Common use of FDA Matters Clause in Contracts

FDA Matters. (a) Seller and each Divesting Entity is, and at all times since January 1, 2021 has been, in compliance Seller and each Divesting Entity is, and at 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 the terms of all necessary Governmental Authorizations, including, without limitation, approvals, clearances, exemptions, licenses and other authorizations, (ii) current Good Manufacturing Practices (“cGMP”), (iii) establishment registration and product listing, (iv) labeling, promotion, and advertising, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”), (vi) the Drug Supply Chain Security Act (“DSCSA”), (vii) payment of all application, product and establishment fees, and (viii) recordkeeping and reporting requirements other than those applicable to cGMP, GCP, GLP and DSCSA. (b) Neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business in the Relevant Jurisdictions) has received any written notice or written communication from any Governmental Authority of any actual or threatened investigation, inquiry, or administrative or regulatory action, hearing, or enforcement proceeding against Seller or any Divesting Entity regarding any material violation of FDA Laws and Regulations. [***], neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business in the Relevant Jurisdictions) is 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, FDA Form 483, notice of violation letter, consent decree, request for information or other notice, response, or commitment made to or with any Governmental Authority with respect to FDA Laws and Regulations, and no such material obligation has been threatened in writing. (c) [***], there is no product liability, civil, or criminal 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 Products or the Business) that involves or arises from a material violation of FDA Laws or Regulations, and neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business) has any known material liability for failure to comply with any FDA Laws and Regulations. [***], there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or lead to any such action, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information or any such material liability.

FDA Matters. (a) Seller and each Divesting Entity Except as set forth on Schedule 3.22, Parent is, and at all times since January 1, 2021 has beento Parent’s knowledge Parent’s agents are, in compliance Seller and each Divesting Entity is, and at all times since January 1, 2021 has been, in compliance with all FDA Laws and Regulations, in all material respects including but not limited 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, other foreign governmental authority (i“Foreign Authorities”) with respect to the requirement for and the terms manufacture, collection, record keeping, reporting of all necessary Governmental Authorizationsadverse events, filing of reports, labeling, storing, testing, or distribution of Parent’s products, including, without limitation, approvalsParent’s investigational gene therapy products (the “Parent Products”). Parent has, clearancesand to Parent’s knowledge Parent’s Agents have, exemptionsadhered to, licenses and other authorizationsin all material respects, (ii) applicable regulations in the manufacture of Parent’s products, including current Good Manufacturing Practices (Practice, or CGMP, regulations, and, “cGMP”)Good Clinical Practice,” regulations “Informed Consent” and “Institutional Review Board” regulations, (iii) establishment and all applicable requirements relating to the protection of human subjects for its clinical trials as required by the FDA and any applicable corresponding requirements of the Foreign Authorities. Parent has all requisite FDA and Foreign Authorities permits, approvals, registration, licenses or the like to conduct Parent’s business as it is currently conducted. Parent has previously delivered or made available to the Company an index of all applications, approvals, registration or licenses obtained by Parent from the FDA or Foreign Authorities or required in connection with the conduct of Parent’s business as it is currently conducted, and has made all such information available to the Company. Parent is in compliance with all applicable registration and product listinglisting requirements set forth in the U.S. Food, (iv) labelingDrug & Cosmetic Act, promotion21 U.S.C. 360 and all similar applicable laws and regulations, and advertisingexcept for noncompliance which, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”)individually or in the aggregate, (vi) the Drug Supply Chain Security Act (“DSCSA”), (vii) payment of all application, product and establishment fees, and (viii) recordkeeping and reporting requirements other than those applicable would not reasonably be expected to cGMP, GCP, GLP and DSCSAhave a Material Adverse Effect on Parent. (b) Neither Seller nor any Divesting Entity (with respect Parent has made available to the Purchased AssetsCompany all written communications and oral communications reduced to written form between Parent and the FDA or Foreign Authorities. Parent shall promptly deliver or make available to the Company copies of all written communications and information and records regarding all oral communications reduced to written form or otherwise recorded, between Parent 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 3.22, Parent 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 Parent Products or the Business in the Relevant Jurisdictions) has received any written notice or written communication from any Governmental Authority of any actual or threatened investigation, inquiry, or administrative or regulatory action, hearing, or enforcement proceeding against Seller or any Divesting Entity regarding any material violation of FDA Laws and Regulations. [***], neither Seller nor any Divesting Entity (with respect to the Purchased Assetsfacilities in which Parent Products are manufactured, collected or handled, by the Products FDA or Foreign Authorities. Except as set forth in Schedule 3.22, there are no pending or, to the Business in knowledge of Parent, threatened actions, proceedings or complaints by the Relevant Jurisdictions) FDA or Foreign Authorities which would prohibit or impede the conduct of Parent’s business as it is 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, FDA Form 483, notice of violation letter, consent decree, request