definiens: mean all laws, statutes, ordinances, codes, rules, regulations, guidelines, and procedures enacted or made by a Government Authorit y, including, without limitation, the FDA, that are in force during the Term, and in each case to the extent app licable to the subject matter of, or the performanc e by the Parties of their respective obligations under, this Agreement . For purposes of this Agreement, shall include, without limitation, the FFDCA, the regulations promulgated thereunder ( including, without limitation, those regulations currently contained i n Title 21 of the Code of Federal Regulations ), and other rules and regulations promulgated under the FFDCA relatin g to the manufacture of pharmaceutical products ; equivalent laws, regulations and standards promulga ted by a Government Authority that may assert juris diction over the Finished Bulk Product, the Finished Commer cial Product or any Facility ; cGMP ; and the FDA ’s regulations for drug establishment registration