FDA Regulatory Compliance. (a) Since January 1, 2009, the Company and its Subsidiaries have complied in all material respects with all applicable provisions of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. § 301 et. seq., as amended from time to time, and all applicable regulations promulgated thereunder by the FDA (collectively, “FDA Law and Regulation”), and analogous provisions of foreign Law governing the conduct of the Business. (b) In the past five (5) years, neither the Company nor any Subsidiary nor to the Company’s Knowledge, any manufacturer of the Company’s products has received any written (or, to the Company’s Knowledge, oral) notice or communication from the FDA alleging noncompliance with any applicable FDA Law and Regulation, or any notice from any other Governmental Authority with respect to analogous provision of foreign Law governing the regulation of the Company’s products or the Business. The Company and its Subsidiaries are not now subject (and have not been subject at any time during the previous five (5) years) to any civil, criminal or administrative action, suit, claim, complaint, hearing, demand letter, warning letter, untitled letter, proceeding, inspection, finding, recall, investigation, penalty assessment, audit or other compliance or enforcement, regulatory or administrative proceedings by the FDA, and to the Company’s Knowledge, no review or investigation has been Threatened against the Company or any Subsidiary or any of the manufacturers of the Company’s products for failure to comply with any FDA Law and Regulation or analogous provision of foreign Law governing the regulation of the Company’s products or the Business. None of the Company or any Subsidiary or any of their respective officers or directors, or, to the Company’s Knowledge, any of their respective employees, has been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a. (c) The Company and its Subsidiaries have obtained all necessary clearances and authorizations from the FDA and other Governmental Authorities for their current and past Business activities, including the commercial distribution of any products that are regulated by the FDA or other Governmental Authorities. Schedule 3.22(c) sets forth a list of all material regulatory registrations, clearances, and approvals issued under the FD&C Act (“FD&C Permits”) and held by the Company or any of its Subsidiaries. Each such FD&C Permit is in full force and effect and no suspension, revocation, cancellation or withdrawal of such FD&C Permit is pending or Threatened. (d) Since January 1, 2009, all human clinical trials have been conducted, monitored or organized by the Company and its Subsidiaries in material compliance with the applicable requirements of Good Clinical Practice, Informed Consent and all other applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54, 56, 58 and 812, and all other applicable foreign, state and local Laws. None of the Company or any Subsidiary has received any written (or, to the Company’s Knowledge, oral) notice that the FDA or any other Governmental Authority has initiated, or to the Company’s Knowledge, has Threatened to initiate, any action to (i) suspend or terminate any clinical trial conducted by the Company or any Subsidiary, or (ii) suspend or otherwise restrict the performance of clinical research by the Company or any Subsidiary. The Company, the Subsidiaries and, to the Company’s Knowledge, their respective contractors and agents have submitted to the applicable Governmental Authority, including the FDA, and any institutional review board, or accreditation body, all mandated material supplemental applications, notices, and annual or other reports and information, including adverse experience reports required to be submitted by such Person. (e) Since January 1, 2009, the Company and its Subsidiaries and, to the Company’s Knowledge, their respective contract manufacturers, have been in material compliance with, and each Company product regulated by FDA as a medical device in current commercial distribution is designed, manufactured, assembled, packaged, labeled, stored, and distributed in material compliance with, the Quality System Regulation set forth in 21 C.F.R. Part 820. (f) The Company and its Subsidiaries are in material compliance with the written procedures, record-keeping and FDA reporting requirements for Medical Device Reporting set forth in 21 C.F.R. Part 803 and Reports of Corrections and Removals set forth in 21 C.F.R. Part 806. To the Company’s Knowledge, there have been no adverse events involving the Company’s or any Subsidiary’s current products or the products the Company or any Subsidiary has under development (in-house or by the manufacturers of the Company’s products) of a type that are required to be reported to the FDA that have not been so reported. Any such adverse events have been specifically disclosed to Biomet and Parent in writing. To the Company’s Knowledge, the Company, its Subsidiaries and the manufacturers of the Company’s products have not