definiens: , or shall mean all labels and other written, printed or graphic matter upon ( i ) the Product or any container or wrapper utilized with the Product, or ( ii ) any written material accompanying the Product, including, without limitation, package inserts and patie nt information leaflet ; 1.1.23 or means any Regulatory Approval for Finished Product granted by the Governmental Authority of the Territory as the same may be varied from time to time during the Term of this Agreement ; 1.1.24 means the minimum purc hase requirements set out in Exhibit B as the same may be amended from time to time during the term of this Agreement under the provisions of Clause 6.5 ; 1.1.25 means the Regulatory Application for Product which is a new drug applicati on submitted by Columbia Laboratories, Inc., with the FDA on August 19, 2002 ; 6 [ * * * ] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION