Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, have been, in compliance with all Health Care Laws, except where failure to comply would not be expected, individually or in the aggregate, to 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 Public 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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)), 18 U.S.C. Sections 286, 287 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 exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other similar local, state, federal, national, supranational and foreign laws; and (v) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv). Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the Company 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 authority 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). 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 Entity. During the last three (3) years, neither the Company nor any of its respective employees, officers, directors, or, to the Company’s knowledge, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research.

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 during the last three (3) years, at all times have been, in compliance with all applicable Health Care Laws, except where failure to comply would not be expected, individually or in the aggregate, to 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 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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)), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), 18 U.S.C. Sections 286, 287 286 and 1349287, 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 exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)HITECH Act; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable U.S. federal, state, local or non-U.S. laws or regulatory bodies; (vi) all other similar 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 (vvii) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes, and any state or non-U.S. counterpart thereof. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company nor any of its subsidiaries has not 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, 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 threatenedthreatened or pending. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by nor any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company of its subsidiaries 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 Entitygovernmental or regulatory authority. During Additionally, none of the last three (3) yearsCompany, neither the Company any of its subsidiaries nor any of its their respective employees, officers, directors, directors or, to the Company’s knowledge, 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 researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, disqualification, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries subsidiary are, and during the last three (3) years, 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 where failure to comply such noncompliance, false claims liability or civil penalties would not reasonably be expectedexpected to, individually singly or in the aggregate, to 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 (21 U.S.C. Section 301 et seq.) and the Public 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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 law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286286 and 287, 287 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law laws (42 U.S.C. Section § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), any and all other similar applicable comparable local, state, federal, national, supranational and foreign laws; health care laws and (v) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)laws, each as amended from time to time. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company has not nor its 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, 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. Except as would not be expectedNeither the Company nor its subsidiary have received any written notice of adverse filing, individually warning letter, untitled letter or in other correspondence or notice from the aggregate, to result in a Material Adverse Effect, during the last three (3) yearsFDA, the Company has filedEuropean Commission, maintained the EMA or submitted all reportsany other Health Regulatory Agencies, documentsor any other court or arbitrator, forms, notices, applications, records, claims, submissions and supplements alleging or amendments (“Submissions”) as required by any asserting material noncompliance with the Health Care Laws, and all such Submissions were accurate on . Neither the date filed (or were corrected or supplemented by a subsequent submission). The Company is not nor its subsidiary are a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company nor its subsidiary nor, to the knowledge of the Company, any of its respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch study or trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, at all times have been, in compliance with all applicable Health Care Laws, Laws except where failure to comply the extent that any non-compliance would not be expectednot, individually or in the aggregate, reasonably be expected to result in 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the 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 False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286, 287 and 1349, the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act HIPAA (42 U.S.C. Section 1320d et seq.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h1320a-7h), and applicable the laws governing government funded or sponsored healthcare programsprograms including, but not limited to, Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health 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 Education Reconciliation Act of 2010; (v) all other similar applicable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (vvi) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or non-U.S. counterpart thereof. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, 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 , except in each case as would not be expectednot, individually or in the aggregate, to result in have a Material Adverse Effect, during the last three (3) years, the . The Company has and its subsidiaries have 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 Submissions 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). The Neither the Company nor any of its subsidiaries, 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company nor Company, any of its subsidiaries nor, to the knowledge of the Company, any of their respective employees, officers, directors, or, to the Company’s knowledge, contractors or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action 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 past five (35) years, years have been, in compliance with all Health Care Laws, Laws except where the failure to comply be in compliance would not reasonably be expected, individually or in the aggregate, expected to 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.) and ), 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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)), 18 U.S.C. Sections 286, 287 286 and 1349287, the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act HIPAA (42 U.S.C. Section 1320d et seq.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) 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 applicable state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of patients; (iv) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (v) all other similar local, state, federal, national, supranational and foreign laws; , relating to the regulation of the Company or its subsidiaries, and (vvi) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or non-U.S. counterpart thereof. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the The Company has and its subsidiaries have 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 Submissions reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission), except as would not reasonably be expected to result in a Material Adverse Change. The Neither the Company nor any of its subsidiaries 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company Company, any of its subsidiaries nor any of its their respective employees, officers, directors, or, to the knowledge of the Company’s knowledge, agents has agents, 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 researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) yearshave been since January 1, have been2017, in material compliance with all Health Care Laws, except where failure to comply would not be expected, individually or in the aggregate, to 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 Act; 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)), 18 U.S.C. Sections 286, 287 287, 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iiiii) HIPAA, as amended by the Health Information Technology for Economic and 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 Education Reconciliation Act of 2010; (iv) licensure and accreditation requirements under applicable federal, state, applicable local or foreign laws or regulatory bodies; and (v) all other similar local, state, federal, national, supranational and foreign laws; , relating to the regulation of the Company or its subsidiaries, and (vvi) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv). Except as statutes and any state or non-U.S. counterpart thereof, except for any such noncompliance or violation that would not be expectednot, individually or in the aggregate, to result in have a Material Adverse Effect. Neither the Company, during the last three (3) yearsany of its subsidiaries, nor any of their respective officers, directors, 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 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the The Company has and its subsidiaries have 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 Submissions 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). The Company Neither the Company, any of its subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company nor Company, any of its subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers, directors, or, to the Company’s knowledge, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, the Subsidiary have operated and during the last three (3) years, have been, currently are in compliance with all Health Care Lawsapplicable health care laws, rules and regulations (except where such failure to comply operate or non-compliance would not be expectednot, individually or in the aggregate, to 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 (21 U.S.C. Section §§ 301 et seq.) and the Public Health Service Act (42 U.S.C. Section 201 et seq.); (ii) all applicable federal, state, local and all applicable foreign health care healthcare related fraud and abuse laws, including, without limitation, the federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the Civil U.S. 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 law False Claims Law (18 U.S.C. § 287), all criminal laws relating to healthcare fraud and abuse, including but not limited to 42 U.S.C. Section 1320a-7b(a), the exclusion laws (42 U.S.C. § 1320a-7), 18 and the civil monetary penalties law (42 U.S.C. Sections 286, 287 and 1349, the health care fraud criminal provisions under the § 1320a-7a); (iii) U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all the regulations promulgated pursuant to such laws; and (v) any other similar local, state, federalfederal or foreign laws (collectively, national, supranational and foreign laws; and (v) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv“Health Care Laws”). Except as would not be expectedNone of the Company, individually or in the aggregateSubsidiary or, to result the knowledge of the Company, any of its officers, directors, employees or agents has engaged in a Material Adverse Effectactivities which are, during the last three (3) yearsas applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor the Subsidiary has not 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 court, arbitrator, governmental or arbitrator regulatory authority or governmental authority third party alleging that any product, operation, 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions were accurate on nor the date filed (or were corrected or supplemented by a subsequent submission). The Company Subsidiary is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred or non-prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plan of correction or similar agreements with or agreement imposed by any Governmental Entitygovernmental or regulatory authority. During Additionally, none of the last three (3) yearsCompany, neither the Company nor Subsidiary or, to the knowledge of the Company, any of its respective employees, officers, directors, oremployees or agents, to the Company’s knowledge, agents has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries Subsidiaries are operated and are currently in compliance in all material respects with all applicable Health Care Laws (defined herein), and have not engaged in activities which are, and during the last three (3) yearsas applicable, have beencause for false claims liability, in compliance with all Health Care Lawscivil penalties, except where failure to comply would not be expectedor mandatory or permissive exclusion from Medicare, individually Medicaid, or in the aggregate, to result in a Material Adverse Effectany other state or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.) and the Public 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 federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), ; the Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), ; the criminal false statements law False Claims Act (42 U.S.C. Section § 1320a-7b(a)); all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287 287, 1035, 1347 and 1349, and the health care fraud criminal provisions under HIPAA; the Health Insurance Portability and Accountability Act exclusion laws (42 U.S.C. Section 1320d et seq.) (“HIPAA”§ 1320a-7), ; the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), ; the Physician Payments Payment Sunshine Act (42 U.S.C. Section 1320-7h§ 1320a-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.); the Medicare statute (iv) all other similar local, state, federal, national, supranational and foreign lawsTitle XVIII of the Social Security Act); and the Medicaid statute (v) Title XIX of the Social Security Act); the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)and any other similar local, state or federal law and regulations. Except as would not be expectedNeither the Company nor any of its Subsidiaries has received any FDA Form 483, individually notice of adverse finding, warning letter, untitled letter or in other correspondence, communication or notice from the aggregateFDA or any other governmental or regulatory authority alleging or asserting noncompliance with any Health Care Laws, and, to result in a Material Adverse Effectthe Company’s knowledge, during the last three (3) years, the Company has not received written notice of any no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental authority 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by nor any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company of its Subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. During Neither the last three (3) yearsCompany, neither the Company any of its Subsidiaries nor any of its their respective employees, officers, directors, or, to the Company’s knowledge, 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 Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, 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 Company and its subsidiaries are, and during the last three (3) years, have been, in compliance with all Health Care Laws, except where failure to comply Except as would not reasonably be expected, individually or in the aggregate, to result in 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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)), 18 U.S.C. Sections 286, 287 and 1349, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) 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; (iviii) all other similar localfederal, state, federal, national, supranational 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 exclusion laws (42 U.S.C. Section 1320a-7 and (v) 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such laws set forth in subparts (i) through statutes); (iv). Except as would not be expected) 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 and all other applicable health care laws and regulations, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, any jurisdiction where the Company has not received written notice or any of any claimits subsidiaries conducts business. Additionally, actionneither the Company, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental authority alleging that any product, operation, or activity is in violation of any Health Care Laws nor, to the knowledge of the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). 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 Entity. During the last three (3) years, neither the Company nor any of its 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, agents Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchis subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would 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 debarment.

Compliance with Health Care Laws. The Company and its subsidiaries Senseonics are, and during the last three (3) years, 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 where failure to comply such noncompliance, false claims liability or civil penalties would not reasonably be expectedexpected to, individually singly or in the aggregate, to 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 (21 U.S.C. Section 301 et seq.) and the Public 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 limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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 law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286286 and 287, 287 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law laws (42 U.S.C. Section § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), any and all other similar applicable comparable local, state, federal, national, supranational and foreign laws; health care laws and (v) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)laws, each as amended from time to time. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company has not nor 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, 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. Except as would not be expectedNeither the Company nor Senseonics have received any written notice of adverse filing, individually warning letter, untitled letter or in other correspondence or notice from the aggregate, to result in a Material Adverse Effect, during the last three (3) yearsFDA, the Company has filedEuropean Commission, maintained the EMA or submitted all reportsany other Health Regulatory Agencies, documentsor any other court or arbitrator, forms, notices, applications, records, claims, submissions and supplements alleging or amendments (“Submissions”) as required by any asserting material noncompliance with the Health Care Laws, and all such Submissions were accurate on . Neither the date filed (or were corrected or supplemented by a subsequent submission). The Company is not nor Senseonics are a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company nor Senseonics nor, to the knowledge of the Company, any of its respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch study or trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries areis, and during the last three (3) years, have at all times has been, in compliance in all material respects with all Health Care Laws, except where failure to comply would not be expected, individually or in the aggregate, to 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)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 false statements law 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 health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286286 and 287, 287 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7)laws, the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h)statutes, regulations and directives of applicable laws governing government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) HIPAAthe Patient Protection and Affordable Care Act of 2010, as amended by the Health Information Technology for Economic Care and Clinical Health Education Affordability Reconciliation Act of 2010, the regulations promulgated thereunder; (iv) the U.S. Controlled Substances Act (42 21 U.S.C. Section 17921 801 et seq.); and (ivv) all other similar local, state, federal, national, supranational and foreign lawslaws applicable to the Company; provided that Health Care Laws does not include the health information data privacy and (v) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)security provisions of HIPAA or other Privacy Laws. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the The Company 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the The Company 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 Submissions 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). 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company nor any of its respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research.any

Compliance with Health Care Laws. The Company and its subsidiaries Subsidiaries are operated and are currently in compliance in all material respects with all applicable Health Care Laws (defined herein), and have not engaged in activities which are, and during the last three (3) yearsas applicable, have beencause for false claims liability, in compliance with all Health Care Lawscivil penalties, except where failure to comply would not be expectedor mandatory or permissive exclusion from Medicare, individually Medicaid, or in the aggregate, to result in a Material Adverse Effectany other state or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.) and the Public 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 federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), ; the Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), ; the criminal false statements law False Claims Act (42 U.S.C. Section § 1320a-7b(a)); all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287 287, 1035, 1347 and 1349, and the health care fraud criminal provisions under HIPAA; the Health Insurance Portability and Accountability Act exclusion laws (42 U.S.C. Section 1320d et seq.) (“HIPAA”§ 1320a-7), ; the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), ; the Physician Payments Payment Sunshine Act (42 U.S.C. Section 1320-7h§ 1320a-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.); the Medicare statute (iv) all other similar local, state, federal, national, supranational and foreign lawsTitle XVIII of the Social Security Act); and the Medicaid statute (v) Title XIX of the Social Security Act); the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)and any other similar local, state or federal law and regulations. Except as would not be expectedNeither the Company nor any of its Subsidiaries has received any FDA Form 483, individually notice of adverse finding, warning letter, untitled letter or in other correspondence, communication or notice from the aggregateFDA or any other governmental or regulatory authority alleging or asserting noncompliance with any Health Care Laws, and, to result in a Material Adverse Effectthe Company’s knowledge, during the last three (3) years, the Company has not received written notice of any no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental authority 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by nor any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company of its Subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. During Neither the last three (3) yearsCompany, neither the Company any of its Subsidiaries nor any of its their respective employees, officers, directors, or, to the Company’s knowledge, 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 Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, 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 Each of the Company and its subsidiaries areSubsidiaries is, and during the last three (3) years, have at all times has been, in compliance in all material respects with all applicable Health Care Laws, except where failure to comply would and has not be expectedengaged in activities which are, individually as applicable, cause for false claims liability, civil penalties, or in the aggregatemandatory or permissive exclusion from Medicare, to result in a Material Adverse EffectMedicaid, or any other state or federal health care program. 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)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 law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286286 and 287, 287 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 (“HIPAA”42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other similar local, state, federal, national, supranational and foreign laws; and (v) the regulations promulgated pursuant to such laws set forth in subparts statutes; (iiii) through 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 and all other applicable health care laws and regulations. Except as would not be expected, individually or in Neither the aggregateCompany nor, to result in a Material Adverse Effectthe knowledge of the Company, during the last three (3) years, the Company any Subsidiary 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 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. Except as would not be expected, individually or in Neither the aggregateCompany nor, to result in a Material Adverse Effectthe knowledge of the Company, during the last three (3) years, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company Subsidiary is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company Company, its Subsidiaries nor any of its respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, at all times have been, in material compliance with all applicable Health Care Laws, except where failure to comply would not be expected, individually or in the aggregate, to 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 Act, Public Health Service Act (42 U.S.C. Section 201 et seq.)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 false statements law U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286286 and 287, 287 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act laws (42 U.S.C. Section 1320-7h7), the statutes, regulations and directives of applicable laws governing government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) 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 Security Standards, 45 C.F.R. parts 160 and 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, 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 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) all other similar localthe 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; and (vi) licensure, quality, safety and accreditation requirements under applicable federal, state, federal, national, supranational and local or foreign laws; and (v) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)or regulatory bodies. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company has not nor its subsidiaries 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, 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 as would not be expectedThe Company and its subsidiaries have filed, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the Company has filedobtained, 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 Submissions reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). The Neither the Company is not nor its subsidiaries are 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company Company, its subsidiaries nor any of its their respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal or state health care program or human clinical research, nor, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, at all times have been, in compliance with all applicable Health Care Laws, except where failure to comply the extent that any non-compliance would not be expectednot, individually or in the aggregate, reasonably be expected to result in 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)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, 287 287, 1035, 1347, and 1349, 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 exclusion 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 applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, Affordable Care Act of 2010 as amended by the Health Information Technology for Economic Care and Clinical Health 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 (iviii) all other similar local, state, federal, national, supranational and foreign laws; , relating to the regulation of the Company or its subsidiaries, and (viv) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or non-U.S. counterpart thereof. Except as would not be expectedNone of the Company, individually any of its subsidiaries, or in the aggregateany of their respective officers, directors, employees or, to result the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Material Adverse Effect, during the last three (3) years, 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 , except in each case as would not be expectednot, individually or in the aggregate, to result in have a Material Adverse Effect, during the last three (3) years, the . The Company has and its subsidiaries have 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 Submissions 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). The Company 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 any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority or body with respect to the business operations of the Company. During Additionally, none of the last three (3) yearsCompany, 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 has been excluded, suspended or debarred from participation in any U.S. federal health care program or or, to the knowledge of the Company, human clinical researchresearch 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 during the last three (3) years, have been, in compliance with all Health Care Laws, except where failure to comply Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse EffectChange, the Company and its subsidiaries are, and during the last five (5) 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.) and ), 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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)), 18 U.S.C. Sections 286, 287 286 and 1349287, the criminal health care fraud criminal provisions under the Health Insurance Portability and Accountability Act law (42 18 U.S.C. Section 1320d et seq.) (“HIPAA”1347), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare governmental health care programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (ivv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other similar local, state, federal, national, supranational and foreign laws; , relating to the regulation of the Company or its subsidiaries, and (vvii) the regulations promulgated pursuant to such laws set forth in subparts statutes and any state or non-U.S. counterpart thereof. In the past five (i) through (iv). Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (35) years, 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, 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 threatenedthreatened or contemplated. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) yearsChange, the Company has and its subsidiaries have 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 Submissions 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). The Neither the Company nor any of its subsidiaries is not a party to any corporate integrity agreements, deferred or non-prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, or similar agreements agreement with or imposed by any Governmental EntityRegulatory Agency. During the last three (3) yearsAdditionally, neither the Company Company, any of its subsidiaries, nor any of its their respective employees, officers, directors, managing employees, owners or, to the knowledge of the Company’s knowledge, agents has been excluded, suspended or debarred from participation in any U.S. federal governmental health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, at all times have been, in material compliance with all applicable Health Care Laws, except where failure to comply the extent that any non-compliance would not be expectednot, individually or in the aggregate, reasonably be expected to result in 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)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, 287 287, 1035, 1347, and 1349, 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 exclusion 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 applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, Affordable Care Act of 2010 as amended by the Health Information Technology for Economic Care and Clinical Health 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 (iviii) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (viv) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or non-U.S. counterpart thereof. Except as would not be expectedNone of the Company, individually any of its subsidiaries, or in the aggregateany of their respective officers, directors, employees or, to result the Company’s knowledge, agents have engaged in activities which are, as applicable, cause for liability under a Material Adverse Effect, during the last three (3) years, 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 , except in each case as would not be expectednot, individually or in the aggregate, to result in have a Material Adverse Effect, during the last three (3) years, the . The Company has and its subsidiaries have 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 Submissions 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). The Company 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 any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority or body with respect to the business operations of the Company. During Additionally, none of the last three (3) yearsCompany, 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 has been excluded, suspended or debarred from participation in any U.S. federal health care program or or, to the knowledge of the Company, human clinical researchresearch 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, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: the Company and its subsidiaries areis, and during the last three (3) yearshas since January 1, have 2017 been, in compliance with all Health Care Laws, except where failure to comply would not be expected, individually or in the aggregate, to 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)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)), 18 U.S.C. Sections 286, 287 287, 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”)HIPAA , the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion exclusions law (42 U.S.C. Section 1320a-7), ) and 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) HIPAAthe Patient Protection and Affordable Care Act of 2010, as amended by the Health Information Technology for Economic Care and Clinical Health Education Reconciliation Act (42 U.S.C. Section 17921 et seq.)of 2010; (iv) licensure and accreditation requirements under applicable federal, state, applicable local or foreign laws or regulatory bodies; (v) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company; and (vvi) and the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)laws. Except as would not be expectedNeither the Company nor any of its officers, individually or in the aggregatedirectors, employees nor, to result the knowledge of the Company, its agents, have engaged in activities which are, as applicable, cause for liability to the Company under a Material Adverse Effect, during the last three (3) years, the Health Care Law. The Company 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 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 as would not be expectednot, individually or in the aggregate, reasonably be expected to result in have a Material Adverse Effect, during the last three (3) years, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions 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). The Neither the Company nor any of its employees, officers, directors, or to the knowledge of the Company, any of its agents, 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company nor any of its respective employees, officers, directors, or, or to the knowledge of the Company’s knowledge, agents its agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, have been, are in compliance with all applicable Health Care Laws, except where failure to comply for any noncompliance that would not reasonably be expected, individually or in the aggregate, expected to result in 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.) and ), 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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)), 18 U.S.C. Sections 286, 287 286 and 1349287, 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 (“HIPAA”42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and 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 Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other similar local, state, federal, national, supranational and foreign laws; , relating to the regulation of the Company or its subsidiaries, and (vvii) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or non-U.S. counterpart thereof. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, 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 adverse 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 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 as would not be expectedThe Company and its subsidiaries have filed, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the Company has filedobtained, 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 Submissions 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). The Neither the Company nor any of its subsidiaries 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company Company, any of its subsidiaries nor any of its their respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company, 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, for purposes of the opinions to be delivered pursuant to Section 4(o) hereof, counsel to the Company and counsel to the Agent, 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 Senseonics are, and during the last three (3) years, 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 where failure to comply such noncompliance, false claims liability or civil penalties would not reasonably be expectedexpected to, individually singly or in the aggregate, to 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 (21 U.S.C. Section 301 et seq.) and the Public 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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 law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286286 and 287, 287 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law laws (42 U.S.C. Section § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), any and all other similar applicable comparable local, state, federal, national, supranational and foreign laws; health care laws and (v) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)laws, each as amended from time to time. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, Neither the Company has not nor 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, 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. Except as would not be expectedNeither the Company nor Senseonics have received any written notice of adverse filing, individually warning letter, untitled letter or in other correspondence or notice from the aggregate, to result in a Material Adverse Effect, during the last three (3) yearsFDA, the Company has filedEuropean Commission, maintained the EMA or submitted all reportsany other Health Regulatory Agencies, documentsor any other court or arbitrator, forms, notices, applications, records, claims, submissions and supplements alleging or amendments (“Submissions”) as required by any asserting material noncompliance with the Health Care Laws, and all such Submissions were accurate on . Neither the date filed (or were corrected or supplemented by a subsequent submission). The Company is not nor Senseonics are a party to and have no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company nor Senseonics nor, to the knowledge of the Company, any of its respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch study or trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension or exclusion.

