definiens: or means ( a ) all applicable c onstitutional provisions, laws, statutes, codes, ru les, regulations, guidances, orders, treaties, judgments, decrees, directives, injunctions and/or ordinance s of any United States or European Union ( as it exists on th e Effective Date ) governmental entity or authority, which are applicable to the Parties, their respective obligat ions under this Agreement, or otherwise to the Pati ent Materials, Process and/or Product ( any component thereof and / o r the manufacture or processing thereof ), including Directive 2001/83 / EC, Directive 2004/23 / EC and Dire ctive 95/374 / EC and the General Data Protection Regulation 2016 ( when in force ), and ( b ) cGMPs . Any reference to a particular law or regulation will b e interpreted to include any revision of or successor to such statute, law, rule or regulation regardles s of how it is numbered or classified