definiens: shall mean the direct or indirect ownership of more than ( 50 % ) percent of the 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 Territory that apply to the performance of either Party 's obligations or covenants under this Agreement ; 1.1 A 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 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 any country in the Territory ; 2 Signature Copy 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 ; 1.1.7 means that part of a Regulatory Application or Regulatory Approval containing the data and other know how relating to the chemistry and manufacturing controls and other manufacturing processes for the Product, including relating to the Packaging and Labelling ; 1.1.8 means all Patent Rights owned by or licensed to Columbia containing claims reciting or covering Product as more particularl y set out in Exhibit A ; 1.1.9 means a company registered in England and Wales under company number 02425939 with the name Columbia Laboratories ( UK ) Limited ; 1.1.1 0 means the date of execution of this Agreement ; 1.1.11,, 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 ; I .1.12 '' European Regulatory Application " means the Regula tory 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 mutual recognition Regulatory Applications in the Territory, as the same is modified or amended from time to time during the Regulatory Application process ; 1.1.13 means the procedure set out in Exhibit E ; 1.1.14 means the Governmental Authority in the USA with the name ; ( ' \ ] 4 Signature Copy 1.1.15 means Product in final Packaged and Labelled form ready for ultimate commercial sale or use ; 1.1.16 means the first invoiced commercial sale by [COMPANY], its Affiliates, agents or sublicensees in any country in the Territory after grant of Regulatory Approval and pricing approval ( if required ) for Finished Product in such country ; 1.1.17 means in relation to either 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 causes the failure of that Party to perform any or all of its ob1igations under this Agreement, including, without limitation, inevitable accidents, perils of navigation, floods, fire, storms, drought, or other weather -related conditions, earthquakes, asteroid or meteor activity, explosion, hostilities, sabotage, act of vandalism, war ( whether declared or undeclared ), civil disturbances, order or act of any government, whether de jure or de facto or any official purporting to act under authority of any such government, illegality arising from domestic or foreign laws or regulations, insurrections, quarantine or custom restrictions, damage in factories or warehouses, strikes, lockouts, other labor difficulty or other disturbance at the Parties or the suppliers of Product, raw materials and/or excipients, energy or other supplies, breakdown of machinery or instruments or acts of God or other similar events beyond the reasonable control of the Party so affected resulting in hindrance of the performance by either Party of its obligations hereunder ; 1.1.18 or shall mean c1inical practice as set out in : ( a ) ICH Harmonised Tripartite Guideline for Good Clinical Practice ( CPMP / ICH/135/95 ) and any amendment thereof ; and ( b ) any guidelines concerning good clinical practice published from time to time by the European Commission pursuant to Directive 2001/20 / EC or any amendment thereof ; and 5 Signature Copy ( c ) US Code of Federal Regulations Title 21, Parts 50 ( Protection of Human Subjects ) and 56 ( Institutional Review Boards ), as may be amended from time to time ; and ( d ) the Declaration of Helsinki as last amended at the 52nd Warid Medical Association October 2000 and any further amendments thereto ; and ( e ) National Institute of Health Standards for the protection of human subjects as may be amended from time to time ; and the equivalent law or regulation in any relevant territory