Common use of FDA Matters Clause in Contracts

FDA Matters. (a) The Company and each of its Subsidiaries has obtained or, to Seller’s Knowledge, reasonably believes that Company will be able to obtain through commercially reasonable means and efforts, in all material respects and to the extent applicable, all necessary approvals, clearances, authorizations, licenses and registrations required by the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activities, including, without limitation, pre-clinical testing, currently undertaken by the Company or each such Subsidiary, respectively, to date (the “Activities to Date”) in jurisdictions where the Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunder, (ii) regulations related to good laboratory practices and good clinical practices issued by the United States Food and Drug Administration (the “FDA”) and (iii) the U.S. Animal Welfare Act, the regulations issued thereunder, and any similar federal, state, and foreign statutes and regulations. The Company is substantially in compliance with all applicable and material reporting requirements for all Regulatory Licenses. (b) None of Seller, the Company, the Company’s Subsidiaries or, to Seller’s Knowledge, any of their respective Affiliates have received any written notice or other written communication (or to Seller’s Knowledge, any oral notice or other oral communication) from the FDA or any other Governmental Authority (i) contesting the premarket approval of, the uses of or the labeling and promotion of any product including, without limitation, those products currently under research or development by the Company or its Subsidiaries, or (ii) otherwise alleging any violation by the Company or its Subsidiaries of any law, regulation or other legal provision applicable to any such product. (c) Neither the Company nor any of its Subsidiaries nor, to Seller’s Knowledge, any officer, employee or Affiliate of the Company or any such Subsidiary has made an untrue statement of a material fact or fraudulent statement to the FDA or any other governmental authority performing similar functions or failed to disclose a material fact required to be disclosed to the FDA or such other governmental authority. (d) No clinical trials involving third party human subjects has been conducted by or on behalf of the Company or any of its Subsidiaries, except in government-approved trials in the jurisdictions where such trials would require approval. (e) The preclinical trials conducted by, on behalf of, or sponsored by, the Company or its Subsidiaries (or, to the extent conducted in connection with the Business, the Company’s or its Subsidiaries’ respective Affiliates) were and, to the extent still pending, are being, conducted in accordance with all applicable FDA rules and regulations in all material respects. To Seller’s Knowledge, neither the Company nor any of its Subsidiaries has received any written notices or correspondence, or oral communications, from the FDA or any other governmental authority exercising comparable authority requiring or requesting the termination, suspension or material modification of any such study, test or trial.

FDA Matters. (a) The Company Seller is, and each of its Subsidiaries at all times has obtained or, to Seller’s Knowledge, reasonably believes that Company will be able to obtain through commercially reasonable means and effortsbeen, in material compliance with all material respects applicable FDA Laws and Regulations including but not limited to (i) the extent applicable, requirement for and the terms of all necessary approvals, clearances, authorizations, licenses and registrations required by the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activitiesGovernmental Approvals, including, without limitation, pre-clinical testingapprovals, currently undertaken by the Company or each such Subsidiaryclearances, respectivelyexemptions, to date (the “Activities to Date”) in jurisdictions where the Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company licenses and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunderother authorizations, (ii) regulations related to good laboratory practices current Good Manufacturing Practices (“cGMP”), (iii) establishment registration and good clinical practices issued by the United States Food product listing, (iv) labeling, promotion, and Drug Administration advertising, (the v) Good Clinical Practices (“FDAGCP”) and Good Laboratory Practices (iii“GLP”), (vi) the U.S. Animal Welfare Actpayment of all application, the regulations issued thereunderproduct and establishment fees, and any similar federal(vii) recordkeeping and reporting requirements other than those applicable to cGMP, stateGCP, and foreign statutes GLP. Without limiting the generality of the foregoing, in each case, with respect to the Business and regulationsTransferred Assets: (a) Seller has not received any written notice or communication from any Governmental Authority of any actual or threatened investigation, inquiry, or administrative or regulatory action, hearing, or enforcement proceeding against Seller regarding any material violation of FDA Laws and Regulations. The Company Seller is substantially in compliance not subject to any material obligation arising under an investigation, inquiry, or administrative, regulatory or