Common use of Health Care Laws Clause in Contracts

Health Care Laws. The Company and each of its subsidiaries is, and at all times has been, in compliance in all material respects with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal 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 286 and 287, 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.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulations. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency or other Governmental Authority. Neither the Company, any of its subsidiaries, any of their respective directors, officers, nor, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company has operated and each of its subsidiaries is, and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. Anti-Kickback federal Antikickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, Company nor any of its subsidiaries, any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company has operated and each of its subsidiaries is, and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, Company nor any of its subsidiaries, any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledgeKnowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s Knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company’s and the Subsidiaries’ business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign Health Care Laws applicable to the Company’s and the Subsidiaries’ respective businesses, and the Company and each of its subsidiaries is, and at all times has been, the Subsidiaries are in compliance in all material respects with all such applicable Health Care Laws, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect. The Company and has the Subsidiaries have not engaged in activities which are, as applicable, to their knowledge are 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. For purposes of this Agreement, “Health Care Laws” meansmeans the: (i) the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse Lawslaws, 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. Section 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), the federal criminal False Claims false claims law (42 U.S.C. § 1320a-7b(a)), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the Xxxxx Law (42 U.S.C. Section 1320a-7b(a)§1395nn), all criminal Laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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.), the exclusion laws (42 U.S.C. §1320a-7), the statutes and regulations of applicable government healthcare programs, including the European Union General Data Protection Regulation (EU 2016 679), Medicare, Title XVIII of the Social Security Act, and Medicaid, Title XIX of the Social Security Act, and the regulations promulgated pursuant to such statutes; and (iii) as amended by the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulationswhich is to protect the privacy of individuals or prescribers. Neither the Company nor any of its subsidiaries Subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other material action from any court, arbitrator, other Governmental Authority court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. The Company and the Subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries are Subsidiary is a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, plans of correction, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither Additionally, neither the Company, any of its subsidiaries, Subsidiary nor any of their respective directorsemployees, officers, nor, to the Company’s knowledge, any of their respective employees officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Except as would not reasonably be expected to be material to the Acquired Companies, taken as a whole, each Acquired Company and each of its subsidiaries ishas operated in the past three years, and at all times has beencurrently is, in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the U.S. Food and Drug Administration (the “FDA”), the U.S. Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare & Medicaid Services, the Department of Justice or any other Governmental Entity having jurisdiction over such Acquired Company or any of its properties, and, to the knowledge of the Company, has not engaged in activities which are, as applicable, cause for material 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. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section Sec. 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section Sec. 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section Sec.Sec. 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section Sec. 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 Sec. 1320d et seq.) (“HIPAA”), the exclusion laws (42 U.S.C. Sec. 1320a-7), the civil monetary penalties law (42 U.S.C. Sec. 1320a-7a), Title II of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section Sec.Sec. 17921 et seq.), the exclusion laws patient privacy, data security and breach notification regulations promulgated under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7Sec.Sec. 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither Except as would not reasonably be expected to be material to the Acquired Companies, taken as a whole, each Acquired Company nor has not received any FDA Form 483, notice of its subsidiaries has received adverse finding, warning letter, untitled letter or other correspondence, written communication or written notice of from the FDA or any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority Entity alleging or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatenedAcquired Companies. Neither the Company nor any of its subsidiaries The Acquired Companies are not a party to or nor have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, any of its subsidiaries, Acquired Companies nor any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to a Legal Proceeding or an inquiry, investigation, proceeding, or other similar action investigation by any a Governmental Authority Entity that would reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Except as would not reasonably be expected to have a Material Adverse Effect, the Company and each of its subsidiaries isare, and at all times has have been, in compliance in all material respects with all applicable Health Care LawsLaws (as defined below), including all binding rules and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care programregulations thereunder. For purposes of this Agreement, “Health Care Laws” means: means all healthcare laws applicable to the operation of the business of the Company and its subsidiaries as currently conducted, including (i) the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. §§ 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care related fraud and abuse Lawslaws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act False Statements Law (42 U.S.C. Section 1320a-7h§ 1320a-7b(a)), 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 Claims Law (42 U.S.C. Section 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including including, but not limited to to, 18 U.S.C. Sections §§ 286 and 287, 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.), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the exclusions law (42 U.S.C. § 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes, including, but not limited to, the coverage and payment provisions of Medicare (Title XVIII of the Social Security Act) as amended by and, Medicaid (Title XIX of the Social Security Act); and (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection regulations promulgated thereunder and any state or other law or regulation the purpose of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulationswhich is to protect the privacy of individuals or prescribers. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority court or arbitrator or governmental or regulatory authority or third party alleging that any product, product operation or activity of the Company is in noncompliance with or a subsidiary is in material violation of any Health Care Laws, Laws and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither None of the Company nor Company, any of its subsidiaries are or any of their respective officers, directors, or to the Company’s knowledge, any of their respective employees or agents, is a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction orders or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither Additionally, none of the Company, any of its subsidiaries, subsidiaries or any of their respective officers, directors, officers, noror, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, proceeding or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, suspension or exclusion. The Company conducts exclusion and debarment checks on physicians employed by or under contract with the Company’s affiliated professional associations and professional corporations as part of its credentialing process and on a recurring, monthly basis thereafter. Except as would not reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed (or were corrected or supplemented by a subsequent submission).

