definiens: shall have the meaning given to it in Section 3.3 ; means any day other than a Saturday, Sunday or statutory holiday in the Province of Ontario ; means the statute of Canada cited as R.S.C. 1985, c. F-27 and regulations thereto, as amended from time to time ; shall have the meaning given to it in Section 9.2(d)(i ) ; means all products from Suppl ier listed in Schedule and all additions, substitutions and deletions to the Schedule from ti me to time occurring during the Term of this Agreement and a Commercial Product means any one of them ; means individuals to be infused with Co mmercial Products or Fractionation Products or the legal guardians / trustees of these individuals ; means the annual average index obtained by av eraging the indices for the twelve ( 12 ) months of the calendar year, as published by Statis tics Canada at the end of the previous calendar yea r ; means April 1, 2008 ; means the Food and Drug Administration of the United States of America, or any successor thereto ; means the fifth ( 5 th ) business day of each month ; means the Plasma Intermedi ates and products resulting from the process whereby Supplier fractionates Plasma ; 2 shall hav e the meaning given to it in Section 5.1 ; means the fractionation of Plasma into Fractionation Products ; means Her Majesty the Queen in righ t of Canada as represented by the federal Minister of Health and is the Regulator of Products in Canada ; and means the blood management o rganization in the province of Quebec ; means a change to any Product or Frac tionation Service which enhances the safety, efficacy, identity, potency or purity of the Produc t ; means the supply management syst em used by CBS for national inventory management of plasma protein products ; means a product licensed by Heal th Canada for sale or distribution in Canada ; means Recovered Plasma and Source Plasma c ollected in Canada ; means any by - products produc ed during the fractionation of the Plasma by Supplier and returned to CBS as directed by CBS fro m time to time ; means collectively Fractionation Product s, Commercial Products, and Replacement Fractionation Products ; or includ es the product monograph, all labelling, package inserts and packaging for the Products as approved by Health Canada and for Commercial Products as set out in Schedule as amended from time to tim e ; means those sites identified in Schedule ; means any action ordered by Supplier to re move a Product from further distribution or use, or correction, of a Product that violates legislation administered by Health Canada, the FDA, or any othe r regulatory body with authority ; means the liquid portion of whol e human blood that remains after separation of the cellular elements from whole blood ; means products required by CBS pursuant to Sections 6.12, 7.3, 7.4, 11.4, and Schedule and a Replacement Fract ionation Product means any one of them ; 3 means products required by CB S pursuant to any of Sections 3.6, 3.8, 3.9, 11.4, 15.1, and Schedule ; means a twenty - four ( 24 ) month r olling forecast of CBS ’ total monthly volume requirement for Commercial Products ; means all of the services expressly set out herein to be provided by Supplier, including th e fractionation of Plasma into Fractionation Products ; means that the total inventory of any Pr oduct, issuable and riot subject to a quarantine, Recall or Withdrawal, of Fractionation Products and /or Commercial Products in the Inventory System has fallen below five ( 5 ) weeks supply for that Pro duct ; means Plasma collected by apheresis ; and means Health C anada ’s program to authorize distribution of unlicensed product in Canada ; means the target inventory for Frac tionation Products and Commercial Products ( in weeks ) as set out in Schedule or as agreed in w riting by the parties ; means that period of time commencing on the Effective Date and ending at the earlier of : ( i ) March 31, 2013 or ( ii ) termination of this Agreement as provided fo r herein