Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws, except to the extent that any non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Act (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Company. Additionally, none of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Change, the Company and its subsidiaries are, and at all times during the last five (5) years have been, in compliance with all applicable Health Care Laws, except to the extent that any non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the applicable provisions of the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law false statements law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the criminal health care fraud criminal provisions under HIPAAlaw (18 U.S.C. Section 1347), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C U.S.C. Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 applicable laws governing governmental health care programs; (iii) HIPAA, as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.); (v) licensure, quality, safety and the accreditation requirements under applicable federal, state, local or foreign laws governing U.S. government funded or sponsored healthcare programsregulatory bodies; and (iiivi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (ivvii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of In the Companypast five (5) years, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation product, operation, or activity is or may be in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case threatened or contemplated. Except as would notnot reasonably be expected, individually or in the aggregate, have to result in a Material Adverse Effect. The Change, the Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Regulatory Agency. Additionally, neither the Company, any of its subsidiaries, or nor any of their respective employees, officers, directors, managing employees, owners or, to the Company’s knowledge, independent contractors, affiliates or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Company. Additionally, none knowledge of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal governmental health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries Senseonics are, and at all times have been, in compliance with all applicable Health Care Laws, and have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except to the extent that any non-compliance where such noncompliance, false claims liability or civil penalties would notnot reasonably be expected to, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation21 U.S.C. Section 301 et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA, the civil monetary penalties law ”) (42 U.S.C. Section 1320a-7a1320d et seq.), the exclusions law exclusion laws (42 U.S.C. Section § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h)HIPAA, the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), any and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other applicable comparable local, state, federal, national, supranational and foreign laws, relating to health care laws and the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Companylaws, any of its subsidiaries, or any of their respective officers, directors, employees or, each as amended from time to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Lawtime. Neither the Company nor any of its subsidiaries has Senseonics have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws norLaws, and, to the Company’s knowledgeknowledge of the Company or Senseonics, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor Senseonics have received any written notice of adverse filing, except in each case as would notwarning letter, individually untitled letter or in other correspondence or notice from the aggregateFDA, have a Material Adverse Effect. The Company and its subsidiaries have filedthe European Commission, maintained the EMA or submitted all any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any noncompliance with the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on . Neither the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is Company nor Senseonics are a party to and have no ongoing reporting obligations pursuant to 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 or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none neither the Company nor Senseonics nor, to the knowledge of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, suspension or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care LawsLaws applicable to the Company and its subsidiaries, except to the extent that any non-compliance as would not, reasonably be expected individually or in the aggregate, reasonably be expected aggregate to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec.Sec. 301 et seq.), Public Health Service Act (42 U.S.C. Sec.Sec. 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Sec. 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), U.S. Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to the criminal U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties exclusion law (42 U.S.C. Section 1320a-7a1320-7), the exclusions law statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (42 U.S.C. Section 1320a-7iii) the Standards for Privacy of Individually Identifiable Health Information, 45 C.F.R. parts 160 and 164 (subparts A and E) (the “Privacy Rule”), the Physician Payments Sunshine Act Security Standards, 45 C.F.R. parts 160 and 164 (42 U.S.C Section 1320-7hsubparts A and C), the Patient Protection Breach Notification Rule, 45 C.F.R. part 164 (subpart D), and Affordable Care Act of 2010 as amended by the Standards for Electronic Transactions and Code Sets, 45 C.F.R. part 162, promulgated under HIPAA, the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, and the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws governing U.S. government funded or sponsored healthcare programsregulatory bodies; and (iiivii) all other local, state, federal, national, supranational and foreign laws, relating applicable to the regulation of the Company or its subsidiaries, and (iv) except as would reasonably be expected individually or in the directives and regulations promulgated pursuant aggregate to such statutes and any state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care LawMaterial Adverse Effect. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws that has not been resolved nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case . Except as would not, not reasonably be expected individually or in the aggregate, aggregate to have a Material Adverse Effect. The , (i) the Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and (ii) all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete complete, accurate and accurate not misleading on the date filed in all material respects (or were materially corrected or supplemented by a subsequent submission). None of Neither the Company, any of Company nor its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents subsidiaries is a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the CompanyHealth Care Laws. Additionally, none neither the Company, its subsidiaries nor, to the knowledge of the Company, any of the Company’s or its subsidiaries or any of their subsidiaries’ respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal or state health care program or, to the knowledge of the Company, or human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company is and its subsidiaries are, and at all times have been, has been in compliance with all applicable Health Care LawsLaws (as hereinafter defined), except to the extent that any where instances of non-compliance would not, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA, the civil monetary penalties law ”) (42 U.S.C. Section 1320a-7a1320d et seq.), the exclusions law exclusion laws (42 U.S.C. Section § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h)HIPAA, the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local or federal health care laws and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and any state all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or non-U.S. counterpart thereof. None disposal of the Company’s products, any of its subsidiaries, or any of their respective officers, directors, employees or, each as amended from time to the Company’s knowledge, agents have time. The Company has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program, except where such noncompliance, false claims liability under or civil penalties would not reasonably be expected to, singly or in the aggregate, result in a Health Care LawMaterial Adverse Effect. Neither the The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is not a party to and has no ongoing reporting obligations pursuant to 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 or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none neither the Company nor, to the knowledge of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program program, clinical trial or clinical registry or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Registration Statement, the General Disclosure Package or engaged the Prospectus or as would not, singly or in any conduct that would the aggregate, reasonably be expected to result in debarmenthave a Material Adverse Effect, suspensionthe Company has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or exclusionother correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws.

Compliance with Health Care Laws. The Company has operated and its subsidiaries are, and at all times have been, currently is in compliance with all applicable Health Care Lawshealth care laws, except to the extent that any non-compliance would notrules and regulations, individually or in the aggregateincluding, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreementwithout limitation, “Health Care Laws” means: (i) the Federal Federal, Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder(21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and all applicable foreign health care healthcare related fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Statements Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care healthcare fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. Section § 1320a-7a); (iii) any applicable provisions of HIPAA, the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Information Technology for Economic Clinical Health Act (42 U.S.C. Section 17921 et seq.), and ; (iv) the laws governing U.S. government funded or sponsored healthcare programsregulations promulgated pursuant to such laws; and (iiiv) all any other similar local, state, federal, nationalor foreign laws (collectively, supranational and foreign lawsthe “Health Care Laws”) , relating except where failure to be so in compliance would not reasonably be expected, individually or in the regulation of the Company or its subsidiariesaggregate, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereofhave a Material Adverse Effect. None of Neither the Company, any of its subsidiaries, or any of their respective officers, directors, employees ornor, to the Company’s knowledge, any of its officers, directors, employees or agents have engaged in activities which are, as applicable, cause for liability under a Health Care Lawfalse claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the The Company nor any of its subsidiaries has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company is not a party to and its subsidiaries does not have filedany ongoing reporting obligations pursuant to any corporate integrity agreement, maintained deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required similar agreement imposed by any Health Care Lawsgovernmental or regulatory authority. Additionally, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of neither the Company, nor any of its subsidiaries, or any of their respective employees, officers, directors, oremployees or agents, to the Company’s knowledge, independent contractors, affiliates or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Company. Additionally, none of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the knowledge of the Company, or human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, Subsidiaries are operated and at all times have been, are currently in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), except to the extent that and have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any non-compliance would not, individually other state or in the aggregate, reasonably be expected to have a Material Adverse Effectfederal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act and (21 U.S.C. §§ 301 et seq.); the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), ; the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), ; the criminal False Statements Law Claims Act (42 U.S.C. Section § 1320a-7b(a)), ; all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 13471347 and 1349, and 1349 the health care fraud criminal provisions under HIPAA, ; the exclusion laws (42 U.S.C. § 1320a-7); the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), ; the Physician Payments Payment Sunshine Act (42 U.S.C Section 1320-7hU.S.C. § 1320a-7h); HIPAA, the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), and ; the laws governing U.S. government funded or sponsored healthcare programs; and Medicare statute (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation Title XVIII of the Company or its subsidiaries, and