Common use of Preclinical and Clinical Trials Clause in Contracts

Preclinical and Clinical Trials. The preclinical and clinical trials conducted by the Company and, to the knowledge of the Company, the preclinical and clinical trials conducted on behalf of the Company or in which the Company has participated, were, and if still pending are, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable rules, regulations and policies, including those of the FDA and comparable regulatory agencies outside of the United States, to which the Company is subject and current Good Clinical Practices and Good Laboratory Practices, except where the failure to be so conducted would not reasonably be expected to result in a Material Adverse Change; the descriptions of the results of such trials contained in the Registration Statement and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement or the Prospectus, the Company has not received any notices or correspondence from the FDA or any other comparable federal, state, local or foreign governmental or regulatory authority requiring the termination or suspension of any preclinical or clinical trials conducted by or on behalf of the Company.