definiens: means a New Drug Application submitted pursuant to the requirements of the FDA, as morefully deﬁned in 21 U.S. CFR.§ 314.3 et seq, a Biologics License Application submitted pursuant to therequirements of the FDA, as more fully deﬁned in 21 U.S. CFR § 601, a European MarketingAuthorization Application ( ) and any equivalent application submitted in any Region in theTerritory, including New Drug Registration Application in the People ’s Republic of China together, ineach case, with all additions, deletions or supplements thereto.121.87 means the gross amounts invoiced by CASI, its Aﬃliates and Sublicensees for sales ofLicensed Products to independent or unaﬃliated Third Party purchasers of the Licensed Product inbona ﬁde, arms - length transactions, less the following deductions with respect to such sales to theextent that such amounts are either included in the billing as a line item as part of the gross amountinvoiced, or otherwise documented in accordance with the applicable Accounting Standard to bespecifically attributable to actual sales of the Licensed Product