definiens: means the agreement entered into between the part ies hereto setting out the quality assurance standards to be applicable to the Manufac turing Services provided by [COMPANY], attached heret o as Schedule H ; shall have the meaning ascribed thereto in Sectio n 6.2(a ) ; shall have the meaning ascribed thereto in Sectio n 11.1 ; shall have the meaning ascribed thereto in Sectio n 6.1(d ) ; means the file, for each Product, which is approv ed by the Client in accordance with the procedures listed in Schedule B hereto and which co ntains documents relating to such Product, includin g, without limitation : ( a ) specifications for Active Mater ials and Components ; ( b ) manufacturing specifications, directions and proces ses ; ( c ) storage requirements ; ( d ) all environmental, health and safety information re lating to the Product including material safety dat a sheets ; ( e ) the finished Product specifications, packaging spec ifications and shipping requirements for each Produ ct, including, but not limited to, any requirements set forth in the applicable regulatory filings made wi th the FDA or other Authority ( e. g., the NDA and/or ANDA ) and provided by Client to [COMPANY] ; - 5 - all as updated, amended and revised from time to ti me by the Client in accordance with the terms of th is Agreement ; has the meaning specified in Section 12.2 ; shall mean ( i ) [ * * * ] and ( ii ) any additional coun try(ies ) and/or commonwealths, territories and possessions which the Client may later designate in its sole discretion in an addendum to this Agreeme nt ; provided that the Client shall bear all incremental costs, including, but not limited to labeling cost s, associated with the manufacture of the Product for such additi onal country(ies ) and/or commonwealths, territories and possessions in amounts to be agreed by the parties ; means the Intellectual Property of any third part y ; means a calendar year, except that the first of this Agreement shall be deemed to be the peri od from the Commencement Date up to and including Dece mber 31, 2007 ; 1.2 Currency