Common use of FDA and Global Regulation Compliance Clause in Contracts

FDA and Global Regulation Compliance. (a) The Company has obtained each federal, state, county, local or non-U.S. Company Permit (including all those that may be required by the Federal Food and Drug Administration (the "FDA") or any other Governmental Authority engaged in the regulation of the Company's products, the Company or the Company's manufacturing and other quality systems) that is required for or has been applied for in operating the Company in any location in which it is currently operated and all of such Permits are in full force and effect. Section 3.20 of the Company Disclosure Schedule lists all regulatory filing requirements that are required to be filed within six months after the Closing Date in order to maintain the Permits. The Company has not received any notice or written communication from any Governmental Authority regarding, and, to the Knowledge of the Company, there are no facts or circumstances that are likely to give rise to, (i) any violation of applicable Law or material adverse change in any Permit, or any failure to materially comply with any applicable Law or any term or requirement of any Permit or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or modification of any Permit. No such Permit will be terminated or impaired, or will become terminable, in whole or in part, as a result of the consummation of the transactions contemplated by this Agreement. (b) The operation of the Company, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of all products, is and at all times has been in material compliance with all applicable Laws, Permits, Governmental Authorities and orders including those administered by the FDA for products sold in the United States. There is no actual or, to the Knowledge of the Company, threatened material action or investigation in respect of the Company by the FDA or any other Governmental Authority which [+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES has jurisdiction over the manufacturing, operations, properties, products or processes of the Company or by any third parties acting on the Company's behalf. Company has no Knowledge that any Governmental Authority is considering such action or of any facts or circumstances that are likely to give rise to any such action or investigation. (c) Except as set forth in Section 3.20 of the Company Disclosure Schedule, neither Company, nor to the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for Company, has had any product or manufacturing site subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, "warning letters," "untitled letters" or, to the Knowledge of the Company, requests or requirements to make changes to the operations of the Company or products that if not complied with would reasonably be expected to result in a Material Adverse Effect, or similar correspondence or written notice from the FDA or other Governmental Authority in respect of the Company, or to the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for Company, and alleging or asserting noncompliance with any applicable Laws, Permits or such requests or requirements of a Governmental Authority, and, to the Knowledge of the Company, neither the FDA nor any Governmental Authority is considering such action. Except as set forth in Section 3.20(c)of the Company Disclosure Schedule, no vigilance report or adverse event report with respect to the products has been reported to the Company, or, to the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for Company, and to the Knowledge of the Company, no vigilance report or adverse event report is under investigation by any Governmental Authority with respect to the products or the Company. (d) All studies, tests and preclinical and clinical trials being conducted by or on behalf of the Company that have been or will be submitted to any Governmental Authority, including the FDA and its counterparts worldwide, including in the European Union, in connection with any Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable local, state, federal and foreign Laws, rules and regulations, including the applicable requirements of Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices and the U.S. Food, Drug and Cosmetic Act of 1938 and its implementing regulations, including 21 CFR Parts 50, 54, 56, 58, 210, and 211. The Company has not received any notices, correspondence or other communication in respect of the Company from the FDA or any other Governmental Authority requiring the termination or suspension of any clinical trials conducted by, or on behalf of, Company or in which Company has participated, and to the Knowledge of the Company neither the FDA nor any other Governmental Authority is considering such action. The Company has not received specific written notification from a Governmental Authority of the rejection of data obtained from any clinical trials conducted by, or on behalf of, Company or in which Company has participated with respect to the Company or its products, which data was submitted to the Governmental Authority and which was necessary to obtain regulatory approval of a particular product. (e) The manufacture of products by, or on behalf of, the Company is being conducted in compliance in all material respects with all applicable Laws including the FDA's Good Manufacturing Practices at 21 CFR §§210-211 and applicable guidelines for products sold in the United States, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. [+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES (f) Company is not the subject of any pending or, to the Knowledge of the Company, threatened investigation in respect of the Company 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. The Company has not committed any act, made any statement, or failed to make any statement, in each case in respect of the Company and 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. Neither Company nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Law. To the Knowledge of the Company, no debarment or exclusionary claims, actions, proceedings or investigations in respect of the Company are pending or threatened against the Company or any of its officers, employees or agents.

