definiens: has the meaning specified in Section 5.1(e ) ; or means the volume of Product for which Client provi des [COMPANY] a 100 % binding commitment to order during the applica ble Calendar Quarters(s ) or three month period covered by the relevant Forecast ; has the meaning specified in Section 8.2(a ) ; means a day other than a Saturday, Sunday or a da y that is a statutory holiday in Ferentino ( FR ), Italy, in Swindon, Wiltshire, Engla nd, or in Massachusetts, USA ; shall mean each 3 month period commencing the fir st day of January, April, July and October of each Year during the Term ; means a separate agreement that the parties may e nter into that will address responsibility for the purchase of capital equipment and facility modifications that may be re quired to perform the Manufacturing Services under this Ag reement ; means, as applicable, current good manufacturing practices as described in : ( a ) Parts 210 and 211 of Title 21 of the United States ’ Code of Federal Regulations ; ( b ) EC Directive 2003/94 / EC ; and ( c ) Division 2 of Part C of the Food and Drug Regulations ( Canada ) ; together with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all as updated, amend ed and revised from time to time ; has the meaning provided in the introductory parag raph ; means Intellectual Property generated or derived by ( a ) Client before or after entering into this Agreement, or ( b ) by Pathe on while performing any Manufacturing Services or otherwise generated or derived by [COMPANY] which Int ellectual Property is specific to, or dependent upo n Client ’s Active Material or Product or Confidential Information ; has the meaning specified in Section 8.4(d ) ; means those Components to be supplied by Client o r that have been supplied by Client ; has the meaning specified in Section 7.8(c ) ; shall mean, with respect to [COMPANY] ’s efforts to s upply volumes of Product in excess of the Annual Limits or volumes s et forth in Binding Forecast Volumes or binding volumes for the first year under any Bi - Annual Fore cast under Section 5.1(h ), that [COMPANY] shall, at t he request of Client, supply the additional volumes of Product as requested by Client only if, and to the extent that, at the time of Client ’s request, [COMPANY] beli eves, acting - 3 - [ * * ] = Portions of this exhibit have been omitted p ursuant to a confidential treatment request