Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (a) With respect to the Medical Device Products, (i) (A) Seller has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United Kingdom and French Governmental Bodies to permit the design, development, pre-clinical and clinical testing, manufacture, and labeling of Cervical Spine Products in the United Kingdom and the clinical testing of Cervical Spine Products in France where it currently conducts such activities (the “Activities to Date”) with respect to the Cervical Spine Product (collectively, the “Medical Device Product Licenses”); (B) Seller is in compliance with all terms and conditions of each Medical Device Product License and with all applicable laws pertaining to the Activities to Date with respect to each Medical Device Product which is not required to be the subject of a Medical Device Product License; (C) Seller is in compliance with all applicable laws regarding registration, license, and certification for each site at which a Medical Device Product is manufactured, labeled, or distributed; and (D) to the extent that any Medical Device Product has been sold outside of the United States, Seller has sold such Medical Device Product in compliance in all material respects with applicable law; (ii) all manufacturing operations performed by or on behalf of Seller have been and are being conducted in all material respects in compliance with ISO 9001 and ISO 13485 and regulations in the European Union; (iii) all non-clinical laboratory studies of Medical Device Products under development, sponsored by Seller and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance with the regulations in the European Union; and (iv) Seller is in compliance with all applicable reporting requirements for all Medical Device Product Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements outside the United States under applicable law.

FDA and Regulatory Matters. (a) (i) With respect to the Medical Device products of the Company that are currently marketed or sold by the Company (collectively, the "Company Products"), (i) (A) Seller the Company has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United Kingdom States Federal government or its agencies and French Governmental Bodies 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 labeling promotion of Cervical Spine the Company Products in jurisdictions where the United Kingdom and the clinical testing of Cervical Spine Products in France where it Company currently conducts such activities or contemplates conducting such activities (the “"Activities to Date”") with respect to the Cervical Spine each Company Product (collectively, the “Medical Device Product "Company Licenses”"); (B) Seller the Company is in material compliance with all terms and conditions of each Medical Device Product Company License and with all applicable laws pertaining to the Activities to Date with respect to each Medical Device Company Product which is not required to be the subject of a Medical Device Product Company License; (C) Seller the Company is in material compliance with all applicable laws regarding registration, license, and certification for each site at which a Medical Device Company Product is manufactured, labeled, sold or distributed; and (D) to the extent that any Medical Device Company Product has been sold outside of exported from the United States, Seller the Company has sold exported such Medical Device Company Product in compliance in all material respects with applicable lawlaws; (ii) all manufacturing operations performed by or on behalf of Seller the Company have been and are being conducted in all material respects in compliance with ISO 9001 the Quality Systems regulations of the U.S. Food and ISO 13485 and Drug Administration (the "FDA") (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European UnionUnion and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Medical Device Company Products under development, sponsored by Seller 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 UnionUnion and all other countries; and (iv) Seller the Company is in material compliance with all applicable reporting requirements for all Medical Device Product 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 lawlaws. 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) With respect to the Medical Device Contingent Payment Products (as defined in the Merger Agreement) and, to the extent applicable, any other products currently under development by the Company (collectively, the “Products”), (i) (A) Seller the Company and each of its Subsidiaries has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United Kingdom and French Governmental Bodies States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and labeling promotion of Cervical Spine its Products in the United Kingdom and the clinical testing of Cervical Spine Products in France jurisdictions where it currently conducts such activities (the “Activities to Date”) with respect to the Cervical Spine each Product (collectively, the “Medical Device Product Company Licenses”); (B) Seller the Company and each of its Subsidiaries, as the case may be, is in compliance in all material respects with all terms and conditions of each Medical Device Product Company License and with all applicable laws pertaining to the Activities to Date with respect to each Medical Device Product which is not required to be the subject of a Medical Device Product Company License; (C) Seller the Company and each of its Subsidiaries, as the case may be, is in compliance with all applicable laws regarding registration, license, and license and/or certification for each site at which a Medical Device Product is manufactured, manufactured or labeled, or distributedfrom which a Product is sold or distributed by the Company or its Subsidiaries; and (D) to the extent that any Medical Device Product has been sold outside of exported from the United States, Seller the Company or, as applicable, a Subsidiary of the Company exporting such Product, has sold exported such Medical Device Product in compliance in all material respects with applicable law; (ii) all manufacturing operations performed by or on behalf of Seller the Company or its Subsidiaries have been and are being conducted in all material respects in compliance with ISO 9001 and ISO 13485 and the Quality Systems Regulations of the FDA and, to the extent applicable to the Company or any of its Subsidiaries, in all material respects with counterpart regulations in the European UnionUnion and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Medical Device Products under development, sponsored by Seller 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 respects 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 or any of its Subsidiaries, counterpart regulations in the European UnionUnion and all other countries; and (iv) Seller the Company and each of its Subsidiaries is in compliance with all applicable reporting requirements for all Medical Device Product 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 law.