received any information or report from the FDA, FDA personnel, or other Governmental Authority indicating that its products are unsafe or that the applicable Governmental Authorities will be unwilling to grant the necessary product approvals. (g) To the Company’s Knowledge, there are no safety or quality related issues regarding any of the Company’s products that are reasonably likely to result in a correction or removal of such product. (h) All of the Company’s FDA-regulated products are labeled, promoted, and advertised in material compliance with the scope of their cleared indications and FDA’s premarket notification requirements in 21 C.F.R. Part 807, Subpart A and E, 21 U.S.C. §360(l) or (m) and applicable rules and regulations thereunder. (i) Each facility of the Company or its Subsidiaries that is required to be registered with the FDA, and each Company product required to be listed with the FDA is so registered or listed with the FDA in material accordance with the regulations set forth in 21 C.F.R. Part 807. (j) None of the Company, any Subsidiary or, to the Company’s Knowledge, any contract manufacturer of the Company’s FDA-regulated products is (or has been at any time since January 1, 2009) subject to FDA’s Applications Integrity Policy. None of the Company or any Subsidiary or any of their respective directors or officers, or, to the Company’s Knowledge, their respective employees, has made, or caused the making of, any false statements on, or material omissions from, any FD&C Permits, applications, reports or other submissions to the FDA or any other Governmental Authority, or made any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Authority. The Company and its Subsidiaries, and, to the Company’s Knowledge, the manufacturers of the Company’s products, have not made or offered any payments, gratuities, or other things of value that are prohibited by any Law to personnel of the FDA or other Governmental Authorities.
Appears in 1 contract
Samples: Merger Agreement (Biomet Inc)
FDA Regulatory Compliance. (a) Since January 1, 2009, Except as set forth in Section 5.16(a) of the Company and its Subsidiaries have complied in all material respects with all applicable provisions Disclosure Schedule, each product of the Federal Company that is subject to the U.S. Food, Drug, Drug and Cosmetic Act (including the rules and regulations of the FDA promulgated thereunder, the “FD&C ActFDCA”) or comparable applicable Laws in any non-U.S. jurisdiction (each such product, a “Medical Device”), 21 U.S.C. § 301 et. seq.is being or has been developed, as amended from time manufactured, sold, licensed, imported for resale, tested, processed, labeled, stored, distributed and marketed in compliance, in all material respects, with all necessary Permits and other applicable requirements under the FDCA and comparable applicable Laws in any non-U.S. jurisdiction, including those relating to timepremarket clearance or approval, and all applicable regulations promulgated thereunder by the FDA establishment registration, device listing, quality system regulation, current Good Manufacturing Practices (collectively, “FDA Law and RegulationcGMP”), labeling, advertising, record keeping and analogous provisions filing of foreign Law governing the conduct of the Businessrequired reports.
(b) In the past five (5) yearsAll material reports, neither the Company nor any Subsidiary nor documents, claims, Permits and notices required to be filed, maintained or furnished with or to the Company’s Knowledge, any manufacturer of the Company’s products has received any written (or, to the Company’s Knowledge, oral) notice FDA or communication from the FDA alleging noncompliance with any applicable FDA Law and Regulation, or any notice from any other Governmental Authority with respect to analogous provision of foreign Law governing the regulation of the Company’s products or the Business. The Company and its Subsidiaries are not now subject (and have not been subject at any time during the previous five (5) years) to any civil, criminal or administrative action, suit, claim, complaint, hearing, demand letter, warning letter, untitled letter, proceeding, inspection, finding, recall, investigation, penalty assessment, audit or other compliance or enforcement, regulatory or administrative proceedings Entity by the FDACompany 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). All such reports, documents, claims, Permits and notices have been provided or made available to the Company’s Knowledge, no review or investigation has been Threatened against the Company or any Subsidiary or any of the manufacturers of the Company’s products for failure to comply with any FDA Law and Regulation or analogous provision of foreign Law governing the regulation of the Company’s products or the Business. None of the Company or any Subsidiary or any of their respective officers or directors, or, to the Company’s Knowledge, any of their respective employees, has been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335aParent.
(c) The Except as set forth in Section 5.16(c) of the Company and its Subsidiaries have obtained all necessary clearances and authorizations Disclosure Schedule, the Company has not received any FDA Form 483, notice of adverse finding, demand letters, warning letters, or other correspondence or notice from the FDA and FDA, or other Governmental Authorities for their current and past Business activitiesEntity (i) alleging or asserting noncompliance with any applicable Laws or Permits; or (ii) contesting the premarket clearance or approval of, including the commercial distribution uses of or the labeling or promotion of any products that are regulated Medical Device.
(d) Except as set forth in Section 5.16(d) of the Company Disclosure Schedule, the Permits issued to the Company by the FDA or any other Governmental Entity have not been limited, suspended, or revoked. No medical device report (or its counterpart in non-U.S. jurisdictions) with respect to any Medical Device has been reported by the Company to the FDA or other Governmental Entity, and to the knowledge of the Company, no medical device report (or its counterpart in non-U.S. jurisdictions) with respect to any Medical Device is under investigation by the FDA or other Governmental Authorities. Schedule 3.22(c) sets forth a list of all material regulatory registrations, clearances, and approvals issued under the FD&C Act (“FD&C Permits”) and held by the Company or any of its Subsidiaries. Each such FD&C Permit is in full force and effect and no suspension, revocation, cancellation or withdrawal of such FD&C Permit is pending or ThreatenedEntity.
(de) Since January 1, 2009, all human clinical trials have been conducted, monitored or organized by the Company and its Subsidiaries Except as set forth in material compliance with the applicable requirements of Good Clinical Practice, Informed Consent and all other applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54, 56, 58 and 812, and all other applicable foreign, state and local Laws. None Section 5.16(e) of the Company Disclosure Schedule, the Company has not voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any Subsidiary recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, or “dear doctor” letter relating to an alleged lack of safety, efficacy or regulatory compliance of any Medical Device.
(f) The Company has not received any written (or, to the Company’s Knowledge, oral) notice that the FDA or any other Governmental Authority Entity has initiated(i) commenced, or to the Company’s Knowledge, has Threatened threatened to initiate, any action to (i) suspend withdraw its premarket clearance or terminate premarket approval of any clinical trial conducted by the Company or any Subsidiary, or Medical Device; (ii) suspend or otherwise restrict requested the performance recall of clinical research by the Company or any Subsidiary. The Company, the Subsidiaries and, to the Company’s Knowledge, their respective contractors and agents have submitted to the applicable Governmental Authority, including the FDA, and any institutional review boardMedical Device; (iii) commenced, or accreditation bodythreatened to initiate, all mandated material supplemental applicationsany action to enjoin manufacture or distribution of any Medical Device; or (iv) commenced, noticesor threatened to initiate, and annual any action to enjoin the manufacture or other reports and information, including adverse experience reports required to be submitted by such Person.
(e) Since January 1, 2009, the Company and its Subsidiaries and, to the Company’s Knowledge, their respective contract manufacturers, have been in material compliance with, and each Company product regulated by FDA as a medical device in current commercial distribution of any Medical Device produced at any facility where any Medical Device is designed, manufactured, assembledtested, packagedprocessed, labeled, stored, and distributed in material compliance with, the Quality System Regulation set forth in 21 C.F.R. Part 820.
(f) The Company and its Subsidiaries are in material compliance with the written procedures, record-keeping and FDA reporting requirements packaged or held for Medical Device Reporting set forth in 21 C.F.R. Part 803 and Reports of Corrections and Removals set forth in 21 C.F.R. Part 806. To the Company’s Knowledge, there have been no adverse events involving the Company’s or any Subsidiary’s current products or the products the Company or any Subsidiary has under development (in-house or by the manufacturers of the Company’s products) of a type that are required to be reported to the FDA that have not been so reported. Any such adverse events have been specifically disclosed to Biomet and Parent in writing. To the Company’s Knowledge, the Company, its Subsidiaries and the manufacturers of the Company’s products have not received any information or report from the FDA, FDA personnel, or other Governmental Authority indicating that its products are unsafe or that the applicable Governmental Authorities will be unwilling to grant the necessary product approvalssale.
(g) To the Company’s Knowledgeknowledge, there are no safety or quality related issues regarding any of the Company’s products that are reasonably likely to result in a correction or removal of such product.
