Common use of Tests and Preclinical Studies Clause in Contracts

Tests and Preclinical Studies. The tests and preclinical studies 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 experimental protocols, procedures and controls pursuant to all Authorizations and Applicable Laws, including, without limitation, protocols submitted to the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of such tests and preclinical studies contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such tests and preclinical studies in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or tests, the results of which the Company believes reasonably call into question the test or preclinical study results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials 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 studies or planned clinical trials, copies of which communications have been made available to you.

Tests and Preclinical Studies. The studies, tests and preclinical studies conducted by or, to the Company’s knowledge, or on behalf of the Company that are described in the Pricing Disclosure Package and the Prospectus (the “Company Studies and Trials”) were and, if still ongoingpending, are being being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to all Authorizations and Applicable Lawsto, includingwhere applicable, without limitation, protocols submitted to the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and current Good Clinical Practices and Good Laboratory Practicesaccepted professional scientific standards; the descriptions of the results of such tests the Company Studies and preclinical studies Trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, are accurate and complete in all material respects and fairly present the data derived from such tests and preclinical studies in all material respects; except to the extent disclosed Company has no knowledge of any other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or tests, the results of which the Company believes reasonably are inconsistent in any material respect with or call into in question the test or preclinical study results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described Prospectus; and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental entity authority exercising comparable authority requiring the termination termination, suspension or suspension material modification of any studiesCompany Studies and Trials where such termination, tests suspension or preclinical material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or clinical trials conducted caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company, other than ordinary course communications with respect to modifications Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the design Company Studies and implementation Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of such studies 1996 and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or planned clinical trialshas been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, copies the manufacturing facilities and operations of its suppliers where the Company’s product candidates are produced are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable governmental authorities outside of the United States to which communications have been made available to youthe Company is subject.

Tests and Preclinical Studies. The studies, tests and preclinical studies conducted by or, to the Company’s knowledge, or on behalf of the Company that are described in the Pricing Disclosure Package and the Prospectus (the “Company Studies and Trials”) were and, if still ongoingpending, are being being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to all Authorizations and Applicable Lawsto, includingwhere applicable, without limitation, protocols submitted to the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and current Good Clinical Practices and Good Laboratory Practicesaccepted professional scientific standards; the descriptions of the results of such tests the Company Studies and preclinical studies Trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, are accurate and complete in all material respects and fairly present the data derived from such tests and preclinical studies in all material respects; except to the extent disclosed Company has no knowledge of any other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or tests, the results of which the Company believes reasonably are inconsistent in any material respect with or call into in question the test or preclinical study results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described Prospectus; and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental entity authority exercising comparable authority requiring the termination termination, suspension or suspension material modification of any studiesCompany Studies and Trials where such termination, tests suspension or preclinical material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or clinical trials conducted caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company, other than ordinary course communications with respect to modifications Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the design Company Studies and implementation Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of such studies 1996 and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or planned clinical trialshas been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, copies the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable governmental authorities outside of the United States to which communications have been made available to youthe Company is subject.