definiens: means ( a ) the product of ( i ) the number of field - and office - based FTEssupporting the coordination of pre - market authorization preparation as well as Post - Approval Studies in the United Statesrelated to a Product as agreed upon in the approved Commercialization Plan and its budget and ( ii ) the applicable MedicalAffairs FTE Rate ; ( b ) the cost of performing Post - Approval Studies in the United States ; and ( c ) External EducationExpenses ( including journal clubs, congresses, and conferences, etc . ) . For purposes of calculating the number of FTEs, an allocated portion of the medical affairs staff directly involved in the coordination of pre - market authorization preparationfor a Product or Post - Approval Studies in the United States for a Product shall be included . Each medical affairs staffmember shall record the percent of time allocated to the Product and to all other products, and time allocated to otherproducts shall be excluded in calculating the number of FTEs