(h) All of the Company’s FDA-regulated products are labeled, promoted, and advertised in material compliance with the scope of their cleared indications and FDA’s premarket notification requirements in 21 C.F.R. Part 807, Subpart A and E, 21 U.S.C. §360(l) or (m) and applicable rules and regulations thereunder.
Company has not: (i) Each facility of employed in any capacity any individual who has been debarred pursuant to the Company FDCA; or its Subsidiaries (ii) committed any act, made any statement or failed to make any statement that is required to be registered with would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery and each Company product required to be listed with the FDA is so registered or listed with the FDA in material accordance with the regulations set forth in 21 C.F.R. Part 807.
Illegal Gratuities,” 56 Fed. Reg. 46191 (j) None of the CompanySeptember 10, any Subsidiary or1991), to the Company’s Knowledge, any contract manufacturer of the Company’s FDA-regulated products is (or has been at any time since January 1, 2009) subject to FDA’s Applications Integrity Policy. None of the Company or any Subsidiary similar laws, rules, regulations or any of their respective directors or officerspolicies, or, to whether under the Company’s Knowledge, their respective employees, has made, or caused the making of, any false statements on, or material omissions from, any FD&C Permits, applications, reports or other submissions to the FDA or any other Governmental Authority, or made any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements jurisdiction of the FDA or a similar entity in any other Governmental Authority. The Company jurisdiction, and its Subsidiaries, and, to the Company’s Knowledge, the manufacturers of the Company’s products, have not made or offered any payments, gratuities, amendments or other things of value that are prohibited by any Law to personnel of the FDA or other Governmental Authoritiesmodification thereto.
Appears in 1 contract
FDA Regulatory Compliance. (a) Since The Concentrates Business products are being or have, since January 13, 20092022, the Company been manufactured, tested, packaged, labeled, distributed, and its Subsidiaries have complied sold in compliance in all material respects with all applicable provisions of requirements under the Federal Food, Drug, Drug and Cosmetic Act (“FDCA”) and the regulations of the Food and Drug Administration (“FD&C ActFDA”), 21 U.S.C. § 301 et) promulgated thereunder and all other applicable Laws. seq., as amended from time Seller holds all authorizations required by applicable Laws to timeoperate the Concentrates Business, and all applicable regulations promulgated thereunder such authorizations are current and in full force and effect. Seller has made available to Purchaser true and complete copies of all material governmental correspondence (including copies of official notices, citations or decisions) in the files of Seller relating to such authorizations. Seller has made available to Purchaser true and 155815138v19 complete copies of all material governmental correspondence (including copies of official notices, citations or decisions) sent or received by Seller primarily related to the FDA (collectivelyConcentrates Business since January 3, “FDA Law and Regulation”), and analogous provisions of foreign Law governing the conduct of the Business2022.
(b) In All Permits required to be obtained from FDA for Seller to conduct the past five (5) years, neither Concentrates Business as currently conducted or for the Company nor any Subsidiary nor to the Company’s Knowledge, any manufacturer ownership and use of the Company’s Acquired Assets, in each case in all material respects, have been obtained by Seller and are valid and in full force and effect, and each of the Concentrates Business products has received any written (or, to the Company’s Knowledge, oral) notice or communication from the FDA alleging noncompliance with any applicable FDA Law and Regulation, or any notice from any other Governmental Authority with respect to analogous provision of foreign Law governing the regulation of the Company’s products or the Business. The Company and its Subsidiaries are not now subject (and have not been subject at any time during the previous five (5) years) to any civil, criminal or administrative action, suit, claim, complaint, hearing, demand letter, warning letter, untitled letter, proceeding, inspection, finding, recall, investigation, penalty assessment, audit or other compliance or enforcement, regulatory or administrative proceedings cleared by the FDA, and to the Company’s Knowledge, no review or investigation has been Threatened against the Company or any Subsidiary or any of the manufacturers of the Company’s products for failure to comply with any FDA Law and Regulation or analogous provision of foreign Law governing the regulation of the Company’s products or the Business. None of the Company or any Subsidiary or any of their respective officers or directors, or, to the Company’s Knowledge, any of their respective employees, has been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted extent required by 21 U.S.C. § 335aapplicable Law.
(c) The Company Since January 3, 2022, to Seller’s Knowledge, all applications, notifications, submissions, information, claims, reports and its Subsidiaries have obtained filings utilized as the basis for or submitted in connection with any and all requests for an authorization relating to a Concentrates Business product were true, accurate and complete in all material respects as of the date of submission. Since January 3, 2022, to Seller’s Knowledge, any necessary clearances and authorizations from the FDA or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other Governmental Authorities for their current and past Business activities, including the commercial distribution of any products that are regulated by the data have been submitted to FDA or other Governmental Authorities. Schedule 3.22(c) sets forth a list of Entity and as so updated, changed, corrected or modified remain true, accurate and complete in all material regulatory registrations, clearances, and approvals issued under the FD&C Act (“FD&C Permits”) and held by the Company or any of its Subsidiaries. Each such FD&C Permit is in full force and effect and no suspension, revocation, cancellation or withdrawal of such FD&C Permit is pending or Threatenedrespects.
(d) Since January 13, 20092022, all human clinical trials have been conducted, monitored or organized by the Company and its Subsidiaries in material compliance with the applicable requirements of Good Clinical Practice, Informed Consent and all other applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54, 56, 58 and 812, and all other applicable foreign, state and local Laws. None of the Company or any Subsidiary Seller has not received any written (or, to the Company’s Knowledge, oral) notice that the communication from FDA or any other Governmental Authority has initiated, or to the Company’s Knowledge, has Threatened to initiate, any action to (i) suspend or terminate any clinical trial conducted by the Company or any Subsidiary, or (ii) suspend or otherwise restrict the performance of clinical research by the Company or any Subsidiary. The Company, the Subsidiaries and, to the Company’s Knowledge, their respective contractors and agents have submitted to the applicable Governmental AuthorityEntity, including without limitation any warning letter or untitled letter that alleges or suggests that the FDA, and Concentrates Business is not in compliance with any institutional review board, applicable requirements under the FDCA or accreditation body, all mandated material supplemental applications, notices, and annual or other reports and information, including adverse experience reports required to be submitted by such Personthe FDA regulations promulgated thereunder.
(e) Since January 1, 2009, the Company and its Subsidiaries and, to the Company’s Knowledge, their respective contract manufacturers, have been in material compliance with, and each Company product regulated by FDA as a medical device in current commercial distribution is designed, manufactured, assembled, packaged, labeled, stored, and distributed in material compliance with, the Quality System Regulation set forth in 21 C.F.R. Part 820.
(f) The Company and its Subsidiaries are in material compliance with the written procedures, record-keeping and FDA reporting requirements for Medical Device Reporting set forth in 21 C.F.R. Part 803 and Reports of Corrections and Removals set forth in 21 C.F.R. Part 806. To the Company’s Knowledge, there have been no adverse events involving the Company’s or any Subsidiary’s current products or the products the Company or any Subsidiary has under development (in-house or by the manufacturers of the Company’s products) of a type that are required to be reported to the FDA that have not been so reported. Any such adverse events have been specifically disclosed to Biomet and Parent in writing. To the Company’s Knowledge, the Company, its Subsidiaries and the manufacturers of the Company’s products have not received any information or report from the FDA, FDA personnel, or other Governmental Authority indicating that its products are unsafe or that the applicable Governmental Authorities will be unwilling to grant the necessary product approvals.
(g) To the CompanySeller’s Knowledge, there are no safety Claims or quality related issues regarding any of the Company’s products that are reasonably likely to result in a correction Legal Proceedings pending or removal of such product.
(h) All of the Company’s FDA-regulated products are labeledthreatened, promoted, and advertised in material compliance with the scope of their cleared indications and FDA’s premarket notification requirements in 21 C.F.R. Part 807, Subpart A and E, 21 U.S.C. §360(l) or (m) and applicable rules and regulations thereunder.
(i) Each facility of the Company or its Subsidiaries that is required to be registered with the FDA, and each Company product required to be listed with the FDA is so registered or listed with the FDA in material accordance with the regulations set forth in 21 C.F.R. Part 807.
(j) None of the Company, any Subsidiary or, against Seller relating to the Company’s KnowledgeConcentrates Business products, any contract manufacturer of the Company’s FDA-regulated products is (including those relating to or has been at any time since January 1arising under applicable Law relating to government health care plans, 2009) subject to FDA’s Applications Integrity Policy. None of the Company or any Subsidiary or any of their respective directors or officers, or, to the Company’s Knowledge, their respective employees, has madeprivate health care plans, or caused the making of, any false statements on, or material omissions from, any FD&C Permits, applications, reports or other submissions to the FDA or any other Governmental Authority, or made any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements privacy and confidentiality of the FDA or any other Governmental Authority. The Company and its Subsidiaries, and, to the Company’s Knowledge, the manufacturers of the Company’s products, have not made or offered any payments, gratuities, or other things of value that are prohibited by any Law to personnel of the FDA or other Governmental Authoritiespatient health information.
Appears in 1 contract
FDA Regulatory Compliance. (a) Since January 1, 2009, the Company and its Subsidiaries have complied Except as disclosed in all material respects with all applicable provisions Section 2.27(a)(i) of the Federal Sellers Disclosure Schedule, each Statcorp Product subject to the U.S. Food, Drug, Drug and Cosmetic Act (including the rules and regulations of the FDA promulgated thereunder, the “FD&C ActFDA”), 21 U.S.C. § 301 et. seq.Canadian Medical Devices Regulation (“CMDR”) SOR 98-282, as amended from time to timeMedical Devices Directive (“MDD”) 93/42/ECC, or comparable applicable Laws and all applicable regulations promulgated thereunder by the FDA Regulations in any non-U.S. jurisdiction (collectivelyeach such product, a “FDA Law and RegulationMedical Device”), is being or has been developed, manufactured, sold, licensed, imported for resale, tested, processed, labeled, stored, distributed and analogous provisions marketed in material compliance with all necessary Permits and other applicable requirements under the FDA, CMDR, MDD and comparable laws in any non-U.S. jurisdiction, including those relating to premarket clearance or approval, establishment registration, device listing, quality system regulation, good manufacturing practices, labeling, advertising, record keeping and filing of foreign Law governing required reports. All applicable technical files have been established and maintained and are in material compliance with the conduct regulations. Section 2.27(a)(ii) of the BusinessSellers Disclosure Schedule lists the Seller’s 510(k) notifications and pre-market approval applications (“PMAs”) for the Statcorp Products and Services, including Medical Devices. All of Statcorp Products and Services, including Medical Devices, in commercial distribution which are marketed without such approvals or under a Letter to File basis are listed on Schedule 2.27(a)(iii) of the Sellers Disclosure Schedule, together with a statement describing the reasons why such products do not require formal market clearance. Sellers are in compliance with all applicable requirements of the FDA, CMDR and MDD relating to the maintenance of technical, clinical and other data generated prior to the Closing Date by Sellers with respect to Medical Devices.
(b) In Except as set forth in Section 2.27(b) of the past five (5) yearsSellers Disclosure Schedule, neither the Company nor any Subsidiary nor to the Company’s Knowledgeall product issues, incidents and complaints have been suitably investigated, documented and managed, any manufacturer of the Company’s products has received any written (or, to the Company’s Knowledge, oral) notice applicable problem or communication from the FDA alleging noncompliance with any applicable FDA Law and Regulation, or any notice from any other Governmental Authority with respect to analogous provision of foreign Law governing the regulation of the Company’s products or the Business. The Company and its Subsidiaries are not now subject (and vigilance reports have not been subject at any time during the previous five (5) years) to any civil, criminal or administrative action, suit, claim, complaint, hearing, demand letter, warning letter, untitled letter, proceeding, inspection, finding, recall, investigation, penalty assessment, audit or other compliance or enforcement, regulatory or administrative proceedings by the FDAfiled, and to the Company’s Knowledge, no review or investigation has any necessary recalls have been Threatened against the Company or any Subsidiary or any of the manufacturers of the Company’s products for failure to comply with any FDA Law and Regulation or analogous provision of foreign Law governing the regulation of the Company’s products or the Business. None of the Company or any Subsidiary or any of their respective officers or directors, or, to the Company’s Knowledge, any of their respective employees, has been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335afully implemented.
(c) The Company Section 2.27(c) of the Sellers Disclosure Schedule identifies all internal audit reports (as required by 21 CFR Section 820.20) conducted by Sellers relating to the Business since January 1, 2004.
