definiens: means : ( A ) the FDCA ; ( B ) the PHSA ; ( C ) federal Medicare and Medicaid statutes andrelated state or local statutes ; ( D ) state or provincial formulary and drug pricing statutes ; ( E ) any comparable foreign Laws forany of the foregoing applicable in jurisdictions in which ( 1 ) in the case of the Company, material quantities of any of theCompany Products are intended by the Company to be sold or ( 2 ) in the case of Parent, material quantities of any of theParent Products are sold ; ( F ) federal, state or provincial criminal or civil Laws ( including the federal Anti - Kickback Statute(42 U.S.C. § 1320a-7(b ) ), Stark Law ( 42 U.S.C. § 1395nn ), False Claims Act ( 42 U.S.C. § 1320a-7b(a ) ), the civil FalseClaims Act ( 31 U.S.C. § § 3729 et seq . ), the Physician Payment Sunshine Act ( 42 U.S.C. § 1320a-7h ), the exclusion laws(42 U.S.C. § 1320a-7 ), the Anti - Inducement Law ( 42 U.S.C. § 1320a-7a(a)(5 ) ), the civil monetary penalties law ( 42 U.S.C. § 1320a-7a ), all criminal laws relating to health care fraud and abuse, including 18 U.S.C. Sections 286 and 287, HealthInsurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq . ), as amended by the Health InformationTechnology for Economic and Clinical Health Act, and any comparable federal, state or provincial Laws ) ; ( G ) state orprovincial licensing, disclosure and reporting requirements ; and ( H ) the rules and regulations promulgated pursuant to all suchapplicable Laws