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. (b) To Seller’s Knowledge, Seller is in compliance with all United Kingdom national and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Products. There have been no adverse event reports or complaints related to the Medical Device Products through the date hereof. (c) Seller has not received any written notice or other written communication from the FDA or any other Governmental Body (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, or (ii) otherwise alleging any violation of any laws by Seller. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or threatened by the FDA or any other Governmental Body with respect to any of the Medical Device Products, including any facilities where any such Medical Device Products are produced, processed, packaged or stored and Seller has not, within the last three (3) years, either voluntarily or at the request of any Governmental Body, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Product. (e) Seller has conducted all of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted in accordance with all applicable laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all filings with and submissions to any Governmental Body in the United Kingdom and France made by Seller with regard to the Medical Device Products, whether oral, written or electronically delivered, were true, accurate and complete as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller has not engaged in any written correspondence with, or made any written submissions to, the FDA with respect to the Cervical Spine Products or other Medical Device Products.

FDA and Regulatory Matters. (a) With respect to the Medical Device Products, (i) (A) Seller The Company 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 Products 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 Product each product (collectively, the “Medical Device Product "Company Licenses”"); (B) Seller . The Company is in compliance in all material respects with all the 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 Company License; (C) Seller . The Company is in compliance in all material respects with all applicable laws Applicable Laws regarding registration, license, and certification for each site at which a Medical Device Product product is manufactured, labeled, sold, or distributed; and (D) to . To the extent that any Medical Device Product product has been sold outside of exported from the United States, Seller the Company has sold exported such Medical Device Product product in compliance in all material respects with applicable law; (ii) all Applicable Laws. 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 and ISO 13485 and the applicable Quality Systems regulations of the FDA and, to the extent applicable to the Company, counterpart regulations in the European Union; (iii) Union and all other countries where compliance is required. All non-clinical laboratory studies of Medical Device Products under development, products sponsored by Seller the Company 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, counterpart regulations in the European Union; Union and (iv) Seller all other countries. The Company is in compliance in all material respects 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 lawApplicable Law. The Disclosure Schedule sets forth a list of all Company Licenses. (b) To Seller’s KnowledgeExcept as set forth in the Disclosure Schedule, Seller the Company is in compliance in all material respects with all FDA and non-United Kingdom national States equivalent agencies and local laws applicable other Applicable Laws relating to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device ProductsCompany's products. There have been no The Disclosure Schedule sets forth a list of all applicable adverse event reports or complaints related to the Products or the Company's Model 1000 heart valve, including any Medical Device Products through Reports (as defined in 21 CFR 803). The Disclosure Schedule sets forth a list of all complaint review and analysis reports of the date hereofCompany, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (c) Seller Except as set forth in the Disclosure Schedule, the Company has not received any written notice or other written communication from the FDA or any other Governmental Body Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Company's products or (ii) otherwise alleging any violation of any laws Applicable Law by Sellerthe Company. (d) There Except as set forth in the Disclosure Schedule, there have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or or, to the Company's knowledge, threatened by the FDA or any other Governmental Body Authority with respect to any of the Medical Device ProductsCompany's products, including any facilities where any such Medical Device Products products are produced, processed, packaged or stored stored, and Seller the Company has not, within the last three (3) years, either voluntarily or at the request of any Governmental BodyAuthority, initiated or participated in a recall of any Medical Device Product product or provided post-sale warnings regarding any Medical Device Productproduct. (e) Seller The Company has conducted all of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted and in all material respects in accordance with all applicable laws Applicable Laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all All filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France any other jurisdiction made by Seller the Company with regard to the Medical Device ProductsCompany's products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller has not engaged in any written correspondence with, or made any written submissions to, the FDA with respect to the Cervical Spine Products or other Medical Device Products.

