Common use of FDA and Related Matters Clause in Contracts

FDA and Related Matters. (a) Section 3.18 of the Company Disclosure Schedule sets forth a complete and accurate list, referencing relevant records and documents, since January 1, 1993, of (i) all Regulatory or Warning Letters, Notices of Adverse Findings, and Section 305 Notices and similar letters or notices issued by the Food and Drug Administration (the "FDA") or any other federal, state, local, or foreign governmental entity that is concerned with the safety, efficacy, reliability, or manufacturing of medical products, including drugs and devices, relating to the conduct of the business of the Company and its Subsidiaries, (ii) all United States Pharmacopoeia product problem reporting program complaints or reports, MedWatch FDA Forms 3500, and device experience network complaints received by the Company or any of its Subsidiaries and all Drug and Medical Device Reports, adverse drug experience reports, and therapeutic failure reports filed by the Company or any of its Subsidiaries, which complaints or reports (A) pertain to any incident involving death, serious injury, or a serious adverse drug experience, and for which incident there has been any (1) notice or follow up inquiry to the Company or any of its Subsidiaries by the FDA, (2) litigation or arbitration claim or cause of action commenced, or (3) notice to any insurance carrier of the Company or any of its Subsidiaries tendering the defense or giving 8/12/97 notice of a possible or actual claim against the Company or any of its Subsidiaries, and (B) are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iii) all product recalls and safety alerts conducted by or issued to the Company or any of its Subsidiaries and any requests from the FDA or any other drug and medical device regulatory agency requesting the Company or any of its Subsidiaries to cease to investigate, test, or market any product, which recalls, safety alerts, or requests are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iv) any civil penalty actions begun by the FDA or any other drug and medical device regulatory agency against the Company or any of its Subsidiaries and all consent decrees issued with respect to the Company or any of its Subsidiaries, and (v) any other written communications between the FDA or any other drug and medical device regulatory agency, on the one hand, and the Company or any of its Subsidiaries, on the other hand, which communications are in the aggregate material to the conduct of the business of the Company and its Subsidiaries. The Company has delivered to the Parent copies of all documents referred to in Section 3.18 of the Company Disclosure Schedule, as well as copies of all complaints and other information required to be maintained by the Company pursuant to Section 820 of Title 21 of the Code of Federal Regulations ("CFR") or 21 CFR Section 211, to the extent that such complaints or other information relate to events that are, in the aggregate, material to the conduct of the business of the Company and its Subsidiaries. (b) The Company and its Subsidiaries have obtained all material consents, approvals, certifications, authorizations, and permits of, and have made all filings with, or notifications to, the FDA and all other drug and medical device regulatory agencies pursuant to applicable requirements of all FDA laws, rules, and regulations, and all corresponding state and foreign laws, rules, and regulations applicable to the Company and its Subsidiaries. All representations made by the Company or any of its Subsidiaries in connection with any such consents, approvals, certifications, authorizations, permits, filings, and notifications were true and correct in all material respects at the time such representations were made, and the products of the Company and its Subsidiaries comply with, and perform in accordance with the specifications described in, such representations. The Company and its Subsidiaries are in all material respects in compliance with all applicable FDA laws, rules, and regulations, and all corresponding applicable state and foreign laws, rules, and regulations (including Good Manufacturing Practices, as defined in 21 CFR Parts 210, 211, and 820, Medical Device Reporting requirements, and Adverse Experience Reporting) applicable to the business of the Company. The Company has not received any notice that any of the consents, approvals, certifications, authorizations, registrations, permits, filings, or notifications that it has received or made to operate its business have been or are being revoked or challenged. Except as set forth on Section 3.18 of the Company Disclosure Schedule, to the knowledge of the Company, there are no investigations or inquiries pending, and there is no material threat of any investigation or inquiry, by the FDA or any other drug and medical device regulatory agency relating to the operation of the business of the Company and its Subsidiaries or its compliance with FDA 8/12/97 laws, rules, and regulations, and corresponding state and foreign laws, rules, and regulations, applicable to the business of the Company and its Subsidiaries. None of the matters set forth on Section 3.18 of the Company Disclosure Schedule is reasonably likely to have, individually or in the aggregate, a Company Material Adverse Effect.

