Common use of Compliance with Laws; Regulatory Matters Clause in Contracts

Compliance with Laws; Regulatory Matters. (a) Except as set forth in Section 5.13(a) of the Seller Disclosure Schedule, the Business is being, and at all times within the past five years has been, conducted in compliance in all material respects with all applicable Laws including but not limited to (A) the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. Sections 301 et seq.) (the “FDCA”) and the regulations promulgated thereunder, (B) the Public Health Service Act (42 U.S.C. Sections 201 et seq.) and the regulations promulgated thereunder; (C) the Veterans Health Care Act (38 U.S.C. Section 126) and the regulations promulgated thereunder; (D) federal Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act) statutes and the regulations promulgated thereunder, and any related Laws; (E) Laws relating to healthcare fraud and abuse, false claims and anti-kickback laws, including the Federal Anti-Kickback Statute (42 U.S.C. Sections 1320a-7b(b))), the Federal False Claims Act (31 U.S.C. Section 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the criminal laws (18 U.S.C. §§ 286 and 287), the exclusion laws (42 U.S.C, § 1320a-7), or any similar Laws; (F) Laws regarding the reporting of prices and promotional expenditures to healthcare professionals including the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and similar state gift and disclosure Laws; (G) the Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, the regulations promulgated thereunder and similar Laws pertaining to privacy, data protection and information security; (H) state Laws relating to the manufacture, sale, and distribution of medical products; and (I) all applicable Laws of other comparable foreign Governmental Bodies (collectively, “Health Care Laws”). (b) Neither Seller nor its Affiliates is debarred under 21 U.S.C. Section 335a or any similar Law, or is otherwise excluded from or restricted in any manner from participation in any government program related to medical devices in the United States or any other country in which Seller conducts business and, to Seller’s Knowledge, no Person affiliated with Seller employs or uses the services of any person who is so debarred or otherwise excluded or restricted. As of the date hereof, no Legal Proceedings, claims or investigations that would reasonably be expected to result in such a debarment, exclusion or restriction are pending or threatened against Seller or its Affiliates. Seller is not a party to, nor does it have, any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Body. (c) Neither Seller nor, to Seller’s Knowledge, any director, officer, agent, employee or affiliate of Seller is aware of or has taken any action, directly or indirectly, that would result in a violation by such persons of any applicable anti-corruption Laws, including the United States Foreign Corrupt Practices Act, 15 U.S.C.§78-dd-1, et seq., including without limitation, directly or indirectly offering, paying, promising to pay or authorizing the payment of any money, or other property, gift, promising to give, or authorizing the giving of anything of value to any government official or any political party or official thereof or any candidate for political office, to obtain or retain business or any business advantage. Seller and, to Seller’s Knowledge, its Affiliates have conducted their businesses in compliance with all applicable anti-corruption Laws and have instituted and maintained policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith. Moreover, Seller represents that it has maintained books, records and accounts which, in reasonable detail, accurately and fairly reflect the transactions and dispositions of Seller’s assets. (d) Except as set forth in Section 5.13(d) of the Seller Disclosure Schedule, Seller has not received notice of or is subject to any pending or, to Seller’s Knowledge, threatened investigation, Legal Proceeding, hearing, enforcement, audit, arbitration or other action by the United States Food and Drug Administration (“FDA”) or any similar state or foreign Governmental Body alleging that any operation or activity of Seller is in violation of any applicable Law or Health Care Law, nor has any Governmental Body indicated to Seller of an intention to conduct or initiate the same. (e) Except as set forth in Section 5.13(e) of the Seller Disclosure Schedule, since the Petition Date, (i) Seller has not received an FDA Form 483 (or other Governmental Body notice of inspectional observations), FDA Warning or Untitled Letter (or the foreign equivalents thereof), or requests or requirements to make changes to products manufactured or sold by Seller that if not complied with would reasonably be expected to result in a material effect on Seller; (ii) no penalty, fine or other sanction has been assessed against Seller by any Governmental Body; (iii) no manufacturing sites or products have been subject to a Governmental Body shutdown or import or export prohibition; and (iv) no compliance order or