for information or other notice, response, or commitment made to or with any Governmental Authority with respect to FDA Laws and Regulations, and no such material obligation has been threatened in writingcurrently conducted. (c) [***]Schedule 3.22 sets forth all Adverse Reaction Reports filed by Parent and Parent’s agents with the FDA and any applicable Foreign Authorities. (d) To the knowledge of Parent, there is no product liabilityParent has, civiland Parent’s agents have, not made any false statements on, or criminal actionomissions from, suitthe applications, proceedingapprovals, 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 reports and other submissions to the Purchased Assets, the Products FDA or the Business) that involves Foreign Authorities or arises in or from a material violation of FDA Laws any other records and documentation prepared or Regulations, and neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business) has any known material liability for failure maintained to comply with the requirements of the FDA or Foreign Authorities relating to Parent Products that would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on Parent. (e) Parent has not received any notification, written or oral, that remains unresolved, from the FDA, Foreign Authorities, or other authorities indicating that any Parent 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 Parent Product has been recalled, suspended or discontinued as a result of any action by the FDA Laws and Regulations. [***]or any foreign authority, there is no by Parent or, to the knowledge of Parent, any licensee or distributor of any Parent Product, in the United States. (g) Parent has not committed any act, omission, event, made any statement or circumstance failed to make any statement that would reasonably be expected to give rise provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts; Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Additionally, neither Parent, nor to the knowledge of Parent any officer, key employee or lead agent of Parent has been convicted of any crime or engaged in any conduct that would reasonably be expected to any such action, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information result in (i) debarment under 21 U.S.C. Section 335a or any such material liabilitysimilar state law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation.

FDA Matters. (a) Seller and each Divesting Entity isNeither 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, and at all times since January 1, 2021 has been, in compliance Seller and each Divesting Entity is, and at 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 FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the terms regulations promulgated thereunder, or any corollary entity in any other jurisdiction. Each of the Company and each Company Subsidiary has obtained in the United States and in all necessary Governmental Authorizationscountries where it is currently marketing its products, includingall applicable material licenses, without limitationregistrations, approvals, clearancesconsents, exemptionsclearances and authorizations required by state or federal agencies in such countries regulating the safety, licenses effectiveness and other authorizationsmarket clearance of such products to sell, (ii) current Good Manufacturing Practices (“cGMP”), (iii) establishment registration promote and product listing, (iv) labeling, promotionmarket such products. Neither the Company nor any Company Subsidiary has received any notice of, and advertisingthe Company is not aware of, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”)any outstanding, (vi) the Drug Supply Chain Security Act (“DSCSA”)pending or overtly threatened actions, (vii) payment of all applicationcitations, decisions, product and establishment feesrecalls, and (viii) recordkeeping and reporting requirements 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 than those applicable to cGMP, GCP, GLP and DSCSAjurisdiction that are material or which the Company is not diligently contesting. (b) Neither Seller nor any Divesting Entity 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 Purchased Assetsdesign, manufacture, labeling, testing and inspection of all of its products and the Products or operation of manufacturing facilities promulgated by the Business in the Relevant Jurisdictions) has received any written notice or written communication from any Governmental Authority of any actual or threatened investigation, inquiry, or administrative or regulatory action, hearing, or enforcement proceeding against Seller FDA or any Divesting Entity regarding corollary entity in any material violation of FDA Laws and Regulations. [***], neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business in the Relevant Jurisdictions) is 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, FDA Form 483, notice of violation letter, consent decree, request for information or other notice, response, or commitment made to or with any Governmental Authority with respect to FDA Laws and Regulationsjurisdiction, and no (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 material obligation has been threatened in writingclinical trials. (c) [***]All of the Company's submissions to the FDA and any corollary entity in any other jurisdiction whether oral, there is no product liabilitywritten or electronically delivered were true, civilaccurate and complete in all material respects as of the date made, and together with any amendments to such submissions or supplemental information provided to the FDA or such other corollary entity, remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or criminal action, suit, proceeding, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against or relating omit to Seller or any Divesting Entity or to any of their employees (with respect to the Purchased Assets, the Products or the Business) that involves or arises from state a material violation of FDA Laws or Regulations, and neither Seller nor any Divesting Entity (with respect fact necessary to make the Purchased Assets, the Products or the Business) has any known material liability for failure to comply with any FDA Laws and Regulations. [***], there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or lead to any such action, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information or any such material liabilitystatements therein not misleading.

FDA Matters. (a) Seller Without limiting the generality of Section 7.06, Holdings and each Divesting Entity is, and at all times since January 1, 2021 has been, in compliance Seller and each Divesting Entity is, and at all times since January 1, 2021 has been, in compliance with all FDA Laws and Regulations, of its Subsidiaries shall comply in all material respects including but not limited with all applicable statutes, rules, regulations, standards, guides, policies or orders administered or issued by the FDA, and shall take all such actions as shall reasonably be necessary to (i) the requirement for and the terms of all necessary Governmental Authorizationsassure such compliance on an ongoing basis, including, without limitationlimitation (A) retaining an independent manufacturing practices consultant (should Holdings or any of its Subsidiaries believe it prudent to do so) to audit Holdings' and each of its Subsidiaries' manufacturing practices, approvals, clearances, exemptions, licenses and other authorizations, (ii) current taking all such reasonable remedial actions as any such consultant retained by Holdings or any of its Subsidiaries shall recommend with respect to any significant deviations from the FDA's Good Manufacturing Practices Regulations; (“cGMP”), (iiiB) establishment registration retaining experienced FDA counsel to advise Holdings and product listing, (iv) labeling, promotion, and advertising, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”), (vi) the Drug Supply Chain Security Act (“DSCSA”), (vii) payment of all application, product and establishment fees, its Subsidiaries on legal issues affecting such compliance; and (viiiC) recordkeeping requesting such FDA counsel (should Holdings or any of its Subsidiaries believe it prudent to do so) to audit Holdings' and each of its Subsidiaries' complaint and medical device reporting requirements files, or other than those applicable to cGMPareas regulated by the FDA, GCP, GLP on a periodic basis and DSCSAtaking all such remedial actions with respect thereto as such FDA counsel shall recommend. (b) Neither Seller nor any Divesting Entity (with respect Holdings will, and will cause each of its Subsidiaries to, report to the Purchased AssetsFDA all events that Holdings, any of its Subsidiaries or its counsel conclude are required to be reported to the Products FDA 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 threatened, relating to Holdings' or any of its Subsidiaries' medical device products. Holdings agrees to provide quarterly summaries to the Business in Agents regarding the Relevant Jurisdictionsregulatory status of Holdings' and each of its Subsidiaries' medical device products. Such summaries will contain information regarding the status of PMA and 510(k) has received any written notice submissions; the status of agency actions regarding such submissions (denial, withdrawal, etc.); the termination or written communication from any Governmental Authority suspension of marketing of any actual or threatened investigation, inquiry, or administrative or regulatory action, hearing, or enforcement proceeding against Seller of Holdings' or any Divesting Entity regarding any material violation of its Subsidiaries' medical device products; the results of FDA Laws inspections of Holdings' and Regulationseach of its Subsidiaries' manufacturing facilities; and the results of any internal inspections and audits conducted by Holdings or any of its Subsidiaries regarding its medical device products. [***], neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business in the Relevant Jurisdictions) is 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, FDA Form 483, notice of violation letter, consent decree, request for information or other notice, response, or commitment made to or with any Governmental Authority with respect to FDA Laws and RegulationsHoldings will, and no such material obligation has been threatened in writing. (c) [***]will cause each of its Subsidiaries to, there is no product liability, civil, or criminal action, suit, proceeding, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against or provide the Agents timely access to all available documentation relating to Seller or any Divesting Entity or to any of their employees (with respect to the Purchased Assets, the Products or the Business) that involves or arises from a material violation of FDA Laws or Regulations, and neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business) has any known material liability for failure to comply with any FDA Laws and Regulations. [***], there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or lead to any such action, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information or any such material liabilityforegoing information.

