Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (a) (i) With respect to the products of the Company that are currently marketed or sold by the Company (collectively, the "Company Products"), (A) the Company has obtained all necessary approvals, clearances, authorizations, licenses and registrations required by the United States Federal government or its agencies and all material approvals, clearances, authorizations, licenses and registrations required by foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities or contemplates conducting such activities (the "Activities to Date") with respect to each Company Product (collectively, the "Company Licenses"); (B) the Company is in material compliance with all terms and conditions of each Company License and with all applicable laws pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company is in material compliance with all applicable laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable laws; (ii) all manufacturing operations performed by the Company have been and are being conducted in all material respects in compliance with the Quality Systems regulations of the U.S. Food and Drug Administration (the "FDA") (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in material compliance with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company is in material compliance with all applicable reporting requirements for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable laws. The Company has not received any written notice or other written communication from the FDA or any other Governmental Entity (x) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (y) otherwise alleging any violation of any laws by the Company. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Entity with respect to any of the Company Products.

FDA and Regulatory Matters. (a) (i) With respect to the products of the Company that are currently marketed or sold by the Company Medical Device Products, (collectively, the "Company Products"), i) (A) the Company Seller has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United States Federal government or its agencies Kingdom and all material approvals, clearances, authorizations, licenses and registrations required by foreign governments or government agencies, French Governmental Bodies to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion labeling of the Company Cervical Spine Products in jurisdictions the United Kingdom and the clinical testing of Cervical Spine Products in France where the Company it currently conducts such activities or contemplates conducting such activities (the "“Activities to Date"”) with respect to each Company the Cervical Spine Product (collectively, the "Company “Medical Device Product Licenses"”); (B) the Company Seller is in material compliance with all terms and conditions of each Company Medical Device Product License and with all applicable laws pertaining to the Activities to Date with respect to each Company Medical Device Product which is not required to be the subject of a Company Medical Device Product License; (C) the Company Seller is in material compliance with all applicable laws regarding registration, license, and certification for each site at which a Company Medical Device Product is manufactured, labeled, sold or distributed; and (D) to the extent that any Company Medical Device Product has been exported from sold outside of the United States, the Company Seller has exported sold such Company Medical Device Product in compliance in all material respects with applicable lawslaw; (ii) all manufacturing operations performed by the Company or on behalf of Seller have been and are being conducted in all material respects in compliance with the Quality Systems regulations of the U.S. Food ISO 9001 and Drug Administration (the "FDA") (21 CFR Part 820) and, to the extent applicable to the Company, counterpart ISO 13485 and regulations in the European Union and all other countries where compliance is requiredUnion; (iii) all non-clinical laboratory studies of Company Medical Device Products under development, sponsored by the Company Seller and intended to be used to support regulatory clearance or approval, have been and are being conducted in material compliance with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countriesUnion; and (iv) the Company Seller is in material compliance with all applicable reporting requirements for all Company Medical Device Product Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable laws. The Company has not received any written notice or other written communication from the FDA or any other Governmental Entity (x) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (y) otherwise alleging any violation of any laws by the Company. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Entity with respect to any of the Company Productslaw.

FDA and Regulatory Matters. (a) (i) With respect to the Contingent Payment Products (as defined in the Merger Agreement) and, to the extent applicable, any other products of the Company that are currently marketed or sold under development by the Company (collectively, the "Company “Products"”), (i) (A) the Company and each of its Subsidiaries has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United States Federal government or its agencies and all material approvals, clearances, authorizations, licenses and registrations required by foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company its Products in jurisdictions where the Company it currently conducts such activities or contemplates conducting such activities (the "“Activities to Date"”) with respect to each Company Product (collectively, the "“Company Licenses"”); (B) the Company and each of its Subsidiaries, as the case may be, is in compliance in all material compliance respects with all terms and conditions of each Company License and with all applicable laws pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries, as the case may be, is in material compliance with all applicable laws regarding registration, license, license and/or certification for each site at which a Company Product is manufactured, manufactured or labeled, or from which a Product is sold or distributeddistributed by the Company or its Subsidiaries; and (D) to the extent that any Company Product has been exported from the United States, the Company or, as applicable, a Subsidiary of the Company exporting such Product, has exported such Company Product in compliance in all material respects with applicable lawslaw; (ii) all manufacturing operations performed by or on behalf of the Company or its Subsidiaries have been and are being conducted in all material respects in compliance with the Quality Systems regulations Regulations of the U.S. Food and Drug Administration (the "FDA") (21 CFR Part 820) FDA and, to the extent applicable to the CompanyCompany or any of its Subsidiaries, in all material respects with counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company or any of its Subsidiaries and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material compliance respects with the FDA's good ’s Good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the CompanyCompany or any of its Subsidiaries, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries is in material compliance with all applicable reporting requirements for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable laws. The Company has not received any written notice or other written communication from the FDA or any other Governmental Entity (x) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (y) otherwise alleging any violation of any laws by the Company. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Entity with respect to any of the Company Productslaw.