definiens: shall mean the following Out - of - Pocket Costs incurred by a Party with respect toDevelopment of the Shared Product for the U.S. market ( pursuant to Section 9(a ) and Section 10 ) in accordance with the JointDevelopment Plan : a ) Out - of - Pocket Costs that are attributable to the Development of the Shared Product for the U.S. market including : i ) Clinical studies, including post - marketing commitments and all activities associated with starting, maintaining, and closing studies ; E-11ii ) Consultants used to obtain, maintain, or expand the Regulatory Approval of the Shared Product;iii ) Regulatory filing fees;iv ) 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;v ) Test method development, stability testing, report writing and ongoing quality assurance / quality controlactivities;vi ) Costs to prepare, submit, or develop data or information for submission to a Regulatory Authority to obtain, maintain, or expand Regulatory Approval of the Shared Product ( pre- or post - launch);vii ) milestone payments made to UNC pursuant to Section 3.4 of the UNC License Agreement;viii ) Subject to Section 9(b ) above, payments to Third Parties ( other than UNC ) under licenses from such ThirdParties for patents Covering the Development of the Shared Product for the U.S., including upfront, milestone, androyalty payments to such Third Parties ; provided, however, that, to the extent that any such Third Party licenseincludes a license to Third Party intellectual property that is applicable to products being or to be developed orcommercialized by such Party or its Affiliates other than such Shared Product in the U.S., then such Party shallreasonably allocate all upfront payments, milestone payments and other non - royalty amounts between the SharedProduct and such other products, and such Party shall only be entitled to include in Shared Development Costshereunder the amounts that are reasonably allocable to the Shared Product for the U.S. ; andix ) 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 by theParties