Common use of Preclinical Studies and Clinical Trials Clause in Contracts

Preclinical Studies and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FDCA”) and the rules and regulations promulgated thereunder and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, General Disclosure Package and Prospectus are accurate in all material respects; the Company is not aware of any studies, tests or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, General Disclosure Package and Prospectus; and, except as disclosed in the Registration Statement, General Disclosure Package and Prospectus, the Company has not received any written notice from the FDA or any comparable governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials currently being conducted or proposed to be conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials. (y)

Preclinical Studies and Clinical Trials. The studies, preclinical studies and tests and preclinical and clinical trials conducted by orthat are described in, or the results of which are referred to in the Company’s knowledgeRegistration Statement, on behalf the Time of Sale Prospectus and the Company were Prospectus were, and, if still ongoingpending, are being conducted in all material respects in accordance with all Authorizations the experimental protocols, procedures and Applicable Lawscontrols pursuant to, includingwhere applicable, without limitationaccepted professional and scientific standards for products or product candidates comparable to those being developed by the Company, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FDCA”) and the rules and regulations promulgated thereunder and any applicable rules, regulations and policies of the jurisdiction except in which such trials and studies are being conductedeach case where failure to comply would not be reasonably expected to have a Material Adverse Effect; the descriptions of the results of such studies, tests and trials trials, and the results thereof, contained in the Registration Statement, General Disclosure Package the Time of Sale Prospectus and the Prospectus are accurate and complete in all material respects; the Company is not aware of any studiestests, tests studies or trials not described in the Registration Statement, the General Disclosure Package Time of Sale Prospectus and the Prospectus, the results of which the Company believes reasonably call into question the studyresults of the tests, test, or trial results studies and trials described or referred to in the Registration Statement, General Disclosure Package the Time of Sale Prospectus and the Prospectus; and, except as disclosed in the Registration Statement, General Disclosure Package and Prospectus, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local Governmental Authority exercising comparable governmental entity authority or any institutional review board or comparable authority requiring the termination termination, suspension, clinical hold or suspension material modification of any studiestests, tests studies or preclinical or clinical trials currently being conducted or proposed to be conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials. (y).

Preclinical Studies and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FDCA”) and the rules and regulations promulgated thereunder and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, General Disclosure Package Statement and Prospectus are accurate in all material respects; the Company is not aware of any studies, tests or trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, General Disclosure Package Statement and Prospectus; and, except as disclosed in the Registration Statement, General Disclosure Package Statement and Prospectus, the Company has not received any written notice from the FDA or any comparable governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials currently being conducted or proposed to be conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials. (y).