definiens: ... DocU : NYI234 : 4325332.2 means the research, development and optimization of the Compound specified in the Activation Letter utilizing one or more Carriers for all medical ailments or indications for the Route of Administration ( in this Agreement, the oral route ) specified in the Activation Letter as well as the manufacture, use, promotion, distribution, marketing and sale of th~ Product(s ) ; means, in the case of su I of Carrier(s ), [COMPANY] 's manufacturing costs of the Carrier(s ), which sh include : ( i ) all material and labor costs directly rei ed to the manufacturing of the Carrier(s ) ( incl ing, without limitation, direct costs relating to pa aging, quality assurance and quality control ) ; ( ii ) allocable share of labor and materials used in sUR art of the manufacturing process, but not directl traceable to the production of the Carrier(s ) ; and . I ) an allocable share of manufacturing overhead osts, including production management and supp, and depreciation of production facilities and equip ent . However, Fully Loaded Manufacturing Cost hall not include any element of corporate overhe and variances related to inventory losses . The c culation of Fully Loaded Manufacturing Cost shall e made in accordance with GAAP, taking into ac aunt the above exclusions