definiens: means a party 's consolidated fully burdened manufacturing cost ( in accordance with GAAP in the United States, in each case as consistently applied by the manufacturing party(ies ) ) of the Option Product ( in bulk, vialed or finished product form, as the case may be ), which shall comprise the sum of : ( a ) The, as determined by the party(ies ) performing ( or contracting with a Third Party for performance of ) each stage of the manufacturing process performed by such party(ies ), including, but not limited to, direct labor and material and product testing costs ( including in - bound freight and insurance ), failed lot charges in the ordinary course of production ( subject to the terms of the Manufacturing and Supply Agreement ), and Allocable Overhead ; ( b ) All of the party 's allocable IP acquisition and licensing costs ( including royalties, milestone payment or up front payments ) paid to third parties to the extent it relates to the Option Product ; ( c ) Any other costs borne by the manufacturing party(ies ) for transport, customs clearance and storage of product ( if necessary ) at the request of another party, an Affiliate or a Third Party ( i.e. freight, customs, duty, and insurance ) ; provided, however, that Fully Burdened Manufacturing Cost shall not include any costs, or expenses included or includible in Distribution Costs as defined above ; ( d ) Bulk manufacturing by Cell Genesys including distribution to [COMPANY] ; and ( e ) Labeling, packing and distribution incurred by [COMPANY] including distribution to [COMPANY] customer