FDA Matters. (a) Seller and each Divesting Entity Except as set forth on Schedule 2.22(a), the Company is, and at all times since January 1, 2021 has beento the Company’s knowledge the Company’s agents are, in compliance Seller and each Divesting Entity is, and at all times since January 1, 2021 has been, in compliance with all FDA Laws and Regulations, in all material respects including but not limited 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, other foreign governmental authority (i“Foreign Authorities”) with respect to the requirement for and manufacture, collection, labeling, storing, testing, or distribution of the terms of all necessary Governmental AuthorizationsCompany’s products, including, without limitation, approvalsthe record keeping, clearancesreporting of adverse events, exemptionsfiling of reports, licenses Company’s investigational gene therapy products (the “Company Products”). The Company has, and other authorizationsto the Company’s knowledge the Company’s agents have, (ii) adhered to, in all material respects, applicable regulations in the manufacture of the Company’s products, including current Good Manufacturing Practices (Practice, or CGMP, regulations, and, “cGMP”)Good Clinical Practice,” regulations “Informed Consent” and “Institutional Review Board” regulations, (iii) establishment and all applicable requirements relating to the protection of human subjects for its clinical trials 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 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 Foreign Authorities or required in connection with the conduct of the Company’s business as it is currently conducted, and has made all such information available to Parent and Merger Sub. The Company is in compliance with all applicable registration and product listinglisting requirements set forth in the U.S. Food, (iv) labelingDrug & Cosmetic Act, promotion21 U.S.C. 360 and all similar applicable laws and regulations, and advertisingexcept for noncompliance which, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”)individually or in the aggregate, (vi) would not reasonably be expected to have a Material Adverse Effect on the Drug Supply Chain Security Act (“DSCSA”), (vii) payment of all application, product and establishment fees, and (viii) recordkeeping and reporting requirements other than those applicable to cGMP, GCP, GLP and DSCSACompany. (b) Neither Seller nor any Divesting Entity (with respect 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 all 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 Purchased AssetsEffective 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 the Business in the Relevant Jurisdictions) has received any written notice or written communication from any Governmental Authority of any actual or threatened investigation, inquiry, or administrative or regulatory action, hearing, or enforcement proceeding against Seller or any Divesting Entity regarding any material violation of FDA Laws and Regulations. [***], neither Seller nor any Divesting Entity (with respect to the Purchased Assetsfacilities in which the Company Products are manufactured, collected or handled, by the Products FDA or Foreign Authorities. Except as set forth in Schedule 2.22(a), there are no pending or, to the Business in the Relevant Jurisdictions) is subject to any material obligation arising under an investigation, inquiry, or administrative, regulatory or judicial action, hearing, or enforcement proceeding by or on behalf knowledge of the FDACompany, warning letterthreatened actions, untitled letter, proceedings or complaints by the FDA Form 483, notice or Foreign Authorities which would prohibit or impede the conduct of violation letter, consent decree, request for information or other notice, response, or commitment made to or with any Governmental Authority with respect to FDA Laws and Regulations, and no such material obligation has been threatened in writingthe Company’s business as it is currently conducted. (c) [***]Schedule 2.22(c) sets forth all Adverse Reaction Reports filed by the Company and the Company’s agents with the FDA and any applicable Foreign Authorities. (d) To the knowledge of the Company, there is no product liability, civilthe Company and the Company’s agents have not made any false statements on, or criminal actionomissions from, suitthe applications, proceedingapprovals, 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 reports and other submissions to the Purchased Assets, the Products FDA or the Business) that involves Foreign Authorities or arises in or from a material violation of FDA Laws any other records and documentation prepared or Regulations, and neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business) has any known material liability for failure maintained to comply with the requirements of the FDA or Foreign Authorities relating to Company Products that would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on the Company. (e) The Company has not received any notification, written or oral, that remains unresolved, from the FDA, Foreign Authorities, or other 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 Laws and Regulations. [***]or any foreign authority, there is no by the Company or, to the knowledge of the Company, any licensee or distributor of any Company Product, in the United States. (g) The Company has not committed any act, omission, event, made any statement or circumstance failed to make any statement that would reasonably be expected to give rise provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts; Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Additionally, neither the Company, nor to the knowledge of the Company any officer, key employee or lead agent of the Company has been convicted of any crime or engaged in any conduct that would reasonably be expected to any such action, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information result in (i) debarment under 21 U.S.C. Section 335a or any such material liabilitysimilar state law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation.

FDA Matters. (a) Seller Except as set forth on Section 3.27(a) of the Company Disclosure Schedule, the Company and each Divesting Entity is, and at all times since January 1, 2021 has been, its Subsidiaries are in compliance Seller and each Divesting Entity is, and at 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 with all applicable statutes, rules and regulations of U.S. Food and Drug Administration or similar federal, state or local governmental authority (ithe "FDA") the requirement for and the terms German Health Authority or other foreign governmental authority ("Foreign Authorities") with respect to the manufacture, collection, sale, labeling, storing, testing, distribution, or marketing of all necessary Governmental Authorizations, the Company's products (including, without limitation, the Company's surgical sealant products) being manufactured, distributed or developed by the Company and its Subsidiaries (the "Company Products"). The Company and its Subsidiaries adhere in all material respects to all applicable regulations (including "Quality System" regulations) in the manufacture of the Company's products and, as applicable, "Good Clinical Practices," "Informed Consent" and all applicable requirements relating to the protection of human subjects for its clinical trials as required by the FDA and any applicable corresponding requirements of the Foreign Authorities. The Company and its Subsidiaries have all requisite FDA and Foreign Authorities permits, approvals, clearances, exemptionsregistrations, licenses or the like to conduct Company's and other authorizationsits 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, (ii) current Good Manufacturing Practices (“cGMP”)approvals, (iii) establishment registrations or licenses obtained by the Company or its Subsidiaries from Foreign Authorities or the FDA or required in connection with the conduct of the Company's or its Subsidiaries' businesses as they are currently conducted and has made all such information available to Parent. The Company and its Subsidiaries are in compliance with all applicable registration and product listing, (iv) labeling, promotion, and advertising, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”), (vi) the Drug Supply Chain Security Act (“DSCSA”), (vii) payment of all application, product and establishment fees, and (viii) recordkeeping and reporting listing requirements other than those applicable to cGMP, GCP, GLP and DSCSA. (b) Neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business set forth in the Relevant Jurisdictions) has received any written notice U.S. Food, Drug & Cosmetic Act, 21 U.S.C. 360 and 21 C.F.R. Part 807 and all similar applicable laws, except for noncompliance which, individually or written communication from any Governmental Authority of any actual or threatened investigation, inquiry, or administrative or regulatory action, hearing, or enforcement proceeding against Seller or any Divesting Entity regarding any material violation of FDA Laws and Regulations. [***], neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business in the Relevant Jurisdictions) is subject to any material obligation arising under an investigationaggregate, inquiry, or administrative, regulatory or judicial action, hearing, or enforcement proceeding by or on behalf of the 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 Governmental Authority with respect to FDA Laws and Regulations, and no such material obligation has been threatened in writing. (c) [***], there is no product liability, civil, or criminal 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 Products or the Business) that involves or arises from a material violation of FDA Laws or Regulations, and neither Seller nor any Divesting Entity (with respect to the Purchased Assets, the Products or the Business) has any known material liability for failure to comply with any FDA Laws and Regulations. [***], there is no act, omission, event, or circumstance that would not reasonably be expected to give rise to or lead to any such action, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information or any such material liabilityhave a Company Material Adverse Effect.