definiens: means all costs and expenses, including FTE Costs and Out - of - Pocket Costs, incurred by or on behalf of a Party in accor dance with this Agreement and attributable to, or r easonably allocable to, the Development of the Licensed Produ cts in the Field in the Territory and European Unio n and that are materially consistent, as applicable, with the Development Plan, including costs and expenses for Regulatory 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