judicial action, hearing, or enforcement proceeding by or on behalf of the FDA, warning letter, untitled letter, Form FDA-483, notice of violation letter, consent decree, request for information or other notice, response, or commitment made to or with all applicable any Governmental Authority with respect to FDA Laws and Regulations, and no such material reporting requirements for all Regulatory Licensesobligation has been threatened. (b) None of SellerThere is no product liability, the Companycivil, the Company’s Subsidiaries oror criminal action, suit, proceeding, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against or relating to Seller’s Knowledge, Seller or to any of their respective Affiliates have received employees that involves or arises from a material violation of FDA Laws and Regulations, and Seller has no material liability for failure to comply with any written notice or other written communication (or to FDA Laws and Regulations. To Seller’s Knowledgeknowledge, any oral notice or other oral communication) from the FDA or any other Governmental Authority (i) contesting the premarket approval ofthere is no act, the uses of or the labeling and promotion of any product includingomission, without limitation, those products currently under research or development by the Company or its Subsidiariesevent, or (ii) otherwise alleging any violation by the Company circumstance that would reasonably be expected to give rise to or its Subsidiaries of any law, regulation or other legal provision applicable lead to any such productaction, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information or any such material liability. (c) Neither There has not been any violation of any FDA Laws and Regulations by Seller in the Company nor any of its Subsidiaries norproduct development efforts, submissions, production, marketing, distribution, labeling, record keeping and mandatory reports to FDA that could reasonably be expected to require or lead to investigation, corrective action or enforcement, regulatory or administrative action or proceedings relating to Seller’s Knowledge, any officer, employee or Affiliate of the Company or nor has there been any such Subsidiary has made an untrue statement of a material fact or fraudulent statement to the FDA or any other governmental authority performing similar functions or failed to disclose a material fact required to be disclosed to the FDA or such other governmental authorityviolation. (d) No clinical trials involving third party human subjects Product has been conducted seized, withdrawn, recalled, detained, or subject to a suspension of research, manufacturing, or distribution, activity by or on behalf of a Governmental Authority. No Action in the Company United States or any other jurisdiction seeking the withdrawal, recall, revocation, suspension, import refusal, or seizure of its Subsidiaries, except in government-approved trials in the jurisdictions where such trials would require approvalany Product are pending or threatened against Seller. (e) The preclinical trials conducted by, on behalf ofSeller conducts and has conducted, or sponsored byengaged with a third party to conduct clinical trials in all material respects in accordance with the applicable principles set forth in the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (E6) and FDA GCP requirements, the Company including institutional research board-approved study protocols, valid informed consent, monitoring and auditing plans, adverse event reporting proper documentation, and valid data collection and reporting procedures. (f) No officer or its Subsidiaries (employee or, to the extent conducted Seller’s knowledge, agent of Seller is, has been, or has been threatened to be: (a) debarred under FDA proceedings under 21 U.S.C. § 335a; (b) disqualified under FDA investigator disqualification proceedings; (c) subject to FDA’s Application Integrity Policy; (d) subject to any enforcement proceeding arising from material false statements to FDA pursuant to 18 U.S.C. § 1001; (e) debarred, excluded or suspended from participating in any “federal health care program” as defined in 42 U.S.C. § 1320a-7b(f); (f) subject to a civil monetary penalty assessed under 42 U.S.C. § 1320a-7a, sanctioned, indicted or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any “federal health care program” requirement or Applicable Law; (g) listed on the BusinessGeneral Services Administrative published list of parties excluded from federal procurement programs and non-procurement programs; (h) debarred, the Company’s or its Subsidiaries’ respective Affiliates) were andexcluded, to the extent still pending, are being, conducted in accordance with all applicable FDA rules and regulations in all material respects. To Seller’s Knowledge, neither the Company nor any of its Subsidiaries has received any written notices or correspondencesuspended, or oral communicationsproposed in writing for debarment from receiving government contracts in any country, from including the FDA U.S. pursuant to 48 C.F.R. Subpart 9.4; or any other governmental authority exercising comparable authority requiring or requesting (i) subject to a civil monetary penalty assessed under Section 1128A of the termination, suspension or material modification of any such study, test or trialSocial Security Act.

FDA Matters. (a) The Company and each of its Subsidiaries has obtained or, to Seller’s Knowledge, reasonably believes that Company will be able to obtain through commercially reasonable means and efforts, in all material respects and to the extent applicable, all necessary approvals, clearances, authorizations, licenses and registrations required by the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activities, including, without limitation, pre-clinical testing, currently undertaken by the Company or each such Subsidiary, respectively, to date (the “Activities to Date”) in jurisdictions where the Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunder, (ii) regulations related to good laboratory practices and good clinical practices issued by the United States Food and Drug Administration (the “FDA”) and (iii) the U.S. Animal Welfare Act, the regulations issued thereunder, and any similar federal, state, and foreign statutes and regulations. The Company is substantially in compliance with all applicable and material reporting requirements for all Regulatory Licenses. (b) None of Seller, the Company, the Company’s Subsidiaries or, to Seller’s Knowledge, any of their respective Affiliates have received any written notice or other written communication (or to Seller’s Knowledge, any oral notice or other oral communication) from the FDA or any other Governmental Authority (i) contesting the premarket approval of, the uses of or the labeling and promotion of any product including, without limitation, those products currently under research or development by the Company or its Subsidiaries, or (ii) otherwise alleging any violation by the Company or its Subsidiaries of any law, regulation or other legal provision applicable to any such product. (c) Neither the Company nor any Company Subsidiary has sold any products anywhere in the world prior to receiving any required or necessary approvals or consents from any Governmental Authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of its Subsidiaries nor1976, to Seller’s Knowledgeas amended, and the regulations promulgated thereunder, or any officer, employee or Affiliate corollary entity in any other jurisdiction. Each of the Company or any such and each Company Subsidiary has made an untrue statement obtained in the United States and in all countries where it is currently marketing its products, all applicable material licenses, registrations, approvals, consents, clearances and authorizations required by state or federal agencies in such countries regulating the safety, effectiveness and market clearance of a such products to sell, promote and market such products. Neither the Company nor any Company Subsidiary has received any notice of, and the Company is not aware of, any outstanding, pending or overtly threatened actions, citations, decisions, product recalls, medical device reports, information requests, warning letters or Section 305 notices from the FDA or similar issues or notifications from any corollary entity in any other jurisdiction that are material fact or fraudulent statement which the Company is not diligently contesting. (b) Except as set forth on Schedule 3.20(b) hereto, each of the Company and each Company Subsidiary has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the design, manufacture, labeling, testing and inspection of all of its products and the operation of manufacturing facilities promulgated by the FDA or any corollary entity in any other governmental authority performing similar functions jurisdiction, and (ii) conducted all of its clinical trials with reasonable care and in accordance with all applicable laws in all material respects and in accordance with the stated protocols for such clinical trials. (c) All of the Company's submissions to the FDA and any corollary entity in any other jurisdiction whether oral, written or failed electronically delivered were true, accurate and complete in all material respects as of the date made, and together with any amendments to disclose a material fact required to be disclosed such submissions or supplemental information provided to the FDA or such other governmental authority. (d) No clinical trials involving third party human subjects has been conducted by or on behalf of the Company or any of its Subsidiariescorollary entity, except in government-approved trials in the jurisdictions where such trials would require approval. (e) The preclinical trials conducted byremain true, on behalf of, or sponsored by, the Company or its Subsidiaries (or, to the extent conducted in connection with the Business, the Company’s or its Subsidiaries’ respective Affiliates) were and, to the extent still pending, are being, conducted in accordance with all applicable FDA rules accurate and regulations complete in all material respects. To Seller’s Knowledgerespects as of the date hereof, neither the Company nor and do not materially misstate any of its Subsidiaries has received any written notices the statements or correspondenceinformation included therein, or oral communications, from omit to state a material fact necessary to make the FDA or any other governmental authority exercising comparable authority requiring or requesting the termination, suspension or material modification of any such study, test or trialstatements therein not misleading.

FDA Matters. (a) The Except as set forth on Schedule 2.22(a), the Company is, and each of its Subsidiaries has obtained orto the Company’s knowledge the Company’s agents are, to Seller’s Knowledge, reasonably believes that Company will be able to obtain through commercially reasonable means and efforts, in compliance in all material respects with all applicable statutes, rules and regulations of the U.S. Food and Drug Administration or similar federal, state or local governmental authority (the “FDA”) and, to the extent applicable, all necessary approvalsother foreign governmental authority (“Foreign Authorities”) with respect to the manufacture, clearancescollection, authorizationslabeling, licenses and registrations required by storing, testing, or distribution of the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activitiesCompany’s products, including, without limitation, pre-the record keeping, reporting of adverse events, filing of reports, Company’s investigational gene therapy products (the “Company Products”). The Company has, and to the Company’s knowledge the Company’s agents have, adhered to, in all material respects, applicable regulations in the manufacture of the Company’s products, including current Good Manufacturing Practice, or CGMP, regulations, and, “Good Clinical Practice,” regulations “Informed Consent” and “Institutional Review Board” regulations, and all applicable requirements relating to the protection of human subjects for its clinical testingtrials as required by the FDA and any applicable corresponding requirements of the Foreign Authorities. The Company has all requisite FDA and Foreign Authorities permits, approvals, registration, licenses or the like to conduct Company’s business as it is currently undertaken conducted. The Company has previously delivered or made available to Parent and Merger Sub an index of all applications, approvals, registration or licenses obtained by the Company from the FDA or each such Subsidiary, respectively, to date (Foreign Authorities or required in connection with the “Activities to Date”) in jurisdictions where conduct of the Company or such Subsidiaries Company’s business as it is currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunder, (ii) regulations related to good laboratory practices and good clinical practices issued by the United States Food and Drug Administration (the “FDA”) and (iii) the U.S. Animal Welfare Act, the regulations issued thereunderconducted, and any similar federal, state, has made all such information available to Parent and foreign statutes and regulationsMerger Sub. The Company is substantially in compliance with all applicable registration and material reporting listing requirements set forth in the U.S. Food, Drug & Cosmetic Act, 21 U.S.C. 360 and all similar applicable laws and regulations, except for all Regulatory Licensesnoncompliance which, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect on the Company. (b) None The Company has made available to Parent and Merger Sub all written communications and oral communications reduced to written form between the Company and the FDA or Foreign Authorities. The Company shall promptly deliver or make available to Parent copies of Sellerall written communications and information and records regarding all oral communications reduced to written form or otherwise recorded, between the Company and the FDA or Foreign Authorities from the date hereof through the Effective Time, but in no event shall such delivery take place later than one day prior to the Effective Time. Except as described in Schedule 2.22(a), the Company is not in receipt of notice of, and not subject to, any adverse inspection, finding of deficiency, finding of non-compliance, notices of adverse findings, warning letters, compelled or voluntary recall, investigation, penalty for corrective or remedial action or other compliance or enforcement action, in each case relating to any Company Products or to the facilities in which the Company Products are manufactured, collected or handled, by the FDA or Foreign Authorities. Except as set forth in Schedule 2.22(a), there are no pending or, to the knowledge of the Company, threatened actions, proceedings or complaints by the FDA or Foreign Authorities which would prohibit or impede the conduct of the Company’s Subsidiaries or, to Seller’s Knowledge, any of their respective Affiliates have received any written notice or other written communication (or to Seller’s Knowledge, any oral notice or other oral communication) from the FDA or any other Governmental Authority (i) contesting the premarket approval of, the uses of or the labeling and promotion of any product including, without limitation, those products business as it is currently under research or development by the Company or its Subsidiaries, or (ii) otherwise alleging any violation by the Company or its Subsidiaries of any law, regulation or other legal provision applicable to any such productconducted. (c) Neither Schedule 2.22(c) sets forth all Adverse Reaction Reports filed by the Company nor any of its Subsidiaries nor, to Sellerand the Company’s Knowledge, any officer, employee or Affiliate of the Company or any such Subsidiary has made an untrue statement of a material fact or fraudulent statement to agents with the FDA or and any other governmental authority performing similar functions or failed to disclose a material fact required to be disclosed to the FDA or such other governmental authorityapplicable Foreign Authorities. (d) No clinical trials involving third party human subjects has been conducted by or on behalf To the knowledge of the Company, the Company and the Company’s agents have not made any false statements on, or omissions from, the applications, approvals, reports and other submissions to the FDA or Foreign Authorities or in or from any other records and documentation prepared or maintained to comply with the requirements of its Subsidiariesthe FDA or Foreign Authorities relating to Company Products that would, except in government-approved trials individually or in the jurisdictions where such trials would require approvalaggregate, reasonably be expected to have a Material Adverse Effect on the Company. (e) The preclinical trials conducted byCompany has not received any notification, on behalf ofwritten or oral, that remains unresolved, from the FDA, Foreign Authorities, or sponsored byother authorities indicating that any Company Product is misbranded or adulterated as defined in the U.S. Food, Drug & Cosmetic Act, 21 U.S.C. 321, et seq., as amended, and the rules and regulations promulgated thereunder. (f) No Company Product has been recalled, suspended or discontinued as a result of any action by the FDA or any foreign authority, by the Company or its Subsidiaries (or, to the extent conducted in connection with the Business, knowledge of the Company’s , any licensee or distributor of any Company Product, in the United States. (g) 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 to invoke its Subsidiaries’ respective Affiliatespolicy with respect to “Fraud, Untrue Statements of Material Facts; Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) were and, to the extent still pending, are being, conducted in accordance with all applicable FDA rules and regulations in all material respectsany amendments thereto. To Seller’s KnowledgeAdditionally, neither the Company, nor to the knowledge of the Company nor any officer, key employee or agent of its Subsidiaries the Company has received been convicted of any written notices crime or correspondence, or oral communications, from the FDA engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any other governmental authority exercising comparable authority requiring similar state law or requesting the termination, suspension regulation or material modification of (ii) exclusion under 42 U.S.C. Section 1320a-7 or any such study, test similar state law or trialregulation.

FDA Matters. (a) The Except as set forth on Section 3.27(a) of the Company Disclosure Schedule, the Company and each of its Subsidiaries has obtained or, to Seller’s Knowledge, reasonably believes that Company will be able to obtain through commercially reasonable means and efforts, are in compliance in all material respects with all applicable statutes, rules and regulations of U.S. Food and Drug Administration or similar federal, state or local governmental authority (the "FDA") and the German Health Authority or other foreign governmental authority ("Foreign Authorities") with respect to the extent applicablemanufacture, all necessary approvalscollection, clearancessale, authorizationslabeling, licenses and registrations required by storing, testing, distribution, or marketing of the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activities, Company's products (including, without limitation, pre-clinical testingthe Company's surgical sealant products) being manufactured, currently undertaken distributed or developed by the Company or each such Subsidiary, respectively, to date and its Subsidiaries (the “Activities to Date”) in jurisdictions where the "Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”Products"). To Seller’s Knowledge, the Company and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunder, (ii) regulations related to good laboratory practices and good clinical practices issued by the United States Food and Drug Administration (the “FDA”) and (iii) the U.S. Animal Welfare Act, the regulations issued thereunder, and any similar federal, state, and foreign statutes and regulations. The Company is substantially and its Subsidiaries adhere in compliance with all material respects to all applicable and material reporting requirements for all Regulatory Licenses. regulations (bincluding "Quality System" regulations) None in the manufacture of Seller, the Company's products and, as applicable, "Good Clinical Practices," "Informed Consent" and all applicable requirements relating to the Company’s Subsidiaries or, to Seller’s Knowledge, any protection of their respective Affiliates have received any written notice or other written communication (or to Seller’s Knowledge, any oral notice or other oral communication) from human subjects for its clinical trials as required by the FDA or and any other Governmental Authority (i) contesting applicable corresponding requirements of the premarket approval ofForeign Authorities. The Company and its Subsidiaries have all requisite FDA and Foreign Authorities permits, the uses of approvals, registrations, licenses or the labeling like to conduct Company's and promotion of any product including, without limitation, those products currently under research or development by the Company or its Subsidiaries' business as it is currently conducted. The Company and its Subsidiaries have previously delivered or made available to Parent an index of all applications, approvals, registrations or (ii) otherwise alleging any violation licenses obtained by the Company or its Subsidiaries of any law, regulation from Foreign Authorities or other legal provision applicable to any such product. (c) Neither the Company nor any of its Subsidiaries nor, to Seller’s Knowledge, any officer, employee or Affiliate of the Company or any such Subsidiary has made an untrue statement of a material fact or fraudulent statement to the FDA or any other governmental authority performing similar functions or failed to disclose a material fact required to be disclosed to the FDA or such other governmental authority. (d) No clinical trials involving third party human subjects has been conducted by or on behalf of the Company or any of its Subsidiaries, except in government-approved trials in the jurisdictions where such trials would require approval. (e) The preclinical trials conducted by, on behalf of, or sponsored by, the Company or its Subsidiaries (or, to the extent conducted in connection with the Business, conduct of the Company’s 's or its Subsidiaries’ respective Affiliates) were and, ' businesses as they are currently conducted and has made all such information available to the extent still pending, Parent. The Company and its Subsidiaries are being, conducted in accordance compliance with all applicable FDA rules registration and regulations listing requirements set forth in the U.S. Food, Drug & Cosmetic Act, 21 U.S.C. 360 and 21 C.F.R. Part 807 and all material respects. To Seller’s Knowledgesimilar applicable laws, neither except for noncompliance which, individually or in the aggregate, would not reasonably be expected to have a Company nor any of its Subsidiaries has received any written notices or correspondence, or oral communications, from the FDA or any other governmental authority exercising comparable authority requiring or requesting the termination, suspension or material modification of any such study, test or trialMaterial Adverse Effect.

FDA Matters. (a) The Company Seller has not tested, manufactured, distributed or sold any products or services relating to the Business prior to receiving any required or materially necessary approvals or consents from any federal or state Governmental Entity, including but not limited to the Food and each Drug Administration (“FDA”) under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any other jurisdiction. Seller has obtained, in all countries where it is marketing the products and services of the Business, all applicable material Permits required by any Governmental Entity to sell, promote and market such products and services. Seller has not received any notice of, nor is Seller aware of, any actions, citations, decisions, product recalls, medical device reports, information requests, warning letters or Section 305 notices from the FDA or similar issues regulated by the FDA or any corollary entity in any other jurisdiction relating to the Business. (b) Seller has complied in all material respects with all applicable Laws and Regulations with respect to the manufacture, design, sale, labeling, storing, testing, distribution, inspection, promotion and marketing of all of its Subsidiaries has obtained or, products and services relating to the Business and the operation of manufacturing facilities promulgated by the FDA or any corollary entity in any other jurisdiction. To Seller’s Knowledgeknowledge, reasonably believes that Company will be able there have been no adverse events with respect to obtain through commercially reasonable means any patients in connection with any clinical trials in which Seller has participated or been involved relating to the Business. (c) All submissions made by Seller relating to the Business to the FDA and effortsany corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and to the extent applicable, all necessary approvals, clearances, authorizations, licenses and registrations required by the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activities, including, without limitation, pre-clinical testing, currently undertaken by the Company or each such Subsidiary, respectively, to date (the “Activities to Date”) in jurisdictions where the Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunder, (ii) regulations related to good laboratory practices and good clinical practices issued by the United States Food and Drug Administration (the “FDA”) and (iii) the U.S. Animal Welfare Act, the regulations issued thereunder, and any similar federal, state, and foreign statutes and regulations. The Company is substantially in compliance with all applicable and material reporting requirements for all Regulatory Licenses. (b) None of Seller, the Company, the Company’s