definiens: shall mean all health care Leg al Requirements applicable to the safety, efficacy, approval, development, testin g, labeling, manufacture, storage, marketing, promo tion, sale, commercialization, import, export or distribution o f pharmaceutical products or otherwise applicable t o the operation of the Company ’s business as currently co nducted and as contemplated by the Company to be conducted, including ( i ) the FDCA and the regulatio ns promulgated thereunder, including, as applicable, those requirements relating to the FDA ’s current Good Man ufacturing Practices, Good Laboratory Practices, Go od Clinical Practices, investigational use, pre - market approval and applications to market new pharmaceut ical or biological products ; ( ii ) the Clinical Laboratory I mprovement Amendments of 1988 ; ( iii ) the Health Ins urance Portability and Accountability Act of 1996, the Hea lth Information and Technology for Economic and Cli nical Health Act, and the regulations promulgated pursuan t thereto ; ( iv ) the U.S. Patient Protection and Aff ordable Care Act, ( v ) the Physician Payment Sunshine Act ( 4 2 U.S.C. § 1320a-7h ) ; ( vi ) federal and state anti - k ickback laws ( including the federal Anti - Kickback Statute ( 42 U.S.C. § 1320 - 7(b ) ) ) ; ( vii ) the Stark Law ( 42 U. S.C. § 1395nn ) ; ( viii ) Legal Requirements governing the de velopment, conduct, monitoring, patient informed co nsent, auditing, analysis and reporting of clinical trials ( including the Good Clinical Practice regulations and guidance of the FDA ) ; ( ix ) Legal Requirements governing data gathering activities relating to the detection, as sessment, and understanding of adverse events ( including phar macovigilance and adverse event regulations and gui dance of FDA and ICH ) ; ( x ) the federal Medicare and Medic aid statutes, as applicable ; ( xi ) any Legal Require ment the violation of which is cause for exclusion from any federal health care program ; and ( xii ) all comparab le state, federal or foreign Legal Requirements relating to a ny of the foregoing, including but not limited to R egulation ( EC ) No 726/2004