Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, and with respect to those studies not conducted by the Company are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies, and all applicable Health Care Laws (as defined below), including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

Clinical Data and Regulatory Compliance. The clinical and preclinical studies and tests and clinical trials, and other studies (collectively, “studies”) conducted by the Company that are described inand its Subsidiaries and, or to the results knowledge of which are referred to inthe Company, the Registration Statementclinical and preclinical studies conducted on behalf of or sponsored by the Company or its Subsidiaries, the Time of Sale Prospectus or the Prospectus were andwere, and if still pending, are, and with respect to those studies not conducted by the Company are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies, and all applicable Health Care Laws (as defined below)Applicable Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description 812. Any descriptions of clinical, preclinical and other studies and tests, including any related results and regulatory status, contained in the results of such studies is accurate Registration Statement, the Prospectus and complete any Permitted Free Writing Prospectus are complete, accurate, and fairly represented in all material respects respects. Except as disclosed in the Registration Statement, the Prospectus and fairly presents any Permitted Free Writing Prospectus and to the data derived from such Company’s knowledge, there are no studies, and tests or trials the result of which the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise believes reasonably call into question, question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale Prospectus or any Permitted Free Writing Prospectus when viewed in the Prospectus; context in which such results are described and the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required clinical state of development. No marketing authorization, including any 510(k) clearance held by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyCompany, or health care facility Institutional Review Board; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the knowledge of the Company’s knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiariesSubsidiaries.

Clinical Data and Regulatory Compliance. The clinical and preclinical studies and tests and clinical trials, and other studies (collectively, “studies”) conducted by the Company that are described inand its Subsidiaries and, or to the results knowledge of which are referred to inthe Company, the Registration Statementclinical and preclinical studies conducted on behalf of or sponsored by the Company or its Subsidiaries, the Time of Sale Prospectus or the Prospectus were andwere, and if still pending, are, and with respect to those studies not conducted by the Company are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies, and all applicable Health Care Laws (as defined below)Applicable Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description 812. Any descriptions of clinical, preclinical and other studies and tests, including any related results and regulatory status, contained in the results of such studies is accurate SEC Documents are complete, accurate, and complete fairly represented in all material respects respects. Except as disclosed in the SEC Documents and fairly presents to the data derived from such Company’s knowledge, there are no studies, and tests or trials the result of which the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise believes reasonably call into question, question in any material respect the clinical trial results described or referred to in the Registration StatementSEC Documents when viewed in the context in which such results are described and the clinical state of development. No marketing authorization, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required including any 510(k) clearance held by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyCompany, or health care facility Institutional Review Board; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the knowledge of the Company’s knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiariesSubsidiaries.

Clinical Data and Regulatory Compliance. The clinical and preclinical studies and tests and clinical trials, and other studies (collectively, “studies”) conducted by the Company that are described inand its subsidiaries and, or to the results knowledge of which are referred to inthe Company, the Registration Statementclinical and preclinical studies conducted on behalf of or sponsored by the Company or its subsidiaries, the Time of Sale Prospectus or the Prospectus were andwere, and if still pending, are, and with respect to those studies not conducted by the Company are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies, and all applicable Health Care Laws (as defined below)Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description 812. Any descriptions of clinical, preclinical and other studies and tests, including any related results and regulatory status, contained in the results Registration Statement, the Time of such studies is accurate Sale Disclosure Package, the Prospectus and complete any Permitted Free Writing Prospectus are complete, accurate, and fairly represented in all material respects respects. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package, the Prospectus and fairly presents any Permitted Free Writing Prospectus and to the data derived from such Company’s knowledge, there are no studies, and tests or trials the Company and its subsidiaries have no knowledge of any other studies the results result of which are inconsistent with, or otherwise reasonably call into question, question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale Prospectus or the any Permitted Free Writing Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required . No marketing authorization, including any 510(k) clearance held by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyCompany, or health care facility Institutional Review Board; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the knowledge of the Company’s knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by the Company that are described in, or the results of which are referred to described in, the Registration Statement, the Time of Sale Prospectus or Statement and the Prospectus were and, if still pending, are, and with respect to those studies not conducted by the Company are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies, and all applicable Health Care Laws (as defined below)Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description . Any descriptions of the results of such studies is contained in the Registration Statement or the Prospectus are accurate and complete in all material respects and fairly presents respects. Except as set forth in the data derived from such studiesRegistration Statement or the Prospectus, and the Company and its subsidiaries have has no knowledge of any other bona fide studies the results of which are inconsistent with, or otherwise call into questionquestion in any material respect, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; . Except as set forth in the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by Registration Statement or the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyProspectus, or health care facility Institutional Review Board; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company. Any certificate signed by an officer of the Company and delivered to the Agent or any of its subsidiariesto counsel for the Agent pursuant to or in connection with this Agreement shall be deemed to be a representation and warranty by the Company, as applicable, to the Agent as to the matters set forth therein.

Clinical Data and Regulatory Compliance. The clinical and preclinical studies and tests and clinical trials, and other studies (collectively, “studies”) conducted by the Company that are described inand, or to the results knowledge of which are referred to inthe Company, the Registration Statementclinical and preclinical studies conducted on behalf of or sponsored by the Company, the Time of Sale Prospectus or the Prospectus were andwere, and if still pending, are, and with respect to those studies not conducted by the Company are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies, and all applicable Health Care Laws (as defined below)Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description 812. Any descriptions of clinical, preclinical and other studies and tests, including any related results and regulatory status, contained in the results Registration Statement, the Time of such studies is accurate Sale Disclosure Package, the Final Prospectus and complete any Permitted Free Writing Prospectus are complete, accurate, and fairly represented in all material respects respects. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package, the Final Prospectus and fairly presents any Permitted Free Writing Prospectus and to the data derived from such Company’s knowledge, there are no studies, and tests or trials the Company and its subsidiaries have no knowledge of any other studies the results result of which are inconsistent with, or otherwise reasonably call into question, question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale Prospectus or the any Permitted Free Writing Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required . No marketing authorization, including any 510(k) clearance held by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyCompany, or health care facility Institutional Review Board; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the knowledge of the Company’s knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiariesCompany.