Common use of Tests and Preclinical and Clinical Trials Clause in Contracts

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.

Appears in 10 contracts

Samples: Securities Purchase Agreement (MeiraGTx Holdings PLC), Securities Purchase Agreement (Clearside Biomedical, Inc.), Securities Purchase Agreement (Aileron Therapeutics Inc)

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Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledgeknowledge, 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 any applicable protocols submitted to the U.S. Food and Drug Administration (the “FDA”) FDA or any foreign governmental body Governmental Authority exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws Laws and regulations; the descriptions of the studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledgeknowledge, on behalf of the Company, and the results thereof, contained in the SEC Filings are accurate and complete in all material respects; to the Company is not aware of any other Company’s knowledge, there are no subsequent studies, tests or preclinical and clinical trials, the results of which call into question in any material respect 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 Governmental Authority 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 currently being conducted by or on behalf of the Company.

Appears in 2 contracts

Samples: Stock Purchase Agreement (Fate Therapeutics Inc), Stock Purchase Agreement (Fate Therapeutics Inc)

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledgeknowledge, on behalf of the Company that are described in the SEC Filings Reports were and, if still pending, are being, conducted in all material respects in accordance with the any applicable protocols submitted to the U.S. Food and Drug Administration (the “FDA”) FDA or any foreign governmental body Governmental Authority exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws laws, rules and regulations; the descriptions of the studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledgeknowledge, on behalf of the Company, and the results thereof, contained in the SEC Filings Reports are accurate and complete in all material respects; to the Company is not aware of any other Company’s knowledge, there are no subsequent studies, tests or preclinical and clinical trials, the results of which call into question the results described in the SEC FilingsReports; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body Governmental Authority 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.

Appears in 2 contracts

Samples: Stock Purchase Agreement (MiNK Therapeutics, Inc.), Stock Purchase Agreement (Agenus Inc)

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.

Appears in 2 contracts

Samples: Securities Purchase Agreement (Selecta Biosciences Inc), Securities Purchase Agreement (Selecta Biosciences Inc)

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 true and complete correct 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 and, except as previously disclosed to the Investor, 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.

Appears in 1 contract

Samples: Note Purchase Agreement (Argos Therapeutics Inc)

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 Company SEC Filings Documents were and, if still pending, are being, conducted in all material respects in accordance with the any applicable protocols submitted to the U.S. Food and Drug Administration (the “FDA”) or any foreign governmental body Governmental Authority exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws 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 Company SEC Filings Documents are accurate and complete in all material respects; to the Company is not aware of any other Company’s Knowledge, there are no subsequent studies, tests or preclinical and clinical trials, the results of which call into question the results described in the Company SEC FilingsDocuments; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body Governmental Authority 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.

Appears in 1 contract

Samples: Stock Purchase Agreement (Tracon Pharmaceuticals, Inc.)

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledgeknowledge, on behalf of the Company that are described in the SEC Filings Reports were and, if still pending, are being, conducted in all material respects in accordance with the any applicable protocols submitted to the U.S. Food and Drug Administration (the “FDA”) FDA or any foreign governmental body Governmental Authority exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws laws, rules and regulations; the descriptions of the studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledgeknowledge, on behalf of the Company, and the results thereof, contained in the SEC Filings Reports are accurate and complete in all material respects; to the Company is not aware of any other Company’s knowledge, there are no subsequent studies, tests or preclinical and clinical trials, the results described in the SEC Reports of which call into question the results described in the SEC Filingsresults; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body Governmental Authority 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.

Appears in 1 contract

Samples: Stock Purchase Agreement (Agenus Inc)

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 true and complete correct 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.

Appears in 1 contract

Samples: Securities Purchase Agreement (Argos Therapeutics Inc)

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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. Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential.

Appears in 1 contract

Samples: Securities Purchase Agreement (MeiraGTx Holdings PLC)

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledgeknowledge, on behalf of the Company that are described in the Company SEC Filings Documents were and, if still pending, are being, conducted in all material respects in accordance with the any applicable protocols submitted to the U.S. Food and Drug Administration (the “FDA”) FDA or any foreign governmental body Governmental Authority exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws Laws and regulations; the descriptions of the studies, tests and preclinical and clinical trials conducted by or, to the Company’s Knowledgeknowledge, on behalf of the Company, and the results thereof, contained in the Company SEC Filings Documents are accurate and complete in all material respects; to the Company is not aware of any other Company’s knowledge, there are no subsequent studies, tests or preclinical and clinical trials, the results of which call into question the results described in the Company SEC FilingsDocuments; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body Governmental Authority 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.

Appears in 1 contract

Samples: Stock Purchase Agreement (Arrowhead Pharmaceuticals, Inc.)

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.. Exhibit 10.1

Appears in 1 contract

Samples: Securities Purchase Agreement (Innovate Biopharmaceuticals, Inc.)

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 pendingongoing, are being, being conducted in all material respects in accordance with all Authorizations and Applicable Laws, including, without limitation, the protocols submitted to Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) and the U.S. Food rules and Drug Administration regulations promulgated thereunder (the FDAFDCA”) or and any foreign governmental body exercising comparable authorityother applicable rules, procedures regulations and controls pursuant to, where applicable, accepted professional policies to which such trials and scientific standards, and all applicable laws and regulationsstudies are subject; the descriptions of the results of such studies, tests and preclinical and clinical trials conducted by orcontained in the SEC Reports are, 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 the Company believes reasonably call into question the study, test, or trial results described or referred to in the SEC FilingsReports when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from the FDA, any foreign, state or local governmental body exercising comparable authority FDA or any Institutional Review Board governmental entity requiring the termination, suspension, material modification termination or clinical hold suspension of any studies, tests or preclinical or clinical trials currently being conducted or proposed to be 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. To the Company’s Knowledge, the studies, tests and preclinical and clinical trials involving the Company’s product candidates are accurately described in the SEC Reports in all material respects.

Appears in 1 contract

Samples: Securities Purchase Agreement (CARGO Therapeutics, Inc.)

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