Exhibit 10.30


 


REF: C2007-034


 


	
   

  	
  FRACTIONATION
  SERVICES

  AND

  COMMERCIAL PRODUCTS

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  AGREEMENT

  	
  ***TEXT OMITTED AND SUBMITTED SEPARATELY
  PURSUANT TO CONFIDENTIAL TREATMENT REQUEST UNDER 17 C.F.R.
  SECTIONS 200.80(b)(4) AND 230.406

  
	
   

  	
   

  
	
   

  	
  BETWEEN
  AND AMONGST

  
	
   

  	
   

  
	
   

  	
  HÉMA-QUÉBEC

  
	
   

  	
   

  
	
   

  	
  AND

  
	
   

  	
   

  
	
   

  	
  TALECRIS
  BIOTHERAPEUTICS LTD.

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  AND

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  TALECRIS
  BIOTHERAPEUTICS INC.

  	
   

  



 


 

















 


TABLE
OF CONTENTS


 


	
  1.

  	
  DEFINED
  TERMS AND INTERPRETATION

  	
  2

  
	
   

  	
   

  	
   

  
	
  1.1

  	
  DEFINITIONS

  	
  2

  
	
  1.2

  	
  SCHEDULES

  	
  4

  
	
  1.3

  	
  LEAD

  	
  5

  
	
   

  	
   

  	
   

  
	
  2.

  	
  PURCHASE
  AND SALE OF GOODS/SERVICES

  	
  5

  
	
   

  	
   

  	
   

  
	
  2.1

  	
  GOODS AND SERVICES

  	
  5

  
	
  2.2

  	
  DISTRIBUTION OF
  PRODUCTS IN CANADA

  	
  5

  
	
   

  	
   

  	
   

  
	
  3.

  	
  DELIVERY
  OF COMMERCIAL PRODUCTS

  	
  6

  
	
   

  	
   

  	
   

  
	
  3.1

  	
  FORECASTING

  	
  6

  
	
  3.2

  	
  PRIOR FORECASTS TO BE HONOURED

  	
  6

  
	
  3.3

  	
  ORDER FOR COMMERCIAL PRODUCTS

  	
  6

  
	
  3.4

  	
  ANNUAL VOLUME AND PRICES ADJUSTMENTS

  	
  6

  
	
  3.5

  	
  DELIVERY

  	
  7

  
	
  3.6

  	
  LATE DELIVERIES

  	
  7

  
	
  3.7

  	
  VIAL SIZE AND PRODUCT INVENTORY

  	
  8

  
	
  3.8

  	
  COMMERCIAL PRODUCT RECALLED, WITHDRAWN OR NOT VALIDLY DISTRIBUTED

  	
  8

  
	
  3.9

  	
  PROCEDURES AND REMEDIES IN THE EVENT OF ALTERNATE SOURCING

  	
  8

  
	
  3.10

  	
  MINIMUM SUPPLY GUARANTEE TO FURTHER PROTECT CANADIANS

  	
  9

  
	
   

  	
   

  	
   

  
	
  4.

  	
  PRODUCT
  SPECIFICATIONS

  	
  10

  
	
   

  	
   

  	
   

  
	
  4.1

  	
  PRODUCT SPECIFICATIONS

  	
  10

  
	
  4.2

  	
  SUPPLIER DETERMINES PRODUCTS ARE UNSUITABLE

  	
  10

  
	
  4.3

  	
  HQ DETERMINES PRODUCTS ARE UNSUITABLE

  	
  10

  
	
  4.4

  	
  SIGNIFICANT REDUCTION IN CONSUMER PREFERENCE

  	
  11

  
	
   

  	
   

  	
   

  
	
  5.

  	
  B19
  TESTING

  	
  12

  
	
   

  	
   

  	
   

  
	
  6.

  	
  ISBT
  128 COMPLIANCE

  	
  12

  
	
   

  	
   

  	
   

  
	
  7.

  	
  FRACTIONATION
  SERVICES

  	
  12

  
	
   

  	
   

  	
   

  
	
  7.1

  	
  FORECASTING

  	
  12

  
	
  7.2

  	
  ORDER FOR FRACTIONATION PRODUCTS

  	
  12

  
	
  7.3

  	
  FORECASTING CONTINUED TO
  TERMINATION DATE

  	
  13

  
	
  7.4

  	
  SURVIVAL OF
  ORDERS AFTER TERMINATION

  	
  13

  
	
   

  	
   

  	
   

  
	
  8.

  	
  PLASMA
  COLLECTION AND PROCESSING

  	
  13

  
	
   

  	
   

  	
   

  
	
  8.1

  	
  PLASMA COLLECTION

  	
  13

  
	
  8.2

  	
  RESPONSIBILITY FOR PLASMA IN HQ’s POSSESSION

  	
  13

  
	
  8.3

  	
  NOTICE OF PLASMA PICKUP BY SUPPLIER

  	
  13

  
	
  8.4

  	
  PICKUP, TRANSPORTATION AND STORAGE OF PLASMA BY SUPPLIER

  	
  13

  
	
  8.5

  	
  PLASMA SEGREGATION

  	
  14

  
	
  8.6

  	
  SUPPLIER RESPONSIBLE FOR
  EXPORTATION OF PLASMA

  	
  14

  
	
  8.7

  	
  SHIPPING DOCUMENTS AND EXPORTATION OF PLASMA

  	
  14

  
	
  8.8

  	
  RESPONSIBILITY FOR
  PLASMA IN SUPPLIER’S
  POSSESSION

  	
  14

  
	
  8.9

  	
  SUPPLIER TO
  INSPECT PLASMA

  	
  15

  
	
  8.10

  	
  HQ DETERMINES PLASMA DELIVERED TO
  SUPPLIER IS UNSUITABLE

  	
  15

  
	
  8.11

  	
  RIGHT OF
  SUPPLIER TO REJECT HQ PLASMA

  	
  15

  
	
  8.12

  	
  PLASMA RENDERED UNUSABLE BY SUPPLIER

  	
  15

  
	
  8.13

  	
  REGULAR MEETINGS

  	
  16

  
	
  8.14

  	
  KEY PERFORMANCE INDICATORS

  	
  16

  
	
  8.15

  	
  CHANGE TO
  HQ STANDARD OPERATING
  PROCEDURES

  	
  17

  
	
   

  	
   

  	
   

  
	
  9.

  	
  DELIVERY
  OF FRACTIONATION PRODUCTS AND RECORDS

  	
  17

  



 


i

















 


	
  9.1

  	
  DELIVERY SCHEDULE AND REPORT ON STATUS OF FRACTIONATION PRODUCT
  DELIVERY

  	
  17

  
	
  9.2

  	
  WORK IN PROCESS

  	
  17

  
	
  9.3

  	
  NOTICE OF DELAY IN DELIVERY OF FRACTIONATION PRODUCTS

  	
  17

  
	
  9.4

  	
  DELAY IN DELIVERY OF FRACTIONATION PRODUCTS DUE
  TO HQ

  	
  18

  
	
  9.5

  	
  RECORDS

  	
  18

  
	
   

  	
   

  	
   

  
	
  10.

  	
  DELIVERY OF PRODUCT

  	
  18

  
	
   

  	
   

  	
   

  
	
  10.1

  	
  PRODUCT SHELF LIFE

  	
  18

  
	
  10.2

  	
  DELIVERY OF PRODUCTS

  	
  19

  
	
  10.3

  	
  RESPONSIBILITY FOR PRODUCTS

  	
  19

  
	
  10.4

  	
  DUTY OF INSPECTION

  	
  20

  
	
   

  	
   

  	
   

  
	
  11.

  	
  PRICES, PAYMENTS TERMS AND INVOICES

  	
  20

  
	
   

  	
   

  	
   

  
	
  11.1

  	
  PRICE

  	
  20

  
	
  11.2

  	
  PRICE ADJUSTMENTS

  	
  20

  
	
  11.3

  	
  PAYMENT TERMS

  	
  21

  
	
  11.4

  	
  INVOICES

  	
  22

  
	
  11.5

  	
  PRICING NOT AFFECTED BY REMEDIES

  	
  22

  
	
   

  	
   

  	
   

  
	
  12.

  	
  REGULATORY AND QUALITY ASSURANCE MATTERS

  	
  22

  
	
   

  	
   

  	
   

  
	
  12.1

  	
  REGULATORY CONDITION OF SUPPLY

  	
  22

  
	
  12.2

  	
  IMPROVEMENTS

  	
  22

  
	
  12.3

  	
  SPECIAL ACCESS PROGRAMME

  	
  23

  
	
  12.4

  	
  COMMUNICATIONS

  	
  23

  
	
  12.5

  	
  SUPPLIER INFORMATION

  	
  24

  
	
  12.6

  	
  COMPLIANCE AUDIT

  	
  24

  
	
   

  	
   

  	
   

  
	
  13.

  	
  PRODUCT WITHDRAWALS/RECALLS

  	
  24

  
	
   

  	
   

  	
   

  
	
  13.1

  	
  RECALL / WITHDRAWAL

  	
  24

  
	
  13.2

  	
  PATIENT NOTIFICATION SYSTEM

  	
  25

  
	
  13.3

  	
  ADVERSE EVENT REPORTING

  	
  25

  
	
  13.4

  	
  REPLACEMENT PRODUCTS AND REPLACEMENT FRACTIONATION
  PRODUCTS

  	
  26

  
	
   

  	
   

  	
   

  
	
  14.

  	
  REPRESENTATIONS, WARRANTIES AND INSPECTION

  	
  26

  
	
   

  	
   

  	
   

  
	
  14.1

  	
  REPRESENTATIONS AND WARRANTIES OF THE PARTIES

  	
  26

  
	
  14.2

  	
  REPRESENTATIONS AND WARRANTIES ON THE PRODUCTS

  	
  27

  
	
  14.3

  	
  TITLE AND WARRANTY ON THE PRODUCTS

  	
  27

  
	
  14.4

  	
  GUARANTEED YIELD

  	
  27

  
	
  14.5

  	
  CURRENT INFORMATION

  	
  28

  
	
  14.6

  	
  NO WAIVER

  	
  28

  
	
  14.7

  	
  SURVIVAL OF REPRESENTATIONS AND WARRANTIES

  	
  28

  
	
   

  	
   

  	
   

  
	
  15.

  	
  PATENT PROTECTION

  	
  28

  
	
   

  	
   

  	
   

  
	
  15.1

  	
  NO INFRINGEMENT

  	
  28

  
	
  15.2

  	
  INFRINGEMENT BY A PRODUCT OR PROCESS

  	
  28

  
	
   

  	
   

  	
   

  
	
  16.

  	
  INSURANCE AND INDEMNIFICATION

  	
  29

  
	
   

  	
   

  	
   

  
	
  16.1

  	
  SUPPLIER’S INSURANCE

  	
  29

  
	
  16.2

  	
  HQ INSURANCE

  	
  29

  
	
  16.3

  	
  INDEMNITY

  	
  30

  
	
  16.4

  	
  APPROVAL OF COUNSEL

  	
  31

  
	
   

  	
   

  	
   

  
	
  17.

  	
  CHANGE

  	
  31

  
	
   

  	
   

  	
   

  
	
  17.1

  	
  TECHNOLOGICAL CHANGE

  	
  31

  
	
  17.2

  	
  DISPUTE RESOLUTION

  	
  32

  
	
   

  	
   

  	
   

  
	
  18.

  	
  TERMINATION

  	
  33

  



 


ii

















 


	
  18.1

  	
  TERMINATION OF AGREEMENT

  	
  33

  
	
  18.2

  	
  SUPPLIER EVENT OF DEFAULT

  	
  33

  
	
  18.3

  	
  HQ EVENT OF DEFAULT

  	
  34

  
	
   

  	
   

  	
   

  
	
  19.

  	
  DISPUTE
  RESOLUTION

  	
  34

  
	
   

  	
   

  	
   

  
	
  19.1

  	
  ARBITRATION

  	
  34

  
	
   

  	
   

  	
   

  
	
  20.

  	
  OPTION
  TO RENEW

  	
  35

  
	
   

  	
   

  	
   

  
	
  20.1

  	
  RENEWAL

  	
  35

  
	
   

  	
   

  	
   

  
	
  21.

  	
  CUSTOMER
  SERVICE

  	
  36

  
	
   

  	
   

  	
   

  
	
  22.

  	
  VALUE
  ADDED

  	
  36

  
	
   

  	
   

  	
   

  
	
  23.

  	
  GENERAL

  	
  36

  
	
   

  	
   

  	
   

  
	
  23.1

  	
  EXTENDED MEANINGS

  	
  36

  
	
  23.2

  	
  TIME

  	
  36

  
	
  23.3

  	
  ENTIRE AGREEMENT

  	
  36

  
	
  23.4

  	
  NOTICES

  	
  36

  
	
  23.5

  	
  ASSIGNMENT

  	
  38

  
	
  23.6

  	
  INDEPENDENT CONTRACTORS

  	
  38

  
	
  23.7

  	
  SEVERABILITY

  	
  38

  
	
  23.8

  	
  COMMUNICATION

  	
  38

  
	
  23.9

  	
  GOVERNING LAW

  	
  38

  
	
  23.10

  	
  CURRENCY

  	
  39

  
	
  23.11

  	
  SUCCESSORS AND ASSIGNS

  	
  39

  
	
  23.12

  	
  NO WAIVER

  	
  39

  
	
  23.13

  	
  JOINT AND SEVERAL LIABILITY

  	
  39

  
	
  23.14

  	
  REMEDIES CUMULATIVE

  	
  39

  
	
  23.15

  	
  COUNTERPARTS

  	
  39

  
	
  23.16

  	
  AMENDMENT

  	
  39

  
	
  23.17

  	
  CONFIDENTIAL INFORMATION

  	
  39

  
	
  23.18

  	
  PRICING INFORMATION TO CUSTOMERS

  	
  40

  
	
  23.19

  	
  PUBLIC ANNOUNCEMENTS

  	
  40

  
	
  23.20

  	
  FORCE MAJEURE

  	
  40

  



 


	
  SCHEDULE
  “A” – COMMERCIAL PRODUCTS

  	
  42

  
	
   

  	
   

  
	
  SCHEDULE
  “B” – CURRENT PLASMA PRODUCTION SITES AND PLASMA PICK-UP SCHEDULE

  	
  43

  
	
   

  	
   

  
	
  SCHEDULE
  “C” – PRODUCT SPECIFICATIONS

  	
  44

  
	
   

  	
   

  
	
  SCHEDULE
  “D” – FRACTIONATION PRODUCTS AND PRICE FOR FRACTIONATION PRODUCTS

  	
  45

  
	
   

  	
   

  
	
  SCHEDULE
  “E” – INVENTORY LEVELS

  	
  46

  
	
   

  	
   

  
	
  SCHEDULE
  “F” – VIAL SIZES SUBSTITUTION / WASTAGE

  	
  47

  
	
   

  	
   

  
	
  SCHEDULE
  “G”– CUSTOMER SERVICE

  	
  48

  
	
   

  	
   

  
	
  SCHEDULE
  “H” – VALUE ADDED

  	
  49

  
	
   

  	
   

  
	
  SCHEDULE
  “I” – B19 TESTING SERVICES

  	
  51

  
	
   

  	
   

  
	
  SCHEDULE
  “J” – KEY PERFORMANCE INDICATORS PROGRAM

  	
  56

  



 


iii

















 


REF: C2007-034


 


FRACTIONATION SERVICES AND COMMERCIAL PRODUCTS AGREEMENT


 


THIS AGREEMENT effective as of and from April 1, 2008 (hereinafter
referred to as “Effective Date”) is made


 


	
  BETWEEN

  	
   

  
	
  AND AMONGST:

  	
   

  
	
   

  	
   

  
	
   

  	
  HÉMA-QUÉBEC

  
	
   

  	
  4045 Côte-Vertu
  Blvd.

  
	
   

  	
  Saint-Laurent
  (Québec) H4R 2W7

  
	
   

  	
  CANADA

  
	
   

  	
   

  
	
   

  	
  (hereinafter
  referred to as “HQ”)

  
	
   

  	
   

  
	
  AND:

  	
   

  
	
   

  	
   

  
	
   

  	
  TALECRIS BIOTHERAPEUTICS LTD.

  
	
   

  	
  5800
  Explorer Drive, Suite 300

  
	
   

  	
  Mississauga
  (Ontario) L4W 5K9

  
	
   

  	
  CANADA

  
	
   

  	
   

  
	
   

  	
  (hereinafter
  referred to as “TALECRIS CANADA”)

  
	
   

  	
   

  
	
  AND:

  	
   

  
	
   

  	
   

  
	
   

  	
  TALECRIS BIOTHERAPEUTICS INC.

  
	
   

  	
  P.O. Box
  11526

  
	
   

  	
  79 TW
  Alexander Drive

  
	
   

  	
  Research
  Triangle Park (North Carolina) 27709

  
	
   

  	
  USA

  
	
   

  	
   

  
	
   

  	
  (hereinafter
  referred to as “TALECRIS US”)

  
	
   

  	
   

  
	
   

  	
  (TALECRIS US
  and TALECRIS CANADA are hereinafter collectively referred to as the
  “Supplier”)

  



 


WHEREAS:


 


1)    HQ and CBS solicited proposals
from various interested parties to provide contract fractionation services and
various plasma derived products as more particularly set out in requests for
proposal “RFP #177-2006” issued January 12, 2007 and “RFP #181-2007”
issued April 16, 2007;


 


1

















 


2)    Supplier submitted proposals
to both HQ and CBS to supply contract fractionation services and commercial
products as more fully set out in the proposals dated February 5, 2007 and
May 14, 2007 ;


 


3)    Supplier submitted a separate
offer in response to HQ request for proposal entitled “AO 2006-027” for the
provision of rabies immune globulin product as more fully set out in its
proposal dated December 7, 2006; and


 


4)    Supplier wishes to sell to HQ
and HQ wishes to purchase from Supplier contract fractionation services
(hereinafter Fractionation Services) and various plasma derived commercial
products (hereinafter Commercial Products), subject to the terms and conditions
hereinafter contained; and


 


5)    The Parties wishe to
incorporate into the Agreement the provision for testing parvovirus B19 Samples
by the Supplier.


 


NOW THEREFORE in consideration
of the premises, covenants and agreements contained herein and other valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:


 


1.             DEFINED TERMS AND
INTERPRETATION


 


1.1          Definitions


 


Where used in this Agreement or
any amendments or supplements to it, the following terms shall have the
following meanings respectively:


 


(a)           “Agreement”, “this
Agreement” and similar expressions refer to this Agreement including the
Schedules referred to in Section 1.2 and not to any particular Article, Section or
other portion of this Agreement and include every amendment or instrument
supplementary to or in implementation of this Agreement;


 


(b)           “Binding Forecast”
shall have the meaning given to it in Section 3.3;


 


(c)           “Business Day” means
any day other than a Saturday, Sunday or statutory holiday in the Province of
Quebec;


 


(d)           “Canadian Food and
Drugs Act” means the statute of Canada cited as R.S.C. 1985, c. F-27 and
regulations thereto, as amended from time to time;


 


(e)           “CBS” means Canadian
Blood Services;


 


(f)            “Commercial Products”
means all products from Supplier listed in Schedule “A” and all additions,
substitutions and deletions to the Schedule from time to time occurring during
the Term of this Agreement and a Commercial Product means any one of them;


 


(g)           “Consumers” means
individuals to be infused with Commercial Products or Fractionation Products or
the legal guardians/trustees of these individuals;


 


(h)           “CPI” means the annual
average index obtained by averaging the “All items” indices for the twelve (12)
months of the calendar year, as published by Statistics Canada at the end of
the previous calendar year;


 


2

















 


(i)            “Effective Date” means
April 1, 2008;


 


(j)            “FDA” means the Food
and Drug Administration of the United States of America, or any successor
thereto;


 


(k)           “Forecast Day” means
the fifth (5th) business day of each month;


 


(l)            “Fractionation
Products” means the Plasma Intermediates and products resulting from the
process whereby Supplier fractionates Plasma;


 


(m)          “Fractionation Services”
means the fractionation of Plasma into Fractionation Products;


 


(n)           “Health Canada” means
Her Majesty the Queen in right of Canada as represented by the federal Minister
of Health and is the Regulator of Products in Canada;


 


(o)           “HQ Process” shall have
the meaning given to it in Section 11.2(d)(i);


 


(p)           “Improvement” means a
change to any Product or Fractionation Services which enhances the safety,
efficacy, identity, potency or purity of the Product;


 


(q)           “Inventory System”
means the supply management system used by HQ for inventory management of
Products;


 


(r)            “Licensed Product”
means a product licensed by Health Canada for sale or distribution in Canada;


 


(s)           “Plasma” means
Recovered Plasma and Source Plasma collected in Canada;


 


(t)            “Plasma and
Fractionation Products Rolling Forecast” shall have the meaning given to it in Section 7.1;


 


(u)           “Plasma Intermediates”
means any by-products produced during the fractionation of the Plasma by
Supplier and returned to HQ as directed by HQ from time to time;


 


(v)           “Products” means
collectively Fractionation Products, Commercial Products and Replacement
Fractionation Products;


 


(w)          “Product Specifications”
or “Specifications” includes 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 “C” as amended from time to time;


 


(x)           “Production Sites”
means those sites identified in Schedule “B”;


 


(y)           “Recall” means any
action ordered by Supplier to remove a Product from further distribution or
use, or correction, of a Product that violates legislation administered by
Health Canada, the FDA, or any other regulatory body with authority;


 


(z)           “Recovered Plasma”
means the liquid portion of whole human blood that remains after separation of
the cellular elements from whole blood;


 


(aa)         “Replacement Fractionation
Products” means products required by HQ pursuant to Sections 8.12, 9.3 and 9.4
and a Replacement Fractionation Product means any one of them;


 


(bb)        “Replacement Product”
means products required by HQ pursuant to any of Sections 3.6, 3.8, 3.9, 13.4 and
17.1;


 


(cc)         “Rolling Forecast” means
a twenty-four (24) month rolling forecast of HQ’s total monthly volume
requirement for Commercial Products;


 


3

















 


(dd)        “Services” means all of
the services expressly set out herein to be provided by Supplier, including the
fractionation of Plasma into Fractionation Products;


 


(ee)         “Shortage” means that the
total inventory of any Product, determined by combining the sum of issuable and
not subject to a quarantine, Recall or Withdrawal, of Fractionation Products
and/or Commercial Products in the Inventory System and in the Supplier
inventory dedicated to HQ has fallen below the level indicated in Schedule “E”;


 


(ff)          “Source Plasma” means
Plasma collected by apheresis;


 


(gg)        “Special Access Programme”
and “SAP” means Health Canada’s program to authorize distribution of unlicensed
product in Canada;


 


(hh)        “Target Levels” means the
target inventory for Fractionation Products and Commercial Products (in weeks)
as set out in Schedule “E” and any changes thereto as agreed in writing by the
Parties;


 


(ii)           “Term” means:


 


For all the Fractionation Products and Commercial Products except
HyperRABMC S/D:


 


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 for
herein.


 


For HyperRABMC S/D:


 


That period of time commencing on June 1, 2007 and ending at the
earlier of:


 


(i)  March 31, 2011; or


(ii) Termination of this Agreement as provided for herein.


 


Term also includes any extension or renewal of this Agreement as
evidenced in writing and signed by the Parties;


 


(jj)           “US”, “USA” and “United
States” refers to United States of America;


 


(kk)         “Warehouse” means HQ’s
primary warehouse at 4300 rue Garand, Saint-Laurent, (Québec), Canada, H4R 2A3,
or such other warehouse as may be designated in writing by HQ to Supplier and
consented to by Supplier, which consent will not unreasonably be withheld; and,


 


(ll)           “Withdrawal” means any
action ordered by Supplier or by HQ, in accordance with the terms of this
Agreement, to remove a Product from further distribution or use, or correction,
of a marketed product that does not violate legislation administered by Health
Canada.


 


1.2          Schedules


 


The following are the schedules which are referred to in this Agreement
and which form part of this Agreement:


 


Schedule “A” – Commercial Products, First
Year Purchase Volumes and Annual Purchase Volumes and Prices;


 


4

















 


	
  Schedule “B”

  	
  –

  	
  Plasma Production Sites and Plasma Pick-up Schedule;

  
	
  Schedule “C”

  	
  –

  	
  Commercial Product Specifications;

  
	
  Schedule “D”

  	
  –

  	
  Fractionation Products and Price Adjustments for Fractionation
  Products - Volume of Plasma Delivered;

  
	
  Schedule “E”

  	
  –

  	
  Inventory Levels;

  
	
  Schedule “F”

  	
  –

  	
  Vial Size Substitution / Wastage;

  
	
  Schedule “G”

  	
  –

  	
  Customer Service;

  
	
  Schedule “H”

  	
  –

  	
  Value Added;

  
	
  Schedule “I”

  	
  –

  	
  B19 Testing Services;

  
	
  Schedule “J”

  	
  –

  	
  Key performance indicators program

  



 


 


1.3          Lead


 


The Parties acknowledge that Supplier has entered into an agreement
similar in form and substance with CBS, for the supply and distribution of
Products. Supplier acknowledges that HQ and CBS pool Plasma for fractionation
and are together responsible for the supply of Fractionation Products to
Canadians. Supplier shall take directions only from CBS with respect to the
following:


 


(i)            decisions relating to
the acceptability of Plasma for pooling as between HQ and CBS;


 


(ii)           decisions relating to
changes in pooling, including but not limited to, the method of pooling,
testing of the pools, and tracking of the pools;


 


(iii)          decisions as to
Fractionation Product to be produced from the pool, including but not limited
to, vial size, and labelling; and


 


(iv)          disposition of Plasma Intermediates.


 


Supplier shall not take directions from HQ with respect to the Plasma,
or the pooling of the Plasma concerning the matters above without the express
written consent of CBS.


 


2.             PURCHASE AND SALE OF
GOODS/SERVICES


 


2.1          Goods and Services


 


HQ shall purchase or obtain from Supplier on a non-exclusive basis and
Supplier shall sell or provide to HQ, on the terms and conditions in this
Agreement, the Products and Services, in the quantities and for the prices set
forth in Schedule “A” and Schedule “D” beginning on April 1, 2008 and on
the Effective Date for HyperRABMC S/D. In connection with the
Fractionation Services, Supplier will, unless otherwise permitted by the
provisions of this Agreement, use Plasma provided to it by HQ.


 


2.2          Distribution of Products
in Canada


 


(a)           HQ hereby acknowledges
and covenants that the Products are and shall be for distribution by HQ in
Canada except that nothing herein shall prevent HQ from donating such Products
to organizations outside Canada for charitable purposes, with the written
permission of Supplier which permission will not unreasonably be withheld.


 


5

















 


(b)           HQ further agrees to
notify Supplier in writing as soon as reasonably possible if it suspects that
any of the Products are being obtained from HQ for use, distribution or sale
outside Canada, other than as set forth in Subsection 2.2(a) above.


 


3.             DELIVERY OF
COMMERCIAL PRODUCTS


 


3.1          Forecasting


 


HQ shall provide Supplier with the Rolling Forecast by the Forecast Day
each month.


 


3.2          Prior Forecasts to be
Honoured


 


The Parties acknowledge that forecasts and commitments have been made
prior to the Effective Date which are applicable for the first six (6) months
of this Agreement.


 


3.3          Order for Commercial
Products


 


(a)           Except for HyperRABMC
S/D, HQ shall provide to Supplier, for each Rolling Forecast provided by HQ,
the Product volumes identified in the first [***] months will be
considered a binding obligation of HQ to purchase and the Supplier to deliver
the Products identified within the forecast period. The volume by vial size of
such Product is then fixed for the first [***] months of each such
forecast (the “Binding Forecast”). Should HQ fail to provide a Rolling Forecast
in any month, the last Rolling Forecast provided will stand with the [***] month
window for product volume and with the [***] month window for vial size
configuration continuing for one (1) additional month.


 


(b)           For HyperRABMC
S/D, the Product volumes provided in the first [***] months will be
considered a binding obligation of HQ to purchase and the Supplier to deliver
the Products identified within the forecast period. Should HQ fail to provide a
Rolling Forecast in any month, the last Rolling Forecast provided will stand
with the [***] month window for product volume continuing for one (1) additional
month.


 


(c)           In each Binding
Forecast, HQ shall indicate the quantities to be delivered to HQ by Supplier in
each weekly delivery.


 


3.4          Annual Volume and Prices
Adjustments


 


(a)           The volume of
Commercial Products projected to be purchased by CBS and HQ and delivered by
Supplier during the first year of the Agreement is set out in Schedule “A”,
unless otherwise agreed to in writing by the Parties.


 


(b)           As of the second year
of the Agreement and for each subsequent Agreement year, HQ shall provide to
Supplier, the annual volume of Commercial Products that HQ will purchase in the
following year by [***] of the preceding year.


 


(c)           For Gamunex®,
Plasbumin® HyperHEPMC B S/D, HyperTETMC S/D
and GamaSTANMC S/D, HQ agrees to purchase, and Supplier agrees to
deliver, a volume for Commercial Product that is:


 






***CONFIDENTIAL TREATMENT REQUESTED


 


 


6

















 


·        For
the second year of the Agreement, between [***] and [***] of the previous year’s
purchase volume, unless otherwise agreed to in writing by both parties.


 


·        For
the subsequent years of the Agreement, between [***] and [***] of the previous
year purchase volume, unless otherwise agreed to in writing by both parties.


 


(d)           For HyperRABMC,
HQ agrees to purchase and Supplier agree to supply a minimum of [***] vials of
2mL HyperRABMC S/D per annum for the Agreement Term. In addition,
Supplier agrees to guarantee the supply of an additional [***] vials of 2 mL
HyperRABMC S/D in any or all years of the Agreement at the
prevailing Agreement price if requested in writing by HQ at least six (6) months
prior to the requested delivery date.


 


(e)           For each Commercial Product,
the unit price invoiced to HQ by the Supplier during the Agreement year will be
determined by the projected combined HQ and CBS purchase volume identified in
Schedule “A” for the 1st year or, for the subsequent years, the
volume communicated to the Supplier by [***] of the preceding Agreement year.


 


(f)            In the event that
actual combined HQ and CBS purchases in any Agreement year move the unit price
into a different price tier as identified in Schedule “A”, the unit price
applicable to the actual volume purchased by HQ shall be adjusted to reflect
the unit price tier applicable to the actual volume purchased by HQ and CBS as
shown in Schedule “A”. Any such adjustments, shall be credited by the Supplier
within thirty (30) days after the anniversary date of the Agreement, or
reimbursed by the Supplier for the last Agreement Year.


 


(g)           Adjustments to annual
purchase volumes may also result from HQ invoking its rights under Section 4.4
(Significant Reduction in Consumer Preference).


 


3.5          Delivery


 


Supplier shall deliver on a weekly basis or such other frequency as may
be agreed upon from time to time the Commercial Products to HQ as set out in
this Agreement and at the times and in the quantities set out in the Binding
Forecast. In the event that HQ’s delivery requirements change during the Term
other than as required by the Binding Forecast, HQ shall notify Supplier in
writing of the revised requirements. Supplier shall use its reasonable best
efforts to satisfy the revised requirements of HQ HQ and Supplier shall agree
in writing to the amended delivery schedule.


 


3.6          Late Deliveries


 


(a)           In the event that the
Supplier becomes aware that it does not expect to meet the delivery schedule in
the Binding Forecast, the Supplier shall promptly (but not later than [***]
after Supplier becomes aware of the delay) advise HQ of the reasons therefore,
and of the date by which the Supplier will be able to confirm whether it will
be able to meet the delivery schedule. As soon as the Supplier is able to
advise whether it can meet the delivery schedule, the Supplier shall notify HQ
in writing, which notice shall indicate the Supplier’s next anticipated
delivery date and delivery quantity. In the event that the Supplier’s inability
to meet one or more deliveries results in HQ inventory having less than [***] weeks
supply of a Product or HQ is expected to have less than [***] weeks supply
of a Product in HQ inventory at the time of Supplier’s next anticipated
shipment, HQ shall notify the Supplier in writing and the Supplier shall have
five (5) Business Days from receipt of such notice to make


 






***CONFIDENTIAL TREATMENT REQUESTED


 


 


7

















 


arrangements reasonably satisfactory to HQ to ensure delivery of
sufficient quantities of such Product, or of a substitute therapeutic for such
Product acceptable to HQ (“Replacement Product”), are delivered to HQ to
increase its inventory of such Product or of a substitute therapeutic to the
Target Level. If Supplier has not made such satisfactory arrangements within
the five (5) Business Days, HQ may purchase the above mentioned
Replacement Product from an alternate source(s) to replace that Product which
the Supplier has indicated that it is unable to supply and the remedies in Section 3.9
shall apply. The Supplier will make all reasonable efforts to assist HQ in
identifying an alternate source from which HQ can obtain Replacement Products.


 


(b)           To the extent that the
late delivery is the result of HQ requiring Products over and above the Binding
Forecast, then the provisions set out in Section 3.9 shall not apply.


 


3.7          Vial Size and Product Inventory


 


When a specific vial size of a Commercial Product is not delivered as
set out in the applicable Binding Forecast then the terms of Schedule “F” shall
govern.


 


In addition to the quantities received by HQ and held in its own
inventory, Supplier shall keep in inventory in Canada for the exclusive use of
HQ the inventory level indicated in Schedule “E” available for immediate
distribution to HQ and shall provide HQ on a weekly basis, a report
reflecting such inventory level. The Supplier shall plan production so as to
ensure continuous supply of the Product and comply with the minimum inventory
requirement identified above.


 


For the purposes of subsections 3.6(a) and 3.7, one (1) week
of inventory shall be 1/52nd of the volume set out in the annual
volumes as described in subsections 3.3 and 3.4 hereof. The quantity will be
adjusted on each Agreement anniversary date.


 


3.8          Commercial Product Recalled, Withdrawn or Not Validly Distributed


 


In the event of a:


 


(i)            Recall or Withdrawal
of any Commercial Product that results in a Shortage, provided that the cause
of such Shortage is not attributable to HQ; or,


 


(ii)           Determination by Health
Canada or any other governmental authority that the Commercial Product may not
be validly distributed or used in Canada and such determination results in a
Shortage, provided that the cause of such Shortage is not attributable to HQ;


 


and HQ acquires Replacement Product specifically to replace inventory
levels, such acquisition shall be governed by Section 3.9.


 


3.9          Procedures and Remedies in the Event of Alternate Sourcing


 


(a)           In the event of the
occurrence of an event as described in Sections 3.6, 3.8 and 3.10, Supplier
shall respond in writing to HQ within two (2) Business Days, or such
longer time period if agreed to by HQ and Supplier, confirming whether it can
provide Replacement Products and, if so, shall provide comprehensive
specifications and proposed delivery schedule for such Replacement Products
(the “Proposal”). If the Proposal is acceptable to HQ, HQ will so


 


8

















 


advise Supplier and the supply of the Replacement Product shall be
governed by the terms of this Agreement.


 


(b)           If HQ, acting
reasonably, rejects the Proposal or if no Proposal is offered within the
stipulated or agreed time frame, HQ may proceed to locate Replacement Products
from a third party selected by HQ. The quantity of Replacement Product
purchased by HQ pursuant to this paragraph shall be obtained solely for the
purpose of averting any Shortage. Supplier acknowledges that HQ has the right
to purchase sufficient Replacement Product to re-establish its Target Level
inventory. Supplier shall have the right to review the proposed purchase of
Replacement Product by HQ and consent of Supplier to the purchase is required
if reimbursement is to be sought by HQ. Supplier shall respond to HQ within one
(1) Business Day of receipt of the notice of the proposed purchase of
Replacement Product. If Supplier fails to respond in one (1) Business Day,
then it shall be deemed to have consented. Consent of Supplier will not be
unreasonably withheld.


 


(c)           A notice sent by
facsimile pursuant to the Sections 3.6, 3.8, 3.9 shall be followed with a
confirmatory discussion with a representative of the Supplier.


 


(d)           If Replacement Product
is purchased by HQ from a third party with the consent of Supplier, or if it is
subsequently determined that Supplier’s refusal to consent to the purchase was
unreasonable, Supplier shall compensate HQ for the amount, if any, that the
price HQ would have had to pay to Supplier for the Commercial Product had it
been delivered pursuant to this Agreement is less than the price paid to
purchase the Replacement Product. Such amounts shall be due and payable, in
cash or in credit at the option of Supplier within fifteen (15) days of
delivery by HQ of an invoice for such amounts. Compensation by Supplier of HQ
pursuant to this paragraph shall be the limit of Supplier’s liability
hereunder.


 


(e)           In the event the price
of a Replacement Product for HyperHEP BMC S/D purchased from an
alternate supplier is higher than the Agreement price, Supplier will compensate
HQ the difference in price up to a maximum of [***] of the projected sales per
Agreement year for HyperHEP BMC S/D, as outlined in Schedule A.


 


(f)            For HyperRabMC
S/D, Supplier will make commercially reasonable efforts to guarantee the supply
of 2 mL vial size HyperRABMC S/D in the appropropriate quantity
however, if HyperRABMC S/D cannot be supplied, Supplier will work
with HQ to identify an acceptable alternate supplier. In the event the price of
a Replacement Product for HyperRABMC S/D purchased from an
alternate supplier is higher than the Agreement price, Supplier will pay a
purchase cost differential not to exceed [***] for the entire Term for HyperRABMC
S/D. The [***] limit will not apply in the event Supplier fails to supply the
agreed upon quantities as a result of willful misconduct.


 


(g)           Nothing in this Section 3.9
shall limit the right of HQ to terminate this Agreement pursuant to Section 18
should the occurrence of an event as described in Section 3.8 constitute a
material breach of this Agreement.


 


3.10        Minimum Supply Guarantee
to Further Protect Canadians


 


Supplier will supply to HQ and CBS as follows:


 


(i)            In the event that
Supplier is able to produce [***] or more of Supplier’s planned global output,
HQ and CBS will receive its full Commercial Product delivery; or


 






***CONFIDENTIAL TREATMENT REQUESTED


 


9

















 


(ii)           In the event that
Supplier produces between [***] and [***] of Supplier’s planned global output,
HQ and CBS will be protected from the full impact of a shortage by receiving [***]
more of Supplier’s Commercial Product allocation from Supplier than HQ and CBS
would be proportionally entitled; or


 


(iii)          In the event that Supplier
produces between [***] and [***] of Supplier’s planned global output, HQ and
CBS will be protected from the full impact of a shortage by receiving [***]
more of Supplier’s Commercial Product allocation from Supplier than HQ and CBS
would be proportionally entitled; or


 


(iv)          In the event that
Supplier produces between [***] and [***] of Supplier’s planned global output,
HQ and CBS will be protected from the full impact of a shortage by receiving [***]
more of Supplier’s Commercial Product allocation from Supplier than HQ and CBS
would be proportionally entitled.


 


(v)           In the event that
Supplier produces less than [***] of Supplier’s planned global output, HQ and
CBS will be protected from the full impact of a shortage by receiving [***]
more of Supplier’s Commercial Product allocation from Supplier than HQ and CBS
would be proportionally entitled.


 


This is in addition to all other rights pursuant to this Agreement when
Supplier is unable to supply Commercial Product.


 


4.             PRODUCT
SPECIFICATIONS


 


4.1          Product Specifications


 


Supplier shall provide to HQ Products in accordance with the
Specifications, as set out in Schedule C, as amended from time to time by
Supplier.


 


4.2          Supplier Determines
Products are Unsuitable


 


If, after any Products have been delivered to HQ, Supplier determines
in its reasonable discretion that any Products are unsuitable or defective in
any manner, and that such unsuitability or defect creates a reasonable
likelihood of adverse risk to the safety or quality of any Products, Supplier
shall give immediate notice by telephone and facsimile transmission to HQ of
any such deficiency. In the event that Supplier, acting reasonably, notifies HQ
that Supplier is Recalling or Withdrawing any Products, or is taking any other
action to remedy any deficiencies in the Products, and requests that HQ
co-operate in any such Recall or Withdrawal, or take action to remedy any
deficiency in the Products (which request shall not be made unreasonably), HQ
shall reasonably co-operate in any such Recall or Withdrawal, or shall take
such action as is reasonably required by Supplier to remedy any deficiency in
the Products. The costs of such Withdrawal, Recall or other action, including
the cost of repairing or replacing any Products, shall be paid by Supplier.


 


4.3          HQ Determines Products
are Unsuitable


 


(a)           If HQ determines, in
its reasonable discretion, that any Product is unsuitable or defective in any
manner and that such unsuitability or defect creates a reasonable likelihood of
adverse risk to the safety or quality of the Product, HQ shall immediately
notify Supplier, by telephone and facsimile transmission, of such deficiency.
In the event that HQ, acting


 






***CONFIDENTIAL TREATMENT REQUESTED


 


10

















 


reasonably, notifies Supplier, that it is proceeding with the
Withdrawal or quarantine of any Product, or is taking any other action to
remedy any deficiencies in the Product, Supplier shall reasonably co-operate in
any such action as is required by HQ to remedy any deficiency. The costs of
such action, including the cost of repairing or replacing any Products, shall
be paid by HQ if it is the party to whom causation is attributable or by
Supplier is the party to whom causation is attributable. For greater certainty,
HQ is not required to notify Supplier of any defect or possible defect caused
by HQ while the Product is in HQ’s care and control and where there is no
impact on Supplier under this Agreement, unless otherwise required by any
regulatory authority.


 


(b)           In the event that HQ
has caused the Withdrawal or quarantine of a Product pursuant to Subsection
4.3(a), and it is subsequently determined that the Product did or does not
create a reasonable likelihood of adverse risk to the safety or quality of the
Product, as determined by Health Canada, HQ will be required to:


 


(i)           return
the Product to the market or remove the quarantine as applicable; and


(ii)          compensate
Supplier for the direct costs to Supplier of such Withdrawal or quarantine.


 


4.4          Significant Reduction in
Consumer Preference


 


(a)           A significant reduction
in Consumer preference for a Commercial Product occurs when issues by HQ to its
Customers for a Commercial Product drop for two (2) consecutive months
with a fifteen percent (15%) monthly decline below the previous six (6) month
rolling average, together with evidence that the total market for the type of
product in question has not decreased. HQ shall be required to notify Supplier
as soon as possible in writing in the event that HQ intends to implement this
Consumer preference clause. Such notification shall contain evidence of two (2) consecutive
months with a fifteen percent (15%) monthly decline in Commercial Products
orders and evidence that the total market for that type of product has not
declined in a similar manner. HQ will informally communicate to Supplier as
soon as it suspects that this Consumer preference clause may need to be invoked
to allow Supplier to implement a plan to restore Consumer preference as soon as
possible. For greater certainty, if the decline in demand is due to a shift by
Consumers to another manufacturer’s product that is functionally equivalent to,
but significantly technologically and/or scientifically superior to the
Commercial Product, then HQ shall exercise the recourse set out in Section 17.1.


 


(b)           Following written
notice that HQ intends to invoke Subsection 4.4(a), Supplier will be granted:


 


(i)            two (2) months to
restore at least twenty-five percent (25%) of the total drop in orders;


(ii)           if at the end of this
two (2) month period, Supplier has restored twenty-five percent (25%) of
the orders, Supplier shall be granted a further two (2) months to restore
orders to the level that existed prior to the two (2) consecutive months
with the fifteen percent (15%) monthly decline.


 


(c)           In the event that
Supplier fails to restore orders as set out in Paragraphs (i) and (ii) above,
then the annual volume of the specific Commercial Product forecast by HQ shall
be adjusted to reflect the loss of demand for the specific Commercial Product
and the pricing shall be adjusted according to Schedule “A”.


 


11

















 


(d)           In the event that
Supplier does restore orders for the Commercial Product as provided for in this
Section, the amount by which the volume declined during the initial two (2) months
decline and the time set out in Subsections 4.4(b)(i) and 4.4(b)(ii), if
applicable, will be deducted without penalty from the annual volume of
Commercial Products forecast by HQ without any increase in price.


 


5.           B19 TESTING


 


The Supplier shall provide testing services for parvovirus B19.
Specific guidelines applicable to this testing are contained in Schedule “I”.


 


6.           ISBT 128 COMPLIANCE


 


The Supplier convenants to develop systems and procedures to receive
and process Plasma and B19 tubes which have been labeled with ISBT 128
barcodes. The implementation of the systems and procedures shall be done no
later than July 1, 2009.


 


The prices charged for the Products and Services are deemed to include
the implementation by the Supplier of the ISBT 128 standards.


 


7.           FRACTIONATION SERVICES


 


7.1          Forecasting


 


By August 1 of each Agreement year, HQ shall provide Supplier with
a twenty-four (24) month rolling forecast of the projected monthly supply of
Plasma available to the Supplier for fractionation (“Plasma Volume Forecast”).
The Plasma Volume Forecast shall be updated by HQ and provided to the Supplier
on a quarterly basis. In the event the Plasma Volume Forecast is not updated
and provided to Supplier for any quarter, the preceding Plasma Volume Forecast
shall stand. Notwithstanding the foregoing, HQ and CBS shall collectively deliver
to Supplier not less than [***] litres of Plasma per year for fractionation.


 


Each month, by the Forecast Day, HQ shall provide to Supplier with a
twenty-four (24) month rolling forecast of HQ’s monthly delivery requirements
for Fractionation Products (“Fractionation Products Rolling Forecast”).


 


7.2          Order for Fractionation
Products


 


The forecast for each [***] month period immediately following
each Forecast Day in the Plasma and Fractionation Products Rolling Forecast
shall be deemed to be a commitment by HQ to purchase from Supplier and for
Supplier to deliver, the Fractionation Products shown in the [***] month
forecast and may not be amended except by the mutual written agreement of HQ
and Supplier. This [***] month portion of the Plasma and Fractionation
Products Rolling Forecast shall include specific ordering instructions for vial
sizes as well as quantities of Fractionation Products.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


 


12














 


7.3                               Forecasting
Continued to Termination Date


 


The
Parties hereto agree that HQ will continue to submit a Fractionation Products
Rolling Forecast to Supplier on a monthly basis until this Agreement is
terminated unless Supplier and HQ agree in writing to phase out or amend the
requirement for a monthly Fractionation Products Rolling Forecast as this
Agreement approaches the end of the Term.


 


7.4                               Survival of
Orders after Termination


 


Any
Plasma picked up by Supplier from HQ for fractionation by Supplier into
Fractionation Products prior to the termination or expiration of this Agreement
shall be fractionated by Supplier into Fractionated Products and for resale to
HQ pursuant to this Agreement, and the rights and obligations of the Parties
hereto shall survive termination of the Agreement.


 


8.                                      PLASMA COLLECTION AND PROCESSING


 


8.1                               Plasma
Collection


 


HQ
agrees that all Plasma it collects in Canada for pickup by Supplier for
fractionation by Supplier shall be collected, stored and transported in
accordance with the Canadian Food and Drugs
Act and the Drugs
Directorate Guidelines on Blood Collection and Blood Component Manufacturing,
1992, established plasma specifications, and any amendments thereto, and in
accordance with current import/export regulations.


 


8.2                               Responsibility
for Plasma in HQ’s Possession


 


HQ
shall be responsible for and shall bear all risk of loss or damage to the
Plasma collected while it is in its care, custody and
control until picked up by Supplier or its agents, including but not limited to
any loss or damage resulting from the improper storage, handling, packing,
crating, and/or blocking, transportation of the Plasma at the Production Sites,
except as otherwise provided in this Agreement.


 


8.3                               Notice of
Plasma Pickup by Supplier


 


As
of the Effective Date, Supplier shall follow the schedule of collection of
Plasma set out in Schedule “B”. Notwithstanding the foregoing, Supplier shall
provide HQ with reasonable advance notice of:


 


(i)                                   the time of
pick up of any Plasma from the Production Sites (during normal business hours),
such advance notice being not less than forty-eight (48) hours; and


(ii)                                an annual
schedule for each calendar year for the pick-up of Plasma from the Production
Sites for transport to Supplier’s fractionation facility will be agreed upon by
Supplier and HQ, taking into account the quantity of Plasma to be collected,
storage capabilities and procurement plans. Such schedule is to serve as a
guideline and may be amended upon reasonable notice to Supplier.


 


8.4                               Pickup,
Transportation and Storage of Plasma by Supplier


 


Supplier
agrees to provide HQ with appropriate shipping containers, at no cost to HQ, to
be utilized for the storage and transportation of the frozen Plasma. Supplier
shall be required at its own expense to


 


13

















 


pick
up the Plasma from the Production Sites and arrange for storage if required.
Supplier reserves the right to select, in reasonable consultation with HQ, an
alternate carrier or storage facility at any time.


 


8.5                               Plasma
Segregation


 


HQ
further acknowledges and agrees that should any Plasma be held by HQ for
transport to a fractionator other than Supplier, HQ must ensure:


 


(i)                                  that the Plasma
destined for a third party never be handled by Supplier;


 


(ii)                               that boxes,
bags or other containers of Supplier are never used to store or transport
Plasma destined for a third party fractionator; and


 


(iii)                            that any Plasma
to be sent to a third party fractionator be stored separately from Plasma to be
picked up by Supplier and be clearly marked as destined for such third party
fractionator.


 


8.6                               Supplier
Responsible for Exportation of Plasma


 


Supplier
is responsible for all costs incurred for the exportation of Plasma outside of
Canada and re-importation of Products to Canada including transportation, duty,
excise, brokerage fees and customs in addition to ensuring documentation is
prepared and available as required for exportation.


 


8.7                               Shipping
Documents and Exportation of Plasma


 


Prior
to each Plasma shipment from the storage facility, Supplier will receive from
HQ;


 


(i)                                     consolidated Plasma shipment
summary document;


(ii)                                  statement of value for
customs purposes; and


(iii)                               copies of Production Sites
Plasma shipment summaries.


 


Donation
detail lists (plasma unit sheets listing testing and acceptance) shall be
shipped directly to the fractionation facility concurrent with the consolidated
Plasma shipment.


 


8.8                               Responsibility
for Plasma in Supplier’s Possession


 


Supplier
shall be responsible for and shall bear all risk of loss or damage to the
Plasma while it is in the care, custody and control of Supplier or that of its
shipper or its agents. This responsibility includes, but is not limited to, any
loss or damage resulting from the improper storage, handling, loading, blocking
and/or transportation of the Plasma, except as otherwise provided for herein,
together with responsibility for the manufacture of all Plasma Intermediates
and Fractionation Products required hereunder. Supplier shall take all
reasonable steps within their respective responsibilities to ensure that Plasma
and Fractionation Products are appropriately segregated and not intermingled
with other raw materials or Fractionation Products when in its care and
control.


 


14

















 


8.9                               Supplier to
Inspect Plasma


 


Immediately
prior to the pooling of Plasma at Supplier’s fractionation facility, Supplier
shall inspect the Plasma or otherwise ascertain that it conforms to the
requirements of the appropriate regulatory authorities.


 


8.10                        HQ
Determines Plasma Delivered to Supplier is Unsuitable


 


If,
after any Plasma has been picked up by Supplier, HQ determines, acting
reasonably, that any of the Plasma is unsuitable or poses a reasonable
likelihood of adverse risk to the safety or quality of any of the Fractionation
Products, HQ shall immediately notify Supplier by telephone and facsimile
transmission and shall provide instructions for disposition of the Plasma. All
rejected Plasma or Plasma Intermediates shall be held at the expense and risk
of HQ until HQ directs Supplier on their disposition. However, if such
circumstance is due to the negligence or wilful misconduct of Supplier, such
costs shall be borne by Supplier.


 


8.11                        Right of
Supplier to Reject HQ Plasma


 


(a)                                  Supplier shall have the
right, at any time while the Plasma is in its possession, as applicable,
including after the Plasma has been pooled and during the fractionation
process, to reject any Plasma or Plasma Intermediates which:


 


(i)                                   are determined
to be deficient by HQ, with notice of any such deficiency to be provided to
Supplier pursuant to Section 8.10, or


(ii)                                do not meet the
standards set out in Section 8.1, or


(iii)                             are otherwise
damaged, possibly contaminated, improperly packaged, labelled, stored, or
improperly documented, or


(iv)                            are, in the
reasonable discretion of Supplier, unsuitable or pose a reasonable likelihood
of adverse risk to the safety, quality, purity, potency or efficacy of any of
Fractionation Products.


 


(b)                                 Supplier shall immediately
notify HQ by telephone and facsimile transmission of any such rejection by
Supplier. HQ shall co-operate with Supplier in any efforts to correct any
deficiency attributable to any Plasma. Any retesting, reprocessing or
additional processing and testing of Plasma, Plasma Intermediates or
Fractionation Products shall be done by Supplier at the sole cost and expense
of HQ with HQ’s consent, except in the case of rejected Plasma or Plasma
Intermediates which are the responsibility of Supplier as provided for in Section 8.12.
All rejected Plasma or Plasma Intermediates shall be held at the expense and
risk of HQ until HQ directs Supplier on their disposition. However, if such
circumstance is due to the negligence or wilful misconduct of Supplier, all
such costs shall be paid by Supplier.


 


8.12                        Plasma
Rendered Unusable by Supplier


 


(a)                                  If any Plasma is rendered
unusable while it is in the care, custody and control of Supplier, it shall
replace Fractionation Products that were to result from the fractionation of
such Plasma with equivalent products manufactured by Supplier (“Replacement
Fractionation Products”). These Replacement Fractionation Products are to be
supplied to HQ at the same cost as HQ


 


15

















 


would
have been required to pay for Fractionation Products had Supplier not rendered
the Plasma unusable. The availability of Replacement Fractionation Products
from Supplier for the purpose of this Section shall be determined at the
sole discretion of Supplier acting reasonably. Supplier shall supply and
deliver Replacement Fractionation Products on the date scheduled for the
delivery of the Fractionation Products.


 


(b)                                 In the event that Supplier
is unable to supply Replacement Fractionation Products as set out above HQ may
begin the procedures set out in Subsections 3.9(b) and (d).


 


8.13                        Regular
Meetings


 


The
Parties will, with CBS, which organization also has an agreement with Supplier,
meet at least every six (6) months during the Term, beginning in the first
quarter after the Effective Date (Fractionation Meeting). The purpose of these
meetings is to discuss matters related to this Agreement including, but not
limited to, reconciliation of Plasma and Products, operational issues, new
processes, procedures and products, inventory levels and regulatory issues.
Supplier shall provide Canadian and global adverse drug reaction data for the
Products at least every six (6) months at these meetings. Meetings may be
cancelled if HQ, CBS and Supplier agree. HQ or Supplier may call a special
meeting by giving written notice to the other party or parties and CBS. The
location of the meetings is to be Ottawa, unless otherwise agreed. The Parties
agree to have the necessary and appropriate representatives, as identified
prior to the meeting, in attendance at the meetings. Supplier shall provide to
HQ in writing, a complete reconciliation report of Plasma and Products two (2) weeks
prior to each meeting, provided that the meeting is scheduled at least six (6) weeks
following the end of the prior quarter.


 


HQ
shall hold independently monthly meetings with the Supplier for the purpose of
discussing, assessing and resolving issues related to or which may arise during
the execution of the Agreement. Meeting agendas will be prepared ahead of the
scheduled meeting date by HQ after consultation with the Supplier. Unless
otherwise agreed by both parties, the venue for the meetings shall be in
Montréal and the parties shall identify ahead of the scheduled meeting date,
and will endeavour to have for such meetings the relevant staff for the issues
on hand. Each party shall be responsible for its respective travel and living
expenses, when applicable.


