definiens: means Gross Sales less : ( i ) price reductions or discounts, including cash discounts, or rebates, actually granted, ( ii ) credits or allowances actually granted upon claims, rejections or returns of Product, including recalls, regardless of the Party requesting such, ( iii ) the actual cost of packaging, freight and insurance that has been included in the Gross Sales amounts invoiced, and ( iv ) any tax imposed or other governmental charge ( other than an income or withholding tax ) charged or levied on the sale, transportation, or delivery of a Product and borne by Sunt < p ' on such sales in the Territory . JIt is estimated that Net Sales will be approximatelyteventy to seventy - fi ~ percent fO%-75~ ) of the NHI Price . ] 1.11 means anyone of : a New Drug Application, or ( as long as equivalent under the U.S. Food, Drugs and Cosmetics Act to a New Drug Application for purposes of securing regulatory approval for commercial sale of the Product in the United States ) a Biologics License Application or a Product License Application filed with the FDA or any such comparable application in Japan