definiens: shall mean a plan for the undertaking of all approp riate activities for commercialization of Licensed Product in the Territ ory, including pre - Commercial Launch and post - Commercial Launch marketing activities, to be prepa red in accordance with Articles 3.3 ; 1.20 shall mean a new drug application or any equivalent of it issued by any of the Regulatory Authorities ; 1.21 shall mean all purchase price amounts invoiced to the ultimate purchaser by PHARMAENGINE or its Affiliates, or any Sub - Licensee s, or their respective agents or distributors, in respect of the sale of the Licensed Product less th e following items to the extent that they are actua lly paid or allowed and specified on any documents rela ted to such sale : ( a ) normal discounts actually granted ; ( b ) packaging, transportation and prepaid insurance charges on shipments or deliveries to customers ; ( c ) cost of samples for regulatory testin g, promotional and hospital listing purposes as set out in the Marketing Plan from time to time ; and ( d ) sales or value added taxes actually i ncurred and paid by [COMPANY], its Affiliates or any Sub - licensees in connection with the sale or delive ry of the Licensed Products to customers