definiens: means all federal, state, local, national and regional statutes, laws, rules, regulations anddirectives applicable to a particular activity hereunder, including performance of clinical trials, medical treatment andthe processing and protection of personal and medical data, that may be in effect from time to time, including thosepromulgated by the United States Food and Drug Administration ( ), national regulatory authorities, the EuropeanMedicines Agency ( ) and any successor agency to the FDA or EMA or any agency or authority performingsome or all of the functions of the FDA or EMA in any jurisdiction outside the United States or the European Union(each a and collectively, ), and including without limitation cGMPand GCP ( each as defined below ) ; all data protection laws, regulations, and requirements, such as those specified inthe EU Data Protection Directive and the General Data Protection Regulation, and the United States Health InsurancePortability and Accountability Act of 1996, as amended, and its associated regulations ( ) ; export control andeconomic sanctions regulations which prohibit the shipment of United States - origin products and technology to certainrestricted countries, entities and individuals ; anti - bribery and anti - corruption laws pertaining to interactions withgovernment agents, officials and representatives ; laws and regulations governing payments to healthcare providers;and any United States or other country ’s or jurisdiction ’s successor or replacement statutes, laws, rules, regulationsand directives relating to the foregoing