Health Care Laws. The Company and each of its subsidiaries isthe Subsidiaries are, and at all times has since January 1, 2013 have been, in compliance in all material respects with all applicable Health Care Laws, and has Laws except where failure to be in compliance would not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care programbe expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic ActAct (21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care related fraud and abuse Lawslaws, 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. Section 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal Federal False Claims Statements Law (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections §§ 286 and 287, 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.), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act) and the regulations promulgated pursuant to such statutes; (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 exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act)regulations promulgated thereunder; (iv) Medicaid the U.S. Physician Payments Sunshine Act (Title XIX of the Social Security Act42 U.S.C. § 1320a-7h), and the regulations promulgated thereunder; and (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulationsregulation applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development by the Company. Neither the Company nor any of its subsidiaries the Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority court or third party arbitrator or governmental or regulatory authority alleging that any product, product operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are the Subsidiaries is a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither Additionally, none of the Company, any of Company or its subsidiaries, Subsidiaries or any of their respective directors, officers, norofficers or directors or, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion. The Company and the Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except in each case, as would not reasonably be expected to have a Material Adverse Effect.

Health Care Laws. The Company and each of its subsidiaries isthe Subsidiaries are, and at all times has since January 1, 2016 have been, in compliance in all material respects with all applicable Health Care Laws, and has Laws except where failure to be in compliance would not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care programbe expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic ActAct (21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care related fraud and abuse Lawslaws, 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. Section 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal Federal False Claims Statements Law (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections §§ 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) ), the Civil Monetary Penalties Law (42 U.S.C. Section 1320d et seq.§ 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act) and the regulations promulgated pursuant to such statutes; (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 exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act)regulations promulgated thereunder; (iv) Medicaid the U.S. Physician Payments Sunshine Act (Title XIX of the Social Security Act42 U.S.C. § 1320a-7h), and the regulations promulgated thereunder; and (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulationsregulation applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development by the Company. Neither the Company nor any of its subsidiaries the Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority court or third party arbitrator or governmental or regulatory authority alleging that any product, product operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are the Subsidiaries is a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither Additionally, none of the Company, any of Company or its subsidiaries, Subsidiaries or any of their respective directors, officers, norofficers or directors or, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion. The Company and the Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except in each case, as would not reasonably be expected to have a Material Adverse Effect.

Health Care Laws. The Company has operated and each of its subsidiaries is, and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, Company nor any of its subsidiaries, any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company has operated and each of its subsidiaries is, and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. Anti-Kickback federal Antikickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion Laws (42 U.S.C. § 1320a-7), the civil monetary penalties Law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7)patient privacy, data security and breach notification provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a)FDCA, (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product regulations promulgated pursuant to such Laws, including but and any other similar local, state or federal Law. The Company has not limited to HIPAAreceived any FDA Form 483, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulations. Neither the Company nor any of its subsidiaries has received written notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, Company nor any of its subsidiaries, any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company and each of Company, its subsidiaries isdirectors, and at all times has beenofficers and, to its knowledge, employees are in compliance in all material respects with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program laws applicable to the Company or federal health care program. For purposes of this Agreementits product candidates or activities, “Health Care Laws” means: (i) including, but not limited to, the Federal Food, Drug, and Cosmetic Act (the “FD&C Act, ”) (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation21 U.S.C. § 301 et seq.), the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. federal Physician Payment Payments Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§3729 et seq.), the criminal False Claims Law (42 U.S.C. Section 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, 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, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section § 17921 et seq.), the exclusion laws (42 U.S.C. Section § 1320a-7), the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Public Health Service Act (21 42 U.S.C. Sections 801 § 201 et seq.), any similar local, state or federal laws, and the regulations promulgated pursuant to such laws (vi) Healthcare Product collectively, the “Health Care Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for civil penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. The Company possesses, and is in material compliance with the terms of, all Permits required under the Health Care Laws, including but and has not limited to HIPAAreceived any notification, relating to data privacy and the protection of personal informationcorrespondence or any other written or oral communication, including personal health informationincluding, and (vii) any and all other applicable health care laws and regulations. Neither the Company nor any of its subsidiaries has received written notice without limitation, notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action action, from any courtgovernmental authority of potential or actual non-compliance by, arbitratoror liability of, other Governmental Authority or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of under any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency or other Governmental Authority. Neither the Company, any of its subsidiaries, any of their respective directors, officers, nor, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company and each of its subsidiaries isare, and at all times has have been, in compliance in all material respects with all applicable Health Care LawsLaws to the extent applicable to the Company’s operations and services, and has except where failure to be so in compliance would not engaged result in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care programa Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), and the regulations promulgated thereunder, and all applicable state laws governing the provision of laboratory tests, including so-called waived tests; (ii) the Federal Food, Drug, and Cosmetic Act, Act (ii21 U.S.C. Section 301 et seq.); (iii) all applicable federal, state, and local and foreign laws relating to health care related fraud and abuse Lawsabuse, 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. Section 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Law false statements 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 286 and 287, 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.), the Xxxxx Law (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), and applicable laws governing government funded