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 that are mate rially consistent, as applicable, with the Development Pla n, including costs and expenses for Regulatory Appr ovals and pricing and/or reimbursement approvals, and costs i ncurred after Regulatory Approval, including Phase 4 Clinical Trial costs, costs of non - clinical studies, costs o f clinical studies for additional Indications in th e Field, insurance costs incurred in connection with Development activ ities ( but excluding costs that are allocable 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