Social Security Act); the Medicaid statute (iv) Title XIX of the directives and Social Security Act); the regulations promulgated pursuant to such statutes laws and any other similar local, state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Lawfederal law and regulations. Neither the Company nor any of its subsidiaries Subsidiaries has received written any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the FDA or any other governmental or regulatory authority alleging or asserting noncompliance with any Health Care Laws, and, to the Company’s knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to threatened. Neither the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents Subsidiaries is a party to or has any ongoing reporting obligations pursuant to 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 or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of Neither the Company, any of its subsidiaries or Subsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates directors or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or, to the knowledge of the Company’s knowledge, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, suspension or exclusion. Any certificate signed by an officer of the Company and delivered to Xxxxx or to counsel for Xxxxx pursuant to or in connection with this Agreement shall be deemed to be a representation and warranty by the Company (and not by such officer in his or her personal capacity) to Xxxxx as to the matters set forth therein. The Company acknowledges that Xxxxx and, for purposes of the opinions to be delivered pursuant to Section 7(n) hereof, counsel to the Company and counsel to Xxxxx, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. The Company and its subsidiaries areis, and at all times have has been, in compliance in all material respects with all applicable Health Care Laws, except to the extent that any non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), all applicable federal, state, local and all foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA, the civil monetary penalties law ”) (42 U.S.C. Section 1320a-7a1320d et seq.), the exclusions law (42 U.S.C. Section 1320a-7)exclusion laws, the Physician Payments Sunshine Act statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (42 U.S.C Section 1320-7h), iii) the Patient Protection and Affordable Care Act of 2010 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH regulations promulgated thereunder; (iv) the U.S. Controlled Substances Act (42 21 U.S.C. Section 17921 801 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iiiv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, laws applicable to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a ; provided that Health Care LawLaws does not include the health information data privacy and security provisions of HIPAA or other Privacy Laws. Neither the The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, Company nor any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.any

Compliance with Health Care Laws. The Company and its subsidiaries subsidiary are, and at all times have been, in compliance with all applicable Health Care LawsLaws (as defined below), and have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except to the extent that any non-compliance where such noncompliance, false claims liability or civil penalties would notnot reasonably be expected to, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation21 U.S.C. Section 301 et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA, the civil monetary penalties law ”) (42 U.S.C. Section 1320a-7a1320d et seq.), the exclusions law exclusion laws (42 U.S.C. Section § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h)HIPAA, the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), any and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other applicable comparable local, state, federal, national, supranational and foreign laws, relating to health care laws and the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Companylaws, any of its subsidiaries, or any of their respective officers, directors, employees or, each as amended from time to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Lawtime. Neither the Company nor any of its subsidiaries has subsidiary have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws norLaws, and, to the Company’s knowledgeknowledge of the Company and its subsidiary, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor its subsidiary have received any written notice of adverse filing, except in each case as would notwarning letter, individually untitled letter or in other correspondence or notice from the aggregateFDA, have a Material Adverse Effect. The Company and its subsidiaries have filedthe European Commission, maintained the EMA or submitted all any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any noncompliance with the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on . Neither the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of Company nor its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is subsidiary are a party to and has no ongoing reporting obligations pursuant to 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 or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none neither the Company nor its subsidiary nor, to the knowledge of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws, Laws except to the extent that any non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347, 287 and 1349 the health care fraud criminal provisions under HIPAAHIPAA (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C U.S.C. Section 1320-7h1320a-7h), and the Patient Protection laws governing government funded or sponsored healthcare programs including, but not limited to, Medicare (Title XVIII of the Social Security Act) and Affordable Care Act Medicaid (Title XIX of 2010 as amended by the Health Care and Education Affordability Reconciliation Act of 2010Social Security Act); (iii) HIPAA, HIPAA as amended by the HITECH Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and the laws governing U.S. government funded or sponsored healthcare programsEducation Reconciliation Act of 2010; and (iiiv) all other applicable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, ; and (ivvi) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of Neither the Company, Company nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, any of its subsidiaries or nor, to the knowledge of the Company, any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates contractors or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have beenbeen since January 1, 2017, in material compliance with all applicable Health Care Laws, except to the extent that any