Compliance with Health Care Laws. The Company has operated and its subsidiaries are, and during the last three (3) years, have been, currently is in compliance with all Health Care Lawsapplicable health care laws, except where failure to comply would not be expectedrules and regulations, individually or in the aggregateincluding, to result in a Material Adverse Effect. For purposes of this Agreementwithout limitation, “Health Care Laws” means: (i) the Federal Federal, Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.) and the Public Health Service Act (42 U.S.C. Section 201 et seq.); (ii) all applicable federal, state, local and all applicable foreign health care healthcare related fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the Civil U.S. 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 law False 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, 287 286 and 1349287, 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.) (“HIPAA”), the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) any applicable provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all the regulations promulgated pursuant to such laws; and (v) any other similar local, state, federal, nationalor foreign laws (collectively, supranational and foreign laws; and (vthe “Health Care Laws”) the regulations promulgated pursuant , except where failure to such laws set forth be so in subparts (i) through (iv). Except as compliance would not reasonably be expected, individually or in the aggregate, to result in have a Material Adverse Effect. Neither the Company, during nor, to the last three (3) yearsCompany’s knowledge, the any of its officers, directors, employees or agents have 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 or federal healthcare program. The Company 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, 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred or non-prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plan of correction or similar agreements with or agreement imposed by any Governmental Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company Company, nor any of its respective employees, officers, directors, oremployees or agents, to the Company’s knowledge, agents has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical researchresearch 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.

Compliance with Health Care Laws. The Except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, the Company and its subsidiaries are, and during at all times within the last past three (3) years, years have been, in compliance with all Health Care Laws, except where failure to comply would not be expected, individually or in the aggregate, to 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 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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)), 18 U.S.C. Sections 286, 287 286 and 1349287, 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 exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other similar locallicensure, quality, safety and accreditation requirements under applicable federal, state, federal, national, supranational and local or foreign lawslaws or regulatory bodies; and (v) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or non-U.S. counterpart thereof. Except as would not be expected, individually or in Within the aggregate, to result in a Material Adverse Effect, during the last past three (3) years, 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 as would not be expected, individually or in Within the aggregate, to result in a Material Adverse Effect, during the last past three (3) years, the Company has and its subsidiaries have 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 Submissions 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). The Neither the Company nor any of its subsidiaries 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 Entitygovernmental or regulatory authority. During Additionally, none of the last three (3) yearsCompany, neither the Company nor any of its subsidiaries or any of their respective employees, officers, directors, oror agents has, to within the Company’s knowledgepast three years, agents has been or is currently excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, at all times have been, in compliance in all material respects with all Health Care Laws, except where failure Laws to comply would not be expected, individually the extent applicable to the Company or in the aggregate, to result in a Material Adverse Effectany of its subsidiaries or their respective businesses. 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)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 False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286, 287 287, 1035, and 1349, the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act HIPAA (42 U.S.C. Section 1320d et seq.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act 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 Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other similar local, state, federal, national, supranational and foreign laws; , relating to the regulation of the Company or any of its subsidiaries, and (vvii) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or non-U.S. counterpart thereof. Except as would not be expectedNeither the Company, individually or in the aggregateany of its subsidiaries, nor any of their respective officers, directors, employees and, to result in a Material Adverse Effect, during the last three (3) years, knowledge of the Company and each of its subsidiaries, any of their respective 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 or any of its subsidiaries’ knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not be expectedNone of the Company nor any of its subsidiaries nor their respective employees, individually or in the aggregateofficers, directors, or, to result in a Material Adverse Effect, during the last three (3) years, knowledge of the Company has filedor any of its subsidiaries, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company their respective agents 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 Entitygovernmental or regulatory authority related to activities conducted by or on behalf of the Company or any of its subsidiaries. During the last three (3) yearsAdditionally, neither none of the Company nor any of its subsidiaries nor their respective employees, officers, directors, or, to the Company’s knowledgeknowledge of the Company or any of its subsidiaries, their respective agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company or any of its subsidiaries, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, at all times have been, in compliance with all Health Care Laws, except where failure to comply such non-compliance would not be expected, individually or in the aggregate, reasonably expected to result in 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)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)), 18 U.S.C. Sections 286, 287 287, 1035, 1347, and 1349, including 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 exclusion 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), and applicable the laws governing U.S. government funded or sponsored healthcare programs; and (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other similar