definiens: means any company, 50 % or more of whose voting stock is owned or controlled, directly or indirectly by [COMPANY] or [COMPANY], any company which owns or controls, directly or indirectly, 50 % or more of the voting stock of [COMPANY] or [COMPANY] and any majority - owned subsidiary of such company ; provided, however, that Somerset Pharmaceuticals, Inc. shall not be treated as an Affiliate of [COMPANY] ; means, in respect of any Product, the new drug application or abbreviated new drug application, as the case may be, filed with the FDA by [COMPANY] or its Affiliate with respect to such Product ; means, in relation to a Product, the costs incurred by [COMPANY] and/or its Affiliates to conduct the bioavailability studies / clinical trials conducted by or on behalf of [COMPANY] or its Affiliates in connection with the ANDA filed or to be filed by [COMPANY] or its Affiliate with respect to such Product, whether such bioavailability study / clinical trial is conducted prior to or subsequent to the date of this agreement, and the costs incurred by [COMPANY] and/or its Affiliates to acquire the raw materials used to produce the Product batches used in such bioavailability studies / clinical trials for the Territory