other compliance monitoring or enforcement activity, nor any similar correspondence or notice from the FDA or other Governmental Body alleging or asserting noncompliance with any applicable Law, Permit or such requests or requirements of a Governmental Body, has been made in respect of Seller by any Governmental Body, and, to Seller’s Knowledge, neither the FDA nor any Governmental Body is considering such action. (f) Neither Seller, nor to Seller’s Knowledge (i) any officer or employee of Seller, (ii) any authorized agent of Seller or (iii) any principal investigator or sub-investigator of any clinical investigation conducted by Seller has, in the case of each of (i) through (iii) on account of actions taken for or on behalf of Seller, been convicted of any crime under the FDCA; nor has any such principal investigator or sub-investigator been disqualified from conducting any clinical investigation that supports an application for a research or marketing permit for products regulated by the FDA, including medical devices, under 21 C.F.R. §312.70 or any similar or applicable foreign laws. (g) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by Seller or in which Seller or its products or product candidates have participated were and, if still pending, are being conducted in all material respects in accordance with all applicable Laws, including, but not limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812. Except as set forth in Section 5.13(g) of the Seller Disclosure Schedule, no investigational device exemption filed by or on behalf of Seller with the FDA has been terminated or suspended by the FDA, and since the Petition Date neither the FDA nor any applicable foreign regulatory agency has commenced, or, to Seller’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Seller. (h) Since the Petition Date, all applications, notifications, submissions, information, claims, reports, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all Permits from the FDA or other Governmental Body relating to Seller, its businesses and its products, when submitted to the FDA or other Governmental Body were true, complete and correct in all material respects as of the date of submission, and all necessary or required applications, notifications, submissions, information, claims, reports, data, and updates, changes, corrections or modifications thereto have been submitted to the FDA or other Governmental Body. (i) Section 5.13(h) of the Seller Disclosure Schedule sets forth a list of (i) all recalls, field notifications, field corrections, market withdrawals or replacements, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the products manufactured or sold by Seller (“Safety Notices”) in the last five (5) years, (ii) the dates such Safety Notices, if any, were resolved or closed, and (iii) to Seller’s Knowledge, any material complaints with respect to the products manufactured or sold by Seller that are currently unresolved. There are no Safety Notices, or, to Seller’s Knowledge, material product complaints with respect to the products manufactured or sold by Seller, and to Seller’s Knowledge, there are no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the products manufactured or sold by Seller, (ii) a material change in labeling of any such products; or (iii) a termination or suspension of marketing or testing of any such product.

Compliance with Laws; Regulatory Matters. (a) Except as set forth in Section 5.13(a3.8(a) of the Seller Company Disclosure Schedule, the Business Company is beingnot now, and since September 30, 2011 has not been, in default or violation of any Law applicable to the Company or by which any property or asset of the Company is bound, including, (i) the Federal Ethics in Patient Referrals Act, 42 U.S.C. § 1395nn, and all regulations promulgated thereunder (known as the “Sxxxx Law”), (ii) the Federal Health Care Program Axxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), and all regulations promulgated thereunder (known as the “Anti-Kickback Statute”), (iii) the Federal False Claim Act, 31 U.S.C. § 3729, and all regulations promulgated thereunder, (iv) the Occupational Safety and Health Act, and all regulations promulgated thereunder that apply to the Company or its business (known as “OSHA”), (v) the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321 et seq., and all regulations promulgated thereunder, (vi) the Clinical Laboratory Improvement Amendments, 42 C.F.R. Part 493, and all regulations promulgated thereunder (“CLIA”), (vii) applicable Laws of the United States Drug Enforcement Administration (“DEA”), (viii) state anti-kickback, fee-splitting and patient brokering Laws, (ix) Information Privacy and Security Laws, and (x) state Laws governing self-referral and the licensure and operation of clinical laboratories. (b) Neither the Company nor the officers, directors, managing employees or agents of the Company nor, to the Knowledge of the Company, any other employees of the Company, have engaged in any activities which are cause for criminal or material