Common use of Preclinical and Clinical Trials Clause in Contracts

Preclinical and Clinical Trials. Except as described in the Registration Statement and the Prospectus: (i) the preclinical and clinical studies and trials conducted by or, to the best knowledge of the Company after due inquiry, that were conducted on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company or its Subsidiaries have participated (collectively “Company Trials”), in each case including the Company’s studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with all applicable standard medical and scientific research standards and procedures and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration (“FDA”), the Department of Health and Human Services and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”), and applicable current Good Clinical Practice and Good Laboratory Practice requirements as detailed in applicable statutes, rules and regulations of an applicable Regulatory Authority; (ii) the descriptions in the Registration Statement and the Prospectus of the Company Trials, including the results of the Company Trials, are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results of the Company Trials described or referred to in the Registration Statement and the Prospectus; (iv) neither the Company nor any of its Subsidiaries, nor, to the Company’s best knowledge after due inquiry, any of its collaboration partners, have received any written notices, written correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any Company Trial that is described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such Company Trials, and, to the Company’s best knowledge after due inquiry, there are no reasonable grounds for the same; (v) to the Company’s best knowledge after due inquiry, the Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial; (vi) in using or disclosing patient information received by the Company in connection with the Company Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements; and (vii) to the Company’s best knowledge after due inquiry, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator by any Regulatory Authority or has been found by any Regulatory Authority to have engaged in scientific misconduct.

Preclinical and Clinical Trials. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus: (i) the preclinical and clinical studies and trials conducted by or, to the best knowledge of the Company after due inquiry, that were conducted on behalf of or sponsored by the Company or its Subsidiariessubsidiaries, or in which the Company or its Subsidiaries subsidiaries have participated (collectively “Company Trials”), in each case including the Company’s studies and trials that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with all applicable standard medical and scientific research standards and procedures and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration (“FDA”), the Department of Health and Human Services and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”), and applicable current Good Clinical Practice and Good Laboratory Practice requirements as detailed in applicable statutes, rules and regulations of an applicable Regulatory Authority; (ii) the descriptions in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus of the Company Trials, including the results of the Company Trials, are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results of the Company Trials described or referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus; (iv) neither the Company nor any of its Subsidiariessubsidiaries, nor, to the Company’s best knowledge after due inquiry, any of its collaboration partners, have received any written notices, written correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any Company Trial that is described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such Company Trials, and, to the Company’s best knowledge after due inquiry, there are no reasonable grounds for the same; (v) to the Company’s best knowledge after due inquiry, the Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial; (vi) in using or disclosing patient information received by the Company in connection with the Company Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements; and (vii) to the Company’s best knowledge after due inquiry, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator by any Regulatory Authority or has been found by any Regulatory Authority to have engaged in scientific misconduct.

Preclinical and Clinical Trials. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus: (i) , the preclinical studies and clinical studies and trials conducted by or, to the best knowledge of the Company after due inquiryCompany, that were conducted on behalf of or sponsored by the Company or its Subsidiariessubsidiary, or in which the Company or its Subsidiaries subsidiary have participated (collectively “Company Trials”)participated, in each case including the Company’s studies and trials that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with all applicable standard medical and scientific research standards and procedures and all applicable statutes and all applicable rules and regulations of the protocols submitted to the U.S. Food and Drug Administration (the “FDA”), national competent authorities of European Member States, Swiss Agency for Therapeutic Products (“swissmedic”), Swiss Association of Research Ethics Committees (“swissethics”) and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the Department FDA, the national competent authorities of Health European Union Member States, swissethics and Human Services and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency swissmedic) (collectively, the “Regulatory Authorities”), and as applicable, the applicable current Good Clinical Practice and Good Laboratory Practice requirements as detailed in applicable statutes, rules and regulations of an applicable the Regulatory AuthorityAuthorities governing the conduct of preclinical studies and clinical trials in their respective territories, and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus of the Company Trials, including the results of the Company Trials, such studies and trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results of the Company Trials described or referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus; (iv) the Company and its subsidiary have operated at all times and are currently in compliance, in all material respects, with all applicable statutes, rules and regulations of the Regulatory Authorities; (v) the Company has provided the Underwriters with all material written notices and correspondence and summaries of all other material information, as applicable, from the Regulatory Authorities; and (vi) neither the Company nor any of its Subsidiaries, nor, to the Company’s best knowledge after due inquiry, any of its collaboration partners, subsidiary have received any written notices, written correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any Company Trial preclinical studies or clinical trials that is are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such Company Trialsstudies or trials, and, to the Company’s best knowledge after due inquiryknowledge, there are no reasonable grounds for the same; (v) to the Company’s best knowledge after due inquiry, the Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial; (vi) in using or disclosing patient information received by the Company in connection with the Company Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements; and (vii) to the Company’s best knowledge after due inquiry, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator by any Regulatory Authority or has been found by any Regulatory Authority to have engaged in scientific misconduct.

