definiens: shall mean all health care Legal Requirements related to, as applicable, the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, import, export or distribution of pharmaceutical or biological products or otherwise applicable to the operation of the business of the Acquired Corporations as currently conducted and as contemplated by the Acquired Corporations to be conducted, including, as applicable : ( i ) the FDCA and the Public Hea lth Service Act and regulations promulgated thereunder, including, as applicable, those requirements relating to the FDA ’s current Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, investigational use, pre -market approval an d applications to market new pharmaceutical or biological products ; ( ii ) the Clinical Laboratory Improvement Amendments of 1988 ; ( iii ) federal and state anti -kickback laws ( including the federal Anti -Kickback Statute ( 42 U.S.C. § 1320 -7(b ) ) ; ( iv ) other Leg al Requirements governing the development, conduct, monitoring, patient informed consent, auditing, analysis and reporting of clinical trials ; ( v ) Legal Requirements governing data gathering activities relating to the detection, assessment, and understandi ng of adverse events ( including pharmacovigilance and adverse event regulations and guidance of FDA and ICH ) ; ( vi ) the federal Medicare and Medicaid statutes, as applicable ; ( vii ) any Legal Requirement the violation of which is cause for exclusion from any federal health care program ; and ( viii ) any comparable state, federal or foreign Legal Requirements relating to any of the foregoing