definiens: shall mean, with respect to the United States, th e U.S. Food and Drug Administration ( ), or any equivalent foreign r egulatory authority or applicable agency ; shall have the meaning ascribed in Section 7.2(a ) ; means the fees set out in Schedule A covering the cost of Materials purchased by [COMPANY] and the conversion of Materials into Product ; shall have the meaning ascribed in table A-1 of S chedule A ; shall have the meaning ascribed in table A-1 of S chedule A ; means those changes to the Facility that are rela ted to ceasing operations at the site that would not occur in the normal course of business in a similar facility providing contract manufacturin g services in an ongoing manner ; means the file, for each Product, which is provid ed by [COMPANY] to [COMPANY] and which contains documents relating to such Product, including, with out limitation : ( a ) written specifications for Materials and Pro duct ; ( b ) manufacturing and packaging process specificati ons ; ( c ) shipping and storage requirements ; ( e ) all environmental, health and safety information re lating to the Product including material safety data sheets . all as updated, amended and revised fr om time to time by [COMPANY] in accordance with the terms of the Agreement ; and ( f ) any other technical information necessary to carry out the contracted operations correctly in accordance with the MA and any other legal requirem ents, all as updated, amended and revised from time to ti me by [COMPANY] in accordance with the - 9 - terms of this Agreement ; shall have the meaning ascribed in Schedule A ; shall be the joint committee of which the details c oncerning representation and functions are set out in Section 6.1 ; means the fees set out in Schedule B covering act ivities performed by [COMPANY] to support the registration of the Product . The Support Fees are i n addition to the Service Fee for the Product ; has the meaning specified in Section 11.2 ; means those technology transfer activities agreed to between [COMPANY] and [COMPANY] prior to the Effective Date in any executed technology tr ansfer proposal as may be amended from time, which [COMPANY] shall undertake as soon as reasonably possible foll owing the Execution Date using Commercially Reasona ble Efforts ; has the meaning specified in Section 7.1 ; means in the geographic area of the United States of America and all its territories and possessions and the states of the European Union and any other geographic regions in which [COMPANY] markets the Pro duct as of the Execution Date or such other geographic regi ons as the Parties may agree in writing ; means the Intellectual Property of any third part y ; shall have the meaning ascribed in Schedule A ; means a commercial agreement between either Pathe on or [COMPANY] with the vendor of a Material covering the supply of such Material ; means the twelve ( 12 ) month period commencing, in the case of the first Year of this Agreement, on t he Effective Date, and thereafter commencing upon comp letion of the immediately preceding Year