Common use of Tests and Preclinical Studies Clause in Contracts

Tests and Preclinical Studies. The studies, tests and preclinical studies conducted by 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 pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, Pricing Disclosure Package and the Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Registration Statement, Pricing Disclosure Package and the Prospectus, the results of which are inconsistent in any material respect with or call in question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and Trials where such termination, suspension or 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 caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and 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 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 has been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, 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 the Company is subject.

Tests and Preclinical Studies. The studies, tests and preclinical studies conducted by or or, to the Company’s knowledge, 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 pendingongoing, are being, being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant toto all Authorizations and Applicable Laws, where applicableincluding, accepted professional scientific standardswithout 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 the Company Studies such tests and Trials preclinical studies contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are 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 Company has no knowledge of any other studies or trials not described 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 are inconsistent in any material respect with or the Company believes reasonably call in 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; and , the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority entity requiring the termination, termination or suspension or material modification of any Company Studies and Trials where such terminationstudies, suspension tests or 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 (preclinical or caused to be obtained) informed consent clinical trials conducted by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company Company, other than ordinary course communications with respect to modifications in connection with the Company Studies design and Trialsimplementation of such studies or planned clinical 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 copies of 1996 and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has which communications have been disqualified as a clinical investigator or has been found by the FDA made available to have engaged in scientific misconduct. To the Company’s knowledge, 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 the Company is subjectyou.

Tests and Preclinical Studies. The studies, tests and preclinical studies conducted by 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 pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, Pricing Disclosure Package and the Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Registration Statement, Pricing Disclosure Package and the Prospectus, the results of which are inconsistent in any material respect with or call in question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and Trials where such termination, suspension or 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 caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and 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 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 has been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, 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 the Company is subject.

Tests and Preclinical Studies. The studies, tests and preclinical studies conducted by or or, to the Company’s knowledge, 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 pendingongoing, are being, being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant toto all Authorizations and Applicable Laws, where applicableincluding, accepted professional scientific standardswithout 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 the Company Studies such tests and Trials preclinical studies contained in the Registration Statement, Pricing Disclosure Package Statement and the Prospectus are 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 Company has no knowledge of any other studies or trials not described extent disclosed in the Registration Statement, Pricing Disclosure Package Statement and the Prospectus, the Company is not aware of any studies or tests, the results of which are inconsistent in any material respect with or the Company believes reasonably call in into question the test or preclinical study results described or referred to in the Registration Statement, the Pricing Disclosure Package Statement 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 or the Prospectus; and , the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority entity requiring the termination, termination or suspension or material modification of any Company Studies and Trials where such terminationstudies, suspension tests or 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 (preclinical or caused to be obtained) informed consent clinical trials conducted by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company Company, other than ordinary course communications with respect to modifications in connection with the Company Studies design and Trialsimplementation of such studies or planned clinical 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 copies of 1996 and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has which communications have been disqualified as a clinical investigator or has been found by the FDA made available to have engaged in scientific misconduct. To the Company’s knowledge, 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 the Company is subjectCxxxx.