definiens: means with respect to any Program or Product where the Managing Party grants a License f or a Program in whole or in part to a Licensee : ( i ) the actual and reasonable FTE Costs and Out - of - Pock et Costs utilized or incurred by a Party after the Effective Date perfor ming the Commercialization of a License activities described in Section 1.1(22)(ii ) for such Program ; ( ii ) the actual and reasonable FTE Costs and Out - of - Pock et Costs utilized or incurred by a Party after the Effective Date in any research and development of the relevant Product after End of De velopment, if - 10 - undertaken in order to secure or maintain Regulatory Approvals for the applicable Product, which may include formulation, process development, Manufacturing for clinical and non - clinical use, non - clinical and clinical studies, regulatory plans and other elements of Regulatory Approvals conducted after the End of Development for the Product, including Pricing and Reimbursement Approvals, and Post Marketing Commitments, each where applicable ; and ( iii ) patent - related costs in respect of Programs and in territories where there has been no agreement between the Parties for Direct Sales of the Product in question, to the extent expressly provided in this Agreement