Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither Neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors directors, agents and agentscontractors, nor, to the knowledge of the Company, any of their respective licensees (if any), nor any of their respective business operations, is in violation of any applicable laws, including Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and Act, the regulations promulgated thereunder, including the thereunder and any applicable non-U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereundercounterpart thereof; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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”); and (iv) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof thereof. Neither the Company nor any of its subsidiaries has received any warning letter, untitled letter or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement correspondence from any U.S. Governmental Authority alleging or state health care programasserting noncompliance with any Health Care Laws. Additionally, including but not limited to except as described in the federal TRICARE statute (10 U.S.C. §1071 et seq.)Registration Statement, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), Pricing Disclosure Package and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionallythe Prospectus, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, nor, to the knowledge of the Company, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the knowledge of the Company, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting Except as described in the generality of subsection 1(a)(45) aboveRegistration Statement, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors Prospectus and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, the Pricing Disclosure Package or except where the failure to be in compliance as would not, individually or in the aggregate, result in be reasonably expected to have a Material Adverse Effect, each of the Company, its subsidiaries and the JVs is, and at all times has been, in compliance 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: means all Applicable Laws of any Governmental Entity pertaining to health care regulatory matters applicable to the operations of the Company, its subsidiaries or its JVs, including (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, state and local and all foreign health care related fraud and abuse laws, including, without limitation, state corporate practice of medicine laws and regulations, state professional fee-splitting laws and regulations, state workers’ compensation laws and regulations, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Sxxxx Law (42 U.S.C. Section 1395nn), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 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 HIPAA (as defined below), the U.S. exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), each as amended, and the implementing rules and regulations promulgated pursuant to such statutes; (ii) Medicare (Title XVIII of the Social Security Act); (iii) Medicaid (Title XIX of the Social Security Act), and the regulations promulgated thereunder; (iv) (a) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information1996, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)§§ 1320d-1329d-8, as amended by the Health Information Technology for Economic and Clinical Health Act, enacted as Title XIII of the American Recovery and Reinvestment Act of 2009, Public Law 111-5 (42 U.S.C. Section 17921 et seq.“HIPAA”), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (ivb) all applicable implementing laws and regulations; and (c) any similar state and local Applicable Laws regarding data protection, data processing, data privacy, data security and/or the U.S. Controlled Substances Actcollection, use, storage, disclosure or cross-border transfer of personal data and information, including protected health information (collectively, including HIPAA, the “Data Privacy and Security Laws”); (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programand federal controlled substance and drug diversion laws, including but not limited to the federal TRICARE statute Federal Controlled Substances Act (10 21 U.S.C. §1071 § 801, et seq.), ) and the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) qualitythe Clinical Laboratory Improvement Amendments of 1988, safety 42 U.S.C. § 263a et seq.; (vii) any Applicable Law pertaining to or regulating the provision or administration of, or payment for, healthcare products and services (such services include physician and allied professional services and related ancillary services); (viii) and Applicable Law regulating the ownership or operation of a health care facility or business, or assets used in connection therewith, including licensing, certification and/or accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesrequirements; and (viiix) any and all other applicable health care laws and regulations regulations, each as amended from time to time, applicable to the operations of the Company, its subsidiaries or its JVs. Except as described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any jurisdictionsubsidiary or any of the JVs has received written notice from any Governmental Entity of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action alleging that any of the Company, the subsidiaries or the JVs is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as well as contractual described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any subsidiary or any of the JVs is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements mandated with or imposed by such lawsany Governmental Entity. Additionally, neither none of the Company nor any of Company, its subsidiaries, or the JVs nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to as could not be in compliance would notexpected, individually or in the aggregate, result in to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section 1320a-7a), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 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”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder thereunder, including the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards for the Protection of Electronic Protected Health Information (the “Security Rule”), and the Standards for Electronic Transactions and Code Sets, and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; Patient Protection and Affordable Care Act of 2010 (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.Public Law 111-148), as amended by the Veterans Administration drug pricing program Health Care and Education Reconciliation Act of 2010 (38 U.S.C. Section 8126Public Law 111-152), and any the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) licensure, quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries. Neither the Company nor its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor its subsidiaries are a party to any jurisdictioncorporate integrity agreements, as well as contractual monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of Company, its