Common use of FDA Regulatory Compliance Clause in Contracts

FDA Regulatory Compliance. (a) The Concentrates Business products are being or have, since January 3, 2022, been manufactured, tested, packaged, labeled, distributed, and sold in compliance in all material respects with all applicable requirements under the Federal Food, Drug and Cosmetic Act (“FDCA”) and the regulations of the Food and Drug Administration (“FDA”) promulgated thereunder and all other applicable Laws. Seller holds all authorizations required by applicable Laws to operate the Concentrates Business, and all 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 Concentrates Business since January 3, 2022. (b) All Permits required to be obtained from FDA for Seller to conduct the Concentrates Business as currently conducted or for the ownership and use of the 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 been cleared by the FDA, to the extent required by applicable Law. (c) Since January 3, 2022, to Seller’s Knowledge, all applications, notifications, submissions, information, claims, reports and 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 or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to FDA or other Governmental Entity and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects. (d) Since January 3, 2022, Seller has not received any written communication from FDA or any other Governmental Entity, including without limitation any warning letter or untitled letter that alleges or suggests that the Concentrates Business is not in compliance with any applicable requirements under the FDCA or the FDA regulations promulgated thereunder. (e) To Seller’s Knowledge, there are no Claims or Legal Proceedings pending or threatened, against Seller relating to the Concentrates Business products, including those relating to or arising under applicable Law relating to government health care plans, private health care plans, or the privacy and confidentiality of patient health information.

FDA Regulatory Compliance. (a) The Concentrates Business products are being or haveExcept as set forth in Section 5.16(a) of the Company Disclosure Schedule, since January 3, 2022, been manufactured, tested, packaged, labeled, distributed, and sold in compliance in all material respects with all applicable requirements under each product of the Federal Company that is subject to the U.S. Food, Drug and Cosmetic Act (including the rules and regulations of the FDA promulgated thereunder, the “FDCA”) or comparable applicable Laws in any non-U.S. jurisdiction (each such product, a “Medical Device”), is being or has been developed, 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 regulations of the Food FDCA and Drug Administration comparable applicable Laws in any non-U.S. jurisdiction, including those relating to premarket clearance or approval, establishment registration, device listing, quality system regulation, current Good Manufacturing Practices (“FDAcGMP”) promulgated thereunder ), labeling, advertising, record keeping and all other applicable Laws. Seller holds all authorizations filing of required by applicable Laws to operate the Concentrates Business, and all 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 Concentrates Business since January 3, 2022reports. (b) All material reports, documents, claims, Permits and notices required to be obtained from filed, maintained or furnished with or to the FDA for Seller to conduct or any other Governmental Entity by the Concentrates Business as currently conducted Company have been so filed, maintained or for the ownership furnished. All such reports, documents, claims, Permits and use of the Acquired Assets, in each case notices were complete and accurate in all material respectsrespects on the date filed (or were corrected in or supplemented by a subsequent filing). All such reports, documents, claims, Permits and notices have been obtained by Seller and are valid and in full force and effect, and each of the Concentrates Business products has been cleared by the FDA, provided or made available to the extent required by applicable LawParent. (c) Since January 3, 2022, to Seller’s Knowledge, all applications, notifications, submissions, information, claims, reports and filings utilized Except as the basis for or submitted set forth 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 Section 5.16(c) of the date Company Disclosure Schedule, the Company has not received any FDA Form 483, notice of submission. Since January 3adverse finding, 2022demand letters, to Seller’s Knowledgewarning letters, any necessary or required updatesother correspondence or notice from the FDA, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to FDA or other Governmental Entity and as so updated(i) alleging or asserting noncompliance with any applicable Laws or Permits; or (ii) contesting the premarket clearance or approval of, changed, corrected the uses of or modified remain true, accurate and complete in all material respectsthe labeling or promotion of any Medical Device. (d) Since January 3Except as set forth in Section 5.16(d) of the Company Disclosure Schedule, 2022the Permits issued to the Company by the FDA or any other Governmental Entity have not been limited, Seller 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 Entity. (e) Except as set forth in 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 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 communication from notice that the FDA or any other Governmental EntityEntity has (i) commenced, including without limitation or threatened to initiate, any warning letter action to withdraw its premarket clearance or untitled letter that alleges premarket approval of any Medical Device; (ii) requested the recall of any Medical Device; (iii) commenced, or suggests that threatened to initiate, any action to enjoin manufacture or distribution of any Medical Device; or (iv) commenced, or threatened to initiate, any action to enjoin the Concentrates Business manufacture or distribution of any Medical Device produced at any facility where any Medical Device is not in compliance with any applicable requirements under the FDCA manufactured, tested, processed, packaged or the FDA regulations promulgated thereunderheld for sale. (eg) To Sellerthe Company’s Knowledgeknowledge, there are no Claims or Legal Proceedings pending or threatened, against Seller relating the Company has not: (i) employed in any capacity any individual who has been debarred pursuant to the Concentrates Business productsFDCA; or (ii) committed any act, including those relating made any statement or failed to or arising under applicable Law relating make any statement that would breach the FDA’s policy with respect to government health care plans“Fraud, private health care plansUntrue 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 privacy jurisdiction of the FDA or a similar entity in any other jurisdiction, and confidentiality of patient health informationany amendments or other modification thereto.

