definiens: means all costs and expenses, other than Internal Costs, that are directly related to the Development of a Collaboration Compound or a Collaboration Product, including ( without limitation ): ( I ) Clinical Studies, including expenses associated with the cost for a clinical protocol, ( 2 ) Pre - Clinical Studies, including outside contractual agreements for research studies that will provide data to facilitate the New Drug Application with the FDA or any other appropriate international authority, 0 ( 3 ) Outside Consultants, including outside contractual agreements with expert consultants, and ( 4 ) R&D Supplies, including expenses associated with the cost of all project related materials and supplies utilized for the development of drug studies and the production of demonstration and experimental batches, " Patent means patents, applications for patent, provisional applications for patent, and reexamination certificates, reissue patents, patent extensions, patent tenn restorations, including any divisions, continuations and continuations - in - part thereot : in any country, region, or jurisdiction