definiens: means the agreement relating to the employment of project staff between [COMPANY] and [COMPANY] dated 7 th November 2006 ; shall have the meaning ascribed in Section 7.2(a ) ; shall have the meaning ascribed in Section 7.3(g ) ; means a day other than a Saturday, Sunday or a da y that is a statutory holiday in the United Kingdom and in the United States of America ; means current Good Manufacturing Practice publish ed by the European Commission in the (, IV Volume ), as specified by the competent Regulator y Authorities, and 21 C.F.R. § 211, and FDA guidanc e pertaining thereto ; shall mean the quantity of Product [COMPANY] is able to produce from the Facility during a defined period of time based on the assumptions set out in Schedule A, which may be amended in writing from time to time as agreed between the Parties ; shall have the meaning ascribed in Section 9.3 ; means the carrying out of obligations in a diligen t and sustained manner using such effort and employing such qualified reso urces as would normally be exerted or employed by a contract manufacturing organization performing similar servi ces that is not undertaking Shutdown Activities