non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act; the Public Health Service Act (42 U.S.C. §§ 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 1349, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act laws governing government funded or sponsored healthcare programs; (42 U.S.C Section 1320-7h)ii) HIPAA, the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iii) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and the Education Reconciliation Act of 2010; (iv) licensure and accreditation requirements under applicable federal, state, applicable local or foreign laws governing U.S. government funded or sponsored healthcare programsregulatory bodies; and (iiiv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (ivvi) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof, except for any such noncompliance or violation that would not, individually or in the aggregate, have a Material Adverse Effect. None of Neither the Company, any of its subsidiaries, or nor any of their respective officers, directors, employees or, to the Company’s knowledge, or agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of Neither the Company, any of its subsidiaries, or nor, to the Company’s knowledge, any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, any of its subsidiaries or nor, to the Company’s knowledge, any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws, except to the extent that any where such non-compliance would not, individually or in the aggregate, not be reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 1349, including the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320X.X.X Xxxxxxx 0000-7h), the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Act (42 U.S.C. Section 17921 et seq.0x), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of Neither the Company, any of its subsidiaries, or any of their respective officers, or directors, employees ornor, to the knowledge of the Company, any of the Company’s knowledge, or any of its subsidiaries’ employees or agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where the failure to file, maintain or submit would not, individually or in the aggregate, have a Material Adverse Effect). None of Neither the Company, nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, Company or any of its subsidiaries or nor any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times since January 1, 2015 have been, in compliance with all applicable Health Care Laws, except to the extent that any non-compliance where such noncompliance would not, individually not singly or in the aggregate, aggregate reasonably be expected to have result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C U.S.C. Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 (iii) HIPAA, as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iiiiv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation Medicare (Title XVIII of the Company or its subsidiariesSocial Security Act), Medicaid (Title XIX of the Social Security Act), the Public Health Service Act (42 U.S.C. § 201 et seq.), and (ivv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. foreign counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where such failure would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. None of Neither the Company, Company nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, any of its subsidiaries or nor any of their respective employees, officers, directors, or, or to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries Senseonics are, and at all times have been, in compliance with all applicable Health Care Laws, and have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except to the extent that any non-compliance where such noncompliance, false claims liability or civil penalties would notnot reasonably be expected to, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA, the civil monetary penalties law ”) (42 U.S.C. Section 1320a-7a1320d et seq.), the exclusions law exclusion laws (42 U.S.C. Section § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h)HIPAA, the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), any and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other applicable comparable local, state, federal, national, supranational and foreign laws, relating to health care laws and the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Companylaws, any of its subsidiaries, or any of their respective officers, directors, employees or, each as amended from time to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Lawtime. Neither the Company nor any of its subsidiaries has Senseonics have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor Senseonics have received any written notice of adverse filing, except in each case as would notwarning letter, individually untitled letter or in other correspondence or notice from the aggregateFDA, have a Material Adverse Effect. The Company and its subsidiaries have filedthe European Commission, maintained the EMA or submitted all any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any noncompliance with the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on . Neither the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is Company nor Senseonics are a party to and has no ongoing reporting obligations pursuant to 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 or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none neither the Company nor Senseonics nor, to the knowledge of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all applicable Health Care Laws, except to the extent that any non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act Act, Public Health Service Act, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), U.S. Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to the criminal U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA, the civil monetary penalties law ”) (42 U.S.C. Section 1320a-7a1320d et seq.), the exclusions law exclusion laws (42 U.S.C. Section 1320a-71320-7), the Physician Payments Sunshine Act statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (42 U.S.C Section 1320-7hiii) the Standards for Privacy of Individually Identifiable Health Information, 45 C.F.R. parts 160 and 164 (subparts A and E) (the “Privacy Rule”), the Patient Protection Security Standards, 45 C.F.R. parts 160 and Affordable Care Act of 2010 as amended by 164 (subparts A and C), the Breach Notification Rule, 45 C.F.R. part 164 (subpart D), and the Standards for Electronic Transactions and Code Sets, 45 C.F.R. part 162, promulgated under HIPAA, the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes thereunder and any state or non-U.S. counterpart thereof. None thereof or other law or regulation the purpose of which is to protect the