(d) In Sellers’ reasonable judgment after due investigation, all reports, documents, claims, Permits and its Subsidiaries notices required to be filed, maintained or furnished with or to the FDA or any other Governmental Entity by Sellers for the Business have obtained been so filed, maintained or furnished. All such reports, documents, claims, Permits and notices were complete and accurate in all necessary clearances material respects on the date filed (or were corrected in or supplemented by a subsequent filing). All such reports, documents, claims, Permits and authorizations notices have been provided or made available to Buyer.
(e) Except as disclosed in Section 2.27(e) of the Sellers Disclosure Schedule, Sellers have not received any FDA Form 483, notice of adverse finding, demand letters, warning letters, untitled letters or other correspondence or notice from the FDA and FDA, or other Governmental Authorities for their current Entity, (i) with respect to the Business alleging or asserting noncompliance with any applicable Laws and past Business activitiesRegulations or Permits; or (ii) contesting the premarket clearance or approval of, the uses of or the labeling or promotion of any Statcorp Products and Services, including Medical Devices.
(f) No Permit issued to Seller with respect to the commercial distribution Business by the FDA or any other Governmental Entity has been limited, suspended, or revoked. Except as disclosed in Section 2.27(f) of the Sellers Disclosure Schedule, no medical device report (or its counterpart in non-U.S. jurisdictions) with respect to any products that are regulated Statcorp Products and Services, including Medical Device, has been reported by Seller to the FDA or other Governmental Entity, and no medical device report (or its counterpart in non-U.S. jurisdictions) with respect to any Statcorp Products and Services, including Medical Devices, is under investigation by the FDA or other Governmental Authorities. Schedule 3.22(c) sets forth a list of all material regulatory registrations, clearances, and approvals issued under the FD&C Act (“FD&C Permits”) and held by the Company or any of its Subsidiaries. Each such FD&C Permit is in full force and effect and no suspension, revocation, cancellation or withdrawal of such FD&C Permit is pending or ThreatenedEntity.
(dg) Since January 1Except as disclosed in Section 2.27(g)(i) of the Sellers Disclosure Schedule, 2009Sellers have not voluntarily or involuntarily initiated, all human clinical trials have been conductedconducted or issued, monitored or organized by the Company and its Subsidiaries in material compliance with the applicable requirements of Good Clinical Practicecaused to be initiated, Informed Consent and all other applicable requirements conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, or “dear doctor” letter relating to protection an alleged lack of human subjects contained in 21 C.F.R. Parts 50safety, 54efficacy or regulatory compliance of any Statcorp Products and Services, 56, 58 and 812including Medical Device. Other than as set forth on Section 2.27(g)(ii) of the Sellers Disclosure Schedule, and all other applicable foreignafter having used reasonably diligent efforts to discover such facts, state Sellers and local Laws. None their consultants, agents and employees know of no facts which would cause or are reasonably likely to cause (i) the recall, market withdrawal or replacement of any Statcorp Products and Services, including Medical Devices; (ii) a change in the marketing classification or change in the labeling of any Statcorp Products and Services, including Medical Device, or (iii) a termination or suspension of the Company or marketing of any Subsidiary has Statcorp Products and Services, including Medical Devices.
(h) Except as disclosed in Section 2.27(h) of the Sellers Disclosure Schedule, Sellers have not received any written (or, to the Company’s Knowledge, oral) notice that the FDA or any other Governmental Authority Entity has initiated(i) commenced, or to the Company’s Knowledge, has Threatened threatened to initiate, any action to (i) suspend withdraw its premarket clearance or terminate premarket approval or request the recall of any clinical trial conducted by the Company or any SubsidiaryStatcorp Products and Services, or including Medical Devices, (ii) suspend commenced, or otherwise restrict the performance threatened to initiate, any action to enjoin manufacture or distribution of clinical research by the Company or any Subsidiary. The Company, the Subsidiaries and, to the Company’s Knowledge, their respective contractors Statcorp Products and agents have submitted to the applicable Governmental AuthorityServices, including the FDA, and any institutional review boardMedical Devices or (iii) commenced, or accreditation bodythreatened to initiate, all mandated material supplemental applications, notices, any action to enjoin the manufacture or distribution of any Statcorp Products and annual or other reports and informationServices, including adverse experience reports required to be submitted by such Person.
