definiens: means any Applicable Law applicable to the Company ’s products, including any Applicable Law thepurpose of which is to ensure the safety, efficacy and quality of medical, pharmaceutical, biotechnology, in vitrodiagnostic and similar products by regulating the research, development, manufacturing and distribution of theseproducts, including Applicable Law relating to good laboratory practices, good clinical practices, investigational use, product marketing authorization, manufacturing facilities compliance and approval, good manufacturing practices, labeling, advertising, promotional practices, safety surveillance, record keeping and filing of required reports . Withoutlimiting the foregoing, Health Law includes ( i ) the Federal Food, Drug, and Cosmetic Act, ( ii ) the Public Health ServiceAct, ( iii ) the Clinical Laboratory Improvement Amendments of 1988, ( iv ) the Anti - Kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ), ( v ) the Stark Law ( 42 U.S.C. 1395nn et seq . ), ( vi ) the False Claims Act ( 31 U.S.C. § 3729 et seq . ), ( vii)the Exclusion Laws ( 42 U.S.C.§§ 1320a-7 and 1320a-7a ), ( viii ) the Program Fraud Civil Remedies Act ( 31 U.S.C. § § 3801 - 3812 ), ( ix ) the Civil Monetary Penalties Law ( 42 U.S.C. § 1320a-7a ), ( x ) the Prohibition on Inducement ofBeneficiaries Statute ( 42 U.S.C. § 1320a-7a(a)(5 ) ), ( xi ) the Federal Health Care Fraud Law ( 18 U.S.C. § 1347 ), ( xii ) theHealth Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology forEconomic and Clinical Health Act of 2009 ( codified at 42 U.S.C. § 300gg and 29 U.S.C. § 1181 et seq . and 42 USC1320d et seq . ), ( xiii ) Medicare ( Title XVIII of the Social Security Act ), ( xiv ) Medicaid ( Title XIX of the Social SecurityAct ) and ( xv ) all applicable state privacy and confidentiality laws, and state laws, including those related to insurance, balance billing, out - of - network services and the waiver of deductibles, copayments or cost - sharing