definiens: , Manufacturing Costs meansj as to a Party, such Party 's direct and identifiable intemal and cxtel11al costs of manufacturing, quality control testing, stability monitoring, re - release, relabeling, packaging and shipment ( including insurance ) of the Licensed Compound or thc Licensed Product, consisting of the following : 6 CONFIDENTIAL EXECUTION COPY ( a ) with regard to a Party 's internal costs, Manufacturing Costs shall consist of all FTE costs of such Party 's personnel engaged in manufacturing, quality control testing, stability monitoring, fe - release, relabeling, packaging and shipment of the Licensed Compound or the Licensed Product, at the FTE Rate ; ( b ) with regard to a Party 's external costs and charges, Manufacturing Costs shall consist of the Out - of - Pocket Costs of suppliers of goods, induding raw materials, and services, including contract manufacturing organizations ( CMO ), directly related to the manufacture, quality control testing, stability monitoring, fe - release, relabeling, packaging and shipment ( including insurance ) of the Licensed Compound or the Licensed Product ; and ( c ) import and export duties, value added taxes and other taxes imposed upon and paid directly with respect to the sale or delivery of the Licensed Compound or the Licensed Product Section 1.43 . Manufacturing Technology means Regulatory Documentation and other Know ~ How that are necessary or useful for a Party ( or the Affiliate or Third Pat1y manufacturer identified by such Pa11y ) to manufacture the Licensed Compound and Licensed Product, including manufacturing processes, analytical methods, specifications, protocols, assays, batch records, quality control data, transportation and storage requirements, and other manufacturing documentation or files