Common use of FDA Regulatory Matters Clause in Contracts

FDA Regulatory Matters. (a) The Company has developed, tested, manufactured and stored, as applicable, its product candidates, including the Products, in compliance in all material respects with Federal Food, Drug and Cosmetic Act of 1938, as amended, to the extent applicable, and applicable regulations issued by the FDA. (b) Section 4.7(b) of the Company Disclosure Letter sets forth a true and complete list of all Regulatory Authorizations from the FDA with respect to the Company’s product candidates currently in effect, and there are no other material Regulatory Authorizations required for the Company in connection with the conduct of the Company’s business as currently conducted. All such Regulatory Authorizations owned by the Company are (i) in full force and effect and the Company has not received written notice from any Governmental Entity or third Person that any such Regulatory Authorization is subject to any adverse action, (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, in the case of each of the foregoing clauses (i) – (iv), as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (c) To the knowledge of the Company, the clinical trials conducted by or on behalf of the Company (which, for the avoidance of doubt, shall not include investigator-sponsored clinical trials) were, and if still pending, are, being conducted in all material respects in accordance with all applicable clinical trial protocols, informed consents and applicable requirements of the FDA, including, as applicable, the FDA’s good clinical practices and good laboratory practices regulations. (d) The Company is not subject to any investigation that is pending or, to the knowledge of the Company which has been threatened, in connection with any of the Company’s product candidates, including the Products. (e) Since January 1, 2007, the Company has complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, including the regulations promulgated thereunder (collectively “HIPAA”), and (ii) other applicable state privacy laws. (f) Since January 1, 2007, all material reports, applications, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Regulatory Authority by the Company 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). Neither the Company nor, to the knowledge of the Company, any officer, employee or agent of the Company, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Regulatory Authority, or failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, with respect to the Products. Neither the Company, nor, to the knowledge of the Company, any current officer, employee, or agent of the Company, 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. (g) The Company has not received any written notices, correspondence or other communication from the FDA or any other Regulatory Authority since January 1, 2007 requiring the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated. To the extent that the Company or, to the knowledge of the Company, any of its clinical trial sites have received FDA483 notices or untitled or warning letters since January 1, 2007, this correspondence has been made available for review by Parent. (h) The Company has made available for review by Parent complete and accurate copies of all (i) investigational new drug applications submitted to the FDA or any other Regulatory Authority by or on behalf of the Company, including any supplements thereto, (ii) correspondence to or from the FDA or any other Regulatory Authority, including meeting minutes and records of material contracts and (iii) documents in the Company’s possession related to inspections by the FDA or any other Regulatory Authority, in case of each of the foregoing clauses (i) – (iii), relating to the Products.

FDA Regulatory Matters. (a) The Company has developed, tested, manufactured and stored, as applicable, its product candidates, including the Products, in compliance in all material respects with Federal Food, Drug and Cosmetic Act of 1938, as amended, to the extent applicable, and applicable regulations issued by the FDA. (b) Section 4.7(b) of the Company Disclosure Letter sets forth a true and complete list of all Regulatory Authorizations from the FDA with respect to the Company’s 's product candidates currently in effect, and there are no other material Regulatory Authorizations required for the Company in connection with the conduct of the Company’s 's business as currently conducted. All such Regulatory Authorizations owned by the Company are (i) in full force and effect and the Company has not received written notice from any Governmental Entity or third Person that any such Regulatory Authorization is subject to any adverse action, (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, in the case of each of the foregoing clauses (i) – (iv), as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (c) To the knowledge of the Company, the clinical trials conducted by or on behalf of the Company (which, for the avoidance of doubt, shall not include investigator-sponsored clinical trials) were, and if still pending, are, being conducted in all material respects in accordance with all applicable clinical trial protocols, informed consents and applicable requirements of the FDA, including, as applicable, the FDA’s 's good clinical practices and good laboratory practices regulations. (d) The Company is not subject to any investigation that is pending or, to the knowledge of the Company which has been threatened, in connection with any of the Company’s 's product candidates, including the Products. (e) Since January 1, 2007, the Company has complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, including the regulations promulgated thereunder (collectively “"HIPAA”"), and (ii) other applicable state privacy laws. (f) Since January 1, 2007, all material reports, applications, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Regulatory Authority by the Company 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). Neither the Company nor, to the knowledge of the Company, any officer, employee or agent of the Company, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Regulatory Authority, or failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, with respect to the Products. Neither the Company, nor, to the knowledge of the Company, any current officer, employee, or agent of the Company, 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. (g) The Company has not received any written notices, correspondence or other communication from the FDA or any other Regulatory Authority since January 1, 2007 requiring the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated. To the extent that the Company or, to the knowledge of the Company, any of its clinical trial sites have received FDA483 notices or untitled or warning letters since January 1, 2007, this correspondence has been made available for review by Parent. (h) The Company has made available for review by Parent complete and accurate copies of all (i) investigational new drug applications submitted to the FDA or any other Regulatory Authority by or on behalf of the Company, including any supplements thereto, (ii) correspondence to or from the FDA or any other Regulatory Authority, including meeting minutes and records of material contracts and (iii) documents in the Company’s 's possession related to inspections by the FDA or any other Regulatory Authority, in case of each of the foregoing clauses (i) – (iii), relating to the Products.

FDA Regulatory Matters. (a) The Company has developedExcept as set forth on Schedule 4.23(a), testedfor the past three (3) years, manufactured and storedthere have been no recalls, as applicablefield actions, its product candidatescorrections, or removals ordered by any Governmental Authority, including the Products, in compliance in all material respects with Federal Food, Drug and Cosmetic Act of 1938, as amended, to the extent applicable, and applicable regulations issued by the FDA. (b) Section 4.7(b) of the Company Disclosure Letter sets forth a true and complete list of all Regulatory Authorizations from the FDA with respect to the Company’s product candidates currently in effect, and there are no other material Regulatory Authorizations required for the Company in connection with the conduct of the Company’s business as currently conducted. All such Regulatory Authorizations owned by the Company are (i) in full force and effect and the Company has not received written notice from any Governmental Entity or third Person that any such Regulatory Authorization is subject to any adverse action, (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, in the case of each of the foregoing clauses (i) – (iv), as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (c) To the knowledge of the Company, the clinical trials conducted by or on behalf of the Company (which, for the avoidance of doubt, shall not include investigator-sponsored clinical trials) were, and if still pending, are, being conducted in all material respects in accordance with all applicable clinical trial protocols, informed consents and applicable requirements of the FDA, including, as applicable, the FDA’s good clinical practices and good laboratory practices regulations. or any seizures or adverse regulatory actions taken (d) The Company is not subject to any investigation that is pending or, to the knowledge of the Company which has been Company, threatened), in connection by the FDA or any other Governmental Authority with respect to any of the Company Products or, to the knowledge of the Company’s product candidates, including any facilities where any Company Products are manufactured, packaged or stored. (b) For the past three (3) years, none of the members of the Company Group has voluntarily initiated or participated in any recalls, field actions, corrections, or removals (other than for commercial business reasons) of any of the Company Products. (ec) Since January 1, 2007, For the Company has complied in all material respects with all applicable security and privacy standards regarding protected health information under past three (i3) the Health Insurance Portability and Accountability Act of 1996, including the regulations promulgated thereunder (collectively “HIPAA”), and (ii) other applicable state privacy laws. (f) Since January 1, 2007years, all material reports, applications, documents, claims, permits permits, notices, and notices other filings required to be filed, maintained or furnished to the FDA or any other Regulatory Governmental Authority by the Company or the Company Subsidiaries under FDA Regulatory Laws have been so filed, maintained or furnishedfurnished in accordance with FDA Regulatory Laws. All such material reports, documents, claims, permits permits, notices, and notices filings were true and complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Neither . (d) For the past three (3) years, the Company norand the Company Subsidiaries have not, nor to the knowledge of the Company, has any officer, employee employee, or agent of the CompanyCompany or the Company Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Regulatory Governmental Authority, or failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, with respect or committed an act, made a statement, or failed to make a statement, in each such case related to the Products. Neither the Company, nor, to the knowledge business of the CompanyCompany or 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 any current officer, employee, or agent of the Company, 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 other Governmental Authority to invoke any similar Lawpolicy. (ge) The Each Company Product is being, and for the past three (3) years has not received any written noticesbeen, correspondence or other communication from the FDA or any other Regulatory Authority since January 1manufactured, 2007 requiring the terminationlabeled, suspension or material modification stored, distributed, and marketed, as applicable, by each member of any clinical trials conducted by, or on behalf of, the Company or Group in which the Company has participatedcompliance with all applicable FDA Regulatory Laws. To the extent that the Company There is no Action pending or, to the knowledge of the Company, any of its clinical trial sites have received FDA483 notices or untitled or warning letters since January 1, 2007, this correspondence has been made available for review by Parent. (h) The Company has made available for review by Parent complete and accurate copies of all (i) investigational new drug applications submitted to the FDA or any other Regulatory Authority by or on behalf of the Companythreatened in writing, including any supplements theretoprosecution, (ii) correspondence to injunction, seizure, civil fine, debarment, suspension or from the FDA or recall, against any other Regulatory Authority, including meeting minutes and records of material contracts and (iii) documents in the Company’s possession related to inspections by the FDA or any other Regulatory Authority, in case of each member of the foregoing clauses (i) – (iii), relating Company Group in each case alleging any material violation applicable to the Productsany Company Product by a Governmental Authority of any applicable FDA Regulatory Law.

FDA Regulatory Matters. (a) The No material investigation or review by any Governmental Entity with respect to the Company has developed, tested, manufactured and stored, as applicable, or any of its product candidates, including the Products, in compliance in all material respects with Federal Food, Drug and Cosmetic Act of 1938, as amendedSubsidiaries is pending or, to the extent applicableCompany’s Knowledge, and applicable regulations issued by threatened, nor has any Governmental Entity delivered in writing to the FDACompany an intention to conduct the same. (b) Section 4.7(bAll applications and other documents submitted within the past five (5) years by the Company or the Company’s Subsidiaries to the FDA and all other applicable Regulatory Authorities in connection with a Governmental Authorization related to or for the Company Product, and since September 16, 2013, any other product of the Company, were true and correct in all material respects as of the date of submission (or were correct in or supplemented by a subsequent filing), and any material updates, changes, corrections or modifications to such applications and other documents required under applicable Laws have been submitted, except as, individually or in the aggregate, have not been, and are not reasonably expected to be, material to the Company Disclosure Letter and its Subsidiaries, taken as a whole. (c) Schedule 3.24(c) sets forth a true and complete list of all Regulatory Authorizations authorizations, approvals, applications, clearances, consents, qualifications and other rights from the FDA with respect and all other applicable Governmental Authorities relating to the Company’s product candidates currently in effectability of the Company and its Subsidiaries to research, manufacture, package or market the Company Product, including Abbreviated New Drug Applications (“Regulatory Authorizations”) and there are no other material Regulatory Authorizations required for the Company Product in connection with the conduct of the Company’s business as currently conducted. All such Regulatory Authorizations owned by the Company are are, in all material respects, (i) in full force and effect and the Company has not received written notice from any Governmental Entity or third Person that any such Regulatory Authorization is subject to any adverse action, (ii) validly registered and on file with applicable Regulatory Authorities, Authorities and (iiiii) in compliance with all formal filing and maintenance requirements and (iv) in good standing, valid and enforceable, except, in the case of each of the foregoing clauses (i) – (iv), as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (c) To the knowledge of the Company, the clinical trials conducted by or on behalf of the Company (which, for the avoidance of doubt, shall not include investigator-sponsored clinical trials) were, and if still pending, are, being conducted in all material respects in accordance with all applicable clinical trial protocols, informed consents and applicable requirements of the FDA, including, as applicable, the FDA’s good clinical practices and good laboratory practices regulationsrequirements. (d) The Company is There are no, and have not subject been within the last five (5) years any, inspection observations, warning or untitled letters, notices pursuant to any investigation that is pending or, 21 U.S.C. Section 305 or similar documents issued to the knowledge Company or its Subsidiaries, nor any manufacturing site which assists in the manufacture of the Company Product which has been threatenedis owned or operated by the Company or any of its Subsidiaries, in connection with any or to the Knowledge of the Company’s product candidates, including the Products. (e) Since January 1, 2007, that of a contract manufacturer for the Company has complied Product at any facility where the Company Product is tested, produced, processed, packaged or stored, that assert a material lack of compliance with any applicable Laws or regulatory requirements. Without limiting the foregoing, within the past five (5) years, except as set forth in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, including the regulations promulgated thereunder (collectively “HIPAA”Schedule 3.24(d), and (iiA) there have been no product warnings with respect to the Company Product (other applicable state privacy laws. (f) Since January 1than warnings detailed on or in the packaging for the Company Product), 2007notifications or safety alerts conducted or issued by the Company or its Subsidiaries, all material reports, applications, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other applicable Regulatory Authority by Authorities or otherwise with respect to the Company have been so filed, maintained Product manufactured or furnished. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (purchased or were corrected in or supplemented marketed by a subsequent filing). Neither the Company nor, to the knowledge of the Company, any officer, employee or agent and none of the Company, foregoing has made an untrue statement of a material fact been requested or a fraudulent statement to demanded by the FDA or any other applicable Regulatory Authority, Authorities; and (B) neither the Company or failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, with respect to the Products. Neither the Company, nor, to the knowledge of the Company, any current officer, employee, or agent of the Company, its Subsidiaries has been convicted of of, charged with, or investigated for, any crime or engaged in any conduct for which such Person could would reasonably be excluded from participating expected to result in criminal liability, debarment or disqualification by the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, FDA or any similar Lawother applicable Regulatory Authority. (ge) The Company has not and its Subsidiaries have made available to Buyer accurate summaries or complete copies of all material serious adverse event reports, and periodic adverse event reports that have been received by the Company or any of its Subsidiaries during the previous five (5) years with respect to the Company Product, or the previous two (2) years with respect to any other product of the Company. (f) Within the past five (5) years, neither the Company nor any of its Subsidiaries have received any written notices, correspondence notice or other written communication from the FDA or any other Regulatory Authority since January 1, 2007 requiring Governmental Entity contesting the termination, suspension pre-market clearance or material modification of any clinical trials conducted by, or on behalf approval of, the uses of or the labeling and promotion of the Company Product, or within the previous two (2) years, any other product of the Company. Within the past five (5) years, no manufacturing site which assists in the manufacture of the Company Product which is owned or operated by the Company or in which the Company has participated. To the extent that the Company any of its Subsidiaries, or, to the knowledge Knowledge of the Company, any that of its clinical trial sites have received FDA483 notices or untitled or warning letters since January 1a contract manufacturer for the Company Product, 2007, this correspondence has been made available for review by Parentsubject to a Governmental Entity (including FDA) shutdown or import or export prohibition. (hg) The Company has made available for review by Parent complete and accurate copies Within the past five (5) years, there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of all action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product, or seizures ordered or adverse regulatory actions taken (i) investigational new drug applications submitted or, to the FDA or any other Regulatory Authority by or on behalf Knowledge of the Company, including any supplements thereto, (iithreatened) correspondence to or from the FDA or any other Regulatory Authority, including meeting minutes and records of material contracts and (iii) documents in the Company’s possession related to inspections by the FDA or any other applicable Regulatory AuthorityAuthority with respect to the Company Product, in case of each or within the previous two (2) years, any other product of the foregoing clauses (i) – (iii)Company, relating or any facilities where any such Company Product is tested, produced, processed, packaged or stored which are owned or operated by the Company or any of its Subsidiaries, or to the ProductsKnowledge of the Company, by a third party.