definiens: shall have the meaning given to it in Section 3.3 ; ( c ) means any day other than a Saturday, Sunday or statutory holiday in the Province of Quebec ; ( d ) means the statute of Canada cited as R.S.C. 1985, c. F-27 and regulations thereto, as amended from time to time ; ( e ) means Canadian Blood Services ; ( f ) 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 ; ( g ) means individuals to be infused with Co mmercial Products or Fractionation Products or the legal guardians / trustees of these individuals ; ( h ) means the annual average index obtained by av eraging the indices for the twelve ( 12 ) months of the calendar year, as published by S tatistics Canada at the end of the previous calenda r year ; 2 ( i ) means April 1, 2008 ; ( j ) means the Food and Drug Administration of the United States of America, or any successor thereto ; ( k ) means the fifth ( 5th ) business day o f each month ; ( l ) means the Plasma Intermedi ates and products resulting from the process whereby Supplier fractionates Plasma ; ( m ) means the fractionation of Plasma into Fractionation Products ; ( n ) 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 ; ( o ) shall have the meaning given to it in Section 11.2(d)(i ) ; ( p ) means a change to any Product or Frac tionation Services which enhances the safety, efficacy, identity, potency or purity of the Produc t ; ( q ) means the supply management syst em used by HQ for inventory management of Products ; ( r ) means a product licensed by Heal th Canada for sale or distribution in Canada ; ( s ) means Recovered Plasma and Source Plasma c ollected in Canada ; ( t ) shall have the meaning given to it in Section 7.1 ; ( u ) means any by - products produc ed during the fractionation of the Plasma by Supplier and returned to HQ as directed by HQ from time to time ; ( v ) means collectively Fractionation Product s, Commercial Products and Replacement Fractionation Products ; ( w ) or includ es the product monograph, all labelling, package inserts and packaging for the Products as approved by Health Canada and for Products as set out in Schedule as amended from time to time ; ( x ) means those sites identified in Schedule ; ( y ) 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 ; ( z ) means the liquid portion of whol e human blood that remains after separation of the cellular elements from whole blood ; ( aa ) means products required by HQ pursuant to Sections 8.12, 9.3 and 9.4 and a Replacement Fractionation Product mea ns any one of them ; ( bb ) means products required by HQ pursuant to any of Sections 3.6, 3.8, 3.9, 13.4 and 17.1 ; ( cc ) means a twenty - four ( 24 ) month r olling forecast of HQ ’s total monthly volume requirement for Commercial Products ; 3 ( dd ) means all of the services expressly set out herein to be provided by Supplier, including th e fractionation of Plasma into Fractionation Products ; ( ee ) means that the total inventory of any Pr oduct, determined by combining the sum of issuable and not subject to a quarantine, Recall or Withdraw al, of Fractionation Products and/or Commercial Products in the Inventory System and in the Supplie r inventory dedicated to HQ has fallen below the level indicated in Schedule ; ( ff ) means Plasma collected by apheresis ; ( gg ) and means Health C anada ’s program to authorize distribution of unlicensed product in Canada ; ( hh ) means the target inventory for Frac tionation Products and Commercial Products ( in weeks ) as set out in Schedule and any changes t hereto as agreed in writing by the Parties ; ( ii ) means : For all the Fractionation Products and Commercial P roducts except HyperRAB MC S / D : That period of time commencing on the Effective Dat e and ending at the earlier of : ( i ) March 31, 2013 or ( ii ) termination of this Agreement as provided for herei n