Common use of Clinical Programs Clause in Contracts

Clinical Programs. The preclinical and clinical trials conducted by or on behalf of the Company that are described in the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in all material respects in accordance with procedures and controls pursuant to accepted professional scientific standards and all applicable local, state and federal and foreign laws, rules, regulations and published guidance, including, but not limited to, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. The descriptions of the results of such studies, tests and trials contained in the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects. Other than as described in the Pricing Disclosure Package, the Company is not aware of any studies, tests or trials the results of which reasonably call into question the clinical trial results described or referred to in the Prospectus when viewed in the context in which such results are described and the clinical state of development. Other than as described in the Pricing Disclosure Package, in the past five years, the Company has not received any written notices or correspondence from the U.S. Food and Drug Administration or any foreign, state or local governmental body exercising comparable authority, including the European Medicines Agency (collectively, the “Regulatory Authorities”) requiring the termination or suspension of any preclinical or clinical trials conducted by or on behalf of the Company. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the Regulatory Authorities or that additional studies, tests or preclinical or clinical trials will reach similar results or conclusions.

Clinical Programs. The preclinical and clinical trials conducted by or on behalf of the Company that are described in the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in all material respects in accordance with procedures and controls pursuant to accepted professional scientific standards and all applicable local, state and federal and foreign laws, rules, regulations and published guidance, including, but not limited to, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. The descriptions of the results of such studies, tests and trials contained in the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects. Other than as described in the Pricing Disclosure Package, the Company is not aware of any studies, tests or trials the results of which reasonably call into question the clinical trial results described or referred to in the Prospectus when viewed in the context in which such results are described and the clinical state of development. Other than as described in the Pricing Disclosure Package, in the past five years, the Company has not received any written notices or correspondence from the U.S. Food and Drug Administration or any foreign, state or local governmental body exercising comparable authority, including the European Medicines Agency (collectively, the “Regulatory Authorities”) authority requiring the termination or suspension of any preclinical or clinical trials conducted by or on behalf of the Company. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the Regulatory Authorities FDA or any foreign, state or local governmental body exercising comparable authority or that additional studies, tests or preclinical or clinical trials will reach similar results or conclusions.