definiens: ( with a correlative meaning for ) means all development activities necessary or useful to obtain ormaintain Regulatory Approval for the CD38 Product in the Field in the Territory, including all non - clinical studies and clinical trials ( other thanPhase 4 Clinical Trials ) of the CD38 Product, technology transfer, manufacture process development, manufacture and distribution of CD38Product for use in clinical trials ( including placebos and comparators ), statistical analyses, and the preparation and submission of RegulatoryMaterials and other regulatory activities related to the CD38 Product.1.10 means all costs incurred by or on behalf of I - Mab or its Affiliates that are reasonably allocable to theDevelopment of CD38 Product in the Field in the Territory, including ( a ) the costs of all preclinical studies and clinical trials ( other than Phase4 Clinical Trials ) ; ( b ) the costs of formulation development, process development and delivery system development ; ( c ) the ManufacturingCosts of CD38 Product for Development use, and the costs of placebos and comparator drugs for use in clinical trials of CD38 Product(calculated in the same manner as Manufacturing Costs are calculated for CD38 Product ) ; ( d ) the cost of regulatory activities to obtain andmaintain Regulatory Approval of CD38 Product, including the preparation and submission of all Regulatory Materials for the CD38 Product;(e ) the costs in connection with the licensing of any intellectual property rights of any Third Party . Development Costs shall include I - Maband its Affiliates ’ internal costs related to the Development efforts, which shall be itemized and subject to annual audit by Everest inaccordance with Section 4.8