definiens: of a Licensed Product means all Out - of - Pocket Costs and Expenses, whetherincurred by [COMPANY] or its Affiliates, or [COMPANY] or its Affiliates, to the extent provided for in an approvedCommercialization Plan or otherwise approved in advance by the Joint Steering Committee, and solely to the extentrelated to marketing such Licensed Product in the United States, consisting of:1.63.1 Marketing, promotion and advertising ( including agency fees ) through any means ( includingconsumer - directed advertising, physician - directed advertising, journal, newspaper, radio, internet or place - basedadvertisements, promotional literature, patient education, field and headquarters ’ grants, exhibits, direct mail, advisoryboards, symposia, congress activities and dinner programs);1.63.2 Sampling and promoting such Licensed Product, speakers ’ programs and symposia, but excluding allcosts and expenses incurred in retaining contract sales forces for such Licensed Product unless otherwise mutuallyagreed by the Parties;1.63.3 Conducting Phase 4 Studies;1.63.4 Conducting primary and secondary market research;1.63.5 Preparing and producing Promotional Materials for distribution and materials and programs used forongoing training of Sales Representatives and of sales trainers;1.63.6 Conducting recalls of Licensed Product to the extent provided in Section 8.6;1.63.7 Manufacturing Costs of Samples, and costs relating to the destruction of unused Samples ; and1.63.8 Such other Out - of - Pocket Costs and Expenses as the Parties may agree upon in writing from time totime