civil penalties against, or mandatory or permissive exclusion of, the Company from Medicare, Medicaid, or any other federal health care program under 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b, or 1395nn, the Federal Employees Health Benefits program statute, or the regulations promulgated pursuant to such statutes or related state or local statutes or regulations. (c) The Company’s past and present collection, use, analysis, disclosure, retention, storage, security and dissemination of Personal Information comply with, and have not violated, (i) any and all applicable Laws, including Information Privacy and Security Laws, (ii) business associate agreements to which the Company is a party, (iii) any Person’s right of publicity and (iv) each of the Company’s privacy policies. To the extent required by applicable Law, the Company has posted in accordance with Information Privacy and Security Laws a privacy policy governing its use of Personal Information on its website and has complied at all times within with such privacy policy. (d) Section 3.8(d) of the past five years has beenCompany Disclosure Schedule contains a true, conducted correct and complete list of all material federal, state, county or local permits (including, without limitation, 510(k) clearances, Medicare, Medicaid and other provider numbers, state laboratory licenses, CLIA and DEA certifications and other permits (other than Environmental Permits)) that have been issued to the Company and that are currently in effect (the “Company Licenses”), and these Company Licenses constitute all the material permits necessary for the conduct of the Current Company Business and use of the Company Facilities as currently used. Each Company License is valid and in full force and effect. To the Knowledge of the Company, the Company is in compliance in all material respects with all terms and conditions of the Company Licenses. There is no investigation or proceeding pending or, to the Knowledge of the Company, threatened that could result in the termination, revocation, suspension, or restriction of any Company License or the imposition of any fine, penalty or other sanctions for violation of any legal or regulatory requirements relating to any Company License. Except as set forth in Section 3.8(d) of the Company Disclosure Schedule, none of the Company Licenses shall be adversely affected in any material respect by the consummation of the Transactions. (e) The Company is in compliance in all material respects with all applicable Laws including but not limited registration and listing requirements set forth in 21 U.S.C. § 360, 21 C.F.R. Part 807. All submissions made by Company or by any third party on behalf of the Company in connection with any Company Products to (A) the Federal Food, Drugany Governmental Authority were when made, and Cosmetic Act, as amended (21 U.S.C. Sections 301 et seq.) (the “FDCA”) and the regulations promulgated thereunder, (B) the Public Health Service Act (42 U.S.C. Sections 201 et seq.) and the regulations promulgated thereunder; (C) the Veterans Health Care Act (38 U.S.C. Section 126) and the regulations promulgated thereunder; (D) federal Medicare (Title XVIII of the Social Security Act) Closing Date will be, accurate and Medicaid (Title XIX of the Social Security Act) statutes and the regulations promulgated thereunder, and any related Laws; (E) Laws relating to healthcare fraud and abuse, false claims and anti-kickback laws, including the Federal Anti-Kickback Statute (42 U.S.C. Sections 1320a-7b(b))), the Federal False Claims Act (31 U.S.C. Section 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the criminal laws (18 U.S.C. §§ 286 and 287), the exclusion laws (42 U.S.C, § 1320a-7), or any similar Laws; (F) Laws regarding the reporting of prices and promotional expenditures to healthcare professionals including the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and similar state gift and disclosure Laws; (G) the Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, the regulations promulgated thereunder and similar Laws pertaining to privacy, data protection and information security; (H) state Laws relating to the manufacture, sale, and distribution of medical products; and (I) complete in all applicable Laws of other comparable foreign Governmental Bodies (collectively, “Health Care Laws”)material respects. (bf) Neither Seller nor its Affiliates is debarred under 21 U.S.C. Section 335a or any similar LawSince September 30, or is otherwise excluded from or restricted in any manner from participation in any government program related to medical devices in 2011, the United States or any other country in which Seller conducts business and, to Seller’s Knowledge, no Person affiliated with Seller employs or uses the services of any person who is so debarred or otherwise excluded or restricted. As of the date hereof, no Legal Proceedings, claims or investigations that would reasonably be expected to result in such a debarment, exclusion or restriction are pending or threatened against Seller or its Affiliates. Seller is not a party to, nor does it have, any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Body. (c) Neither Seller nor, to Seller’s Knowledge, any director, officer, agent, employee or affiliate of Seller is aware of or has taken any action, directly or indirectly, that would result in a violation by such persons of any applicable anti-corruption Laws, including the United States Foreign Corrupt Practices Act, 15 U.S.C.