definiens: means * * * * * * * * * 1.5 mean all laws, statutes, ordinances, codes, rules, regulations, guidelines, and procedures enacted or made by a Government Authority, including, without limitation, the FDA a nd any applicable Foreign Regulatory Authority, that are in force during the Term, and in each case only to the extent applicable to the subject matter of, or the performance by the Parties of their respective obligations under, this Agreement, including without limitation, in respect of [COMPANY] and [COMPANY], the commercial manufacture of the Finished Product by [COMPANY] and, in respect of [COMPANY] only, the commercial marketing of the Finished Product in the United Sta tes by [COMPANY] . For purposes of this Agreement, shall include, without limitation, the FFDCA, the regulations promulgated thereunder ( incl uding, without limitation, those regulations currently contained in Title 21 o f the Code of Federal Regulations ), and other rules and regulations promu lgated under the FFDCA relating to the manufacture of pharmaceutical produ cts ; and equivalent laws, regulations and standards promulgated by a Governme nt Authority that may assert jurisdiction over the Finished Product or any appli cable [COMPANY] manufacturing facilities, including without limitation, the laws of the Province of Ontario and the laws of Canada applicable therein ; GMP, inc luding the FDA 's Guidance for Industry, Manufacturing, Processing or Holding Acti ve Pharmaceutical Ingredients, March 1998, and any updates thereto ; a nd the FDA 's regulations for drug establishment registration