 


8.14                        Key
performance indicators


 


The
performance of the Supplier will be monitored by HQ based on four (4) indicators:
delivery performance, product conformance, contract-partnership and customer
service. The main objective of the program is to optimize the results to ensure
maximum efficiency of the management of the Products. The objective of the
program, as set out in Schedule “J” is for the Supplier to achieve an overall
global performance of [***]. However, the Supplier is required to maintain a
minimum performance rating of [***] for deliveries, and of [***] for Supplier
Inventory Level. Failure to meet the minimum performance rating of [***] for
deliveries, and [***] for Supplier Inventory Level shall constitute a material
breach of the Supplier under the Agreement. Notwithstanding the foregoing,
Supplier’s failure to achieve an overall performance of [***], shall not
constitute a breach of this Agreement by the Supplier.


 






***CONFIDENTIAL
TREATMENT REQUESTED


 


16

















 


8.15                        Change to
HQ Standard Operating Procedures


 


(a)                                 In the event
that HQ materially alters any of its Standard Operating Procedures (“SOP”)
affecting the collection of the Plasma to be used for Fractionation Services
during the Term of this Agreement, unless otherwise agreed in writing, HQ must
inform Supplier of the proposed change at least sixty (60) days in advance of
implementing the change or, if such change is imposed by Health Canada within a
shorter time frame, then HQ will notify Supplier as soon as reasonably
possible. HQ will work with
Supplier to evaluate the consequences of any such change on the Services.


 


(b)                                Within sixty
(60) days of receipt of plan from HQ regarding implementing a change, Supplier
shall submit to HQ a report detailing any increased or decreased costs
associated with the change in SOP, including the cost of investigation such as
additional validation work or pathogen safety research that may be required. it
deems such costs reasonable and agrees to pay such costs.


 


9.                                      DELIVERY OF FRACTIONATION PRODUCTS AND RECORDS


 


9.1                               Delivery
Schedule and Report on Status of Fractionation Product Delivery


 


Supplier
shall deliver Fractionation Products in accordance with the Fractionation
Products Rolling Forecast and Supplier shall be required to provide written
updates to HQ by the 10th business day of each month, which shall
include delivery status plans, split reconciliation report and a confirmation
that the Fractionation Products to be delivered for the upcoming two (2) month
period (“Projected Delivery”).


 


9.2                               Work in
Process


 


(a)                                  The amount of Work in
Process Inventory (as defined in Section 9.2 (b) below) as measured
by the volume in litres of Plasma held and in process, shall not exceed the
volume of Plasma picked up by Supplier from HQ and CBS in the previous eight (8) months
unless the excess volume is caused directly or indirectly by HQ or CBS.  Supplier shall not be responsible for
disruption in processing caused by insufficient Plasma available for pickup
from HQ and CBS.


 


(b)                                 Work in Process Inventory
includes all Plasma provided by HQ and CBS that has been picked up by Supplier
for Fractionation Services. It also includes all Fractionation Products, not
yet released for distribution by Health Canada, processed from Plasma provided
by HQ and CBS in the possession of Supplier. Work in Process Inventory does not
include Plasma collected by HQ and CBS held in Canada awaiting pick up by
Supplier unless delay in processing is due to Supplier’s failure to pick up
Plasma.


 


9.3                               Notice of
Delay in Delivery of Fractionation Products


 


(a)                                  Except as provided for in Section 9.4,
should it become apparent prior to a projected delivery date that a delivery of
Fractionation Products cannot be made as scheduled in the four (4) month
forecast, Supplier shall promptly (but not later than forty-eight (48) hours
after Supplier becomes aware of the delay) notify HQ of such delay and provide
HQ with an estimate, by telephone and facsimile transmission, of when
Fractionation Product will be


 


17

















 


delivered.
If the delay in delivery will result in, or is likely to result in, a Shortage
of any Fractionation Product, Supplier shall be required, whenever possible, to
provide Replacement Fractionation Products to HQ at the same price at which
Supplier would have provided Fractionation Products pursuant to this Agreement.
The availability of Replacement Fractionation Products from Supplier for the
purpose of this Section shall be determined at the sole discretion of
Supplier acting reasonably.


 


(b)                                 In the event that Supplier
is unable to supply Replacement Fractionation Products as set out above, HQ may
begin the procedures set out in Subsections 3.9 (b) and (d).


 


(c)                                  Supplier shall reimburse HQ
for any reasonable out-of-pocket expenses incurred by HQ in connection with any
delay described in Section 9.3 (a) above, including, without
limitation, expenses relating to required communications with Consumers,
hospitals and clinics.


 


9.4                               Delay in
Delivery of Fractionation Products due to HQ


 


Any
delay in the delivery of Fractionation Products resulting from the failure of
HQ or CBS to make the Plasma available to Supplier in accordance with the
Plasma and Fractionation Products Rolling Forecast shall be the responsibility
of HQ and CBS, and Supplier shall have no liability or responsibility
therefrom. Supplier will make reasonable effort to fractionate the delayed
shipment in a timely manner. In the event of any such delay, Supplier agrees to
substitute Replacement Fractionation Products for Fractionation Products if
available, on the terms and conditions provided for in this Agreement. The
availability of Replacement Fractionation Products from Supplier for the
purpose of this Section shall be determined at the sole discretion of
Supplier acting reasonably.


 


9.5                               Records


 


Supplier
shall maintain accurate records from the time that Supplier, as applicable,
takes possession of the Plasma, including but not limited to, as applicable,
records of the Plasma, Plasma Intermediates and Fractionation Products during
acceptance, processing and storage, as well as laboratory testing reports,
assays, correspondence and other documents concerning lot processing, tracking
plasma units throughout the fractionation process and releases. Such records
shall be made available for examination by duly authorized representatives of
HQ upon reasonable request.


 


10.                               DELIVERY OF PRODUCT


 


10.1                        Product
Shelf Life


 


Supplier
shall ensure that all Products shipped to HQ pursuant to this Agreement shall
have a remaining minimum shelf life of twelve (12) months from the date of
receipt by HQ. Where a Product or vial size is in short supply, and the
available Product has less than the minimum remaining shelf life but no less
than six (6) months remaining shelf life, Supplier shall be entitled to
deliver to HQ the Product with Supplier’s agreement to take back any unused
Product remaining in HQ’s inventory at the time of outdating. Where the only
Product available has less than six (6) months remaining shelf life,
Supplier and HQ must agree to the shortened shelf life in writing and Supplier
agrees to take back any unused Product remaining in HQ’s inventory at the time
of outdating, all at Supplier’s cost. All costs incurred for Products returned
by HQ under this Section shall be either credited by the Supplier or if
the contract has been terminated or has ended, a check shall be sent no later
than thirty (30) days from the date of such claim submitted in writing by HQ.


 


18

















 


10.2                        Delivery of
Products


 


(a)                                  Supplier will provide to HQ
documentation satisfactory to HQ to establish that the Products received by HQ
were transported under conditions where their quality and safety were not
compromised.


 


(b)                                 Supplier agrees to transport
all Products using a carrier
selected by Supplier, which shall be required to operate in compliance with
Supplier’s established standard operating procedures.


 


(c)                                  When Products are available
for shipment to HQ, a shipment notification shall be sent by Supplier, by
facsimile or email to HQ at least 24 hours prior to shipment for each lot, outlining
the projected delivery date and method, product code, lot number expiry date,
quantity, and include a copy of Health Canada’s lot release, and the
certificate of analysis which includes the date and place of manufacture of the
Product and the quality control test results as well as their acceptable
ranges.


 


(d)                                 Supplier agrees to
coordinate all importation of the Products into Canada and to be responsible
for all costs associated with the delivery of the Products into Canada and to
the Warehouse, including transportation, storage, customs, excise, duty and
brokerage fees.


 


(e)                                  The Products will be
delivered by Supplier to the Warehouse. In the event that HQ changes the
location of its Warehouse during the Term:


 


(i)                                     where there are additional
costs associated with the change of location, HQ shall be responsible for such
additional costs associated with the delivery of the Products to the new
location; or


 


(ii)                                  where there is a decrease in
cost associated with the change of location, HQ shall be entitled to a price
reduction for such decrease in costs associated with the delivery of the
Products to the new location.


 


Such
costs shall include transportation, storage, customs, excise, duty and
brokerage fees incurred by reason of such change of location. In emergencies or
other extenuating circumstances Supplier will, at the request of HQ, deliver
Products to destinations other than the Warehouse. Any additional costs
resulting from such change in delivery shall be the responsibility of HQ;
unless said emergency and/or extenuating circumstances arise directly or
indirectly from the actions, whether negligent or not, omissions or misconduct
of Supplier, Supplier’s carrier or its permitted assigns. In this event,
Supplier shall be liable for all such costs.


 


10.3                        Responsibility
for Products


 


Supplier
shall be responsible for and bear all risk of loss or damage to the Products to
be delivered by Supplier to the Warehouse while the Products are in Supplier’s
care, custody and control. Such responsibility includes, but is not limited to,
any loss or damage resulting from the improper storage, handling, packing,
crating, loading, blocking and/or transportation of the Products to be
delivered by Supplier. For the purpose of this Section, the time during which
the Products are in transit from Supplier’s facility to the Warehouse, or other
reasonable destination designated by HQ, shall be deemed to be a period during
which the Products are in the care, custody and control of Supplier. For
greater certainty, the Products shall be f.o.b. the Warehouse.


 


19

















 


10.4                        Duty of
Inspection


 


(a)                                  HQ shall inspect the pallets
of Products within ten (10) days after delivery to ensure there is no
obvious damage to external packaging;


 


(b)                                 HQ shall notify Supplier of
damage as set out above and shall return any damaged Products to Supplier, at
Supplier’s expense, and shall receive a full credit. For greater certainty, HQ
has no duty to test the Products and this provision does not apply to latent
defects or product deficiencies and shall not relieve Supplier of its liability
or responsibility for such defects or deficiencies.


 


11.                               PRICES, PAYMENTS TERMS AND INVOICES 


 


11.1                        Price


 


The
prices for Commercial Products to be charged to HQ by Supplier, during the
first twelve (12) months of the Term are in US dollars in accordance with
Schedule “A”. The prices to be charged to HQ for the Services during the first
twelve (12) months of the Term are in US Dollars and charged according to
Fractionation Products produced in accordance with Schedule “D”.


 


11.2                        Price
Adjustments


 


(a)                                  Annual


 


(i)                                    Prices for all
Products may increase at the start of each Agreement year commencing April 1,
2009 by up to the maximum of the average increase in CPI over the previous
calendar year. Supplier shall notify HQ in writing within forty-five (45) days
of the start of each Agreement year of the proposed price change otherwise it
shall be deemed that the current agreement year prices will remain in effect
for an additional year.


 


(ii)                                 Notwithstanding
the foregoing, if the average wholesale prices in the US of any Product in
Agreement year 3 is less expensive compared to the prices paid by HQ in the
same Agreement year 3, then the price for such Product payable under this Agreement
in years 4 shall be [***]. Supplier shall notify HQ in writing within
forty-five (45) days of the start of the fourth Agreement year by providing
justification for the proposed price reduction.


 


(iii)                              Price for the
product HyperRABMC S/D may increase commencing January 1, 2008
by up to the maximum of the average increase in CPI over the previous calendar
year. Supplier shall notify HQ in writing of the proposed price change. In
addition, prices for HyperRABMC S/D may increase annually at the
start of the second Agreement year commencing April 1, 2009 by up to the
maximum of the average increase in CPI over the previous calendar yar. Supplier
shall notify HQ in writing within forty-five (45) days of the start of each
Agreement year of the proposed price change otherwise it shall be deemed that
the current agreement year prices will remain in effect for an additional year.


 






***CONFIDENTIAL
TREATMENT REQUESTED


 


 


20

















 


(b)                                 Improvements
Mandated by Regulator – Products


 


Where
Supplier is directed by the regulator with authority, to make an Improvement
which will result in a price increase for a Product, Supplier shall provide HQ
with notice in accordance with Section 12.2 and shall substantiate the
proposed price increase. Supplier and HQ shall negotiate in good faith the
amount and timing of any proposed price increase to HQ. If HQ provides final
notice to Supplier in writing that it does not agree to the price from
Supplier, then Supplier shall have thirty (30) days to withdraw the price
increase. Price increase shall not take effect until after said thirty (30) day
period. If Supplier does not do so, then HQ may elect to accept the increase or
terminate the Agreement with respect to the Product immediately without cost or
penalty.


 


(c)                                  Supplier
Initiated Improvements – Commercial Products


 


With
respect to an Improvement initiated by Supplier for a Commercial Product which
will result in a price increase to HQ, Supplier shall notify HQ by April 1
of the prior year. Supplier shall substantiate the price increase and Supplier
and HQ shall negotiate in good faith the amount and timing of any proposed
price increase to HQ which, for greater clarity, will not be implemented prior
to April 1 of the following year. If HQ does not agree to accept the price
from Supplier, and Supplier does not withdraw the proposed price increase, then
HQ has the right to terminate the Agreement with respect to the Commercial
Product, immediately upon notice to the Supplier, without any cost or penalty.


 


(d)                                 Supplier
Initiated Improvements – Fractionation Products


 


With
respect to an Improvement initiated by Supplier for a Fractionation Product,
Supplier shall notify HQ in accordance with Section 12.2, and;


 


(i)                                    If this
Improvement will increase the price of the Fractionation Product to HQ, or will
require HQ to make a change to its collection, processing, storage or shipping
of Plasma (“HQ Process”), HQ and Supplier shall negotiate in good faith the
amount and timing of the proposed price increase to HQ. If HQ does not agree to
accept a price increase, or is unwilling or unable to make the required change
to HQ Process then Supplier remains obligated to continue to provide
Fractionation Services in accordance with this Agreement until the expiry of
the Term. If the Supplier Initiated Improvement becomes mandated by the
regulator during the Term of the Agreement then HQ agrees to pay the price
increase retroactively to the date of implementation. If HQ and Supplier do not
agree on the price increase for the mandated Improvement, the Parties shall
proceed to arbitration.


 


(ii)                                 If this
Improvement will not increase the price and does not require a change to HQ
Process, Supplier may implement such Improvement on notice by Supplier to HQ.


 


11.3                        Payment
Terms


 


Payment
of invoices not disputed in good faith shall be net thirty (30) days from the
latter of the date of receipt of the Product by HQ or invoice from Supplier.
The Supplier agrees to provide HQ with a prompt payment discount of one percent
(1%) whenever payment for an invoice is made to the Supplier withint ten (10) days
of receipt of invoice.


 


21

















 


11.4                        Invoices


 


Supplier
shall include a packing slip with all deliveries of Products. Supplier shall
deliver to HQ an invoice, in duplicate, for the Products delivered. All
invoices shall be in US Dollars and shall set out the amounts of the Products,
less any Products returned in accordance with this Agreement, Goods and
Services Tax (“GST”) and other taxes payable on the order as well as Supplier’s
GST registration number if applicable.


 


11.5                        Pricing Not
Affected by Remedies


 


Notwithstanding
anything to the contrary in this Agreement, in the event that HQ exercises any
right or remedy as a result of supply problems caused or to the extent
contributed by Supplier that reduces the amount of any Product delivered to HQ
by Supplier under this Agreement, the annual volume for that Product may be
reduced by such amount at the discretion of HQ but the pricing for that Product
shall remain at the level determined by Schedule “A” as if the annual volume
were not so reduced.


 


12.                               REGULATORY AND QUALITY ASSURANCE MATTERS


 


12.1                        Regulatory
Condition of Supply


 


Supplier
shall obtain and submit a copy of the Notice of Compliance (“NOC”) issued by
Health Canada to HQ in order to show that the Products to be supplied meet the
requirements of Health Canada. If the NOC is subject to any conditions, then
Supplier shall, not less than one (1) time per year, update HQ on the progress
in satisfying the conditions, and shall issue a letter to health care providers
not less than one (1) time per year describing the original conditions and
the progress in satisfying the conditions. This letter shall be distributed to
hospitals by HQ.


 


12.2                        Improvements


 


(a)                                  Supplier
Initiated Improvements for all Products


 


(i)                                    In the event
that Supplier makes or plans to make an Improvement, Supplier shall advise HQ
of such change or planned change at least three (3) months prior to the
implementation of any such change, except under exceptional circumstances, such
as where patient safety is involved, when the notification period may be
shorter. Updates will be provided by Supplier at the regular Fractionation
Meetings.


 


(ii)                                 No party shall
be responsible for, or have any liability to, any other party with respect to
any delays in obtaining such approval to the extent these delays are caused by
Health Canada or result from the failure to meet any requirements imposed or
administered by Health Canada that are significantly more onerous than those of
the FDA.


 


(b)                                 Supplier
Initiated Improvements – Commercial Products


 


(i)                                    If Supplier
makes any Improvement to the Commercial Products, and unless the Parties
otherwise agree, Supplier shall use all reasonable efforts to include such
Improvement in the Commercial Products being supplied under this Agreement.
Supplier will at the time of, or within a reasonable timeframe and no longer
than six (6) months after filing


 


22

















 


the
submission for the improved or changed Commercial Product, apply for approval
of Health Canada for the Improvement. Should the Improvement not be permitted
due to Health Canada requirements, Supplier will advise HQ.


 


(c)                                  Supplier
Initiated Improvements – Fractionation Products


 


(i)                                    In the event
that the Improvement will require HQ to change its process for plasma
collection, Supplier shall provide HQ with one (1) year advance notice to
enable it to make the change, validate it and apply to Health Canada for
amendment to its license.


 


(ii)                                 In the event
that any regulator with authority notifies Supplier that it will be requiring
any such Improvement in a shorter timeframe, Supplier shall notify HQ within
five (5) Business Days of receipt of notice by Supplier of such required
change.


 


(iii)                              In addition, if
the Improvement requires approval by Health Canada, Supplier shall notify HQ
within five (5) Business Days of the date the application is filed with
Health Canada.


 


12.3                        Special
Access Programme


 


(a)                                  If any Commercial Product,
licensed at the time of execution of this Agreement, is no longer licensed by
Health Canada and becomes available only under SAP during the Term, such
Commercial Product shall be provided to HQ for release pursuant to SAP (“SAP
Commercial Product”) whenever HQ notifies the Supplier in writing that the SAP
Commercial Product needs to be provided.


 


(b)                                 Notwithstanding Subsection
12.3(a), if an equivalent licensed product produced by any other manufacturer
is available on the market, HQ could move to such licensed product, Supplier
shall reimburse HQ for any inventory of SAP product(s) upon return of such
SAP product. In this event, HQ will have the option to terminate this Agreement
with respect to such SAP Commercial Product(s).