FDA and Related Matters. (a) Section 3.18 of the Company Disclosure 2.31.1. Schedule 2.31 sets forth a complete and accurate list, referencing relevant records and documents, since January 1, 1993for the last five (5) years, of (i) all Regulatory regulatory or Warning Letterswarning letters, Notices notices of Adverse Findings, and Section 305 Notices adverse findings and similar letters or notices issued to the Company or any Subsidiary by the Food and Drug Administration (the "FDA") or any other federal, state, local, or foreign governmental entity that is concerned with the safety, efficacy, reliability, reliability or manufacturing of the medical productsdevices developed, including drugs and devices, relating to the conduct of the business of manufactured or sold by the Company and its Subsidiariesor any Subsidiary (hereinafter for purposes of this Section 2.31, "Medical Device Regulatory Agency"); (ii) all United States Pharmacopoeia product problem reporting program complaints or reports, MedWatch FDA Forms 3500, and device experience network complaints received filings or communications made by the Company or any of its Subsidiaries and all Drug and to or with a Medical Device ReportsRegulatory Agency regarding the medical devices developed, adverse drug experience reports, and therapeutic failure reports filed manufactured or sold by the Company or any Subsidiary (but excluding any reports, filings or communications in connection with applications seeking approval from any such Medical Device Regulatory Agency for the marketing and sale of its Subsidiaries, which complaints or reports (A) pertain to any incident involving death, serious injury, or a serious adverse drug experience, and for which incident there has been any (1) notice or follow up inquiry to the Company or any of its Subsidiaries by the FDA, (2) litigation or arbitration claim or cause of action commenced, or (3) notice to any insurance carrier of the Company or any of its Subsidiaries tendering the defense or giving 8/12/97 notice of a possible or actual claim against the Company or any of its Subsidiaries, and (B) are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, such medical devices); (iii) all product recalls and safety alerts conducted by or issued to the Company or any of its Subsidiaries Subsidiary and any requests from the FDA or any other drug and medical device regulatory agency Medical Device Regulatory Agency requesting the Company or any of its Subsidiaries Subsidiary to cease to investigate, test, manufacture, market or market sell any product, which recalls, safety alerts, or requests are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, ; (iv) any civil penalty actions begun by the FDA or any other drug and medical device regulatory agency Medical Device Regulatory Agency against the Company or any of its Subsidiaries Subsidiary and all consent decrees issued with respect to the Company or any of its Subsidiaries, Subsidiary; and (v) any other written communications between the Company or any Subsidiary on the one hand and the FDA or any other drug and medical device regulatory agency, on the one hand, and the Company or any of its Subsidiaries, Medical Device Regulatory Agency on the other hand, which communications are in the aggregate material to the conduct of the business of the Company and its Subsidiaries. The Company has delivered to the Parent Investors copies of all documents referred to in Section 3.18 of the Company Disclosure Schedule, as well as copies of all complaints and other information required to be maintained by the Company pursuant to Section 820 of Title 21 of the Code of Federal Regulations ("CFR") or 21 CFR Section 211, to the extent that such complaints or other information relate to events that are, in the aggregate, material to the conduct of the business of the Company and its SubsidiariesSchedule 2.31. (b) 2.31.2. The Company and its Subsidiaries have obtained all material consents, approvals, certifications, authorizations, authorizations and permits of, and have made all filings with, or notifications to, the FDA and all other drug and medical device regulatory agencies Medical Device Regulatory Agencies pursuant to applicable requirements of all FDA federal laws, rules, rules and regulations, and all corresponding state and foreign laws, rules, rules and regulations applicable to the Company and its Subsidiaries. All representations made by the Company or any of Subsidiary and relating to its Subsidiaries in connection with any such consents, approvals, certifications, authorizations, permits, filings, and notifications were true and correct in all material respects at the time such representations were made, and the products of the Company and its Subsidiaries comply with, and perform in accordance with the specifications described in, such representationsbusiness. The Company and its Subsidiaries are in all material respects in compliance with all applicable FDA federal laws, rules, rules and regulations, regulations and all corresponding applicable state and foreign laws, rules, rules and regulations (including Good Manufacturing Practices, as defined in 21 CFR Parts 210, 211, and 820, Medical Device Reporting requirements, and Adverse Experience Reporting) applicable relating to the business of the Companymedical device manufacturers. The Company has not received any notice no reason to believe that any of the consents, approvals, certifications, authorizations, registrations, certifications, permits, filings, filings or notifications that it or any of its Subsidiaries has received or made to operate its business their respective businesses have been or are being revoked questioned, challenged or challengedrevoked. Except as set forth on Section 3.18 of the Company Disclosure Schedule, to the knowledge of the Company, there There are no investigations or inquiries pending, and there is no material threat of any investigation or inquiry, by the FDA or any other drug and medical device regulatory agency Medical Device Regulatory Agency pending or threatened relating to the operation of the business of Company's or the Company and its Subsidiaries Company's Subsidiaries' businesses or its the Company's or any Subsidiary's compliance with FDA 8/12/97 applicable laws, rules, and regulations, and corresponding state and foreign laws, rules, and regulations, applicable rules or regulations relating to the business of the Company and its Subsidiaries. None of the matters set forth on Section 3.18 of the Company Disclosure Schedule is reasonably likely to have, individually or in the aggregate, a Company Material Adverse Effectmedical device manufacturers.

FDA and Related Matters. (a) Section 3.18 of the Company Disclosure Schedule sets forth a complete and accurate list, referencing relevant records and documents, since January 1, 1993, of (i) all Regulatory or Warning Letters, Notices of Adverse Findings, and Section 305 Notices and similar letters or notices issued by the Food and Drug Administration (the "FDA") or any other federal, state, local, or foreign governmental entity that is concerned with the safety, efficacy, reliability, or manufacturing of medical products, including drugs and devices, relating to the conduct of the business of the Company and its Subsidiaries, (ii) all United States Pharmacopoeia product problem reporting program complaints or reports, MedWatch FDA Forms 3500, and device experience network complaints received by the Company or any of its Subsidiaries and all Drug and Medical Device Reports, adverse drug experience reports, and therapeutic failure reports filed by the Company or any of its Subsidiaries, which complaints or reports (A) pertain to any incident involving death, serious injury, or a serious adverse drug experience, and for which incident there has been any (1) notice or follow up inquiry to the Company or any of its Subsidiaries by the FDA, (2) litigation or arbitration claim or cause of action commenced, or (3) notice to any insurance carrier of the Company or any of its Subsidiaries tendering the defense or giving 8/12/97 notice of a possible or actual claim against the Company or any of its Subsidiaries, and (B) are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iii) all product recalls and safety alerts conducted by or issued to the Company or any of its Subsidiaries and any requests from the FDA or any other drug and medical device regulatory agency requesting the Company or any of its Subsidiaries to cease to investigate, test, or market any product, which recalls, safety alerts, or requests are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iv) any civil penalty actions begun by the FDA or any other drug and medical device regulatory agency against the Company or any of its Subsidiaries and all consent decrees issued with respect to the Company or any of its Subsidiaries, and (v) any other written communications between the FDA or any other drug and medical device regulatory agency, on the one hand, and the Company or any of its Subsidiaries, on the other hand, which communications are in the aggregate material to the conduct of the business of the Company and its Subsidiaries. The Company has delivered to the Parent copies of all documents referred to in Section 3.18 of the Company Disclosure Schedule, as well as copies of all complaints and other information required to be maintained by the Company pursuant to Section 820 of Title 21 of the Code of Federal Regulations ("CFR") or 21 CFR Section 211, to the extent that such complaints or other information relate to events that are, in the aggregate, material to the conduct of the business of the Company and its Subsidiaries. (b) The Company and its Subsidiaries have obtained all material consents, approvals, certifications, authorizations, and permits of, and have made all filings with, or notifications to, the FDA and all other drug and medical device regulatory agencies pursuant to applicable requirements of all FDA laws, rules, and regulations, and all corresponding state and foreign laws, rules, and regulations applicable to the Company and its Subsidiaries. All representations made by the Company or any of its Subsidiaries in connection with any such consents, approvals, certifications, authorizations, permits, filings, and notifications were true and correct in all material respects at the time such representations were made, and the products of the Company and its Subsidiaries comply with, and perform in accordance with the specifications described in, such representations. The Company and its Subsidiaries are in all material respects in compliance with all applicable FDA laws, rules, and regulations, and all corresponding applicable state and foreign laws, rules, and regulations (including Good Manufacturing Practices, as defined in 21 CFR Parts 210, 211, and 820, Medical Device Reporting requirements, and Adverse Experience Reporting) applicable to the business of the Company. The Company has not received any notice that any of the consents, approvals, certifications, authorizations, registrations, permits, filings, or notifications that it has received or made to operate its business have been or are being revoked or challenged. Except as set forth on Section 3.18 of the Company Disclosure Schedule, to the knowledge of the Company, there are no investigations or inquiries pending, and there is no material threat of any investigation or inquiry, by the FDA or any other drug and medical device regulatory agency relating to the operation of the business of the Company and its Subsidiaries or its compliance with FDA 8/12/97 laws, rules, and regulations, and corresponding state and foreign laws, rules, and regulations, applicable to the business of the Company and its Subsidiaries. None of the matters set forth on Section 3.18 of the Company Disclosure Schedule is reasonably likely to have, individually or in the aggregate, a Company Material Adverse Effect.other

FDA and Related Matters. (a) Section 3.18 of the Company Disclosure Schedule sets forth a complete and accurate list, referencing relevant records and documents, since January 1, 1993, of (i) all Regulatory or Warning Letters, Notices of Adverse Findings, and Section 305 Notices and similar letters or notices issued by the Food and Drug Administration (the "FDA") or any other federal, state, local, or foreign governmental entity that is concerned with the safety, efficacy, reliability, or manufacturing of medical products, including drugs and devices, relating to the conduct of the business of the Company and its Subsidiaries, (ii) all United States Pharmacopoeia product problem reporting program complaints or reports, MedWatch FDA Forms 3500, and device experience network complaints received by the Company or any of its Subsidiaries and all Drug and Medical Device Reports, adverse drug experience reports, and therapeutic failure reports filed by the Company or any of its Subsidiaries, which complaints or reports (A) pertain to any incident involving death, serious injury, or a serious adverse drug experience, and for which incident there has been any (1) notice or follow up inquiry to the Company or any of its Subsidiaries by the FDA, (2) litigation or arbitration claim or cause of action commenced, or (3) notice to any insurance carrier of the Company or any of its Subsidiaries tendering the defense or giving 8/12/97 notice of a possible or actual claim against the Company or any of its Subsidiaries, and (B) are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iii) all product recalls and safety alerts conducted by or issued to the Company or any of its Subsidiaries and any requests from the FDA or any other drug and medical device regulatory agency requesting the Company or any of its Subsidiaries to cease to investigate, test, or market any product, which recalls, safety alerts, or requests are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iv) any civil penalty actions begun by the FDA or any other drug and medical device regulatory agency against the Company or any of its Subsidiaries and all consent decrees issued with respect to the Company or any of its Subsidiaries, and (v) any other written communications between the FDA or any other drug and medical device regulatory agency, on the one hand, and the Company or any of its Subsidiaries, on the