definiens: shall mean any clinical t rial, or part of a clinical trial, of a Product tha t is not designed or required to procure data necessary for the accep tance of filing of an NDA . Non - NDA Trials may be co nducted before or after the filing of an NDA, before Approv al or at any time after Approval . Non - NDA Trials sh all specifically not include ( that is, costs associated with such trials may be deemed Direct Development Costs ) any ( i ) clinical trials designed to obtain favorable la beling at the time of initial Approval, ( ii ) post - A pproval or post - marketing trials required by the FDA or other regul atory authority in granting a conditional Approval, or ( iii ) trials required to obtain Approval for pediatric us e of a Product, whether such trials are prior or su bsequent to the filing of an NDA or Approval