or sponsored healthcare programs, each as amended; (iv) patient privacy and security provisions under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.)licensure, quality, safety and accreditation requirements under applicable federal, state, or local laws; (vi) Healthcare Product Lawsall other local, including but not limited state, federal, national, supranational and foreign laws to HIPAA, relating the extent applicable to data privacy and regulation of the protection of personal information, including personal health information, Company or its subsidiaries; and (vii) the directives and regulations promulgated pursuant to such statutes and any and all other applicable health care laws and regulationsstate or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received any written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority governmental authority, Regulatory Agency, or third party alleging that any product, product operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries are subsidiary is a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plans of correction or similar agreements agreement with or imposed by any governmental authority or Regulatory Agency or other Governmental AuthorityAgency. Neither Additionally, neither the Company, any of its subsidiaries, nor any of its or their respective directorsemployees, officers, nordirectors, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company and each of its subsidiaries isare, and at all times has have been, in compliance in all material respects with all applicable Health Care LawsLaws (as defined below), and has have not engaged in activities which are, as applicable, cause for reasonably expected to result in 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. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse Lawslaws and regulations, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Payments Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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.), the exclusion laws (42 U.S.C. § 1320a-7) and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section §§ 17921 et seq.), ; (iv) the exclusion laws Public Health Service Act (42 U.S.C. Section 1320a-7§§ 201 et seq.) (“PHS”), ; (v) the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare statute (Title XVIII of the Social Security Act); (ivvi) the Medicaid statute (Title XIX of the Social Security Act), ; (vvii) the Controlled Substances Act regulations promulgated pursuant to such laws; (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (viiviii) any and all other applicable health care laws and regulations, including, without limitation, the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), PHS, the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (ix) any federal, state and local laws and regulations relating to the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical products, kickbacks, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure or any other aspect of providing pharmaceutical services and products. Neither Except as disclosed in the Registration Statement or the Prospectus, since January 1, 2014, neither the Company nor any of its subsidiaries has have received written notice of any claim, action, suit, audit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action (“Actions”) from any courtGovernmental Authority, arbitrator, other Governmental Authority or third party alleging or asserting any liability under, any non-compliance with, or that any product, operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action Action is threatened. Neither the Company nor any of its subsidiaries are a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency or other Governmental Authority. Neither the Company, any of its subsidiaries, any of their respective directors, officers, nor, to To the Company’s knowledge, any of their respective employees there are no facts or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding, or other similar action by any Governmental Authority circumstances that would reasonably be expected to result in debarmentgive rise to liability of the Company or its subsidiaries under Health Care Laws. The Company and its subsidiaries have filed, suspensionobtained, maintained, and submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or exclusion.amendments as required by any Health Care Law or any Permit (“Filings”), and all such Filings were materially complete, correct and not misleading on

Health Care Laws. The Company’s and the Subsidiaries’ business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign Health Care Laws applicable to the Company’s and the Subsidiaries’ respective businesses, and the Company and each of its subsidiaries is, and at all times has been, the Subsidiaries are in compliance in all material respects with all such applicable Health Care Laws, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect. The Company and has the Subsidiaries have not engaged in activities which are, as applicable, to their knowledge are 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. For purposes of this Agreement, “Health Care Laws” meansmeans the: (i) the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse Lawslaws, 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. Section 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), the federal criminal False Claims false claims law (42 U.S.C. § 1320a-7b(a)), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the Sxxxx Law (42 U.S.C. Section 1320a-7b(a)§1395nn), all criminal Laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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.), the exclusion laws (42 U.S.C. §1320a-7), the statutes and regulations of applicable government healthcare programs, including the European Union General Data Protection Regulation (EU 2016 679), Medicare, Title XVIII of the Social Security Act, and Medicaid, Title XIX of the Social Security Act, and the regulations promulgated pursuant to such statutes; and (iii) as amended by the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulationswhich is to protect the privacy of individuals or prescribers. Neither the Company nor any of its subsidiaries Subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other material action from any court, arbitrator, other Governmental Authority court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. The Company and the Subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries are Subsidiary is a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, plans of correction, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither Additionally, neither the Company, any of its subsidiaries, Subsidiary nor any of their respective directorsemployees, officers, nor, to the Company’s knowledge, any of their respective employees officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company and each of its subsidiaries isthe Subsidiaries are, and at all times has since January 1, 2013 have been, in compliance in all material respects with all applicable Health Care Laws, and has Laws except where failure to be in compliance would not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care programbe expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic ActAct (21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care related fraud and abuse Lawslaws, 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. Section 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal Federal False Claims Statements Law (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections §§ 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) ), the Civil Monetary Penalties Law (42 U.S.C. Section 1320d et seq.§ 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act) and the regulations promulgated pursuant to such statutes; (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 exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act)regulations promulgated thereunder; (iv) Medicaid the U.S. Physician Payments Sunshine Act (Title XIX of the Social Security Act42 U.S.C. § 1320a-7h), and the regulations promulgated thereunder; and (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulationsregulation applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development by the Company. Neither the Company nor any of its subsidiaries the Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority court or third party arbitrator or governmental or regulatory authority alleging that any product, product operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are the Subsidiaries is a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither Additionally, none of the Company, any of Company or its subsidiaries, Subsidiaries or any of their respective directors, officers, norofficers or directors or, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion. The Company and the Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except in each case, as would not reasonably be expected to have a Material Adverse Effect.

Health Care Laws. The Company and each of its subsidiaries is, Subsidiaries has operated and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (as defined below), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 -11- ACTIVE/107652629.3 U.S.C. Section § 1320d et seq.) (“HIPAA”), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), Public Health Service Act (42 U.S.C. Section 1320a-7§§ 262 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, any of its subsidiaries, Subsidiaries nor any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company has operated and each of its subsidiaries is, and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. Anti-Kickback federal Anti- kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, Company nor any of its subsidiaries, any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledgeKnowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s Knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Except where instances of failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company is and each of its subsidiaries is, and at all times has been, been in compliance in all material respects with all applicable Health Care Lawsforeign, federal, state and has not engaged in activities which arelocal healthcare laws, as applicablerules and regulations, cause for false claims liabilityincluding, civil penaltieswithout limitation, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and foreign health care healthcare related fraud and abuse Lawslaws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law (42 U.S.C. Section § 1320a-7b(a)), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the exclusion law (42 U.S.C. § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), all criminal Laws laws relating to health care healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 286, 287, 1035, 1347 and 1349, the health care healthcare fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§1320d et seq.), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act); and (iii) the patient privacy, data security and breach notification provisions under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section §§17921 et seq.), ; each as amended and the exclusion regulations promulgated pursuant to such laws (42 U.S.C. Section 1320a-7collectively, “Healthcare Laws”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but . The Company has not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulations. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority court or arbitrator or governmental or regulatory authority or third party alleging that any product, product operation or activity of the Company or a subsidiary is in material violation of any Health Care Healthcare Laws, and, to the Company’s knowledgeKnowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the The Company nor any of its subsidiaries are a is not party to or and does not have any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plans plan of correction or similar agreements agreement with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither Additionally, neither the Company, nor any of its subsidiariesemployees, any of their respective officers or directors, officers, nor, or to the Company’s knowledge, any of their respective employees agents, is or agents has been excluded, suspended suspended, debarred or debarred is otherwise ineligible from participation in any U.S. state or federal health care healthcare program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company: has not received any Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence, or to the Company’s knowledge any oral or other notice from any governmental authority alleging or asserting noncompliance with any Healthcare Laws (as defined above) or the terms of any Governmental Licenses, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect; (ii) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority or third party alleging that any product operation or activity is in violation of any Healthcare Laws or Governmental Licenses and have no knowledge that any such governmental authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect; (iii) (a) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Healthcare Laws or Governmental Licenses, (b) except as would not, individually or in the aggregate, have a Material Adverse Effect, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission), and (c) the Company is not aware of any reasonable basis for any material liability with respect to such filings; and (iv) has not, and to the knowledge of the Company, the Company’s officers, employees and agents have not, made any untrue statement of a material fact or fraudulent statement to any governmental authority or failed to disclose a material fact required to be disclosed to any governmental authority.

