Common use of Clinical Trials Clause in Contracts

Clinical Trials. (i) Except as disclosed in the Registration Statement, Disclosure Package and Prospectus, any preclinical studies and clinical trials conducted by the Company or any of the Subsidiaries and, 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 or the Subsidiaries have participated for the purposes of supporting a regulatory filing or application submitted to a Regulatory Authority, were, and if still pending, are, being conducted in all material respects in accordance with approved study protocols and Applicable Laws, including those of the FDA and other regulatory authorities, to which the Company and the Subsidiaries are subject; (ii) the descriptions of the results of such studies, tests and trials contained in the Registration Statement, Disclosure Package and Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trial; (iii) neither the Company nor any of the Subsidiaries have received any notices or correspondence from the FDA, any other Regulatory Authority or any other governmental agency, institutional review board, ethics committee or other similar entity requiring, or 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 the Company or any of the Subsidiaries, nor is the Company aware of any facts that would form a reasonable basis for any such termination, suspension or modification; and (iv) except to the extent disclosed in the Registration 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.

Clinical Trials. (i) Except as disclosed in the Registration StatementThe studies, Disclosure Package tests and Prospectus, any preclinical studies and clinical trials conducted by the Company or any of the Subsidiaries andon behalf of, to the knowledge of or sponsored by, 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 Subsidiaries have participated for Prospectus, or the purposes results of supporting a regulatory filing which are referred to in the Registration Statement or application submitted to a Regulatory Authoritythe Prospectus, werewere and, and if still pending, are, are being conducted in all material respects in accordance with approved study protocols protocols, procedures and Applicable Lawscontrols pursuant to, including where applicable, accepted professional and scientific standards for products or product candidates comparable to those of the FDA and other regulatory authorities, to which being developed by the Company and all applicable statutes, rules and regulations of the Subsidiaries 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; (ii) the descriptions of the results of such studies, tests and trials contained in the Registration StatementStatement 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, Disclosure Package and tests or trials not described in the Prospectus are accurate and complete the results of which reasonably call into question in all any material respects and fairly present respect the data derived from such results of the studies, tests and trialtrials described in the Registration Statement or Prospectus; (iii) neither and the Company nor any of the Subsidiaries have has not received any notices or other correspondence from the FDA, any other Regulatory Authority EMEA, Health Canada or any other foreign, state or local governmental agency, institutional review board, ethics committee body exercising comparable authority or other similar entity requiring, any Institutional Review Board or would reasonably be expected to result in a requirement for, 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 of, or sponsored by, the Company or any of the Subsidiaries, nor is in which the Company aware of any facts that would form a reasonable basis for any such terminationhas participated, suspension or modification; and (iv) except and, to the extent Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration 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 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. (i) Except as disclosed in the Registration StatementThe studies, Disclosure Package tests and Prospectus, any preclinical studies and clinical trials conducted by the Company or any of the Subsidiaries andon behalf of, to the knowledge of or sponsored by, 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 Subsidiaries have participated for Prospectus, or the purposes results of supporting a regulatory filing which are referred to in the Registration Statement or application submitted to a Regulatory Authoritythe Prospectus, werewere and, and if still pending, are, are being conducted in all material respects in accordance with approved study protocols protocols, procedures and Applicable Lawscontrols pursuant to, including where applicable, accepted professional and scientific standards for products or product candidates comparable to those of the FDA and other regulatory authorities, to which being developed by the Company and all applicable statutes, rules and regulations of the Subsidiaries 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; (ii) the descriptions of the results of such studies, tests and trials contained in the Registration StatementStatement 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, Disclosure Package and tests or trials not described in the Prospectus are accurate and complete the results of which reasonably call into question in all any material respects and fairly present respect the data derived from such results of the studies, tests and trialtrials described in the Registration Statement or Prospectus; (iii) neither and the Company nor any of the Subsidiaries have has not received any notices or other correspondence from the FDA, any other Regulatory Authority EMEA, Health Canada or any other foreign, state or local governmental agency, institutional review board, ethics committee body exercising comparable authority or other similar entity requiring, any Institutional Review Board or would reasonably be expected to result in a requirement for, 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 of, or sponsored by, the Company or any of the Subsidiaries, nor is in which the Company aware of any facts that would form a reasonable basis for any such terminationhas participated, suspension or modification; and (iv) except and, to the extent Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration 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 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 could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. (i) Except as disclosed in the Registration StatementThe studies, Disclosure Package tests and Prospectus, any preclinical studies and clinical trials conducted by the Company or any of the Subsidiaries andon behalf of, to the knowledge of or sponsored by, 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 Subsidiaries have participated for Prospectus, or the purposes results of supporting a regulatory filing which are referred to in the Registration Statement or application submitted to a Regulatory Authoritythe Prospectus, werewere and, and if still pending, are, are being conducted in all material respects in accordance with approved study protocols protocols, procedures and Applicable Lawscontrols pursuant to, including where applicable, accepted professional and scientific standards for products or product candidates comparable to those of the FDA and other regulatory authorities, to which being developed by the Company and all applicable statutes, rules and regulations of the Subsidiaries 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; (ii) the descriptions of the results of such studies, tests and trials contained in the Registration StatementStatement 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, Disclosure Package and tests or trials not described in the Prospectus are accurate and complete the results of which reasonably call into question in all any material respects and fairly present respect the data derived from such results of the studies, tests and trialtrials described in the Registration Statement or the Prospectus; (iii) neither and the Company nor any of the Subsidiaries have has not received any notices or other correspondence from the FDA, any other Regulatory Authority EMEA, Health Canada or any other foreign, state or local governmental agency, institutional review board, ethics committee body exercising comparable authority or other similar entity requiring, any Institutional Review Board or would reasonably be expected to result in a requirement for, 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 of, or sponsored by, the Company or any of the Subsidiaries, nor is in which the Company aware of any facts that would form a reasonable basis for any such terminationhas participated, suspension or modification; and (iv) except and, to the extent Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration 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 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 could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. (i) Except as disclosed in To the Registration StatementCompany’s knowledge, Disclosure Package and Prospectus, any the preclinical studies and clinical trials conducted by the Company or any of the Subsidiaries and, to the knowledge of the Company, any preclinical studies tests and clinical trials described in the Time of Sale Prospectus and the Prospectus being conducted by or on behalf of the Company or the Subsidiaries or in which the Company or the Subsidiaries have participated for the purposes of supporting a regulatory filing or application submitted to a Regulatory Authority, were, and and, if still pending, are, are being conducted in all material respects in accordance with approved study protocols the experimental protocols, procedures and Applicable Lawscontrols pursuant to, including where applicable, accepted professional and scientific standards for products or product candidates comparable to those of being developed by the FDA and other regulatory authorities, to which the Company and the Subsidiaries are subjectCompany; (ii) the descriptions of the results of such studies, tests and trials trials, and the results thereof, contained in the Registration Statement, Disclosure Package Time of Sale Prospectus and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trialrespects; (iii) neither the Company nor any of the Subsidiaries have received any notices or correspondence from the FDA, any other Regulatory Authority or any other governmental agency, institutional review board, ethics committee or other similar entity requiring, or 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 the Company or any of the Subsidiaries, nor is the Company aware of any facts that would form a reasonable basis for any such termination, suspension or modification; and (iv) except to the extent disclosed in the Registration Statement, Disclosure Package or Prospectus, the Company is not aware of any studiestests, tests studies or trialstrials not described in the 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, Disclosure Package Time of Sale Prospectus and the Prospectus; and the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials. Any certificate signed by any officer of the Company or any of its subsidiaries and delivered to any Underwriter or to counsel for the Underwriters in connection with the offering, or the purchase and sale, of the 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 this Section 1. The Company acknowledges that the Underwriters and, for purposes of the opinions to be delivered pursuant to Section 6 hereof, counsel 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. (i) Except as disclosed in the Registration StatementThe studies, Disclosure Package tests and Prospectus, any preclinical studies and clinical trials conducted by the Company or any of the Subsidiaries andon behalf of, to the knowledge of or sponsored by, 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 and the Prospectus, or the Subsidiaries have participated for results of which are referred to in the purposes of supporting a regulatory filing or application submitted to a Regulatory AuthorityRegistration Statement and the Prospectus, werewere and, and if still pending, are, are being conducted in all material respects in accordance with approved study protocols protocols, procedures and Applicable Lawscontrols pursuant to, including where applicable, accepted professional and scientific standards for products or product candidates comparable to those of the FDA and other regulatory authorities, to which being developed by the Company and all applicable statutes, rules and regulations of the Subsidiaries 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; (ii) the descriptions of the results of such studies, tests and trials contained in the Registration StatementStatement 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, Disclosure Package and tests or trials not described in the Prospectus are accurate and complete the results of which reasonably call into question in all any material respects and fairly present respect the data derived from such results of the studies, tests and trialtrials described in the Registration Statement and the Prospectus; (iii) neither and the Company nor any of the Subsidiaries have has not received any notices or other correspondence from the FDA, any other Regulatory Authority EMEA, Health Canada or any other foreign, state or local governmental agency, institutional review board, ethics committee body exercising comparable authority or other similar entity requiring, any Institutional Review Board or would reasonably be expected to result in a requirement for, 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 of, or sponsored by, the Company or any of the Subsidiaries, nor is in which the Company aware of any facts that would form a reasonable basis for any such terminationhas participated, suspension or modification; and (iv) except and, to the extent Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration 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 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 could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. (i) Except as disclosed in the Registration Statement, Disclosure Package and Prospectus, any preclinical studies and clinical trials conducted by the Company or any of the Subsidiaries and, 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 or the Subsidiaries have participated for the purposes of supporting a regulatory filing or application submitted to a Regulatory Authority, were, and if still pending, are, are being conducted in all material respects in accordance with approved study protocols and Applicable Laws, including those of the FDA and other regulatory authorities, authorities to which the Company and the Subsidiaries are subject; (ii) the descriptions of the results of such studies, tests and trials contained in the Registration Statement, Disclosure Package and Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trialtrials; (iii) neither the Company nor any of the Subsidiaries have received any notices or correspondence from the FDA, any other Regulatory Authority or any other governmental agency, institutional review board, ethics committee or other similar entity requiring, or 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 the Company or any of the Subsidiaries, nor is the Company aware of any facts that would form a reasonable basis for any such termination, suspension or modification; and (iv) except to the extent disclosed in the Registration 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.