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

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by the Company (“Company Trials”), and, to the Company’s knowledge, the investigator-sponsored trials (“ISTs”), that are described in the Registration Statement, the General Disclosure Package and the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols submitted to the U.S. Food and Drug Administration (the “FDA”) or any foreign governmental body exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws and regulations. The descriptions of the Company Trials and, to the Company’s knowledge, the ISTs, and the results thereof, contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects. The Company is not aware of any other studies, tests or preclinical and clinical trials other than the Company Trials and the ISTs, the results of which call into question the results described in the Registration Statement, the General Disclosure Package and the Prospectus. The Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board requiring the termination, suspension, material modification or clinical hold of the Company Trials or the ISTs, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The Company has operated and currently is in compliance with all applicable rules and regulations of the FDA or any other federal, state, local or foreign governmental body exercising comparable authority, except where the failure to so operate or be in compliance would not have a Material Adverse Effect. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company (“Company Trials”), and, to the Company’s knowledge, the investigator-sponsored trials (“ISTs”), that are described in the Registration Statement, the General Disclosure Package and the Prospectus were and, if still pending, to the knowledge of the Company, are being being, conducted in all material respects in accordance with the protocols submitted to the U.S. Food and Drug Administration (the “FDA”) FDA or any foreign governmental body government exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws and regulations. The ; the descriptions of the Company Trials andstudies, to tests and preclinical and clinical trials conducted by or on behalf of the Company’s knowledge, the ISTs, and the results thereof, contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects. The ; the Company is not aware of any other studies, or tests or preclinical and clinical trials other than the Company Trials and the ISTstrials, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus. The ; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable body requiring the termination, suspension, material modification or clinical hold of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company Trials Company, which termination, suspension, modification or the ISTs, other than ordinary course communications with respect clinical hold would reasonably be expected to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to youa Material Adverse Effect.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company (“Company Trials”), and, to the Company’s knowledge, the investigator-sponsored trials (“ISTs”), that are described in the Registration Statement, the General Disclosure Package and the Prospectus were and, if still pending, are being being, conducted in all material respects in accordance with the protocols submitted to the U.S. Food and Drug Administration (the “FDA”) FDA or any foreign governmental body government exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws and regulations. The ; the descriptions of the Company Trials andstudies, to tests and preclinical and clinical trials conducted by or on behalf of the Company’s knowledge, the ISTs, and the results thereof, contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects. The ; the Company is not aware of any other studies, or tests or preclinical and clinical trials other than the Company Trials and the ISTstrials, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus. The ; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board requiring the termination, suspension, material modification or clinical hold of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company Trials Company, which termination, suspension, modification or the ISTs, other than ordinary course communications with respect clinical hold would reasonably be expected to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to youa Material Adverse Effect.