Health Care Laws. The Except as described in the Registration Statement, the Time of Sale Information and the Prospectus, the Company and each of its subsidiaries isSubsidiaries are, and at all times has have been, in material compliance in all material respects with all applicable Health Care Laws, Laws applicable to their business and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care programoperations. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic ActAct (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care related fraud and abuse Lawslaws, 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. Section 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Law false statements 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 286 and 287, 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.), the Xxxxx Law (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.), the exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX the Patient Protection and Affordable Care Act of 2010, as amended by the Social Security Act), Health Care and Education Reconciliation Act of 2010; (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.)licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) Healthcare Product Lawsall other local, including but not limited to HIPAAstate, federal, national, supranational and foreign laws, relating to data privacy and the protection regulation of personal information, including personal health informationthe Company or its Subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any and all other applicable health care laws and regulationsstate or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries Subsidiaries has received written notice of any material claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority court or arbitrator or governmental or regulatory authority or third party alleging that any product, product operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. The Company and its Subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries are Subsidiaries is a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither Additionally, neither the Company, any of its subsidiaries, Subsidiaries nor any of their respective directorsemployees, officers, nordirectors, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company has operated and each of its subsidiaries is, and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (as defined in this Section 6(pp)), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other Regulatory Authority having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Payments Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section §§ 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a- 7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sections 801 §§ 301 et seq.), (vi) Healthcare Product Laws, including but not limited the regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any similar federal, state and all other applicable health care local laws and regulations, including the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence or notice from the FDA or any court, arbitrator, other Governmental Regulatory Authority alleging or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care LawsLaws applicable to the Company. Except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, the Company has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any post-market recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to any lack of safety, efficacy or regulatory compliance of any product or any alleged defect or violation with respect to any product and, to the Company’s knowledge, no third party has initiated or conducted any such claimnotice or action and, actionto the Company’s knowledge, suitthere are no facts which are reasonably likely to cause, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither and the Company nor has not received any written notice from the FDA or any other regulatory agency requesting, a post-market recall, market withdrawal or replacement of its subsidiaries are any product sold or intended to be sold by the Company, a change in the marketing classification or a change in the labeling of any such products, or a termination or suspension of the manufacturing of any such products. Additionally, the Company is not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency or other Governmental Authority. Neither the Company, any of its subsidiaries, any of their respective directors, officers, nor, to the knowledge of the Company’s knowledge, any of their its respective employees employees, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company and each of its subsidiaries is, are and at all times has have been, in compliance in all material respects with all applicable Health Care LawsLaws (as defined below), and has have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, criminal conviction, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program, other than any instances of non-compliance or activities that would not reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (iA) the Federal Food, Drug, and Cosmetic Act, Act (ii21 U.S.C. §§ 301 et seq.); (B) all applicable supranational, foreign, federal, state, provincial, and local and foreign health care related fraud and abuse Lawslaws and regulations, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Payments Sunshine Act (42 U.S.C. Section § 1320a-7h), the Xxxxx Law (42 U.S.C. § 1395nn), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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.), the exclusion laws (42 U.S.C. § 1320a-7) and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (C) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section §§ 17921 et seq.), ; (D) the exclusion laws Public Health Service Act (42 U.S.C. Section 1320a-7§§ 201 et seq.) (“PHS”), ; (E) the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare statute (Title XVIII of the Social Security Act); (ivvi) the Medicaid statute (Title XIX of the Social Security Act), ; (vF) the Controlled Substances Act regulations promulgated pursuant to such laws; (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (viiG) any and all other applicable supranational, foreign, federal, state, provincial, and local laws relating to the manufacturing, development, testing, labeling, marketing, advertising, promotion, or distribution of medical devices; the billing, payment, or reimbursement of or for medical devices or medical procedures involving those devices; kickbacks; referrals; the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care laws programs; and regulationsquality, safety, privacy, security, licensure or any other aspect of providing medical devices. Neither the Company nor any of its subsidiaries has have received written notice of any claim, action, suit, audit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action (“Actions”) from any court, arbitrator, or any other Governmental Authority governmental or regulatory authority, or third party alleging or asserting any liability under, any non-compliance with, or that any product, operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the knowledge of the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action Action is threatened, other than any Action that would not reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Company, there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company under Health Care Laws, other than any liability that would not reasonably be expected to result in a Material Adverse Effect. The Company and its subsidiaries have filed, obtained, maintained, and submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Law or any Permit (“Filings”) in all material respects, and all such Filings were complete and correct in all material respects and not misleading in any material respect on the date filed (or were corrected or supplemented by a subsequent Filing). Neither the Company nor any of its subsidiaries have offered, paid, solicited or received any remuneration, discount, or rebate, to or from any Person except in compliance in all respects with all Health Care Laws, other than any instance of non-compliance as would not reasonably be expected to result in a Material Adverse Effect. Neither the Company nor any of its subsidiaries are a party to or have has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency or any other Governmental Authoritygovernmental or regulatory authority, which is reasonably likely to result in a Material Adverse Effect. Neither Additionally, neither the Company, nor any of its subsidiaries, nor any of their respective directorsemployees, officers, nordirectors and agents (while acting in such capacity), to the Company’s knowledge, any of their respective employees or agents has have been excluded, suspended or debarred from participation in in, or is otherwise ineligible to participate in, any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company, is subject to an a pending or threatened governmental inquiry, investigation, proceeding, or any other similar action by any Governmental Authority Action that would reasonably be expected to result in debarment, suspension, exclusion or exclusionineligibility. The manufacturing of products by or on behalf of the Company and any of its subsidiaries is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products sold in the United States, and the respective counterparts thereof promulgated by governmental authorities in countries outside the United States, except for any instances of non-compliance as would not reasonably be expected to result in a Material Adverse Effect. Except as would not reasonably be expected to result in a Material Adverse Effect, neither the Company nor any of its subsidiaries have had any product or manufacturing site (whether Company- or subsidiary-owned or that of a contract manufacturer for the products) subject to a governmental authority (including the FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company or any of its subsidiaries’ products, processes or operations, or similar correspondence or notice from the FDA or other governmental or regulatory authority alleging or asserting material noncompliance with any applicable Health Care Law. To the knowledge of the Company, neither the FDA nor any other governmental authority is considering such action.

