definiens: means all ( a ) federal, state, local, national and regional statutes, laws, rules, regulationsand directives applicable to a particular activity under this Agreement ( including the performance of clinical trials andmedical treatment ) that may be in effect from time to time ( including GCP, GLP, GMP and others promulgated byRegulatory Authorities ) ; ( b ) applicable data protection and patient privacy laws and requirements ( including thosespecified in the EU Data Protection Directive and the regulations issued under HIPAA ) ; ( c ) export control andeconomic sanctions regulations that prohibit the shipment of United States - origin products and technology to certainrestricted countries, entities and individuals ; ( d ) anti - bribery and anti - corruption laws pertaining to interactions withgovernment agents, officials and representatives ( including the United States Foreign Corrupt Practices Act ) ; ( e ) lawsand regulations governing payments to healthcare providers ; ( f ) laws and requirements governing ineligibility toparticipate in federal, state or other healthcare programs ( including debarment under 21 USC § 335a, disqualificationunder 21 CFR § 312.70 or § 812.119, sanctions by a Federal Health Care Program ( as defined in42 USC § 1320a-7b(f ) ), including the federal Medicare or a state Medicaid program ) ; and ( g ) successor or replacementstatutes, laws, rules, regulations and directives relating to the foregoing