definiens: December in each year and has a corresponding meaning ; means the EMEA and any other body with responsibility for granting Marketing Authorisations in any part of the Territory ; means the royalties payable to KSB in accordance with Clauses 12 and 13 ; means in respect of each Product and each country in the Territory the period from the Effective Date to whichever shall be the later of : ( a ) the expiry of a period of 10 years from the Launch Date of such Product in such country or in respect of the member states of the ED, from the Launch Date of such Product in the ED ; and ( b ) the date of expiry of the Orphan Medicine Status applicable to such Product ; and ( c ) the date of expiry of any Product Patent in respect of such Product ; means documentation / data ( registration documents and CtX documents ) filed with any Regulatory Authority in the Territory with the purpose of obtaining Marketing Authorisation or pellnission to 9""DeltaView comparison ofiManageDeskSite : IINYDMSOIINYDOCS / I1567481I and iManageDeskSite:/INYDMS01INYDOCS / I156748/2, Performed on 6/14/2004,,, I ~ I,,, 1-,,,, • undertake Clinical Trials in the Territory . The documentation includes CMC Data and Product Data, including investigator brochure ; means the Development Plan relating to the Second Indication ; means newly diagnosed malignant brain neoplasms ; means in relation to any Product a Supplementary Protection Certificate for medicinal products and their equivalents provided under Council Regulation ( EEC ) No . 1768192 of 18th June 1992 or analogous extensions of Patent protection in any jurisdiction ; means any sublicense agreement entered into by [COMPANY] ( or any Affiliate of [COMPANY] ) and a Sub­licensee ( except for Affiliates ), pursuant to which [COMPANY] ( or such [COMPANY] Affiliate ) grants such Sub - licensee rights to market, distribute and sell Product in a part of the Territory ; means any person ( including distributors but excluding for the avoidance of doubt any [COMPANY] Affiliates ) to whom [COMPANY] has, directly or indirectly granted rights to market, distribute or sell Product in any part ofthe Territory ; means the supply agreement between the Parties to be entered into in accordance with Clause 8 ; means an agreement specitying details concerning quality issues and product delivery as set out in the Schedule to the Supply Agreement ; means the tenn of the exclusive license granted to [COMPANY] to market, distribute and sell Product, as defined in Clause I 8, I ; means the countries from time to time of the European Union and Iceland and CIS and the Baltic States of Estonia, Latvia and Lithuania, Poland, Hungary, Romania, Bulgaria, the Czech Republik and Slovakia ; means the Development Plan relating to the Third Indication ; IO""DeltaView comparison ofiManageDeskSite:/INYDMSOIINYDOCS / I 156748/1 and iManageDeskSite:/INYDMSOIINYDOCS / I 15674812 . Perfonned on 6/14/2004 . •,,,,, •,, • • means brain metastases in patients, relevant cancer types to be defined ; means the trade names and marks ( both registered and unregistered ) selected by [COMPANY] in respect of any Product in the Territory and notified to KSB under the tenns of Clause 10.2 ; means a calendar year commencing 1 January