Common use of Health Care Laws Clause in Contracts

Health Care Laws. “Health Care Laws” shall mean (a) the FDA Act and the regulations promulgated thereunder, (b) the Public Health Service Act (42 U.S.C. § 201 et seq.), and the regulations promulgated thereunder, (c) all federal and state fraud and abuse laws, including the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the exclusion laws (42 U.S.C. § 1320a-7), and the regulations promulgated pursuant to such statutes, (d) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d et seq.), the regulations promulgated thereunder and comparable state laws, (e) the Controlled Substances Act (21 U.S.C. § 801 et seq.), (f) Titles XVIII (42 U.S.C. § 1395 et seq.) and XIX (42 U.S.C. § 1396 et seq.) of the Social Security Act and the regulations promulgated thereunder, (g) the Clinical Laboratories Improvement Amendments (42 U.S.C. § 263a et seq.), (h) the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), (i) all criminal laws relating to health care fraud and abuse and (j) all applicable laws, and rules and regulations administered by the FDA and other Governmental Bodies.

Health Care Laws. “Health Care Laws” shall mean (a) the FDA Act and the regulations promulgated thereunder, (b) the Public Health Service Act (42 U.S.C. § 201 et seq.), and the regulations promulgated thereunder, (c) all federal and state fraud and abuse laws, including the Federal Anti-Kickback Statute (42 U.S.C. § §1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § §1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § §1320a-7a(a)(5)), the exclusion laws (42 U.S.C. § §1320a-7), and the regulations promulgated pursuant to such statutes, (d) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ §1320d et seq.), the regulations promulgated thereunder and comparable state laws, (e) the Controlled Substances Act (21 U.S.C. § 801 et seq.), (f) Titles XVIII (42 U.S.C. § §1395 et seq.) and XIX (42 U.S.C. § 1396 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, (g) the Clinical Laboratories Improvement Amendments (42 U.S.C. § §263a et seq.), and (h) the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), (i) all criminal laws relating to health care fraud and abuse and (j) all applicable laws, and rules and regulations regulations, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies.

Health Care Laws. “Health Care Laws” shall mean (a) the FDA Act and the regulations promulgated thereunder, (b) the Public Health Service Act (42 U.S.C. § 201 et seq.), and the regulations promulgated thereunder, (c) all federal and state fraud and abuse laws, including the Federal Anti-Kickback Statute (42 U.S.C. § §1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § §1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § §1320a-7a(a)(5)), the exclusion laws (42 U.S.C. § §1320a-7), and the regulations promulgated pursuant to such statutes, (d) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ §1320d et seq.), the regulations promulgated thereunder and comparable state laws, (e) the Controlled Substances Act (21 U.S.C. § 801 et seq.), (f) Titles XVIII (42 U.S.C. § 1395 et seq.) and XIX (42 U.S.C. § 1396 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, (g) the Clinical Laboratories Improvement Amendments (42 U.S.C. § §263a et seq.), and (h) the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), (i) all criminal laws relating to health care fraud and abuse and (j) all applicable laws, and rules and regulations regulations, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies.

Health Care Laws. Without limiting the generality of clause (xxiii) above and except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its business operations are and at all times have been in compliance in all material respects with Health Care Laws. For purposes of this Agreement, “Health Care Laws” shall mean means (aA) the FDA Act federal Food, Drug and the regulations promulgated thereunder, (b) the Public Health Service Act (42 U.S.C. § 201 et seq.)Cosmetic Act, and the regulations promulgated thereunder, (cB) all federal and state fraud and abuse laws, including including, without limitation, the Federal federal Anti-Kickback Statute (42 U.S.C. § §1320a-7b(b)), the Sxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. § 3729 U.X.X. §0000 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the exclusion laws (42 U.S.C. § 1320a-7), United States Code and the regulations promulgated pursuant to such statutes, (dC) the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §§ 1320d et seq.), ) and the regulations promulgated thereunder and comparable state lawsthereunder, (eD) the Controlled Substances Act (21 U.S.C. § §801 et seq.), (fE) Titles XVIII (42 U.S.C. § §1395 et seq.) and XIX (42 U.S.C. § 1396 U.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, (gF) the Clinical Laboratories Improvement Amendments Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. § 263a §1395w-101 et seq.)) and the regulations promulgated thereunder, (hG) the Physician Payment Sunshine Act quality, safety and accreditation standards and requirements of all applicable state laws or regulatory bodies and (42 U.S.C. § 1320a-7h), (iH) any and all criminal laws relating to other applicable health care fraud and abuse and (j) all applicable laws, regulations, manual provisions, policies and rules and regulations administered by the FDA and other Governmental Bodiesadministrative guidance, each of (A) through (H) as may be amended from time to time.

Health Care Laws. “Health Care Laws” shall mean (a) the FDA Act and the regulations promulgated thereunder, (b) the Public Health Service Act (42 U.S.C. § 201 et seq.), and the regulations promulgated thereunder, (c) all federal and state fraud and abuse laws, including the Federal Anti-Kickback Statute (42 U.S.C. § §1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § §1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § §1320a-7a(a)(5)), the exclusion laws (42 U.S.C. § §1320a-7), and the regulations promulgated pursuant to such statutes, (d) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ §1320d et seq.), the regulations promulgated thereunder and comparable state laws, (e) the Controlled Substances Act (21 U.S.C. § 801 et seq.), (f) Titles XVIII (42 U.S.C. § 1395 et seq.) and XIX (42 U.S.C. § 1396 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, (g) the Clinical Laboratories Improvement Amendments (42 U.S.C. § §263a et seq.), and (h) the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), (i) all criminal laws relating to health care fraud and abuse and (j) all applicable laws, and rules and regulations regulations, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies, including foreign agencies with comparable roles as the FDA.

Health Care Laws. “Except as disclosed in the Time of Sale Information and the Prospectus, neither the Company nor any of its business operations is in violation of any Health Care Laws” shall mean , 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 (ai) the FDA Act and the regulations promulgated thereunder, (b) the Public Health Service Act (42 U.S.C. § 201 et seq.)FFDCA, and the regulations promulgated thereunder, (cii) all federal and state fraud and abuse laws, including including, without limitation, the Federal federal Anti-Kickback Statute (42 U.S.C. § §1320a-7b(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the exclusion laws (42 U.S.C. § 1320a-7), United States Code and the regulations promulgated pursuant to such statutes, (diii) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §§ 1320d et seq.), ) and the regulations promulgated thereunder and comparable state lawsthereunder, (e) the Controlled Substances Act (21 U.S.C. § 801 et seq.), (fiv) Titles XVIII (42 U.S.C. § §1395 et seq.) and XIX (42 U.S.C. § 1396 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, (gv) the Clinical Laboratories Improvement Amendments Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. § 263a §1395w-101 et seq.)) and the regulations promulgated thereunder, (hvi) quality, safety and accreditation requirements of all applicable foreign or state laws or regulatory bodies and (viii) any and all other health care laws and regulations applicable to the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h)business of the Company as currently conducted, each of (i) all criminal laws relating through (vii) as may be amended from time to health care fraud and abuse and (j) all applicable laws, and rules and regulations administered by the FDA and other Governmental Bodiestime.

Health Care Laws. (a) Except as set forth in Section 2.19(a) of the Company Disclosure Schedule, the Company and each of the Subsidiaries has materially complied and is currently in material compliance with all applicable Health Care Laws. The term “Health Care Laws” shall mean collectively: (ai) Title XVIII of the FDA Act and Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the regulations promulgated thereunderMedicare statute), including specifically, the Ethics in Patient Referrals Act, as amended (b) the Public Health Service Act (Starx Xxx), 42 U.S.C. § 201 et seq.1395nn; (ii) Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute), and the regulations promulgated thereunder, ; (ciii) all federal and state fraud and abuse laws, including the Federal Health Care Program Anti-Kickback Statute (Statute, 42 U.S.C. § 1320a-7b(b)), ; (iv) the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.3729-3733 (as amended); (v) the Program Fraud Civil Remedies Act, the administrative False Claims Law 31 U.S.C. §§ 3801-3812; (42 U.S.C. § 1320a-7b(a)), vi) the Anti-Inducement Law Kickback Act of 1986, 41 U.S.C. §§ 51-58; (vii) the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a(a)(5))1320a-7a and 1320a-7b; (viii) the Exclusion Laws, the exclusion laws (42 U.S.C. § 1320a-7); (ix) the Federal Controlled Substances Act, and the regulations promulgated pursuant to such statutes, 21 U.S.C. § 801 et seq.; (dx) the Health Insurance Portability and Accountability Act of 1996 (1996, 42 U.S.C. §§ 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 (collectively, “HIPAA”), ; (xi) Laws governing the regulations promulgated thereunder provision of substance abuse treatment and comparable state laws, maintenance of related records (e) the Controlled Substances Act (21 U.S.C. § 801 et seq.), (f) Titles XVIII (including 42 U.S.C. § 1395 et seq.§290dd-2); (xii) all applicable implementing Laws and XIX Orders; (42 U.S.C. § 1396 et seq.xiii) any similar state and local Laws and Orders; and (xiv) all applicable federal, state, and local licensing, certificate of need, corporate practice of medicine, fee splitting, state anti-kickback or self-referral, regulatory and reimbursement Laws and Orders applicable to the items and services that the Company or any of the Subsidiaries provides. Except as set forth in Section 2.19(a) of the Social Security Act and Company Disclosure Schedule, neither the regulations promulgated thereunderCompany nor any of the Subsidiaries has received any written communication from a Governmental Authority or other Person that alleges that it is not in compliance with any Health Care Law, (g) the Clinical Laboratories Improvement Amendments (42 U.S.C. § 263a et seq.), (h) the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), (i) all criminal laws relating to health care fraud and abuse and (j) all applicable laws, and rules and regulations administered by the FDA other than any statements of deficiencies from a Governmental Authority in connection with surveys and other Governmental Bodiesreviews occurring in the ordinary course of business.