definiens: shall mean all health care Legal Requirements app licable to the pricing, reimbursement, safety, efficacy, approval, development, testing, l abeling, manufacture, storage, marketing, promotion, sale, commercialization, import, export or distribution o f pharmaceutical products or otherwise applicable t o the operation of the Acquired Companies ’ businesses as currently conducted and as contemplated by the Acqu ired Companies to be conducted, including ( i ) the FDCA a nd the regulations promulgated thereunder, includin g, as applicable, those requirements relating to the FDA ’ s current Good Manufacturing Practices, Good Labora tory Practices, Good Clinical Practices, investigational use, pre - market approval and applications to marke t new pharmaceutical or biological products ; ( ii ) the Cli nical Laboratory Improvement Amendments of 1988 ; ( i ii ) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and the regulatio ns promulgated pursuant thereto ; ( iv ) the U.S. Pati ent Protection and Affordable Care Act, ( v ) the Physici an Payment Sunshine Act ( 42 U.S.C. § 1320a-7h ) ; ( vi ) federal and state anti - kickback laws ( including the federal Anti - Kickback Statute ( 42 U.S.C. § 1320 - 7 ( b ) ) ) ; ( vii ) the Stark Law ( 42 U.S.C. § 1395nn ) ; ( viii ) Le gal Requirements governing the development, conduct, monitoring, patient informed consent, auditing, ana lysis and reporting of clinical trials ( including t he Good Clinical Practice regulations and guidance of the F DA ) ; ( ix ) Legal Requirements governing data gatheri ng activities relating to the detection, assessment, a nd understanding of adverse events ( including pharmacovigilance and adverse event regulations and guidance of FDA and the International Conference o n Harmonization ) ; ( x ) the federal Medicare and Medica i d statutes, as applicable ; ( xi ) any Legal Requirem ent 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 Regulation ( EC ) No 7 26/2004