definiens: shall mean ( i ) as used for calculating Past Development Costs, the following costs incurredby [COMPANY] with respect to Development of a Shared Product allocated for the U.S. market prior to the effective date ofAlnylam ’s exercise of its Profit - Sharing Option with respect to such Shared Product, and ( ii ) for purpose of the Profit - Sharing Agreement, the following costs incurred by a Party with respect to Development of the Shared Product for theU.S. market in accordance with the Joint Development Plan:(i ) Direct out - of - pocket costs paid to Third Parties that are attributable to the Development of the Shared Product forthe U.S. market including but not limited to:1 . Clinical studies, including post - marketing commitments and all activities associated with starting, maintaining, and closing studies;2 . Clinical materials and manufacturing costs;3 . Consultants and temporaries used to obtain, maintain, or expand the Development of a the Shared Product formarket approval;-10- 4 . Regulatory fees;5 . Costs associated with chemical, formulation or process development activities relating to the Shared Product, including conformance or qualification lots, process improvements, scale - up and manufacturing facility transfers;6 . Test method development, stability testing, report writing and ongoing quality assurance / quality controlactivities;7 . Costs to prepare, submit, or develop data or information for submission to a Governmental Authority to obtain, maintain, or expand marketing approval of the Shared Product ( pre- or post - launch);8 . Payments to Third Parties under Third Parties ’ licenses covering the Development of the Shared Product in theU.S., including upfront, milestone, royalty payment to Third Parties ; and9 . Other payments to Third Parties for the performance of any development activities with respect to thedevelopment of the Shared Product in accordance with the Joint Development Plan or otherwise agreed upon bythe Parties ; and ( ii ) FTE Costs of a Party ’s internal scientific, medical, technical, regulatory or managerial personnel necessary toconduct, managing and overseeing Development activities and the preparation and updating of the Joint DevelopmentPlan ( and the budget contained therein ) and monitoring the implementation of the Joint Development Plan ( and thebudget contained therein ) shall mean Net Sales of the Shared Product in the U.S., ( i ) less Development Costs, Cost ofGoods and Commercialization Costs and ( ii ) plus Recoveries, if any . For the avoidance of doubt, costs deducted incalculating Net Sales shall not be deducted a second time in calculating Net Profit / Losses