definiens: means the Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the rules and regulations promulgated thereunder . /0 . (, f ' IIAffiliate " means, with respect to any Person, any other Person controlled b, lling or under common control with such Person, where control means more than 500/0 owners ip ~:;;;:R;-:ft ~ H'~~·frn -- rights of a Person or the power to direct the management or policy of a Person . ' vK;,C k1 ' f&H / J means the active pharmaceutical ingredient, loratadine HC ! . NO V 1 7 2004 means the current Good Manufacturing Practices regulations of t fCRETARY effect from time to time ) in 21 C.F.R. pts . 210 and 211, as applicable, to the manufacture, processing, packaging, handling, storage and control of the Product in the Territory, as same may be supplemented and/or amended from time to time during the term of this Agreement