§78-dd-1, et seq., including without limitation, directly or indirectly offering, paying, promising to pay or authorizing the payment of any money, or other property, gift, promising to give, or authorizing the giving of anything of value to any government official or any political party or official thereof or any candidate for political office, to obtain or retain business or any business advantage. Seller and, to Seller’s Knowledge, its Affiliates have conducted their businesses in compliance with all applicable anti-corruption Laws and have instituted and maintained policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith. Moreover, Seller represents that it has maintained books, records and accounts which, in reasonable detail, accurately and fairly reflect the transactions and dispositions of Seller’s assets. (d) Except as set forth in Section 5.13(d) of the Seller Disclosure Schedule, Seller Company has not received notice of or is subject to any pending or, to Seller’s Knowledge, threatened investigation, Legal Proceeding, hearing, enforcement, audit, arbitration or other action by the United States Food and Drug Administration (“FDA”) or any similar state or foreign Governmental Body alleging that any operation or activity of Seller is in violation of any applicable Law or Health Care Law, nor has any Governmental Body indicated to Seller of an intention to conduct or initiate the same. (e) Except as set forth in Section 5.13(e) of the Seller Disclosure Schedule, since the Petition Date, (i) Seller has not received an FDA Form 483 (or other Governmental Body Authority notice of inspectional observations), FDA Warning or Untitled Letter (or “warning letters,” “untitled letters” or, to the foreign equivalents thereof)Knowledge of the Company, or requests or requirements to make changes to products manufactured the operations of the Current Company Business or sold the Company Products, or similar correspondence or written notice from the FDA or other Governmental Authority in respect of the Current Company Business or Company Products and alleging or asserting noncompliance with any applicable Laws, permits or such requests or requirements of a Governmental Authority. (g) To the Knowledge of the Company, all studies, tests and preclinical and clinical trials in respect of the Current Company Business and Company Products being conducted by Seller or on behalf of the Company that if have been or will be submitted to any Governmental Authority, including the FDA, are being or have been conducted in material compliance with all applicable Laws and guidance of the FDA, including the FDA’s Good Laboratory Practices regulations, and regulations and guidance restricting the use and disclosure of individually identifiable health information. (h) To the Knowledge of the Company, the Company is not complied the subject of any pending or threatened investigation in respect of the Company’s business by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of the Company, the Company has not committed any act, made any statement, or failed to make any statement, in each case in respect of the Current Company Business or the Company Products that would provide a reasonable basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities” and any amendments thereto. Neither the Company nor, to the Knowledge of the Company, any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in a material effect on Seller; (ii) no penalty, fine debarment or other sanction has been assessed against Seller by any Governmental Body; (iii) no manufacturing sites or products have been subject to a Governmental Body shutdown or import or export prohibition; and (iv) no compliance order or other compliance monitoring or enforcement activity, nor any similar correspondence or notice from the FDA or other Governmental Body alleging or asserting noncompliance with any applicable Law, Permit or such requests or requirements of a Governmental Body, has been made in respect of Seller by any Governmental Body, and, to Seller’s Knowledge, neither the FDA nor any Governmental Body is considering such action. (f) Neither Seller, nor to Seller’s Knowledge exclusion (i) any officer under 21 U.S.C. Section 335a, or employee of Seller, (ii) any authorized agent similar applicable state Law. To the Knowledge of Seller the Company, no debarment proceedings or (iii) investigations in respect of the Current Company Business or Company Products are pending or threatened against the Company or any principal investigator of its officers, employees or sub-investigator of any clinical investigation conducted by Seller