Common use of Compliance with Healthcare Laws and Regulations Clause in Contracts

Compliance with Healthcare Laws and Regulations. (i) Except as described in the SEC Documents, the preclinical and clinical studies conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company or its Subsidiaries have participated, that are described in the SEC Documents, or the results of which are referred to in the SEC Documents, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the "Regulatory Authorities") and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the SEC Documents of the results of such studies are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies not described in SEC Documents, the results of which are inconsistent with or call into question the results described or referred to in the SEC Documents; (iv) the Company and its Subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and (v) neither the Company nor any of its Subsidiaries, to the Company's knowledge, have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical or clinical studies that are described in the SEC Documents or the results of which are referred to in the SEC Documents, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies, and, to the Company's knowledge, there are no reasonable grounds for the same. The Company has not failed to file with the Regulatory Authorities any required filing, declaration, listing, registration, report or submission with respect to the Company's product candidates that are described or referred to in the SEC Documents, except where such failure would not, individually or in the aggregate, have a Material Adverse Effect; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no deficiencies regarding compliance with applicable law have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Compliance with Healthcare Laws and Regulations. (i) Except as described in the SEC Documents, the preclinical and clinical studies conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its Subsidiariessubsidiaries, or in which the Company or its Subsidiaries subsidiaries have participated, that are described in the SEC Documents, or the results of which are referred to in the SEC Documents, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the "“Regulatory Authorities"”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the SEC Documents of the results of such studies are accurate and complete descriptions in all material respects and fairly present the data derived therefromthere-from; (iii) the Company has no knowledge of any other studies not described in SEC Documents, the results of which are inconsistent with or call into question the results described or referred to in the SEC Documents; (iv) the Company and its Subsidiaries subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and (v) neither the Company nor any of its Subsidiariessubsidiaries, to the Company's ’s knowledge, have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical or clinical studies that are described in the SEC Documents or the results of which are referred to in the SEC Documents, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies, and, to the Company's ’s knowledge, there are no reasonable grounds for the same. The Company has not failed to file with the Regulatory Authorities any required filing, declaration, listing, registration, report or submission with respect to the Company's ’s product candidates that are described or referred to in the SEC Documents, except where such failure would not, individually or in the aggregate, have a Material Adverse Effect; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no deficiencies regarding compliance with applicable law have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Compliance with Healthcare Laws and Regulations. (i) Except as described in the SEC DocumentsFilings, the preclinical and clinical studies conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company or its Subsidiaries have participated, that are described in the SEC Documentswere (and, or the results of which are referred to in the SEC Documents, were, and if still pending arepending, being are being) conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the "Regulatory “Healthcare Authorities"”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) . The descriptions of the descriptions protocols for, and data and other results of, such studies in the SEC Documents of Filings or otherwise provided to the results of such studies Investor are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the . The Company has no knowledge of any other studies not described in SEC DocumentsFilings, the results of which are inconsistent with or call into question the results described or referred to in the SEC Documents; (iv) the Filings. The Company and its Subsidiaries have operated at all times and are currently in compliance in all material respects with all statutes, rules and regulations applicable to the ownership, testing, development, marketing, promotion, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product manufactured or distributed by the Company or any of its Subsidiaries (including, without limitation, all statutes, rules and regulations of the Regulatory Healthcare Authorities, ) except where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and (v) neither . Neither the Company nor any of its Subsidiaries, to the Company's knowledge, Subsidiaries have received any written notices, correspondence or other communications from the Regulatory Healthcare Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical or clinical studies studies, tests or trials that are described in the SEC Documents Filings or the results of which are referred to in the SEC DocumentsFilings, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies, and, to the Company's ’s knowledge, there are no reasonable grounds for the same. The Company has not failed to file with the Regulatory Healthcare Authorities any required filing, declaration, listing, registration, report or submission with respect to the Company's ’s product candidates that are described or referred to in the SEC DocumentsFilings, except where such failure would not, individually or in the aggregate, have a Material Adverse Effect; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies regarding compliance with applicable law have been asserted by any applicable regulatory authority Healthcare Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.