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

Tests and Preclinical and Clinical Trials. The preclinical studies, tests and clinical trials conducted by or on behalf of the Company that are described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus, were and, if still pending, are being conducted in accordance with all applicable Regulatory Laws, including, without limitation, regulations relating to Good Clinical Practices and Good Laboratory Practices applicable to clinical trials, and all Authorizations. The descriptions of such studies, tests and trials, including the results thereof, contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete and fairly present the data derived from such studies, tests and trials in all material respects. The Company is not aware of any studies, tests or trials, the results of which the Company believes are materially inconsistent with the study, test or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development. The Company has not received any notices or written correspondence from the FDA or any other federal, state, local or foreign governmental or regulatory authority or Institutional Review Boards or comparable authorities requiring the termination, suspension, material adverse modification, or partial or full clinical hold of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company and, to the knowledge of the Company, there are no reasonable grounds for the same.