definiens: means a legal entity that, directly or indit throLlgh one or more intermediaries, controls, is controlled by, or is under common control \\ Fotcontm!reiative meanings, the tel'controlled by'under COll1mon contml with ' " means ( a ) the possession . directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities or by contract Iights or corporate governance, or ( b ) the ownct indilC than 50 % of the voting secul other ownership interest of a legal entity6 .Iinsul Jllce\RA_l'ooll':'d\ Ve::lc:(lnLlOC CO,\FlIlE:\TL\1 . nn:,' .. nlE,\'1 IU.Ql ESTEl ) EXECUTION COPY 1.3 means the laws, rules, and n,,:gulations, inclllding any statutes, rules, regulations, guidelines, or other reljuirements that may be in effect from time to time and apply to the development, manufacture, registration, and marketing of the Product in the countries of the Territory, including any such statutes, niles . regulations, guidelines, or other requirements of the FDA or the EME!\