definiens: means ( x ) any pharmaceutical preparation in final form, including all dosage forms, formulations andline extensions thereof, comprising Collaboration Compound, or ( y ) any diagnostic product intended to be used in connectionwith the Product described in ( x ) above that ( 1 ) identifies whether a patient is a candidate for treatment with such Product,(2 ) assesses the efficacy of such Product, and/or ( 3 ) helps to define therapeutic objectives for treatment with such Product, inall cases within the Licensed Field . For clarity, for all purposes of the Agreement, all Combination Products and single agentProducts comprising the same Collaboration Compound ( as well as all Products comprising any prodrug, metabolite, [ * ] saltform or radio - labeled form of such Collaboration Compound ) shall be considered the same Product, regardless of theformulation, dosage strength, route of administration, packaging or Product Indication thereof or any other ActiveIngredient(s ) contained therein