definiens: means a report of Details performed by a party during the Calendar Quarter covered by such statement containing such information and in such format as determined by the JMC 1.33 means with respect to a particular Product the sum of all internal costs, including to the extent allocated to the foregoing directly related overhead ( but not general or corporate overhead ), and direct out - of - pocket costs, in each case incurred by a party and/or its Affiliates in connection with the conduct of the activities assigned to it by the JDC pursuant to the Development Plan, including, without limitation, fTE costs ( which fairly reflect the actual FIE costs of each party for its personnel in the applicable functional areas ( but excluding senior executives ), to be discussed and agreed upon by the parties respective finance departments ), costs of preparation of regulatory filings, costs of clinical supply of Product, and any other activities conducted under the Development Plan that support obtaining or maintaining NDA Approval of Product in the Territory, such as surveillance studies and pharmacovigilance