Health Care Laws. The Company and each of its subsidiaries is, Subsidiaries has operated and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 286, 287, 1347 and 2871349, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), Public Health Service Act (42 U.S.C. Section 1320a-7)§§ 201 et seq.) and the regulations promulgated thereunder, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the Company nor or any of its subsidiaries Subsidiaries has received written any FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any courtother governmental or regulatory authority alleging or asserting noncompliance with any Health Care Laws applicable to the Company. The Company and its subsidiaries have filed, arbitratormaintained or submitted all material reports, other Governmental Authority documents, forms, notices, applications, records, claims, submissions and supplements or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of amendments as required by any Health Care Laws, andand all such reports, to documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration date filed in all material respects (or other action were corrected or supplemented by a subsequent submission). The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor 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 Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, any of its subsidiaries, Subsidiaries nor any of their respective directorsemployees, officers, nordirectors, or to the Company’s knowledge, any of their respective employees consultants or agents agents, has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company, or is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company has operated and each of its subsidiaries is, and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. Anti-Kickback federal Antikickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including including, but not limited to to, 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, Company nor any of its subsidiaries, any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, each of the Company and each of its subsidiaries is, is and at all times has been, been in compliance in all material respects with all applicable the Health Care LawsLaws (as defined below), to the extent such Health Care Laws are applicable to the business of the Company and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care programits subsidiaries. For purposes of this Agreement, the “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act, (ii) all applicable U.S. federal, state, local and all applicable foreign health care related fraud and abuse Lawslaws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act “Xxxxx” physician self-referral law (42 U.S.C. Section 1320a-7h§ 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal 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 286 and 287, and the federal health care program false statement law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§ 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), applicable Medicare (Title XVIII of the Social Security Act) as amended by and Medicaid (Title XIX of the Social Security Act)laws, the Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801-3812), the False Statements Relating to Health Care Matters statute (18 U.S.C. § 1035), the Health Care Fraud statute (18 U.S.C. § 1347), and the statutes of applicable government funded or sponsored health care programs, and the regulations promulgated pursuant to such statutes; (ii) the Administrative Simplification provisions of HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), and the exclusion regulations promulgated under both laws (42 U.S.C. Section 1320a-7), and any applicable state or non-U.S. counterpart thereof or other law or regulation the civil monetary penalties law (42 U.S.C. Section 1320a-7a), purpose of which is to protect the data and/or privacy of individuals or information related to health information or medical records; (iii) Medicare (Title XVIII of the Social Security Federal Food, Drug, and Cosmetic Act), as amended, and the regulations promulgated thereunder; (iv) Medicaid (Title XIX applicable provisions of the Social Security Act)Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, and the regulations promulgated thereunder; and (v) quality, safety and accreditation requirements under applicable federal, state or local laws or regulatory bodies, each as applicable to the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulations. Company; Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction orders or similar agreements with or imposed by any Regulatory Agency governmental or regulatory authority, or has any reporting obligations, plan of correction or other Governmental Authorityremedial measures entered into pursuant to any such agreement entered into with, or such decree or order issued by, any such governmental or regulatory authority that would, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. Neither To the extent required in connection with its business, except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiaries has the requisite provider number or other authorization to xxxx federal health care programs (including Medicare and Medicaid) in the state or states in which such entity operates; none of the Company or any of its subsidiaries has engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from any federal health care programs or is subject to any pending, or, to the knowledge of the Company, threatened or contemplated action which could reasonably be expected to result either in revocation of any provider number or authorization or in the Company’s or any of its subsidiaries’ exclusion from any federal health care programs; the Company and its subsidiaries’ business practices have been structured in a manner reasonably designed to comply to the extent applicable to the business of the Company and its subsidiaries with the federal or state laws governing federal health care programs, including, without limitation, Sections 1320a-7a and 1320a-7b of Title 42 of the United States Code, and the Company reasonably believes that it is in material compliance with such laws to the extent such laws are applicable to the business of the Company and is subsidiaries; the Company and each subsidiary has taken reasonable actions designed to ensure it is in material compliance with the Health Care Laws to the extent such laws are applicable to the business of the Company and is subsidiaries; the Company and each of its subsidiaries has taken reasonable actions designed to ensure that each of its subsidiaries does not allow any individual to have a five percent or greater ownership or control interest (as defined in 42 U.S.C. § 1320a-3(a)(3)) in the Company or any subsidiary or to be an officer, director or managing employee (as defined in 42 U.S.C. § 1320a-5(b)) of the Company or any of its subsidiaries such that the Company or any of its subsidiaries could be subject to permissive exclusion from participation in any federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) as described in 42 U.S.C. § 1320a-7(b)(8); and none of the Company or any of its subsidiaries nor any of their respective employees, officers or directors, or, to the knowledge of the Company or any of its subsidiaries, any of their respective directorsagents or contractors, officers, nor, to the Company’s knowledge, any of their respective employees is listed as or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program program, or human clinical research or, to the knowledge of the CompanyCompany or any of its subsidiaries, is subject to an a governmental inquiry, investigation, proceeding, proceeding or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, suspension or exclusion.