Company, any privacy of its subsidiaries, individuals or any prescribers; (iv) the Patient Protection and Affordable Care Act of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are2010, as applicable, cause for liability under a amended by the Health Care Lawand Education Reconciliation Act of 2010, and the regulations promulgated thereunder; and (vi) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies. Neither the Company nor any of its subsidiaries has have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete timely, complete, accurate and accurate not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of Neither the Company, any of Company nor its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is subsidiaries are a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, any of its subsidiaries or nor any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal or state health care program oror human clinical research, nor, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws, except to the extent that any non-compliance Except as would notnot reasonably be expected, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: means (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law exclusion laws (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud 1320a-7 and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Act (42 U.S.C. Section 17921 et seq.)1395nn, and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any state and all other applicable health care laws and regulations, in any jurisdiction where the Company or non-U.S. counterpart thereofany of its subsidiaries conducts business. None Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Company’s knowledge, independent contractors, affiliates or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Company. Additionally, none of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of the Company, human clinical research or is subject to a governmental or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar action matter that could reasonably be expected to result in debarment, suspensionwould subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, Subsidiaries are operated and at all times have been, are currently in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), except to the extent that and have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any non-compliance would not, individually other state or in the aggregate, reasonably be expected to have a Material Adverse Effectfederal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act and (21 U.S.C. §§ 301 et seq.); the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), ; the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), ; the criminal False Statements Law Claims Act (42 U.S.C. Section § 1320a-7b(a)), ; all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 13471347 and 1349, and 1349 the health care fraud criminal provisions under HIPAA, ; the exclusion laws (42 U.S.C. § 1320a-7); the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), ; the Physician Payments Payment Sunshine Act (42 U.S.C Section 1320-7hU.S.C. § 1320a-7h); HIPAA, the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), and ; the laws governing U.S. government funded or sponsored healthcare programs; and Medicare statute (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation Title XVIII of the Company or its subsidiaries, and Social Security Act); the Medicaid statute (iv) Title XIX of the directives and Social Security Act); the regulations promulgated pursuant to such statutes laws and any other similar local, state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Lawfederal law and regulations. Neither the Company nor any of its subsidiaries Subsidiaries has received written any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the FDA or any other governmental or regulatory authority alleging or asserting noncompliance with any Health Care Laws, and, to the Company’s knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to threatened. Neither the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents Subsidiaries is a party to or has any ongoing reporting obligations pursuant to 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 or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of Neither the Company, any of its subsidiaries or Subsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates directors or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or, to the knowledge of the Company’s knowledge, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, suspension or exclusion. Any certificate signed by an officer of the Company and delivered to XX Xxxxx or to counsel for XX Xxxxx pursuant to or in connection with this Agreement shall be deemed to be a representation and warranty by the Company (and not by such officer in his or her personal capacity) to XX Xxxxx as to the matters set forth therein. The Company acknowledges that XX Xxxxx and, for purposes of the opinions to be delivered pursuant to Sections 7(n) and 8(f) hereof, counsel to the Company and counsel to XX Xxxxx, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. The Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws, except to the extent that any non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable U.S. federal, state, local and foreign non-U.S. health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law false statements law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abusethe civil monetary penalties law (42 U.S.C. Section 1320a-7a), including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the HITECH Act; (iv) the Patient Protection and Affordable Care Act of 2010 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010; (v) licensure, HIPAA as amended by the HITECH Act quality, safety and accreditation requirements under applicable U.S. federal, state, local or non-U.S. laws or regulatory bodies; (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iiivi) all other local, state, U.S. federal, national, supranational and foreign laws, non-U.S. health care laws relating to the regulation of the Company or its subsidiaries, and (ivvii) the directives and regulations promulgated pursuant to such statutes statutes, and any state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually threatened or in pending. Neither the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of the Company, any of its subsidiaries or nor any of their respective employees, officers, directors, directors or, to the Company’s knowledge, independent contractors, affiliates or their respective agents has been excluded, suspended suspended, debarred or debarred disqualified from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarmentdisqualification, suspension, or exclusion.