FDA and Regulatory Matters. (ai) With respect to the Medical Device Company Products, (i1) (A) Seller the Company 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 “"Company Activities to Date”") with respect to the Cervical Spine Product each of its Products (collectively, the “Medical Device Product "Company Licenses”"); (B2) Seller the Company is in compliance in all material respects with all the terms and conditions of each Medical Device Product Company License and with all applicable laws Laws pertaining to the Company 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; (C3) Seller the Company is in compliance in all material respects with all applicable laws Laws regarding registration, license, and certification for each site at which a Medical Device Company Product is manufactured, labeled, sold, or distributed; and (D4) 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 lawLaw; (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 and ISO 13485 and the quality systems regulations of the FDA 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 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, counterpart regulations in the European UnionUnion and all other countries; and (iv) Seller the Company is in compliance in all material respects 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 lawLaw. (b) To Seller’s Knowledge, Seller The Company is in compliance in all material respects with all FDA and non-United Kingdom national States equivalent agencies and similar state and local laws Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Company Products. There have been no Section 2.19(b) of the Disclosure Schedule sets forth a list of all applicable adverse event reports or complaints related to the Company Products, including any Medical Device Products Reports (as defined in 21 CFR 803). Set forth on Section 2.19(b) of the Disclosure Schedule are complaint review and analysis reports of the Company through the date hereof, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (c) Seller The Company has not received any written notice or other written communication from the FDA or any other Governmental Body Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Company Products or (ii) otherwise alleging any violation of any laws Laws by Sellerthe Company. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or threatened to the knowledge of the Company threatened) by the FDA or any other Governmental Body Authority with respect to any of the Medical Device Company Products, including any facilities where any such Medical Device Company Products are produced, processed, packaged or stored and Seller the Company has not, not within the last three (3) years, either voluntarily or at the request of any Governmental BodyAuthority, initiated or participated in a recall of any Medical Device Company Product or provided post-sale warnings regarding any Medical Device Company Product. (e) Seller The Company has conducted all of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted and in all material respects in accordance with all applicable laws Laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all All filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France any other jurisdiction made by Seller the Company with regard to the Medical Device Company Products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller has not engaged in any written correspondence with, or made any written submissions to, the FDA with respect to the Cervical Spine Products or other Medical Device Products.

FDA and Regulatory Matters. (ai) 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 law. (b) To Seller’s Knowledge, Seller is in compliance with all United Kingdom national and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Productslaws. There have been no adverse event reports or complaints related to the Medical Device Products through the date hereof. (c) Seller The Company has not received any written notice or other written communication from the FDA or any other Governmental Body Entity (ix) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Company Products or (iiy) otherwise alleging any violation of any laws by Seller. (d) the Company. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or threatened to the knowledge of the Company threatened) by the FDA or any other Governmental Body Entity with respect to any of the Medical Device Company Products, including any facilities where any such Medical Device Products are produced, processed, packaged or stored and Seller has not, within the last three (3) years, either voluntarily or at the request of any Governmental Body, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Product. (eb) Seller has conducted all All of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted in accordance with all applicable laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all Company's filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France made by Seller any other jurisdiction with regard to the Medical Device Products, whether oral, written or electronically delivered, Company Products were true, accurate and complete complete, in all material respects, as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do did not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller . To the extent required by applicable law, the Company has not engaged updated all filings and submissions to the FDA and any corollary entity in any written correspondence with, or made any written submissions to, the FDA other jurisdiction with respect regard to the Cervical Spine Products or other Medical Device Company Products.

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 law. (b) To Seller’s Knowledge, Seller is in compliance with all United Kingdom national and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Productslaws. There have been no adverse event reports or complaints related to the Medical Device Products through the date hereof. (c) Seller The Company has not received any written notice or other written communication from the FDA or any other Governmental Body Entity (ix) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Company Products or (iiy) otherwise alleging any violation of any laws by Seller. (d) the Company. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or threatened to the knowledge of the Company threatened) by the FDA or any other Governmental Body Entity with respect to any of the Medical Device Company Products, including any facilities where any such Medical Device Products are produced, processed, packaged or stored and Seller has not, within the last three (3) years, either voluntarily or at the request of any Governmental Body, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Product. (eb) Seller has conducted all All of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted in accordance with all applicable laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all Company's filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France made by Seller any other jurisdiction with regard to the Medical Device Products, whether oral, written or electronically delivered, Company Products were true, accurate and complete complete, in all material respects, as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do did not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller . To the extent required by applicable law, the Company has not engaged updated all filings and submissions to the FDA and any corollary entity in any written correspondence with, or made any written submissions to, the FDA other jurisdiction with respect regard to the Cervical Spine Products or other Medical Device Company Products.

FDA and Regulatory Matters. (a) With respect to the Medical Device Products, (i) (A) Seller Parent 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 Products 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 Product each product (collectively, the “Medical Device Product "Parent Licenses”"); (B) Seller . Parent is in compliance in all material respects with all the 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 Parent License; (C) Seller . Parent is in compliance in all material respects with all applicable laws Applicable Laws regarding registration, license, and certification for each site at which a Medical Device Product product is manufactured, labeled, sold, or distributed; and (D) to . To the extent that any Medical Device Product product has been sold outside of exported from the United States, Seller Parent has sold exported such Medical Device Product product in compliance in all material respects with applicable law; (ii) all Applicable Laws. All manufacturing operations performed by or on behalf of Seller Parent have been and are being conducted in all material respects in compliance with ISO 9001 and ISO 13485 and the applicable Quality Systems regulations of the FDA and, to the extent applicable to Parent, counterpart regulations in the European Union; (iii) Union and all other countries where compliance is required. All non-clinical laboratory studies of Medical Device Products under development, products sponsored by Seller Parent 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 Parent, counterpart regulations in the European Union; Union and (iv) Seller all other countries. Parent is in compliance in all material respects with all applicable reporting requirements for all Medical Device Product Parent 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 lawApplicable Law. (b) To Seller’s Knowledge, Seller The Company is in compliance in all material respects with all FDA and non-United Kingdom national States equivalent agencies and local laws applicable other Applicable Laws relating to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device ProductsCompany's products. There have been no Parent has disclosed to the Company all applicable adverse event reports or complaints related to the its products, including any Medical Device Products through Reports (as defined in 21 CFR 803). Parent has disclosed to the date hereofCompany all complaint review and analysis reports of Parent, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (c) Seller Parent has not received any written notice or other written communication from the FDA or any other Governmental Body Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Parent's products or (ii) otherwise alleging any violation of any laws Applicable Law by SellerParent. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or or, to Parent's knowledge, threatened by the FDA or any other Governmental Body Authority with respect to any of the Medical Device ProductsParent's products, including any facilities where any such Medical Device Products products are produced, processed, packaged or stored and Seller stored, except where such occurrences could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Parent has not, within the last three (3) years, either voluntarily or at the request of any Governmental BodyAuthority, initiated or participated in a recall of any Medical Device Product product or provided post-sale warnings regarding any Medical Device Productproduct, except where such occurrences could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (e) Seller has conducted all of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted in accordance with all applicable laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all All filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France any other jurisdiction made by Seller Parent with regard to the Medical Device ProductsParent's products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller has not engaged in any written correspondence with, or made any written submissions to, the FDA with respect to the Cervical Spine Products or other Medical Device Products.

FDA and Regulatory Matters. (a) With respect to the Medical Device Company Products 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 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 certification for each site at which a Medical Device Product is manufactured, labeled, sold, or distributed; 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, 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 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. (b) To Seller’s Knowledge, Seller The Company and each of its Subsidiaries is in compliance with all FDA and non-United Kingdom national States equivalent agencies and similar state and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Products. There have been no Section 3.22(b) of the Company Disclosure Schedule sets forth a list of all applicable adverse event reports or complaints related to the Products, including any Medical Device Products Reports (as defined in 21 CFR 803). Set forth on Section 3.22(b) of the Company Disclosure Schedule are complaint review and analysis reports of the Company and each of its Subsidiaries through the date hereof, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (c) Seller Neither the Company nor any of its Subsidiaries has not received any written notice or other written communication from the FDA or any other Governmental Body Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, or (ii) otherwise alleging any violation of any laws by Sellerthe Company or any of its Subsidiaries. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or threatened (or, to the Knowledge of the Company, threatened) by the FDA or any other Governmental Body Authority with respect to any of the Medical Device Products, including any facilities where any such Medical Device Products are produced, processed, packaged or stored and Seller neither the Company nor any of its Subsidiaries has not, within the last three (3) years, either voluntarily or at the request of any Governmental BodyAuthority, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Product. (e) Seller has The Company and each of its Subsidiaries have conducted all of its their clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted and in accordance with all applicable laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledgethe Knowledge of the Company, all filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France any other jurisdiction made by Seller the Company or any of its Subsidiaries with regard to the Medical Device Products, whether oral, written or electronically delivered, were true, accurate and complete as of the date mademade in all material respects, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereofof such update, and do not materially misstate any to the Knowledge of the statements Company such updates comply with all regulations of the FDA or information included therein, or omit such corollary entity regarding material misstatements and omissions to state a material fact necessary to make the statements therein not misleadingfacts. (g) Seller The Company has not engaged made available to Parent true, correct and complete copies of all written communications with the FDA and any corollary entity in any other jurisdiction, as well as correct and complete written correspondence withsummaries of all material oral communications between the Company or its officers, employees, agents or representatives, on the one hand, and the FDA or any such corollary entity in any other jurisdiction, or made any written submissions totheir respective employees, agents or representatives, on the FDA with respect to the Cervical Spine Products or other Medical Device Productshand.

FDA and Regulatory Matters. (a) (i) With respect to the Medical Device Company Products and, to the extent applicable, products currently under development by the Company (collectively, the “Products”), (i) (A) Seller except as set forth on Section 3.20 of the Company Disclosure Schedule, the Company 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 the Products in the United Kingdom and the clinical testing of Cervical Spine Products in France jurisdictions where it currently conducts such activities or contemplates conducting 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 is in material compliance with all terms and conditions of each Medical Device Product Company License and with all applicable laws 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 is in compliance with all applicable laws Laws regarding registration, license, and certification for each site at which a Medical Device Product is manufactured, labeled, sold or distributed; distributed and (D) to the extent that any Medical Device Product has been sold outside of exported from the United States, Seller the Company has sold exported such Medical Device Product in compliance in all material respects with applicable lawLaw; (ii) all manufacturing operations performed by or on behalf of Seller the Company have been been, and are being 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, counterpart regulations in the European Union, Canada 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 and intended to be used to support regulatory clearance or approval, have been and are being conducted in 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, Canada and all other countries; and (iv) Seller the Company 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 lawLaw. (b) To Seller’s Knowledge, Seller The Company is in compliance with all requirements of the FDA and non-United Kingdom national States equivalent agencies and similar state and local laws Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Products. There have been no Section 3.20(b) of the Company Disclosure Schedule sets forth a list of all applicable adverse event reports or complaints related to the Products, including any Medical Device Products Reports (as defined in 21 CFR 803). Set forth on Section 3.20(b) of the Company Disclosure Schedule are complaint review and analysis reports of the Company through the date hereof, including information regarding complaints by product and root cause analysis of closed complaints, and such reports are correct in all material respects. (c) Seller The Company has not received any written notice or other written communication from the FDA or any other Governmental Body Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Products or (ii) otherwise alleging any violation of any laws Laws by Sellerthe Company. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or threatened (or, to the knowledge of the Company, threatened) by the FDA or any other Governmental Body Authority with respect to any of the Medical Device Products, including any facilities where any such Medical Device Products are produced, processed, packaged or stored stored, and Seller the Company has not, within the last three (3) years, either voluntarily or at the request of any Governmental BodyAuthority, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Product. (e) Seller The Company has conducted conducted, and is continuing to conduct, all of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted and in accordance with all applicable laws Laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all All filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France any other jurisdiction made by Seller the Company with regard to the Medical Device Products, whether oral, written or electronically delivered, were true, accurate and complete as of the date made, made and, to the extent required to be updated, as so updated updated, remain true, accurate and complete as of the date hereof, hereof and do not materially misstate any of the statements or information included therein, therein or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller has not engaged in any written correspondence with, or made any written submissions to, the FDA with respect to the Cervical Spine Products or other Medical Device 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. (b) To Seller’s Knowledge, Seller The Company and each of its Subsidiaries is in compliance with all FDA and non-United Kingdom national States equivalent agencies and similar state and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Products. There have been no Section 4.21(b) of the Company Disclosure Schedule sets forth a list of all adverse event reports or complaints related to the Products, including any Medical Device Products Reports (as defined in 21 CFR 803). Set forth on Section 4.21(b) of the Company Disclosure Schedule are complaint review and analysis reports of the Company and each of its Subsidiaries through the date hereof, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (c) Seller Neither the Company nor any of its Subsidiaries has not received any written notice or other written communication from the FDA or any other Governmental Body Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, or (ii) otherwise alleging any material violation of any laws by Sellerthe Company or any of its Subsidiaries. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or threatened (or, to the knowledge of the Company, threatened) by the FDA or any other Governmental Body Authority with respect to any of the Medical Device Products, including any facilities where any such Medical Device Products are produced, processed, packaged or stored and Seller neither the Company nor any of its Subsidiaries has not, within the last three (3) years, either voluntarily or at the request of any Governmental BodyAuthority, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Product. (e) Seller has The Company and each of its Subsidiaries have conducted all of its their clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted and in accordance with all applicable laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all All filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France any other jurisdiction made by Seller the Company or any of its Subsidiaries with regard to the Medical Device Products, whether oral, written or electronically delivered, were true, accurate and complete as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller has not engaged in any written correspondence with, or made any written submissions to, the FDA with respect to the Cervical Spine Products or other Medical Device Products.

