definiens: means any device for the buccal delivery of drugs designed and/or manufactured by or for Generex or [COMPANY] . means the preliminary device Generex is currently developing for use for buccal delivery of drugs, which is substantially similar to that represented by the prototype in existence as of the Effective Date, as well as any improvements and/or changes ( material or otherwise ) to the Device which occur as a result of development efforts hereunder after the Effective Date . Specifications for the Standard Device represented by the prototype in existence as of the Effective Date will be provided by Generex as Exhibit F and which shall include updates and amendments by the Parties thereto . Unless otherwise noted, the use of the tenn in this Agreement is not intended to indicate the definition of in the Federal -4 - CONfIO(NTIAL Food, Drug and Cosmetic Act, as amended or to definitions by other regulatory authorities in the Territory