Subsidiaries or, to Seller’s Knowledge, do not materially misstate any of their respective Affiliates have received any written notice the statements or other written communication (or to Seller’s Knowledge, any oral notice or other oral communication) from the FDA or any other Governmental Authority (i) contesting the premarket approval of, the uses of or the labeling and promotion of any product including, without limitation, those products currently under research or development by the Company or its Subsidiariesinformation included therein, or (ii) otherwise alleging any violation by the Company or its Subsidiaries of any law, regulation or other legal provision applicable omit to any such product. (c) Neither the Company nor any of its Subsidiaries nor, to Seller’s Knowledge, any officer, employee or Affiliate of the Company or any such Subsidiary has made an untrue statement of state a material fact or fraudulent statement necessary to make the FDA or any other governmental authority performing similar functions or failed to disclose a material fact required to be disclosed to the FDA or such other governmental authoritystatements therein not misleading. (d) No clinical trials involving third party human subjects has been conducted by or on behalf of the Company or any of its Subsidiaries, except in government-approved trials in the jurisdictions where such trials would require approval. (e) The preclinical trials conducted by, on behalf of, or sponsored by, the Company or its Subsidiaries (or, to the extent conducted in connection with the Business, the Company’s or its Subsidiaries’ respective Affiliates) were and, to the extent still pending, are being, conducted in accordance with all applicable FDA rules and regulations in all material respects. To Seller’s Knowledge, neither the Company nor any of its Subsidiaries has received any written notices or correspondence, or oral communications, from the FDA or any other governmental authority exercising comparable authority requiring or requesting the termination, suspension or material modification of any such study, test or trial.

FDA Matters. (a) The Company Seller and each of its Subsidiaries Divesting Entity is, and at all times since January 1, 2021 has obtained orbeen, to Seller’s Knowledgein compliance Seller and each Divesting Entity is, reasonably believes that Company will be able to obtain through commercially reasonable means and effortsat all times since January 1, 2021 has been, in compliance with all FDA Laws and Regulations, in all material respects including but not limited to (i) the requirement for and to the extent applicable, terms of all necessary approvals, clearances, authorizations, licenses and registrations required by the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activitiesGovernmental Authorizations, including, without limitation, pre-clinical testingapprovals, currently undertaken by the Company or each such Subsidiaryclearances, respectivelyexemptions, to date (the “Activities to Date”) in jurisdictions where the Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company licenses and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunderother authorizations, (ii) regulations related to good laboratory practices current Good Manufacturing Practices (“cGMP”), (iii) establishment registration and good clinical practices issued by the United States Food product listing, (iv) labeling, promotion, and Drug Administration advertising, (the v) Good Clinical Practices (“FDAGCP”) and Good Laboratory Practices (iii“GLP”), (vi) the U.S. Animal Welfare ActDrug Supply Chain Security Act (“DSCSA”), the regulations issued thereunder(vii) payment of all application, product and establishment fees, and any similar federal, state, (viii) recordkeeping and foreign statutes and regulations. The Company is substantially in compliance with all applicable and material reporting requirements for all Regulatory Licensesother than those applicable to cGMP, GCP, GLP and DSCSA. (b) None of SellerNeither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Company, Products or the Company’s Subsidiaries or, to Seller’s Knowledge, any of their respective Affiliates have Business in the Relevant Jurisdictions) has received any written notice or other written communication (from any Governmental Authority of any actual or to Seller’s Knowledgethreatened investigation, any oral notice inquiry, or other oral communication) from the FDA administrative or regulatory action, hearing, or enforcement proceeding against Seller or any other Governmental Authority Divesting Entity regarding any material violation of FDA Laws and Regulations. [***], neither Seller nor any Divesting Entity (i) contesting with respect to the premarket approval ofPurchased Assets, the uses of Products or the labeling and promotion of Business in the Relevant Jurisdictions) is subject to any product includingmaterial obligation arising under an investigation, without limitation, those products currently under research or development by the Company or its Subsidiariesinquiry, or (ii) otherwise alleging any violation by the Company administrative, regulatory or its Subsidiaries of any lawjudicial action, regulation hearing, or other legal provision applicable to any such product. (c) Neither the Company nor any of its Subsidiaries nor, to Seller’s Knowledge, any officer, employee or Affiliate of the Company or any such Subsidiary has made an untrue statement of a material fact or fraudulent statement to the FDA or any other governmental authority performing similar functions or failed to disclose a material fact required to be disclosed to the FDA or such other governmental authority. (d) No clinical trials involving third party human subjects has been conducted enforcement proceeding by or on behalf of the Company FDA, warning letter, untitled letter, FDA Form 483, notice of violation letter, consent decree, request for information or other notice, response, or commitment made to or with any of its SubsidiariesGovernmental Authority with respect to FDA Laws and Regulations, except and no such material obligation has been threatened in government-approved trials in the jurisdictions where such trials would require approvalwriting. (ec) The preclinical trials conducted by[***], on behalf ofthere is no product liability, civil, or sponsored bycriminal action, suit, proceeding, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against or relating to Seller or any Divesting Entity or to any of their employees (with respect to the Purchased Assets, the Company Products or its Subsidiaries the Business) that involves or arises from a material violation of FDA Laws or Regulations, and neither Seller nor any Divesting Entity (or, with respect to the extent conducted in connection with Purchased Assets, the Products or the Business) has any known material liability for failure to comply with any FDA Laws and Regulations. [***], the Company’s or its Subsidiaries’ respective Affiliates) were andthere is no act, to the extent still pendingomission, are being, conducted in accordance with all applicable FDA rules and regulations in all material respects. To Seller’s Knowledge, neither the Company nor any of its Subsidiaries has received any written notices or correspondenceevent, or oral communicationscircumstance that would reasonably be expected to give rise to or lead to any such action, from the FDA suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information or any other governmental authority exercising comparable authority requiring or requesting the termination, suspension or such material modification of any such study, test or trialliability.