subsidiaries, subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors 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 Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting The Company and the generality of subsection 1(a)(45) aboveSubsidiaries are, neither the Company nor any of its subsidiariesand since January 1, nor any of their respective employees2017 have been, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, Laws except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended(21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the Federal False Statements Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 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”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under 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 regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersthereunder; (iv) the U.S. Controlled Substances Act; Physician Payments Sunshine Act (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 42 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126§ 1320a-7h), and any the regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiv) any and all other applicable health care laws and regulations regulation 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 the Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor the Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither none of the Company nor any of or its subsidiaries, nor Subsidiaries or any of their respective employeesofficers or directors or, officersto the Company’s knowledge, directors, agents or contractors any of their respective employees 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 Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employeesexclusion. The Company and the Subsidiaries have filed, officersobtained, directorsmaintained or submitted all reports, agents documents, forms, notices, applications, records, claims, submissions and supplements or contractors 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 exclusion, suspension or debarmenthave a Material Adverse Effect.

Compliance with Health Care Laws. Without limiting The Company and the generality of subsection 1(a)(45) aboveSubsidiaries are, neither the Company nor any of its subsidiariesand since January 1, nor any of their respective employees2013 have been, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, Laws except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended(21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the Federal False Statements Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 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”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under 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 regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersthereunder; (iv) the U.S. Controlled Substances Act; Physician Payments Sunshine Act (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 42 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126§ 1320a-7h), and any the regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiv) any and all other applicable health care laws and regulations regulation 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 the Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor the Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither none of the Company nor any of or its subsidiaries, nor Subsidiaries or any of their respective employeesofficers or directors or, officersto the Company’s knowledge, directors, agents or contractors any of their respective employees 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 Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employeesexclusion. The Company and the Subsidiaries have filed, officersobtained, directorsmaintained or submitted all reports, agents documents, forms, notices, applications, records, claims, submissions and supplements or contractors 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 exclusion, suspension or debarmenthave a Material Adverse Effect.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is and at all times has been, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programPatient Protection and Affordable Care Act of 2010, including but not limited to as amended by the federal TRICARE statute (10 U.S.C. §1071 et seq.)Health Care and Education Affordability Reconciliation Act of 2010, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (viv) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesthe U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (viivi) any and all other applicable health care laws and regulations regulations. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors 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 Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither Neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors directors, agents and agentscontractors, nor, to the knowledge of the Company, any of their respective licensees (if any), nor any of their respective business operations, is in violation of any applicable laws, including Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and Act, the regulations promulgated thereunder, including the thereunder and any applicable non-U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereundercounterpart thereof; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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”); and (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards Standardsp for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof thereof. Neither the Company nor any of its subsidiaries has received any warning letter, untitled letter or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement correspondence from any U.S. governmental or state health care programregulatory authority alleging or asserting noncompliance with any Health Care Laws. Additionally, including but not limited to except as described in the federal TRICARE statute (10 U.S.C. §1071 et seq.)Registration Statement, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), Pricing Disclosure Package and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionallythe Prospectus, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, nor, to the knowledge of the Company, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the knowledge of the Company, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting None of the generality of subsection 1(a)(45) aboveCompany, neither the Company nor any of its subsidiaries, nor nor, to Company’s knowledge, any director, officer, employee or agent of their respective employees, officers, directors and agents, nor any of their respective business operations, the Company is in violation of any applicable Health Care LawsLaws (as defined below), except where the failure to be in compliance would not, individually or in the aggregate, result in reasonably be expected have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; thereunder; (ii) all applicable federal, state, local and all foreign health health-care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections Section 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; statutes; (iii) any 