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 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.), as amended by the Health Information, Technology for Economic and Clinical Health Act of 2009, 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 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, and (g) all applicable laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the design, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care services.

Health Care Laws. “Health Care Laws” shall mean Except as disclosed in the Registration Statement, Disclosure Package and Prospectus, the Company and each of the Subsidiaries (ai) have operated and currently operate their respective businesses in compliance with all statutes, rules and regulations applicable to them and their respective businesses, including, without limitation, (A) requirements governing investigational drugs and biologics under the U.S. Federal Food, Drug and Cosmetic Act and rules and regulations thereunder, including regulations relating to Good Clinical Practices and Good Laboratory Practices for studies and tests that are submitted to regulatory authorities to support regulatory approvals, (B) the FDA U.S. Animal Welfare Act and rules and regulations thereunder, (C) 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.), all applicable federal, state, local and 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 thereunder, pursuant to such statutes; (bD) the Public Standards for Privacy of Individually Identifiable Health Service Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §201 Section 17921 et seq.), and the regulations promulgated thereunder, thereunder and any state or non-U.S. counterpart thereof or any other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (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 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, (dE) the Health Insurance Portability Patient Protection and Accountability Affordable Care Act of 1996 (42 U.S.C. §§1320d et seq.)2010, as amended by the Health Information, Technology for Economic Care and Clinical Health Education Reconciliation Act of 20092010, the regulations promulgated thereunder and comparable state laws, thereunder; (eF) the U.S. Controlled Substances Act (21 U.S.C. §Section 801 et seq.); and (G) all other local, (f) Titles XVIII (42 U.S.C. §1395 et seq.) state, federal, national, supranational and XIX (42 X.X.X. §0000 et seq.) foreign laws, relating to the regulation of the Social Security Act Company and the regulations promulgated thereunderownership, and (g) all applicable laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the designtesting, development, testingregistration, studyinglicensure, manufacturingmanufacture, packaging, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program chargesuse, recordkeeping, claims processfiling of reports, documentation requirementsdistribution, medical necessitymarketing, referralslabeling, promotion, sale, offer for sale, storage, import, export or disposal of any product or product candidate under development, manufactured or distributed by or on behalf of the hiring Company or such subsidiary (collectively, “Applicable Laws”), except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Change; (ii) have not received any FDA Form 483, written notice of employees adverse finding, warning letter, untitled letter or acquisition other correspondence or written notice alleging or asserting material noncompliance with any Applicable Laws or Authorizations or otherwise providing notice of services any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or supplies other action from those who any Regulatory Authority, any court or arbitrator or other governmental authority or agency; (iii) have not received any recalls, field notifications, field corrections, market withdrawals, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products or product candidates; (iv) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws, that 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) and no material deficiencies regarding compliance with applicable law have been excluded from government health care programsasserted by any applicable Regulatory Authority with respect to any such reports, qualitydocuments, safetyforms, privacynotices, securityapplications, licensurerecords, accreditation claims, submissions and supplements or amendments; and (v) are not a party to any other aspect of providing health care servicescorporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any governmental or regulatory authority.

Health Care Laws. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, neither the Company nor any of its business operations is in violation of any Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. 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, 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 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, (dC) 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.), as amended by the Health Information, Technology for Economic ) and Clinical Health Act of 2009, the regulations promulgated thereunder and comparable state lawsthereunder, (e) the Controlled Substances Act (21 U.S.C. §801 et seq.), (fD) Titles XVIII XVII (42 U.S.C. §1395 et seq.) and XIX (42 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, (E) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (g42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (F) the Patient Protection and Affordable Care Act, (G) all applicable lawsstatutes, rules and regulationsor regulations applicable to the ownership, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the designtesting, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programsmanufacture, quality, safety, privacyaccreditation, securitypackaging, licensureuse, accreditation distribution, labeling, promotion, sale, offer for sale, import, export or disposal of any product manufactured or distributed by the Company and (H) any and all other aspect of providing health care serviceslaws and regulations applicable to the business of the Company as currently conducted by it as described in the Registration Statement, the General Disclosure Package and the Prospectus, 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 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.), as amended by the Health Information, Technology for Economic and Clinical Health Act of 2009, 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 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, and (g) all applicable laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the design, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care services.

