Common use of Preclinical and Clinical Studies Clause in Contracts

Preclinical and Clinical Studies. The preclinical and clinical studies conducted or sponsored by or on behalf of the Company and its subsidiaries have been and, if still pending, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the FDCA and its implementing regulations, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies, the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals, authorizations or exemptions as may be required by the FDA and any other regulatory authority or agency, notified body, or health care facility Institutional Review Board required for the conduct of such preclinical or clinical studies; neither the Company nor its subsidiaries have received any notice of, or correspondence from, any regulatory authority or agency requiring or threatening the termination, suspension or material modification of any studies currently being conducted or proposed to be conducted by or for the Company or its subsidiaries.

Preclinical and Clinical Studies. The preclinical and clinical studies conducted or sponsored by or on behalf of the Company and its subsidiaries have been and, if still pending, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the FDCA and its implementing regulations, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies, the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals, authorizations or exemptions as may be required by the FDA and any other regulatory authority or agency, notified body, or health care facility Institutional Review Board required for the conduct of such preclinical or clinical studies; neither the Company nor its subsidiaries have received any notice of, or correspondence from, any regulatory authority or agency requiring or threatening the termination, suspension or material modification of any studies currently being conducted or proposed to be conducted by or for the Company or its subsidiaries.