Compliance with Health Care Laws. The Each of the Company and its subsidiaries areSubsidiaries is, and at all times have has been, in compliance in all material respects with all applicable Health Care Laws, except to the extent that and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any non-compliance would not, individually other state or in the aggregate, reasonably be expected to have a Material Adverse Effectfederal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7)HIPAA, the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes statutes; (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act); (v) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated thereunder; and (vi) any state or non-U.S. counterpart thereofand all other applicable health care laws and regulations. None Neither the Company nor, to the knowledge of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries Subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor, except in each case as would not, individually or in to the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None knowledge of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents Subsidiary is a party to or has any ongoing reporting obligations pursuant to 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 or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, its Subsidiaries nor any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times during the past five (5) years have been, in compliance with all applicable Health Care Laws, Laws except where the failure to the extent that any non-be in compliance would not, individually or in the aggregate, not reasonably be expected to have result in a Material Adverse EffectChange. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law false statements law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under HIPAAHIPAA (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C U.S.C. Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the laws governing regulations promulgated thereunder, and any applicable state or non-U.S. government funded counterpart thereof or sponsored healthcare programsother law or regulation the purpose of which is to protect the privacy of patients; and (iiiiv) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (v) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (ivvi) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except as would not reasonably be expected to result in a Material Adverse Change. None of Neither the Company, Company nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, any of its subsidiaries or nor any of their respective employees, officers, directors, or, to the knowledge of the Company’s knowledge, independent contractorsagents, affiliates or agents has has, during the past five (5) years, been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, are in compliance with all applicable Health Care Laws, except to the extent for any noncompliance that any non-compliance would not, individually or in the aggregate, not reasonably be expected to have a Material Adverse EffectChange. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law false statements law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C U.S.C. Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and the Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws governing U.S. government funded or sponsored healthcare programsregulatory bodies; and (iiivi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (ivvii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other adverse action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other adverse action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of Neither the Company, Company nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, any of its subsidiaries or nor any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, or engaged in any conduct that would reasonably for purposes of the opinions to be expected delivered pursuant to result in debarmentSection 4(o) hereof, suspensioncounsel to the Company and counsel to the Agent, or exclusionwill rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws, except to the extent that any non-compliance Except as would not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse EffectChange, the Company and its subsidiaries are, and at all times within the past three years have been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law false statements law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 286 and 287, 1035, 1347, and 1349 the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C U.S.C. Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) licensure, quality, safety and the accreditation requirements under applicable federal, state, local or foreign laws governing U.S. government funded or sponsored healthcare programsregulatory bodies; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (ivv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of Within the Companypast three years, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Within the past three years, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of Neither the Company, Company nor any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents has has, within the past three years, been or is currently excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times during the last three (3) years, have been, in compliance with all applicable Health Care Laws, except where failure to the extent that any non-compliance comply would notnot be expected, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunderPublic Health Service Act (42 U.S.C. Section 201 et seq.); (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law false statements law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287287 and 1349, 1035, 1347, and 1349 the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act (42 U.S.C. Section 1320d et seq.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C U.S.C. Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Care Information Technology for Economic and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iiiiv) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, ; and (ivv) the directives and regulations promulgated pursuant to such statutes and any state laws set forth in subparts (i) through (iv). Except as would not be expected, individually or non-U.S. counterpart thereof. None of in the Company, any of its subsidiaries, or any of their respective officers, directors, employees oraggregate, to result in a Material Adverse Effect, during the Company’s knowledgelast three (3) years, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation product, operation, or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case . Except as would notnot be expected, individually or in the aggregate, have to result in a Material Adverse Effect. The , during the last three (3) years, the Company and its subsidiaries have has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments Submissions were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents The Company is not a party to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to Governmental Entity. During the business operations of last three (3) years, neither the Company. Additionally, none of the Company, Company nor any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of the Company, or human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all applicable Health Care Laws, except to the extent that any non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320X.X.X Xxxxxxx 0000-7h0x), the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Act (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, ; and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. None of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Company. Additionally, none of the Company, any of its subsidiaries or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws, except to the extent that any non-compliance Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: the Company is, and has since January 1, 2017 been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 1349, the health care fraud criminal provisions under HIPAAHIPAA , the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), ) and the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), ; (iii) the Patient Protection and Affordable Care Act of 2010 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010; (iv) licensure and accreditation requirements under applicable federal, HIPAA as amended by the HITECH Act state, applicable local or foreign laws or regulatory bodies; (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iiiv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, Company; and (ivvi) and the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereoflaws. None of Neither the Company, Company nor any of its subsidiaries, or any of their respective officers, directors, employees ornor, to the knowledge of the Company’s knowledge, agents its agents, have engaged in activities which are, as applicable, cause for liability to the Company under a Health Care Law. Neither the The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the knowledge of the Company’s knowledge, is has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened, except in each case . Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. The , the Company and its subsidiaries have has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None Neither the Company nor any of its employees, officers, directors, or to the knowledge of the Company, any of its subsidiariesagents, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of neither the Company, Company nor any of its subsidiaries or any of their respective employees, officers, directors, or, or to the knowledge of the Company’s knowledge, independent contractorsits agents, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, suspension or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, the Subsidiary have operated and at all times have been, currently are in compliance with all applicable Health Care Lawshealth care laws, rules and regulations (except where such failure to the extent that any operate or non-compliance would not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect. For purposes of this Agreement), “Health Care Laws” means: including, without limitation, (i) the Federal Federal, Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder(21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and all applicable foreign health care healthcare related fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Statements Claims Law (42 18 U.S.C. Section 1320a-7b(a)§ 287), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 42 U.S.C. Sections 286Section 1320a-7b(a), 287, 1035, 1347the exclusion laws (42 U.S.C. § 1320a-7), and 1349 the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusions law ; (iii) U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320a-71320d et seq.), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Affordability Reconciliation Act of 2010, HIPAA as amended by the HITECH Information Technology for Economic Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes laws; and (v) any state other similar local, state, federal or non-U.S. counterpart thereofforeign laws (collectively, the “Health Care Laws”). None of the Company, the Subsidiary or, to the knowledge of the Company, any of its subsidiaries, or any of their respective officers, directors, employees or, to the Company’s knowledge, or agents have has engaged in activities which are, as applicable, cause for liability under a Health Care Lawfalse claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries the Subsidiary has received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any court or arbitrator or court, arbitrator, governmental or regulatory authority or third party alleging that any product product, operation or activity is in violation of any Health Care Laws norLaws, and, to the knowledge of the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except in each case as would not, individually or in . Neither the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on nor the date filed in all material respects (or were corrected or supplemented by a subsequent submission). None of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the Company’s knowledge, independent contractors, affiliates or agents Subsidiary is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred prosecution agreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plan of correction or similar agreements with or agreement imposed by any governmental or regulatory authority or body with respect to the business operations of the Companyauthority. Additionally, none of the Company, the Subsidiary or, to the knowledge of the Company, any of its subsidiaries or any of their respective employees, officers, directors, oremployees or agents, to the Company’s knowledge, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company, human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, suspension or exclusion.