Health Care Laws. The Company has operated and each of its subsidiaries is, and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. Anti-Kickback federal Antikickback Statute (42 U.S.C. Section 1320a-7b(b§ 1320a- 7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, Company nor any of its subsidiaries, any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company and each of its subsidiaries is, has operated and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, any of its subsidiaries, subsidiary nor any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, each of the Company and each of its subsidiaries is, is and at all times has been, been in compliance in all material respects with all applicable the Health Care LawsLaws (as defined below), to the extent such Health Care Laws are applicable to the business of the Company and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care programits subsidiaries. For purposes of this Agreement, the “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act, (ii) all applicable U.S. federal, state, local and all applicable foreign health care related fraud and abuse Lawslaws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act “Sxxxx” physician self-referral law (42 U.S.C. Section 1320a-7h§ 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal 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 286 and 287, and the federal health care program false statement law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§ 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), applicable Medicare (Title XVIII of the Social Security Act) as amended by and Medicaid (Title XIX of the Social Security Act)laws, the Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801-3812), the False Statements Relating to Health Care Matters statute (18 U.S.C. § 1035), the Health Care Fraud statute (18 U.S.C. § 1347), and the statutes of applicable government funded or sponsored health care programs, and the regulations promulgated pursuant to such statutes; (ii) the Administrative Simplification provisions of HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), and the exclusion regulations promulgated under both laws (42 U.S.C. Section 1320a-7), and any applicable state or non-U.S. counterpart thereof or other law or regulation the civil monetary penalties law (42 U.S.C. Section 1320a-7a), purpose of which is to protect the data and/or privacy of individuals or information related to health information or medical records; (iii) Medicare (Title XVIII of the Social Security Federal Food, Drug, and Cosmetic Act), as amended, and the regulations promulgated thereunder; (iv) Medicaid (Title XIX applicable provisions of the Social Security Act)Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, and the regulations promulgated thereunder; and (v) quality, safety and accreditation requirements under applicable federal, state or local laws or regulatory bodies, each as applicable to the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulations. Company; Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction orders or similar agreements with or imposed by any Regulatory Agency governmental or regulatory authority, or has any reporting obligations, plan of correction or other Governmental Authorityremedial measures entered into pursuant to any such agreement entered into with, or such decree or order issued by, any such governmental or regulatory authority that would, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. Neither To the extent required in connection with its business, except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiaries has the requisite provider number or other authorization to bxxx federal health care programs (including Medicare and Medicaid) in the state or states in which such entity operates; none of the Company or any of its subsidiaries has engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from any federal health care programs or is subject to any pending, or, to the knowledge of the Company, threatened or contemplated action which could reasonably be expected to result either in revocation of any provider number or authorization or in the Company’s or any of its subsidiaries’ exclusion from any federal health care programs; the Company and its subsidiaries’ business practices have been structured in a manner reasonably designed to comply to the extent applicable to the business of the Company and its subsidiaries with the federal or state laws governing federal health care programs, including, without limitation, Sections 1320a-7a and 1320a-7b of Title 42 of the United States Code, and the Company reasonably believes that it is in material compliance with such laws to the extent such laws are applicable to the business of the Company and is subsidiaries; the Company and each subsidiary has taken reasonable actions designed to ensure it is in material compliance with the Health Care Laws to the extent such laws are applicable to the business of the Company and is subsidiaries; the Company and each of its subsidiaries has taken reasonable actions designed to ensure that each of its subsidiaries does not allow any individual to have a five percent or greater ownership or control interest (as defined in 42 U.S.C. § 1320a-3(a)(3)) in the Company or any subsidiary or to be an officer, director or managing employee (as defined in 42 U.S.C. § 1320a-5(b)) of the Company or any of its subsidiaries such that the Company or any of its subsidiaries could be subject to permissive exclusion from participation in any federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) as described in 42 U.S.C. § 1320a-7(b)(8); and none of the Company or any of its subsidiaries nor any of their respective employees, officers or directors, or, to the knowledge of the Company or any of its subsidiaries, any of their respective directorsagents or contractors, officers, nor, to the Company’s knowledge, any of their respective employees is listed as or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program program, or human clinical research or, to the knowledge of the CompanyCompany or any of its subsidiaries, is subject to an a governmental inquiry, investigation, proceeding, proceeding or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, suspension or exclusion.

