definiens: means quality ( aka CMC ) module, a component of the CTD ( common technical document ) usedfor the registration of pharmaceuticals for human use defined by the ICH ( International Council forHarmonisation ) ; means, for any period, the amount of ( whereby equals Price timesnumber of Products sold ) in the applicable country in the Territory by Licensee or its Affiliates, less thefollowing deductions ( specifically excluding any payments made by Licensee or its Affiliates to Licensorpursuant to this Agreement ), in each case related specifically to the Product in such country in the Territoryand actually allowed and taken by such Third Parties and, in the case of items ( i ), ( ii ) and ( v ) only, nototherwise recovered by or reimbursed to Licensee or its Affiliates : ( i ) trade, cash and quantity discounts, including in relation to Portfolio Offerings, ( other than pricediscounts granted at the time of invoicing and already included in the gross amount invoiced ), albeitcapped at a maximum of 1 % of Net Sales per Year ; ( ii ) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid toRegulatory Authorities or Payers ; 10 ( iii ) taxes on sales ( such as business tax and VAT ), but not including ( a ) taxes assessed against theincome derived from such sales, and ( b ) import and customs duties ; ( iv ) freight, insurance and other transportation and handling charges to the extent added to the sale priceand set forth separately as such in the total amount invoiced ; and ( v ) amounts repaid or credited by reason of rejections, defects, one percent ( 1 % ) return credits, recalls orreturns or because of retroactive price reductions ( including rebates or wholesaler charge backs )