definiens: shall mean the direct or indirect ownership of more than ( 50 % ) percent of theoutstanding shares or other voting rights of the subject entity or possession, directly orindirectly, of the power to direct or cause the direction of management and policies of suchentity;1.1.2 shall mean this license and supply agreement ( which expression shall bedeemed to include the Recitals and Exhibits hereto);1.1.3 means all applicable laws, rules, regulations, directives and guidelines(including any amendments, extensions or replacements thereto ) ( i ) in the Territory that applyto the Commercialization of the Product in the Territory ; and ( ii ) in or outside the Territorythat apply to the performance of either Party 's obligations or covenants under thisAgreement;1.1.4 shall mean 9.30 am to 5.30 pm local time on a day other than a Saturday, Sunday, or public holiday in the UK ( or any part thereof ) or New York, New York, USA;1.1.5 shall mean manufacture in accordance with:(a)EC Directive 2003/94 / EC as may be amended from time to time;(b)the current guide to good manufacturing practice for medicinal products as publishedby the European Commission from time to time during the Term ; and(c)the equivalent law or regulation in the Territory;1.1.6 shall mean a document of that name as described in detail in thecurrent guide to good manufacturing practice for medicinal products as published by theEuropean Commission from time to time during the Term;1.1.7 means all Patent Rights owned by or licensed to Columbia or itsAffiliates containing claims reciting or covering Product including but not limited to thepatents set out in Exhibit A;1.1.8 means a company registered in England and Wales under companynumber 02425939 with the name Columbia Laboratories ( UK ) Limited;1.1.9 means the date first written above;1.1.10,, or shall mean all activities inthe Territory relating to the import, export, promotion, marketing, detail, distribution, storage, handling, offering for sale and sale of the Product ; 1.1.11 means an independent third party to whom Urology Company or its Affiliategrants exclusive sublicense, distribution or marketing rights, or otherwise collaborates orpartners on an exclusive basis, even as to Urology Company, to Commercialize the Productin any country in the Territory