biovail Permits, including all authorizations under the FDA to conduct the Business Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDA FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, the Food and Drugs Act, as amended (the “Food and Drugs Act”), the Controlled Drugs and Substances Act, as amended (the “CDSA”), and the regulations of Health Canada promulgated thereunder, and any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, distribution, sale, import or export of the Biovail Products (any such Governmental Entity, a “Biovail Regulatory Agency”) necessary for the lawful operating of the businesses of Biovail or any of the Biovail Subsidiaries and the testing, manufacturing, sale or distribution, as applicable, of each of the Biovail Products (the “Biovail Regulatory Permits”). All of the FDA ) and (ii) all such Biovail Regulatory Permits held by or issued to the Company are valid and in full force and effect. Since January 1, 2009, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Biovail Regulatory Permit, except as has not had and would not reasonably be expected to have, individually or in the Company is aggregate, a Biovail Material Adverse Effect. Biovail and each of the Biovail Subsidiaries are in compliance in all material respects withwith the terms of all Biovail Regulatory Permits, and is not in default in any material respect 30 under (and no event has occurred that, to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or bothBiovail, would become reasonably be expected to result in a default under)penalty under or the revocation, each such cancellation, non-renewal or adverse modification of any Biovail Regulatory Permit, except as has not had and none of such Permits will would not reasonably be terminated or impaired or become terminableexpected to have, in whole individually or in partthe aggregate, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingBiovail Material Adverse Effect.
(b) Except as set forth on Section 4.13(bwould not, individually or in the aggregate, reasonably be expected to have a Biovail Material Adverse Effect, the businesses of each of Biovail and the Biovail Subsidiaries are being conducted in compliance with all applicable Laws, including (i) the FDCA, including the rules and regulations promulgated thereunder; (ii) federal Medicare and Medicaid statutes and related state or local statutes or regulations; (iii) the Food and Drugs Act and the CDSA, including the rules and regulations promulgated thereunder; (iv) provincial formulary and drug pricing statutes, including the rules and regulations promulgated thereunder, (v) any comparable foreign Laws for any of the Company Disclosure Scheduleforegoing; (vi) federal, since January 1state or provincial criminal or civil Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), 2007Sxxxx Law (42 U.S.C. §1395nn), there has not been False Claims Act (42 U.S.C. §1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et. seq., and any voluntarily comparable state, provincial or involuntarily initiatedlocal Laws) and (vii) state or provincial licensing, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companydisclosure and reporting requirements.
(c) The Company is Each of Biovail and the Biovail Subsidiaries are in compliance in all material respects with the terms of the Corporate Integrity Agreement, dated September 11, 2009, between the Office of Inspector General of the Department of Health and Human Services and Biovail.
(d) All pre-clinical and clinical investigations conducted or sponsored by each of Biovail and the Biovail Subsidiaries are being conducted in compliance in all material respects with all applicable Laws and any other letters, notices administered or guidances issued by the applicable Regulatory Authorities, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (iii) Division 5 of the Food and Drug Regulations regarding Drugs for Clinical Trials Involving Human Subjects, and (iv) federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information.
(e) Neither Biovail nor any of the Biovail Subsidiaries has received any written information from the FDA, the European Medicines Agency (“EMEA”) or Health Canada or any Governmental Authority foreign agency with jurisdiction over the marketing, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which regulates would reasonably be expected to lead to the sale denial of pharmaceutical products any application for marketing approval currently pending before the FDA, Health Canada or biologicalsuch other Biovail Regulatory Agency.
(f) All material reports, device documents, claims, permits and notices required to be filed, maintained or regenerative medicine products furnished to the FDA, Health Canada or any other Biovail Regulatory Agency by Biovail and the Biovail Subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no liability exists with respect to such filing. Neither Biovail nor any jurisdiction. There are no pending orof the Biovail Subsidiaries, nor, to the Knowledge of the CompanyBiovail, threatened regulatory Actions (other than non-material routine any officer, employee, agent or periodic inspections distributor of Biovail or reviews) against the Company, and to the Knowledge any of the CompanyBiovail Subsidiaries, there are no pending has made an untrue statement of a material fact or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining a fraudulent statement to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA Health Canada or any other Governmental AuthorityBiovail Regulatory Agency, including, for avoidance of doubt, records and reports relating failed to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, disclose a material fact required to be disclosed to the Knowledge of the CompanyFDA, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA Health Canada or any other Governmental AuthorityBiovail Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA FDA, Health Canada or any other Biovail Regulatory Agency to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy. Neither Biovail nor any of the Biovail Subsidiaries, nor, to the Knowledge of Biovail, any officer, employee, agent or distributor of Biovail or any of the Biovail Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. Neither Biovail nor any of the Biovail Subsidiaries, nor, to the Knowledge of Biovail, any officer, employee, agent or distributor of Biovail or any of the Biovail Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program.
(g) There have been no Serious Adverse Events, Serious Injuries As to each Biovail Product or MDR Reportable Events associated with Biovail Product candidate subject to the use (including in clinical trials) FDCA and the regulations of the products FDA promulgated thereunder, the Food and Drugs Act, the CDSA and the regulations of the Company Health Canada promulgated thereunder, or product candidates of the Company similar Law in any foreign jurisdiction that have not is or has been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Companydeveloped, all studiesmanufactured, teststested, and preclinical and clinical research being conducted distributed or marketed by the Company, and to the Knowledge of the Company, or on behalf of the Company by Biovail or any of its Collaborative Partnersthe Biovail Subsidiaries, are beingeach such Biovail Product or Biovail Product candidate is being or has been developed, and at all times have beenmanufactured, conducted tested, distributed or marketed in compliance in all material respects with all applicable Lawsrequirements under the FDCA and the regulations of the FDA promulgated thereunder, includingthe Food and Drugs Act, as applicablethe CDSA and the regulations of Health Canada promulgated thereunder, and similar Laws in any foreign jurisdiction, including those relating to investigational use, premarket clearance or marketing approval, good laboratory practice regulations set forth in 21 C.F.R. Part 58manufacturing practices, good clinical practices, good laboratory practices, labeling, advertising, record keeping, filing of reports, and security. There is no action or proceeding pending or threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Biovail Product or Biovail Product candidate by Biovail or any of the Biovail Subsidiaries of any Law, except as defined would not, individually or recognized in the aggregate, reasonably be expected to have a Biovail Material Adverse Effect.
(h) Since January 1, 2009, each of Biovail and the Biovail Subsidiaries have neither voluntarily nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Biovail Product. Each of Biovail and the Biovail Subsidiaries are not aware of any facts which are reasonably likely to cause (i) the recall, market withdrawal or replacement of any Biovail Product sold or intended to be sold by Biovail or the Biovail Subsidiaries, (ii) a change in the marketing classification or a material change in the labeling of any such Biovail Products, or (iii) a termination or suspension of the marketing of such Biovail Products.
(i) To Biovail’s Knowledge, no data generated by Biovail or any of the Biovail Subsidiaries with respect to the Biovail Products that has been provided to its customers or otherwise made public or filed with a Biovail Regulatory Agency is the subject of any regulatory or other action, either pending or threatened, by any Biovail Regulatory Agency relating to the truthfulness or scientific adequacy of such data.
(j) Since January 1, 2009, neither Biovail nor any of the Biovail Subsidiaries has received any written notice that the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of Health Canada or any other Governmental Authority. No clinical trial conducted by the Company orBiovail Regulatory Agency has (i) commenced, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order onrequest the recall of any product sold or intended to be sold by Biovail or the Biovail Subsidiaries, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against itcommenced, him or her under Section 1128A of the Social Security Act of 1935threatened to initiate, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) any action to the Knowledge of the Company, is the target enjoin manufacture or subject distribution of any current investigation product sold or intended to be sold by a Governmental Authority relating to any Federal Health Care Program-related offense; Biovail or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care ProgramBiovail Subsidiaries.
(k) The Company reasonably believes that it Since January 1, 2009, neither Biovail nor any of the Biovail Subsidiaries has received any written notice from the requisite know-how and processes toFDA, subject to Health Canada or any required regulatory approvals, manufacture and market Dermagraft based on other Biovail Regulatory Agency regarding inappropriate advertising or marketing of a new cell line Biovail Product or a negative change in the event that the current cell line is no longer viablereimbursement status of a Biovail Product.
(l) To Except as would not, individually or in the Knowledge aggregate, reasonably be expected to have a Biovail Material Adverse Effect, no Biovail Product manufactured or distributed by Biovail or any of the Company, there are no pending or threatened filings against Biovail Subsidiaries is (i) adulterated within the Company meaning of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 21 U.S.C. § 3729 et seq.351 (or any similar Law), (ii) misbranded within the meaning of 21 U.S.C. § 352 (or any similar Law).
(m) To the Knowledge of the CompanyBiovail, the Company is not under investigation by any Governmental Authority for a violation all of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been its vendors are in compliance in all material respects with federal good manufacturing practice and state data breach Lawssimilar regulations promulgated by regulatory agencies with jurisdiction over Biovail’s vendors.
(n) To This Section 3.17 does not apply to environmental matters, which are the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements subject of Medicare and other Federal Health Care Program LawsSection 3.13.
Appears in 1 contract
Samples: Merger Agreement (BIOVAIL Corp)
Regulatory Matters. (a) The Company has all Permits Save-A-Lot Entities hold, and are operating in compliance with, such permits, licenses, franchises, approvals, authorizations, certifications and clearances of the United States Food and Drug Administration (“FDA”), the United States Department of Agriculture (“USDA”) or other Governmental Authority required by for the FDA to conduct of the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company currently conducted (collectively, the “Company Regulatory FilingsPermits”) ), except where the failure to hold or operate in compliance with the Regulatory Permits would not, individually or in the aggregate, reasonably be expected to be material to the Business and holds the Save-A-Lot Entities, taken as a whole. Since January 1, 2014, the Save-A-Lot Entities have fulfilled and performed all rightof their material obligations with respect to the Regulatory Permits, title and interest no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in and to all Company Regulatory Filings free and clear any other material impairment of the rights of the holder of any Encumbrance (other than Permitted Encumbrances)Regulatory Permit, except where the failure to so fulfill or perform, or the occurrence of such event, would not, individually or in the aggregate, reasonably be expected to be material to the Business and the Save-A-Lot Entities, taken as a whole. Since January 1, 2014, the Save-A-Lot Entities have operated and currently are in compliance with applicable statutes and implementing regulations administered or enforced by the FDA or the USDA, except where the failure to so comply has not had and would not reasonably be expected to have, individually or in the aggregate, a Business Material Adverse Effect. The Company Save-A-Lot Entities have not received written notice since January 1, 2014 of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, USDA, or other Governmental Authority alleging that any operation or activity of the Business is in violation of any applicable Laws, except as has not granted any third party any right had and would not reasonably be expected to have, individually or license to usein the aggregate, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filinga Business Material Adverse Effect.
(b) Except All applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as set forth on Section 4.13(b) the basis for or submitted in connection with any and all requests for a Regulatory Permit by the Save-A-Lot Entities from the FDA, USDA or other Governmental Authority relating to the Business and its products were true, complete and correct as of the Company Disclosure Scheduledate of submission, since January 1except as would not, 2007individually or in the aggregate, there has not been any voluntarily or involuntarily initiatedreasonably be expected to be material to the Business and the Save-A-Lot Entities, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Companytaken as a whole.
(c) The Company is in compliance in all material respects with all applicable Laws and Business has not had since January 1, 2014 any other letters, notices product or guidances issued by the FDA or any distribution site subject to a Governmental Authority which regulates (including FDA and USDA) shutdown, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations or warning letters to make changes to the sale Business products, composition, labeling or packaging, that if not complied with has resulted or would reasonably be expected to result in a Business Material Adverse Effect.
(d) Section 3.21(d) of pharmaceutical products the Save-A-Lot Disclosure Schedule sets forth a complete and accurate list of all recalls, field notifications, field corrections, market withdrawals or biologicalreplacements, device product warnings, safety alerts and other notices of action relating to an alleged lack of safety or regenerative medicine products in regulatory compliance (“Safety Notices”) since January 1, 2014 with respect to any jurisdiction. There are no pending product manufactured by or, to the Knowledge of Supervalu, on behalf of, the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company Business pursuant to a developmentBusiness specifications, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there except for those that have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that not had and would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would not reasonably be expected to provide have, individually or in the aggregate, a basis for Business Material Adverse Effect. To Supervalu’s Knowledge, as of the FDA to invoke its policy date hereof there are no product complaints with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” any product manufactured by or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any Business pursuant to the Business specifications that would be reasonably likely to result in (A) a Safety Notice, or (B) a termination or suspension of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined manufacturing or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws marketing of any other Governmental Authority. No clinical trial conducted by the Company orBusiness products, to the Knowledge of the Companyin each case, on behalf of the Company except as has been terminated not had and would not, individually or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableaggregate, reasonably be expected to have a Business Material Adverse Effect.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Merger Agreement (Supervalu Inc)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effectCompany, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits Bank and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance Subsidiaries (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivitiesBank) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is are in compliance in all material respects with all applicable Laws laws administered by and any other letters, notices or guidances issued by the FDA or regulations of any Governmental Authority applicable to it or to them (including, without limitation, all regulations and orders of, or agreements with, the Office of the Comptroller of the Currency and the FDIC, the HOLA, Equal Credit Opportunity Act, the Fair Housing Act, the Community Reinvestment Act, the Home Mortgage Disclosure Act, all other applicable fair lending laws or other laws relating to discrimination and the Bank Secrecy Act and Title III of the U.S.A. Patriot Act), the failure to comply with which regulates would have a Material Adverse Effect. Neither the sale Company nor any of pharmaceutical products the Subsidiaries is subject or biologicalis party to, device or regenerative medicine products has received any notice or advice that any of them may become subject or party to any investigation with respect to, any corrective, suspension or cease-and-desist order, agreement, consent agreement, memorandum of understanding or other regulatory enforcement action, proceeding or order with or by, or is a party to any commitment letter or similar undertaking to, or is subject to any directive by, or has been a recipient of any supervisory letter from, or has adopted any board resolutions at the request of, any Regulatory Agency (as defined below) that currently restricts in any jurisdiction. There are no pending ormaterial respect the conduct of their business, that in any manner relates to their capital adequacy, or that in any material respect relates to credit policies or management (each, a “Regulatory Agreement”), nor has the Knowledge Company or any of the Subsidiaries been advised by any Regulatory Agency that it is considering issuing or requesting any such Regulatory Agreement which, in the reasonable judgment of the Company, threatened regulatory Actions (other than non-material routine is expected to have a Material Adverse Effect. There is no unresolved violation, criticism or periodic inspections exception by any Regulatory Agency with respect to any report or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law statement relating to the Company or the products or product candidates any examinations of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of Subsidiaries which, in the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge reasonable judgment of the Company, is expected to result in a Material Adverse Effect. As used herein, the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under term “Regulatory Agency” means any federal or state whistleblower statute, including under agency charged with the False Claims Act supervision or regulation of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge depositary institutions or holding companies of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”)depositary institutions, or engaged in the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department insurance of Health and Human Services Office of Civil Rights relating to any such violationsdepositary institution deposits, or any comparable state court, administrative agency or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects commission or other Governmental Authority having supervisory or regulatory authority with federal and state data breach Laws.
(n) To the extent respect to the Company provides reimbursement coding or billing advice regarding products offered for sale by any of the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program LawsSubsidiaries.
Appears in 1 contract
Regulatory Matters. (a) The Section 3.16(a) of the Company Disclosure Letter sets forth a true and complete list, as of the date of this Agreement, and the Company has made available to Parent true and complete copies of all Permits required Regulatory Authorizations from the FDA, EMA and all other applicable Regulatory Authorities held by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued Company relating to the Company Products and/or necessary to conduct its business as presently conducted, except those Regulatory Authorizations the absence of which would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect. All such Regulatory Authorizations are (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements, and (iv) in good standing, valid and enforceable, except where any such failure would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect. Except as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, the Company is in compliance in has filed all material respects withrequired notices and responses to notices, supplemental applications, reports (including all adverse event/experience reports) and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications other information with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company EMA and all other applicable Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingAuthorities.
(b) Except as set forth on Section 4.13(bwould not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, to the knowledge of the Company, (i) the Company is in compliance with applicable Health Laws, (ii) the Company has not received any written notice or other communication from any Regulatory Authority (A) withdrawing or placing any of the Company Disclosure ScheduleProducts on “clinical hold” or requiring the termination or suspension or investigation of any pre-clinical studies or clinical trials of the Company Products or (B) alleging any material violation of any Health Law and (iii) as of the date hereof, there are no investigations, suits, claims, actions or proceedings against any of the Company Products.
(c) Except as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, all pre-clinical studies and clinical trials currently being conducted or conducted since January 1, 2007, there has not been any voluntarily 2015 with respect to the Company Products by or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product at the direction of the Company have been and are being conducted in compliance with applicable Law, including the applicable requirements of Health Laws, Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Laws (including the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009) governing the privacy of patient medical records and other personal information and data. To the knowledge of the Company, the Company has not received any material notifications or product candidate other communications from any institutional review board, ethics committee or safety monitoring committee raising any issues, including from any Regulatory Authority in any jurisdiction that requires or would require the termination or suspension or investigation of any clinical studies conducted by, or on behalf of, the Company, or in which the Company have participated and, to knowledge of the Company, no such action has been threatened against the Company.
(ci) The Except as would not reasonably be expected to, individually or in the aggregate, have a Company is Material Adverse Effect, any manufacture of the Company Products, including any clinical supplies used in any clinical trials, by or on behalf of the Company has been conducted in compliance in all material respects with all the applicable Laws specifications and any other lettersrequirements of current Good Manufacturing Practices and applicable Law, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, and (ii) to the Knowledge knowledge of the Company, threatened regulatory Actions (other than non-material routine no Company Product has been adulterated or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820misbranded.
(e) The Except as would not reasonably be expected to, individually or in the aggregate, have a Company is and Material Adverse Effect, the Company has been in compliance in all not (i) made an untrue statement of a material respects with all Laws requiring the maintenance fact or submission of reports or records under requirements administered by the FDA fraudulent statement to any Regulatory Authority, (ii) failed to disclose a material fact required to be disclosed to any Regulatory Authority or any other Governmental AuthorityEntity, including, for avoidance of doubt, records and reports relating to product corrections and removals or (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(fiii) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make a statement, including with respect to any statement that scientific data or information, that, at the time such disclosure was made or failure to disclose occurred, would reasonably be expected to provide a basis for any Regulatory Authority or any other Governmental Entity to invoke the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991), or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the . The Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, testsis not, and preclinical and clinical research being conducted by the Companysince January 1, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have 2015 has not been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws subject of any other Governmental Authority. No clinical trial conducted by the Company pending or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company’s knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) investigation by the FDA. Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party toits respective officers, employees, or bound by, agents has been convicted of any order, individual integrity agreement, corporate integrity agreement crime or engaged in any conduct that could result in a debarment or exclusion under 21 U.S.C. § 335a or any other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(jf) Neither Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the Company nor any officeris in compliance and, directorsince January 1, managing employee (as those terms are defined 2015, has been in 42 C.F.R. § 1001.1001) of the Companycompliance, norin each case, in all material respects with all Health Laws applicable to the Knowledge operation of the Companyits business as currently conducted, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: including (i) has been debarredany and all federal, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs state and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how local fraud and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statuteabuse laws, including under the federal Anti-Kickback Statute (42 U.S.C. § 1320a- 7(b)), the civil False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
) and the regulations promulgated pursuant to such statutes and (mii) To the Knowledge FDCA. Neither the Company nor its Representatives (in each case, acting in the capacity of a Representative of the Company), is subject to any enforcement, regulatory or administrative proceedings against or affecting the Company relating to or arising under the FDCA, the Company is not under investigation by any Governmental Authority for a violation Anti-Kickback Statute, or similar Health Laws, and, to the Company’s knowledge, as of the Health Insurance Portability and Accountability Act date of 1995this Agreement, no such enforcement, regulatory or administrative proceeding has been threatened in writing, except, in each case, as amended by would not have, and would not reasonably be expected to have, individually or in the Health Information Technology for Economic and Clinical Health Act (“HIPAA”)aggregate, or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The a Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach LawsMaterial Adverse Effect.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company (i) Seller or its applicable Affiliate (including the Transferred Entity) possesses, or has rights to control directly or through Third Party distributors, all Permits required by Transferred Marketing Authorizations, (ii) the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company Transferred Marketing Authorizations are in full force and effect, (iii) no Proceeding is pending or, to the Company is Knowledge of Seller, has been threatened in compliance writing, regarding the withdrawal or suspension of any Transferred Marketing Authorization, (iv) none of Seller or its applicable Affiliates (including the Transferred Entity) nor, to the Knowledge of Seller, any of their Third Party distributors, have received during the three years prior to the date hereof any written communication from any Regulatory Authority or other Governmental Entity threatening to withdraw or suspend any Transferred Marketing Authorization and (v) none of Seller or its applicable Affiliates (including the Transferred Entity) nor, to the Knowledge of Seller, any of their distributors, are in material violation of the terms of any Transferred Marketing Authorization. All Products Sold by or on behalf of Seller or its Affiliates (including the Transferred Entity) during the last three years under the Transferred Marketing Authorizations have been Manufactured, marketed, Sold and otherwise Exploited in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which accordance with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How specifications contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingTransferred Marketing Authorizations.
(b) Except as set forth During the last three years, the Product has been developed, tested, labeled, packaged, Manufactured, distributed, stored and otherwise Exploited by or on Section 4.13(bbehalf of Seller and its Affiliates (including the Transferred Entity) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all
(c) Seller and its Affiliates (including the Transferred Entity) are in material compliance with all applicable Laws Transferred Entity Permits.
(i) No Transferred Entity Permits have lapsed, been cancelled, terminated, been withdrawn or been restricted and (ii) no Proceeding to modify, suspend, revoke, withdraw, terminate, or otherwise limit any other letterssuch Transferred Entity Permit is pending, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the CompanySeller, threatened regulatory Actions in writing. Seller and its Affiliates (including the Transferred Entity) do not own any Permits (other than non-material routine Marketing Authorizations or periodic inspections or reviewsthe Transferred Entity Permits) against the Company, and exclusively related to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyBusiness.
(d) The manufacture All Manufacturing operations conducted by or for Seller and its applicable Affiliates (including the Transferred Entity) with respect to the units of Product Manufactured or Sold in the products of Territory during the Company is last three years have been and are being conducted in material compliance in with applicable Law, including cGMP. The Seller and its applicable Affiliates (including the Transferred Entity) have filed with the applicable Regulatory Authorities, where required by applicable Law, including Health Care Laws, all material respects with current “good manufacturing practices,” as defined by the FDArequired notices, includingregistration applications, as applicablereports, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is supplemental applications and has been in compliance in all material respects with all Laws requiring the maintenance annual or submission of other reports or records under requirements administered by documents, including Medical Device Reports, that are material to the FDA or continued development, Manufacture, Sale, distribution and other Exploitation of the Product in the Territory. During the three years prior to the date hereof, with respect to the Product in the Territory, neither Seller nor any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals its applicable Affiliates (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(fthe Transferred Entity) None of the Company ornor, to the Knowledge of the CompanySeller, any of its Collaborative Partnerscontract manufacturers, agents have received any Form 483 observations, warning letters, untitled letters, or subcontractors has been convicted of other similar written correspondence from any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy applicable Regulatory Authority with respect to “Fraudthe Product in which such Regulatory Authority asserted that the operations of the Seller, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use its applicable Affiliates (including the Transferred Entity), or any of their contract manufacturers were not in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance compliance with applicable Law.
(he) To the Knowledge All preclinical studies and clinical trials of the Company, all studies, tests, and preclinical and clinical research being Product conducted by the Company, and to the Knowledge of the Company, or on behalf of Seller or its Affiliates (including the Company by any of its Collaborative PartnersTransferred Entity) during the three years prior to the date hereof have been and, if still pending, are being, and at all times have been, conducted in compliance compliance, in all material respects respects, with all the applicable Laws, including, as applicableprotocol for such study or trial, good laboratory practice regulations set forth in 21 C.F.R. Part 58, practices and good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other practices and all Laws applicable provisions of the Federal Food, Drug to such studies and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authoritytrials. No clinical trial of the Product conducted by the Company or, to the Knowledge of the Company, or on behalf of Seller or its Affiliates (including the Company Transferred Entity) during the three years prior to the date hereof has been terminated or suspended prior to completion for safety or non- compliance reasonsscheduled completion, and neither the FDA nor any other Governmental Authority, clinical investigator no Regulatory Authority or institutional review board that has or had jurisdiction over or participated in any such clinical trial has have initiated, or, to the Knowledge of the CompanySeller, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay terminate or suspend, any such proposed or ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) investigation of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.Product
Appears in 1 contract
Samples: Stock and Asset Purchase Agreement (Emergent BioSolutions Inc.)
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All Each of the FDA Permits held by or issued to the Company are in full force and effectSellers, the Company is in compliance in all material respects with, Companies and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, their respective Affiliates have been since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is 2020 and currently are operating in compliance in all material respects with all applicable Laws Healthcare Laws. None of Sellers, the Companies or their respective Affiliates is subject to any material Action against or affecting the Companies or the Business relating to or arising under any Healthcare Laws, and, to the Knowledge of the Sellers, no such Action has been threatened.
(b) All products that have been developed, tested, sourced, manufactured, packaged, stored, used, distributed, labeled, sold, imported, and exported by or on behalf of the Companies or Business are, and since January 1, 2020 have been, in material compliance with all Healthcare Laws, including those relating to Good Manufacturing Practices, establishment registration, product listing, product labeling, record keeping, and filing of reports. To the Knowledge of Sellers, no such products have been subject to, nor are there any facts or circumstances reasonably likely to lead to, any recalls, field notifications, market withdrawals or replacements, warnings, “dear doctor” letters, safety alerts, suspensions of manufacturing or distribution, seizures, detentions, holds, or other notices of action relating to an alleged lack of safety or regulatory compliance, except as would not, individually or in the aggregate, reasonably be expected to be, material to the Business, taken as a whole.
(c) Since January 1, 2020, none of the Sellers, the Companies or their respective Affiliates have received any Form FDA-483, notice of adverse finding, warning letters, notice of violation or “untitled letters,” notice of FDA action for import detentions or refusals, notice of any pending investigation, or any other letters, notices correspondence or guidances issued by notice from the FDA or other Governmental Entity alleging or asserting any material noncompliance with any applicable Healthcare Laws with respect to the Business. None of the Sellers, the Companies or their respective Affiliates are subject to any obligation arising under an administrative or regulatory action, inspection, warning letter, notice of violation, notice of adverse finding, notice of deficiency, or other notice, response or commitment made to or with FDA or any comparable Governmental Authority which regulates Entity with respect to a violation or FDA action, and no such proceedings have been threatened in writing, in each case, with respect to the sale Business, except as would not, individually or in the aggregate, reasonably be expected to be, material to the Business, taken as a whole.
(d) The Sellers, the Companies and their respective Affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Healthcare Laws with respect to the Business. To the Knowledge of pharmaceutical products Sellers, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity made with respect to the Business by the Sellers, the Company and their respective Affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(e) None of Sellers, the Companies or biological, device or regenerative medicine products in any jurisdiction. There are no pending their respective Affiliates or, to the Knowledge of the CompanySellers, threatened regulatory Actions (other than non-material routine their employees, agents or periodic inspections contractors has made any materially false or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredientfraudulent statement on, or material used in manufacturing the products or the product candidates of the Company pursuant omission from, any notifications, applications, approvals, reports and other submission to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products Entity or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material Action with respect with any applicable Law relating to the Company or the products or product candidates of the Company or Business, including any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any such statement or failed to make any statement omission that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” .”
(f) None of the Sellers, the Companies or for their respective Affiliates or their employees, agents, or contractors (in each case, with respect to the Business) has been suspended, excluded, debarred, or convicted of any other Governmental Authority crime or engaged in any conduct that would reasonably be expected to invoke result in (i) debarment under 21 U.S.C. Section 335(a) or (b) or any similar policyLaw, (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Healthcare Law. None of the Sellers, the Companies or their respective Affiliates nor, to the Knowledge of Sellers, their employees, agents, or independent contractors has engaged in any conduct that would reasonably be expected to result in such a debarment or exclusion. None of Sellers, the Companies or their respective Affiliates nor, to the Knowledge of Sellers, any of its respective directors, officers, employees, or agents is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or other similar written agreement, in each case, entered into with or imposed by any Governmental Entity.
(g) There have been are no Serious Adverse Eventspreclinical tests, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) , or studies involving human subjects or identifiable data of human subjects being conducted by or on behalf of the products of Companies or the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable LawBusiness.
(h) To The Sellers, the Knowledge of the CompanyCompanies and their respective Affiliates have in place an operational regulatory compliance program that governs all employees, agents and contractors and that is designed to address compliance with all studies, tests, and preclinical and clinical research being conducted by the Company, and applicable Healthcare Laws with respect to the Knowledge of Business. The Companies and the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted Business operate in compliance with such regulatory compliance program in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialrespects.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) None of the Company, nor, to Companies nor the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating Business have access to any Federal Health Care Program-related offense; or protected health information (v“PHI”) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service as defined under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 19951996 (42 U.S.C. § 1320d et seq.), as amended amended, by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations (collectively “HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(nj) To As of the extent Execution Date, none of the Company provides reimbursement coding Companies nor the Business are experiencing and have not announced any material business interruptions or billing advice regarding products offered for sale by material liabilities arising out of, resulting from or related to COVID-19 or COVID-19 Measures, whether directly or indirectly, including (i) disruptions to the Company Company’s supply chains, (ii) the failure of the Business’s agents and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawsservice providers to timely perform services or (iii) labor shortages.
Appears in 1 contract
Samples: Equity Purchase Agreement (Baxter International Inc)
Regulatory Matters. (a) The To the Knowledge of Seller, the Target Company is in material compliance with all applicable laws, rules and regulations of the United States, including of the FDA, applicable to the sale and distribution of the Products except as would not reasonably be expects to have a Material Adverse Effect or as is caused by the failure of a manufacturer of a Product to comply with the provisions of this sentence. Target Company has all Permits required by requisite permits, approvals, registrations, licenses from the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, currently conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating except as would not reasonably be expects to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdictionhave a Material Adverse Effect. There are no pending or, to the Knowledge of the CompanySeller, threatened regulatory Actions (other than non-material routine threatened, actions, suits, proceedings, hearings, investigations, charges, claims, demands, notices or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) complaints by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Business except as would not reasonably be expects to have a Material Adverse Effect. Target Company has not made any false statements on, or omissions from, the products applications, approvals, reports and other submissions to the FDA prepared or product candidates maintained to comply with the requirements of the Company or any subpoenas or investigative demands or other written inquiries that FDA except as would not reasonably be interpreted as raising expects to have a compliance concern sent or delivered by any Governmental Authority with regard to any product of Material Adverse Effect. Target Company has properly handled and stored all Products included in the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted Inventory in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authorityapplicable laws, includingrule and regulations except as would not reasonably be expects to have a Material Adverse Effect. Target Company has not, for avoidance of doubt, records and reports relating nor to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Seller has any officer or employee of Target Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for result in (i) debarment under 21 U.S.C. Section 335a or (ii) exclusion under 42 U.S.C. Section 1320a-7. Certain Business Relationships with Parent and its Affiliates. Except as set forth on the FDA Section 4(r) of the Disclosure Schedule, Target Company has not been involved in any material business arrangement or relationship with Parent or its Affiliates related to invoke the Business within the past twelve months. Except as set forth on the Section 4(r) of the Disclosure Schedule, as of the Closing, Target Company will have no business arrangement, contract or relationship with Parent or its policy Affiliates other than (i) as contemplated by this Agreement, (ii) with respect to “Fraud, Untrue Statements of Material Facts, BriberyKxxxxx or other branded pharmaceutical products on terms and conditions reasonably acceptable to Buyer, and Illegal Gratuities” (iii) on commercially reasonable terms and, in any case, as may be terminable by Target Company without advance notice or for any other Governmental Authority penalty. Organization, Qualification, and Corporate Power. Target Company is a corporation duly organized, validly existing, and in good standing under the laws of its jurisdiction of incorporation. Target Company is duly authorized to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with conduct business and is in good standing under the laws of each jurisdiction where such qualification is required. Target Company has full corporate power and authority to carry on the business in which it is engaged and to own and use (including in clinical trialsthe properties owned and used by it. Section 4(s) of the products Disclosure Schedule lists the directors and officers of each the Target Company. The Target Company has no direct or indirect subsidiaries. Capitalization. Section 4(t) of the Disclosure Schedule sets forth for the Target Company or product candidates (A) its jurisdiction of incorporation, (B) the number of authorized shares for each class of its capital stock, (C) the number of issued and outstanding shares of each class of its capital stock, and (D) the number of shares of its capital stock held in treasury. All of the Company that issued and outstanding Target Shares have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Companyduly authorized, all studiesare validly issued, testsfully paid, and preclinical and clinical research being conducted by the Companynon-assessable, and are held of record and beneficially by Seller. There are no outstanding or authorized options, warrants, purchase rights, subscription rights, conversion rights, exchange rights, or other contracts or commitments that could require the Target Company to the Knowledge of the Companyissue, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order onsell, or otherwise terminatecause to become outstanding any additional shares of its capital stock. There are no outstanding or authorized stock appreciation, materially delay or suspendphantom stock, any such ongoing clinical trialprofit participation, or similar rights with respect to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) shares of the Target Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business Each of Seller and its Subsidiaries (the “FDA Permits”). All of the FDA Permits held by or issued in each case solely with respect to the Company Product Portfolio and the Business) have complied with all material terms and conditions of each Transferred Approval and no Governmental Authority has provided notice to either Seller or its Subsidiaries that Seller or its Subsidiaries (in each case solely with respect to the Product Portfolio and the Business) is in material breach of any Transferred Approval.
(b) All Transferred Approvals are in full force and effect. No material suspension, the Company cancellation or modification is in compliance in all material respects withpending or, and is not in default in to Seller’s Knowledge, threatened, with respect to any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the CompanyTransferred Approvals.
(c) The Company During the past three (3) years, (i) there has not been, nor is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued there currently under consideration by the FDA Seller or any of its Subsidiaries, or to Seller’s Knowledge, any Governmental Authority which regulates Authority, the initiation or threat of any Recall or post-sale of pharmaceutical products or biologicalwarning, device or regenerative medicine products in nor is there any jurisdiction. There are no Recall pending or, to the Knowledge of the CompanySeller’s Knowledge, threatened Legal Proceedings or requests for information, voluntary or involuntary market withdrawals, field corrective actions, safety alerts or other regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Companyenforcement actions, in respect of any Product, and (ii) no Product manufactured, distributed or sold prior to the Knowledge of the Companydate hereof has been discontinued (whether voluntarily or otherwise) by Seller due to concerns over potential harm to human health or safety. To Seller’s Knowledge, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any componentact, ingredientomission, event, or material used in manufacturing the products or the product candidates of the Company pursuant circumstance has occurred with respect to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA Seller or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries its Subsidiaries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard expected to give rise to any product of the Company or any product candidate of the Companysuch action.
(d) The manufacture There is no pending, completed or, to Seller’s Knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint or investigation) related to the Business or Product Portfolio against Seller or any of its Affiliates, and, during the products past three (3) years, neither Seller nor any of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDAits Affiliates has received any notice, includingwarning or untitled letter, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance FDA Form 483 or submission of reports or records under requirements administered by other communication from the FDA or any other Governmental Authority; in either case, includingwhich (i) contests the premarket clearance, for avoidance licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of doubtany Product, records and reports (ii) alleges any material violation of or non-compliance with any applicable Law, (iii) withdraws or proposes to withdraw the approval of, requests the Recall, suspension, or seizure of, or withdraws any Product or orders the withdrawal of advertising or sales promotional materials relating to, any Product, (iv) imposes a clinical hold on any clinical investigation by Seller or any of its Affiliates relating to product corrections any Product, (v) enjoins production of any Product at any facility of Seller, its Affiliates or Third Party contract manufacturer, or (vi) enters or proposes to enter into a consent decree of permanent injunction with Seller or its Affiliates with regards to any Product, and removals which, in each case (including FDA requirements set forth in 21 C.F.R. Part 806i) through (vi), MDRs (including FDA requirements set forth either individually or in 21 C.F.R. Part 803)the aggregate, Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents would have a material impact on the Business or near-incidents and product malfunctionsProduct Portfolio.
(fe) None Neither Seller nor any of the Company orBusiness Employees, in each case, solely with respect to the Knowledge conduct of the CompanyBusiness, any of its Collaborative Partners, agents or subcontractors has been suspended, debarred, or excluded, or convicted of any crime or engaged in any conduct which has resulted or could that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335(a) or disqualification by any similar Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law.
(f) To Seller’s Knowledge, neither Seller nor any of the Business Employees, in each case, solely with respect to the conduct of the Business, has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submissions to the FDA or any other Governmental AuthorityAuthority or in any material lawsuit, and there are no proceedings pending orarbitration, to the Knowledge of the Companyor legal or administrative or regulatory proceeding, threatened that reasonably might be expected to result in criminal charge, complaint or civil liability investigation; or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has (ii) committed any an act, made any a statement or failed to make any a statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy.
(g) There During the past (3) years, in conducting the Business and with respect to the Product Portfolio, Seller and its Subsidiaries are and have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Asset Purchase Agreement (Spectrum Pharmaceuticals Inc)
Regulatory Matters. (a) The Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect or that, individually or in the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of the Company has to perform its obligations under this Agreement or to consummate the Mergers, (i) each of Parent and its Subsidiaries holds (A) all Permits required by authorizations under the FDCA, the PHSA, and the regulations of the FDA to conduct promulgated thereunder, and (B) authorizations of any applicable Governmental Authority that are concerned with the Business quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Parent Products (any such Governmental Authority, a “Parent Regulatory Agency”) necessary for the lawful operation of the businesses of Parent or any of its Subsidiaries as currently conducted (the “FDA Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent and its Subsidiaries are in compliance with the terms of all Parent Regulatory Permits. All of the FDA Parent Regulatory Permits held by or issued to the Company are in full force and effect, except where the Company is failure to be in compliance in all material respects withfull force and effect (A) has not had, and is would not reasonably be expected to have, individually or in default the aggregate, a Parent Material Adverse Effect or (B) individually or in any material respect 30 the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of Parent to perform its obligations under this Agreement or to consummate the Mergers (and to in the Knowledge case of this clause (B), as of the Company, no event which with the giving date of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Neither Parent nor any of its Subsidiaries are party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any Parent Regulatory Agency that have had or would reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) All pre-clinical and clinical investigations in respect of a Parent Product conducted or sponsored by Parent or any of its Subsidiaries are being, and since January 1, 2019 have been, conducted in compliance with all Applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(d) Except as set forth has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, during the period beginning on Section 4.13(b) January 1, 2019 and ending on the date of this Agreement, neither Parent nor any of its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of the Company Disclosure ScheduleParent Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Parent Regulatory Permits or of any application for marketing approval currently pending before the FDA or such other Parent Regulatory Agency.
(e) Since January 1, 2019, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.2019,
(ci) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, neither Parent nor any of its Collaborative Partners, agents or subcontractors Subsidiaries has been debarred or convicted of any crime or engaged in any conduct for which has resulted debarment is mandated by 21 U.S.C. § 335a(a) any similar Applicable Law or could result in debarment or disqualification authorized by the FDA 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other Governmental Authority, and there are no proceedings pending or, to the Knowledge jurisdictions in which material quantities of any of the Company, threatened that reasonably might Parent Products are sold or intended by Parent to be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, sold; and (ii) neither Parent nor any of its Collaborative Partners Subsidiaries has committed been excluded from participation in any act, made federal health care program or convicted of any statement crime or failed to make engaged in any statement that would conduct for which such Person could reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated be excluded from participating in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her federal health care program under Section 1128A 1128 of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, 1935 or any comparable state similar Applicable Law or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsprogram.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Samples: Merger Agreement
Regulatory Matters. (a) The Company Except as set forth on Schedule 5.19, each Loan Party is, and for the last six (6) years, has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effectbeen, the Company is conducting its business in compliance in all material respects with, and is not in default in any material respect 30 under (and with all Healthcare Laws applicable to the Knowledge of the CompanyLoan Party, no event which with the giving of notice its property, any Product or lapse of time, or both, would become a default under), each such Permit, and none other asset of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingLoan Party.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company Each Loan Party and its Subsidiaries is in compliance in all material respects with all applicable Laws Applicable Law governing the reporting and any other lettersrecordkeeping of Product modifications, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale adverse event reporting, recordkeeping for each Product, reporting of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Companycorrections and removals, and to the Knowledge of the Company, there all other manufacturing and release documents and records are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance true in all material respects with current “good manufacturing practices,” as defined by the FDArespects, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and no Loan Party or any of its Subsidiaries has received or been in compliance in all material respects with all Laws requiring the maintenance subject to any written or submission of reports or records under requirements administered by oral communications from the FDA or any other Governmental AuthorityAuthority asserting that any Loan Party or any of its Subsidiaries was not in compliance with Applicable Law or any Permit which would reasonably be expected, includingindividually or in the aggregate, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth result in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), a Material Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsEffect.
(fc) Each Loan Party and its Subsidiaries owns, free and clear of all Liens, except Liens permitted under this Credit Agreement, all Permits that are necessary (i) for the research, development and commercialization of the Products, including without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling any of the Products, and (ii) to carry on the business of the Loan Parties and their Subsidiaries. Each Permit is valid and in full force and effect and the Loan Parties and their Subsidiaries are in material compliance with all of the terms and conditions of such Permits and has made all declarations and filings with the applicable Governmental Authorities reasonably necessary to the conduct of the business of such Loan Party or Subsidiary. None of the Company orLoan Parties or their Subsidiaries has received any notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof, has issued an order or recommendation stating that the development, testing and/or manufacturing of such Product should cease or that any Product should be withdrawn from the market which would reasonably be expected, individually or in the aggregate, to the Knowledge of the Company, result in a Material Adverse Effect.
(d) No Loan Party nor any of its Collaborative Partners, Subsidiaries has made any material untrue statement of fact and no Loan Party or any of its Subsidiaries or any of their respective agents or subcontractors representatives has been convicted of made any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by fraudulent statement to the FDA or any other Governmental Authority, and there are no proceedings pending or, Loan Party nor any of its Subsidiaries has failed to the Knowledge of the Company, threatened that reasonably might disclose any material fact otherwise required to be expected disclosed to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None .
(e) Each Product (whether manufactured by the Borrower or any of the Company or, to the Knowledge of the Companyits Subsidiaries, any of their respective Affiliates or a third party manufacturer under the direction of the Borrower or any of its Collaborative Partners Subsidiaries) has committed been, and currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed by the Borrower and its Subsidiaries or third parties on their behalf, in compliance with all Applicable Laws, including, without limitation, all Healthcare Laws and all required Permits.
(f) There have been no adverse clinical test results, clinical holds, serious adverse health events or injuries, or enforcement actions by any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy Governmental Authority with respect to “Fraud, Untrue Statements any of Material Facts, Briberythe Products, and Illegal Gratuities” there have been no recalls or for voluntary market withdrawal from any other Governmental Authority to invoke any similar policymarket, except as set forth on Schedule 5.19. No investigational Product or product candidate that has not yet received the requisite FDA marketing approval or clearance has been, or is being, marketed, sold, commercialized, or promoted in the United States.
(g) There have To the knowledge of the Loan Parties, none of the clinical investigators who is providing or has provided services in connection with any clinical trial sponsored by any Loan Party or any of their Subsidiaries has been or is disqualified, debarred, or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Loan Parties, no Serious Adverse Eventssuch disqualification, Serious Injuries or MDR Reportable Events associated other sanction of any such clinical investigator is pending or threatened. None of the Loan Parties or any of their Subsidiaries has received from the FDA or other applicable Governmental Authority any notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in connection with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable LawProducts.
(h) To the Knowledge of the CompanyExcept as set forth on Schedule 5.19 (other than routine surveillance audits and inspections), all studies, tests, and preclinical and clinical research being conducted no investigation by the Company, and any Governmental Authority with respect to the Knowledge of the Company, on behalf of the Company by Borrower or any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company Subsidiaries is pending or, to the Knowledge knowledge, threatened in writing. None of the CompanyBorrower or any of its Subsidiaries has received any written or oral communications from any Governmental Authority of any noncompliance with any Applicable Laws or any written or oral communication from any Governmental Authority of any material issues, on behalf problems, or concerns regarding the quality or performance of the Company Products which would reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. No Loan Party nor any of their Subsidiaries has been terminated served with or suspended prior to completion for safety or non- compliance reasonsreceived any search warrant, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order onsubpoena, or otherwise terminatecivil investigative demand from any Governmental Authority regarding any actual or alleged violation of Healthcare Laws, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialexcept as set forth on Schedule 5.19.
(i) Neither Except as set forth on Schedule 5.19, no Loan Party nor any of its Subsidiaries has been the Company subject of any “for cause” inspection, investigation or audit by any Governmental Authority in connection with any improper activity. No Loan Party, nor any of its Subsidiaries, nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) employee, or any other personnel of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company Loan Party or Subsidiary is a party to, or bound by, any order, individual integrity agreement, to a corporate integrity agreement or has any reporting obligations pursuant to a settlement agreement, plan of correction, deferred prosecution agreement, consent decree or other formal or informal agreement remedial measure entered into with any Governmental Authority concerning compliance with Federal Health Care Program LawsAuthority.
(j) Neither No Loan Party or any of its Subsidiaries, and to the Company knowledge of such Loan Party or Subsidiary, nor any officer, director, managing employee employee, or contractor of any Loan Party or Subsidiary (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, except with respect to the Knowledge actions of former employees and officers of any Loan Party or Subsidiary which are public knowledge or have otherwise been disclosed in writing to the CompanyAdministrative Agent and the Lenders), in such capacity on behalf of any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the CompanyPerson, directly or indirectly, has: (i) has been debarredoffered or paid or solicited or received any remuneration, excluded in cash or suspended from participation in kind, or made any Federal Health Care Programfinancial arrangements, in material violation of any applicable Healthcare Law; (ii) has had a civil monetary penalty assessed against itgiven any gift or gratuitous payment of any kind, him nature or her under Section 1128A description (whether in money, property or services) in material violation of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”)any applicable Healthcare Law; (iii) is currently listed established or maintained any unrecorded fund or asset for any purpose or made any misleading, false or artificial entries on the General Services Administration published list any of parties excluded from federal procurement programs and non-procurement programsits books or records in material violation of applicable Healthcare Laws; or (iv) knowingly or willfully offered, paid, solicited or received any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind (A) in return for referring an individual to a person for the Knowledge of the Company, is the target furnishing or subject arranging of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under for which payment may be made in whole or in part by any Federal Health Care Program
“federal health care program” (kas defined in 42 U.S.C. § 1320a-7b(f)), commercial health insurer, or self-pay patient, or (B) The Company reasonably believes that it has the requisite knowin return for purchasing, leasing, ordering or arranging for or recommending purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part by any “federal health care program” (as defined in 42 U.S.C. § 1320a-7b(f)), commercial health insurer, or self-how and processes topay patient, subject or otherwise made any payment to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line Person with the intention that any part of such payment would be in the event that the current cell line is no longer viable.
(l) material violation of any applicable Healthcare Law. To the Knowledge knowledge of the Companyany Loan Party, there are no pending Person has filed, or has threatened filings in writing to file, against the Company of any Loan Party or any Subsidiary, an action relating to the Company under any federal or state whistleblower statutestatute related to alleged noncompliance with applicable Healthcare Laws, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(mk) To the Knowledge Except where any of the Companyfollowing would not be reasonably expected, individually or in the Company aggregate, to result in a Material Adverse Effect, no Loan Party or any of its Subsidiaries, nor any officer, director, employee, contractor, or Person with a “direct or indirect ownership interest” (as that phrase is not under investigation defined in 42 C.F.R. § 420.201) in any Loan Party or Subsidiary, is: (i) excluded, debarred, disqualified, or suspended from any “federal health care program” (as such term is defined in 42 U.S.C. § 1320a-7b(f)) or any other medical reimbursement program; (ii) “suspended” or “debarred” from selling products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4); (iii) listed on the General Services Administration list of excluded parties; or (iv) made a party to any other action by any Governmental Authority for that may prohibit it from selling products or providing services to any governmental or other purchaser pursuant to any Applicable Law. To the knowledge of any Loan Party, no such debarment, disqualification, suspension, exclusion, or prohibition is threatened or pending.
(l) Each of the Loan Parties and their Subsidiaries maintains and adheres to, in all material respects, compliance policies and procedures that are designed to promote compliance with and to detect, prevent, and address material violations of Laws, including all material Healthcare Laws, applicable to it and/or its assets, business or operations (collectively, “Health Care Compliance Program”). No Loan Party or any of its Subsidiaries is aware of any complaints from employees, independent contractors, vendors, physicians, customers, patients or other Persons that could reasonably be considered to indicate a violation of any Applicable Law, including any applicable Healthcare Law, which would be reasonably expected, individually or in the Health Insurance Portability aggregate, to result in a Material Adverse Effect.
(m) The Loan Parties and Accountability Act their Subsidiaries are and have been for the last six (6) years, to the extent directly applicable, conducting their business in material compliance with all - 98 - regulations promulgated under HIPAA. To the extent the Loan Parties or any of 1995their Subsidiaries create any de-identified protected health information, the Loan Parties and their Subsidiaries do so in compliance with the HIPAA regulations. No Loan Party nor any of its Subsidiaries have (i) suffered any breach of unsecured health protected health information (except as amended by would not reasonably be expected, individually or in the Health Information Technology for Economic and Clinical Health Act (“HIPAA”aggregate, to result in a Material Adverse Effect), or the regulations contained in 45 C.F.R. Parts 160 and 164(ii) failed to notify any individual or required third party, including receiving any notices appropriate Governmental Authority, of an event that triggered a notification or reporting requirement under any contract to which any Loan Party or any of its Subsidiaries is a party, or any applicable requirement related to the unauthorized access, use or disclosure of protected health information. The Loan Parties have no knowledge of any complaints to or investigations by any Governmental Authority with respect to HIPAA compliance by the Loan Parties or any of their Subsidiaries, have not received any notice or audit request from the United States Department of Health and Human Services Office for Civil Rights, is currently conducting their businesses in material compliance with all Applicable Laws governing the privacy, security or confidentiality of Civil Rights relating health information and/or other records generated in the course of providing or paying for health care services, including without limitation, all laws to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale not preempted by the Company and procedures related theretoHIPAA, such advice is and has been true and complete conducted its businesses in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawssuch laws since such laws first became applicable to it.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) 3.22 of the Company Disclosure Schedule, since January 1and except with respect to licenses, 2007approvals, there consents, registrations and permits required under applicable Environmental Laws (as to which certain representations and warranties are made pursuant to Section 3.18), the Company and its Subsidiaries hold all material permits, approvals, authorizations, certificates, registrations, licenses, franchises, variances, exemptions and other authorizations (including all product certifications), issued or granted to the Company or any of its Subsidiaries by a Governmental Authority (the “Company Licenses”) that are required for the Company and each of its Subsidiaries to own, lease and operate its properties or other assets and to conduct its business, as presently conducted, except where the failure to hold Company Licenses would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(b) Each Company License is valid and in full force and effect and has not been any voluntarily suspended, revoked, cancelled or involuntarily initiatedadversely modified, conductedexcept where the failure thereof to be in full force and effect, or issued recallthe suspension, market withdrawalrevocation, safety alertcancellation or modification thereof, warningwould not reasonably be expected to have, “dear doctor” letterindividually or in the aggregate, market correctiona Material Adverse Effect. As of the date of this Agreement, there is no pending or, to the Company’s knowledge, threatened Proceeding that would reasonably be expected to result in any suspension, adverse modification, revocation or investigator notice relating to an alleged material lack of safety or efficacy cancellation of any product of the Company or product candidate of the CompanyLicenses.
(c) The licensee of each Company License is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the such Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is License and has been in compliance in fulfilled and performed all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partnersobligations with respect thereto, agents including the payment of all regulatory fees and contributions, except (i) for exemptions, waivers or subcontractors has been convicted similar concessions or allowances and (ii) where such failure of any crime such licensee to be in compliance, fulfill or engaged in any conduct which has resulted perform its obligations or could result in debarment pay such fees or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that contributions would not reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraudhave, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” individually or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableaggregate, a Material Adverse Effect.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All Schedule 4.07(a) sets forth, as of the FDA Permits held by Effective Date, a list of all Governmental Authorizations granted to Seller or issued any Divesting Entity by, or application therefor pending with, any Governmental Authority to manufacture, have made, market, package, import, distribute, sell and commercialize the Products in the United States, except for those Governmental Authorizations that the failure to possess would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge operation of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingBusiness.
(b) Except All Products sold under the Governmental Authorizations are manufactured, marketed, distributed and sold in accordance with such Governmental Authorizations, including the specifications and standards contained therein, except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating and would not reasonably be expected to an alleged material lack of safety or efficacy of any product of be materially adverse to the Company or product candidate of the CompanyBusiness.
(c) The Company is in compliance in all material respects with all applicable Laws and With respect to the Business, neither Seller nor any other lettersof the Divesting Entities, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending ornor, to the Knowledge of Seller, any officer, employee, or agent of Seller or any of the CompanyDivesting Entities, threatened regulatory Actions (other than non-i) has made an untrue statement of a material routine fact or periodic inspections or reviews) against the Company, and a fraudulent statement to the Knowledge of the CompanyFDA, there are no pending or threatened regulatory Actions (other than non-failed to disclose a material routine or periodic inspections or reviews) pertaining fact required to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant be disclosed to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Gratuities policy set forth in the FDA’s Compliance Policy Guide Sec. 120.100 (CPG 7150.09), or for (ii) has been convicted of any other Governmental Authority crime or engaged in any conduct that would reasonably be expected to invoke result in debarment under 21 U.S.C. 335a or any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(hd) To the Knowledge Since [***] neither Seller nor any of the CompanyDivesting Entities has (i) voluntarily nor involuntarily initiated, all studiesconducted or issued, testsor caused to be initiated, and preclinical and clinical research being conducted by the Companyor issued, any recall, field alerts, market withdrawal or replacement, safety alert, “dear doctor” letter, investigator notice, or other notice or action relating to an alleged lack of safety, or efficacy of any Product, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the CompanySeller, there are no pending facts which are reasonably likely to cause (A) the recall, market withdrawal or threatened filings against the Company replacement of an action relating any Product sold or intended to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation be sold by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), Seller or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.Divesting Entities,
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required by Except as described in the FDA to conduct Registration Statement, the Business (Time of Sale Disclosure Package and the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effectProspectus, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.its subsidiaries:
(bA) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted been in compliance with all statutes, rules, regulations, policies, or guidances applicable to Company and its subsidiaries, relating to the ownership, testing, approval, clearance, safety, effectiveness, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export, disposal, laboratory quality, or analytical validation of any product, product component, or research-use only product manufactured, sold or distributed, or any service provided, including but not limited to laboratory services, by the Company or its subsidiaries or to billing, kickbacks, referral relationships or arrangements, ethics, claims processing, claims submission and privacy and security of health information (“Applicable Regulatory Laws”), except as would not reasonably be expected to have a Material Adverse Effect;
(B) have not received any FDA Form 483, Establishment Inspection Report, notice of adverse finding, warning letter, untitled letter, “It has come to our attention” letter, or other correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), the Centers for Medicare and Medicaid Services (CMS) or any other Governmental Authority alleging, asserting, or inquiring about the Company’s or its subsidiaries’ noncompliance with any Applicable Regulatory Laws or the Company’s or its subsidiaries’ noncompliance with, or absence of, any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”);
(C) are aware that the FDA has indicated its intention to discontinue its exercise of enforcement discretion relating to many laboratory developed tests, but have not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations, or to require the Company or any of its subsidiaries to obtain an Authorization thereto that Company does not currently possess, and, to the Company’s knowledge, no Governmental Authority is intending to take such action against the Company or any of its subsidiaries’ products specifically; and
(D) have filed, obtained, created and maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects with all applicable Lawson the date filed, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order oncreated, or otherwise terminatesubmitted (or were corrected or supplemented by a subsequent filing, materially delay or suspend, any such ongoing clinical trialcreation, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.submission).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company has all Permits required by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth in the Disclosed Matters on Section 4.13(bSchedule 3.25(a), (i) each Loan Party and each of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is its Subsidiaries are in compliance in all material respects with all applicable FDA Laws and applicable DEA Laws, including all applicable requirements of the FDCA, the CSA, or any implementing regulations thereof, all laws and regulations administered or enforced by the U.S. Drug Enforcement Administration, and all applicable statutes, rules, regulations, standards, policies and orders administered or issued by any foreign Governmental Authority, relating to any Product or any aspect of the development, Manufacture, production or Commercialization thereof or otherwise, (ii) none of the Products are articles which may not be introduced into interstate commerce pursuant to the requirements of the FDCA, the CSA or foreign equivalents, as applicable, (iii) each Product has been developed, Manufactured or produced in all material respects in accordance with FDA Good Manufacturing Practices (or any foreign equivalent, as applicable) and FDA Registration and Listing Requirements (or foreign equivalent, as applicable) and (iv) each of the Products required to be approved or cleared by the FDA pursuant to the FDCA (or any foreign equivalent, as applicable) has been so approved or cleared.
(b) None of the Loan Parties or their respective Subsidiaries nor any officer, affiliate, employee or any of its Subsidiaries, agent, of any Loan Party or its Subsidiaries, has (i) made an untrue statement of any material fact or fraudulent statement to any Governmental Authority (including the FDA), (ii) failed to disclose any material fact to any Governmental Authority (including the FDA), or (iii) except as otherwise disclosed on Schedule 3.25(a), committed any act, made any statement, or failed to make any statement that, in any such case, at the time such disclosure was made, could reasonably be expected to constitute a material violation of any FDA Law.
(c) Except as provided on Schedule 3.25(c), there are no facts, circumstances or conditions that could reasonably be expected to form the basis for any material investigation, suit, claim, audit, action (legal or regulatory) or proceeding (legal or regulatory) by a Governmental Authority (other letters, notices than any routine GMP Regulation or guidances issued compliance audits required by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in routine audits conducted by notified bodies with respect to any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviewsforeign good manufacturing practices requirements) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine in writing against any Loan Party or periodic inspections or reviews) pertaining any of its Subsidiaries relating to the products or product candidates any of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA Laws or any Governmental Authority which regulates the sale of pharmaceutical products applicable statutes, rules, regulations, standards, policies or biologic, device orders administered or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered issued by any foreign Governmental Authority with regard to any product of the Company or any product candidate of the CompanyAuthority.
(d) The manufacture Schedule 3.25(d) contains a list of all Products that have been Commercialized as of the products Effective Date and each date required by Section 5.01(j). Each Loan Party and its Subsidiaries, as applicable, has all Regulatory Authorizations necessary to conduct its business in the manner in which such business is currently conducted. Borrower has previously made available to Lender all Regulatory Authorizations, all material correspondence with Regulatory Agencies (including the FDA and any foreign equivalent, as applicable) with respect to such Regulatory Authorization and all adverse event reports with respect to the Products that have been Commercialized and all requested documents related to the Products that have been Commercialized, in each case, in the possession and control of Holdings or any of its Subsidiaries. Borrower has not withheld any document or information with respect to the Products that have been Commercialized that would reasonably be considered to be material to Lender’s decision to provide the financing contemplated by this Agreement.
(e) Except as set forth in the Disclosed Matters on Schedule 3.25(e), (i) each Loan Party and its Subsidiaries, and, to the knowledge of each Loan Party or any of its Subsidiaries, each licensee of a Loan Party or any of its Subsidiaries of any intellectual property, are in compliance with, and have complied with, all applicable federal, state, provincial, municipal, local and foreign laws, rules and regulations, governing its business, including all regulations promulgated by each applicable Regulatory Agency, the failure of compliance with which could reasonably be expected to result in a Material Adverse Effect and (ii) no Loan Party or its Subsidiaries has received any written notice from any Regulatory Agency citing action or inaction by any Loan Party or any of its Subsidiaries that would constitute a violation of any applicable federal, state, provincial, municipal, local and foreign laws, rules, regulations or standards, which could reasonably be expected to result in a Material Adverse Effect.
(f) Without limiting the generality of clause (e) above, to the knowledge of each Loan Party or any of its Subsidiaries, any and all studies, tests and preclinical and clinical trials and investigations conducted by or on behalf of the Company is being Loan Parties relating to any Product have been, and are being, conducted in all material respects in accordance with all applicable Requirements of Law, including good clinical practices (including under FDA (and foreign equivalent, as applicable) regulations (including the requirements set forth in 21 C.F.R. Part 11, Part 50, Part 54, Part 56, Part 312 and Part 314, as applicable)), good laboratory practices, and investigational new drug exemption requirements; Borrower has previously made available to Lender descriptions of the results of such studies, tests, trials and investigations, which descriptions are accurate in all material respects; and no Loan Party or any of its Subsidiaries has received any notices or correspondence from any applicable Regulatory Agency or comparable authority requiring the termination, suspension, material modification or clinical hold of any such studies, tests, trials or investigations conducted by or on behalf of a Loan Party or its Subsidiaries, which termination, suspension, material modification or clinical hold could reasonably be expected to result in a Material Adverse Effect.
(g) To the knowledge of each Loan Party or any of its Subsidiaries, the development, Manufacturing and production of each Product has at all times been (i) in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth final release quality specifications in 21 C.F.R. Part 820.
effect for such Product and (eii) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable LawsRequirements of Law, includingincluding the FDCA, the CSA, and any foreign equivalents thereto. Except as set forth on Schedule 3.25(g), no Person currently Manufacturing Product and currently party to a Manufacturing Agreement and, to the actual knowledge of each Loan Party or any of its Subsidiaries, no other Person Manufacturing Product, in each case has received in the past five (5) years an FDA Form 483 or is currently subject to a Form 483 impacting any Product with respect to any facility Manufacturing Product and that, with respect to each such Form 483, all scientific and technical violations or other issues relating to good manufacturing practice requirements documented therein, and any disputes regarding any such violations or issues, have been corrected or otherwise resolved.
(h) Except as set forth on Schedule 3.25(h), (i) no Product has been recalled, suspended, subject to a market withdrawal or field correction, or discontinued as a result of any action by the FDA or any other Governmental Authority (or any foreign equivalent, as applicable), good laboratory practice regulations set forth by any Loan Party or any of its Subsidiaries or by any licensee, distributor or marketer of such Product and (ii) where required by Applicable Law, the Loan Parties and their Subsidiaries have maintained global post-marketing surveillance programs and procedures specifically designed to comprehensively monitor, collect and timely report any adverse event reports required to be reported in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions relation to any of the Federal FoodProducts in accordance with any Requirements of Law. To the knowledge of each Loan Party or any of its Subsidiaries, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50there are no facts, 54circumstances, 56or conditions that could reasonably be expected to result in a recall, 58suspension, 312 and 812market withdrawal, and comparable Laws field correction or discontinuance of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trialProduct.
(i) Neither Schedule 3.25(i) contains a true, correct and complete list of all manufacturing and supply Contracts entered into by any Loan Party or any of its Subsidiaries with third parties and in effect for the Company nor any officer, director, managing employee supply of Product (the “Manufacturing Agreements”) as those terms are defined in 42 C.F.R. § 1001.1001) of the CompanyEffective Date. Borrower has previously made available to Lender true, norcorrect and complete copies of each Manufacturing Agreement, and each such Manufacturing Agreement contains, or is accompanied by an adequate quality agreement. After giving effect to consummation of the transactions contemplated by this Agreement and the other Loan Documents, except as described on Schedule 3.25(i), each Manufacturing Agreement and quality agreement is a valid and binding obligation of the applicable Loan Party or Subsidiary and is in full force and effect, and to the knowledge of each Loan Party or any of its Subsidiaries, is a valid and binding obligation of any other party thereto, and neither the applicable Loan Party or its Subsidiaries or, to the Knowledge knowledge of the Companyeach Loan Party or any of its Subsidiaries, any agent (other party thereto is in breach thereof or default thereunder. Except as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(iidescribed on Schedule 3.25(i)) , no Loan Party or any of the Company is a its Subsidiaries has received any notice from any party tothereto, oral or bound bywritten, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: regarding (i) has been debarredthe cancellation, excluded termination or suspended from participation in invalidation of any Federal Health Care Program; Manufacturing Agreement or (ii) has had a civil monetary penalty assessed against it, him any indication by or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target intent or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related theretothreat of, such advice is and has been true and complete in all material respects and in compliance in all material respects with party, oral or written, to reduce or cease the payment requirements supply of Medicare and other Federal Health Care Program LawsProduct through calendar year 2022.
Appears in 1 contract
Regulatory Matters. (a) The Company has and each of its Subsidiaries are, and since January 1, 2020 have been, in compliance in all Permits required respects with all applicable Laws, including the FDCA and any other similar Laws administered or promulgated by the FDA or other comparable Governmental Entity, except for any noncompliance, either individually or in the aggregate, which would not be material to the Company. To the Company’s Knowledge, no investigation, inspection, claim, suit, proceeding, audit or other action by any Governmental Entity is pending or threatened against the Company or any of its Subsidiaries.
(b) There is no agreement, judgment, injunction, order or decree binding upon the Company or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company or any of its Subsidiaries, any acquisition of material property by the Company or any of its Subsidiaries or the conduct of business by the Business Company or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(c) The Company and its Subsidiaries have at all times since January 1, 2020 held and have operated in compliance with all Governmental Authorizations that are necessary for the conduct of business of the Company and its Subsidiaries as currently being conducted (the “FDA Company Permits”), except where such failures to hold or remain so in compliance would not, either individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. All of the FDA such Company Permits held by or issued to the Company are valid and are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and will continue to the Knowledge be so upon consummation of the CompanyContemplated Transactions, no event which with except as would not, either individually or in the giving of notice or lapse of timeaggregate, reasonably be expected to have a Company Material Adverse Effect. No notice, filing, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, other Consent is required as a result of the transaction contemplated by this AgreementContemplated Transactions under any material Company Permit. Section 3.16(c) of the Company Disclosure Schedule identifies each Company Permit. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds its Subsidiaries hold all right, title and interest in and to all the Company Regulatory Filings Permits free and clear of any Encumbrance (other than Permitted Encumbrances)Lien. All fees and charges with respect to such Company Permits, as of the date hereof, have been paid in full and all filing, reporting and maintenance obligations have been completely and timely satisfied, except as would not, either individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company has not granted any third party any right or license to use, access or reference any and each of its Subsidiaries are in material compliance with the terms of the Company Regulatory FilingsPermits. To the Company’s Knowledge, includingno Legal Proceeding is pending or threatened, without limitationwhich seeks to revoke, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedulelimit, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conductedsuspend, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of materially modify any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyPermit.
(d) The manufacture To the Company’s Knowledge, there are no proceedings pending or threatened with respect to an alleged material violation by the Company or any of its Subsidiaries of the products FDCA or any other similar Law administered or promulgated by any comparable Governmental Entity. Neither the Company, any of its Subsidiaries nor to the Company’s Knowledge, any Person providing services to the Company is being conducted in compliance in all material respects or any of its Subsidiaries with respect to the Company’s current products or product candidates (the “good manufacturing practices,” as defined by the FDACompany Products”) has received any written notice, includingincluding any warning letter, as applicableuntitled letter, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance FDA Form-483, written notice of other adverse finding, or submission notice of reports deficiency or records under requirements administered by violation, or similar written communication from the FDA or any other Governmental AuthorityEntity alleging that the Company or its Subsidiaries, includingtheir respective operations, for avoidance or the Company Products are in material violation of doubtany applicable Law or Company Permit.
(e) As required under applicable Law or pursuant to a Governmental Authorization, records the Company and reports relating its Subsidiaries have maintained, filed, or furnished to product corrections the applicable Governmental Entities or Person all filings, documents, claims, reports, notices, and removals other submissions (including FDA requirements set forth in 21 C.F.R. Part 806the “Reports”), MDRs (including FDA requirements set forth required to be maintained, filed, or furnished on a timely basis, and, at the time of maintenance, filing, or furnishing all such Reports were complete and accurate when submitted, or were subsequently updated, changed, corrected, or modified, except where the failures to so maintain, file, furnish, update, change, correct or modify would not, either individually or in 21 C.F.R. Part 803)the aggregate, reasonably be expected to have a Company Material Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctionsEffect.
(f) None of the Company or, to the Knowledge of Neither the Company, its Subsidiaries, nor to the Company’s Knowledge, any Person providing services to the Company or its Subsidiaries has made an untrue statement of its Collaborative Partners, agents a material fact or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by fraudulent statement to the FDA or any other a Governmental AuthorityEntity, and there are no proceedings pending or, failed to the Knowledge of the Company, threatened that reasonably might disclose a material fact required to be expected disclosed to result in criminal or civil liability or debarment or disqualification by the FDA or any other a Governmental Authority. None of the Company orEntity, to the Knowledge of the Companyor made a statement, any of its Collaborative Partners has committed any act, made any statement or failed to make any a statement that that, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the “FDA Ethics Policy”). Neither the Company, its Subsidiaries, nor to the Company’s Knowledge, any Person providing services to the Company or its Subsidiaries has ever been investigated by the FDA or other Governmental Entity for data or healthcare program fraud. Neither the Company, its Subsidiaries, nor to the Company’s Knowledge, any Person providing services to the Company or its Subsidiaries is the subject of any pending or, to the Company’s Knowledge, threatened investigation pursuant to the FDA Ethics Policy, or resulting from any other Governmental Authority to invoke any similar policyuntrue or false statement or omission.
(g) There have been no Serious Adverse EventsNeither the Company, Serious Injuries or MDR Reportable Events associated with its Subsidiaries, nor, to the use (including in clinical trials) of the products of Company’s Knowledge, any Person providing services to the Company or product candidates its Subsidiaries, nor their respective officers, directors, partners, employees, or agents have been:
(i) debarred or suspended pursuant to 21 U.S.C. § 335a;
(ii) excluded under 42 U.S.C. § 1320a-7 or any similar law, rule or regulation of any Governmental Entity;
(iii) excluded, debarred, suspended or deemed ineligible to participate in federal procurement and non-procurement programs, including those produced by the Company U.S. General Services Administration;
(iv) charged, named in a complaint, convicted, or otherwise found liable in any Legal Proceeding that have not been reported to falls within the FDA in accordance with ambit of 21 U.S.C. § 331, 21 U.S.C. § 333, 21 U.S.C. § 334, 21 U.S.C. § 000x, 00 X.X.X. § 000x, 00 X.X.X. § 0000x—7, 31 U.S.C. §§ 3729 – 3733, 42 U.S.C. § 1320a-7a, or any other applicable Law;
(v) disqualified or deemed ineligible pursuant to 21 C.F.R. Parts 312, 511, or 812, or otherwise restricted, in whole or in part, or subject to an assurance; or
(vi) had a pending Legal Proceeding, or otherwise received any written notice from any Governmental Entity or any Person threatening, investigating, or pursuing (i)-(v) above.
(h) To the Knowledge of the CompanyAll clinical, all studies, tests, pre-clinical and preclinical other studies and clinical research being tests conducted by the Company, and to the Knowledge of the Company, or on behalf of of, or sponsored by, the Company by or any of its Collaborative PartnersSubsidiaries, or in which the Company or any of its Subsidiaries or the Company Products have participated were and, if still pending, are being, and at all times have been, being conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice Laws and regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized enforced by the FDAFDA or any comparable Governmental Entity, including the ICH Tripartite Guideline for Good Clinical Practicewithout limitation, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 58 and 812, and comparable Laws of any other Governmental Authority312. No clinical trial conducted by the Company or, to the Knowledge of To the Company’s Knowledge, on behalf there are no other studies, the results of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order onwhich are inconsistent with, or otherwise terminatecall into question, materially delay or suspend, the results of any such ongoing clinical trialstudies or tests conducted by or on behalf of, or sponsored by, the Company or any of its Subsidiaries, or in which the Company or any of its Subsidiaries or the Company Products. The Company has not received written notice of any complaints, information, or adverse drug experience reports related to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical triala Company Product that would reasonably be expected to have a Company Material Adverse Effect.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, norits Subsidiaries, nor to the Knowledge of the CompanyParent’s Knowledge, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating Person providing services to the Company under or its Subsidiaries has received any federal written notice, correspondence, or state whistleblower statuteother written communications from the FDA, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Companyany other Governmental Entity, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act Institutional Review Board (“HIPAAIRB”), or other Person or board responsible for the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving oversight or conduct of any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violationsstudy conducted by or on behalf of, or sponsored by, the Company or any comparable state of its Subsidiaries, or local Lawsin which the Company or any of the Company Products are participating, requiring or threatening the termination, hold, material adverse modification or suspension of any clinical study that is being or is proposed to be conducted. The All clinical studies conducted or sponsored by or on behalf of the Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance were and, if still pending, are being conducted in all material respects in accordance with federal all applicable Laws, the protocols, procedures and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered controls designed and approved for sale by the Company and procedures related theretosuch studies, such advice is and has been true and complete in all material respects and in compliance in all material respects accordance with the payment requirements any requirement of Medicare and an IRB or other Federal Health Care Program LawsPerson or board responsible for review of such studies.
Appears in 1 contract
Regulatory Matters. (a) The Neither the Company nor any of its Affiliates nor any predecessor thereof has all Permits required by received any oral or written communication (including any Warning Letter, Courtesy Letter, untitled letter conveying adverse inspectional observations, Form 483 or similar notices) from any Governmental Authority, including but not limited to the FDA to conduct or FTC, or from any counterpart regulatory authorities in the Business (European Union, or any other country, regarding the “FDA Permits”). All of Company’s currently marketed products, or regarding claims that are currently being made for the FDA Permits held by or issued to the Company are in full force and effectCompany’s currently marketed products, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the CompanyCompany and its Affiliates, there is no event which with the giving of notice action or lapse of time, proceeding pending or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any of its Subsidiaries or Affiliates is not currently in compliance with any and all applicable Laws implemented by the FDA or FTC, or any counterpart regulatory exclusivities) associated with each such authorities in the European Union or any other country, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Regulatory FilingMaterial Adverse Effect. There are no pending voluntary or involuntary market withdrawals, field corrective actions (including recalls), destruction orders, seizures or other regulatory enforcement actions related to any product that have had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) Except as set forth on Section 4.13(b) The Company has, prior to the execution of this Agreement, made available to Parent copies of any and all documents in its or its Subsidiaries’ possession that are material to assessing the Company Disclosure ScheduleCompany’s or any of its Subsidiaries’ material compliance with the Federal Food, since January 1Drug, 2007and Cosmetic Act, there has not been any voluntarily or involuntarily initiated, conductedFederal Trade Commission Act, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, the International Standards Organization and their respective implementing regulations or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) other similar regulations in any applicable jurisdiction. The Company is and its Subsidiaries are in compliance in all material respects with all applicable Laws requirements of the Federal Food, Drug, and any other lettersCosmetic Act and the Federal Trade Commission Act and the regulations promulgated thereunder (collectively, notices or guidances issued the “FDA Requirements”).
(c) To the extent currently required, all manufacturing, including testing, by the FDA Company and its Subsidiaries have been conducted in all material respects in compliance with applicable good manufacturing practices, and good laboratory practices as set forth by the FDA.
(d) The Company and its Subsidiaries have not filed any biologics license applications, new drug applications, medical device premarket notifications or applications and neither the Company nor its Subsidiaries market any biologic, drug or medical device products.. None of the Company, any of its Subsidiaries or any Governmental Authority which regulates the sale of pharmaceutical products their respective officers or biological, device or regenerative medicine products in any jurisdiction. There are no pending employees or, to the Knowledge of the Company, threatened regulatory Actions (other than non-agents has made an untrue statement of a material routine or periodic inspections or reviews) against the Company, and fact to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates Office of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product Inspector General of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services or failed to disclose a material fact required to be disclosed to the FDA, FTC or the Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawsthe Inspector General.
(ne) To the extent Company’s Knowledge, as of the Company provides reimbursement coding date hereof, there are no facts or billing advice regarding products offered for sale by circumstances that would render unlikely the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in Company’s compliance in all material respects with the payment requirements of Medicare Dietary Supplement and other Federal Health Care Program LawsNonprescription Drug Consumer Protection Act (due to be effective on December 22, 2007), in the form in which that Act currently exists, or the regulations for Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (21 C.F.R. Part 111), as to which compliance is required by June 25, 2009.
Appears in 1 contract
Samples: Merger Agreement (Natrol Inc)
Regulatory Matters. (a) The Company has all Permits required Each of the products under development by the FDA to conduct Company is identified in Section 4.15(a) of the Business Company Disclosure Schedule (the “Company Products”). The Company is not currently marketing any product. The Company holds all material licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all required authorizations under the FDCA, PHSA and the regulations of the FDA promulgated thereunder, and any other Government Authority that regulates the quality, identity strength, purity, safety, efficacy or manufacturing of the Company Products (any such Government Authority a “Company Regulatory Agency”) required for the lawful operation of the business of the Company (the “Company Permits”), except, in each case, as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company. All of the FDA such Company Permits held by or issued to the Company are valid and in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none . None of such Permits Company Permit will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction transactions contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits Company Permit and the associated filings and applications with the FDA, including any biologics license application, new drug application, abbreviated new drug application, drug master files, biologics master files, master files for devices, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds hold all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances)encumbrance. The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, including any of the Knowknow-How how contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except Since January 1, 2010, there has not occurred any breach or violation of, default (with or without notice or lapse of time or both) under or event giving rise to any right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any Company Permit. The Company is in compliance in all material respects with the terms of all Company Permit, and no event has occurred and no facts or circumstances exist that, to the knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any the Company Permit.
(c) Since January 1, 2010, all material applications, submissions, information and data used by the Company as set forth the basis for, or submitted by or, to the knowledge of the Company, on Section 4.13(b) behalf of the Company Disclosure Schedulein connection with, since any and all requests for Company Permit when submitted to the FDA or other Company Regulatory Agency, were, to the Company’s knowledge, accurate and complete in all material respects as of the date of submission, and any updates, changes, corrections or modifications to such applications, submissions, information and data required under Applicable Law have been submitted to the FDA or other Company Regulatory Agency.
(d) Since January 1, 20072010, the Company has not committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or similar policies under Applicable Law. Neither the Company nor, to the knowledge of the Company, any agent, subcontractor, director, officer, employee or other Person associated with or acting on behalf of the Company has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Government Authority, and there are no proceedings pending or threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Government Authority.
(e) The Company nor, to the knowledge of the Company, any director, officer, agent, employee or other Person associated with or acting on behalf of the Company, has: (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the FCPA or any similar Applicable Law; or (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment. There are no pending or, to the knowledge of the Company, threatened filings against the Company of an action relating to the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)).
(f) Since January 1, 2010, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, field notification, field correction, market withdrawalwithdrawal or replacement, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the CompanyProduct.
(cg) The Company is in compliance in all material respects with all applicable Applicable Laws and any other letters, notices or guidances guidance issued by the FDA or any Governmental Government Authority which regulates regulate the sale clinical investigation, manufacture, sale, promotion, sampling and distribution of pharmaceutical products or biological, or device or regenerative medicine products in any jurisdiction. The Company has at all times and is currently distributing, marketing, promoting, labeling and selling its products in accordance with the FDCA and Prescription Drug Marketing Act of 1987. There are no pending or, to the Knowledge knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 2010 there have been no written notices, reports, FDA Form 483 observations that have not been disclosed by the Company warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Applicable Law relating to the Company or the products or product candidates of the any Company Product or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Government Authority with regard to any product of the Company or any product candidate of the CompanyProduct.
(dh) The manufacture of the products of the Company Products is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the . The Company has been in material compliance with FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820registration and listing requirements to the extent required by FDA.
(ei) The Company is and has been in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Government Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, and Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Events or Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the any Company or product candidates of the Company Products that have not been reported to the FDA in accordance with applicable Applicable Law.
(hj) To the Knowledge knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge knowledge of the Company, on behalf of the Company by any of its Collaborative PartnersCompany, are being, and at all times have been, conducted in compliance incompliance in all material respects with all applicable Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws laws of any other Governmental Government Authority. No clinical trial conducted by the Company or, to the Knowledge knowledge of the Company, on behalf of the Company Company, has been terminated or suspended prior to completion for safety or non- non-compliance reasons, and neither the FDA nor any other Governmental Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person Person or entity involved in any such clinical trial.
(ik) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, monitoring agreement, consent decree, settlement order, deferred prosecution agreement or other formal or informal agreement with any Governmental Government Authority concerning compliance with the laws governing any Federal Health Care Program LawsProgram. The Company meets all the requirements of participation and payment of Medicare, Medicaid, and any Programs to the extent in which it participates. There is no action pending, received or, to the Company’s knowledge, threatened against the Company which relates in any way to a violation of any health care laws or which could result in the imposition penalties against or the exclusion of the Company from participation in any Programs. Neither the Company nor any officer, director or managing employee has engaged in any activities which are cause for civil penalties or mandatory or permissive exclusion from any Program. To the Company’s knowledge, there is no pending, proposed or final Medicare national or local coverage determination that, if finalized, would restrict coverage for the Company’s products. The Company has not established any reimbursement support program, such that payment for the Company product is contingent upon a purchaser’s receipt of payment from a third party payer. The Company does not furnish any coverage, coding or billing advice to any health care professionals regarding off-label indications of the Company products.
(jl) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended under 21 U.S.C. § 335a, or (ii) any similar law, from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge knowledge of the Company, is the target or subject of any current investigation by a Governmental Government Authority relating to any Federal Health Care Program-Program related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
; or (kvi) The Company reasonably believes that it has is the requisite know-how subject of any pending or threatened investigation by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and processes toIllegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, subject to 1991) and any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viableamendments thereto. .
(lm) To There are no pending or, to the Knowledge knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the civil False Claims Act of 1863 (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)) or the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)).
(mn) To the Knowledge knowledge of the Company, the Company is not under investigation by any Governmental Government Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health the Company and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Lawslaws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Lawslaws.
(no) To the extent the The Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with all Applicable Laws requiring state registration, state reporting of applicable sales and marketing expenditures and transactions to health care professionals, and state compliance program requirements, which may include (depending on the payment requirements state) but is not limited to adoption of Medicare and other Federal the OIG Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers, the AdvaMed Code, and/or the PhRMA Code. See Cal. Health Care Program Laws.& Safety Code §§ 119400 — 119402; Connecticut, Subst. Senate Xxxx Xx. 000, Xxxx Xx. 000, Xxx. Xx. 000; D.C., D.C. Code Xxx. §§ 48-833.01—48-833.09; Maine, Maine Rev.
Appears in 1 contract
Regulatory Matters. (ai) The Company SIGA has all Permits required provided or made available, when requested by the FDA MMT to conduct the Business (the “FDA Permits”). All of the FDA Permits held its due diligence review, documents and communications in its possession from and to any Governmental Authority, or prepared by or issued any Governmental Authority, related to the Company are in full force and effectProduct, that may bear on the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving requirements of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDAany Governmental Authority, including any biologics license applicationnotice of inspection, new drug applicationinspection report, 510(kwarning letter, deficiency letter, or similar communication (collectively “Compliance Communications”);
(ii) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference Neither SIGA nor any of its Affiliates has received, with respect to SIGA Intellectual Property and the Company Regulatory Filings, including, without limitationProduct, any of the Know-How contained in any of the Company Regulatory Filings oral or rights written communication (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedulewarning letter, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducteduntitled letter, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(csimilar notices) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued by the FDA or from any Governmental Authority which regulates the sale of pharmaceutical products or biologicaland, device or regenerative medicine products in any jurisdiction. There are there is no action pending or, to the Knowledge of the CompanySIGA’s knowledge, threatened regulatory Actions (other than non-material routine including any prosecution, injunction, seizure, civil fine, suspension or periodic inspections or reviews) against the Companyrecall), and in each case alleging that with respect to the Knowledge SIGA Intellectual Property or Product, SIGA or any of the Companyits Affiliates is not currently materially in compliance with any and all Laws implemented by such Governmental Authority (collectively, there are no pending a “Non-Compliance Action”). Neither SIGA nor any of its Affiliates has received any oral or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or written notice from any Governmental Authority which regulates claiming that the sale Development, Commercialization or Promotion of pharmaceutical products or biologicthe Product is not in material compliance with all Laws and permits;
(iii) As to any Product, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning lettersduring the Term SIGA shall provide, or untitled letters alleging make available, to MMT copies of any (A) Compliance Communications within five (5) Business Days after provision to, or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by receipt from, any Governmental Authority with regard and (B) Non-Compliance Action within five (5) Business Days after receipt from a Governmental Authority; except (in the cases of (A) and (B)) to any product the extent that SIGA’s counsel reasonably believes that such disclosure to MMT could violate applicable privacy Laws or have a significant adverse impact on SIGA’s legal position or defense (including the loss of attorney-client privilege). In the Company event that SIGA determines that disclosure could violate applicable privacy laws or any product candidate of the Company.have a significant adverse impact on its legal position or defense, SIGA shall promptly notify MMT that it is exercising its right not to disclose; and
(div) The manufacture To SIGA’s knowledge, none of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the CompanySIGA, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA Affiliates or any other Governmental Authorityof their respective officers, and there are no proceedings pending oremployees or agents has made, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraudthe SIGA Intellectual Property or the Product, Untrue Statements an untrue statement of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority a material fact to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Lawsor has failed to disclose a material fact required to be disclosed to such Governmental Authority.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.
Appears in 1 contract
Regulatory Matters. (a) The Except as would not have a Company Material Adverse Effect, the Company Products are in compliance with all applicable Device Regulatory Laws. Except as would not have a Company Material Adverse Effect, (i) each member of the Company Group is in compliance with all applicable Device Regulatory Laws relating to the sourcing and procurement or the import of raw materials for the Company Products and the methods and materials used in, and the facilities and controls used for, the design, manufacture, processing, packaging, labeling, storage, distribution and export of the Company Products and (ii) since January 1, 2021, all such raw materials and all Company Products have been sourced, procured, processed, manufactured, packaged, labeled, stored, handled and distributed by the Company Group in compliance with all applicable Device Regulatory Laws. Without limiting the generality of the foregoing, each member of the Company Group is, and since January 1, 2021, has been, in material compliance with all Permits required applicable Device Regulatory Laws regarding developing, testing, manufacturing, marketing, distributing or promoting the Company Products and complaint handling, adverse event reporting or the submission of medical device reports regarding the Company Products, except where such a failure to comply would not have a Company Material Adverse Effect.
(b) Except as would not have a Company Material Adverse Effect, all preclinical and clinical investigations sponsored by or on behalf of a member of the Company Group with respect to any Company Product are being, and since January 1, 2021, have been, conducted in compliance with applicable Device Regulatory Laws, including Good Clinical Practices requirements, and federal and state Laws restricting the use and disclosure of individually identifiable health information. None of the members of the Company Group has received any written notices or other correspondence from the FDA or any other applicable Governmental Authority performing functions similar to those performed by the FDA with respect to conduct any ongoing clinical or pre-clinical studies or tests requiring the Business termination, suspension or material modification of such studies or tests.
(the “FDA Permits”). All of the FDA Permits held c) No action has been taken by or issued to the Company are in full force and effectany Governmental Authority or, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with is in the giving process of notice being taken that would slow, halt or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of enjoin the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any manufacturing of the Company Regulatory Filings, including, without limitation, any Products or the operation of the Know-How contained in any business of the Company Regulatory Filings Group or rights (including any subject the manufacturing of the Company Products or a member of the Company to regulatory exclusivities) associated with each such Company Regulatory Filingenforcement action.
(bd) Except as set forth on Section 4.13(b) of the would not have a Company Disclosure ScheduleMaterial Adverse Effect, since January 1, 20072021, there the members of the Company Group have maintained records relating to the development, manufacture, testing, storage, handling, labeling, packaging, sale, marketing, promotion, distribution, import or export of the Company Products in compliance with all applicable Device Regulatory Laws. Except as would not have a Company Material Adverse Effect, each member of the Company Group and, to the Knowledge of the Company, each of their respective contractors and agents have submitted to FDA, Notified Bodies and all other applicable regulatory authorities, institutional review boards, or accreditation bodies, all supplemental applications, 510(k) premarket notifications, premarket approvals, notices, filings and annual or other reports and information, including adverse event reports and product deviation reports, related to the development, manufacture, testing, storage, handling, labeling, packaging, sale, marketing, promotion, distribution, import or export of the Company Products that are required under the applicable Device Regulatory Laws. To the Knowledge of the Company, each member of the Company Group has made all required filings with, or notifications to, the FDA, all Notified Bodies and all other applicable regulatory authorities pursuant to applicable requirements of all Device Regulatory Laws applicable to the Company Group, except where a failure to comply with such a requirement would not be material to the Company Group, taken as a whole. Since January 1, 2021, the Company Products, where required, are being marketed under and consistent with valid 510(k) clearances or approved Premarket Approval Applications (“PMAs”) exclusively owned by a member of the Company Group. In each case since January 1, 2021, in circumstances where the Company has determined that 510(k) clearance is not required with respect to any Company Product that is not the subject of an approved PMA, the Company has documented that no 510(k) clearance is required, has marketed such Company Product in material compliance with all applicable Device Regulatory Laws, and has not taken any action that would require a 510(k) clearance.
(e) Except as would not have a Company Material Adverse Effect, since January 1, 2021, all manufacturing operations for the Company Products conducted by or on behalf of a member of the Company Group have been and are being conducted in compliance with the QSR and any voluntarily similar requirements of the FDA’s Quality Systems Regulation (21 C.F.R. Part 820) and any Notified Bodies, and the Company Products are not adulterated within the meaning of 21 U.S.C. § 351 or involuntarily initiatedmisbranded within the meaning of 21 U.S.C. § 352. No member of the Company Group or to the Knowledge of the Company, conductedofficers, employees, contractors or issued recallagents of a member of the Company Group have received from the FDA or any other Governmental Authority, market withdrawalinstitutional review board or accreditation body in respect to the ownership, development, testing, manufacturing, operation, storage, distribution, warehousing, packaging, labeling, handling, sale, promotion or marketing of the Company Products any written notice of any material violation of any Law concerning any Company Product, adverse inspection findings, finding of deficiency or non-compliance, penalty for corrective or remedial action, FDA warning letter or untitled letters, FDA Form 483 notice, OAI establishment inspection report, regulatory letters, safety alert, warningstop sale/importation letters, “dear doctor” letternotices of violations, market correctionimport refusals, Section 305 criminal proceeding notices under the FDCA, prosecution notices or other similar communication from the FDA or any other Governmental Authority, or investigator notice relating other similar compliance or enforcement action. There have been no seizures conducted or, to an alleged material lack of safety or efficacy of any product of the Company or product candidate Knowledge of the Company.
(c) The Company is , threatened in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued writing by the FDA or any other Governmental Authority which regulates the sale Authority, and no voluntary or mandatory recalls, market withdrawals, field notifications, notifications of pharmaceutical products misbranding or biologicaladulteration, device or regenerative medicine products in any jurisdiction. There are no safety alerts pending or, to the Knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered writing by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals the Company Products. To the Knowledge of the Company, there is no material act, omission, event or circumstance relating to the activities of a member of the Company Group, or any officers or employees of a member of the Company Group, or their conduct that would reasonably be expected to (including FDA requirements set forth i) cause the withdrawal or recall, or require suspension or additional approvals or clearances, of any Company Products, (ii) require a change in 21 C.F.R. Part 806)the manufacturing, MDRs marketing classification, labeling or intended use of any such Company Products in order to comply in all material respects with applicable Device Regulatory Laws, (including FDA requirements set forth in 21 C.F.R. Part 803)iii) require the termination or suspension of marketing or sale of any such Company Products or (iv) give rise to or lead to any Action, Adverse Experiencescomplaint, Serious Adverse Eventsinspection, Serious Injuriesnotice, incidents demand letter, warning or near-incidents and product malfunctionsuntitled letter, request for information or any associated liability with regard to the Company Products.
(f) None No member of the Company Group or, to the Knowledge of the Company, any officer, employee, contractor or agent of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None a member of the Company Group is the subject of any pending Action or, to the Knowledge of the Company, any ongoing investigation or inquiry or have received any notice of any actual investigation, inquiry, for cause inspection or audit or other Action by FDA pursuant to its Collaborative Partners “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar Governmental Authority pursuant to any similar policy, or concerning allegations of a violation by a member of the Company Group or any officers, employees, contractors or agents of a member of the Company Group of any Device Regulatory Laws, nor has a member of the Company Group or, to the Knowledge of the Company, any officer, employee, contractor or agent of a member of the Company Group committed any act, or made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” the FDA Application Integrity Policy or for any other similar Governmental Authority to invoke any a similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products . No member of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company Group or, to the Knowledge of the Company, on behalf any officer, employee, contractor or agent of a member of the Company Group has knowingly made any false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to a Governmental Authority relating to any Company Product or has voluntarily disclosed any violations of Laws related to any Company Product.
(g) To the Knowledge of the Company, no member of the Company Group has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated is currently engaged in any such clinical trial has initiatedconduct that would reasonably be expected to lead to being suspended, ordisqualified, debarred, convicted or excluded from participating in, or bidding on contracts with, any Governmental Authority or private third party health care program, pursuant to the Department of Health and Human Services Office of Inspector General’s exclusion authority under 42 U.S.C. § 1320a-7(a), as implemented at 42 C.F.R. §§ 1001.101, 1001.201 or FDA’s suspension and debarment authority under 21 U.S.C. § 335a, and, to the Knowledge of the Company, no such suspension, disqualification, debarment or exclusion has been initiated or threatened to initiatein writing.
(h) Since January 1, 2021, no member of the Company Group has promoted or marketed Company Products for any action to place a clinical hold order on, uses other than the uses cleared or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator approved by the FDA or other person or entity involved in any such clinical trialGovernmental Authority.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) The members of the Company is a party toGroup are in compliance and at all times since January 1, or bound by2021, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Company, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has have been in compliance in with all material respects with federal and state data breach Laws.
(n) To Healthcare Laws applicable to the extent operation of the businesses of the Company provides reimbursement coding or billing advice regarding products offered for sale by Group, except where the failure to comply would not have a Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program LawsMaterial Adverse Effect.
Appears in 1 contract
Samples: Merger Agreement (Axonics, Inc.)
Regulatory Matters. (a) The Company has all Permits required is a savings and loan holding company supervised by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued to the Company are in full force and effect, the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all right, title and interest in and to all Company Regulatory Filings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory FilingFRB.
(b) Except as set forth on Section 4.13(b) The Bank is a federal savings bank supervised by the OCC. The deposit accounts of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the Company or product candidate of the Company.
(c) The Company is in compliance in all material respects with all applicable Laws and any other letters, notices or guidances issued Bank are insured by the FDA FDIC to the fullest extent permitted by law. The Bank has paid or any Governmental Authority which regulates properly reserved or accrued for all current premiums and assessments with respect to such deposit insurance, all premiums and assessments required to be paid in connection therewith have been paid when due, and no proceedings for the sale termination of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There such insurance are no pending or, to the Knowledge Company’s Knowledge, threatened. The Bank received a rating of at least “satisfactory” in its most recent examination or interim review under the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the CompanyCommunity Reinvestment Act.
(d) The manufacture of the products of the Company is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or suspended prior to completion for safety or non- compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(ic) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge of the Company, any agent (as such term its Subsidiaries is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound bythe subject of, any cease-and-desist order, individual integrity consent order, written agreement, corporate integrity agreement order for civil money penalty, prompt corrective action directive, memorandum of understanding, supervisory letter, individual minimum capital requirement, operating agreement, or any other formal or informal agreement with enforcement action issued by, or entered into with, any Governmental Regulatory Authority. Except as set forth in Schedule 8.14, none of the Companies has made, adopted, or implemented any currently Table of Contents effective commitment, board resolution, policy, or procedure at the request or recommendation of any Regulatory Authority concerning that limits in any material respect the conduct of its business or that in any material manner relates to its capital adequacy, its payment of dividends or distribution of capital, its credit or risk management, its compliance with Federal Health Care Program Lawsprogram, its management, its growth, or its business.
(jd) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) Except for examinations of the CompanyCompanies conducted by their respective primary regulators in the ordinary course of business, norno Regulatory Authority has initiated or has pending any proceeding or, to the Knowledge Company’s Knowledge, any inquiry or investigation into the business or operations of the CompanyCompanies, any agent (as except where such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarredproceeding, excluded inquiry, or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against itinvestigation would not reasonably be likely to be, him either individually or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Companyaggregate, there are no pending or threatened filings against the Company of an action relating material to the Company under any federal and its Subsidiaries, taken as a whole. There is no unresolved violation, apparent violation, criticism, matter requiring attention, recommendation, or state whistleblower statuteexception cited, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the Companymade, the Company is not under investigation or threatened by any Governmental Regulatory Authority for a violation in any report of examination, report of inspection, supervisory letter or other communication that would reasonably be likely to be, either individually or in the Health Insurance Portability and Accountability Act of 1995aggregate, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating material to any such violations, or any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related theretoits Subsidiaries, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Lawstaken as a whole.
Appears in 1 contract
Regulatory Matters. (a) The Section 3.16(a) of the Company Disclosure Letter sets forth a true and complete list, as of the date of this Agreement, and the Company has made available to Parent true and complete copies of, all Permits required Regulatory Authorizations from the FDA, EMA and all other applicable Regulatory Authorities held by the FDA to conduct the Business (the “FDA Permits”). All of the FDA Permits held by or issued Company relating to the Company Products and/or necessary to conduct its business as presently conducted. All such Regulatory Authorizations are (i) in full force and effect, the Company is (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance in with all material respects withformal filing and maintenance requirements, and is not (iv) in default in any good standing, valid and enforceable. The Company has fulfilled and performed all of its material obligations with respect 30 under (to such Regulatory Authorizations, and to the Knowledge of the Company, no event has occurred which with the giving of allows, or after notice or lapse of timetime would allow, revocation or bothtermination thereof. Except as would not reasonably be expected to, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole individually or in partthe aggregate, as have a result of Company Material Adverse Effect, (x) the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications has filed, maintained or furnished with the FDAapplicable Regulatory Authorities all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including any biologics license application, new drug application, 510(kall adverse event/experience reports) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company and other information (collectively, the “Company Regulatory FilingsHealth Care Submissions”) with the FDA, EMA and holds all rightother applicable Regulatory Authorities and (y) all such Health Care Submissions were complete and accurate and in compliance with applicable Health Laws when filed (or were corrected or completed in a subsequent filing).
(i) The Company is in material compliance with all applicable Health Laws that affect the business, title Company Products, properties, assets and interest in and to all Company Regulatory Filings free and clear activities of any Encumbrance the Company, (other than Permitted Encumbrances). The ii) as of the date of this Agreement the Company has not granted received any third party written notice or other communication from any right Regulatory Authority (A) withdrawing or license to use, access or reference placing any of the Company Regulatory Filings, including, without limitation, Products on “clinical hold” or requiring the termination or suspension or investigation of any pre-clinical studies or clinical trials of the Know-How contained in Company Products or (B) alleging any material violation of any Health Law and (iii) there are no investigations, suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened against the Company with respect to any of the Company Regulatory Filings Products or rights (including alleging any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as set forth on Section 4.13(b) of the Company Disclosure Schedule, since January 1, 2007, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of violation by the Company or product candidate the Company Products of the Companyany such Health Law.
(c) The Company is in compliance in all material respects All pre-clinical studies and clinical trials conducted or being conducted with all applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no pending or, respect to the Knowledge of Company Products by or at the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Company, there are no pending or threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates direction of the Company against any Person that manufactures any component, ingredient, or material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (“Collaborative Partners”) by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2007 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Company or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to any product of the Company or any product candidate of the Company.
(d) The manufacture of the products of the Company is and are being conducted in material compliance in all material respects with current “good manufacturing practices,” as defined by the FDArequired experimental protocols, including, as applicable, the FDA’s “Quality System Regulation” set forth in 21 C.F.R. Part 820.
(e) The Company is procedures and has been in compliance in all material respects with all Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions.
(f) None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners, agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authoritycontrols, and there are no proceedings pending or, to the Knowledge of the Company, threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. None of the Company or, to the Knowledge of the Company, any of its Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 5858 and 312, 312 all applicable requirements of Good Laboratory Practices and 812, Good Clinical Practices and comparable Laws of any other Governmental Authority. applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Laws governing the privacy of patient medical records and other personal information and data.
(i) No clinical trial conducted by or, on behalf of, the Company orhas been terminated or suspended by any Regulatory Authority and (ii) the Company has not received any notifications or other communications from any institutional review board, ethics committee or safety monitoring committee raising any issues, including from any Regulatory Authority in any jurisdiction that requires or would require the termination or suspension or investigation, or place a clinical hold order on or otherwise delay or materially restrict any clinical studies proposed or currently conducted by, or on behalf of, the Company, or in which the Company has participated and, to the Knowledge knowledge of the Company, no such action has been threatened against the Company. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of the Company and all material written correspondence that exists as of the date of this Agreement between the Company and the applicable Regulatory Authorities.
(d) All manufacture of the Company Products, including any clinical supplies used in any clinical trials, by or on behalf of the Company has been terminated conducted in all material respects in compliance with the applicable specifications and requirements of Good Manufacturing Practices and applicable Law. Neither the Company nor, to the knowledge of the Company, any person acting on its behalf has, with respect to any Company Product, (i) been subject to a Regulatory Authority shutdown or suspended prior import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to completion for safety make any change to any Company Product or non- compliance reasonsany of the Company’s processes or procedures, and neither or any similar correspondence from any Regulatory Authority in respect of the FDA nor Company or its business operations alleging or asserting noncompliance with any other Governmental Authorityapplicable Law, clinical investigator permit or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiatedrequests or requirements of a Regulatory Authority and, to the knowledge of the Company, no Regulatory Authority is considering such action.
(e) None of the Company or any of its officers, employees or agents, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the Knowledge knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of clinical investigator acting for the Company, nor, to the Knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: has (i) has been debarred, excluded made an untrue statement of a material fact or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any current investigation by a Governmental Authority relating fraudulent statement to any Federal Health Care Program-related offense; Regulatory Authority or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(l) To the Knowledge of the Company, there are no pending or threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statuteother Governmental Entity, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(m) To the Knowledge of the CompanyCenters for Medicare and Medicaid Services, the Company is not under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States U.S. Department of Health and Human Services Services, HHS Office of Civil Rights relating Inspector General or the Center for Medicare and Medicaid Innovation, (ii) failed to disclose a material fact required to be disclosed to any such violationsRegulatory Authority or any other Governmental Entity, including the Centers for Medicare and Medicaid Services, the U.S. Department of Health and Human Services, HHS Office of Inspector General or the Center for Medicare and Medicaid Innovation, or (iii) committed an act, made a statement, or failed to make a statement, including with respect to any comparable state or local Laws. The Company is not a “covered entity” as that term is defined in HIPAA. The Company has been in compliance in all material respects with federal and state scientific data breach Laws.
(n) To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in all material respects and in compliance in all material respects with the payment requirements of Medicare and other Federal Health Care Program Laws.or
Appears in 1 contract
