definiens: means the costs and expenses that are actually incurred by or onbehalf of a Party and specifically identifiable or specifically allocable to Development activitiesfor a given Program . shall include:(a ) the FTE costs ( determined by multiplying the number of FTE hours of servicespent by the FTE Rate ) of Agios or its Affiliates with respect to such Development, and in thecase of [COMPANY] or its Affiliates, instead of reimbursing [COMPANY] on an FTE basis, [COMPANY] shallbe reimbursed for [ * * ] % of Out - of - Pocket costs incurred by [COMPANY] in connection with anyDevelopment Activity);(b ) all Out - of - Pocket Costs incurred by the Parties or their Affiliates, includingpayments made to Third Parties with respect to such Development ( except to the extent that suchcosts have been included in FTE costs);(c ) Regulatory Expenses;(d ) the cost of contract research organizations ( CROs ) ; and(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 activities relatedto pre - clinical or clinical supply, including formulation development activities;all of such costs, as determined from the books and records of the applicable Party and itsAffiliates maintained in accordance with the Accounting Standards . Notwithstanding anything inthis definition to the contrary, only those Development Costs that are contemplated by, andmaterially consistent with, the Development Plan and Development Budget for the applicableProgram shall be chargeable as Development Costs