CONFIDENTIAL
1.34 “Ex Vivo Option Transaction” means any transaction for the license, transfer or other disposition of any [***] for use in the Ex Vivo Option Field.
1.35 “Executive Officer” means, with respect to HCW, its Chief Executive Officer, and with respect to Wugen, its Chief Executive Officer.
1.36 “Exploit” or “Exploitation” means to make, have made, import, export, use, sell, or offer for sale, including to research, discover, develop, commercialize, register, hold or keep (whether for disposal or otherwise), formulate, optimize, modify, have used, export, transport, distribute, promote, market, have sold or otherwise dispose of a compound, molecule, construct or product. The term “Exploit” excludes Manufacturing.
1.37 “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended.
1.38 “FDA” means the U.S. Food and Drug Administration or any successor entity.
1.39 “Field” means the diagnosis, treatment or prevention of any and all Disease Areas.
1.40 “First Commercial Sale” means, with respect to a product, the first sale on a commercial basis to a Third Party of such product in a given regulatory jurisdiction after Regulatory Approval has been obtained in such jurisdiction for such product.
1.41 “FTE” means full time employee.
1.42 “FTE Rate Cap” means an aggregate of $[***] per year for [***] [***] FTEs.
1.43 “GAAP” means the U.S. generally accepted accounting principles, consistently applied.
1.44 “GMP” means the current good manufacturing practices applicable to the Manufacturing, handling, storage and distribution of the Licensed Molecules pursuant to applicable Laws, as from time to time in effect.
1.45 “Governmental Authority” means any multi-national, federal, state, local, municipal, provincial or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.46 “HCW Impact Situation” has the meaning set forth in Section 8.4(a).
1.47 “HCW Indemnitees” has the meaning set forth in Section 10.2.
1.48 “HCW Initial Proteins” means the fusion protein referred to as [***], and the fusion protein referred to as [***], as further described in Exhibit 1.48.
1.49 “HCW Linker” means the [***], as further described in Exhibit 1.49.
1.50 “HCW Proteins” means any multi-functional fusion protein [***]. For clarity, [***] [***] and [***] are excluded from the Option.
5.