definiens: . Ficlatuzumab means the humanized monoclonal Antibody that binds hepatocyte growthfactor and is designated by AVEO as 1.30 . . Ficlatuzumab Cost of Goods means the standard unit cost of Manufactureof Ficlatuzumab, consisting of direct material and direct labor costs plus Manufacturing overhead attributable toFiclatuzumab ( including all directly incurred manufacturing variances ), all calculated in accordance with GAAP, consistently applied . Direct material costs will include the costs incurred in Manufacturing or purchasing materials, including freight - in costs, sales and excise taxes imposed thereon and customs duty and charges levied bygovernment authorities, and all costs of packaging components . Direct labor costs will include the FTE Costs ofemployees engaged in direct Manufacturing activities and direct or indirect quality control and quality assuranceactivities who are directly employed in Manufacturing and packaging Ficlatuzumab . Overhead attributable toFiclatuzumab will be calculated and allocated in a manner consistent with the method used to allocate overhead toother products Manufactured in the same facility . Overhead attributable to Ficlatuzumab will include a reasonableallocation of indirect labor ( not previously included in direct labor costs ), a reasonable allocation of administrativecosts, and a reasonable allocation of facilities costs, all in accordance with GAAP, consistently applied . Overhead willnot include corporate administrative overhead or plant start - up costs or costs associated with excess or idle capacity