definiens: means all monies invoiced by SOSEI or its Affiliates or any Sub­Licensees in respect of the sale by SOSEI, its Affiliates or any Sub - Licensees of the Product to an independent third party less the following items to the extent that they are actually paid or allowed and specified on any documents related to such sale : ( i ) normal discounts actually granted ( including for the avoidance of doubt reimbursement to a customer of promotional costs ) ; ( ii ) credit actually allowed for any Product returned or not accepted by customers ; ( iii ) packaging, transportation and prepaid insurance charges on shipments or deliveries to customers ; and ( iv ) sales or value added taxes actually incurred and paid by SOSEI, its Affiliates or any Sub - licensees in connection with the sale or delivery of the Products to customers ; Provided That : the Product reasonably supplied as samples shall not be treated as being disposed of on a commercial basis and shall be ignored for the purpose of calculating the Net Sales ; means the designation by the Regulatory Authority in the Territory as an orphan drug after filing an application for obtaining such status of the Product with the Regulatory Authorities in the Territory ; means any phannaceutical product in finished dosage or in finished dosage package fmm ready for sale to third parties which consists of or contains the Active Ingredient for human use ; means each three calendar - month period in any year during the telln of this Agreement ending on 31st March, 30th June, 30th September and 31 st December in each year and has a corresponding meaning ; means the body with responsibility for granting the Marketing Authorisations of the Product ; means the royalties payable to KSB in accordance with Clause 11 ', means any trademark or name or logo proprietary to SOSEI used on products marketed by SOSEI ( in addition to any mark, logo or 5 .. DeltaView comparison ofiManageDeskSite:/INYDMSOIINYDOCS / I156674/1 and iManageDeskSite:/INYDMSOIINYDOCS / I156674/2 . Perf 011 ned on 6/1412004 . .,,,,, • • 1.1.31 1.1.32 1.1.33 1.1.34 1.1.35 1.1.36 name identifying the product ) to identify SOSEI as the holder of a Marketing Authorisation for such product ; means any sublicense agreement entered into by SOSE ! ( or any Affiliate of SOSE ! ) and a Sub - Licensee, pursuant to which SOSEI ( or such SOSEI Affiliate ) grants such Sub - Licensee rights to market, distribute and sell the Product in the Territory, or any part thereof, means any person ( including distributors but excluding for the avoidance of doubt any SOSE ! Affiliates ) to whom SOSE ! has directly or indirectly, granted rights to market, distribute or sell the Product in any part of the Territory ; means the supply agreement between the parties to be entered into in accordance with Clause 8 ; means Japan ; means the trade names and marks ( both registered and umegistered ) selected by SOSE ! in respect of the Product in the Territory and notified to KSB under the tenns of Clause 9.1 ; means a calendar year commencing from 1st January