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, insu rance costs incurred in connection with Development activities ( but excl uding costs that are allocable to Commercialization Costs and the costs of general company management, financial, legal or business development personnel ) . Developm ent Costs will not include any costs incurred by either Party prior to the Effective Date, including, with out limitation, costs for purchasing raw materials, for manufacturi ng clinical supplies of Licensed Product or for any 5 labeling or packaging materials, whether or not suc h raw materials, clinical supplies or labeling or p ackaging materials are used by the Parties for Development a ctivities after the Effective Date . In this Agreeme nt, means a post - registration clinical trial or post- marketing surveillance study performed in accordance with Applicable Laws and required as a c ondition to, or for the maintenance of, any Regulat ory Approval or pricing and/or reimbursement approval f or a Licensed Product