 


(c)                                  If a SAP Commercial Product
becomes licensed by Health Canada during the Term, and HQ has not moved to a
licensed product produced by another manufacturer, Supplier agrees to replace
any inventory of SAP Commercial Product with licensed Commercial Product at no
cost to HQ. If the SAP Commercial Product is converted into a licensed
Commercial Product by Health Canada and may validly be distributed, then HQ
will not be entitled to the replacement of said inventory.


 


12.4                        Communications


 


Supplier
shall promptly advise HQ and provide HQ with electronic and hard copies of the
following documents regarding the Products manufactured by Supplier, their
manufacture, the processing of Plasma into Fractionated Product, and/or the
inspection of any of Supplier’s facilities:


 


(i)                                    Supplemental/New
Drug Submission and New Drug Submission cover letters only, or if the said
letters do not clearly identify the nature of the submission, documentation
identifying the nature of the submission;


 


23

















 


(ii)                                Notices of
Compliance;


 


(iii)                             Printed
components including cartons, labels and package insert with explanation with
changes thereto;


 


(iv)                            Product
Monographs approved by Health Canada;


 


(v)                               Health Canada
Exit Notices and Supplier’s Responses;


 


(vi)                            FDA 483’s and
Supplier’s Responses;


 


(vii)                         Recall/Withdrawal
information and correspondence;


 


(viii)                     Warning letters issued by
the FDA or Notices of Intent issued by Health Canada with respect to premises
where Products are manufactured; and


 


(ix)                              Changes to the
telephone numbers to be used by Consumers or healthcare professionals to report
adverse drug reactions both during normal business hours and afterhours.


 


Other
documents regarding regulatory issues will be provided to HQ by agreement of
Supplier, on a case by case basis.


 


12.5                        Supplier
Information


 


Supplier,
shall, upon execution of this Agreement, notify HQ in writing, of the name of
its senior regulatory person. In the event of a change of either designated
person during the Term, Supplier shall immediately notify HQ, in writing, of
such change.


 


12.6                        Compliance
Audit


 


HQ
shall be entitled to audit Supplier’s facilities and quality systems, the books
and records of Supplier in respect of production and quality assurance matters
arising from the Agreement; provided that HQ shall be responsible for its own
costs and the audit is conducted at a reasonable time. The results of all
audits will be maintained as confidential to be used for the purposes of and as
contemplated by this Agreement or as otherwise required by law.


 


Supplier
shall provide responses including corrective measures to audit observations in
a timely manner. Supplier shall use its best efforts to implement said measures
within a reasonable time frame.


 


13.                               PRODUCT WITHDRAWALS/RECALLS


 


13.1                        Recall /
Withdrawal


 


(a)                                  Immediately upon execution
of this Agreement, Supplier shall establish and HQ shall be notified by
Supplier of its respective toll-free telephone number and contact name(s) for
customers’ enquiries or questions.


 


24

















 


(b)                                 Supplier must provide
supporting information or documentation to HQ for dissemination immediately and
not later than twenty-four (24) hours by telephone and facsimile of a decision
to Recall/Withdraw any of the Products.


 


(c)                                  Subject to Sections 4.2 and
4.3, all costs of Recall/Withdrawal including all incremental costs incurred by
the Parties, both internal and out of pocket, shall be the responsibility of
and shall be paid by HQ if the causation is attributable to HQ or by Supplier
if the causation is attributable to Supplier.


 


(d)                                 Subject to Subsection
13.1(g), Supplier will provide the spokesperson on the specifics of the
Recall/Withdrawal and shall provide an explanation as to why the Product was
recalled/withdrawn unless the Withdrawal is initiated by HQ.


 


(e)                                  Any notification to be given
to HQ relative to a product recall/withdrawal must be faxed to the attention of
the Director, Fractionation Products. The document must include the relevant
product name, lot number(s) and a brief explanation of the reason
justifying the recall/withdrawal. A statement confirming whether or not the
targeted lot was distributed to HQ and/or within Canada must also be included.


 


(f)                                    The transmission of a facsimile
must be preceded by a telephone call to the fractionation products department
(24 hours/ 7 days) Support Telephone line at (514) 832-5000 extension 6926, in
order to inform HQ of the incoming facsimile in connection with a product
recall/withdrawal.


 


(g)                                 Any news release or
disclosure relating to a removal from the market, quarantine, Recall or
Withdrawal of a Product and referencing HQ must be reviewed and approved by HQ
prior to release by Supplier.


 


(h)                                 Any news release or
disclosure, excluding customer cover letters, relating to a removal from the
market, quarantine, Recall or Withdrawal of a Product and referencing Supplier
must be reviewed and approved by Supplier prior to release by HQ.


 


13.2                        Patient
Notification System


 


Supplier
understands that the Patient Notification System (“PNS”) was created to provide
a fast, confidential method to provide information to Consumers on Recall or
Withdrawal events. Supplier agrees, at its cost, to participate in the PNS as a
subscriber and to provide all information regarding Recalls or Withdrawals to
PNS at the same time the information is provided to Health Canada and HQ.


 


13.3                        Adverse
Event Reporting


 


In
accordance with Health Canada regulations, HQ will promptly notify Supplier by
facsimile of any adverse drug reactions potentially associated with the use of
the Products reported to it. Supplier shall provide final written reports on
the investigation within sixty (60) days of receipt of HQ’s written
notification.


 


25

















 


13.4                        Replacement
Products and Replacement Fractionation Products


 


Any
Replacement Products or Replacement Fractionation Products proposed by Supplier
under Sections 3.6, 3.8, 3.9, 8.12, 9.3 and 9.4 must be licensed by Health
Canada or if no Replacement Products or Replacement Fractionation Products are
licensed by Health Canada, approved by Health Canada under its SAP.


 


14.                               REPRESENTATIONS, WARRANTIES AND INSPECTION


 


14.1                        Representations
and Warranties of the Parties


 


Each
of the Parties represent and warrant that at the time of entering into this
Agreement:


 


(a)                                  It is duly organized,
validly existing and is in good standing under the laws of its jurisdiction of
incorporation, and is qualified to do business and in the case of HQ to carry
on its activities, and is in good standing in each jurisdiction in which the
performance of its obligations hereunder requires such qualification (except
where such failure to qualify would not have a material adverse effect) and has
all requisite power and authority, corporate or otherwise, to conduct its
business as now being conducted, to own, lease and operate its properties and
to execute, deliver and perform this Agreement.


 


(b)                                 The execution, delivery and
performance by it of this Agreement have been duly authorized by all necessary
corporate or other legal action and do not and will not:


 


(i)                                    require any
consent or approval of its shareholders or members as the case may be;


 


(ii)                                 violate any
provision of any law, rule, regulation, order, writ, judgment, injunction
decree, determination or award presently in effect having applicability to it
and known to it or any provision of its charter documents; or


 


(iii)                              result in a
breach of or constitute a default under any material agreement, mortgage,
lease, license, permit or other instrument or obligation to which it is a party
or by which it or its properties may be bound or affected.


 


(c)                                  This Agreement is a legal,
valid and binding obligation of it enforceable against it in accordance with
its terms, except as enforceability may be limited by applicable bankruptcy,
insolvency, reorganization, moratorium or similar laws affecting creditors’ and
contracting Parties’ rights generally and except as enforceability may be
subject to general principles of equity (regardless of whether such
enforceability is considered in a proceeding in equity or at law).


 


(d)                                 It is not under any
obligation to any person, or entity, contractual or otherwise, that is
conflicting or inconsistent in any respect with the terms of this Agreement or
that would impede the diligent and complete fulfillment of its obligations.


 


(e)                                  It has good and marketable
title to or valid leases or licenses for all its properties, rights and assets
necessary for the completion of its responsibilities under this Agreement,
subject only to the claim of any relevant lessor or licensor.


 


26

















 


(f)                                    There are no legal or
arbitral proceedings, or any proceedings by or before any governmental or
regulatory authority or agency, now pending or (to its knowledge) threatened
against it that, if adversely determined could (either individually or in the
aggregate) have a material adverse effect on its ability to perform its
obligations under this Agreement.


 


14.2                        Representations
and Warranties on the Products


 


14.2.1                Supplier represents and warrants to HQ that
the Products shall:


 


(i)                                    Be
manufactured, stored, released and transported in accordance with:


 


(a)                                 Canadian
regulations (including without limiting the generality of the foregoing, Good
Manufacturing Practices and all other applicable laws and regulations); and


 


(b)                                 Suppliers Quality Assurance
and Quality Control processes;


 


(ii)                                 Comply with the
certificates of analysis;


 


(iii)                             Conform to any
and all Specifications, descriptions or designs furnished by Supplier in any
product inserts or labelling;


 


(iv)                             Comply with all
laws regulations or codes in force in Canada;


 


(v)                                Be transported
to HQ in a manner in which quality, safety and efficacy are not compromised.


 


14.2.2                Supplier further represents
and warrants that, if required, valid Health Canada approvals have been issued
and are in good standing. Supplier shall notify HQ immediately upon any notice
of deficiencies or requests for submissions with respect to any of the
Products.


 


14.3                        Title and
Warranty on the Products


 


Supplier
hereby warrants title in and to the Commercial Products.


 


14.4                        Guaranteed
Yield


 


(a)                                  Supplier guarantees that the
minimum annual g/litre IGIV yield from Recovered Plasma shall be [***] g/litre.


 


(b)                                 Supplier guarantees that the
minimum annual g/litre IGIV yield from Recovered Plasma and buffy coat plasma
shall be the average yield of the first [***] IGIV lots (excluding
reprocessed lots) adjusted to [***] of the actual effective average yield of
these lots.


 


(c)                                  Supplier guarantees that the
minimum yield for Albumin 25% will be [***] g/litre.


 


(d)                                 If the yield falls below the
above stated amounts for either IGIV or Albumin 25%, Supplier will provide
additional Commercial Product to make up the deficiency, at the lesser of the
price HQ pays for Fractionation Products or Commercial Products.


 






***CONFIDENTIAL
TREATMENT REQUESTED


 


27














 


14.5        Current
Information


 


Supplier represents and warrants that the information currently
provided to HQ and which will, from time to time, be amended or further
provided with the Products, including without limitation, any regulatory
filings, circulars and package inserts, are current, accurate and fulfill any
regulatory requirements for the Products.


 


14.6        No
Waiver


 


Each of the foregoing warranties shall not be (nor shall the same be
deemed to be) waived, in whole or in part, as a result of any audit or
pre-testing conducted by or on behalf of HQ or any third party, except as
expressly provided for herein.


 


14.7        Survival
of Representations and Warranties


 


All representations, warranties, covenants and indemnities made herein
or in any document delivered pursuant hereto or incorporated by reference
herein, whether expressed or implied by law or otherwise, shall survive
inspection and acceptance thereof and payment thereof and shall enure to the
benefit of the Parties notwithstanding the termination or expiration of this
Agreement.


 


15.         PATENT
PROTECTION 


 


15.1        No
Infringement


 


Supplier hereby represents and warrants to the best of its knowledge to
HQ that none of the Commercial Products or processes related to the provision
of Fractionation Services or any component thereof infringe or will constitute
an infringement of any patents, trademarks, cell ownership, industrial designs,
copyrights and trade secrets when Products are used according to approved uses.


 


15.2        Infringement
by a Product or Process


 


Should any Commercial Product or process related to the fractionation
of Plasma be found to infringe any third party intellectual property rights and
such infringement negatively impacts HQ or creates liability for HQ, Supplier
shall, in addition to the indemnity provided in Section 16.3, in respect
to each infringing Product or process:


 


	
  (i)

  	
   

  	
  substitute the Product with fully equivalent non-infringing product;

  
	
   

  	
   

  	
   

  
	
  (ii)

  	
   

  	
  modify the infringing Product or process so that it no longer
  infringes but remains functionally equivalent; or

  
	
   

  	
   

  	
   

  
	
  (iii)

  	
   

  	
  obtain for HQ at Supplier’s expense, the right to continue to use the
  Commercial Products, or Fractionation Products manufactured by the infringing
  process.

  



 


 


28

















 


16.    INSURANCE
AND INDEMNIFICATION 


 


16.1      Supplier’s
Insurance


 


Supplier shall provide and
maintain during the Term of the Agreement, at its own expense, the following
insurance coverage: general liability insurance shall have limits no less than
ten million dollars ($10,000,000) and product liability insurance shall have
limits no less than ten million dollars ($10,000,000) per incident and ten
million dollars ($10,000,000) per annum in the aggregate.


 


(a)                    Supplier shall provide HQ with
proof of valid insurance coverage for Supplier. A certificate of insurance
issued by the insurer shall be acceptable to HQ as proof of coverage.


 


(b)                   All of the aforementioned
certificates provided by the insurer to Supplier shall certify the following:


 


	
  (i)

  	
   

  	
  that the required insurance policies are valid and the coverage
  specified in Section 16.1, is in effect;

  
	
   

  	
   

  	
   

  
	
  (ii)

  	
   

  	
  that HQ has been added to the certificate as an additional named
  insured with respect to the general liability insurance referred to in
  Section 16.1;

  
	
   

  	
   

  	
   

  
	
  (iii)

  	
   

  	
  a cross-liability clause is in existence;

  
	
   

  	
   

  	
   

  
	
  (iv)

  	
   

  	
  the insurer shall provide notice of amendments or cancellation to HQ;
  and

  
	
   

  	
   

  	
   

  
	
  (v)

  	
   

  	
  a waiver of subrogation in favour of HQ.

  



 


(c)                    Supplier
shall provide HQ with at least fifteen (15) days advance written notice of any
policy cancellation or any change in the amount of coverage or type of
insurance stipulated with respect to Supplier. In no case shall Supplier
materially alter, cancel or allow to lapse any stipulated insurance while HQ is
receiving Products or Services pursuant to the terms and conditions of this
Agreement.


 


(d)                   The foregoing insurance provisions
shall not limit the amount or type of insurance otherwise required by law. It
shall be the sole responsibility of Supplier to determine what additional
insurance coverage, if any, is necessary and advisable for its own protection
or to fulfill its obligations under this Agreement. Any such additional
insurance shall be provided and maintained by Supplier, as applicable, at its
own expense.


 


(e)                    Supplier warrants to HQ that it has
not done or will not do anything which would cause the stipulated insurance
policy or policies carried by Supplier to be suspended, impaired, cancelled or
otherwise adversely affected.


 


(f)                      In the event of a proceeding,
claim or demand brought or made against HQ, involving Supplier, HQ shall
forthwith provide notice to Supplier and vice versa.


 


16.2        HQ
Insurance


 


HQ shall provide and maintain
during the Term of the Agreement, at its own expense, the following insurance
coverage: general liability insurance shall have limits no less than ten
million dollars ($10,000,000) per incident and ten million dollars
($10,000,000) per annum in the aggregate.


 


(a)                        HQ shall provide Supplier with
proof of valid insurance coverage. A certificate of insurance issued by the
insurer shall be acceptable to Supplier as proof of coverage.


 


29

















 


(b)                       All of the aforementioned
certificates provided by the insurer to HQ shall certify the following:


 


(i)         that
the required insurance policies are valid and the coverage specified in
Section 16.2, is in effect;


 


(ii)        that
Supplier has been added to a certificate as an additional named insured with
respect to the general liability insurance referred to in Section 16.2;


 


(iii)       a
cross-liability clause is in existence;


 


(iv)       the
insurer shall provide notice of amendments or cancellation to Supplier; and


 


(v)        a
waiver of subrogation in favour of Supplier.


 


(c)                        HQ shall provide Supplier with
at least fifteen (15) days advance written notice of any policy cancellation or
any change in the amount of coverage or type of insurance stipulated. In no
case shall HQ materially alter, cancel or allow to lapse the stipulated
insurance during the Term.


 


(d)                       The foregoing insurance
provisions shall not limit the amount or type of insurance otherwise required
by law. It shall be the sole responsibility of HQ to determine what additional
insurance coverage, if any, is necessary and advisable for its own protection
or to fulfill its obligations under this Agreement. Any such additional
insurance shall be provided and maintained by HQ at its own expense.


 


(e)                        HQ warrants to Supplier that HQ
has not done or will not do anything which would cause the stipulated insurance
policy or policies carried by HQ to be suspended, impaired, cancelled or
otherwise adversely affected.


 


(f)                          In the event of a proceeding,
claim or demand brought or made against Supplier involving HQ, Supplier shall
forthwith provide notice to HQ and vice versa.


 


16.3        Indemnity


 


(a)                        Each of the Parties shall
indemnify and hold the other(s) and its respective members, directors,
officers, employees, agents and other representatives harmless from and against
all damages, costs, expenses, charges, losses or liabilities whatsoever
(including, without limitation, legal fees and claims of third parties of
whatsoever kind, but excluding special, incidental or consequential damages)
arising from or incidental to any failure by such party to perform and
discharge its obligations and liabilities herein; PROVIDED HOWEVER that this
indemnity shall not apply (nor shall it be deemed to apply) to the extent of
any damages, costs, expenses, charges, losses or liabilities whatsoever
resulting from, or contributed to by, the negligence, wrongful intentional act
or failure to act or breach of Agreement of the claiming party or its members,
trustees, directors, officers, employees, agents and representatives.


 


(b)                       HQ hereby agrees to indemnify
and hold Supplier, and its respective directors, officers, employees, agents
and other representatives harmless from and against all damages, costs,
expenses, charges, losses or liabilities whatsoever (but excluding special,
incidental or consequential damages) arising from or incidental to any latent
defect in the Plasma; PROVIDED HOWEVER that this indemnity shall not apply (nor
shall it be deemed to apply) to the extent that those damages, costs, expenses,
charges, losses or liabilities whatsoever resulted from:


 


30

















 


 


(i)                           the negligence of, or an
intentional act or failure to act by Supplier; or,


(ii)                        the material breach by
Supplier, of any of the terms or conditions of this Agreement; or,


(iii)                     any unauthorized or false warranty
made by Supplier.


 


(c)                        Supplier hereby agrees to
indemnify and hold HQ and its respective directors, officers, employees, agents
and other representatives harmless from and against all damages, costs,
expenses, charges, losses or liabilities whatsoever (but excluding special,
incidental or consequential damages) arising from or incidental to any latent
defect in the Products; PROVIDED HOWEVER that this indemnity shall not apply
(nor shall it be deemed to apply) to the extent that those damages, costs,
expenses, charges, losses or liabilities whatsoever resulted from:


 


(i)                           the negligence of, or an
intentional act or failure to act by HQ or,


(ii)                        the material breach by HQ of
any of the terms or conditions of this Agreement; or,


(iii)                     any unauthorized or false warranty
made by HQ.


