definiens: or means(a ) to the extent PCYC manufactures PCYC Excipient pursuant to Section 3.04, and to the extentPCYC Excipient or any direct materials used to manufacture PCYC Excipient ( collectively, ) are manufactured by Third Party contract manufacturing organizations andsimilar contractors ( collectively, ), the Out - of - Pocket Costs paid to such CMO(s ) by PCYC forthe manufacture of PCYC Excipient Materials, together with FTE Costs of PCYC or its Affiliate associatedwith quality control or quality assurance with respect to PCYC Excipient Materials, otherwise managing andcoordinating the activities of such CMO(s ) by PCYC, and any technical assistance provided to NovoNordisk by PCYC in connection with Novo Nordisk ’s manufacture of Licensed Products, includingwithout limitation technical support for drug manufacturing, quality control, analytical methods and process, quality assurance, and quality control methods transfer to Novo Nordisk or its CMO, and the Out - of - PocketCosts representing transportation costs including clearance and storage of such PCYC Excipient Materials(if necessary ), customs, duty and transit insurance on account of such PCYC Excipient Materials ; or(b ) to the extent PCYC or its Affiliate itself manufactures PCYC Excipient pursuant to Section 3.04,the cost of goods sold of such PCYC Excipient Materials, as calculated in accordance with United Statesgenerally accepted accounting principles ( ), consistently applied by PCYC in accordance with itsstandard accounting practice for public financial reporting purposes ( “ Cost of [ * * ] Certain information in this document has been omitted and filed separately with the Securities and ExchangeCommission