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 and theprocessing and protection of personal and medical data, that may be in effect from time to time, including those promulgated bythe United States Food and Drug Administration ( ), national regulatory authorities, the European Medicines Agency ( ) and any successor agency to the FDA or EMA or any agency or authority performing some or all of the functions of the FDA orEMA in any jurisdiction outside the United States or the European Union ( each a and collectively, ), and including cGMP and GCP ( each as defined below ) ; all data protection requirements such asthose specified in the EU Data Protection Directive and the regulations issued under the United States Health InsurancePortability and Accountability Act of 1996 ( ) ; export control and economic sanctions regulations which prohibit theshipment of United States - origin products and technology to certain restricted countries, entities and individuals ; anti - bribery andanti - corruption laws pertaining to interactions with government agents, officials and representatives ; laws and regulationsgoverning payments to healthcare providers ; and any United States or other country ’s or jurisdiction ’s successor or replacementstatutes, laws, rules, regulations and directives relating to the foregoing