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”); (iv) the Standards for Privacy Administrative Simplification provisions of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder including the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and any state or non-U.S. counterpart thereof or thereof, and any other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; prescribers; (ivv) the U.S. Controlled Substances Act; Act (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 21 U.S.C. Section 8126)801 et seq.); (vi) the U.S. Prescription Drug Marketing Act of 1987, as amended, and any the rules and regulations promulgated thereunder; (viviii) the Clinical Laboratory Improvement Act; and (ix) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (viix) any and all other applicable health care laws and regulations related to clinical research, testing, and medical product development activities, in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither none of the Company nor any of Company, its subsidiaries, nor any director, officer, employee or agent of their respective employees, officers, directors, agents or contractors the Company has been excluded, suspended or debarred from participation in any federal health care program orprogram. To the Company’s knowledge, no director, officer, employee or agent of the Company has been disqualified by FDA as a clinical investigator. Neither the Company, its subsidiaries, nor, to the knowledge Company’s knowledge, any director, officer, employee or agent of the Company and its subsidiaries, is subject to an or has been threatened in writing with a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companywould reasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting Except as set forth in the generality of subsection 1(a)(45) aboveRegistration Statement or the Prospectus, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable material compliance with all Health Care LawsLaws applicable to it and its business, except where the failure to be and has not engaged in compliance would notactivities which are, individually as applicable, cause for false claims liability, civil penalties, or in the aggregatemandatory or permissive exclusion from Medicare, result in a Material Adverse EffectMedicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. §§ 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 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 exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) Medicare (Title XVIII of the U.S. Controlled Substances Social Security Act); (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Medicaid (Title XIX of the federal TRICARE statute (10 U.S.C. §1071 et seq.Social Security Act), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viivi) any and all other applicable health care laws and regulations regulations. Except as set forth in the Registration Statement or the Prospectus, the Company has not received written notice of any jurisdictionclaim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as well as contractual set forth in the Registration Statement or the Prospectus, the Company is not 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 mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, except as set forth in the Registration Statement or the Prospectus, neither the Company nor nor, to the Company’s knowledge, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors has directors have been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to do so would not reasonably be in compliance would not, individually or in the aggregate, result in expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder(“FDCA”), including the U.S. Prescription Drug Marketing Act of 1987, as amended21 U.S.C. §301 et seq., and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the federal criminal false claims law (42 U.S.C. § 1320a-7b), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 the Xxxxx Law (42 U.S.C. § 1395nn), the exclusion laws (42 U.S.C. § 1320a-7), all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign 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 HIPAA, (ii) the U.S. Health Insurance Portability statutes, regulations and Accountability Act directives of 1996 (“HIPAA”)applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under 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.)HITECH Act, and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), the regulations promulgated thereunder; (v) any laws or regulations that govern participation in or coverage or reimbursement from any the U.S. or state health care program, including but not limited to the federal TRICARE statute Controlled Substances Act (10 21 U.S.C. §1071 Section 801 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any Medicare, Title XVIII of the Social Security Act, Medicaid, Title XIX of the Social Security Act; and (viii) all other applicable health care laws local, state, federal, national, supranational and regulations foreign laws, relating to the regulation of the Company or its subsidiary. Except as otherwise disclosed in any jurisdictionthe Registration Statement, as well as contractual agreements mandated by such laws. Additionallythe Pricing Disclosure Package and Prospectus, neither the Company nor any of its subsidiariessubsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all required and material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable 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 is a party to any corporate integrity agreements, plans of correction, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors 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 Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(451(a)(—) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors directors, agents and agentscontractors, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all 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. Xxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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”); (iv) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII, XIX and XXI of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vivii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiviii) any and all other applicable health care laws laws, regulations, manual provisions, policies and regulations administrative guidance in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45(39) above, neither the Company nor any of its subsidiarieslicensees (if any), nor any of their respective employees, officers, directors and agents, nor any of their respective its business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “"Health Care Laws” " means: (i) the Federal U.S. Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all 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. Xxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersindividuals; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any Titles XVIII and XIX of the U.S. or state health care program, including but not limited to Social Security Act and the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) the U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (viii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiix) any and all other applicable health care laws laws, regulations, manual provisions, policies and regulations administrative guidance in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45(hh) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse EffectChange. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal U.S. Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all 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. Sxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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 administrative simplification provisions under of the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other applicable state law or regulation the purpose of which is to protect the privacy of individuals or prescribersindividuals; (iv) Titles XVIII and XIX of the U.S. Controlled Substances ActSocial Security Act and the regulations promulgated thereunder; (v) any laws or regulations that govern participation in or coverage or reimbursement from any the U.S. or state health care programMedicare Prescription Drug, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126)Improvement, and any Modernization Act of 2003 and the regulations promulgated thereunder; (vi) the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (vii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiviii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, applicable to the knowledge business of the Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarmentsubsidiaries as currently conducted.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance Except as would not, individually or in the aggregate, result in reasonably be expected to have a Material Adverse Effect, each of the Company, its subsidiaries and their respective directors, officers, employees, agents, contractors or licensees (if any), is and has been in compliance with applicable Health Care Laws (as defined below). For purposes of this Agreement, “Health Care Laws” means: means (i) the United States Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code Code, the Xxxxx Law (42 U.S.C. Section 1395nn) and the regulations promulgated pursuant to such statutes; (iii) any 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”); (iv) the Standards for Privacy Administrative Simplification provisions of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersprescribers or information related to health or medical records; (ivv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Act and the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety Titles XVIII and accreditation standards XIX of the U.S. Social Security Act and requirements the regulations promulgated thereunder; (vii) the Clinical Laboratory Improvement Act and the regulations promulgated thereunder; (viii) the Medicare Access and CHIP Reauthorization Act of any applicable federal, state, local or foreign laws or regulatory bodies2015; (ix) the Emergency Medical Treatment and Labor Act; (x) the Fair Debt Collection Practices Act; (xi) the Telephone Consumer Protection Act; and (viixii) any amendments to such laws and all other applicable health care laws and regulations regulations, in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or other governmental or regulatory authority or third party alleging that any services, products, operations or activities of the Company or any of its subsidiaries is in material violation of any Health Care Laws nor, to the knowledge of the Company or its subsidiaries, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, plan of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, none of the Company, its subsidiaries or their respective employees, officers, directors, agents or contractors has been excluded, suspended suspended, debarred or debarred disqualified from participation in any federal health care program or, to or disqualified or restricted under the knowledge of Company and its subsidiaries, Health Care Laws or is subject to or has been threatened in writing with an inquiry, claim, investigation, proceeding, proceeding or other similar matter that could would subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors contractors, to exclusion, suspension suspension, debarment, disqualification or debarmentrestriction.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all 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. Sxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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”); (iv) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII, XIX and XXI of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vivii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiviii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting Except as set forth in the generality of subsection 1(a)(45) aboveRegistration Statement, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors General Disclosure Package and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, the Prospectus or except where the failure to be in compliance as would not, individually or in the aggregate, result in be reasonably expected to have a Material Adverse Effect, each of the Company, its Subsidiaries and its JVs is, and at all times has been, in compliance 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: means all Laws of any Governmental Entity pertaining to health care regulatory matters applicable to the operations of the Company, its Subsidiaries or its JVs, including (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, state and local and all foreign health care related fraud and abuse laws, including, without limitation, state corporate practice of medicine laws and regulations, state professional fee-splitting laws and regulations, state workers’ compensation laws and regulations, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Xxxxx Law (42 U.S.C. Section 1395nn), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 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”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is pursuant to protect the privacy of individuals or prescriberssuch statutes; (ivii) Medicare (Title XVIII of the U.S. Controlled Substances Social Security Act); (viii) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Medicaid (Title XIX of the federal TRICARE statute (10 U.S.C. §1071 et seq.Social Security Act), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiiv) any and all other applicable health care laws and regulations regulations, each as amended from time to time, applicable to the operations of the Company, its Subsidiaries or its JVs. Except as set forth in the Registration Statement, the General Disclosure Package and the Prospectus, none of the Company or any jurisdictionof its JVs or, to the knowledge of the Company, any Subsidiary has received written notice from any Governmental Entity of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action alleging that the Company, its Subsidiaries or its JVs is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as well as contractual set forth in the Registration Statement, the General Disclosure Package and the Prospectus, none of the Company or any of its JVs or, to the knowledge of the Company, any Subsidiary is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements mandated with or imposed by such lawsany Governmental Entity. Additionally, neither none of the Company Company, its JVs or its Subsidiaries nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting Except as described in the generality of subsection 1(a)(45) aboveRegistration Statement, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors Prospectus and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, the Pricing Disclosure Package or except where the failure to be in compliance as would not, individually or in the aggregate, result in be reasonably expected to have a Material Adverse Effect, each of the Company, its subsidiaries and the JVs is, and at all times has been, in compliance 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: means all Applicable Laws of any Governmental Entity pertaining to health care regulatory matters applicable to the operations of the Company, its subsidiaries or its JVs, including (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, state and local and all foreign health care related fraud and abuse laws, including, without limitation, state corporate practice of medicine laws and regulations, state professional fee-splitting laws and regulations, state workers’ compensation laws and regulations, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Xxxxx Law (42 U.S.C. Section 1395nn), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 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 HIPAA (as defined below), the U.S. exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), each as amended, and the implementing rules and regulations promulgated pursuant to such statutes; (ii) Medicare (Title XVIII of the Social Security Act); (iii) Medicaid (Title XIX of the Social Security Act), and the regulations promulgated thereunder; (iv) (a) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information1996, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)§§ 1320d-1329d-8, as amended by the Health Information Technology for Economic and Clinical Health Act, enacted as Title XIII of the American Recovery and Reinvestment Act of 2009, Public Law 111-5 (42 U.S.C. Section 17921 et seq.“HIPAA”), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (ivb) all applicable implementing laws and regulations; and (c) any similar state and local Applicable Laws regarding data protection, data processing, data privacy, data security and/or the U.S. Controlled Substances Actcollection, use, storage, disclosure or cross-border transfer of personal data and information, including protected health information (collectively, including HIPAA, the “Data Privacy and Security Laws”); (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programand federal controlled substance and drug diversion laws, including but not limited to the federal TRICARE statute Federal Controlled Substances Act (10 21 U.S.C. §1071 § 801, et seq.), ) and the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) qualitythe Clinical Laboratory Improvement Amendments of 1988, safety 42 U.S.C. § 263a et seq.; (vii) any Applicable Law pertaining to or regulating the provision or administration of, or payment for, healthcare products and services (such services include physician and allied professional services and related ancillary services); (viii) and Applicable Law regulating the ownership or operation of a health care facility or business, or assets used in connection therewith, including licensing, certification and/or accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesrequirements; and (viiix) any and all other applicable health care laws and regulations regulations, each as amended from time to time, applicable to the operations of the Company, its subsidiaries or its JVs. Except as described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any jurisdictionsubsidiary or any of the JVs has received written notice from any Governmental Entity of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action alleging that any of the Company, the subsidiaries or the JVs is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as well as contractual described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any subsidiary or any of the JVs is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements mandated with or imposed by such lawsany Governmental Entity. Additionally, neither none of the Company nor any of Company, its subsidiaries, or the JVs nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the The Company nor any and each of its subsidiaries, nor any of their respective employees, officers, directors Subsidiaries have operated and agents, nor any of their respective business operations, is currently are in violation of any material compliance with all applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: means health care laws, rules, regulations, accreditations and ethical standards, including, without limitation, (i) the Federal Federal, Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder(21 U.S.C. § 301 et seq.); (ii) the Public Health Service Act (42 U.S.C. § 201 et seq.); (iii) all applicable rules and regulations of the U.S. Food and Drug Administration (“FDA”), including, to the extent applicable, those requirements relating to investigational use, establishment registration, and complaint handling; (iv) all applicable federal, state, local and all applicable foreign health care healthcare related fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), as well as any state statutes governing disclosure of payments by manufacturers or suppliers to healthcare professionals, the civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), Sections 1320a-7 and 1320a-7a the Program Fraud Civil Remedies Act of Title 1986 (31 U.S.C. §§ 3891 et seq.), the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all applicable criminal laws relating to health care healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care healthcare fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA exclusion laws (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.