Common use of Clinical Trials Clause in Contracts

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that would reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies(i) Except as disclosed in the Registration Statement, tests Disclosure Package and Prospectus, any preclinical studies and clinical trials conducted by the Company or on behalf ofany of the Subsidiaries and, or sponsored by, to the knowledge of the Company, any preclinical studies and clinical trials conducted on behalf of the Company or the Subsidiaries or in which the Company has participated, that are described in the Registration Statement or the ProspectusSubsidiaries have participated for the purposes of supporting a regulatory filing or application submitted to a Regulatory Authority, or the results of which are referred to in the Registration Statement or the Prospectuswere, were and, and if still pending, are are, being conducted in all material respects in accordance with protocolsapproved study protocols and Applicable Laws, procedures including those of the FDA and controls pursuant toother regulatory authorities, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by which the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they Subsidiaries are subject; (ii) the descriptions of the results of such studies, tests and trials contained in the Registration Statement or Statement, Disclosure Package and Prospectus are accurate and complete in all material respects and fairly present the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make data derived from such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectustrial; and (iii) neither the Company has not nor any of the Subsidiaries have received any notices or other correspondence from the FDA, EMEA, Health Canada any other Regulatory Authority or any other foreigngovernmental agency, state institutional review board, ethics committee or local governmental body exercising comparable authority other similar entity requiring, or any Institutional Review Board or comparable authority requiring or threatening would reasonably be expected to result in a requirement for, the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, of the Company or in which any of the Subsidiaries, nor is the Company has participatedaware of any facts that would form a reasonable basis for any such termination, and, suspension or modification; and (iv) except to the Company’s knowledge, there are no reasonable grounds for the same. Except as extent disclosed in the Registration Statement Statement, Disclosure Package or Prospectus, the Company is not aware of any studies, tests or trials, 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, Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that would reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or the Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that would could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that would could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studiesTo the Company’s knowledge, the preclinical studies and tests and preclinical and clinical trials described in the Time of Sale Prospectus and the Prospectus being conducted by or on behalf of, or sponsored by, the Company, or in which of the Company has participatedwere, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with the experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectCompany; the descriptions of the results of such studies, tests and trials trials, and the results thereof, contained in the Registration Statement or Time of Sale Prospectus and the Prospectus do not contain any misstatement of a are accurate and complete in all material fact or omit a material fact necessary to make such statements not misleadingrespects; the Company has no knowledge is not aware of any studiestests, tests studies or trials not described in the Time of Sale Prospectus and the Prospectus, the results of which reasonably call into question in any material respect the results of the studiestests, tests studies and trials described in the Registration Statement or Time of Sale Prospectus and the Prospectus; and the Company has not received any notices written notice or other correspondence from the FDA, EMEA, Health Canada FDA or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board institutional review board or comparable authority requiring or threatening the termination, suspension suspension, clinical hold or material modification of any studiestests, tests studies or preclinical or clinical trials conducted trials. Any certificate signed by or on behalf of, or sponsored by, any officer of the Company or in which the Company has participated, and, any of its subsidiaries and delivered to the Company’s knowledge, there are no reasonable grounds any Underwriter or to counsel for the same. Except as disclosed Underwriters in connection with the Registration Statement offering, or the purchase and sale, of the Prospectus, there has not been any violation of law or regulation Offered Shares shall be deemed a representation and warranty by the Company to each Underwriter as to the matters covered thereby. The Company has a reasonable basis for making each of the representations set forth in its respective product development effortsthis Section 1. The Company acknowledges that the Underwriters and, submissions or reports for purposes of the opinions to any regulatory authority that would reasonably be expected delivered pursuant to require investigationSection 6 hereof, corrective action or enforcement actioncounsel to the Company and counsel to the Underwriters, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or and the Prospectus, or the results of which are referred to in the Registration Statement or and the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or and the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or and the Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that would could reasonably be expected to require investigation, corrective action or enforcement action.