definiens: means all costs and expenses, including FTE Costs and Out - of - Pocket Costs, incurred by or on behalf of a Party in accordance w ith this Agreement and attributable to, or reasonab ly 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 Deve lopment Plan, including costs and expenses for Regu latory Approvals and pricing and/or reimbursement approval s, and costs incurred after Regulatory Approval, in cluding Phase 4 Clinical Trial costs, costs of non - clinical studies, costs of clinical studies for additional Indications in the Field, insurance costs incurred in connection with Development activities ( but excluding costs that ar e allocable to Commercialization Costs and the costs of general company management, financial, legal or business development personnel ) . Development Costs will not include any costs incurred by either Party prior to the Effective Date, including, without limitation, cost s for purchasing raw materials, for manufacturing c linical supplies of Licensed Product or for any labeling or packaging materials, whether or not such raw mater ials, clinical supplies or labeling or packaging materials are use d by the Parties for Development activities after t he Effective Date . In this Agreement, means a post - registration clinical trial or post- marketing surveillance study performed in accordance with App licable Laws and required as a condition to, or for the maintenance of, any Regulatory Approval or pricing and/or reimbursement approval for a Licensed Produc t