definiens: means a Biologics License Application and amendments theretofiled pursuant to the requirements of the FDA, as defined in 21C.F.R. § 600 et seq ., for FDA approval of a Product ; means a supplemental BLA ; and means a New DrugApplication and amendments thereto filed pursuant to therequirements of the FDA, as defined in 21 C.F.R. § 314 et seq .,for FDA approval of a Product and means a supplementalNDA ; [ * * * ] [ * * * ] Milestone Eventsis defined in Clause 8.3;Milestonesis defined in Clause 8.3;Net Salesmeans, with respect to a particular Product for any period, theamount which reflects the gross amount invoiced for suchProduct sold by [COMPANY] or its Affiliates or Sublicenseesless the following deductions in relation to each Product, to theextent in each case such deductions are actually made andaccounted for within [COMPANY] ’s or its Affiliates ’ orSublicensees ’ accounts:(a ) credits, reserves or allowances granted for damaged, outdated, returned, rejected, withdrawn or recalledProduct;(b ) trade, quantity and cash discounts allowed;(c ) discounts, refunds, rebates, chargebacks, retroactiveprice adjustments, and any other similar allowances whicheffectively reduce the net selling price;(d ) that portion of the sales value associated with, andreasonably attributable to, drug delivery systems or otherassociated therapy requirements ( including screeningassays, companion diagnostics and other associatedassays ) and to the extent invoiced with a Product;6CONFIDENTIAL – FINAL ( e ) allowance for distribution expenses;(f ) taxes imposed in connection with the sales anddisposition of such Product and actually paid byAdaptimmune or its Affiliates or Sublicensees;(g ) duties and any other governmental charges or leviesimposed upon the import or export, or manufacture or saleof a Product, including the annual fee imposed on thepharmaceutical manufacturers by the US government ( but, for clarity, excluding income or franchise taxes ) ; and(h ) any other similar and customary deductions which are inaccordance with the Accounting Standards and which areconsistently used by [COMPANY], its Affiliates orSublicensees in connection with its public financialreporting requirements