definiens: means, with respect to a Product, all Third Party c osts and expenses for Development FTEs ( calculated at the Development FTE Rate ) in each case that are incurred with respect to or reasonably allocable to the Development ( including CMC Development and any validation batches that are unusable for commercial purposes ) of the Compounds and Products and in conformance with the EDP, or th e Phase 3 Program Plan, as the case may be, including ( a ) the cost of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of s uch Product conducted internally or by individual investigators, or consultants, ( b ) costs for prepar ing, submitting, reviewing or developing data or in formation for the purpose of a Regulatory Filing for such Product, ( c ) Manufacturing Costs for Compound or such Prod uct or any comparator compound or other materials used in connection with the activities under the EDP or the Phase 3 Program Plan, and ( d ) costs of process development scale - up and recovery ( but excluding CMC related ca pital expenses and any costs for idle plant capacity ) . Fo r clarity, Development Costs will include the cost of Phase 4 Clinical Trials other than Voluntary Phase 4 Clinic al Trials, provided, however, that Development Cost s will exclude ( a ) Allowable Expenses, and ( b ) income tax liabilities of either Party