local, state, federal, national, supranational and foreign laws; , relating to the regulation of the Company or its subsidiaries, and (viv) the directives and regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or non-U.S. counterpart thereof. Except as would not be expectedNeither the Company, individually any of its subsidiaries, any of their respective officers, or in the aggregatedirectors, nor, to result the knowledge of the Company, any of the Company’s or any of its subsidiaries’ employees or agents have engaged in activities which are, as applicable, cause for liability under a Material Adverse Effect, during the last three (3) years, 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the The Company has and its subsidiaries have 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 Submissions 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). The Company Neither the Company, nor any of its subsidiaries 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company or any of its subsidiaries nor any of its their respective employees, officers, directors, or, to the Company’s knowledge, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) yearsat all times since January 1, 2015 have been, in compliance with all Health Care Laws, except where failure to comply such noncompliance would not be expected, individually singly or in the aggregate, aggregate reasonably be expected to 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 Public Health Service Act (42 U.S.C. Section 201 et seq.)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)), 18 U.S.C. Sections 286, 287 and 1349287, and 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , (iv) all other similar localMedicare (Title XVIII of the Social Security Act), stateMedicaid (Title XIX of the Social Security Act), federalthe Public Health Service Act (42 U.S.C. § 201 et seq.), national, supranational and foreign laws; and (v) the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv)statutes and any state or foreign counterpart thereof. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the The Company has and its subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all 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. The Neither the Company nor any of its subsidiaries 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 Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company Company, any of its subsidiaries nor any of its their respective employees, officers, directors, or, or to the Company’s knowledge, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and during the last three (3) years, at all times have been, in compliance with all Health Care LawsLaws applicable to the Company and its subsidiaries, except where failure to comply as would not reasonably be expected, expected individually or in the aggregate, aggregate to result in 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 Sec.Sec. 301 et seq.) and the ), Public Health Service Act (42 U.S.C. Section 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 false statements law U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286286 and 287, 287 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-71320-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h)statutes, regulations and directives of applicable laws governing government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) 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 Security Standards, 45 C.F.R. parts 160 and 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, 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 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 or regulatory bodies; and (vii) all other similar local, state, federal, national, supranational and foreign laws; and (v) , applicable to the regulations promulgated pursuant to such laws set forth in subparts (i) through (iv). Except Company or its subsidiaries, except as would not reasonably be expected, expected individually or in the aggregate, aggregate to result in have a Material Adverse Effect, during the last three (3) years, . Neither the Company nor 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 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 as would not reasonably be expected, expected individually or in the aggregate, aggregate to result in have a Material Adverse Effect, during the last three (3i) years, the Company has and its subsidiaries have filed, obtained, 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 (ii) all such Submissions reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, accurate and not misleading on the date filed in all material respects (or were materially corrected or supplemented by a subsequent submission). The Neither the Company nor its subsidiaries 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 Entitygovernmental or regulatory authority with respect to Health Care Laws. During the last three (3) yearsAdditionally, neither the Company nor Company, its subsidiaries nor, to the knowledge of the Company, any of the Company’s or its subsidiaries’ respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal or state health care program or human clinical researchresearch 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.

Compliance with Health Care Laws. The Company is and its subsidiaries are, and during the last three (3) years, have been, has been in compliance with all Health Care LawsLaws (as hereinafter defined), except where failure to comply instances of non-compliance would not be expectednot, individually singly or in the aggregate, reasonably be expected to 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 (21 U.S.C. Section 301 et seq.) and the Public 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 limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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 law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286286 and 287, 287 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.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law laws (42 U.S.C. Section § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar local, state, federal, national, supranational local or federal health care laws and foreign laws; and (v) the regulations promulgated pursuant to such laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and all other laws set forth and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each as amended from time to time. The Company has not engaged in subparts (i) through (iv). Except 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 or civil penalties would not reasonably be expectedexpected to, individually singly or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the . The Company 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 as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. During the last three (3) yearsAdditionally, neither the Company nor nor, to the knowledge of the Company, any of its respective employees, officers, directors, or, to the Company’s knowledge, agents officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program program, clinical trial or human clinical researchregistry or, to the knowledge of the Company, 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 the Prospectus or as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other 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.