Common use of FDA Regulations Clause in Contracts

FDA Regulations. Except to the extent disclosed in the Prospectus (or any amendment or supplement thereto), to the Company’s knowledge after reasonable inquiry, the clinical, pre-clinical and other studies, tests and research conducted by or on behalf of or sponsored by the Company and intended to be submitted to U.S. regulatory authorities and to serve as a basis for approval are, and at all times have been, conducted in accordance with the FD&C Act and the regulations promulgated thereunder, including Title 21 of the Code of Federal Regulations, and other U.S. Food and Drug Administration (“FDA”) regulations governing clinical studies, current Good Laboratory Practices and Good Clinical Practices, the protection of human subjects and applicable institutional review board and independent ethics committee requirements, as well as other applicable federal, state, local and foreign Laws and consistent with current clinical and scientific research standards and procedures. The published descriptions of the results of such studies, tests and research are accurate and complete in all material respects and fairly present the data derived from such studies, tests and research, and the Company has no knowledge of any other studies, tests or research the results of which are inconsistent with or otherwise call into question the results described or referred to in the Prospectus. Except to the extent disclosed in the Prospectus (or any amendment or supplement thereto), the Company has not notified the FDA of any adverse reactions with respect to any clinical or pre-clinical studies, tests or research that are described in the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, and the Company has not received any notices or other correspondence from the FDA or any other governmental agency with respect to any clinical or pre-clinical studies, tests or research that are described in the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, in either case that would reasonably be expected to result in any action to place a clinical hold order on or otherwise result in the termination or suspension of such studies, tests or research, otherwise require the Company to engage in any remedial activities with respect to such studies, test or research, or threaten to impose or actually impose any fines or other disciplinary actions.