Health Care Laws. None of the Company, its subsidiaries, or their respective business operations, is in violation of any applicable Health Care Laws, except as would not reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” shall mean means (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, (ci) all federal and state fraud and abuse laws, including including, but not limited to, the Federal federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 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), the civil monetary penalty laws (42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such statutes, ; (dii) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§1320d et seq.), as amended by Pub. L. No. 104-191) and the Health Information, Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated thereunder and comparable state privacy and security laws, (eiii) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (iv) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (v) any and all federal and state anti-markup and balance billing laws and regulations promulgated thereunder; (vi) the Controlled Substances federal Food, Drug, and Cosmetic Act (21 U.S.C. §801 et seq.), (f) Titles XVIII (42 U.S.C. §1395 § 301 et seq.) and XIX the regulations promulgated pursuant thereto; (42 X.X.X. §0000 et seq.vii) the Clinical Laboratory Improvement Amendments of the Social Security Act 1988 (Pub. L. No. 100-578) and the regulations promulgated thereunderpursuant thereto; (viii) quality, safety and accreditation standards and requirements of all applicable state laws or regulatory bodies; and (ix) any and all other applicable health care laws, regulations, manual provisions, policies and administrative guidance, each of (i) through (ix) as may be amended from time to time. The Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority alleging that any product, operation or activity is in material violation of any applicable Health Care Law or Permit, except as would not reasonably be expected to result in a Material Adverse Effect, and (g) all applicable lawshas no knowledge that any such governmental authority is considering any such claim, rules litigation, arbitration, action, suit, investigation or proceeding; and regulationsthe Company has not received notice, ordinanceseither verbally or in writing, judgmentsthat any governmental authority has taken, decreesis taking or intends to take action to limit, orderssuspend, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the design, development, testing, studying, manufacturing, processing, storing, importing modify or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or revoke any other aspect of providing health care servicesmaterial Permits.

Health Care Laws. The Company is, and at all times has been, in 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” 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, the Federal federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the civil False Claims Act (31 X.X.X. U.S.C. §0000 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code, the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286, 287, 1349 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 administrative False Claims Law Physician Payments Sunshine Act (42 U.S.C. §1320a-7b(a)), the AntiSection 1320-Inducement Law (42 U.S.C. §1320a-7a(a)(5)), the exclusion laws (42 U.S.C. §1320a-77h), and the regulations promulgated pursuant to such statutes, (dC) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§1320d et seq.)HIPAA, as amended by the Health Information, Information Technology for Economic and Clinical Health Act of 2009, (42 U.S.C. Section 17921 et seq.) and the regulations promulgated thereunder and comparable state lawsthereunder, (e) the Controlled Substances Act (21 U.S.C. §801 et seq.), (fD) Titles XVIII XVII (42 U.S.C. §1395 et seq.) and XIX (42 X.X.X. U.S.C. §0000 1396 et seq.) of the Social Security Act and the regulations promulgated thereunder, and any applicable laws governing government funded or sponsored healthcare programs (gE) the Patient Protection and Affordable Care Act, (F) all applicable lawsstatutes, directives, rules and regulationsor regulations applicable to the ownership, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the designtesting, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programsmanufacture, quality, safety, privacyaccreditation, securitypackaging, licensureuse, accreditation distribution, labeling, promotion, sale, offer for sale, import, export or disposal of any product or product candidate manufactured, developed, tested, imported, exported, advertised, promoted, sold or distributed by the Company applicable to the business of the Company as currently conducted by it as described in the Registration Statement; (G) any and all other aspect of providing health care serviceslaws and regulations applicable to the business of the Company as currently conducted by it as described in the Registration Statement, the General Disclosure Package and the Prospectus, each of (A) through (G) as may be amended from time to time. The Company has not received any FDA Form-483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or Governmental Entity or regulatory authority alleging or asserting material non-compliance by the Company with any applicable Health Care Laws or Permits required by any such Health Care Laws. 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 of the Company is in material violation of any applicable 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 has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where the failures to file, maintain or submit the same would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. The Company is not a party to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus. Additionally, neither the Company nor any of its respective employees, officers, directors, or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Health Care Laws. Except as disclosed in the Time of Sale Information and the Offering Circular, neither the Company nor any of its business operations is in violation of any Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect on the Company and its subsidiaries, taken as a whole. For purposes of this Agreement, “Health Care Laws” shall mean means (ai) 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, (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 Starx Xxx (42 U.S.C. §1395nn), the civil False Claims Act (31 X.X.X. U.S.X. §0000 et xx 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.), as amended by the Health Information, Technology for Economic ) and Clinical Health Act of 2009, 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 X.X.X. U.S.X. §0000 et xx seq.) of the Social Security Act and the regulations promulgated thereunder, (v) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (g42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (vi) the Patient Protection and Affordable Care Act, (vii) all applicable lawsstatutes, rules and regulationsor regulations applicable to the ownership, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the designtesting, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programsmanufacture, quality, safety, privacyaccreditation, securitypackaging, licensureuse, accreditation distribution, labeling, promotion, sale, offer for sale, import, export or disposal of any product manufactured or distributed by the Company and (viii) any and all other aspect of providing health care serviceslaws and regulations applicable to the business of the Company as currently conducted by it as described in the Time of Sale Information and the Offering Circular, each of (i) through (viii) as may be amended from time to time.

