definiens: means all international, federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular acti vity hereunder, including performance of clinical trials, medical treatment and the processing and protection of personal and medical data, that may be in effect from time to time, including those promulgated by the United States Food and Drug Administrati on ( ), state and 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 or EMA in any jurisdiction outside the Uni ted States or the European Union ( each a and collectively, ), and including without limitation cGMP and GCP ( each as defined below ) ; all data protection requirements such as those specified in the EU General D ata Protection Regulation and the regulations issued under the United States Health Insurance Portability and Accountability Act of 1996, as amended ( ) ; export control and economic sanctions regulations which 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 regulations governing payments to heal thcare 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