definiens: mean all laws, statutes, ordi nances, codes, rules, regulations, guidelines, and procedures enacted or made by a Government Authorit y, including, without limitation, the FDA and any applicable Foreign Regulatory Authority, that are i n force during the Term, and in each case only to t he extent applicable to the subject matter of, or the perform ance by the Parties of their respective obligations under, this Agreement . For purposes of this Agreement, shall include, without limitation, the FF DCA, the regulations promulgated thereunder ( including, without limitation, those regulations currently con tained in Title 21 of the Code of Federal Regulations ), and o ther rules and regulations promulgated under the FF DCA relating to the manufacture of pharmaceutical produ cts ; and equivalent laws, regulations and standards promulgated by a Government Authority that may asse rt jurisdiction over the Finished Product or any ap plicable Manufacturer manufacturing facilities ; GMP, includi ng the FDA ’s Guidance for Industry, Manufacturing, Processing or Holding Active Pharmaceutical Ingredi ents, March 1998, and any updates thereto ; and the FDA ’s regulations for drug establishment registration