FDA; HCT/P Compliance Sample Clauses

FDA; HCT/P Compliance. (i) The Company’s and its Subsidiaries’ primary products are human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) as defined in 21 C.F.R. § 1271.3(d), which are regulated by the U.S. Food and Drug Administration (“FDA”) under Section 361 of the Public Health Service Act and 21 C.F.R. Part 1271. The Company and its Subsidiaries are, and at all times during the past three (3) years have been, in compliance with all applicable requirements of 21 C.F.R. Part 1271, including without limitation establishment registration, product listing, donor eligibility, current good tissue practices (“cGTP”), and all applicable reporting requirements, except where the failure to be in compliance would not have a Material Adverse Effect. (ii) As to each product subject to the jurisdiction of the FDA under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”), or under Section 351 or 361 of the Public Health Service Act and the regulations thereunder (including 21 C.F.R. Part 1271), that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Regulated Product”), such Regulated Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under the FDCA, the Public Health Service Act, and similar laws, rules and regulations relating to registration, establishment listing, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good tissue practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. (iii) Each Regulated Product that is marketed by the Company or its Subsidiaries as an HCT/P regulated solely under Section 361 of the Public Health Service Act and 21 C.F.R. Part 1271 satisfies all of the criteria set forth in 21 C.F.R. § 1271.10(a), including that it is minimally manipulated, is intended for homologous use only, its manufacture does not involve combination with another article (except for water, crystalloids, or a sterilizing, preserving, or storage agent), and either it does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function, or it is for aut...