definiens: means any international, national, federal, state, provincial, commonwealth, or local government law, statute, rul e, requirement, code, regulation, or ordinance that applies to either party or to a Project, the Servic es, or this Agreement, including, without limitatio n : the Health Insurance Portability and Accountability Act of 1996, and the regulations promulgated pursuant thereto ( ), to the extent applicable ; the Federal Food, Dru g and Cosmetics Act ( ) and its implementing regulations ; the European Dire ctive 2001/20 / EC and the General Data Protection Regulation ( EU ) 2016/679 ( the ) as well as the current good clinical practices g uidelines of the International Conference on Harmonization of Te chnical Requirements for Registration of Pharmaceuticals for Human Use Topic E6 : Guidelines on Good Clinical Practice ( ), and applicable version(s ) of the World Medical Associat ion Declaration of Helsinki, and, where applicable, rules governing distribution practice, manufacturin g practice and good laboratory practice, and rules governing the collection and processing of personal data and the collection and storage of human tissu e samples and the performance of DNA testing