FDA and Regulatory Matters. (a) With respect to the Medical Device Products, (i) (A) Seller The Company 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, and labeling distribution of Cervical Spine Products 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 Product each product, but excluding Environmental Permits which are addressed in Section 2.22 below (collectively, the “Medical Device Product Company Licenses”); (B) Seller . The Company is in compliance in all material respects with all the 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 Company License; (C) Seller . The Company is in compliance in all material respects with all applicable laws Applicable Laws regarding registration, license, and certification for each site at which a Medical Device Product product is manufactured, labeled, or distributed; and (D) to . To the extent that any Medical Device Product product has been sold outside of exported from the United States, Seller the Company has sold exported such Medical Device Product product in compliance in all material respects with applicable law; (ii) all Applicable Laws. 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 and ISO 13485 and the Quality Systems regulations of the FDA and, to the extent applicable to the Company, counterpart regulations in the European Union; (iii) Union and all other countries where compliance is required. All non-clinical laboratory studies of Medical Device Products under development, products sponsored by Seller the Company and intended to be used submitted to regulatory authorities in support of 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, counterpart regulations in the European Union; Union and (iv) Seller all other countries. The Company is in compliance in all material respects 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 lawApplicable Law. The Disclosure Schedule sets forth a list of all Company Licenses. (b) To Seller’s Knowledge, Seller The Company is in compliance in all material respects with all FDA and non-United Kingdom national States equivalent agencies and local laws applicable other Applicable Laws relating to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device ProductsCompany’s products. There have been no The Disclosure Schedule sets forth a list of all applicable adverse event reports or complaints related to the Medical Device Products through the date hereofProducts, including any report filed under 21 CFR § 812.150(b). (c) Seller Neither the Company nor any Subsidiary has not received any written notice or other written communication from the FDA or any other Governmental Body (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, or (ii) otherwise Authority alleging any violation of any laws Applicable Law by Sellerthe Company. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or or, to the Company’s Knowledge, threatened by the FDA or any other Governmental Body Authority with respect to any of the Medical Device ProductsCompany’s products, including any facilities where any such Medical Device Products products are produced, processed, packaged or stored stored, and Seller neither the Company nor any Subsidiary has not, within the last three (3) years, either voluntarily or at the request of any Governmental BodyAuthority, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Productproduct. (e) Seller has The Company and each Subsidiary have conducted all of its their clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted and in all material respects in accordance with all applicable laws Applicable Laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all All filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France any other jurisdiction made by Seller the Company with regard to the Medical Device Products, whether oral, written or electronically deliveredCompany’s products, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller has not engaged in any written correspondence with, or made any written submissions to, the FDA with respect to the Cervical Spine Products or other Medical Device Products.

FDA and Regulatory Matters. (aA) With respect to Except as set forth in Part 3.7 of the Medical Device ProductsParent Disclosure Schedule, (i) with respect to the Parent Products and, to the extent applicable, any currently under development (A) Seller has the Parent Entities have 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 Parent Products in the United Kingdom and the clinical testing of Cervical Spine Products in France jurisdictions where it they currently conducts conduct such activities (the “Activities to Date”"PARENT ACTIVITIES TO DATE") with respect to the Cervical Spine each Parent Product (collectively, the “Medical Device Product Licenses”"PARENT LICENSES"), except where the failure to hold such Parent Licenses has not been material to the Parent Entities and would not reasonably be expected to be material to the Parent Entities; (B) Seller is the Parent Entities are in material compliance with all terms and conditions of each Medical Device Product Parent License and with all applicable laws pertaining to the Parent Activities to Date with respect to each Medical Device Parent Product which is not required to be the subject of a Medical Device Product Parent License; (C) Seller is the Parent Entities are in compliance in all material respects with all applicable laws Legal Requirements regarding registration, license, and certification for each site at which a Medical Device Parent Product is manufactured, labeled, sold, or distributed; and (D) to the extent that any Medical Device Parent Product has been sold outside of exported from the United States, Seller Parent or, as applicable, a subsidiary of Parent exporting such Parent Product, has sold exported such Medical Device Parent Product in compliance in all material respects with applicable law; all Legal Requirements, and (ii) all manufacturing operations performed by or on behalf of Seller have been and the Parent Entities are being conducted in compliance 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 Parent 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. (bB) To Seller’s Knowledge, Seller is The Parent Entities are in material compliance with all FDA and non-United Kingdom national States equivalent agencies and similar state and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Products. There have been no Part 3.7(b) of the Parent Disclosure Schedule sets forth a list of all applicable adverse event reports or complaints related to the Parent Products, including any Medical Device Products through the date hereofReports (as defined in 21 CFR 803). (cC) Seller has Since January 1, 2000, the Parent Entities have not received any written notice or other written communication from the FDA or any other Governmental Body (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Parent Products or (ii) otherwise alleging any violation of any laws by SellerParent with respect to any Parent Products. (dD) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or threatened (or, to the knowledge of Parent, threatened) by the FDA or any other Governmental Body with respect to any of the Medical Device Parent Products, including any facilities where any such Medical Device Parent Products are produced, processed, packaged or stored and Seller has not, within the last three (3) years, either voluntarily or at the request of any Governmental Body, initiated or participated in a recall of any Medical Device Parent Product or provided post-sale warnings regarding any Medical Device Parent Product. (eE) Seller has conducted all of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted in accordance with all applicable laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all All filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France any other jurisdiction made by Seller the Parent Entities with regard to the Medical Device Parent Products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller has not engaged in any written correspondence with, or made any written submissions to, the FDA with respect to the Cervical Spine Products or other Medical Device Products.

FDA and Regulatory Matters. (a) With respect to the Medical Device teeth whitening products of Sellers related to, used in or necessary to the operation of the Associated Center Business in the Ordinary Course of Business, including lighting devices and gel kits supplied to dentists and tooth paste, mouth wash, whitening pens and other products supplied through dentists and distributors to consumers (collectively, the “Products, (i”) (A) Seller has Sellers have obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by Governmental Authorizations listed on Section 3.25 of the United Kingdom and French Governmental Bodies to permit Disclosure Schedule (“Regulatory Licenses”) in connection with the design, development, pre-clinical labeling, sale, distribution and clinical testing, manufacture, and labeling promotion of Cervical Spine the Products in each jurisdiction indicated in Section 3.25 of the United Kingdom and the clinical testing of Cervical Spine Products in France where it currently conducts such activities Disclosure Schedule. To Sellers’ Knowledge, (the “Activities to Date”A) with respect to the Cervical Spine Product (collectively, the “Medical Device Product Licenses”); (B) Seller is Sellers are in compliance in all material respect with all the 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 Regulatory 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 (DB) to the extent that Sellers have exported any Medical Device Product has been sold outside of from the United States, Seller has sold Sellers have exported such Medical Device Product in compliance in all material respects with applicable law; (ii) all manufacturing operations performed by Legal Requirements. Section 3.25 of the Disclosure Schedule sets forth a complete and accurate list of each jurisdiction worldwide where Sellers design, develop, manufacture, label, sell, distribute or on behalf target promotion 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 lawtheir Products. (b) To Seller’s Sellers’ Knowledge, Seller is Sellers are in compliance in all material respects with all United Kingdom national States Food and Drug Administration (“FDA”) and non-United States equivalent agencies and similar state and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Products. There Sellers have been no not received any applicable adverse event reports or complaints related to the Products, including any Medical Device Products through the date hereofReports (as defined in 21 CFR 803). (c) Seller has Except as set forth on Section 3.25 of the Disclosure Schedule, Sellers have not received any written notice or other written communication from the FDA or any other Governmental Body (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Products or (ii) otherwise alleging any violation of any laws by SellerSellers. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or threatened (or, to Sellers’ Knowledge, threatened) by the FDA or any other Governmental Body with respect to any of the Medical Device Products, including any facilities where any such Medical Device Products are produced, processed, packaged or stored and Seller has not, within the last three (3) years, either voluntarily or at the request of any Governmental Body, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Productstored. (e) Seller has conducted all of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted in accordance with all applicable laws and the stated protocols for such clinical trials. All written (fincluding electronic) To Seller’s Knowledge, all filings with and submissions to the FDA and any other Governmental Body in the United Kingdom and France made by Seller Sellers with regard to the Medical Device Products, whether oral, written or electronically delivered, Products were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (gf) Seller has not engaged This Section 3.25 contains the sole and exclusive representations and warranties of Sellers in any written correspondence with, or made any written submissions to, the FDA this Agreement with respect to any regulatory compliance with any Regulatory Licenses or Legal Requirements imposed by the Cervical Spine Products FDA or other Medical Device Productscomparable international authorities.