§ 1320a-7), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other civil monetary penalties law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act42 U.S.C. § 1320a-7a); (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. applicable federal or state health care programlaws pertaining to the privacy and security of patient information, including laws pertaining to the protection of genetic data or biospecimens, including, without limitation, HIPAA; (vi) the Medicare program (Title XVIII of the Social Security Act, including the amendments implemented by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Medicare Improvements for Patients and Providers Act of 2008), (vii) the Medicaid program (Title XIX of the Social Security Act), (viii) the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), and (ix) laws applicable to clinical research, including but not limited to the federal TRICARE statute Policy for Protection of Human Subjects (10 U.S.C. §1071 et seq.42 C.F.R. Part 46), the Veterans Administration drug pricing program FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, the United States Animal Welfare Act, the International Conference on Harmonization’s (38 U.S.C. Section 8126ICH) Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals and the ICH Guideline on Safety Pharmacology Studies for Human Pharmaceuticals, and all equivalent legal requirements in other jurisdictions in which the Company operates, in each case for clauses (i)-(ix), to the extent applicable to the Company, if at all. The Company and each of its Subsidiaries have timely filed all material reports, applications, statements, documents, registrations, filings, corrections, updates, amendments, supplements, and submissions required to be filed by them under applicable Health Care Laws, except where failure to timely file would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Change. Each such filing was true and correct in all material respects as of the date of submission, or was corrected in or supplemented by a subsequent filing, and any regulations promulgated thereunder; (vi) qualitymaterial and legally necessary or required updates, safety changes, corrections, amendments, supplements, or modifications to such filings have been submitted to the applicable governmental or regulatory authorities. The Company maintains an operational healthcare compliance program that governs all employees and accreditation standards contractors and requirements is consistent with guidance by the U.S. Department of Health and Human Services Office of Inspector General for effective compliance programs. The Company and its Subsidiaries further operates in material compliance with such healthcare compliance program. The Company and each of its Subsidiaries have not received written notice or other correspondence of any applicable federalclaim, stateaction, local suit, audit, or foreign laws survey finding, proceeding, hearing, enforcement, investigation, arbitration or other action (“Health Care Action”) from any court or arbitrator or governmental or regulatory bodies; and (vii) authority or third party alleging that any and all of their product, operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such Health Care 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 agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental or regulatory authority. Neither the Company nor any of its Subsidiaries have received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other applicable health care laws and regulations in correspondence or notice from the FDA or any jurisdiction, as well as contractual agreements mandated by such lawsother governmental or regulatory authority alleging or asserting any material noncompliance with any Health Care Laws. Additionally, (i) neither the Company nor any of its subsidiariesSubsidiaries has, nor and (ii) none of its employees, officers or directors is or has, been included in the HHS/OIG List of Excluded Individuals/Entities, the General Service Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. To the Company’s knowledge, none of the Company, any of their respective its Subsidiaries, or any of its employees, officers, officers or directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any exclusion. Any certificate signed by an officer of their respective employeesthe Company and delivered to XX Xxxxx or to counsel for XX Xxxxx pursuant to or in connection with this Agreement shall be deemed to be a representation by the Company to XX Xxxxx as to the matters set forth therein. The Company acknowledges that XX Xxxxx and, officersfor purposes of the opinions to be delivered pursuant to Section 7 hereof, directorscounsel to the Company and counsel to XX Xxxxx, agents or contractors will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to exclusion, suspension or debarmentsuch reliance.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to do so would not reasonably be in compliance would not, individually or in the aggregate, result in expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder(“FDCA”), including the U.S. Prescription Drug Marketing Act of 1987, as amended21 U.S.C. §301 et seq., and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the federal criminal false claims law (42 U.S.C. § 1320a-7b), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 the Xxxxx Law (42 U.S.C. § 1395nn), the exclusion laws (42 U.S.C. § 1320a-7), all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign 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 HIPAA, (ii) the U.S. Health Insurance Portability statutes, regulations and Accountability Act directives of 1996 (“HIPAA”)applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under 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.)HITECH Act, and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), the regulations promulgated thereunder; (v) any laws or regulations that govern participation in or coverage or reimbursement from any the U.S. or state health care program, including but not limited to the federal TRICARE statute Controlled Substances Act (10 21 U.S.C. §1071 Section 801 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any Medicare, Title XVIII of the Social Security Act, Medicaid, Title XIX of the Social Security Act; and (viii) all other applicable health care laws local, state, federal, national, supranational and regulations foreign laws, relating to the regulation of the Company or its subsidiary. Except as otherwise disclosed in any jurisdiction, as well as contractual agreements mandated the documents incorporated by such laws. Additionallyreference in the Time of Sale Information and the Offering Memorandum, neither the Company nor any of its subsidiariessubsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all required and material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable 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 is a party to any corporate integrity agreements, plans of correction, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors 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 Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance Except as would not, individually or in the aggregate, result in reasonably be expected to have a Material Adverse Effect, each of the Company, its subsidiaries and their respective directors, officers, employees, agents, contractors or licensees (if any), is and has been in compliance with applicable Health Care Laws (as defined below). For purposes of this Agreement, “Health Care Laws” means: means (i) the United States Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code Code, the Xxxxx Law (42 U.S.C. Section 1395nn) and the regulations promulgated pursuant to such statutes; (iii) any 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”); (iv) the Standards for Privacy Administrative Simplification provisions of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersprescribers or information related to health or medical records; (ivv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Act and