definiens: mean all laws, statutes, ordinances, codes, rules, regulations, guidelines, and procedures enacted or made by a Government Authority, including, withoutlimitation, the FDA and any applicable Foreign Regulatory Authority, that are in force during theTerm, and in each case only to the extent applicable to the subject matter of, or the performanceby the Parties of their respective obligations under, this Agreement, including without limitation, in respect of [COMPANY] and [COMPANY], the coirnnercial manufacture of the Finished Product byPatheon and, in respect of [COMPANY] only, the commercial marketing of the Finished Product in theUnited States by [COMPANY] . For purposes of this A~~reeinent, shall include, without limitation, the FFDCA, the regulations promulgated thereunder ( including, withoutlimitation, 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 ofpharmaceutical products ; and equivalent laws, regulations and standards promulgated by aGovenlment Authority that may assert jurisdiction over the Finished Products or any applicablePatheon manufacturing facilities, including without limitation, the laws of the Province of Ontarioand the laws of Canada applicable therein ; cGMP, including the FDA 's Guidance for Industry, Manufacturing, Processing or Holding Active Pharmaceutical Ingredients, March 1998, and anyupdates thereto ; and the FDA 's regulations for drug establishment registration