Preclinical and Clinical Trials. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus: (i) , the preclinical studies and clinical studies and trials conducted by or, to the best knowledge of the Company after due inquiryCompany, that were conducted on behalf of or sponsored by the Company or its Subsidiariessubsidiary, or in which the Company or its Subsidiaries subsidiary have participated (collectively “Company Trials”)participated, in each case including the Company’s studies and trials that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with all applicable standard medical and scientific research standards and procedures and all applicable statutes and all applicable rules and regulations of the protocols submitted to the U.S. Food and Drug Administration (the “FDA”), the Department of Health and Human Services and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (the “EMA”), Swiss Agency for Therapeutic Products (“swissmedic”), Swiss Association of Research Ethics Committees (“swissethics”) and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA, EMA, swissethics and swissmedic) (collectively, the “Regulatory Authorities”), and the applicable current Good Clinical Practice and Good Laboratory Practice requirements as detailed in applicable statutes, rules and regulations of an applicable the Regulatory AuthorityAuthorities, and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus of the Company Trials, including the results of the Company Trials, such studies and trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results of the Company Trials described or referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus; (iv) the Company and its subsidiary have operated at all times and are currently in compliance, in all material respects, with all applicable statutes, rules and regulations of the Regulatory Authorities; (v) the Company has provided the Underwriters with all material written notices and correspondence and summaries of all other material information, as applicable, from the Regulatory Authorities; and (vi) neither the Company nor any of its Subsidiaries, nor, to the Company’s best knowledge after due inquiry, any of its collaboration partners, subsidiary have received any written notices, written correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any Company Trial preclinical studies or clinical trials that is are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such Company Trialsstudies or trials, and, to the Company’s best knowledge after due inquiryknowledge, there are no reasonable grounds for the same; (v) to the Company’s best knowledge after due inquiry, the Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial; (vi) in using or disclosing patient information received by the Company in connection with the Company Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements; and (vii) to the Company’s best knowledge after due inquiry, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator by any Regulatory Authority or has been found by any Regulatory Authority to have engaged in scientific misconduct.

Preclinical and Clinical Trials. (i) Except as described in the Registration Statement and the Prospectus: (i) , the preclinical studies and clinical studies and trials conducted by or, to the best knowledge of the Company after due inquiryCompany, that were conducted on behalf of or sponsored by the Company or its Subsidiariessubsidiary, or in which the Company or its Subsidiaries subsidiary have participated (collectively “Company Trials”)participated, in each case including the Company’s studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with all applicable standard medical and scientific research standards and procedures and all applicable statutes and all applicable rules and regulations of the protocols submitted to the U.S. Food and Drug Administration (the “FDA”), the Department of Health and Human Services and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (the “EMA”), Swiss Agency for Therapeutic Products (“swissmedic”), Swiss Association of Research Ethics Committees (“swissethics”) and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA, EMA, swissethics and swissmedic) (collectively, the “Regulatory Authorities”), and the applicable current Good Clinical Practice and Good Laboratory Practice requirements as detailed in applicable statutes, rules and regulations of an applicable the Regulatory AuthorityAuthorities, and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement and the Prospectus of the Company Trials, including the results of the Company Trials, such studies and trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results of the Company Trials described or referred to in the Registration Statement and the Prospectus; (iv) the Company and its subsidiary have operated at all times and are currently in compliance, in all material respects, with all applicable statutes, rules and regulations of the Regulatory Authorities; (v) the Company has provided the Agent with all material written notices and correspondence and summaries of all other material information, as applicable, from the Regulatory Authorities; and (vi) neither the Company nor any of its Subsidiaries, nor, to the Company’s best knowledge after due inquiry, any of its collaboration partners, subsidiary have received any written notices, written correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any Company Trial preclinical studies or clinical trials that is are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such Company Trialsstudies or trials, and, to the Company’s best knowledge after due inquiryknowledge, there are no reasonable grounds for the same; (v) to the Company’s best knowledge after due inquiry, the Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial; (vi) in using or disclosing patient information received by the Company in connection with the Company Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements; and (vii) to the Company’s best knowledge after due inquiry, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator by any Regulatory Authority or has been found by any Regulatory Authority to have engaged in scientific misconduct.