definiens: shaH mean, in relation to either Party hereto, ( a ) any entity in which the relevant Party directly or indirectly holds more than 50 % of the voting stock or power, ( b ) any entity ( ) which holds directly or indirectly more than 50 % of the voting stock or power of the relevant Party, ( c ) any other entity in which more than 50 % of the voting stock or power is directly or indirectly held by any Holding Entity of the relevant Party or ( d ) any entity in which the relevant Party directly or indirectly holds less than 50 % of the voting stock or power but has management control of such entity in that it has the ability to appoint and remove the majority of the Board of Directors ( or other governing body ) of such Party _ 1.3 shaH mean : ( a ) any and all federal, national, supranational, state and local laws, regulations, ordinances, orders and requirements applicable to the activities under this Agreement ; and ( b ) any other specifications, guidelines, procedures and directives mutually agreed to by the Parties, applicable to the Products, bnproved Products or [COMPANY] Components, as applicable, or activities under this Agreement . In the case of the United States, Applicable Legal Requirements shall include, without limitation, all applicable laws, regulations and guidelines of and under the U.S. Federal Food, Drug, and Cosmetic Act and Public Health Service Act, including all applicable current Good Manufacturing Practices (, see, e.g., 21 CFR 211 ) ; provided that, in the event of any conflict between such sourcea of authority, U.S. federal law and regulations shall be given priority . In the case of the European Union, Applicable Legal Requirements shaH include, without limitation, all applicable regulations and directives of the European Union, the European Commission and guidelines of the CPMP and all applicable national legislation ; provided that, in the event of any conflict between the foregoing sources of authority, European Union law shall be given priority