Health Care Laws. The Company and each of its subsidiaries is, has operated and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, any of its subsidiaries, subsidiaries nor any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company and each of its subsidiaries is, Subsidiaries has operated and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (as defined below), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), Public Health Service Act (42 U.S.C. Section 1320a-7§§ 262 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, any of its subsidiaries, Subsidiaries nor any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Company and each of its subsidiaries is, Subsidiaries has operated and at all times has been, currently is in compliance in all material respects with all applicable Health Care LawsLaws (as defined below), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) shall mean the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and foreign health care related fraud and abuse Laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. Section § 1320a-7h), the U.S. Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Claims Law Act (42 U.S.C. Section § 1320a-7b(a)), all criminal Laws laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.), the exclusion laws patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (42 21 U.S.C. Section 1320a-7§§ 301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) , Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited regulations promulgated pursuant to HIPAA, relating to data privacy and the protection of personal information, including personal health informationsuch laws, and (vii) any and all other applicable health care laws similar local, state or federal law and regulations. Neither the The Company nor has not received any of its subsidiaries has received written FDA Form 483, notice of any claimadverse finding, actionwarning letter, suit, proceeding, hearing, enforcement, audit, investigation, arbitration untitled letter or other action correspondence, communication or notice from the FDA or any court, arbitrator, other Governmental Authority governmental or third party regulatory authority alleging that any product, operation or activity of the Company or a subsidiary is in material violation of asserting noncompliance with any Health Care Laws, and, Laws applicable to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action . The Company is threatened. Neither the Company nor any of its subsidiaries are not a party to or have nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency governmental or other Governmental Authorityregulatory authority. Neither the Company, any of its subsidiaries, Subsidiaries nor any of their respective directorsemployees, officers, nordirectors or, to the Company’s knowledge, any of their respective employees or agents consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to an a governmental inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. The Except as disclosed in the Time of Sale Information and the Offering Memorandum, neither the Company and each nor any of its subsidiaries is, and at all times has been, business operations is in compliance in all material respects with all applicable violation of any Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect on the Company and has not engaged in activities which areits subsidiaries, taken 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 programa whole. For purposes of this Agreement, “Health Care Laws” means: means (i) the Federal Food, Drug, and Cosmetic Act, and the regulations promulgated thereunder, (ii) all applicable federal, state, local federal and foreign health care related state fraud and abuse Lawslaws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section §1320a-7b(b)), the U.S. Starx Xxx (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.X. §0000 xx seq.), the Physician Payment Payments Sunshine Act (42 U.S.C. Section § 1320a-7h), Sections 1320a-7 and 1320a-7a of Title 42 of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal 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 286 and 287, United States Code and the health care fraud criminal regulations promulgated pursuant to such statutes, (iii) the administrative simplification provisions under of the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. Section §1320d et seq.) ), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§17921 et seq.), and the exclusion laws regulations promulgated thereunder, (iv) Titles XVIII (42 U.S.C. Section 1320a-7), the civil monetary penalties law §1395 et seq.) and XIX (42 U.S.C. Section 1320a-7a), (iiiU.S.X. §0000 xx seq.) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of Act and the Social Security Act)regulations promulgated thereunder, (v) the Controlled Substances Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 42 U.S.C. Sections 801 §1395w-101 et seq.)) and the regulations promulgated thereunder, (vi) Healthcare Product Lawsthe Patient Protection and Affordable Care Act, including but not limited as amended by the Health Care and Education Reconciliation Act of 2010, (vii) all statutes, rules or regulations applicable to HIPAAthe ownership, relating to data privacy and testing, development, manufacture, quality, safety, accreditation, packaging, use, distribution, labeling, promotion, sale, offer for sale, import, export or disposal of any product manufactured or distributed by the protection of personal information, including personal health information, Company and (viiviii) any and all other applicable health care laws and regulations. Neither regulations applicable to the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority or third party alleging that any product, operation or activity business of the Company or a subsidiary is as currently conducted by it as described in material violation the Time of any Health Care LawsSale Information and the Offering Memorandum, and, each of (i) through (viii) as may be amended from time to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency or other Governmental Authority. Neither the Company, any of its subsidiaries, any of their respective directors, officers, nor, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would reasonably be expected to result in debarment, suspension, or exclusiontime.