Common use of Tests and Preclinical and Clinical Studies Clause in Contracts

Tests and Preclinical and Clinical Studies. The Company has operated and currently is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The preclinical and clinical studies conducted by or, to the Company’s knowledge, on behalf of the Company that are described in the Registration Statement and the Prospectus 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 and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge on the behalf of the Company contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects; the Company is not aware of any trials or studies not described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company is not in receipt of any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority that reasonably call into question results of the trials or studies described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; and the Company has not received any notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any tests or preclinical or clinical studies, or such notice or correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have a Material Adverse Effect.

Tests and Preclinical and Clinical Studies. The Company has operated and currently is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The preclinical and clinical studies conducted by or, to the Company’s knowledge, on behalf of the Company that are described in the Registration Statement and the Prospectus were, and and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures the protocols submitted to the FDA and controls pursuant to, where applicable, accepted professional all applicable laws and scientific standards for products or product candidates comparable to those being developed by the Companyregulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge knowledge, on the behalf of the Company contained in the Registration Statement, the General Disclosure Package Statement and the Prospectus are accurate and complete in all material respects; the Company is not aware of any other trials or studies not described or referred to in the Registration Statement, the General Disclosure Package and the Prospectusstudies, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus; the Company is not in receipt of any notices or correspondence communications from the FDA or any foreign, state or local governmental body exercising comparable authority that reasonably call into question the results of the trials or studies described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus; and the Company has not received any notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any tests or preclinical or clinical studies, or such notice or correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have a Material Adverse Effect.

Tests and Preclinical and Clinical Studies. The Company has and its subsidiaries have operated and currently is are in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The preclinical and clinical studies conducted by or, to the Company’s knowledge, on behalf of the Company or its subsidiaries that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus were, and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and all applicable laws and regulations; the preclinical studies conducted by or, to the Company’s knowledge, on behalf of the Company or its subsidiaries that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus 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 and scientific standards for products or product candidates comparable to those being developed by the CompanyCompany and its subsidiaries; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge knowledge, on the behalf of the Company or its subsidiaries contained in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects; the Company is not aware of any other trials or studies not described or referred to in the Registration Statement, the General Disclosure Package and the Prospectusstudies, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus; except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company is not nor any of its subsidiaries are in receipt of any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority that reasonably call into question the results of the trials or studies described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus; and, except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company has not nor any of its subsidiaries have received any notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any tests or preclinical or clinical studiesstudies with respect to product candidates currently under development, or such notice or correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have a Material Adverse Effect.

Tests and Preclinical and Clinical Studies. The Company and the each subsidiary has operated and currently is are in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable laws, rules and regulations of the FDA and or any other federal, state, local and foreign governmental bodies Governmental Body exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The tests and preclinical and clinical studies conducted by or, to the Company’s knowledge, on behalf of the Company that are described in the Registration Statement and the Pricing Prospectus werewere and, and if still pending, are being, conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA or other applicable foreign Governmental Body exercising comparable authority, and the procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Companystandards, and all applicable laws, rules and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge knowledge, on the behalf of the Company contained in the Registration Statement, the General Disclosure Package Statement and the Prospectus are accurate and complete in all material respects; the Company is not aware of any trials other trials, studies or studies not described or referred to in the Registration Statement, the General Disclosure Package and the Prospectustests, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus; the Company is not in receipt of any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority that reasonably call into question results of the trials or studies described or referred to in the Registration Statement, the General Disclosure Package and the Pricing Prospectus; and the Company has not received any written notice or correspondence from the FDA or any foreignother Governmental Body, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any tests or preclinical or clinical studies, or such written notice or correspondence from any Institutional Review Board institutional review board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have a Material Adverse Effect.

Tests and Preclinical and Clinical Studies. The Company has operated and currently is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The preclinical tests and clinical studies trials conducted by or, to the Company’s knowledge, on behalf of the Company that are described in the Registration Statement and the Prospectus werewere and, and if still pending, are being, conducted conducted, where applicable, in all material respects in accordance with experimental protocols(i) the protocols submitted to the FDA or any foreign government exercising comparable authority for each such test or trial, as the case may be and (ii) 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; the descriptions of the tests and preclinical studies and clinical studiestrials, and results thereof, conducted by or, to the Company’s knowledge knowledge, on the behalf of the Company contained in the Registration Statement, the General Disclosure Package Statement and the Prospectus are accurate and complete do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements, in all material respectsthe light of the circumstances under which they were made, not misleading; the Company is not aware of any trials other trials, studies or studies tests not described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which reasonably and materially call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company is not in receipt of any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority that reasonably call into question results of the trials or studies described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus; and the Company has not received any written notice or written correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any tests or preclinical or clinical studies, or such written notice or or, where applicable, correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have result in a Material Adverse EffectChange.

Tests and Preclinical and Clinical Studies. The Company has and its subsidiaries have operated and currently is are in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The preclinical and clinical studies conducted by or, to the Company’s knowledge, on behalf of the Company or its subsidiaries that are described in the Registration Statement and the Prospectus were, and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and all applicable laws and regulations; the preclinical studies conducted by or, to the Company’s knowledge, on behalf of the Company or its subsidiaries that are described in the Registration Statement and the Prospectus 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 and scientific standards for products or product candidates comparable to those being developed by the CompanyCompany and its subsidiaries; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge knowledge, on the behalf of the Company or its subsidiaries contained in the Registration Statement, the General Disclosure Package Statement and the Prospectus are accurate and complete in all material respects; the Company is not aware of any other trials or studies not described or referred to in the Registration Statement, the General Disclosure Package and the Prospectusstudies, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus; neither the Company is not nor any of its subsidiaries are in receipt of any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority that reasonably call into question the results of the trials or studies described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus; and neither the Company has not nor any of its subsidiaries have received any notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any tests or preclinical or clinical studiesstudies with respect to product candidates currently under development, or such notice or correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have a Material Adverse Effect.

Tests and Preclinical and Clinical Studies. The Company has operated and currently is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The preclinical and clinical studies conducted by or, to the Company’s knowledge, on behalf of the Company that are described in the Registration Statement and the Prospectus SEC Documents 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 and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge on the behalf of the Company contained in the Registration Statement, the General Disclosure Package and the Prospectus SEC Documents are accurate and complete in all material respects; the Company is not aware of any trials or studies not described or referred to in the Registration Statement, the General Disclosure Package and the ProspectusSEC Documents, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the ProspectusSEC Documents; the Company is not in receipt of any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority that reasonably call into question results of the trials or studies described or referred to in the Registration Statement, the General Disclosure Package and the ProspectusSEC Documents; and the Company has not received any notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any tests or preclinical or clinical studies, or such notice or correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have a Material Adverse Effect.

Tests and Preclinical and Clinical Studies. The Company has operated and currently is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The preclinical and clinical studies conducted by or, to the Company’s knowledge, on behalf of the Company that are described in the Registration Statement and the Prospectus were, and 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 and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge knowledge, on the behalf of the Company contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects; the Company is not aware of any trials or studies not described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company is not in receipt of any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority that reasonably call into question the results of the trials or studies described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; and the Company has not received any notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any tests or preclinical or clinical studies, or such notice or correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have a Material Adverse Effect.