the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety Titles XVIII and accreditation standards XIX of the U.S. Social Security Act and requirements the regulations promulgated thereunder; (vii) the Clinical Laboratory Improvement Act and the regulations promulgated thereunder; (viii) the Medicare Access and CHIP Reauthorization Act of any applicable federal, state, local or foreign laws or regulatory bodies2015; (ix) the Emergency Medical Treatment and Labor Act; (x) the Fair Debt Collection Practices Act; (xi) the Telephone Consumer Protection Act; and (viixii) any amendments to such laws and all other applicable health care laws and regulations regulations, in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, demand, inquiry, arbitration or other action from any court or arbitrator or other governmental or regulatory authority or third party alleging that any services, products, operations or activities of the Company or any of its subsidiaries is in material violation of any Health Care Laws nor, to the knowledge of the Company or its subsidiaries, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, demand, inquiry, arbitration or other action threatened. Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, plan of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, none of the Company, its subsidiaries or their respective employees, officers, directors, agents or contractors has been excluded, suspended suspended, debarred or debarred disqualified from participation in any federal health care program or, to or disqualified or restricted under the knowledge of Company and its subsidiaries, Health Care Laws or is subject to or has been threatened in writing with an inquiry, claim, investigation, proceeding, proceeding or other similar matter that could would subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors contractors, to exclusion, suspension suspension, debarment, disqualification or debarmentrestriction.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the The Company nor any of and its subsidiaries, nor any of their respective employeesdirectors, officers, directors employees, contractors, and agentsagents are, nor any of their respective business operationsand for the previous three (3) years have been, is in violation of any compliance with all applicable Health Care Laws, as defined below, except where the failure to noncompliance would not reasonably be in compliance would notexpected to, individually or in the aggregate, result in a Material Adverse Effectmaterial adverse effect on the Company. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and (21 U.S.C. §§ 301 et seq.), the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Public Health Service Act of 1987, as amended, (42 U.S.C. §§ 201 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, and local and all 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. False Statements Law (42 U.S.C. § 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.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any 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. §§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) and Medicaid (Title XIX of the Social Security Act); (iviii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) (42 U.S.C. Section §§ 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programlicensure, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodiesRegulatory Agencies; and (viivi) any and all other applicable health care laws and regulations 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 candidate manufactured or distributed by the Company. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental authority or Regulatory Agency or third party alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual agreements mandated by and, to the Company’s knowledge, no such lawsclaim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Additionally, neither Neither the Company nor any of nor, to the Company’s knowledge, its subsidiaries, nor any of their respective employees, officers, directors, agents employees, contractors or contractors agents, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental authority or Regulatory Agency. Neither the Company nor, to the Company’s knowledge, any of its employees, contractors, agents, officers or 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 Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion. Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company, the Company has 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 in all material respects (or were corrected or supplemented by a subsequent submission). Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company, the Company possesses and is in compliance with all licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws except where such noncompliance would not be expected to, individually or in the aggregate, have a material adverse effect on the Company. The Company has not received any FDA Form 483, notice of its subsidiariesadverse finding, warning letter, untitled letter or other written correspondence or notice from the FDA or any other Regulatory Agency or governmental entity alleging or asserting material noncompliance with any Health Care Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws. Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company, the Company has fulfilled and performed all of their respective employeesmaterial obligations with respect to all licenses, officerssublicenses, directorscertificates, agents permits and other authorizations and no event has occurred which allows, or contractors to exclusionafter notice or lapse of time would allow, suspension revocation or debarmenttermination thereof or results in any other impairment of the rights of the holder.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to any non-compliance could not reasonably be in compliance would notexpected, individually or in the aggregate, result in to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 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.), the exclusion laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programPatient Protection and Affordable Care Act of 2010, including but not limited to as amended by the federal TRICARE statute (10 U.S.C. §1071 et seq.)Health Care and Education Reconciliation Act of 2010, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) licensure, quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries. Neither the Company nor its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, except as could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor its subsidiaries are a party to any jurisdictioncorporate integrity agreements, as well as contractual monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of Company, its subsidiaries, subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors 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 Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employeesexclusion, officersexcept, directorsin each case, agents or contractors to exclusionfor such debarment, suspension or debarmentexclusion that could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.