has, in the case of each of agents. (i) through To the Knowledge of the Company, there are no investigations, suits, claims, actions or proceedings against or affecting the Company pending or threatened, relating to or arising under (iiii) on account the FDCA or the regulations of actions taken for the FDA promulgated thereunder or on behalf of Sellersimilar Laws, been convicted or (ii) Information and Privacy Security Laws, including alleging a violation of any crime Person’s rights under any Information Privacy and Security Laws or the FDCA; nor Company’s former or current published privacy policies. The Company has not received any notices from the United States Department of Health and Human Services Office for Civil Rights, Department of Justice, Federal Trade Commission, or the Attorney General of any state relating to any such principal investigator violations. The Company has not acted and is not acting in a manner that would reasonably be expected to trigger a notification or sub-investigator been disqualified from conducting reporting requirement under any clinical investigation that supports an application for applicable Law or business associate agreement to which the Company is a research or marketing permit for products regulated by the FDAparty, including medical devices, under 21 C.F.R. §312.70 or any similar or applicable foreign lawsInformation Privacy and Security Laws related to the disclosure of Personal Information. (gj) Except as set forth in Section 3.8(j) of the Company Disclosure Schedule, there are no pending, concluded, since January 1, 2012, or, to the Knowledge of the Company, threatened investigations, suits, claims, actions or proceedings relating to the Company’s participation in any payment program, including without limitation, Medicare, Medicaid, and private third party payor programs (“Payment Programs”). The clinicalCompany is not subject to, nor, since September 30, 2011, has the Company been subjected to, any pre-clinical and payment utilization review or other studies and tests conducted utilization review by or on behalf of or sponsored by Seller or in which Seller or its products or product candidates have participated were and, if still pending, are being conducted in all material respects in accordance with all applicable Laws, including, but not limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812any Payment Program. Except as set forth in Section 5.13(g3.8(j) of the Seller Company Disclosure Schedule, no investigational device exemption filed by Payment Program is currently requesting or on behalf of Seller with the FDA has been terminated or suspended by the FDArequested since September 30, and since the Petition Date neither the FDA nor any applicable foreign regulatory agency has commenced, 2011 or, to Seller’s Knowledgethe Knowledge of the Company, is threatening or has since September 30, 2011 threatened to initiateany recoupment, any action to place a clinical hold order onrefund, or otherwise terminateset-off from the Company in excess of $10,000. Since September 30, delay 2011, no Payment Program has imposed a fine, penalty or suspendother sanction on the Company. Since September 30, 2011, the Company has not been excluded from participation in any proposed or ongoing clinical investigation conducted or proposed Payment Program. All billing practices of the Company with respect to be conducted by or on behalf of Sellerall Payment Programs have been in compliance with all Laws applicable to the Company in all material respects. (hk) Since the Petition DateThe negotiation, all applications, notifications, submissions, information, claims, reports, execution and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all Permits from the FDA or other Governmental Body relating to Seller, its businesses and its products, when submitted to the FDA or other Governmental Body were true, complete and correct in all material respects as consummation of the date of submissionTransactions will not breach or otherwise violate any applicable Information Privacy and Security Laws, and all necessary or required applications, notifications, submissions, information, claims, reports, data, and updates, changes, corrections the Company’s executed HIPAA business associate agreements or modifications thereto have been submitted to the FDA or other Governmental Bodycurrent published privacy policy. (il) Section 5.13(h) Complete and accurate copies of the Seller Disclosure Schedule sets forth a list compliance policies and/or procedures and privacy notices of the Company relating to Information Privacy and Security Laws have been furnished or made available to Parent. All of the Company’s employees who have access to Personal Information that is subject to Information Privacy and Security Laws have received training with respect to compliance with Information Privacy and Security Laws. (im) all recallsThe Company has taken reasonable measures consistent with reasonable industry practices and in compliance with applicable Laws including Information Privacy and Security Laws to ensure that Personal Information is protected against loss and unauthorized access, field notificationsacquisition, field correctionsuse, market withdrawals or replacementsmodification, safety alerts disclosure or other notices misuse, and there has been no known unauthorized access, acquisition, use, disclosure, compromise or other misuse of action relating to such Personal Information. (n) The Company has performed a HIPAA security rule risk assessment as required by 45 C.F.R. 164.308(a)(1)(ii)(A), including an alleged lack of safetyassessment as required by 45 C.F.R. 164.306(d)(3), efficacy, or regulatory compliance of taking into account the products manufactured or sold by Seller (“Safety Notices”) factors set forth in the last five (5) years45 C.F.R. 164.306(a), (ii) the dates such Safety Notices, if any, were resolved or closedb), and (iiic) to Seller’s Knowledge, any material complaints and created and maintained documentation in accordance with respect to 45 C.F.R. 164.316 (the products manufactured or sold by Seller that are currently unresolved“Security Risk Assessment”). There are no Safety Notices, or, to Seller’s Knowledge, material product complaints The Company has addressed and remediated all threats and deficiencies identified in the Security Risk Assessment in accordance with respect to the products manufactured or sold by Seller, and to Seller’s Knowledge, there are no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the products manufactured or sold by Seller, (ii) a material change in labeling of any such products; or (iii) a termination or suspension of marketing or testing of any such productHIPAA.

Compliance with Laws; Regulatory Matters. ‌ (a) Except as set forth in Section 5.13(a) of the Seller Disclosure Schedule, the Business is being, and at all times within the past five years has been, conducted in compliance in all material respects with all applicable Laws including but not limited to (A) the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. Sections 301 et seq.) (the “FDCA”) and the regulations promulgated thereunder, (B) the Public Health Service Act (42 U.S.C. Sections 201 et seq.) and the regulations promulgated thereunder; (C) the Veterans Health Care Act (38 U.S.C. Section 126) and the regulations promulgated thereunder; (D) federal Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act) statutes and the regulations promulgated thereunder, and any related Laws; (E) Laws relating to healthcare fraud and abuse, false claims and anti-anti- kickback laws, including the Federal Anti-Kickback Statute (42 U.S.C. Sections 1320a-7b(b1320a- 7b(b))), the Federal False Claims Act (31 U.S.C. Section 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(51320a- 7a(a)(5), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the criminal laws (18 18‌ U.S.C. §§ 286 and 287), the exclusion laws (42 U.S.C, § 1320a-7), or any similar Laws; (F) Laws regarding the reporting of prices and promotional expenditures to healthcare professionals including the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and similar state gift and disclosure Laws; (G) the Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, the regulations promulgated thereunder and similar Laws pertaining to privacy, data protection and information security; (H) state Laws relating to the manufacture, sale, and distribution of medical products; and (I) all applicable Laws of other comparable foreign Governmental Bodies (collectively, “Health Care Laws”). (b) Neither Seller nor its Affiliates is debarred under 21 U.S.C. Section 335a or any similar Law, or is otherwise excluded from or restricted in any manner from participation in any government program related to medical devices in the United States or any other country in which Seller conducts business and, to Seller’s Knowledge, no Person affiliated with Seller employs or uses the services of any person who is so debarred or otherwise excluded or restricted. As of the date hereof, no Legal Proceedings, claims or investigations that would reasonably be expected to result in such a debarment, exclusion or restriction are pending or threatened against Seller or its Affiliates. Seller is not a party to, nor does it have, any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Body. (c) Neither Seller nor, to Seller’s Knowledge, any director, officer, agent, employee or affiliate of Seller is aware of or has taken any action, directly or indirectly, that would result in a violation by such persons of any applicable anti-corruption Laws, including the United States Foreign Corrupt Practices Act, 15 U.S.C.