definiens: means, with respect to each Clinical Development Plan, all of the external and internal costsand expenses ( including applicable overhead costs and expenses, including applicable general and administrativeexpenses, but excluding any Commercialization Costs and Commercial Manufacturing Costs ) incurred or paid by a Partyand its Affiliates in connection with the clinical development of Clinical Development Candidates or Cell TherapyProducts, including, without limitation, the following costs to the extent such costs are actually incurred by a Party, accounted for in accordance with U.S. GAAP as consistently applied by such Party and attributable to the activitiesassigned to it under the Clinical Development Plan ( except to the extent such costs constitute Commercialization Costs orCommercial Manufacturing Costs ): ( a ) All direct costs of preparing and conducting clinical trials that is / are subject of the Clinical Development Plan, including all direct costs related to site recruitment, enrollment, project management, site management and monitoring, biostatistics, clinical event classification, medical communication, data management, outcome studies, regulatorysubmissions and compliance, safety surveillance, clinical monitoring and all Clinical Manufacturing Costs ; and ( b ) A reasonable allocation of indirect costs associated with the foregoing