definiens: means, in relation to a Royalty - Bearing Product, the Party entitled to receive royalties from the other Party under the terms and conditions of this Agreement 1.78 means, with respect to a Profit - Sharing Product, the internal and external costs and expenses incurred by the Parties and their Related Parties in connection with the pre - launch market development, and the promotion, marketing, 13 selling and product support of such Profit - Sharing Product in the United States, in accordance with the Commercialization Plan for such Profit - Sharing Product and the related budget for Sales and Marketing Expenses, including without limitation : ( a ) promotional and training materials for the sales representatives ; ( b ) patient support program costs ; ( c ) disease management programs specifically developed for such Profit - Sharing Product ; ( d ) outcomes and pharmacoeconomic studies and Post - Approval Studies for Profit­Sharing Product ; ( e ) costs incurred in conducting joint meetings relating to Commercialization of such Profit - Sharing Product ( excluding JCC meetings ) prior to the date of First Commercial Sale of such Profit - Sharing Product in the United States ( including lodging expenses and travel expenses associated with such a meeting ) ; ( f ) costs associated with Detailing to physicians ; ( g ) costs associated with market development activities and other similar pre - launch activities ; ( h ) Cost of Goods Sold of samples of such Profit - Sharing Product distributed in accordance with the Commercialization Plan ; ( i ) the costs of internal scientific, medical, technical, quality assurance, quality control or managerial personnel engaged in Commercialization efforts ( including without limitation Health Science Associates fielded by the Parties ), which costs shall be determined based on the FfE Costs, unless another basis is otherwise agreed by the Parties in writing ; ( j ) other out - of - pocket costs and expenses related to promotion, marketing, selling and product support of such Profit - Sharing Product, including without limitation costs and expenses associated with symposia, seminars, media advertising, market research and direct mailing, that are incurred in accordance with the applicable Commercialization Plan and the related budget ; and ( k ) any other costs explicitly included in the budget for the Commercialization Plan