FDA and Global Regulation Compliance. (a) The Company has obtained each federal, state, county, local or non-U.S. Company Permit (including all those that may be required by the Federal Food and Drug Administration (the "FDA") or any other Governmental Authority engaged in the regulation of the Company's products, the Company or the Company's manufacturing and other quality systems) that is required for or has been applied for in operating the Company in any location in which it is currently operated and all of such Permits are in full force and effect. Section 3.20 of the Company Disclosure Schedule lists all regulatory filing requirements that are required to be filed within six months after the Closing Date in order to maintain the Permits. The Company has not received any notice or written communication from any Governmental Authority regarding, and, to the Knowledge of the Company, there are no facts or circumstances that are likely to give rise to, (i) any violation of applicable Law or material adverse change in any Permit, or any failure to materially comply with any applicable Law or any term or requirement of any Permit or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or modification of any Permit. No such Permit will be terminated or impaired, or will become terminable, in whole or in part, as a result of the consummation of the transactions contemplated by this Agreement. (b) The operation of the Company, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of all products, is and at all times has been in material compliance with all applicable Laws, Permits, Governmental Authorities and orders including those administered by the FDA for products sold in the United States. There is no actual or, to the Knowledge of the Company, threatened material action or investigation in respect of the Company by the FDA or any other Governmental Authority which [+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES has jurisdiction over the manufacturing, operations, properties, products or processes of the Company or by any third parties acting on the Company's behalf. Company has no Knowledge that any Governmental Authority is considering such action or of any facts or circumstances that are likely to give rise to any such action or investigation. (c) Except as set forth in Section 3.20 of the Company Disclosure Schedule, neither Company, nor to the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for Company, has had any product or manufacturing site subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, "warning letters," "untitled letters" or, to the Knowledge of the Company, requests or requirements to make changes to the operations of the Company or products that if not complied with would reasonably be expected to result in a Material Adverse Effect, or similar correspondence or written notice from the FDA or other Governmental Authority in respect of the Company, or to the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for Company, and alleging or asserting noncompliance with any applicable Laws, Permits or such requests or requirements of a Governmental Authority, and, to the Knowledge of the Company, neither the FDA nor any Governmental Authority is considering such action. Except as set forth in Section 3.20(c)of 3.20(c) of the Company Disclosure Schedule, no vigilance report or adverse event report with respect to the products has been reported to the Company, or, to the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for Company, and to the Knowledge of the Company, no vigilance report or adverse event report is under investigation by any Governmental Authority with respect to the products or the Company. (d) All studies, tests and preclinical and clinical trials being conducted by or on behalf of the Company that have been or will be submitted to any Governmental Authority, including the FDA and its counterparts worldwide, including in the European Union, in connection with any Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable local, state, federal and foreign Laws, rules and regulations, including the applicable requirements of Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices and the U.S. Food, Drug and Cosmetic Act of 1938 and its implementing regulations, including 21 CFR Parts 50, 54, 56, 58, 210, and 211. The Company has not received any notices, correspondence or other communication in respect of the Company from the FDA or any other Governmental Authority requiring the termination or suspension of any clinical trials conducted by, or on behalf of, Company or in which Company has participated, and to the Knowledge of the Company neither the FDA nor any other Governmental Authority is considering such action. The Company has not received specific written notification from a Governmental Authority of the rejection of data obtained from any clinical trials conducted by, or on behalf of, Company or in which Company has participated with respect to the Company or its products, which data was submitted to the Governmental Authority and which was necessary to obtain regulatory approval of a particular product. (e) The manufacture of products by, or on behalf of, the Company is being conducted in compliance in all material respects with all applicable Laws including the FDA's Good Manufacturing Practices at 21 CFR §§210-211 and applicable guidelines for products sold in the United States, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. [+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES. (f) Company is not the subject of any pending or, to the Knowledge of the Company, threatened investigation in respect of the Company 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. The Company has not committed any act, made any statement, or failed to make any statement, in each case in respect of the Company and 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. Neither Company nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Law. To the Knowledge of the Company, no debarment or exclusionary claims, actions, proceedings or investigations in respect of the Company are pending or threatened against the Company or any of its officers, employees or agents.

