Common use of Clinical Studies Clause in Contracts

Clinical Studies. The studies, tests and preclinical and clinical investigations conducted by or on behalf of the Company and its Subsidiaries were and, if still pending, are, in all material respects, being conducted in accordance with established protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an IND; the descriptions of the results of such studies, tests and trials contained in the Registration Statement and the Prospectuses are accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement and the Prospectuses, 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 and the Prospectuses when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its Subsidiaries have received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical investigations conducted by or on behalf of the Company or any of its Subsidiaries.

Clinical Studies. The studies, tests and preclinical and clinical investigations conducted by or on behalf of the Company and its Subsidiaries were and, if still pending, are, in all material respects, being conducted in accordance with established protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an IND; the descriptions of the results of such studies, tests and trials contained in the Registration Statement and the Prospectuses Prospectus are accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement and the ProspectusesProspectus, 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 and the Prospectuses Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its Subsidiaries have received any notices or correspondence from any Governmental Authority governmental authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical investigations conducted by or on behalf of the Company or any of its Subsidiaries.

Clinical Studies. The studies, tests and preclinical and clinical investigations trials conducted by or on behalf of the Company and its Subsidiaries subsidiaries that are material to the Company and its subsidiaries taken as a whole were and, if still pending, are, in all material respects, being conducted in accordance with established experimental protocols, procedures and controls pursuant to accepted professional and scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND requirements (at 21 C.F.R. Parts 50, 54, 56, 58 and 312) if any such studies812; the approved Investigational Device Exemption applications, tests and other applicable federal, state, local or preclinical foreign government or regulatory requirements, and clinical investigations were or are the rules, regulations, requirements, and guidelines regarding human subject to good clinical practice regulations or were or are being conducted under an INDprotections; the descriptions of the results of such studies, tests and trials contained in the Registration Statement Statement, the General Disclosure Package and the Prospectuses Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement Statement, the General Disclosure Package and the ProspectusesProspectus, 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 Statement, the General Disclosure Package and the Prospectuses Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its Subsidiaries subsidiaries have received any notices or correspondence from any Governmental Authority Entity requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical investigations trials conducted or being conducted by or on behalf of the Company or any of its Subsidiariessubsidiaries that are material to the Company and its subsidiaries taken as a whole.

Clinical Studies. The To the Company’s knowledge, the studies, tests and preclinical and clinical investigations conducted by or on behalf of the Company and its Subsidiaries described in the Prospectus were and, if still pending, are, in all material respects, being conducted in accordance with established protocols, procedures and controls pursuant to to, where applicable, accepted professional scientific standards for products or product candidates comparable to those being developed by the Company, and all Applicable Laws (as defined below) and AuthorizationsAuthorizations (as defined below), including, without limitation, the Federal Food, Drug, and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND Investigational New Drug Application (an “IND”) requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an IND; the descriptions of the results of such studies, tests and trials contained in the Registration Statement and the Prospectuses Prospectus are accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement and the ProspectusesProspectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question question, in any material respect, the study, test, or trial results described or referred to in the Registration Statement and the Prospectuses Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its Subsidiaries subsidiaries have received any written notices or correspondence from any Governmental Authority governmental authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical investigations conducted by or on behalf of the Company or any of its Subsidiariessubsidiaries.

Clinical Studies. The studiesclinical trials, pre-clinical trials and other studies and tests and preclinical and clinical investigations conducted by or on behalf of or sponsored by the Company that are described in the Registration Statement, the Time of Sale Disclosure Package and its Subsidiaries the Prospectus were and, if still pending, are, in all material respects, are being conducted in material compliance with all applicable federal, state or foreign statutes, laws, rules and regulations (including, without limitation, those administered by the United States Food and Drug Administration (the “FDA”) or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA and current Good Laboratory and Good Clinical Practices) and in accordance with established experimental protocols, procedures and controls pursuant to to, where applicable, accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitationmethods. The descriptions in the Registration Statement, the Federal Food, Drug, Time of Sale Disclosure Package and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an IND; the descriptions Prospectus of the results of such studies, tests and trials contained in the Registration Statement and the Prospectuses are accurate and complete in all material respects and fairly present the published data derived from such studies, tests and trials; except . Except to the extent disclosed in the Registration Statement Statement, the Time of Sale Disclosure Package and the ProspectusesProspectus, the Company is not aware of any studies, tests or trials trials, the results of which the Company believes reasonably call into question the study, test, test or trial results described in or referred to in the Registration Statement Statement, the Time of Sale Disclosure Package and the Prospectuses Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the . The Company nor any of its Subsidiaries have has not received any notices or other correspondence from the FDA or any Governmental Authority other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of any such studies, tests or preclinical or clinical investigations conducted by or on behalf of the Company or any of its Subsidiariestrials.

