definiens: means all federal, state, local, national and regional statutes, laws, rules, regulations and directivesapplicable to a particular activity hereunder, including performance of clinical trials, medical treatment and the processing and protection ofpersonal and medical data, that may be in effect from time to time, including those promulgated by the United States Food and DrugAdministration ( ), national regulatory authorities, the European Medicines Agency ( ) and any successor agency to the FDA orEMA or any agency or authority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the United States orthe European Union ( each a and collectively, ), and including cGMP and GCP ( each asdefined below ) ; all data protection requirements such as those specified in the EU Data Protection Directive and the regulations issued underthe United States Health Insurance Portability and Accountability Act of 1996 ( ) ; export control and economic sanctions regulationswhich prohibit the shipment of United States - origin products and technology to certain restricted countries, entities and individuals ; anti - bribery and anti - 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 replacement statutes, laws, rules, regulations and directives relating to the foregoing