Common use of FDA Compliance Clause in Contracts

FDA Compliance. (a) The operations of the Company, including, without limitation, the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing and distribution of all products, are in compliance in all material respects with all applicable federal and state laws and permits held by the Company including, without limitation, those administered by the Food and Drug Administration (the “FDA”) relating to the business, assets, properties, products, operations or processes of the Company. There are no actual or, to the knowledge of the Company, threatened actions against the Company by the FDA or any other governmental entity that has jurisdiction over the operations of the Company. The Company has not received notice of any pending or threatened claim, and the Company has no knowledge that any governmental entity is considering such action. (b) The Company has not received any FDA Form 483 notice of adverse findings, warning letters, untitled letters or other written correspondence or notice from the FDA, or other governmental entity alleging or asserting noncompliance with any applicable federal or state laws or permits, and the Company has no knowledge that the FDA or any governmental entity is considering such action. (c) All studies, tests and preclinical and clinical trials being conducted by or on behalf of the Company are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable federal and state laws. The Company has not received any notices, correspondence or other communication from the FDA or any other governmental entity requiring the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company, or in which they have participated, and the Company has no knowledge that the FDA or any other governmental entity is considering such action. (d) 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 Quality Systems Regulation. In addition, the Company, and, to the Company’s knowledge, any third-party manufacturer of products on the Company’s behalf, are in material compliance with all applicable FDA requirements, including registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207. (e) The Company is not the subject of any pending or, to the Company’s knowledge, 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. The Company has not, to the Company’s knowledge, 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. (f) To the extent that the Company markets or sells any products or services in any jurisdiction outside of the United States, or manufactures any products outside of the United States, the Company has acted in compliance in all material respects with the applicable laws of such jurisdiction pertaining to the approval of marketing or sale of such medical devices; the use of good manufacturing practices; and such other laws and regulations that that pertain to the same subject area under the jurisdiction of the FDA.

FDA Compliance. (a) The operations of the Company, including, without limitation, the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing and distribution of all products, are in compliance in all material respects with all applicable federal and state laws and permits held by the Company including, without limitation, those administered by the Food and Drug Administration (the “FDA”) relating to the business, assets, properties, products, operations or processes of the Company. There are no actual or, to the knowledge of the Company, threatened actions against the Company by the FDA or any other governmental entity that has jurisdiction over the operations of the Company. The Company has not received notice of any pending or threatened claim, and the Company has no knowledge that any governmental entity is considering such action. (b) The Company has not received any FDA Form 483 notice of adverse findings, warning letters, untitled letters or other written correspondence or notice from the FDA, or other governmental entity alleging or asserting noncompliance with any applicable federal or state laws or permits, and the Company has no knowledge that the FDA or any governmental entity is considering such action. (c) All studies, tests and preclinical and clinical trials being conducted by or on behalf of the Company are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable federal and state laws. The Company has not received any notices, correspondence or other communication from the FDA or any other governmental entity requiring the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company, or in which they have participated, and the Company has no knowledge that the FDA or any other governmental entity is considering such action. (d) 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 Quality Systems Regulation. In addition, the Company, and, to the Company’s knowledge, any third-party manufacturer of products on the Company’s behalf, are in material compliance with all applicable FDA requirements, including registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207. (e) The Company is not the subject of any pending or, to the Company’s knowledge, 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 theretoFDA. The Company has not, to the Company’s knowledge, 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. (f) To the extent that the Company markets or sells any products or services in any jurisdiction outside of the United States, or manufactures any products outside of the United States, the Company has acted in compliance in all material respects with the applicable laws of such jurisdiction pertaining to the approval of marketing or sale of such medical devices; the use of good manufacturing practices; and such other laws and regulations that that pertain to the same subject area under the jurisdiction of the FDA.