Clinical Studies. The studiesTo the Company’s knowledge, the clinical and/or preclinical studies and tests and preclinical and clinical investigations conducted by or on behalf of trials described in the Company and its Subsidiaries were Prospectus were, and, if still pending, areare being, to the Company’s knowledge, conducted in all material respects, being conducted respects in accordance with established the experimental protocols, procedures and controls pursuant to to, where applicable, accepted professional and scientific standards and all Applicable Laws and Authorizationsfor products or product candidates comparable to those being developed by the Company or its Subsidiaries, including, without limitation, the Federal Food, Drug, and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if except for any such studies, tests or preclinical and clinical investigations are being conducted pursuant failures to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an IND; the descriptions of the results of conduct such studies, tests and trials contained in accordance with such protocols, procedures and controls as would not, individually or in the Registration Statement and the Prospectuses are accurate aggregate, reasonably be expected to result in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement and the Prospectuses, a Material Adverse Effect. Neither the Company is not nor any of its Subsidiaries are aware of any studiesclinical and/or preclinical tests, tests studies or trials not described in 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 and the Prospectuses when viewed in the context in which such results are described and the clinical state of developmentProspectus; and neither the Company nor any of its Subsidiaries have received any notices written notice or correspondence from the FDA or any Governmental Authority foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring the termination, suspension suspension, clinical hold or material modification of any studiestests, tests studies or trials. The Company and its Subsidiaries have conducted, and currently are conducting, all research, development, production and clinical and/or preclinical studies in accordance, in all material respects, with Current Good Tissue Practices, Good Clinical Practices and Good Laboratory Practices as issued by the FDA, and in accordance, in all material respects, with the parameters and guidelines of any applicable research or clinical investigations conducted development grant program, whether awarded by a governmental or on behalf of the Company or any of its Subsidiariesprivate entity.

Clinical Studies. The studies, tests and preclinical and clinical investigations trials conducted by or on behalf of the Company and its Subsidiaries were and, if still pendingongoing, are, are being conducted in all material respects, being conducted respects in accordance with established experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act and implementing the rules and regulations including good laboratory practice promulgated thereunder (“GLP”) regulations (21 C.F.R. Part 58) if any such studiescollectively, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an IND"FFDCA"); the descriptions of the results of such studies, tests and trials contained in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectuses Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusesProspectus, the Company is not aware of any studies, tests or trials 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 Statement, the Pricing Disclosure Package and the Prospectuses Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company nor any of its Subsidiaries have has not received any notices or correspondence from the FDA or any Governmental Authority other federal, state, local or foreign governmental or regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical investigations trials conducted by or on behalf of the Company or any of its SubsidiariesCompany.

Clinical Studies. The studies, tests and preclinical and clinical investigations conducted by or on behalf of the Company and its Subsidiaries were and, if still pending, are, in all material respects, being conducted in accordance with established protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an IND; the descriptions of the results of such studies, tests and trials contained in the Registration Statement and the Prospectuses Prospectus are accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement and the ProspectusesProspectus, 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 and the Prospectuses Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its Subsidiaries have received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical investigations conducted by or on behalf of the Company or any of its Subsidiaries.

Clinical Studies. The studies, tests and preclinical and No clinical investigations trials have been conducted by or on behalf of the Company or its subsidiaries. The preclinical studies and tests conducted by or on behalf of the Company or its Subsidiaries were subsidiaries have been and, if still pending, are, are being conducted in all material respects, being conducted in accordance with established protocols, procedures and controls respects pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, includingas well as any conditions of approval and policies imposed by any applicable institutional review board, without limitation, the Federal Food, Drugany other applicable ethics review board or committee, and Cosmetic Act any institution at which the preclinical studies and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an INDhave been conducted; the descriptions of the results of such studies, preclinical studies and tests and trials contained in the Registration Statement and the Prospectuses Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests preclinical studies and trialstests; except to the extent disclosed in the Registration Statement and the ProspectusesProspectus, the Company is not aware of any studiespreclinical trials, tests or trials the results of which the Company believes reasonably call into question the studyresearch, test, nonclinical or trial preclinical study or test results described or referred to in the Registration Statement and the Prospectuses Prospectus when viewed in the context in which such results are described described; and the clinical state of development; Company and neither the Company nor any of its Subsidiaries subsidiaries have not received any written notices or correspondence from any Governmental Authority federal or state governmental agency, any foreign regulatory agency, any applicable institutional review board, any other applicable ethics review board or committee or any institution at which the preclinical studies and tests have been conducted requiring the termination, suspension or material modification of any studiespreclinical study or test conducted by, tests or preclinical or clinical investigations conducted by in collaboration with or on behalf of the Company or any of its Subsidiariessubsidiaries.

Clinical Studies. The studies, tests and preclinical and clinical investigations trials conducted by or on behalf of the Company and its Subsidiaries that are material to the Company and its Subsidiaries taken as a whole were and, if still pending, are, in all material respects, being conducted in accordance with established experimental protocols, procedures and controls pursuant to accepted professional and scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted pursuant to GLP, and good clinical practice and IND requirements (at 21 C.F.R. Parts 50, 54, 56, 58 and 312) if any such studies812, tests the approved Investigational Device Exemption applications, and other applicable federal, state, local or preclinical foreign government or regulatory requirements, and clinical investigations were or are the rules, regulations, requirements, and guidelines regarding human subject to good clinical practice regulations or were or are being conducted under an INDprotections; the descriptions of the results of such studies, tests and trials contained in the Registration Statement Statement, the General Disclosure Package and the Prospectuses Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement Statement, the General Disclosure Package and the ProspectusesProspectus, 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 Statement, the General Disclosure Package and the Prospectuses Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its Subsidiaries have received any notices or correspondence from any Governmental Authority Entity requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical investigations trials conducted or being conducted by or on behalf of the Company or any of its SubsidiariesSubsidiaries that are material to the Company and its Subsidiaries taken as a whole.

Clinical Studies. The studies, tests and preclinical and clinical investigations conducted by or on behalf of the Company and its Subsidiaries were and, if still pending, are, in all material respects, being conducted in accordance with established protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being or have been conducted pursuant to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations or were or are being conducted under an IND; the descriptions of the results of such studies, tests and trials contained in the Registration Statement and the Prospectuses Prospectus are accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement and the ProspectusesProspectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect, the study, test, or trial results described or referred to in the Registration Statement and the Prospectuses Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its Subsidiaries have received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical investigations conducted by or on behalf of the Company or any of its Subsidiaries.