other hand, which communications are in the aggregate material to the conduct of the business of the Company and its Subsidiaries. The Company has delivered to the Parent copies of all documents referred to in Section 3.18 of the Company Disclosure Schedule, as well as copies of all complaints and other information required to be maintained by the Company pursuant to Section 820 of Title 21 of the Code of Federal Regulations ("CFR") or 21 CFR Section 211, to the extent that such complaints or other information relate to events that are, in the aggregate, material to the conduct of the business of the Company and its Subsidiaries. (b) The Company and its Subsidiaries have obtained all material consents, approvals, certifications, authorizations, and permits of, and have made all filings with, or notifications to, the FDA and all other drug and medical device regulatory agencies pursuant to applicable requirements of all FDA laws, rules, and regulations, and all corresponding state and foreign laws, rules, and regulations applicable to the Company and its Subsidiaries. All representations made by the Company or any of its Subsidiaries in connection with any such consents, approvals, certifications, authorizations, permits, filings, and notifications were true and correct in all material respects at the time such representations were made, and the products of the Company and its Subsidiaries comply with, and perform in accordance with the specifications described in, such representations. The Company and its Subsidiaries are in all material respects in compliance with all applicable FDA laws, rules, and regulations, and all corresponding applicable state and foreign laws, rules, and regulations (including Good Manufacturing Practices, as defined in 21 CFR Parts 210, 211, and 820, Medical Device Reporting requirements, and Adverse Experience Reporting) applicable to the business of the Company. The Company has not received any notice that any of the consents, approvals, certifications, authorizations, registrations, permits, filings, or notifications that it has received or made to operate its business have been or are being revoked or challenged. Except as set forth on Section 3.18 of the Company Disclosure Schedule, to the knowledge of the Company, there are no investigations or inquiries pending, and there is no material threat of any investigation or inquiry, by the FDA or any other drug and medical device regulatory agency relating to the operation of the business of the Company and its Subsidiaries or its compliance with FDA 8/12/97 laws, rules, and regulations, and corresponding state and foreign laws, rules, and regulations, applicable to the business of the Company and its Subsidiaries. None of the matters set forth on Section 3.18 of the Company Disclosure Schedule is reasonably likely to have, individually or in the aggregate, a Company Material Adverse Effect.

FDA and Related Matters. (a) Section 3.18 of the Company Disclosure 2.31.1. Schedule 2.31 sets forth a complete and accurate list, referencing relevant records and documents, since January 1, 1993for the last five (5) years, of (i) all Regulatory regulatory or Warning Letterswarning letters, Notices notices of Adverse Findings, and Section 305 Notices adverse findings and similar letters or notices issued to the Company or any Subsidiary by the Food and Drug Administration (the "“FDA"”) or any other federal, state, local, or foreign governmental entity that is concerned with the safety, efficacy, reliability, reliability or manufacturing of the medical productsdevices developed, including drugs and devices, relating to the conduct of the business of manufactured or sold by the Company and its Subsidiariesor any Subsidiary (hereinafter for purposes of this Section 2.31, “Medical Device Regulatory Agency”); (ii) all United States Pharmacopoeia product problem reporting program complaints or reports, MedWatch FDA Forms 3500, and device experience network complaints received filings or communications made by the Company or any of its Subsidiaries and all Drug and to or with a Medical Device ReportsRegulatory Agency regarding the medical devices developed, adverse drug experience reports, and therapeutic failure reports filed manufactured or sold by the Company or any Subsidiary (but excluding any reports, filings or communications in connection with applications seeking approval from any such Medical Device Regulatory Agency for the marketing and sale of its Subsidiaries, which complaints or reports (A) pertain to any incident involving death, serious injury, or a serious adverse drug experience, and for which incident there has been any (1) notice or follow up inquiry to the Company or any of its Subsidiaries by the FDA, (2) litigation or arbitration claim or cause of action commenced, or (3) notice to any insurance carrier of the Company or any of its Subsidiaries tendering the defense or giving 8/12/97 notice of a possible or actual claim against the Company or any of its Subsidiaries, and (B) are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, such medical devices); (iii) all product recalls and safety alerts conducted by or issued to the Company or any of its Subsidiaries Subsidiary and any requests from the FDA or any other drug and medical device regulatory agency Medical Device Regulatory Agency requesting the Company or any of its Subsidiaries Subsidiary to cease to investigate, test, manufacture, market or market sell any product, which recalls, safety alerts, or requests are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, ; (iv) any civil penalty actions begun by the FDA or any other drug and medical device regulatory agency Medical Device Regulatory Agency against the Company or any of its Subsidiaries Subsidiary and all consent decrees issued with respect to the Company or any of its Subsidiaries, Subsidiary; and (v) any other written communications between the Company or any Subsidiary on the one hand and the FDA or any other drug and medical device regulatory agency, on the one hand, and the Company or any of its Subsidiaries, Medical Device Regulatory Agency on the other hand, which communications are in the aggregate material to the conduct of the business of the Company and its Subsidiaries. The Company has delivered to the Parent Investors copies of all documents referred to in Section 3.18 of the Company Disclosure Schedule, as well as copies of all complaints and other information required to be maintained by the Company pursuant to Section 820 of Title 21 of the Code of Federal Regulations ("CFR") or 21 CFR Section 211, to the extent that such complaints or other information relate to events that are, in the aggregate, material to the conduct of the business of the Company and its SubsidiariesSchedule 2.31. (b) 2.31.2. The Company and its Subsidiaries have obtained all material consents, approvals, certifications, authorizations, authorizations and permits of, and have made all filings with, or notifications to, the FDA and all other drug and medical device regulatory agencies Medical Device Regulatory Agencies pursuant to applicable requirements of all FDA federal laws, rules, rules and regulations, and all corresponding state and foreign laws, rules, rules and regulations applicable to the Company and its Subsidiaries. All representations made by the Company or any of Subsidiary and relating to its Subsidiaries in connection with any such consents, approvals, certifications, authorizations, permits, filings, and notifications were true and correct in all material respects at the time such representations were made, and the products of the Company and its Subsidiaries comply with, and perform in accordance with the specifications described in, such representationsbusiness. The Company and its Subsidiaries are in all material respects in compliance with all applicable FDA federal laws, rules, rules and regulations, regulations and all corresponding applicable state and foreign laws, rules, rules and regulations (including Good Manufacturing Practices, as defined in 21 CFR Parts 210, 211, and 820, Medical Device Reporting requirements, and Adverse Experience Reporting) applicable relating to the business of the Companymedical device manufacturers. The Company has not received any notice no reason to believe that any of the consents, approvals, certifications, authorizations, registrations, certifications, permits, filings, filings or notifications that it or any of its Subsidiaries has received or made to operate its business their respective businesses have been or are being revoked questioned, challenged or challengedrevoked. Except as set forth on Section 3.18 of the Company Disclosure Schedule, to the knowledge of the Company, there There are no investigations or inquiries pending, and there is no material threat of any investigation or inquiry, by the FDA or any other drug and medical device regulatory agency Medical Device Regulatory Agency pending or threatened relating to the operation of the business of Company’s or the Company and its Subsidiaries Company’s Subsidiaries’ businesses or its the Company’s or any Subsidiary’s compliance with FDA 8/12/97 applicable laws, rules, and regulations, and corresponding state and foreign laws, rules, and regulations, applicable rules or regulations relating to the business of the Company and its Subsidiaries. None of the matters set forth on Section 3.18 of the Company Disclosure Schedule is reasonably likely to have, individually or in the aggregate, a Company Material Adverse Effectmedical device manufacturers.