definiens: or means a. to the extent PCYC manufactures PCYC Excipient p ursuant to Section 3.04, and to the extent PCYC Excipient or any direct materials used to manufactu re PCYC Excipient ( collectively, ) are manufactured by Third Party contract manufac turing organizations and similar contractors ( collectively, ), the Out - of - Pocket Costs paid to such CMO(s ) by PCYC for the manufacture of PCYC Excipient Materials, together with FTE Costs of PCY C or its Affiliate associated with quality control or quality assurance with respect to PCYC Excipient Materials, otherwise managing and coordinating the activities of such CMO(s ) by PCYC, and any technical assistance provid ed to Novo Nordisk by PCYC in connection with Novo Nordisk 's manufacture of Licensed Products, includi ng without 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 -Pocket Costs representing transportation costs inc luding clearance and storage of such PCYC Excipient Materi als ( if necessary ), customs, duty and transit insur ance on account of such PCYC Excipient Materials ; or b. to the extent PCYC or its Affiliate itself manuf actures PCYC Excipient pursuant to Section 3.04, th e cost of goods sold of such PCYC Excipient Materials, as calculated in accordance with United States general ly accepted accounting principles ( ), consistently applied by PCYC in accordance with its standard accounting practice for public financial reporting purposes ( or ) . Subject to the foregoing, Cost of Goods Sold shall be the sum of S tandard Cost of Goods Manufactured, Cost Variances and Other Costs Not Included in Standard, where : i. are [ * * ] ; ii . are [ * * ], and iii . are [ * * ]