3.20 Regulatory Compliance.
(a) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole, (i) the Company and its Subsidiaries are, and since January 1, 2021, have been, in compliance with the Health Care Laws, and (ii) since January 1, 2021, the Company and its Subsidiaries have not received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation or arbitration from any Governmental Authority, including the FDA or a similar Regulatory Agency, alleging non-compliance by, or Liability of, the Company or any of its Subsidiaries under any Health Care Law.
(b) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole, the Company and its Subsidiaries, or the Company’s partners and collaborators, hold all Regulatory Permits required for the conduct of the Company’s and its Subsidiaries’ respective businesses as currently conducted. As used herein, “Regulatory Permits” shall mean: (i) all authorizations under the FFDCA, the Public Health Service Act and any similar applicable federal, foreign, state, or local Laws, and (ii) authorizations of any applicable Governmental Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, development, testing, manufacturing, labeling, marketing, distribution, sale, pricing, import or export of the Company Products (any such Governmental Authority, a “Regulatory Agency”) necessary for the lawful operating of the businesses of the Company or any Subsidiary thereof. All Regulatory Permits are in full force and effect and the Company and its Subsidiaries are in material compliance with the terms of all Regulatory Permits.
(c) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole, since January 1, 2021, (i) all reports, documents, claims and notices required to be filed, maintained, or furnished to any Regulatory Agency by the Company and its Subsidiaries have been so filed, maintained or furnished, and (ii) all such reports, documents, claims and notices, if any, were true, complete and correct on the date filed (or were corrected in or supplemented by a subsequent filing).
(d) All development programs, clinical and pre-clinical studies, trials, investigations and other research studies in respect of a Company Product or conducted by or on behalf of or sponsored by the Company or its Subsidiaries (including all “chemical, manufacturing and control” (CMC) processes pertaining thereto) (“Company Programs”) have been and, if still pending are being, conducted in all material respects in accordance with all applicable clinical protocols, informed consents and Laws, including Good Clinical Practices (pre-clinical and clinical), Good Manufacturing Practices, Good Laboratory Practices and pharmacovigilance requirements and Health Care Laws and FDA regulations for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulation (and any similar applicable federal, foreign state or local Laws applicable to foreign Regulatory Agencies) (collectively, “Company Program Requirements”).
(e) The Company has made available to Parent true, correct and complete copies of (i) all clinical data available as the date hereof with respect to Company Programs, (ii) all correspondence with, and research, pre-clinical, clinical and other applicable reports filed with or submitted to, Regulatory Agencies (and all summaries of such correspondence, Regulatory Agency interactions or reports to the extent available) with respect to Company Programs through the date hereof and (iii) all material correspondence with any counterparties, contract manufacturing organizations, site operators, partners and other third parties relating to Company Programs (each such Person, a “Company Program Party”), in the case of this clause (iii), since January 1, 2021 through the date hereof.
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