definiens: means the costs and expenses that are actually incurred by or on behalf of a Party andspecifically identifiable or specifically allocable to the Development of the Licensed Products or CompanionDiagnostics throughout the Territory . shall include:(a ) the FTE Costs of the relevant Party or its Affiliates with respect to such Development;(b ) all Out - of - Pocket Costs incurred by the Parties or their Affiliates, including payments made to ThirdParties with respect to such Development, including Phase IV Trial Expenses ( except to the extent that such costshave been included in FTE Costs);(c ) Regulatory Expenses other than Regulatory Maintenance Costs;(d ) the cost of contract research organizations ( CROs);(e ) Manufacturing Costs for clinical supply, including:(i ) costs of packaging of drug products and distribution of drug products used in Clinical Trials;(ii ) expenses incurred to purchase or package comparator drugs;(iii ) costs and expenses of disposal of clinical samples ; and(iv ) costs and expenses incurred in scaling up Manufacturing activities related to pre - clinical or clinicalsupply, including formulation development activities;(f ) Manufacturing Scale - Up Costs ; and(g ) Third Party Patent Costs and Patent and Trademark Prosecution and Enforcement Costs incurred ineach country of the Territory prior to the First Commercial Sale of a Licensed Product in the country