 


(d)                       In the event that a party (the
“Indemnitee”) becomes aware of any action, claim or demand in respect of which
the other party (the “Indemnitor”) is liable to indemnify Indemnitee pursuant
to this Agreement, the Indemnitee shall promptly notify the Indemnitor thereof.
The Indemnitor shall at all times have the right at its sole and only expense
to dispute and contest in the name of the Indemnitee or otherwise any such
action, claim or demand. The Indemnitee shall fully co-operate with the
Indemnitor and its counsel in any proceedings with respect to any such action,
claim or demand.


 


(e)                        These indemnities shall survive
the termination of this Agreement and shall be in addition to and shall not affect any other indemnity
contained herein. The Indemnitor shall also have the right at all times, at its
sole and only expense, to settle any action, claim or demand subject to the
right of the Indemnitee to approve any and all documentation of or relating to,
such settlement.


 


16.4        Approval of Counsel


 


The Indemnitee reserves the right to approve or reject (acting
reasonably) counsel for any lawsuit or proceeding for which any claim for
indemnification may be made against the Indemnitor. In the event of any such
suit neither party nor its representatives shall make any public disclosure or
comment (other than as part of the actual legal proceedings) without the prior
written consent of the other.


 


17.         CHANGE


 


17.1        Technological
Change


 


(a)                        If HQ believes, acting
reasonably, that:


 


(i)                           a third party has Health
Canada’s approval to introduce a new product to the Canadian market which is
functionally equivalent to, but significantly technologically and/or
scientifically superior to any of the Commercial Products supplied under this
Agreement; or


 


(ii)                        the Commercial Products are obsolete;


 


31

















 


HQ shall promptly notify Supplier as to its belief and shall provide
reasoning and documentation to support such claim. Supplier shall have fifteen
(15) days from the receipt of the said notice to respond to HQ, either agreeing
or disagreeing with such belief and shall provide reasoning and documentation
for its position.


 


If Supplier agrees with HQ, HQ may immediately proceed to acquire
Replacement Products from alternative sources. If Replacement Products are
obtained by HQ the relevant quantity of Commercial Product to be obtained by
Supplier pursuant to the Agreement shall be decreased accordingly.


 


If Supplier fails to respond to HQ within fifteen (15) days, then HQ
shall have the right to cancel the Agreement with respect to the Commercial
Product(s) in question.


 


(b)                       If HQ believes, acting
reasonably, that:


 


(i)                           a third party will be
introducing or has introduced a new process for fractionating Plasma which is
functionally equivalent to, but significantly technologically and/or
scientifically superior to the process used for fractionating HQ Plasma
pursuant to this Agreement; or


(ii)                        the Fractionation Products are
obsolete;


 


HQ shall promptly notify Supplier, as to its belief and shall provide
reasoning and documentation to support such claim. Supplier shall have fifteen
(15) days from the receipt of the said notice to respond to HQ, either agreeing
or disagreeing with such belief and shall provide reasoning and documentation
for its position.


 


If Supplier agrees with HQ, HQ may immediately proceed to contract with
alternative source(s) for the purchase of fractionation services. If an
alternative source of service is obtained by HQ the portion of the Agreement
relating to Fractionation Services or particular Fractionation Products shall
be terminated, subject to Section 7.4.


 


If Supplier fails to respond to HQ within fifteen (15) days, then HQ
shall have the right to cancel the Agreement with respect to the Services,
subject to Section 7.4.


 


17.2        Dispute
Resolution


 


(a)                        For the purposes of
Section 17.1 only, if
Supplier does not agree:


 


(i)                           that the third party’s
product or service is significantly technologically and/or scientifically
superior or,


(ii)                        that the Commercial Product is
obsolete;


 


Supplier shall so notify HQ and Supplier shall attempt, by bona fide negotiations to resolve their differences, within a reasonable
period not to exceed thirty (30) days from HQ’s receipt of Supplier’s notice.


 


In the event that HQ and Supplier cannot resolve a dispute under this
Section within the thirty (30) day period, the matter shall be referred to
arbitration by Supplier pursuant to the provisions of Section 19.


 


32

















 


(b)                       If, after the thirty (30) day period
set out in (a) such dispute remains unresolved, HQ shall be entitled to
purchase Commercial Products or Fractionation Services from the third party
pending resolution of the dispute. If the dispute is resolved in Supplier’s
favour, HQ shall be required to resume purchasing the Products or Services from
Supplier as soon as is reasonably possible and shall be liable to Supplier for
any loss, including any loss of profit, incurred by Supplier as a result of HQ
purchasing products or fractionation services from a third party pursuant to
this Section. The Parties hereto agree that a reasonable estimate of Supplier’s
loss for the purposes of this Section shall be fifteen percent (15%) of
the price HQ pays for Product that HQ failed to purchase because of HQ’s
decision to purchase products or services from a third party.


 


18.         TERMINATION


 


18.1        Termination
of Agreement


 


HQ or Supplier, at its option, may, without prejudice to any other
right or remedy it may have, immediately terminate this Agreement or suspend its
obligations hereunder if an Event of Default (as defined in Section 18.2
or 18.3 as applicable) occurs (other than, in the case of HQ, an Event of
Default with respect to itself), or in the case of Supplier, an Event of
Default with respect to itself, by giving the other party written notice
thereof. If such termination or suspension occurs, the terminating party shall
be relieved of any further obligations under this Agreement, other than
obligations that are intended to survive termination and payment of any
outstanding invoices or obligations previously incurred.


 


18.2        Supplier
Event of Default


 


A “Supplier Event of Default” shall mean:


 


(a)                        the failure by Supplier to meet
the claims, representations or warranties made on labelled promotional or Product
information or on labelled Products as required pursuant to this Agreement;


 


(b)                       any misrepresentation herein
contained resulting in a material adverse effect on HQ, or any material breach
by Supplier of any warranty, obligation or other provision of this Agreement.
It is acknowledged and agreed that persistent or repeated minor breaches can
amount to a material breach if they cause a significant adverse effect to HQ;


 


(c)                        an attachment is made of all or
substantially all of the property or assets of Supplier;


 


(d)                       the making of a general
assignment by Supplier for the benefit of its creditors;


 


(e)                        the appointment (by court order
or otherwise) of a receiver, receiver/manager or a trustee for the benefit of
one or more of the creditors of Supplier;


 


(f)                          the filing of a voluntary
petition in bankruptcy, adjudication as a bankrupt or the filing of an answer
or admission seeking relief pursuant to applicable bankruptcy law pertaining to
Supplier or any filing by or against Supplier of any proceedings under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C.-36, as amended;
or comparable legislation in the USA; or


 


33

















 


(g)                       the filing of an involuntary
petition in bankruptcy pertaining to Supplier which petition is not dismissed,
vacated, set aside or stayed within forty-five (45) days.


 


A Supplier Event of Default shall, for the events described in
Subsections 18.2(a) and (b) above, take effect thirty (30) days after notice
being given by HQ to Supplier, specifying the default or branch, during which
time Supplier shall be entitled to cure the noted default.


 


18.3        HQ
Event of Default


 


A “HQ Event of Default” shall mean:


 


(a)                        any misrepresentation herein
contained resulting in a material adverse effect on Supplier or any material
breach by HQ of any warranty, obligation or other provision of this Agreement.
It is acknowledged and agreed that persistent or repeated minor breaches can
amount to a material breach if they cause a significant adverse effect to
Supplier;


 


(b)                       an attachment is made of all or
substantially all of the property or assets of HQ;


 


(c)                        the making of a general
assignment by HQ for the benefit of its creditors;


 


(d)                       the appointment (by court order
or otherwise) of a receiver, receiver/manager or a trustee for the benefit of
one or more of the creditors of HQ;


 


(e)                        the filing of a voluntary
petition in bankruptcy, adjudication as a bankrupt or the filing of an answer
or admission seeking relief pursuant to applicable bankruptcy law pertaining to
HQ or any filing by or against HQ of any proceedings under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C.-36, as amended;


 


(f)                          the filing of an involuntary
petition in bankruptcy pertaining to HQ which petition is not dismissed, vacated,
set aside or stayed within forty-five (45) days; or


 


(g)                       HQ, or its successor, ceases to
coordinate or loses the authority to distribute the Products in the province of
Québec.


 


A HQ Event of Default shall, for the events described in Subsection
18.3(a) above, take effect thirty (30) days after notice being given by
Supplier specifying the default or breach, during which time HQ shall be
entitled to cure the noted default.


 


19.         DISPUTE
RESOLUTION 


 


19.1        Arbitration


 


(a)                        The Parties agree that in the
event of any dispute or claim between HQ and Supplier arising under or in
connection with this Agreement, or any order issued pursuant to this Agreement
other than described in Section 17.2, including, but not limited to, the
interpretation or application of this Agreement, the Parties will endeavour to
resolve the dispute with diligence and good faith negotiations.


 


(b)                       If the Parties have been unable
to resolve the dispute, despite diligence and good faith negotiations, such
dispute or claim shall be settled by arbitration, as dictated by this Section.


 


34

















 


(c)                        All questions, disputes or
differences of opinion involving the interpretation, application,
administration, or alleged violation of this Agreement including a question of
whether a matter is arbitrable, shall be settled by arbitration.


 


(d)                       The arbitration will take place
in the City of Ottawa unless otherwise agreed by the Parties, and each party
may be represented by counsel at the arbitration.


 


(e)                        In the event that one party
wishes a dispute to be put to arbitration then such party shall give fifteen
(15) days written notice thereof to the others. If the Parties cannot agree
upon a single arbitrator within fifteen (15) days after demand by one of them for
arbitration, then each of (i) HQ, and (ii) Supplier shall select one
arbitrator. The two arbitrators selected shall then choose a third arbitrator
in order that the dispute may be finally resolved by a majority of the panel of
three arbitrators.


 


(f)                          The Parties acknowledge that
it would be advantageous to the resolution of disputes if the arbitrators
chosen possess relevant scientific, technical, legal or medical knowledge, and
they will endeavour to select arbitrators with the requisite expertise. The expense
of the arbitration shall be divided equally among the Parties. Any such
arbitration shall be conducted in accordance with the laws of the Province of
Ontario including, but not limited to, the Arbitration
Act (Ontario) and
the rules and procedures set forth therein, from time to time in force and
effect. The decision of the arbitrators shall be final and binding and any of
the Parties may make application to a court of competent jurisdiction for the
judicial acceptance of the award and an order for enforcement.


 


(g)                       The Parties hereby agree that
prior to the disclosure of any material in furtherance of this Section, the
Parties and the selected arbitrators shall be required to enter into
confidentiality agreements to protect information disclosed during the
arbitration process and the ruling of the arbitrators.


 


20.          OPTION
TO RENEW


 


20.1        Renewal


 


(a)                        For all the Fractionation
Products and Commercial Products excluding for HyperRABMC S/D


 


	
  (i)

  	
   

  	
  The Term be extended for a first one (1) year term from April 1,
  2013 upon written consent of Supplier and HQ.

  
	
   

  	
   

  	
   

  
	
  (ii)

  	
   

  	
  The Term may be extended for a second one (1) year term from
  April 1, 2014 upon
  written consent of Supplier and HQ.

  
	
   

  	
   

  	
   

  
	
  (iii)

  	
   

  	
  A written notice must be sent at least one hundred and eighty (180)
  days prior to the end of the Term or the extended Term by the party
  requesting the extension of the Term to the other party.

  



 


(b)                       For HyperRABMC S/D


 


(i)                           The Supplier hereby grants
to HQ an irrevocable option to extend, at its own discretion, the Term of the
Agreement for an additional period of one (1) year. The option shall be
exercised by HQ by giving the Supplier at least a six (6) month written
notice prior to the expiry of the initial term of the Agreement. In the event
the option is exercised by


 


35

















 


HQ, the terms and conditions of this Agreement shall remain unchanged,
except for prices which may be adjusted in accordance with the provisions of
Section 11.2.


 


21.         CUSTOMER
SERVICE


 


During the Term, the Supplier shall perform the customer service
obligations set forth in Schedule G.


 


22.         VALUE
ADDED


 


During the Term, Supplier shall provide value added contributions as
set forth in Schedule H for the benefit of HQ and such other parties listed
therein.


 


23.         GENERAL


 


23.1        Extended
Meanings


 


In this Agreement, words importing the singular number include the
plural and vice versa.


 


23.2        Time


 


Time shall be of the essence. 


 


23.3        Entire
Agreement


 


This Agreement, including the attached Schedules, constitutes the
entire Agreement between and among the Parties pertaining to its subject matter
and supersedes all prior and contemporaneous agreements, understandings,
negotiations and discussions, whether oral or written, between and among the
Parties. There are no warranties, representations, or other agreements between
or among the Parties in connection with its subject matter except as
specifically set forth in this Agreement. No supplement, modification,
amendment, or waiver of this Agreement shall be binding unless executed in
writing by all Parties.


 


23.4        Notices


 


(a)                        Any notice or demand required
or permitted to be given by one party to the other shall be in writing and
shall be:


 


(i)                           personally delivered;


(ii)                        sent by courier, prepaid;


(iii)                     sent by facsimile; or


(iv)                    sent by electronic mail.


 


(b)                       The address of each party for
any such notice shall be as follows:


 


	
  To HQ:

  	
   

  	
  HÉMA-QUÉBEC

  
	
   

  	
   

  	
  4045 Côte-Vertu Blvd.

  
	
   

  	
   

  	
  Saint-Laurent (Québec) H4R 2W7 

  CANADA

  



 


36

















 


(i)                           Operational issues and
regulatory issues including Quality Assurance matters, Product
recall/withdrawal document or correspondance:


 




	
  Attention:

  	
  Director of Fractionation products

  
	
  Telephone:

  	
  (514) 832-5000 ext. 319

  
	
  Facsimile:

  	
  (514) 832-0267

  
	
  e-mail:

  	
  jean.lapierre@hema-quebec.qc.ca

  






 


(ii)                        Contractual matters including
formal notice to be given pursuant to the Agreement:


 




	
  Attention:

  	
  Director of Purchasing & Warehousing

  
	
  Telephone:

  	
  (514) 832-5000 ext. 379

  
	
  Facsimile:

  	
  (514) 832-1027

  
	
  e-mail

  	
  jean-francois.deschenes@hema-quebec.qc.ca

  






 


In the case of Supplier to:


 


TALECRIS BIOTHERAPEUTICS LTD. 


5800 Explorer Drive, Suite 300


Mississauga (Ontario) L4W 5K9


CANADA


 


(i)                           In all cases to:


 




	
  Attention:

  	
  Mr. Joel Abelson

  
	
  Vice President,  Canadian and
  Intercontinental Commercial Operations

  
	
  Telephone: 

  	
  (905) 614-5580

  
	
  Fax:

  	
  (905) 614-5590

  
	
  e-mail:

  	
  joel.abelson@talecris.com

  






 


	
  and to

  	
  Attention:

  	
  Ms. Janet Thompson Mar

  
	
   

  	
  Director, Contract Operations

  
	
   

  	
  Telephone:

  	
  (613) 730-3905

  
	
   

  	
  Fax:

  	
  (613) 730-3910

  
	
   

  	
  e-mail:

  	
  janet.thompson-mar@talecris.com

  



 


(ii)                        And to:


 


TALECRIS BIOTHERAPEUTICS INC. 


P.O. Box 11526


79 TW Alexander Drive


Research Triangle Park (North Carolina) 27709



USA


 




	
  Attention:

  	
  Alberto R. Martinez, M.D.

  
	
   

  	
  President

  
	
  Telephone:

  	
  (919) 316-6543

  
	
  Fax:

  	
  (919) 316-6669

  
	
  e-mail:

  	
  alberto.martinez@talecris.com

  






 


37

















 


Any party may from time to time change its address by written notice to
the other party given in accordance with the provisions of this Section. Any
notice given by personal delivery or courier shall be deemed to be received on
the date of delivery. Any notice by facsimile shall be deemed to be received
when it is properly sent.


 


23.5      Assignment


 


Neither this Agreement nor any of the rights or obligations of any
party may be assigned without the prior written consent of the other parties
which consent shall not unreasonably be withheld provided that such consent
will not be required for assignment to an Affiliate as defined by the Canada Business
Corporations Act, R.S.C., 1985, c. C-44 as amended.


 


23.6      Independent
Contractors


 


The Parties are contractors independent of each other and none of them
has the authority to bind any other to any third person or otherwise to act in
any way as the representative of the other unless otherwise expressly agreed to
in writing by the other or required by the provisions of this Agreement. Except
as may be set forth herein, the Parties shall not have, and they shall not hold
themselves out as having, any right, power or authority to create any contract
or obligation, either express or implied, on behalf of, in the name of or
binding upon the other. It is understood and agreed that no party, their
respective shareholders, members, directors, officers, employees, agents, and
other legal representatives have, nor are they to be construed to have, any
relationship with the others (whether as an employee, agent, partner or
otherwise) except that of the Parties being independent contractors in respect
of the matters which are subject of this Agreement.


 


23.7      Severability


 


If any provision of this Agreement is determined to be invalid or
unenforceable in whole or in part by a court of competent jurisdiction, such
invalidity or unenforceability shall attach only to such provision and
everything else in this Agreement shall continue in full force and effect.


 


23.8      Communication


 


HQ may, in its sole discretion, contact Supplier at any time and from
time to time to discuss issues arising in connection with the performance of
this Agreement.


 


23.9      Governing
Law


 


This Agreement shall be governed by and construed in accordance with
the laws in force in the province of Ontario and shall be treated in all
respects as an Ontario contract. The parties submit to the jurisdiction of the
Courts of Ontario with respect to any dispute, claim or other matter arising
under this Agreement and the Courts of Ontario shall have exclusive
jurisdiction with respect to any such dispute, claim or other matter subject to
the provisions of Section 19. The parties agree that the United Nations
Convention on contracts for the International Sale of goods shall not apply to
this Agreement.


 


38

















 


23.10      Currency


 


All references to currency are in US dollars unless otherwise
specifically stated. 


 


23.11      Successors and Assigns


 


This Agreement shall enure to the benefit of and be binding upon the
Parties and their respective heirs, executors, administrators, and permitted
successors and assigns.


 


23.12      No
Waiver


 


No waiver by any party hereto of any breach of any of the provisions of
this Agreement by another shall take effect or be binding upon the party unless
agreed in writing. Unless otherwise provided therein, a waiver shall not limit
or affect the rights of the party granting the waiver with respect to any other
breach.


 


23.13      Joint
and Several Liability


 


TALECRIS CANADA and TALECRIS US shall be jointly and severally liable
for the obligations of Supplier set out in this Agreement.


 


23.14      Remedies
Cumulative


 


Except as otherwise expressly provided in this Agreement, the rights
and remedies of the Parties under this Agreement are cumulative and in addition
to and not in substitution for any other rights and remedies available at law
or in equity or otherwise, and no single or partial exercise by a party of any
right or remedy precludes or otherwise affects the exercise of any other right
or remedy to which that party may be entitled.


 


23.15      Counterparts


 


This Agreement may be executed in two or more counterparts, each of
which shall be deemed to be an original and all of which together shall
constitute the Agreement.


 


23.16      Amendment


 


This Agreement may not be amended or modified in any way except by the
written consent of the Parties hereto.


 


23.17      Confidential
Information


 


All information pertaining to the technology, business and affairs of
the other parties obtained as a result of or in respect of this Agreement shall
be kept and maintained in confidence and will not be disclosed to any other
person, except:


 


(i)                           to the auditors, legal
counsel and professional advisors of the Parties hereto provided that the
professional advisors have signed a confidentiality agreement with the
disclosing party,


 


39

















 


(ii)        if
such information enters the public domain otherwise than by a breach of this Agreement;
and


 


(iii)       if
disclosure of such information is required by virtue of any present or future
applicable law, regulation or ruling by a relevant government or governmental
board, commission, department, bureau or authority to which the relevant party
hereto is subject, such disclosure will be made after the disclosing party has
consulted with the other party and has taken reasonable measures to protec the
confidential information.


 


23.18    Pricing
Information to Customers


 


(a)                        Supplier agrees that HQ has the
right to provide detailed pricing or cost information to its members, the
provincial Minister of Health and their delegates, and to health care
professionals, hospitals and HQ stakeholders.


 


(b)                       Supplier will consult with HQ
prior to Supplier releasing any pricing or cost information relating to any
Fractionation Products.


 


23.19    Public
Announcements


 


No public announcement or press release relating in any way to this
Agreement shall be made without the prior written consent of the other parties
and the joint approval of the contents of such announcement or release except
where any such announcement is required by law, in which case the announcing
party will send by facsimile the draft announcement to the others immediately
upon becoming aware of the legal requirement and, in any event, before
releasing such announcement.


 


23.20    Force
Majeure


 


Except as otherwise provided in this Agreement, neither party shall be
liable to the other party and no party hereto shall be deemed in default
hereunder for any failure or delay to perform any of its covenants and
Agreements caused or arising out of the following acts (providing the same is
not within the control of the said party): acts of God, strikes, lockouts or
other industrial disputes, acts of the public enemy, riots, fire, storm, flood
or explosion. If a failure or delay is caused by one of the events
above-mentioned, all times provided for in this Agreement shall be extended for
a period commensurate with the period of the delay and, to the extent possible,
the said party affected will take all reasonable steps to remedy the delay
caused by the events above-mentioned; provided however, that nothing contained
in this Section shall require either party to settle any industrial
dispute.


 


40

















 


IN WITNESS WHEREOF Supplier and HQ have executed this Agreement, each
on the date indicated.


 


 


	
  HÉMA-QUÉBEC

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  BY:

  	
  /s/ Francine Decary

  	
   

  
	
   

  	
   

  
	
  NAME: Dr. Francine Décary

  	
   

  
	
   

  	
   

  
	
  TITLE:President and Chief Executive Officer

  	
   

  
	
   

  	
   

  
	
  DATE:

  	
   

  	
   

  
	
   

  	
   

  
	
  AND

  	
   

  
	
   

  	
   

  
	
  TALECRIS BIOTHERAPEUTICS INC.

  	
  APPROVED AS TO

  
	
   

  	
  LEGAL FORM

  
	
  BY:

  	
  /s/ Alberto R. Martinez

  	
  /s/ [ILLEGIBLE] 120607

  
	
   

  	
  TALECRIS BIOTHERAPEUTICS

  
	
  NAME: Alberto R. Martinez, M.D.

  	
  LAW DEPT.

  
	
   

  	
   

  
	
  TITLE: President

  	
   

  
	
   

  	
   

  
	
  DATE:

  	
  12/07/07

  	
   

  
	
   

  	
   

  
	
  AND

  	
   

  
	
   

  	
   

  
	
  TALECRIS BIOTHERAPEUTICS LTD.

  	
   

  
	
   

  	
   

  
	
  BY:

  	
  /s/ Alberto R. Martinez

  	
   

  
	
   

  	
   

  
	
  NAME: Alberto R. Martinez, M.D.

  	
   

  
	
   

  	
   

  
	
  TITLE: President

  	
   

  
	
   

  	
   

  
	
  DATE:

  	
  12/07/07

  	
   

  
							



 


41

















 


SCHEDULE “A” – COMMERCIAL PRODUCTS


 


HQ
First Year Purchase Volumes and Combined HQ/CBS Annual Purchase Volumes and
Prices 


 


HQ
First Year Purchase Volumes and Prices :


 


	
  Product

  	
   

  	
  Formats

  	
   

  	
  Unit of

  Measure

  	
   

  	
  HQ First
  Year

  Volume

  	
   

  	
  Price
  per Unit of

  Measure ($US)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  GamaSTANMC S/D

  	
   

  	
  2
  mL

  	
   

  	
  mL

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Gamunex® 10%

  	
   

  	
  25
  mL

  50 mL

  100 mL

  200 mL

  	
   

  	
  gram

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  HyperRABMC S/D

  	
   

  	
  2
  mL

  	
   

  	
  mL

  	
   

  	
  [***]

  	
   

  	
  [***]

  (2006-2007 price)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  HyperTETMC S/D

  	
   

  	
  250
  U

  	
   

  	
  pce

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Plasbumin® - 5%

  	
   

  	
  50
  mL

  250 mL

  	
   

  	
  25
  gram eqv.

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Plasbumin® - 25%

  	
   

  	
  50
  mL

  100 mL

  	
   

  	
  25
  gram eqv.

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


The First Year Projected Purchase Volumes in the table above shall be
the volumes for the purpose of Section 3.4(a).


 


Combined
HQ/CBS First Year Purchase Volumes and Prices :


 


	
  Product

  	
   

  	
  Formats

  	
   

  	
  Unit of

  Measure

  	
   

  	
  HQ

  First

  Year

  Volume

  	
   

  	
  CBS

  First

  Year

  Volume

  	
   

  	
  Combined

  First Year

  Volume

  (HQ and

  CBS)

  	
   

  	
  Combined

  Annual

  Volume

  (HQ and

  CBS)

  	
   

  	
  Price per

  Unit of

  Measure

  ($US)

  
	
  HyperHEP
  BMC  S/D

  	
   

  	
  0.5 mL

  5 mL

  	
   

  	
  mL

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] – [***]

  >[***]

  	
   

  	
  [***]

  [***]

  



 


The Price per Unit of Measure may be adjusted in accordance with
Section 11.2 of the Agreement.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


 


42














 


SCHEDULE “B” – CURRENT PLASMA PRODUCTION SITES AND PLASMA PICK-UP

SCHEDULE


 


HQ


 


	
  CENTRE NAME

  	
   

  	
  ADDRESS

  	
   

  	
  MINIMUM PICK UP

  FREQUENCY

  	
   

  
	
  Montréal

  	
   

  	
  4300 rue Garand

  Saint-Laurent (Québec),
  H4R 2A3

  Canada

  	
   

  	
  Once a week

  	
   

  
	
  Québec

  	
   

  	
  1070 avenue des Sciences-de-la-vie

  Québec
  (Québec), G1V 5C3

  Canada

  	
   

  	
  Every two weeks

  	
   

  



 


43

















 


SCHEDULE “C” – PRODUCT SPECIFICATIONS


 


	
  Product

  	
   

  	
  Drug Identification Number

  (DIN)

  	
   

  	
  Specifications

  (Product Monograph Date)

  	
   

  
	
  GamaSTANMC S/D

  	
   

  	
  02230579

  	
   

  	
  6-Sep-06

  	
   

  
	
  Gamunex® 10%

  	
   

  	
  02247724

  	
   

  	
  1-Jun-06

  	
   

  
	
  Human Albumin 25%

  	
   

  	
  02223708

  	
   

  	
  30-Jun-06

  	
   

  
	
  HyperHEP BMC S/D

  	
   

  	
  02230738

  	
   

  	
  6-Sep-06

  	
   

  
	
  HyperRABMC S/D

  	
   

  	
  02230700

  	
   

  	
  28-Jun-06

  	
   

  
	
  HyperTETMC S/D

  	
   

  	
  02230697

  	
   

  	
  8-Jun-05

  	
   

  
	
  IGIVnexMC 10%

  	
   

  	
  02277921

  	
   

  	
  4-May-06

  	
   

  
	
  Plasbumin® - 5%

  	
   

  	
  02189100

  	
   

  	
  30-Jun-06

  	
   

  
	
  Plasbumin® - 25%

  	
   

  	
  02189119

  	
   

  	
  30-Jun-06

  	
   

  



 


44

















 


SCHEDULE “D” – FRACTIONATION PRODUCTS AND
PRICE FOR FRACTIONATION

PRODUCTS


 


(Plasma volumes and prices)


 


Price Adjustments for Fractionation Products –
Volume of Plasma Picked-Up


 


	
  Product

  	
   

  	
  Formats

  	
   

  	
  [***] –

  [***]

  	
   

  	
  [***] –

  [***]

  	
   

  	
  > [***]

  	
   

  
	
  IGIVnexMC 10%

  	
   

  	
  100 mL and

  200 mL

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  
	
  Albumin 25%

  	
   

  	
  50 mL and 100 mL

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  



 


The Price Per Unit of Measure may be adjusted in accordance with Section 11.2
of the Agreement.


 


For the purposes of this Schedule “D”, the volumes shall be determined
by the amount delivered by both HQ and CBS for fractionation in each Agreement
year.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


 


45

















 


SCHEDULE “E” – INVENTORY LEVELS


 


In this Schedule “Supplier Inventory Levels” shall mean the volume of
Commercial Product and Fractionation Products released by Supplier and by
Health Canada, and kept in appropriate storage by Supplier at a site in Canada
for the benefit of HQ.
All amounts per week in this Schedule shall be determined by dividing
the annual volume referenced in Section 3.4 of this Agreement by 52 weeks
and multiplied by the number of weeks set out in this Schedule.


 


	
  Product

  	
   

  	
  Formats

  	
   

  	
  Target HQ

  Inventory Level

  (weeks)

  	
   

  	
  Supplier

  Inventory Level

  (weeks)

  	
   

  	
  Shortage Level

  Combined HQ

  and Supplier

  Inventory

  (weeks)

  	
   

  
	
  GamaSTANMC S/D

  	
   

  	
  2 mL

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  
	
  Gamunex®
  10%

  	
   

  	
  25 mL

  50 mL

  100 mL

  200 mL

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  
	
  Human
  Albumin 25%

  	
   

  	
  50 mL

  100 mL

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  
	
  HyperHEP
  BMC S/D

  	
   

  	
  0.5 mL

  5 mL

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  
	
  HyperRABMC
  S/D

  	
   

  	
  2 mL

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  	
   

  	
   

  
	
  HyperTETMC
  S/D

  	
   

  	
  250 U

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  
	
  IGIVnexMC

  	
   

  	
  100 mL

  200 mL

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  	
  [***] weeks

  	
   

  
	
  Plasbumin®
  - 5%

  	
   

  	
  50 mL

  250 mL

  	
   

  	
  [***] weeks

  	
   

  	
  * [***] weeks

  	
   

  	
  [***] weeks

  	
   

  
	
  Plasbumin®
  - 25%

  	
   

  	
  50 mL

  100 mL

  	
   

  	
  [***] weeks

  	
   

  	
  * [***] weeks

  	
   

  	
  [***] weeks

  	
   

  



 






·       *  Supplier will keep for the first
Agreement year commencing April 1, 2008, [***] weeks inventory of each
format of Plasbumin® - 5% and Plasbumin® - 25%. The level
will increase at the start of the second agreement year to [***] weeks of
inventory of each format.


 


·       For GamaSTANMC S/D and HyperHEP BMC
S/D, Supplier shall keep in a site in Canada, in addition to the [***] weeks
inventory of products released by Supplier and by Health Canada, a minimum of [***]
weeks inventory of un-released products.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


46

















 


SCHEDULE “F” – VIAL SIZES SUBSTITUTION / WASTAGE


 


The Parties hereby agree that the following clauses shall govern any
Wastage as that term is described herein.


 


Wastage


 


1.           Wastage occurs when a specific vial size of
a Product is not delivered by Supplier as provided for in the applicable
Rolling Forecast, and the HQ inventory of that vial size falls below five (5) weeks
coverage, resulting in HQ customer orders for that vial size being filled with
the next available larger vial size (“Substitution”).


 


2.           In the event of wastage, Supplier shall
compensate HQ (“Compensation”). The time period during which Supplier will
compensate HQ (“Compensation Period”) will commence when the HQ inventory falls
below five (5) weeks coverage due to the failure of Supplier to deliver to
HQ as provided for in the applicable Rolling Forecast. The Compensation Period
will end when sufficient product is delivered to HQ to restore inventory to at
least the five (5) week level.


 


3.           Compensation will be calculated as follows:


 


(a)       The number of vials of Product purchased in
Substitution during the Compensation Period will be estimated by comparing the
weekly demand for the vial size that is unavailable during the Compensation
Period to the average weekly demand for that vial size during the previous
twenty-six (26) weeks. In cases where inconsistent supply may result in the
average weekly demand during the previous twenty-six (26) weeks not being representative
of true demand, the Parties will agree on another more applicable historical
demand period; and,


 


(b)      The average price during the Compensation Period
of the vial size that was being purchased in Substitution will then be compared
to the average price during the Compensation Period of the vial size that was
substituted for, and a price differential will be calculated (the “Price
Differential”); and,


 


(c)       The estimated number of vials purchased in
Substitution during the Compensation Period as determined in (a), will be
multiplied by the Price Differential as determined in (b) and this will be
the total amount of Compensation owing by Supplier to HQ.


 


4.           Compensation may be in credit or free
Product, as mutually agreed to by HQ and Supplier.


 


5.           This will be the mechanism for determining
Compensation unless otherwise mutually agreed upon in writing by the Parties.


 


47

















 


SCHEDULE “G”- CUSTOMER SERVICE


 


Without limiting any of Supplier’s obligations at law, during the term
of this Agreement, Supplier shall:


 


1.     maintain tracking procedures, as outlined in
Appendix B.2.1 to the Supplier’s Proposal;


 


2.     maintain the safety and QA testing program
described in the Supplier’s proposals supporting documentation on Supplier’s
fractionation technology.


 


3.     adhere to the Pharmaceutical Advertising Advisory
Board Code of Advertising Acceptance as well as related Health Canada
guidelines for advertising requirements in Canada;


 


4.     continue to be a member of Biotech Canada;


 


5.     provide a Medical Information Service accessible
toll free, which responds to inquiries from CBS and HQ, physicians, nurses,
allied health professionals and consumers about the Products;


 


6.     employ a cross-Canada field team, capable of
providing service in both official languages, and maintain its established
infrastructure including a Regulatory and Quality Assurance Team to handle all
ongoing customer inquiries for scientific and medical information.


 


Inquiries may be made to Supplier’ medical and scientific affairs
inquiries in the manner as described below.


 


If the inquiry is non-urgent and during normal business hours, the
process shall be to:


 


(i)         Contact
the Supplier extension of the Business Regional Manager that is responsible for
that account and region.


 


If the inquiry is urgent and during normal business hours, the process
shall be to:


 


(i)         Attempt to contact the Business Regional
Manager directly;


(ii)        If delayed, attempt to contact another Business
Regional Manager directly, the responsible market manager, Contract Director or
the QA director;


(iii)       Attempt to contact the vice-president directly.


 


If the inquiry is either urgent or non-urgent outside of business
hours, the process shall be to call after hours number and attempts will be
made by the Supplier customer service team to resolve the issue;


 


7.     staff its Quality Department with trained
professionals responsible for the management of product complaints as outlined
by standard operating procedures and Health Canada’s guidelines;


 


8.     Implement a comprehensive Business
Continuity/Disaster Recovery (BC/DR) Program including an Influenza Pandemic
Preparedness action plan.


 


48

















 


SCHEDULE “H” - VALUE ADDED


 


Research Activities Inside Canada


 


Supplier shall provide collaborative initiatives with practical
applications for improving healthcare in Canada:


 


1.     The Talents
Program, will
support global investigator-led trials conceived by researchers and clinicians
with an interest in using IGIV. This peer-reviewed, competitive program is
fully funded and administered by Supplier research grants with annual support
provided in the amount of $[***] US with scientists from CBS/HQ participating
as part of the Talents Grant Review Committee, as determined and organized by
the Supplier. As members of this committee, these scientists would be part of a
larger team-based approach to better understanding global issues in IGIV
research, as well as continuing to promote research in Canada.


 


[***]


 


3.     Supplier shall, in lieu of the Partnership Fund
provide an unrestricted grant of [***], to be shared by CBS and HQ on a
pro-rata basis, each of HQ and CBS administrating his share. Such grant shall
be payable at the start of each Agreement year.


 


	
  Value-added funds

  	
   

  	
  2008/09

  	
   

  	
  2009/10

  	
   

  	
  2010/11

  	
   

  	
  2011/12

  	
   

  	
  2012/13

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Talents Program*

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  US

  	
   

  	
  US

  	
   

  	
  US

  	
   

  	
  US

  	
   

  	
  US

  	
   

  
	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  CDN

  	
   

  	
  CDN

  	
   

  	
  CDN

  	
   

  	
  CDN

  	
   

  	
  CDN

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Unrestricted Grant

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
  [***]

  	
   

  
	
  (in lieu of Partnership Fund)

  	
   

  	
  CDN

  	
   

  	
  CDN

  	
   

  	
  CDN

  	
   

  	
  CDN

  	
   

  	
  CDN

  	
   

  



 






*: Total funds of [***] per year for the Talents Program will
be provided by Supplier to worldwide selected researchers and clinicians by the
Talents Grant Review Committee.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


49

















 


Additional Value Added


 


[***]


 


Hospital Data Collection Initiative


 


Supplier commits to continue to collect hospital data with enrolled
hospitals for the purpose of understanding IVIG utilization trends and patterns
in hospitals.


 


Maintenance of Current Programs


 


[***]


 


Supplier shall fund clinical/pre-clinical program spending of [***] CDN
in Canada during the contract term.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


 


50

















 


SCHEDULE “I” - B19 TESTING SERVICES


 


In this Schedule “I”:


 


“Samples” means the plasma sample which will be collected in a [***] by
HQ and will be tested for parvovirus B19 by Supplier as described in this
Schedule I.


