definiens: means all federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity hereunder, including performanceof clinical trials, and the processing and protection of personal and medical data, that may be in effectfrom time to time, including the U.S. Food, Drug, and Cosmetic Act and the regulations promulgatedthereunder by the United States Food and Drug Administration ( ), and those promulgated bynational regulatory authorities, the European Medicines Agency ( ) and any successor agencyto 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 asdefined 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 andAccountability Act of 1996 ( ) ; export control and economic sanctions regulations whichprohibit 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 withgovernment agents, officials and representatives ; laws and regulations governing payments tohealthcare providers ; and any United States or other country ’s or jurisdiction ’s successor orreplacement statutes, laws, rules, regulations and directives relating to the foregoing.1.5