definiens: means : ( a ) to the extent Licensed Compounds, Products o r any direct materials used to manufacture Products ( collectively, ) are manufactured by Third Party contract manufac turing organizations and similar contractors ( collectively, ) the costs paid to such CMO(s ) for the manufactur e and testing of such Product Materials, together with the internal costs of a Party or its Affiliate associated with quality control, quality assurance and validation with respect to Product Materials, and otherwise managing and coord inating the activities of such CMOs ( provided that, with respect to commercial supply of Products, such costs of otherw ise managing and coordinating the activities of suc h CMO shall be capped, for purposes of determining Fully Burdened Manufacturing Costs, at [ * ] % of the Out - of - Pocket a mounts paid to the CMO(s ) for such commercial supply ), and costs of tr ansportation, clearance and storage of such Product Materials ( if necessary ), customs, duty and transit insurance on account of such Product Materials ; or 8 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omit ted and filed separately with the Securities and Exchange Commiss ion pursuant to Rule 24b-2 of the Securities Exchan ge Act of 1934, as amended