definiens: means any governmental or regulatory authority, d epartment, body or agency or any couxx, tribunal, bureau, commission or other simila r body, whether federal, state, provincial, county or municipal ; means the expenses for all third party supplier fee s for the purchase or use of columns, standards, tooling, non - standard pallets, PAPR or PPE suits ( where applicable ) and other project - specific items necessary for [COMPANY] to per form the Manufacturing Services, and which are not included as Components ; 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 ( a ) Boston, Massachusetts, ( b ) United Kingdom or ( c ) th e jurisdiction where the relevant Manufacturing Site is located ; means, with respect to any given calendar year, the respective periods of three ( 3 ) consecutive calendar months ending on March 31, Jun e 30, September 30 or December 31 ; provided, however, that ( a ) the first Calendar Quarter of the Term shall extend from the Effective Date to the e nd of the first complete Calendar Quarter thereafter a nd ( b ) the last Calendar Quarter of the Term shall end upon the effective date of expiration or terminatio n of this Agreement ; [ * * * ] ; 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 required to perform the Manufacturing Services unde r a particular Product Agreement ; means, as applicable, current good manufacturing practices as described in : ( a ) Parts 210 and 211 of Title 21 of the United S tates ' 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 ; means Intellectual Property [ * * * ] ; has the meaning specified in Section 8.3(a)(vi ) ; has the meaning specified in Section 10.3(a ) ; means those Components to be supplied by Client o r that have been supplied by Client ; - 3 - THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT O F A CONFIDENTIAL TREATMENT REQUEST