definiens: means requirements and specifications for the Raw Materials, Master Virus Seed, Manufacturing Working Virus Seed, and the Intermediate Product and its Manufacture, incorporated herein and attached hereto as Appendix 2, as may be amended from time to time in accordance with Gause 7.3 means [COMPANY] 's live, attenuated, intranasally delivered cold adapted influenza vaccine in the frozen formulation made using the Master Donor Strains ( i.e. which, during the dating period established by the FDA, maintains stability at temperatures of [ -20 ° C to -15 ° q, and may maintain stability at temperatures of [ -15 ° to ooq, but does not maintain stability at [ refrigeration temperatures ( i.e. 0 ° to 8 ° q ] or at [ room temperatures ( i.e. temperatures above 8 ° q ], as further described in the FDABLA " W - N ' means Wyeth - Ayerst Laboratories Division of America Home Products, CDrp . or any entity that directly or indirectly owns, is owned by or is under common ownership with W - A, where own or ownership means direct or indirect possession of at least fifty percent ( 50 % ) of the outstanding voting securities of a corporation or a comparable equity interest in any other type of entity