definiens: means all healthcare - related Laws applicable to the Business or any CompanyProduct, including, as applicable : ( a ) the FDCA and all regulations promulgated thereunder, including thoserequirements relating to the FDA ’s current Good Manufacturing Practices, Good Laboratory Practices, Good ClinicalPractices, investigational use, pre - market approval and applications to market new pharmaceutical or biologicalproducts ; ( b ) the Clinical Laboratory Improvement Amendments of 1988 ; ( c ) the Health Insurance Portability andAccountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and theregulations promulgated pursuant thereto ; ( d ) the U.S. Patient Protection and Affordable Care Act, ( e ) the PhysicianPayment Sunshine Act ( 42 U.S.C. § 1320a-7h ) ; ( f ) federal and state anti - kickback Laws ( including the federal Anti - Kickback Statute ( 42 U.S.C. § 1320 - 7(b ) ) ) ; ( g ) federal and state referral Laws ( including the Stark Law ( 42 U.S.C. § 1395nn ) ) ; ( h ) false claims Laws ( including the Federal False Claims Act ( 31 U.S.C. § § 3729, et seq . ) ) ; ( i ) Lawsgoverning the development, conduct, monitoring, patient informed consent, auditing, 9 analysis and reporting of Clinical Trials ( including the Good Clinical Practice regulations and guidance of the FDA);(j ) Laws governing data gathering activities relating to the detection, assessment, and understanding of adverseevents ( including pharmacovigilance and adverse event regulations and guidance of FDA and ICH ) ; ( k ) Lawsgoverning government and private healthcare programs, including the federal Medicare and Medicaid statutes;(l ) Laws, the violation of which is cause for exclusion from any federal health care program ; and ( m ) all comparablestate, federal or foreign Laws relating to any of the foregoing