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.

Appears in 3 contracts

Samples: Agreement and Plan of Merger (Innoviva, Inc.), Agreement and Plan of Merger (La Jolla Pharmaceutical Co), Agreement and Plan of Merger (La Jolla Pharmaceutical Co)

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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.

Appears in 2 contracts

Samples: Agreement and Plan of Merger (Acelrx Pharmaceuticals Inc), Agreement and Plan of Merger (Tetraphase Pharmaceuticals Inc)

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.

Appears in 2 contracts

Samples: Agreement and Plan of Merger (La Jolla Pharmaceutical Co), Agreement and Plan of Merger (Tetraphase Pharmaceuticals Inc)

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.

Appears in 1 contract

Samples: Purchase Agreement (Alexza Pharmaceuticals Inc.)

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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.

Appears in 1 contract

Samples: Agreement and Plan of Merger (Applied Genetic Technologies Corp)

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