definiens: means the costs and expenses that are actually incurred by or onbehalf of a Party and specifically identifiable or specifically allocable to the Development of theLicensed Products or Companion Diagnostics throughout the Territory . shall include:(a ) the FTE Costs of the relevant Party or its Affiliates with respect to suchDevelopment ; it being understood and agreed that, in the case of FTE Costs involvingDevelopment activities incurred by [COMPANY] and its Affiliates, in lieu of an FTE Costreimbursement, [COMPANY] shall be reimbursed at an amount equal to [ * * ] percent ( [ * * ] % ) of the Out - of - Pocket Costs referred to in clause ( b ) below;(b ) all Out - of - Pocket Costs incurred by the Parties or their Affiliates, includingpayments made to Third Parties, with respect to such Development, including Phase IV StudyExpenses ( except to the extent that such costs have 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 usedin 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 activitiesrelated to pre - clinical or clinical supply, including formulation development activities;(f ) Manufacturing Scale - Up Costs ; and D-2(g ) Third Party Patent Costs and Patent and Trademark Prosecution andEnforcement Costs incurred in each country of the Territory prior to the First Commercial Sale ofa Licensed Product in the country