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 that are materially con sistent, as applicable, with the Development Plan, including co sts and expenses for Regulatory Approvals and prici ng and/or reimbursement approvals, and costs incurred after R egulatory Approval, including Phase 4 Clinical Tria l costs, costs of non - clinical studies, costs of clinical st udies for additional Indications in the Field, 5 insurance costs incurred in connection with Develop ment activities ( but excluding costs that are alloc able to Commercialization Costs and the costs of general co mpany management, financial, legal or business deve lopment personnel ) . Development Costs will not include any costs incurred by either Party prior to the Effecti ve 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 suppli es 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 surveillance study performed in accordance with Applicable Laws and re quired as a condition to, or for the maintenance of, any Regulatory Approval or pricing and/or reimbursement approval for a Licensed Product