 


“Elevated Manufacturing Pool” means a Plasma pool that yields parvovirus
B19 viral load that exceeds [***].


 


Supplier will perform the B19 Testing Services described in this
Schedule “I” at its Facility located in Raleigh, North Carolina (“Talecris
Facility”), but may perform such testing at another location upon written
notice to HQ.


 


SAMPLES AND PLASMA PROCESSING


 


1.     All Samples provided to Supplier must meet the
specifications, packaging and shipping requirements set forth in this Schedule
I (“Sample Specifications”).


 


Supplier has the right to refuse Samples not meeting specifications as
set out in HQ Standard Operating Procedure (“SOP”) PCS-INS-031 Réception des dons de sang.


 


2.     HQ shall ensure that Samples of each Plasma unit
to be collected by Supplier pursuant to this Agreement are made available for
pickup at the HQ Production Sites and conform to the Sample Specifications.


 


3.     Supplier shall have no liability or responsibility
for delay in the performance of the testing or delay in the delivery of
Fractionation Products resulting from HQ’s failure to provide the Samples in a
timely manner.


 


4.     The Supplier confirm that the Samples are viable
for testing for a period of twelve (12) months in a frozen state based on a
temperature validation study made on the Samples.


 


5.     All distribution costs, including without
limitation, transportation costs, duties, excise, brokerage fees and customs,
shall be borne by Supplier, provided that Supplier shall not be responsible for
any additional costs arising from HQ’s failure to meet its obligations under
this Agreement in a timely manner and which are not attributable to any action
or omission of Supplier.


 


6.     In the event that HQ materially alters any of its
SOPs affecting the collection of Samples to be used by Supplier for the
performance of the testing during the Term of this Agreement, HQ must inform
Supplier of the proposed change at least sixty (60) days in advance of
implementing the change or, if such change is imposed by Health Canada within a
shorter time frame, then HQ shall notify Supplier as soon as reasonably
possible. HQ will work with Supplier to evaluate the consequences of any such
change to the testing. Talecris shall submit to HQ the costs associated with
the change in HQ’s SOP, including the cost of investigation such as additional
validation work or pathogen safety research that may be required. HQ will
notify Supplier if it accepts such costs.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


51

















 


LOSS


 


1.     HQ shall be responsible for and shall bear all
risk of loss or damage to the Samples collected while such Samples are in its
care, custody and control, including but not limited to any loss or damage
resulting from the improper storage, handling, packing, crating, and/or
blocking of the Samples at the HQ Production Centres.


 


2.     Supplier shall be responsible for and shall bear
all risk of loss and damage to the Samples as soon as such Samples are picked
up by Supplier’s carrier and during the period such Samples are in Supplier’s
care, custody and control. This responsibility includes but is not limited to,
any loss or damage resulting from the improper storage, handling, loading,
blocking and/or transportation of the Samples, except as such loss or damage
results from HQ’s actions or omission. Any loss of Plasma resulting from the
loss or the damage of the Samples attributable to the Supplier shall be
compensated by the Supplier providing Replacement Fractionation Products
pursuant to Section 8.12 of the Agreement. Supplier shall ensure that the
Samples are appropriately segregated and not intermingled with other samples
which are being tested by Supplier for parties other than HQ and CBS.


 


3.     In the event that a minimum of one (1) clamshell
holder of Samples is missing, where HQ admits that the Samples are missing due
to HQ’s act or omission, and HQ cannot locate the Samples within ten (10) Business
Days from the date Supplier notifies HQ of the missing Samples, Supplier will
use its reasonable efforts to find a solution acceptable to HQ and to Supplier
to avoid the loss of the corresponding Plasma. If the Samples are missing and
it can be established that this occurred while Supplier was responsible for
them, then Supplier shall have ten (10) Business Days to attempt to locate
them, and failing this, Supplier shall provide Replacement Products pursuant to
Section 8.12 to this Agreement.


 


4.     For any Elevated Manufacturing Pools, a root cause
analysis on these pools will be performed by Supplier and the liability for
such pools shall be as follows:


 


(i)        if the Elevated Manufacturing Pool resulted
from Supplier’s action or omission, including but not limited to failure to
interdict higher titre units, wrong units interdicted, misreading results, or
system failure, then Supplier shall provide Replacement Fractionation Products
pursuant to Section 8.12 of the Agreement. The quantity of Replacement
Fractionation Products from the Plasma rendered unusable shall be calculated as
follows: the number of litres of Plasma destroyed multiplied by the
year-to-date average yield from Plasma processed (excluding re-processed lots);


 


(ii)       if the destruction of the Elevated Manufacturing
Pool is necessitated because of any action or omission by HQ, including but not
limited to mislabelling, cross-contamination at collection, and Supplier
provides sufficient evidence of this to HQ’s reasonable satisfaction, then HQ
shall bear the loss;


 


With respect to both (i) and (ii) above, each Party agrees to
provide the other with its corrective and preventive action report and all
related information to permit a full review of the findings.


 


(iii)      [***]


 






***CONFIDENTIAL TREATMENT REQUESTED


 


52

















 


[***]


 


TERM AND TERMINATION


 


HQ acknowledges that Plasma being processed by Supplier must be B19
tested. However, HQ reserves the right to terminate the portions of the
Agreement relating to this Schedule I on one hundred and eighty (180) days
written notice. In the event of such termination, HQ will assume responsibility
for ensuring that B19 testing meets the requirements of the Plasma Protein
Therapeutic Association.


 


TESTING


 


For each unit of Plasma shipped to Supplier, HQ will provide a Sample
of processed whole blood in a PPT Vacutainer Tube. Supplier shall provide
parvovirus B19 testing services for all Plasma shipped for fractionation.
Testing will be done according to Supplier’s approved SOPs designed to remove
high titre units to provide a Plasma pool that does not exceed [***] B19 units
per mL, Interdiction of high titred plasma units will be based on the
correlation of individual Sample disposition to plasma unit identifiers. No
direct testing of individual plasma units shall occur.


 


POOLING


 


Supplier will resolve any high titre mini-pools to the high titre
reactive Sample(s). Pooling will be conducted using the standard algorithm in
place at the Supplier Facility for source plasma samples and in accordance with
the Supplier SOPs provided to HQ.


 


TIMING


 


[***]


 


DATA MANAGEMENT / RESULTS


 


All interdicted high titre
parvovirus B19 plasma units will be destroyed according to Supplier plasma
destruction procedures that include destruction documentation, reconciliation
and quality review that will be made available to HQ. Supplier will bear the
costs of the plasma unit destruction. Supplier will not provide individual test
results to HQ.


 


SAMPLES MANAGEMENT


 


Supplier shall not use Samples for any purposes other than B19 testing.
Samples will be destroyed by Supplier, at its own cost, according to Supplier’s
destruction procedure that includes destruction documentation, reconciliation
and quality review.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


53

















 


SAMPLE
SPECIFICATIONS


 


1.          The Sample shall be collected by HQ in a [***]


 


2.          Supplier will accept Samples of a minimum
volume of [***] of centrifuged whole blood. However, if the plasma yield is
less than a volume of [***] Supplier may not be able to test the Sample. This may
result in the destruction of the Plasma unit.


 


3.          The Sample
shall be labelled by HQ with a barcode label having the same unique numerical
identifier as the corresponding plasma unit. The positioning and design of the
Sample tube label will be handled as set forth in HQ SOP CLI-INS-051 Prélèvement des échantillons avec ou sans
don de sang.


 


4.          The Sample shall be centrifuged by HQ [***]
in order to separate the plasma from the cellular components.


 


5.          The Samples shall be handled following the
temperature specifications as set forth in HQ SOPs LAB-INS-015 Traitement des échantillons and PCS-INS-044 Traitement
des échantillons
destinés
au test du parvovirus B19, and as provided to Supplier.


 


SHIPPING
LOGISTICS:


 


1.          Each Plasma unit consigned to Supplier must
be accompanied by a Sample for B19 testing. Upon discovery of, at minimum, a
missing Sample clamshell holder during receipt of shipments at Supplier,
Supplier will immediately contact HQ Director, Fractionation Products by
telephone and facsimile transmission as stated in subsection 23.4. HQ will have
ten (10) Business Days to retrieve any missing Samples and ship any
missing Samples. Such deviations to be reported back to HQ at the regular
Fractionation Meetings.


 


2.          The Samples shall be packed in a clamshell
holder. Samples shall be packed for shipment in the same quantity aggregates as
the plasma units (i.e. if a carton of plasma contains 28 plasma units, the
corresponding Sample clamshell shall contain 28 Samples). Each sample clamshell
shall be labelled with the same numerical identifier as the corresponding
plasma case. HQ shall supply the Sample clamshell holder material.


 


3.          Sample clamshells (up to 24) shall be packed
into sample boxes. The sample box shall be labelled, the content and position which
are described in HQ SOP LGP-INS-018 Envoi du plasma et des échantillons destinés au
fractionnateur. Supplier shall provide the sample boxes.


 


4.          Plasma
units and Samples shall be stored and pre-conditioned at -20°C or colder when
consigned for pick up by Supplier as set forth in HQ SOP LGP-INS-018 Envoi du plasma et des échantillons destinés au fractionnateur.


 


5.          Samples for each Vendor Batch (Lot Number)
will be shipped on the same stretch-wrapped pallet as the Plasma cases, packed
in a separate carton on the top tier of cases and clearly identified as a
Sample container.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


54

















 


6.          The
shipping documents that will accompany each Vendor Batch (HQ Lot Number) are
listed in HQ SOP LOP-INS-018 Envoi du plasma
et des échantillons destinés au fractionnateur.


 


7.          If there is an issue with a Vendor Batch (HQ
Lot Number) leading to the quarantine of the affected Vendor Batch for
investigational or other purpose, only the affected Vendor Batch shall be
affected (i.e. testing of other Vendor Batches remaining in the truck will not
be delayed).


 


FEES


 


1.     Supplier may invoice HQ for the fees as set out
below.


 


2.     On April 1 of each year during the Term of
this Agreement, Supplier may, in its sole discretion, increase the fees for the
testing up to the maximum of CPI over the previous calendar year. Supplier
shall notify HQ in writing within forty-five (45) days of the start of each
Agreement year of the proposed price change otherwise it shall be deemed that
the current Agreement year prices will remain in effect for an additional year.


 


The total fee for the Testing Services shall be [***] per sample
commencing April 1, 2008.


 


All invoices shall be submitted in duplicate to HQ to the attention of
the Accounts Payable Department and each invoice shall:


 


(a)           reference the applicable Purchase Order if
any and Agreement Number;


 


(b)           set out the details of the testing that are
the subject of the invoice:


 


·      Supplier will invoice HQ 1/12th of the
annual estimated cost based on the forecasted total number of Samples (base
from litres forecast) in a Agreement year.


 


·      Supplier will report the total number of Samples
tested by the Supplier Facility on each monthly invoice. On a quarterly basis,
Supplier will prepare a report outlining the reasons for a Sample not tested or
removed (low volume, high titre, etc.) for the regular Fractionation Meetings.


 


·      On a quarterly basis, a reconciliation of total
actual Samples and the forecast volume will be completed with the difference
either credited or debited through Supplier’s invoicing process.


 


(c)           set out the GST owing as a separate line
item;


 


(d)           set out Supplier’s GST registration number;
and


 


(e)           set out the PST (if applicable) owing as a
separate line item.


 


VOLUME OF SAMPLES ADJUSTMENTS


 


A year-end reconciliation, to be conducted within thirty (30) days of
the contract year-end, to determine the number of Samples processed versus
forecast, will form the basis for any necessary correction in either direction.
Payment terms will be Net 30 days.


 






***CONFIDENTIAL TREATMENT REQUESTED


 


55

















 


SCHEDULE “J” – KEY PERFORMANCE INDICATORS
PROGRAM


 


Extended performance measurement program


 


1.        Objective:


 


The extended performance measurement program has been created to
measure and document HQ’s supplier performance for different aspects related to
Products with the goal of optimizating performance and ensuring maximum
efficiency.


 


2.        Key Performance Indicators (KPI):


 


The extended performance measurement is based on four indicators :


 


a)    Delivery performance (20%)


b)    Product conformance (15%)


c)    Contract – partnership


1.     Regulatory documentation
(15%)


2.     Inventory level (20%)


d)    Customer service (30%)


 


a)    Delivery performance (20%)


 


Delivery performance is based on three criteria:


 


·     Quantity;


·     Delivery date;


·     Documentation.


 


A global result is calculated based on the number of line items
respecting all three criteria


 


Formula : Number of line items respecting
all 3 criteria


Total number of line items


 


HQ has established a delivery objective of 98% or more on the monthly
performance rating for Supplier.


 


The results compiled by criteria are, however, not in direct relation
to the global result.


 


For each measurement criteria, there are three possibilities:


 


·     Respect;


·     Non-respect; or


·     Not received.


 


Respect : The criteria is considered as “in respect” if :


 


·     The criteria is respected;


·     HQ is notified of a change and if HQ is in
acceptance of the change.


 


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Non-respect : The criteria is considered as “non respect” if:


 


·     The criteria is not respected or is erroneous;


·     A change is not notified to HQ;


·     A change is notified to but not accepted by HQ for
a delay within the same month.


 


Not received : The criteria is considered as “not received” if:


 


·     The criteria is not fulfilled in the current
month;


·     A change is notified to but not accepted by HQ and
which in consequence entails a delivery delay to a subsequent month.


 


Note: Any change that is affected within the Binding Forecast and is
accepted by Parties is measured according to the established criteria based on
the updated requirement.


 


Quantity criteria:


 


·      A line item delivered at ± 10% is considered as a
“non-respect” if a change in quantity has not been confirmed to HQ fractionation
department;


·      A pre-shipment notification must be provided to
HQ prior to delivery, confirming the exact quantity/quantities to be shipped.
Upon receipt, should the quantity for any line item differ from the quantity
confirmed, the applicable line item will be considered as a “non-respect”;


·      If the total quantity for a line item will not be
received in a single delivery and if the HQ fractionation department has
accepted the split delivery, a new line item will be created to reflect the
subsequent delivery and will in consequence be measured according to the
updated information.


 


Delivery date criteria:


 


·      Supplier must supply a written pre-shipment
notification confirming the precise delivery date for each line item. If the
actual receipt date differs from the confirmed date, the applicable line item(s) will
be considered as “non-respect”;


·      A line item which is delivered in a month other
then the current month and for which HQ fractionation department has not
accepted the schedule change, the line item will be considered as “not received”.


 


Documentation criteria:


 


·      The documentation criteria includes two types of
documentation :


 


·    Pre-shipment
notification


·    Documentation
at the time of receipt


 


Pre-shipment notification:


 


·      Includes all necessary documentation required for
the receipt and the Quality Assurance release for each line item. These
documents are required by HQ minimum one (1) business day prior to the
receipt. Any documentation containing erroneous information will constitute a ‘non-respect’.


·      Documentation requirements : Pre-shipment
notification


 


·    Lot
release letter issued by Health Canada (if applicable)*


·    Certificate
of analysis*


 


57

















 


Note: The lot release letter and the certificate of analysis is
required only prior to the first receipt of any given lot to HQ.


 


Documentation at the time of receipt:


 


·      The packing slip must be included with the
shipment and received by HQ at the time of receipt. If any pertinent
information included therein is erroneous, the documentation criteria will be
considered as ‘non-respect’.


·      For example:


 


·    HQ
purchase order number & line item


·    HQ
item number


·    Quantity


·    Expiry
date


 


b)    Product conformance (15%)


Non-exhaustive list of elements to be measured (when applicable):


 


·      Integrity of packaging


·      Temperature excursion


·      Missing product


·      Labelling or printing issues (lot number, expiry
date)


 


c)    Contract – Partnership 


Regulatory documentation (15%)


 


Timely receipt of documentation pursuant to Section 12.4.
Non-exhaustive list of elements to be measured (when applicable):


 


·      Notice of Supplemental/New drug Submission


·      Notice of compliance


·      Product Monographs


·      Health Canada Exit Notices


·      FDA 483


·      Recall/Withdrawal


·      Warning Letters


 


Inventory level (20%)


 


The respect of the Supplier Inventory level is evaluated for a security
of supply and a customer service (availability of all formats of products)
standpoint.


 


Method of calculation:


 


·      Monthly average of weekly level


·      Should the inventory level of a format fall below
50% of the target level during the month, Supplier will need to inform HQ, on
the first working day following the end month, of the number of days that such
product was under 50%.


·      The inventory performance rating for the month
will be reduced by 2% per working day for each product at less than 50% of the
target level during that month.


 


d)    Customer service (30%)


Timely response: Non-exhaustive list of elements to be measured (when
applicable): 10%


 


58

















 


·      Specific questions about product(s)


·      Questions of a general nature


·      Request for documentation or missing information


·      Complaints


·      Adverse event reporting


·      SAP management by the Supplier


 


Quality of information: Non-exhaustive list of elements to be measured
(when applicable): 10%


 


·      Information received is clear and complete


·      Information received meets the request of HQ


·      Information received is accurate


 


Quality of support / service: non-exhaustive list of elements to be
measured (when applicable): 10%


 


·      Accessibility of appropriate personnel


·      Pro activity


·      Responsiveness to HQ requests


 


3.        Evaluation


 


·      HQ evaluates each indicator/criterion on a scale
from 20 % to 100% (with the exception of delivery performance and inventory
level)


 


·    100%
: Perfect performance


·    95%
:   Good, consistent


·    80%
:   Acceptable Effort, but should be more
steadfast


·    60%
:   Poor, negligent


·    20%
:   Unacceptable


 


·      Each indicator/criterion is attributed a
weighting (%).


 


HQ has determined an annual target of 96% for overall Supplier
performance. An overall performance of is considered as:


 


Excellent performance: 96% +


 


The performance of the supplier largely and constantly exceeds all the criteria sets out in the
stable products key performance indicators program.


 


Good performance: 90% - 95%


 


The supplier’s performance is good based on the criteria set out in
stable products key performance indicators program. However, efforts are
expected in order to improve results on a few criteria.


 


Improvements are required: Less than 90%:


 


The performance of the supplier is not meeting the objective(s) of
the stable products key performance indicators program. Improvements are
required on several criteria of the program.


 


4.        Reporting:


 


·      On a monthly basis, HQ will identify any
incidents that were documented during the preceding month.


·      Supplier is encouraged to instate corrective
action in order to improve performance rating for appropriate
indicator/criterion.


·      A preliminary report will be presented to
Supplier after the first 6 months.


·      A final report will be presented to Supplier at
year end.


 


59