definiens: means, with respect to each Clinical Development Candidate ( the ) and Cell Therapy Product ( the ), all of the external and internal costs andexpenses ( including applicable overhead costs and expenses, including applicable general and administrative expenses, but excluding any Clinical Development Costs ) incurred or paid by [COMPANY] and its Affiliates ( or [COMPANY] and itsAffiliates if [COMPANY] has acquired manufacturing rights hereunder ) in connection with the manufacturing of ClinicalDevelopment Candidates or Cell Therapy Products ( as applicable ), including, without limitation, the following costs to theextent such costs are actually incurred by the manufacturing Party, accounted for in accordance with U.S. GAAP asconsistently applied by the manufacturing Party and attributable to the manufacture and supply of the ClinicalDevelopment Candidate or Cell Therapy Product ( as applicable ) to [COMPANY] or any Third Party : ( a ) All direct costs of manufacturing and supply the Clinical Development Candidate or Cell Therapy Product ( asapplicable ), including all direct costs of raw materials, labor, license fees ( if any ), maintenance and repair of equipmentused to manufacture the Clinical Development Candidate or Cell Therapy Product ( as applicable ), storage andpackaging and shipping costs ; and ( b ) A reasonable allocation of indirect costs associated with the foregoing, including depreciation associated with the costof capital for equipment used to manufacture the Clinical Development Candidate or Cell Therapy Product ( asapplicable )