Health Care Laws. Except as disclosed in the Time of Sale Information and the Offering Memorandum, neither the Company nor any of its business operations is in violation of any Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect on the Company and its subsidiaries, taken as a whole. For purposes of this Agreement, “Health Care Laws” shall mean means (ai) 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, (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 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.), as amended by the Health Information, Technology for Economic ) and Clinical Health Act of 2009, 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 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, (v) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (g42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (vi) the Patient Protection and Affordable Care Act, (vii) all applicable lawsstatutes, rules and regulationsor regulations applicable to the ownership, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the designtesting, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programsmanufacture, quality, safety, privacyaccreditation, securitypackaging, licensureuse, accreditation distribution, labeling, promotion, sale, offer for sale, import, export or disposal of any product manufactured or distributed by the Company and (viii) any and all other aspect of providing health care serviceslaws and regulations applicable to the business of the Company as currently conducted by it as described in the Time of Sale Information and the Offering Memorandum, each of (i) through (viii) as may be amended from time to time.

Health Care Laws. Neither the Company nor any of its subsidiaries, nor any of their respective business operations, is in violation of any Health Care Laws (as defined below), except as would not reasonably be expected to result in a Material Adverse Change. “Health Care Laws” shall mean means (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, (ci) all federal and state fraud and abuse laws, including including, but not limited to, the Federal federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 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), the civil monetary penalty laws (42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such statutes, ; (dii) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§1320d et seq.), as amended by Pub. L. No. 104-191) and the Health Information, Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated thereunder and comparable state privacy and security laws, (eiii) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (iv) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (v) any and all federal and state anti-markup and balance billing laws and regulations promulgated thereunder; (vi) the Controlled Substances federal Food, Drug, and Cosmetic Act (21 U.S.C. §801 et seq.), (f) Titles XVIII (42 U.S.C. §1395 § 301 et seq.) and XIX the regulations promulgated pursuant thereto; (42 X.X.X. §0000 et seq.vii) the Clinical Laboratory Improvement Amendments of the Social Security Act 1988 (Pub. L. No. 100-578) and the regulations promulgated thereunderpursuant thereto; (viii) quality, safety and accreditation standards and requirements of all applicable state laws or regulatory bodies; and (ix) any and all other applicable health care laws, regulations, and manual provisions, policies and administrative guidance of any governmental authority, each of (gi) all applicable laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the design, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related through (ix) as may be amended from time to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referralstime. Except as described in each Applicable Prospectus, the hiring Company has not received written notice of employees any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or acquisition other similar action from any governmental authority alleging that any product, operation or activity of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation the Company or any other aspect subsidiary is in material violation of providing health care servicesany applicable Health Care Law and the Company has no knowledge that any such governmental authority has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding.

Health Care Laws. The Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of applicable regulatory authorities, including but are not limited to the National Medical Product Administration of the People’s Republic of China (collectively, the “Health Care Laws” shall mean Regulatory Authorities”) and all applicable federal, state, local and foreign health care laws, including, without limitation: (ai) the FDA Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, ; (bii) the Public Health Service Act and the regulations promulgated thereunder; (iii) the Orphan Drug Act and the regulations promulgated thereunder; (iv) the PRC Drug Administration Law and the regulations promulgated thereunder; (v) the U.S. Anti-Kickback Statute (42 U.S.C. §201 Section 1320a–7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section 1320a–7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and 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 exclusions law (42 U.S.C. Section 1320a-7), the statutes and regulations of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (vi) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, thereunder and any state or non-U.S. counterpart thereof; (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 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, (dvii) the Health Insurance Portability Patient Protection and Accountability Affordable Care Act of 1996 (42 U.S.C. §§1320d et seq.)2010, as amended by the Health Information, Technology for Economic Care and Clinical Health Education Reconciliation Act of 20092010, 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 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, and ; (gviii) all applicable other local, state, federal, national, supranational and foreign laws, rules and regulationsrelating to the ownership, ordinances, judgments, decrees, orders, writs and injunctions administered by the FDA and other Governmental Bodies that regulate the designtesting, development, testingmanufacture, studying, manufacturingpackaging, processing, storinguse, importing distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or exportingdisposal of any product under development, licensingmanufactured or distributed by the Company; (clauses (i) through (viii), labeling or packagingcollectively, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care services“Health Care Laws”).