definiens: means, with respect to a Shared Product and with respect to a Calendar Quarter, all costsdirectly incurred in such Calendar Quarter by Infinity and Infinity Related Parties in accordance with the CommercialPlan in connection with all medical and regulatory activities directed to supporting such Shared Product in the Field inthe United States after Marketing Authorization, including medical education, use of medical science liaisons, post - approval regulatory activities, and post - approval clinical studies ( including grants to support investigator - initiatedstudies ) ; provided that for any medical and regulatory activities with respect to such Shared Product that supportactivities both in the United States and outside the United States, costs for such medical and regulatory activities shall beappropriately allocated by agreement of the JCC between costs allocable to the United States, which shall be included inPost - approval 81Medical Costs, and costs not allocable to the United States, which shall not be included in Post - approval Medical Costs;and provided, further, that any such amounts that are included in Post - approval Medical Costs will not be included inMarketing Expenses, Selling and Promotion Expenses or any other category of Shared Commercial Expenses so as not todouble count such amounts