FDA Matters. (a) The Company Without limiting the generality of Section 7.06, Holdings and each of its Subsidiaries has obtained or, to Seller’s Knowledge, reasonably believes that Company will be able to obtain through commercially reasonable means and efforts, shall comply in all material respects and to the extent applicablewith all applicable statutes, all necessary approvalsrules, clearancesregulations, authorizationsstandards, licenses and registrations required guides, policies or orders administered or issued by the United States Federal government FDA, and its agencies and approvals, clearances, authorizations, licenses and registrations required by shall take all other governmental authorities, such actions as shall reasonably be necessary to permit the activitiesassure such compliance on an ongoing basis, including, without limitation, pre-clinical testing, currently undertaken by the Company limitation (A) retaining an independent manufacturing practices consultant (should Holdings or each such Subsidiary, respectively, any of its Subsidiaries believe it prudent to date (the “Activities do so) to Date”) in jurisdictions where the Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company audit Holdings' and each of its Subsidiaries' manufacturing practices, and taking all such reasonable remedial actions as any such consultant retained by Holdings or any of its Subsidiaries is substantially in compliance shall recommend with all material terms respect to any significant deviations from the FDA's Good Manufacturing Practices Regulations; (B) retaining experienced FDA counsel to advise Holdings and conditions its Subsidiaries on legal issues affecting such compliance; and (C) requesting such FDA counsel (should Holdings or any of its Subsidiaries believe it prudent to do so) to audit Holdings' and each applicable Regulatory License of its Subsidiaries' complaint and with all applicable and material lawsmedical device reporting files, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunder, (ii) regulations related to good laboratory practices and good clinical practices issued or other areas regulated by the United States Food FDA, on a periodic basis and Drug Administration (the “FDA”) and (iii) the U.S. Animal Welfare Act, the regulations issued thereunder, and any similar federal, state, and foreign statutes and regulations. The Company is substantially in compliance taking all such remedial actions with all applicable and material reporting requirements for all Regulatory Licensesrespect thereto as such FDA counsel shall recommend. (b) None Holdings will, and will cause each of Sellerits Subsidiaries to, the Company, the Company’s Subsidiaries or, report to Seller’s Knowledge, any of their respective Affiliates have received any written notice or other written communication (or to Seller’s Knowledge, any oral notice or other oral communication) from the FDA or any other Governmental Authority (i) contesting the premarket approval ofall events that Holdings, the uses of or the labeling and promotion of any product including, without limitation, those products currently under research or development by the Company or its Subsidiaries, or (ii) otherwise alleging any violation by the Company or its Subsidiaries of any law, regulation or other legal provision applicable to any such product. (c) Neither the Company nor any of its Subsidiaries nor, or its counsel conclude are required to Seller’s Knowledge, any officer, employee or Affiliate of the Company or any such Subsidiary has made an untrue statement of a material fact or fraudulent statement be reported to the FDA or any other governmental authority performing similar functions or failed to disclose a material fact required to be disclosed under the FDA's medical device reporting regulations and shall furnish promptly to the Agents copies of all notices of adverse findings (including 485 observations and establishment inspection reports), regulatory letters, Section 305 Notices, recalls and FDA regulatory actions filed or such other governmental authority. (d) No clinical trials involving third party human subjects has been conducted by or on behalf of the Company threatened, relating to Holdings' or any of its Subsidiaries, except in government-approved trials in the jurisdictions where such trials would require approval. (e) The preclinical trials conducted by, on behalf of, or sponsored by, the Company or its Subsidiaries (or, ' medical device products. Holdings agrees to provide quarterly summaries to the extent conducted in connection with Agents regarding the Business, the Company’s or regulatory status of Holdings' and each of its Subsidiaries’ respective Affiliates' medical device products. Such summaries will contain information regarding the status of PMA and 510(k) were andsubmissions; the status of agency actions regarding such submissions (denial, to withdrawal, etc.); the extent still pending, are being, termination or suspension of marketing of any of Holdings' or any of its Subsidiaries' medical device products; the results of FDA inspections of Holdings' and each of its Subsidiaries' manufacturing facilities; and the results of any internal inspections and audits conducted in accordance with all applicable FDA rules and regulations in all material respects. To Seller’s Knowledge, neither the Company nor by Holdings or any of its Subsidiaries has received regarding its medical device products. Holdings will, and will cause each of its Subsidiaries to, provide the Agents timely access to all available documentation relating to any written notices or correspondence, or oral communications, from of the FDA or any other governmental authority exercising comparable authority requiring or requesting the termination, suspension or material modification of any such study, test or trialforegoing information.

FDA Matters. (a) The Neither the Company nor the Subsidiary has sold any products anywhere in the world prior to receiving any required or necessary approvals or consents from any Governmental Authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any other jurisdiction. Except as set forth on Schedule 3.20(a) hereto, each of the Company and each Subsidiary has obtained in the United States and in all countries where it is currently marketing its products, all applicable licenses, registrations, approvals, consents, clearances and authorizations required by local, state or federal agencies in such countries regulating the safety, effectiveness and market clearance of such products to sell, promote and market such products. Neither the Company nor the Subsidiary has received any notice of, and the Company is not aware of, any outstanding, pending or threatened actions, citations, decisions, product recalls, medical device reports, information requests, warning letters or Section 305 notices from the FDA or similar issues or notifications from any corollary entity in any other jurisdiction. (b) Except as set forth on Schedule 3.20(b) hereto, each of the Company and each Subsidiary has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the design, manufacture, labeling, testing and inspection of all of its Subsidiaries has obtained orproducts and the operation of manufacturing facilities promulgated by the FDA or any corollary entity in any other jurisdiction, to Seller’s Knowledge, reasonably believes that Company will be able to obtain through commercially and (ii) conducted all of its clinical trials with reasonable means care and efforts, in accordance with all applicable laws in all material respects and to in accordance with the extent applicable, all necessary approvals, clearances, authorizations, licenses and registrations required by the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activities, including, without limitation, pre-stated protocols for such clinical testing, currently undertaken by the Company or each such Subsidiary, respectively, to date (the “Activities to Date”) in jurisdictions where the Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Federal Food, Drug and Cosmetic Act and regulations issued thereunder, (ii) regulations related to good laboratory practices and good clinical practices issued by the United States Food and Drug Administration (the “FDA”) and (iii) the U.S. Animal Welfare Act, the regulations issued thereunder, and any similar federal, state, and foreign statutes and regulations. The Company is substantially in compliance with all applicable and material reporting requirements for all Regulatory Licenses. (b) None of Seller, the Company, the Company’s Subsidiaries or, to Seller’s Knowledge, any of their respective Affiliates have received any written notice or other written communication (or to Seller’s Knowledge, any oral notice or other oral communication) from the FDA or any other Governmental Authority (i) contesting the premarket approval of, the uses of or the labeling and promotion of any product including, without limitation, those products currently under research or development by the Company or its Subsidiaries, or (ii) otherwise alleging any violation by the Company or its Subsidiaries of any law, regulation or other legal provision applicable to any such producttrials. (c) Neither the Company nor any of its Subsidiaries nor, to Seller’s Knowledge, any officer, employee or Affiliate All of the Company or any such Subsidiary has made an untrue statement of a material fact or fraudulent statement Company's submissions to the FDA or and any corollary entity in any other governmental authority performing similar functions jurisdiction whether oral, written or failed electronically delivered were true, accurate and complete in all material respects as of the date made, and together with any amendments to disclose a material fact required to be disclosed such submissions or supplemental information provided to the FDA or such other governmental authority. (d) No clinical trials involving third party human subjects has been conducted by or on behalf of the Company or any of its Subsidiariescorollary entity, except in government-approved trials in the jurisdictions where such trials would require approval. (e) The preclinical trials conducted byremain true, on behalf of, or sponsored by, the Company or its Subsidiaries (or, to the extent conducted in connection with the Business, the Company’s or its Subsidiaries’ respective Affiliates) were and, to the extent still pending, are being, conducted in accordance with all applicable FDA rules accurate and regulations complete in all material respects. To Seller’s Knowledgerespects as of the date hereof, neither the Company nor and do not materially misstate any of its Subsidiaries has received any written notices the statements or correspondenceinformation included therein, or oral communications, from omit to state a material fact necessary to make the FDA or any other governmental authority exercising comparable authority requiring or requesting the termination, suspension or material modification of any such study, test or trialstatements therein not misleading.