FDA and Regulatory Matters. (ai) With respect to the Medical Device products of the Borrower that are currently marketed or sold by the Borrower (collectively, the "Borrower Products"), (i) (A) Seller the Borrower 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 Borrower Products in jurisdictions where the United Kingdom and the clinical testing of Cervical Spine Products in France where it Borrower currently conducts such activities or contemplates conducting such activities (the “"Activities to Date”") with respect to the Cervical Spine each Borrower Product (collectively, the “Medical Device Product "Borrower Licenses”"); (B) Seller the Borrower is in material compliance with all terms and conditions of each Medical Device Product Borrower License and with all applicable laws pertaining to the Activities to Date with respect to each Medical Device Borrower Product which is not required to be the subject of a Medical Device Product Borrower License; (C) Seller the Borrower is in material compliance with all applicable laws regarding registration, license, and certification for each site at which a Medical Device Borrower Product is manufactured, labeled, sold or distributed; and (D) to the extent that any Medical Device Borrower Product has been sold outside of exported from the United States, Seller the Borrower has sold exported such Medical Device Borrower Product in compliance in all material respects with applicable lawlaws; (ii) all manufacturing operations performed by or on behalf of Seller the Borrower 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 Borrower, counterpart regulations in the European UnionUnion and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Medical Device Borrower Products under development, sponsored by Seller the Borrower 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 Borrower, counterpart regulations in the European UnionUnion and all other countries; and (iv) Seller the Borrower is in material compliance with all applicable reporting requirements for all Medical Device Product Borrower 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. (b) To Seller’s Knowledge, Seller is in compliance with all United Kingdom national and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Medical Device Productslaws. There have been no adverse event reports or complaints related to the Medical Device Products through the date hereof. (c) Seller The Borrower has not received any written notice or other written communication from the FDA or any other Governmental Body Entity (ix) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Medical Device Products, Borrower Products or (iiy) otherwise alleging any violation of any laws by Seller. (d) the Borrower. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or threatened to the knowledge of the Borrower threatened) by the FDA or any other Governmental Body Entity with respect to any of the Medical Device Borrower Products, including any facilities where any such Medical Device Products are produced, processed, packaged or stored and Seller has not, within the last three (3) years, either voluntarily or at the request of any Governmental Body, initiated or participated in a recall of any Medical Device Product or provided post-sale warnings regarding any Medical Device Product. (eb) Seller has conducted all All of its clinical trials with reasonable care and, to Seller’s Knowledge, such trials have been conducted in accordance with all applicable laws and the stated protocols for such clinical trials. (f) To Seller’s Knowledge, all Borrower's filings with and submissions to the FDA and any Governmental Body corollary entity in the United Kingdom and France made by Seller any other jurisdiction with regard to the Medical Device Products, whether oral, written or electronically delivered, Borrower Products were true, accurate and complete complete, in all material respects, as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do did not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (g) Seller . To the extent required by applicable law, the Borrower has not engaged updated all filings and submissions to the FDA and any corollary entity in any written correspondence with, or made any written submissions to, the FDA other jurisdiction with respect regard to the Cervical Spine Products or other Medical Device Borrower Products.