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 requirements such as those specified in the EU Data ProtectionDirective and the regulations issued under the United States Health Insurance Portability and Accountability Act of1996 ( ) ; export control and economic sanctions regulations which prohibit the shipment of United States - originproducts and technology to certain restricted countries, entities and individuals ; anti - bribery and anti - corruption lawspertaining to interactions with government agents, officials and representatives ; laws and regulations governingpayments 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