definiens: mean all laws, statutes, ordinances, codes, rules, regulations, guidelines, and procedures enacted or made by a Government Authority, including, without limitation, the FDA and 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 States by [COMPANY] . For purposes of this Agreement, shall include, without limitation, the FFDCA, the regulations promulgated thereunder ( including, without limitation, those regulations currently contained in Title 21 of the Code of Federal Regulations ), and other rules and regulations promulgated under the FFDCA relating to the manufacture of pharmaceutical products ; and equivalent laws, regulations and standards promulgated by a Government Authority that may assert jurisdiction over the Finished Product or any applicable [COMPANY] manufacturing facilities, including without limitation, the laws of the Province of Ontario and the laws of Canada applicable therein ; GMP, including the FDA 's Guidance for Industry, Manufacturing, Processing or Holding Active Pharmaceutical Ingredients, March 1998, and any updates thereto ; and the FDA 's regulations for drug establishment registration