FDA and Global Regulation Compliance. (a) The Company Seller and each of the Transferred Subsidiaries has obtained each federal, state, county, local or non-U.S. Company Business Permit (including all those that may be required by the Federal Food and Drug Administration (the "FDA") or any other Governmental Authority engaged in the regulation of the Company's productsProducts, the Company Business or the CompanyBusiness's manufacturing and other quality systems) that is required for or has been applied for in operating the Company Business in any location in which it is currently operated and all of such Business Permits are in full force and effect. Section 3.20 5.23(a) of the Company Disclosure Schedule Letter lists all annual manufacturing registration and device listing, annual reports and similar regulatory filing requirements that are required to be filed within six months after the Closing Offer Date in order to maintain Business Permits and manufacturing facility licenses and where failure to timely file would result in a Seller Material Adverse Effect. Neither Seller nor any of the Permits. The Company Transferred Subsidiaries has not received any notice or written communication with respect to the Business from any Governmental Authority regarding, and, to the Knowledge of the Company, there are no facts or circumstances that are likely to give rise to, (i) any violation of applicable Law or material adverse change in any Business Permit, or any failure to materially comply with any applicable Law or any term or requirement of any Business Permit or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or modification of any Business Permit. No such Business Permit will be terminated or impaired, or will become terminable, in whole or in part, as a result of the consummation of the transactions contemplated by this Agreement. (b) The operation of the CompanyBusiness, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of all productsProducts, is and at all times has been in material compliance with all applicable Laws, Business Permits, Governmental Authorities and orders including those administered by the FDA for products sold in the United States. There is no actual or, to the Knowledge of the CompanySeller, threatened material action or investigation in respect of the Company Business by the FDA or any other Governmental Authority which [+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES has jurisdiction over the manufacturing, operations, properties, products or processes of the Company Business or the Transferred Subsidiaries, or, to the Knowledge of Seller, by any third parties acting on the Company's their behalf. Company Seller has no Knowledge that any Governmental Authority is considering such action or of any facts or circumstances that are likely to give rise to any such action or investigation. (c) Except as set forth in Section 3.20 5.23(c) of the Company Disclosure ScheduleLetter, during the three (3) year period ending on the Offer Date, neither Company, Seller nor to the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for Company, Transferred Subsidiary has had any product or manufacturing site subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, "warning letters," "untitled letters" or, to the Knowledge of the CompanySeller, requests or requirements to make changes to the operations of the Company Business or products Products that if not complied with would reasonably be expected to result in a Seller Material Adverse Effect, or similar correspondence or written notice from the FDA or other Governmental Authority in respect of the Company, or to the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for Company, Business and alleging or asserting noncompliance with any applicable Laws, Business Permits or such requests or requirements of a Governmental Authority, and, to the Knowledge of the CompanySeller, neither the FDA nor any Governmental Authority is considering such action. Except as set forth in Section 3.20(c)of 5.23(c) of the Company Disclosure ScheduleLetter, no vigilance report or adverse event medical device report with respect to the products Business or the Products has been reported to Seller during the Company, or, to 90 day period ending on the Knowledge of the Company, any third party acting on Company's behalf with respect to services conducted for CompanyOffer Date, and to the Knowledge of Seller, as of the Company, Offer Date no vigilance report or adverse event medical device report is under investigation by any Governmental Authority with respect to the products Products or the CompanyBusiness. (d) All studies, tests and preclinical and clinical trials in respect of the Business being conducted by or on behalf of the Company Seller or any Transferred Subsidiary that have been or will be submitted to any Governmental Authority, including the FDA and its counterparts worldwide, including in the European Union, in connection with any Business Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable local, state, federal and foreign Laws, rules and regulations, including the applicable requirements of Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices and the U.S. Food, Drug and Cosmetic Act of 1938 and its implementing regulations, including 21 CFR Parts 50, 54, 56, 58, 210, and 211812. The Company Neither Seller nor any Transferred Subsidiary has not received any notices, correspondence or other communication in respect of the Company Business from the FDA or any other Governmental Authority requiring the termination or suspension of any clinical trials conducted by, or on behalf of, Company Seller or in which Company Seller has participated, and to the Knowledge of the Company Seller neither the FDA nor any other Governmental Authority is considering such action. The Company During the six month period ending on the Offer Date, neither Seller nor any Transferred Subsidiary has not received specific written notification from a Governmental Authority of the rejection of data obtained from any clinical trials conducted by, or on behalf of, Company Seller or in which Company Seller has participated with respect to the Company Business or its productsProducts, which data was submitted to the Governmental Authority and which was necessary to obtain regulatory approval of a particular productProduct. (e) The manufacture of products Products by, or on behalf of, the Company Seller or any Transferred Subsidiary is being conducted in compliance in all material respects with all applicable Laws including the FDA's Good Manufacturing Practices Quality Systems Regulation at 21 CFR §§210-211 and applicable guidelines Part 820 for products sold in the United States, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. [+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSESSeller and each of the Transferred Subsidiaries, and, to the Knowledge of Seller, any third party assembler, sterilizer or manufacturer of Products, components or accessories, are in material compliance with all applicable Laws and certifications currently held by Seller governing quality systems, manufacturing processes and all other quality standards, registration and listing requirements governing those third parties' activities, including set forth in 21 CFR Part 807 and 21 CFR Part 820 for products sold in the United States and all other similar applicable Laws. (f) Company Neither Seller nor any of the Transferred Subsidiaries is not the subject of any pending or, to the Knowledge of the CompanySeller, threatened investigation in respect of the Company Business 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. The Company Neither Seller nor any of its Transferred Subsidiaries has not committed any act, made any statement, or failed to make any statement, in each case in respect of the Company Business and 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. Neither Company Seller nor any of its the Transferred Subsidiaries or any of their respective officers, employees Employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable state Law. To the Knowledge of the CompanySeller, no debarment or exclusionary claims, actions, proceedings or investigations in respect of the Company Business are pending or threatened against Seller, any of the Company Transferred Subsidiaries or any of its their respective officers, employees or agents, except for such debarments, claims, actions, proceedings or investigations that, individually or in the aggregate, have not or would not reasonably be expected to have a Seller Material Adverse Effect.