Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledge, on behalf of the Company that are described in the SEC Filings were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the U.S. Food and Drug Administration (the “FDA”) or any foreign governmental body exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws and regulations; the descriptions of the studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledge, on behalf of the Company, and the results thereof, contained in the SEC Filings are accurate and complete in all material respects; the Company is not aware of any other studies, tests or preclinical and clinical trials, the results of which call into question the results described in the SEC Filings; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board requiring the termination, suspension, material modification or clinical hold of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.
Tests and Preclinical and Clinical Trials. Except as would not reasonably be expected to be material to the Acquired Companies, taken as a whole, the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Acquired Companies were and, if still ongoing, are being, conducted in all material respects in accordance with the protocols submitted to the FDA or any foreign governmental body exercising comparable authority, procedures and controls pursuant to, where applicable, good clinical practice, informed consent and all applicable laws, regulations and requirements. The Acquired Companies have filed with the FDA or other appropriate Governmental Entity all material required notices, and annual or other reports, including notices of adverse experiences and reports of serious and unexpected adverse experiences, related to the use of its product candidates in clinical trials. The descriptions of the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Acquired Companies, contained in the SEC Filings are accurate and complete in all material respects; to the Company’s knowledge, there are no other studies, tests or preclinical and clinical trials, the results of which call into question the results described in the SEC Filings; and the Acquired Companies have not received any written notices or correspondence from the FDA, any Governmental Entity exercising comparable authority or any institutional review board requiring the termination, suspension, material modification or clinical hold of any preclinical studies or clinical trials conducted by or on behalf of the Acquired Companies. The properties, business and operations of the Acquired Companies have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA and any other Governmental Entity. The Acquired Companies have not been informed by the FDA or any other Governmental Entity that the FDA or any other Governmental Entity will prohibit the testing, distribution, marketing, sale, license or use of any product proposed to be developed, produced, tested, distributed or marketed by the Acquired Companies. Neither the Acquired Companies nor, to the Company’s knowledge, any of their officers or employees has 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 policy with respect to “Fraud, Untrue S...
Tests and Preclinical and Clinical Trials. (i) Except for such noncompliance as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the preclinical studies, clinical studies, and clinical trials conducted by or on behalf of or sponsored by the Company or its Subsidiaries (“Studies”) were and, if still ongoing, are being conducted in accordance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), and the implementing regulations thereunder (“FDCA”), including 21 C.F.R. Parts 11, 50, 54, 56, 58, and 312, and any applicable laws, rules and regulations of the jurisdiction in which such Studies are being conducted; and (ii) the Company and its Subsidiaries have not received any written notices, correspondence or other communications from the U.S. Food and Drug Administration (“FDA”) or any governmental or regulatory authority requiring or threatening the termination or suspension of any Studies.