Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The clinical and preclinical studies and tests conducted by the Company and its Subsidiaries and, to the knowledge of the Company, the clinical and preclinical studies conducted on behalf of or sponsored by the Company or its Subsidiaries, were, and if still pending, are, being conducted in all material respects in accordance with all 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 812. Any descriptions of clinical, preclinical and other studies and tests, including any related results and regulatory status, contained in the Registration Statement, the Prospectus and any Permitted Free Writing Prospectus are complete, accurate, and fairly represented in all material respects. Except as disclosed in the Registration Statement, the Prospectus and any Permitted Free Writing Prospectus and to the Company’s knowledge, there are no studies, tests or trials the result of which the Company believes reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Prospectus or any Permitted Free Writing Prospectus when viewed in the context in which such results are described and the clinical state of development. No marketing authorization, including any 510(k) clearance held by the Company, has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to 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 preclinical other studies and tests (collectively, “studies”) conducted by the Company and its Subsidiaries 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, to the knowledge of the Company, the clinical and preclinical studies conducted on behalf of or sponsored by the Company or its Subsidiaries, 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 Lawsapplicable 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 812. Any descriptions 312; each description of clinical, preclinical the results of such studies is accurate and other studies and tests, including any related results and regulatory status, contained in the Registration Statement, the Prospectus and any Permitted Free Writing Prospectus are complete, accurate, and fairly represented complete in all material respects. Except as disclosed in respects and fairly presents the Registration Statementdata 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 Prospectus and any Permitted Free Writing Prospectus and to the Company’s knowledge, there are no studies, tests or trials the result of which the Company believes reasonably call into 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 context in which Prospectus; the Company and its subsidiaries have made all such results are described filings and the clinical state of development. No marketing authorization, including any 510(k) clearance held obtained all such approvals as may be required by the CompanyFood 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’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 conducted by the Company and its Subsidiaries and, to the knowledge of the Company, the clinical and preclinical studies conducted on behalf of or sponsored by the Company or its Subsidiaries, were, and if still pending, are, being conducted in all material respects in accordance with all 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 812. Any descriptions of clinical, preclinical and other studies and tests, including any related results and regulatory status, contained in the Registration Statement, the Prospectus and any Permitted Free Writing Prospectus SEC Documents are complete, accurate, and fairly represented in all material respects. Except as disclosed in the Registration Statement, the Prospectus and any Permitted Free Writing Prospectus SEC Documents and to the Company’s knowledge, there are no studies, tests or trials the result of which the Company believes reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Prospectus or any Permitted Free Writing Prospectus SEC Documents when viewed in the context in which such results are described and the clinical state of development. No marketing authorization, including any 510(k) clearance held by the Company, has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to 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 clinical and preclinical studies and tests conducted by the Company and its Subsidiaries subsidiaries and, to the knowledge of the Company, the clinical and preclinical studies conducted on behalf of or sponsored by the Company or its Subsidiariessubsidiaries, were, and if still pending, are, being conducted in all material respects in accordance with all Applicable applicable Health Care 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 812. Any descriptions of clinical, preclinical and other studies and tests, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale Disclosure Package, the Prospectus and any Permitted Free Writing Prospectus are complete, accurate, and fairly represented in all material respects. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package, the Prospectus and any Permitted Free Writing Prospectus and to the Company’s knowledge, there are no studies, tests or trials the result of which the Company believes reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Prospectus or any Permitted Free Writing Prospectus when viewed in the context in which such results are described and the clinical state of developmentProspectus. No marketing authorization, including any 510(k) clearance held by the Company, has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to 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 preclinical tests and clinical trials, and preclinical other studies (collectively, “studies”) that are described in, or the results of which are described in, the Registration Statement and tests conducted by the Company and its Subsidiaries Prospectus were and, to the knowledge of the Company, the clinical and preclinical studies conducted on behalf of or sponsored by the Company or its Subsidiaries, were, and if still pending, are, are being conducted in all material respects in accordance with all Applicable applicable Health Care 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 812312. Any descriptions of clinical, preclinical and other the results of such studies and tests, including any related results and regulatory status, contained in the Registration Statement, Statement or the Prospectus are accurate and any Permitted Free Writing Prospectus are complete, accurate, and fairly represented complete in all material respects. Except as disclosed set forth in the Registration StatementStatement or the Prospectus, the Prospectus and Company has no knowledge of any Permitted Free Writing Prospectus and to other bona fide studies the Company’s knowledge, there are no studies, tests or trials the result results of which the Company believes reasonably are inconsistent with, or otherwise call into question in any material respect respect, the clinical trial results described or referred to in the Registration Statement, Statement or the Prospectus or any Permitted Free Writing Prospectus when viewed Prospectus. Except as set forth in the context in which such results are described and Registration Statement or the clinical state Prospectus, no investigational new drug application filed by or on behalf of development. No marketing authorization, including any 510(k) clearance held by the Company, Company with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory 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. 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 conducted by the Company and its Subsidiaries and, to the knowledge of the Company, the clinical and preclinical studies conducted on behalf of or sponsored by the Company or its SubsidiariesCompany, were, and if still pending, are, being conducted in all material respects in accordance with all Applicable applicable Health Care 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 812. Any descriptions of clinical, preclinical and other studies and tests, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale Disclosure Package, the Final Prospectus and any Permitted Free Writing Prospectus are complete, accurate, and fairly represented in all material respects. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package, the Final Prospectus and any Permitted Free Writing Prospectus and to the Company’s knowledge, there are no studies, tests or trials the result of which the Company believes reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Prospectus or any Permitted Free Writing Prospectus when viewed in the context in which such results are described and the clinical state of developmentProspectus. No marketing authorization, including any 510(k) clearance held by the Company, has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to 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.