(e) Since January 1Medical Devices, 2009produced at any facility where any Statcorp Products and Services, the Company and its Subsidiaries andincluding Medical Devices, to the Company’s Knowledge, their respective contract manufacturers, have been in material compliance with, and each Company product regulated by FDA as a medical device in current commercial distribution is designed, manufactured, assembledtested, packagedprocessed, labeledpackaged or held for sale or (iv) identified any Statcorp Products and Services, storedincluding Medical Devices, and distributed in material compliance with, the Quality System Regulation set forth in 21 C.F.R. Part 820.
(f) The Company and its Subsidiaries are in material non-compliance with the written proceduresreporting, record-keeping registration, labeling, good manufacturing practices, advertising and FDA reporting other requirements for Medical Device Reporting set forth in 21 C.F.R. Part 803 and Reports of Corrections and Removals set forth in 21 C.F.R. Part 806. To the Company’s Knowledge, there have been no adverse events involving the Company’s or any Subsidiary’s current products or the products the Company or any Subsidiary has under development (in-house or by the manufacturers of the Company’s products) of a type that are required to be reported to the FDA that have not been so reported. Any such adverse events have been specifically disclosed to Biomet and Parent in writing. To the Company’s Knowledge, the Company, its Subsidiaries and the manufacturers or regulations of the Company’s products have not received any information or report from the FDA, FDA personnel, or other Governmental Authority indicating that its products are unsafe or that the applicable Governmental Authorities will be unwilling to grant the necessary product approvals.
(g) To the Company’s Knowledge, there are no safety or quality related issues regarding any of the Company’s products that are reasonably likely to result in a correction or removal of such product.
(h) All of the Company’s FDA-regulated products are labeled, promoted, and advertised in material compliance with the scope of their cleared indications and FDA’s premarket notification requirements in 21 C.F.R. Part 807, Subpart A and E, 21 U.S.C. §360(l) or (m) and applicable rules and regulations thereunderEntity.
(i) Each facility Sellers have not, with respect to the Business: (i) employed in any capacity any individual who has been debarred pursuant to the FDA; or (ii) committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities,” 56 Fed. Reg. 46191 (September 10, 1991), or any similar laws, rules, regulations or policies, whether under the jurisdiction of the Company FDA or its Subsidiaries that is required to be registered with the FDA, and each Company product required to be listed with the FDA is so registered or listed with the FDA a similar entity in material accordance with the regulations set forth in 21 C.F.R. Part 807any other jurisdiction.
(j) None The Sellers have performed all of its services in connection with the CompanyBusiness in a manner consistent with, any Subsidiary oror in a manner that permits those to whom it provides services to perform in a manner consistent with, all Federal, state and local requirements applicable to the Company’s Knowledgeconduct of clinical and nonclinical trials, any contract manufacturer and the submission of applications for the Company’s FDA-regulated products is (or has been at any time since January 1approval of products, 2009) subject to FDA’s Applications Integrity Policy. None of the Company or any Subsidiary or any of their respective directors or officersincluding but not limited to, or, to the Company’s Knowledge, their respective employees, has made, or caused the making of, any false statements on, or material omissions from, any FD&C Permits, applications, reports or other submissions to the FDA or any other Governmental Authority, or made any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Authority. The Company Federal Food Drug and Cosmetic Act and its Subsidiariesimplementing regulations, andparticularly those found in 21 CFR Parts 50 (Protection of human subjects), 54 (Financial disclosure by clinical investigators), 56 (Institutional review boards), 58 (Good laboratory practice for nonclinical laboratory studies), 312 (Investigational new drug application) 314 (Applications for FDA approval to market a new drug), all requirements applicable to the Company’s Knowledgeconduct of Good Clinical Practices, the manufacturers International Conference on Harmonization of the Company’s products, have not made or offered any payments, gratuities, or Technical Requirements for Registration of Pharmaceuticals for Human Use and all other things of value that are prohibited by any Law to personnel of the FDA or other Governmental Authoritiessimilar international requirements.
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