FDA Compliance. (a) The operations operation of the CompanyCompany Business, including, without limitation, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing marketing, and distribution of all productsCompany Products, are is and at all times has been in material compliance in all material respects with all applicable federal Laws, Permits, Governmental Entities and state laws and permits held by the Company including, without limitation, orders including those administered by the Food and Drug Administration (FDA for products sold in the “FDA”) relating to the business, assets, properties, products, operations or processes of the CompanyUnited States. There are is no actual or, to the knowledge Knowledge of the Company, threatened actions against material action or investigation in respect of the Company Business by the FDA or any other governmental entity that Governmental Entity which has jurisdiction over the operations operations, properties, products or processes of the CompanyCompany and its Subsidiaries or by any third parties acting on their behalf. The Company has not received notice of any pending or threatened claim, and the Company has no knowledge Knowledge that any governmental entity Governmental Entity or third party is considering such actionaction or of any facts or circumstances that are likely to give rise to any such action or investigation. (b) The During the three (3) year period ending on the Closing Date, neither the Company nor any of its Subsidiaries has not had any product or manufacturing site subject to a Governmental Entity (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Entity notice of adverse findingsinspectional observations, “warning letters,” “untitled letters” or requests or requirements to make changes to the operations of the Company Business or the Company Products that if not complied with would reasonably be expected to result in a Company Material Adverse Effect, untitled letters or other written similar correspondence or written notice from the FDA, FDA or other governmental entity Governmental Entity alleging or asserting noncompliance by the Company or any of its Subsidiaries with any applicable federal Laws, Permits or state laws such requests or permitsrequirements of a Governmental Entity, and and, to the Company has no knowledge that Knowledge of the Company, neither the FDA or nor any governmental entity Governmental Entity is considering such action. No vigilance report or medical device report with respect to the Company, any of its Subsidiaries or the Company Products has been reported to the Company or any of its Subsidiaries, and to the Knowledge of the Company, no vigilance report or medical device report is under investigation by any Governmental Entity with respect to the Company Products or the Company Business. (c) All studies, tests and preclinical and clinical trials in respect of the Company Business being conducted by or on behalf of the Company or any of its Subsidiaries 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 state lawsforeign 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, and 812. The Neither the Company nor any of its Subsidiaries has not received any notices, correspondence or other communication in respect of the Company Business from the FDA or any other governmental entity Governmental Entity requiring the termination, termination or suspension or material modification of any clinical trials conducted by, or on behalf of, the Company, Company or any of its Subsidiaries or in which they have the Company or any of its Subsidiaries has participated, and to the Company has no knowledge that Knowledge of the Company, neither the FDA or nor any other governmental entity Governmental Entity is considering such action. (d) The manufacture . Neither the Company nor any of products its Subsidiaries has received written notification from a Governmental Entity of the rejection of data obtained from any clinical trials conducted by, or on behalf of, the Company or any of its Subsidiaries or in which the Company or any of its Subsidiaries has participated with respect to the Company Business or Company Products, which data was submitted to the Governmental Entity and which was necessary to obtain regulatory approval of a particular Company Product. (d) The manufacture of Company Products by, or on behalf of, the Company and its Subsidiaries is being conducted in compliance in all material respects with all applicable laws Laws including the FDA’s Quality Systems RegulationRegulation at 21 CFR Part 820 for products sold in the United States, and the respective counterparts thereof promulgated by Governmental Entities in countries outside the United States. In addition, Each of the Company, andits Subsidiaries, to the Company’s knowledgeand any third party assembler, any third-party sterilizer or manufacturer of products on the Company’s behalfCompany Products, are components or accessories, is in material compliance with all applicable FDA requirementsLaws and certifications currently held by the Company’s and its Subsidiaries’ governing quality systems, including manufacturing processes and all other quality standards, registration and listing requirements governing those third parties’ activities, including set forth in 21 U.S.C. Section 360 CFR Part 807 and 21 C.F.R. CFR Part 207820 for products sold in the United States and all other similar applicable Laws. (e) The Neither the Company nor any of its Subsidiaries is not the subject of any pending or, to the Knowledge of the Company’s knowledge, 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 Neither the Company nor any of its Subsidiaries has not, to the Company’s knowledge, committed any act, made any statement, or failed to make any statement 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 the Company, any of its Subsidiaries nor any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (fi) under 21 U.S.C. Section 335a, or (ii) any similar applicable state Law. To the extent that Knowledge of the Company, no debarment or exclusionary claims, actions, proceedings or investigations in respect of the Company markets Business are pending or sells threatened against the Company, any products of its Subsidiaries or services any of their respective officers, employees or agents, except for such debarments, claims, actions, proceedings or investigations that, individually or in any jurisdiction outside of the United Statesaggregate, have not or manufactures any products outside of the United States, the would not reasonably be expected to have a Company has acted in compliance in all material respects with the applicable laws of such jurisdiction pertaining to the approval of marketing or sale of such medical devices; the use of good manufacturing practices; and such other laws and regulations that that pertain to the same subject area under the jurisdiction of the FDAMaterial Adverse Effect.