Common use of Preclinical and Clinical Studies Clause in Contracts

Preclinical and 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 FDCA 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 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 Prospectus, 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 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, except for material modifications reflected in protocol amendments to clinical and preclinical trials arising from joint discussions with such Governmental Authority.

Preclinical and Clinical Studies. The studies, tests and preclinical and clinical investigations conducted by or on behalf of the Company and its subsidiaries 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 laws and authorizations, including, without limitation, the FDCA 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 Prospectus SEC Reports 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 ProspectusSEC Reports, 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 Prospectus SEC Reports 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 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, except for material modifications reflected in protocol amendments to clinical and preclinical trials arising from joint discussions with such Governmental Authority.

Preclinical and Clinical Studies. The studies, tests and preclinical studies and clinical investigations trials conducted by or on behalf of the Company that are described in the General Disclosure Package and its subsidiaries the Prospectus (the “Company Studies and Trials”) were and, if still pending, areare being, conducted in all material respectsrespects with all applicable federal, being conducted state and foreign laws, rules, orders and regulations, as well as 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 limitation, the FDCA 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 INDstandards; the descriptions of the results of such studies, tests the Company Studies and trials Trials contained in the Registration Statement General Disclosure Package and the Prospectus are accurate in all material respects and fairly present respects; the data derived from such studies, tests and trials; except to the extent disclosed Company has no Knowledge of any other studies or trials not described in the Registration Statement Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials the results of which are inconsistent with or call in question 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 General Disclosure Package and the Prospectus when viewed in the context in which such results are described Prospectus; and the clinical state of development; and neither the Company nor any of its subsidiaries have has not received any notices or correspondence from with the FDA or any Governmental Authority foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any studiesCompany Studies or Trials that termination, tests suspension or preclinical material modification would reasonably be expected to have a Material Adverse Effect. The Company has obtained (or clinical investigations conducted 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 (“HIPAA”) 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 subsidiariessuppliers are operated in compliance in all material respects with all applicable statutes, except for material modifications reflected in protocol amendments rules and regulations of the FDA and any comparable regulatory agencies outside of the United States to clinical and preclinical trials arising from joint discussions with such Governmental Authoritywhich the Company is subject.

Preclinical and Clinical Studies. The studies, tests and preclinical and clinical investigations studies conducted by or or, to the Company’s Knowledge, on behalf of or sponsored by the Company and or its subsidiaries, or in which the Company or its subsidiaries were andhave participated, that are described in the SEC Filings, or the results of which are referred to in the SEC Filings, were, and if still pending, pending are, in all material respects, being conducted in all material respects in accordance with established protocols, standard medical and scientific research standards and procedures and controls pursuant for products or product candidates comparable to accepted professional scientific standards those being developed by the Company and all applicable Laws and authorizations, including, without limitation, provisions of the FDCA 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 INDHealth Care Laws; the descriptions in the SEC Filings of the results of such studies, tests and trials contained in the Registration Statement and the Prospectus studies are accurate and complete descriptions in all material respects and fairly present the data derived from such studies, tests and trialstherefrom; except to the extent disclosed Company’s Knowledge, there are no studies not described in the Registration Statement and the ProspectusSEC Filings, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably are materially inconsistent with or call into question in any material respect, the study, test, or trial results described or referred to in the Registration Statement SEC Filings; the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable provisions of the Prospectus when viewed Health Care Laws including Good Clinical Practice and Good Laboratory Practice requirements, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; the Company has provided the Placement Agent with all material written notices, correspondence and summaries of all other communications from the clinical state of developmentApplicable Regulatory Authorities; and neither the Company nor any of its subsidiaries have received any notices written notices, correspondence or correspondence other communications from the Applicable Regulatory Authorities or any Governmental Authority other governmental agency requiring or threatening the termination, suspension or material modification or suspension of any studies, tests or preclinical or clinical investigations conducted by studies that are described in the SEC Filings or on behalf the results of which are referred to in the Company SEC Filings, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or any of its subsidiariestrials, except and, to the Company’s Knowledge, there are no reasonable grounds for material modifications reflected in protocol amendments to clinical and preclinical trials arising from joint discussions with such Governmental Authoritythe same.