definiens: means all international, federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity hereunder, including performance of clinical trials, medicaltreatment 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 Administration ( ), state and national regulatoryauthorities, the European Medicines Agency ( ) and any successor agency to the FDA or EMA or any agency orauthority 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 withoutlimitation cGMP and GCP ( each as defined below ) ; all data protection requirements such as those specified in the EUData Protection Directive and the regulations issued under the United States Health Insurance Portability andAccountability Act of 1996, as amended ( ) ; export control and economic sanctions regulations which prohibitthe 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 healthcare providers ; and any United States or other country ’s orjurisdiction ’s successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing