definiens: means all costs and expenses, including FTE Costs and Out -of - Pocket Costs, incurred by or on behalf of a Party in accordance with this Agr eement and attributable to, or reasonably allocable to, the Development of the Licensed Products in the Field in the Territory and European Union and that are materially consistent, as applicable, with the Development Plan, including costs and expenses for Regulatory Approvals and pricing and/or reimbursement approvals, and costs incurred after Regulatory Approval, including Phase 4 Clinical Trial costs, costs of non -clinical studies, costs of clinical studies for additional Indications in the Field, insura nce costs incurred in connection with Development activities ( but excluding costs that are allocable to Commercialization Costs and the costs of general company management, financial, legal or business development personnel ) . Development Costs will not inc lude any costs incurred by either Party prior to the Effective Date, including, without limitation, costs for purchasing raw materials, for manufacturing clinical supplies of Licensed Product or for any labeling or packaging materials, whether or not such raw materials, clinical supplies or labeling or packaging materials are used by the Parties for Development activities after the Effective Date . In this Agreement, means a post -registration clinical trial or post -marketing surveill ance study performed in accordance with Applicable Laws and required as a condition to, or for the maintenance of, any Regulatory Approval or pricing and/or reimbursement approval for a Licensed Product