definiens: means, in the case of sales by or for the benefit of TIZIANA and its Affiliates ( the ) to independent, unrelated persons ( ) in bona fide arm ’s length transactions ( except as provided below with respect to clinical trial samples ), the gross amount billed or invoiced by Seller with resp ect to the Licensed Product, less the following deductions, in each case to the extent actually allowed and taken by such Buyers and not otherwise recovered by or reimbursed to Seller in connection with such Licensed Product ( ): trade, cash, promotional and quantity discounts to the extent that such amounts are set forth separate ly as such in the total amount billed or invoiced ; taxes on sales ( such as excise, sales or use taxes or value added tax ) to the extent imposed upon and paid directly with respect to the sales price and set fo rth separately as such in the total amount billed o r invoiced ( and excluding national, state or local taxes based on i ncome ) ; taxes on sales of pharmaceutical specialties reimbu rsed pursuant to a government health service, healt h insurance, social insurance or similar social servi ces program ; freight, insurance, packing costs and other transpo rtation charges to the extent added to the sales pr ice and set forth separately as such in the total amoun t billed or invoiced ; amounts repaid or credits taken by reason of reject ions, defects or returns or because of retroactive price reductions, or due to recalls or laws or regulation s requiring rebates ; free goods, rebates taken by or fees paid to distri butors, and charge - backs to the extent that such am ounts are documented ; documented customs duties actually paid by Seller o n import into the country of sale ; and rebates and/or discounts on sales of Licensed Produ ct given to health insurance and other types of pay ers in any given country of the Territory due to specif ic agreement ( type of agreements ) invol ving the Licensed Product