Common use of FDA Compliance Clause in Contracts

FDA Compliance. (a) All products currently being manufactured, tested, developed, processed, labeled, stored or distributed by or on behalf of the Company or any of its Subsidiaries and which are subject to the jurisdiction of the FDA are being manufactured, tested, developed, processed, labeled, stored, distributed, and marketed in compliance in all material respects with all applicable Laws, guidances or orders administered or issued by the FDA or any other Governmental Entity, including without limitation, the FDA’s current Good Manufacturing Practice regulations. All applicable operations of the Company and each of its Subsidiaries have achieved and maintained ISO 13485 Quality System certification, and there is no pending or, to the Company’s Knowledge threatened, audit, repeal, failure to renew or challenge to any such certifications. All products being manufactured by the Company or any of its Subsidiaries are in compliance in all material respects with applicable registration, licensing and notification requirements required by applicable Law for each site at which a product of the Company or any of its Subsidiaries is manufactured. All pre-clinical and clinical trials being conducted by or on behalf of the Company or any of its Subsidiaries are being conducted in compliance in all material respects with all applicable Laws and guidances of the FDA or any other Governmental Entity, including without limitation, the FDA’s current Good Clinical Practice regulations and federal and state Laws, regulations and guidances restricting the use and disclosure of individually identifiable health information. Neither the Company nor any of its Subsidiaries is the subject, officially or otherwise, of any pending or threatened investigation by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Company’s Knowledge, neither the Company nor any of its Subsidiaries has committed any act, made any statement, or failed to make any statement that would provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities” and any amendments thereto. To the Company’s Knowledge, each product distributed, sold or leased, or service rendered, by the Company or any of its Subsidiaries complies in all material respects with all applicable product safety standards of each applicable product safety agency, commission, board or other Governmental Entity. (b) The Company and each of its Subsidiaries is in compliance in all material respects with all applicable FDA import and export requirements, including, but not limited to, import-for-export requirements, export notifications or authorizations and record keeping requirements.

FDA Compliance. (a) All products currently being manufactured, tested, developed, processed, labeled, stored or distributed by or on behalf of the Company Company, or any of its Subsidiaries and other Person pursuant to any arrangement with the Company, which are subject to the jurisdiction of the FDA FDA, are being manufactured, tested, developed, processed, labeled, stored, distributed, and marketed in compliance in all material respects with all applicable Applicable Laws, guidances or orders administered or issued by the FDA or any other Governmental EntityAuthority, including without limitation, the FDA’s current Good Manufacturing Practice regulations. All applicable operations of the Company and each of its Subsidiaries have achieved and maintained ISO 13485 Quality System certification, and there is no pending or, to the Company’s Knowledge threatened, audit, repeal, failure to renew or challenge to any such certificationsin all material respects. All products being manufactured by the Company Company, or any of its Subsidiaries other Person pursuant to any arrangement with the Company, are in compliance in all material respects with applicable registration, licensing and notification requirements required by applicable Applicable Law for each site at which a product of the Company or any of its Subsidiaries is manufactured. All pre-clinical and clinical trials being conducted by or on behalf of the Company Company, or any of its Subsidiaries other Person pursuant to any arrangement with the Company, are being conducted in compliance in all material respects with all applicable Applicable Laws and guidances of the FDA or any other Governmental EntityAuthority, including without limitation, the FDA’s current Good Clinical Practice regulations and federal and state Lawslaws, regulations and guidances restricting the use and disclosure of individually identifiable health information. Neither the Company nor Company, nor, to the Knowledge of the Company, any of its Subsidiaries Person manufacturing, marketing, distributing or developing products pursuant to any arrangement with the Company, is the subject, officially or otherwise, of any pending or threatened investigation by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) ), and any amendments thereto. To Neither the Company’s Knowledge, neither nor, to the Company nor Knowledge of the Company, any of its Subsidiaries Person marketing, distributing or developing products pursuant to any arrangement with the Company, has committed any act, made any statement, or failed to make any statement that would provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities” and any amendments thereto. To the Company’s Knowledge, each product distributed, sold or leased, or service rendered, by the Company or any of its Subsidiaries complies in all material respects with all applicable product safety standards of each applicable product safety agency, commission, board or other Governmental Entity. (b) The Company and each of its Subsidiaries is in compliance in all material respects with all applicable FDA import and export requirements, including, but not limited to, import-for-export requirements, export notifications or authorizations and record keeping requirements.”

FDA Compliance. (ai) All products currently being manufacturedThe Company holds all clearances, testedapprovals, developedregistrations, processedauthorizations, labeledand orders of any governmental or self-regulatory body required for the conduct of its business, stored except where the failure to hold would not, individually or distributed by or on behalf in the aggregate, have a Material Adverse Change. As of the date of this Agreement, the Company is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees, except where the failure to comply would not, individually or any of its Subsidiaries and which are subject to in the jurisdiction aggregate, result in a Material Adverse Change. Without limiting the foregoing, as of the FDA are being manufactureddate of this Agreement, testedthe Company is in compliance with all requirements of the FDA, developedincluding, processedamong other things, labeledthe provisions of the Federal Food, stored, distributedDrug, and marketed Cosmetic Act (“FDC”) relating to drugs or medical devices, except where such noncompliance would not result, individually or in the aggregate, in a Material Adverse Change. Each regulatory submission for the Company’s products has been filed, cleared and maintained in compliance in all material respects with all Applicable Laws and Authorizations, including without limitation applicable Lawsfederal statutes, guidances rules, regulations or orders administered or issued promulgated by the FDA or other Governmental Authority, and all laboratory, preclinical and clinical studies, and tests have been conducted in all material respects in compliance with accepted professional scientific standards and all Applicable Laws and Authorizations in all material respects. No filing or submission to the FDA or any other Governmental EntityAuthority, including without limitationintended to be the basis for any Authorization, contains any material omission or material false information, and the Company has not received any notices or correspondence from any Governmental Authority (including, but not limited to, the FDA’s current Good Manufacturing Practice regulations. All applicable operations ) requiring suspension of any studies, tests, or clinical trials conducted by or on behalf of the Company. The Company believes it has submitted all reports necessary to be submitted in accordance with the Medical Device Reporting regulations, 21 C.F.R. Part 803. (ii) The studies, tests and each of its Subsidiaries have achieved and maintained ISO 13485 Quality System certification, and there is no pending or, to the Company’s Knowledge threatened, audit, repeal, failure to renew or challenge to any such certifications. All products being manufactured by the Company or any of its Subsidiaries are in compliance in all material respects with applicable registration, licensing and notification requirements required by applicable Law for each site at which a product of the Company or any of its Subsidiaries is manufactured. All pre-clinical preclinical and clinical trials being conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus accurately describes the status and results of such studies, tests and trials. The Company has not received any notices or any of its Subsidiaries are being conducted in compliance in all material respects with all applicable Laws and guidances of correspondence from the FDA or other governmental agency, foreign or domestic, requiring the termination, suspension or material modification of any other Governmental Entitypreclinical or clinical trials conducted by, including without limitation, the FDA’s current Good Clinical Practice regulations and federal and state Laws, regulations and guidances restricting the use and disclosure of individually identifiable health information. Neither the Company nor any of its Subsidiaries is the subject, officially or otherwiseon behalf, of any pending or threatened investigation by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Company’s Knowledge, neither the Company nor any of its Subsidiaries has committed any act, made any statement, or failed to make any statement that would provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities” and any amendments thereto. To the Company’s Knowledge, each product distributed, sold or leased, or service rendered, by the Company or any of its Subsidiaries complies in all material respects with all applicable product safety standards of each applicable product safety agency, commission, board or other Governmental Entitywhich the Company has participated. (b) The Company and each of its Subsidiaries is in compliance in all material respects with all applicable FDA import and export requirements, including, but not limited to, import-for-export requirements, export notifications or authorizations and record keeping requirements.

FDA Compliance. (ai) All products currently being manufacturedThe Company holds all clearances, testedapprovals, developedregistrations, processedauthorizations, labeledand orders of any governmental or self-regulatory body required for the conduct of its business, stored except where the failure to hold would not, individually or distributed by or on behalf in the aggregate, result in a Material Adverse Change. As of the date of this Agreement, the Company is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees, except where the failure to comply would not, individually or any of its Subsidiaries and which are subject to in the jurisdiction aggregate, result in a Material Adverse Change. Without limiting the foregoing, as of the FDA are being manufactureddate of this Agreement, testedthe Company is in compliance with all requirements of the FDA, developedincluding, processedamong other things, labeledthe provisions of the Federal Food, stored, distributedDrug, and marketed Cosmetic Act (“FDC”) relating to medical devices, except where such noncompliance would not result, individually or in the aggregate, in a Material Adverse Change. Each regulatory submission for the Company’s products has been filed, cleared and maintained in compliance in all material respects with all Applicable Laws and Authorizations, including without limitation applicable Lawsfederal statutes, guidances rules, regulations or orders administered or issued promulgated by the FDA or any other Governmental Entity, including without limitation, the FDA’s current Good Manufacturing Practice regulations. All applicable operations of the Company and each of its Subsidiaries have achieved and maintained ISO 13485 Quality System certificationAuthority, and there is no pending orall laboratory, to the Company’s Knowledge threatened, audit, repeal, failure to renew or challenge to any such certifications. All products being manufactured by the Company or any of its Subsidiaries are in compliance in all material respects with applicable registration, licensing and notification requirements required by applicable Law for each site at which a product of the Company or any of its Subsidiaries is manufactured. All pre-clinical preclinical and clinical trials being studies, and tests conducted by or on behalf of the Company or any of its Subsidiaries are being have been conducted in compliance in material accordance with accepted professional scientific standards and all material respects with all applicable Applicable Laws and guidances of Authorizations. No filing or submission to the FDA or any other Governmental EntityAuthority, including without limitationintended to be the basis for any Authorization, the FDA’s current Good Clinical Practice regulations contains any material omission or material false information, and federal and state Laws, regulations and guidances restricting the use and disclosure of individually identifiable health information. Neither the Company nor has not received any of its Subsidiaries is the subject, officially notices or otherwise, of correspondence from any pending or threatened investigation by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 Governmental Authority (September 10, 1991) and any amendments thereto. To the Company’s Knowledge, neither the Company nor any of its Subsidiaries has committed any act, made any statement, or failed to make any statement that would provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities” and any amendments thereto. To the Company’s Knowledge, each product distributed, sold or leased, or service rendered, by the Company or any of its Subsidiaries complies in all material respects with all applicable product safety standards of each applicable product safety agency, commission, board or other Governmental Entity. (b) The Company and each of its Subsidiaries is in compliance in all material respects with all applicable FDA import and export requirements, including, but not limited to, import-for-export requirementsthe FDA) requiring suspension of any studies, export notifications tests, or authorizations clinical trials conducted by or on behalf of the Company. (ii) To the knowledge of the Company, the status and record keeping requirementsresults of any studies, tests and preclinical and clinical trials conducted by or on behalf of the Company that are disclosed in the Registration Statement and the Prospectus are accurately described. The Company has not received any notices or correspondence from the FDA or other governmental agency, foreign or domestic, requiring the termination, suspension or material modification of any preclinical or clinical trials conducted by, or on behalf, of the Company or in which the Company has participated.