definiens: means all applicable local, st ate, and federal laws, rules and regulations and ot her governmental requirements relating to the performan ce of their respective responsibilities under this Agreement, that may be in effect from time to time, including, but not limited to, the Federal Food, D rug and Cosmetic Act of 1938, as amended ( the ), a nd all applicable regulations promulgated thereunde r including regulations of the United States Food and Drug Administration or its foreign equivalent, including, without limitation, 21 C.F.R. Parts 50, 54, 56, and 312 ( the regulations governing the prot ection of human subjects, financial disclosure of clinical investigators, Institutional Review Boards or its foreign equivalent, and investigational new drug applicatio ns ), and including without limitation all applicabl e good practice quality guidelines and regulations encompa ssing internationally recognized standards ( as adop ted by the FDA and as related to guidance provided by N CI, NCORP, CTMB and OFIRP guidelines ) such as Good Manufacturing Practice, Good Clinical Practice ( as adopted by the FDA ), Good Laboratory Practice, Good Distribution Practice and Good Review Practice ( collectively, ), FDA Form 1572 Statement of Investigator, the federal Anti - Kickback Statute ( 42 U.S.C. § 1320a-7b ), and state and federal False Claims Acts, as well as all applicable data prot ection and medical privacy laws or regulations, inc luding, the Health Insurance Portability and Accountability Act of 1996 ( HIPAA ), as amended by Subtitle D of the Health Information Technology for Economic and Clin ical Health Act ( ) and the Standards for Privacy of Individually Identifiable Health Informa tion 45 C.F.R. Parts 160 and 164