§78-dd-1, et seq., including without limitation, directly or indirectly offering, paying, promising to pay or authorizing the payment of any money, or other property, gift, promising to give, or authorizing the giving of anything of value to any government official or any political party or official thereof or any candidate for political office, to obtain or retain business or any business advantage. Seller Seller‌ and, to Seller’s Knowledge, its Affiliates have conducted their businesses in compliance with all applicable anti-corruption Laws and have instituted and maintained policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith. Moreover, Seller represents that it has maintained books, records and accounts which, in reasonable detail, accurately and fairly reflect the transactions and dispositions of Seller’s assets. (d) Except as set forth in Section 5.13(d) of the Seller Disclosure Schedule, Seller has not received notice of or is subject to any pending or, to Seller’s Knowledge, threatened investigation, Legal Proceeding, hearing, enforcement, audit, arbitration or other action by the United States Food and Drug Administration (“FDA”) or any similar state or foreign Governmental Body alleging that any operation or activity of Seller is in violation of any applicable Law or Health Care Law, nor has any Governmental Body indicated to Seller of an intention to conduct or initiate the same. (e) Except as set forth in Section 5.13(e) of the Seller Disclosure Schedule, since the Petition Date, (i) Seller has not received an FDA Form 483 (or other Governmental Body notice of inspectional observations), FDA Warning or Untitled Letter (or the foreign equivalents thereof), or requests or requirements to make changes to products manufactured or sold by Seller that if not complied with would reasonably be expected to result in a material effect on Seller; (ii) no penalty, fine or other sanction has been assessed against Seller by any Governmental Body; (iii) no manufacturing sites or products have been subject to a Governmental Body shutdown or import or export prohibition; and (iv) no compliance order or other compliance monitoring or enforcement activity, nor any similar correspondence or notice from the FDA or other Governmental Body alleging or asserting noncompliance with any applicable Law, Permit or such requests or requirements of a Governmental Body, has been made in respect of Seller by any Governmental Body, and, to Seller’s Knowledge, neither the FDA nor any Governmental Body is considering such action. (f) Neither Seller, nor to Seller’s Knowledge (i) any officer or employee of Seller, (ii) any authorized agent of Seller or (iii) any principal investigator or sub-sub- investigator of any clinical investigation conducted by Seller has, in the case of each of (i) through (iii) on account of actions taken for or on behalf of Seller, been convicted of any crime under the FDCA; nor has any such principal investigator or sub-investigator been disqualified from conducting any clinical investigation that supports an application for a research or marketing permit for products regulated by the FDA, including medical devices, under 21 C.F.R. §312.70 or any similar or applicable foreign laws. (g) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by Seller or in which Seller or its products or product candidates have participated were and, if still pending, are being conducted in all material respects in accordance with all applicable Laws, including, but not limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812. Except as set forth in Section 5.13(g) of the Seller Disclosure Schedule, no investigational device exemption filed by or on behalf of Seller with the FDA has been terminated or suspended by the FDA, and since the Petition Date neither the FDA nor any applicable foreign regulatory agency has commenced, or, to Seller’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Seller. (h) Since the Petition Date, all applications, notifications, submissions, information, claims, reports, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all Permits from the FDA or other Governmental Body relating to Seller, its businesses and its products, when submitted to the FDA or other Governmental Body were true, complete and correct in all material respects as of the date of submission, and all necessary or required applications, notifications, submissions, information, claims, reports, data, and updates, changes, corrections or modifications thereto have been submitted to the FDA or other Governmental Body. (i) Section 5.13(h) of the Seller Disclosure Schedule sets forth a list of (i) all recalls, field notifications, field corrections, market withdrawals or replacements, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the products manufactured or sold by Seller (“Safety Notices”) in the last five (5) years, (ii) the dates such Safety Notices, if any, were resolved or closed, and (iii) to Seller’s Knowledge, any material complaints with respect to the products manufactured or sold by Seller that are currently unresolved. There are no Safety Notices, or, to Seller’s Knowledge, material product complaints with respect to the products manufactured or sold by Seller, and to Seller’s Knowledge, there are no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the products manufactured or sold by Seller, (ii) a material change in labeling of any such products; or (iii) a termination or suspension of marketing or testing of any such product.