definiens: mean all laws, statutes, ordinances, codes, rules, regulations, guidelines, and procedures enacted ormade 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 bythe Parties of their respective obligations under, this Agreement, including without limitation, in respect of [COMPANY] andSantarus, the commercial manufacture of the Finished Product by [COMPANY] and, in respect of [COMPANY] only, the commercialmarketing of the Finished Product in the United States by [COMPANY] . For purposes of this Agreement, shallinclude, without limitation, the FFDCA, the regulations promulgated thereunder ( including, without limitation, thoseregulations currently contained in Title 21 of the Code of Federal Regulations ), and other rules and regulations promulgatedunder the FFDCA relating to the manufacture of pharmaceutical products ; and equivalent laws, regulations and standardspromulgated by a Government Authority that may assert jurisdiction over the Finished Products or any applicable Patheonmanufacturing facilities, including without limitation, the laws of the Province of Ontario and the laws of Canada applicabletherein ; cGMP, including the FDA ’s Guidance for Industry, Manufacturing, Processing or Holding Active PharmaceuticalIngredients, March 1998, and any updates thereto ; and the FDA ’s regulations for drug establishment registration