FDA Regulatory Compliance. (a) The Concentrates Business products are being or haveExcept as disclosed in Section 2.27(a)(i) of the Sellers Disclosure Schedule, since January 3, 2022, been manufactured, tested, packaged, labeled, distributed, and sold in compliance in all material respects with all applicable requirements under each Statcorp Product subject to the Federal U.S. Food, Drug and Cosmetic Act (“FDCA”) including the rules and the regulations of the Food and Drug Administration (FDA promulgated thereunder, the “FDA”), Canadian Medical Devices Regulation (“CMDR”) promulgated thereunder SOR 98-282, Medical Devices Directive (“MDD”) 93/42/ECC, or comparable applicable Laws and Regulations in any non-U.S. jurisdiction (each such product, a “Medical Device”), is being or has been developed, manufactured, sold, licensed, imported for resale, tested, processed, labeled, stored, distributed and marketed in material compliance with all necessary Permits and other applicable Laws. Seller holds all authorizations required by applicable Laws to operate requirements under the Concentrates BusinessFDA, CMDR, MDD and all such authorizations are current and comparable laws in full force and effect. Seller has made available to Purchaser true and complete copies of all material governmental correspondence (any non-U.S. jurisdiction, including copies of official notices, citations or decisions) in the files of Seller those relating to premarket clearance or approval, establishment registration, device listing, quality system regulation, good manufacturing practices, labeling, advertising, record keeping and filing of required reports. All applicable technical files have been established and maintained and are in material compliance with the regulations. Section 2.27(a)(ii) of the Sellers 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 authorizationsapprovals 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. Seller has made available to Purchaser true Sellers are in compliance with all applicable requirements of the FDA, CMDR and 155815138v19 complete copies of all material governmental correspondence (including copies of official notices, citations or decisions) sent or received by Seller primarily related MDD relating to the Concentrates Business since January 3maintenance of technical, 2022clinical and other data generated prior to the Closing Date by Sellers with respect to Medical Devices. (b) All Permits required to be obtained from FDA for Seller to conduct the Concentrates Business Except as currently conducted or for the ownership and use set forth in Section 2.27(b) of the Acquired AssetsSellers Disclosure Schedule, in each case in all material respectsproduct issues, incidents and complaints have been obtained by Seller suitably investigated, documented and are valid and in full force and effectmanaged, any applicable problem or vigilance reports have been filed, and each of the Concentrates Business products has any necessary recalls have been cleared by the FDA, to the extent required by applicable Lawfully implemented. (c) Since January 3, 2022, to Seller’s Knowledge, Section 2.27(c) of the Sellers Disclosure Schedule identifies all applications, notifications, submissions, information, claims, internal audit reports and filings utilized (as the basis for or submitted in connection with any and all requests for an authorization required by 21 CFR Section 820.20) conducted by Sellers relating to a Concentrates the Business product were truesince January 1, accurate and complete in all material respects as of the date of submission. Since January 3, 2022, to Seller’s Knowledge, any necessary or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to FDA or other Governmental Entity and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects2004. (d) Since January 3In Sellers’ reasonable judgment after due investigation, 2022all reports, Seller has not received any written communication from documents, claims, Permits and notices required to be filed, maintained or furnished with or to the FDA or any other Governmental EntityEntity by Sellers for the Business have been so filed, including without limitation any warning letter maintained or untitled letter that alleges furnished. All such reports, documents, claims, Permits and notices were complete and accurate in all material respects on the date filed (or suggests that the Concentrates Business is not were corrected in compliance with any applicable requirements under the FDCA or the FDA regulations promulgated thereundersupplemented by a subsequent filing). All such reports, documents, claims, Permits and notices have been provided or made available to Buyer. (e) To Seller’s KnowledgeExcept as disclosed in Section 2.27(e) of the Sellers Disclosure Schedule, there are 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, or other Governmental Entity, (i) with respect to the Business alleging or asserting noncompliance with any applicable Laws and Regulations 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 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 Claims medical device report (or Legal Proceedings pending its counterpart in non-U.S. jurisdictions) with respect to any Statcorp Products and Services, including Medical Device, has been reported by Seller to the FDA or threatenedother Governmental Entity, against Seller 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 Entity. (g) Except as disclosed in Section 2.27(g)(i) of the Sellers Disclosure Schedule, Sellers have not voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, or “dear doctor” letter relating to an alleged lack of safety, efficacy or regulatory compliance of any Statcorp Products and Services, including Medical Device. Other than as set forth on Section 2.27(g)(ii) of the Concentrates Sellers Disclosure Schedule, and after having used reasonably diligent efforts to discover such facts, Sellers and 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 marketing of any 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 notice that the FDA or any other Governmental Entity has (i) commenced, or threatened to initiate, any action to withdraw its premarket clearance or premarket approval or request the recall of any Statcorp Products and Services, including Medical Devices, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Statcorp Products and Services, including Medical Devices or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any Statcorp Products and Services, including Medical Devices, produced at any facility where any Statcorp Products and Services, including Medical Devices, is manufactured, tested, processed, packaged or held for sale or (iv) identified any Statcorp Products and Services, including Medical Devices, non-compliance with reporting, registration, labeling, good manufacturing practices, advertising and other requirements under the FDA or regulations of any Governmental Entity. (i) 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 FDA or a similar entity in any other jurisdiction. (j) The Sellers have performed all of its services in connection with the Business in a manner consistent with, or 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 conduct of clinical and nonclinical trials, and the submission of applications for the approval of products, including but not limited to, the requirements of the Federal Food Drug and Cosmetic Act and its implementing regulations, particularly those relating 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 or arising under market a new drug), all requirements applicable Law relating to government health care plansthe conduct of Good Clinical Practices, private health care plans, or the privacy International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and confidentiality of patient health informationall other similar international requirements.