definiens: means all Patent Rights owned by or licensed to Columbia containing claims reciting or covering Product as more particularly set out in Exhibit A ; 1.1.8 means a company registered in England and Wales under company number 02425939 with the name Columbia Laboratories ( UK ) Limited ; 1.1.9 means the date of execution of this Agreement ; 1.1.10,, or shall mean all activities in the Territory relating to the import, export, promotion, marketing, detail, distribution, storage, handling, offering for sale and sale of the Finished Product ; 1.1.11 means the Regulatory Application to be filed by Columbia UK with the Medicines Control Agency in the UK seeking Regulatory Approval for the Product in the UK and to be used by Columbia UK as the basis for the mutual recognition Regu latory Application in the Territory, as the same is modified or amended from time to time during the Regulatory Application process ; 1.1.12 means the procedure set out in Exhibit D ; 1.1.13 means the Governmental Au thority in the USA with the name ; 1.1.14 means Product in final Packaged and Labelled form ready for ultimate commercial sale or use ; 1.1.15 means the first invoiced commercial sale by [COMPANY], its Affiliates, agents or sublicensees in the Territory after grant of Regulatory Approval and pricing approval ( if required ) for Finished Product ; 1.1.16 means in relation to e ither Party, any event or circumstance which is beyond the reasonable control of that Party and without the fault or negligence of that Party so affected which results in or 3 [ * * * ] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION