definiens: shall mean any entity controlling, controlled by or under the common control of Columbia or [COMPANY], as the case may be . For the purpose of this Agreement, shall mean the direct or indirect ownership of more than ( 50 % ) percent of t he outstanding shares or other voting rights of the subject entity or possession, directly or indirectly, of the power to direct or cause the direction of management and policies of such entity ; 1.1.2 shall mean this license and supply agreement ( which expression shall be deemed 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 apply to the Commercialization of the Product in the Territory ; and ( ii ) in or outside the T erritory that apply to the performance of either Party ’s obligations or covenants under this Agreement ; 1.1.4 shall mean 9 am to 5 pm local time on a day other than a Saturday, Sunday, or public holiday in Bermuda, Italy, or the USA ; 1.1.5 shall mean manufacture in accordance with : ( a ) EC Directive 91/356 / EEC as may be amended from time to time ; ( b ) the current guide to good manufacturing practice for medicinal products published by the European Commission ; 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 the current guide to good manufacturing practice for medicinal products published by the European Commission ; 2 [ * * * ] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION