Exhibit 10.28.1


 


*** TEXT OMITTED AND SUBMITTED SEPARATELY


PURSUANT TO CONFIDENTIAL TREATMENT REQUEST


UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 230.406


 


Agreement
#805-2005


 


ASSIGNMENT


AND


SECOND AMENDED AND RESTATED


 


PURCHASE AGREEMENT


 


FOR


 


FRACTIONATION SERVICES


AND


COMMERCIAL PRODUCTS


 


 


BETWEEN AND AMONGST


 


 


CANADIAN BLOOD SERVICES


 


BAYER INC.


 


BAYER HEALTHCARE LLC


 


 


AND


 


TALECRIS BIOTHERAPEUTICS, INC.


(F/K/A NPS BIOTHERAPEUTICS, INC.)


 


 

















 


Table of Contents


 


	
   

  	
   

  	
  Page

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  1.

  	
  DEFINED TERMS AND INTERPRETATION

  	
  2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.1

  	
  Definitions

  	
  2

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.2

  	
  Extended Meanings

  	
  4

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.3

  	
  Schedules

  	
  4

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.4

  	
  Time

  	
  5

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.5

  	
  Entire Agreement

  	
  5

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.6

  	
  Lead

  	
  5

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  2.

  	
  PURCHASE AND SALE OF GOODS/SERVICES

  	
  6

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.1

  	
  Goods and Services

  	
  6

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.2

  	
  Distribution of Products in Canada

  	
  6

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
  DELIVERY OF COMMERCIAL PRODUCTS

  	
  6

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.1

  	
  Forecasting

  	
  6

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.2

  	
  Prior Forecasts to be Honoured

  	
  6

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.3

  	
  Order for Commercial Products

  	
  7

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.4

  	
  Annual Volume

  	
  7

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.5

  	
  Delivery

  	
  7

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.6

  	
  Late Deliveries

  	
  7

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.7

  	
  Vial Size

  	
  8

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.8

  	
  Commercial Product Recalled, Withdrawn or Not Validly Distributed

  	
  8

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.9

  	
  Procedures for Alternate Sourcing

  	
  8

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.10

  	
  Minimum Supply Guarantee to Further Protect Canadians

  	
  9

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
  COMMERCIAL PRODUCTS SPECIFICATIONS

  	
  9

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.1

  	
  Commercial Product Specifications

  	
  9

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.2

  	
  Bayer Canada Determines Commercial Products are Unsuitable

  	
  10

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.3

  	
  CBS Determines Commercial Products are Unsuitable

  	
  10

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.4

  	
  Significant Reduction in Consumer Preference

  	
  11

  	
   

  
	
   

  	
   

  	
   

  	
   

  



 


 


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  5.

  	
  FRACTIONATION SERVICES

  	
  11

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.1

  	
  Forecasting

  	
  11

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.2

  	
  Order for Fractionation Products

  	
  12

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.3

  	
  Prior Forecasts to be Honoured

  	
  12

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.4

  	
  Forecasting Continued to Termination Date

  	
  12

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.5

  	
  Survival of Orders after Termination

  	
  12

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
  PLASMA COLLECTION AND PROCESSING

  	
  12

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.1

  	
  Plasma Collection

  	
  12

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.2

  	
  Responsibility for Plasma in CBS’ Possession

  	
  12

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.3

  	
  Notice of Plasma Pickup by Bayer Canada

  	
  13

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.4

  	
  Pickup, Transportation and Storage of Plasma by Bayer Canada

  	
  13

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.5

  	
  Maximizing Transportation Efficiency

  	
  13

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.6

  	
  Bayer Canada Responsible for Exportation of Plasma

  	
  13

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.7

  	
  Shipping Documents and Exportation of Plasma

  	
  14

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.8

  	
  Responsibility for Plasma in Talecris’ or Bayer Canada’s Possession

  	
  14

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.9

  	
  Talecris to Inspect Plasma

  	
  14

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.10

  	
  CBS Determines Plasma Delivered to Bayer Canada is Unsuitable

  	
  14

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.11

  	
  Right of Talecris and Bayer Canada to Reject CBS Plasma

  	
  14

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.12

  	
  Plasma Rendered Unusable by Talecris or Bayer Canada

  	
  15

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.13

  	
  Quarterly Meetings

  	
  15

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.14

  	
  Change to CBS Standard Operating Procedures

  	
  16

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.15

  	
  Work in Process

  	
  16

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
  DELIVERY OF FRACTIONATION PRODUCTS AND RECORDS

  	
  16

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.1

  	
  Delivery Schedule and Report on Status of Fractionation Product
  Delivery

  	
  16

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.2

  	
  Notice of Delay in Delivery of Fractionation Products

  	
  17

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.3

  	
  Delay in Delivery of Fractionation Products due to CBS

  	
  17

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.4

  	
  Records

  	
  17

  	
   

  
	
   

  	
   

  	
   

  	
   

  



 


 


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  8.

  	
  DELIVERY OF PRODUCTS

  	
  18

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.1

  	
  Product Shelf Life

  	
  18

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.2

  	
  Delivery of Products

  	
  18

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.3

  	
  Responsibility for Products

  	
  19

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.4

  	
  Duty of Inspection

  	
  19

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  9.

  	
  INVOICES AND PAYMENT

  	
  19

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.1

  	
  Invoices

  	
  19

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.2

  	
  Price

  	
  19

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.3

  	
  Price Adjustments

  	
  19

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.4

  	
  Payment Terms

  	
  20

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.5

  	
  Value added

  	
  20

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.6

  	
  Pricing Not Affected by Remedies

  	
  21

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  10.

  	
  REGULATORY AND QUALITY ASSURANCE MATTERS

  	
  21

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.1

  	
  Regulatory Condition of Supply

  	
  21

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.2

  	
  Improvements

  	
  21

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.3

  	
  Special Access Program

  	
  22 

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.4

  	
  Communications

  	
  22

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.5

  	
  Talecris and Bayer Canada Information

  	
  23

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.6

  	
  Compliance Audit

  	
  23

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  11.

  	
  PRODUCT WITHDRAWALS/RECALLS

  	
  23

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  11.1

  	
  Recall / Withdrawal

  	
  23

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  11.2

  	
  Patient Notification System

  	
  24

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  11.3

  	
  Adverse Event Reporting

  	
  24

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  11.4

  	
  Replacement Products and Replacement Fractionation Products

  	
  24

  	
   

  



 


 


iii of
v

















 


	
  12.

  	
  REPRESENTATIONS, WARRANTIES AND INSPECTION

  	
  24

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.1

  	
  Representations and Warranties of the Parties

  	
  24

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.2

  	
  Applicable Laws and Notice of Compliance

  	
  25

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.3

  	
  Title and Warranty on the Products

  	
  25

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.4

  	
  Guaranteed Yield

  	
  26

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.5

  	
  Current Information

  	
  26

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.6

  	
  No Waiver

  	
  26

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.7

  	
  Survival of Representations and Warranties

  	
  26

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  13.

  	
  PATENT PROTECTION

  	
  26

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  13.1

  	
  No Infringement

  	
  26

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  13.2

  	
  Infringement by a Product or Process

  	
  27

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  14.

  	
  INSURANCE AND INDEMNIFICATION

  	
  27

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  14.1

  	
  Talecris’ and Bayer Canada’s Insurance

  	
  27

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  14.2

  	
  CBS Insurance

  	
  28

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  14.3

  	
  Indemnity

  	
  29

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  14.4

  	
  Approval of Counsel

  	
  30

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  15.

  	
  CHANGE

  	
  30

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15.1

  	
  Technological Change

  	
  30

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15.2

  	
  Dispute Resolution

  	
  31

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15.3

  	
  Intentionally Omitted

  	
  31

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15.4

  	
  Parvovirus B19 Testing and the Change to the Caprylate/Chromatography
  Process

  	
  31

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16.

  	
  TERMINATION

  	
  32

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  16.1

  	
  Termination of Agreement

  	
  32

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  16.2

  	
  Talecris Event of Default

  	
  32

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  16.3

  	
  CBS Event of Default

  	
  32

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  16.4

  	
  Bayer Canada Event of Default

  	
  33

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  17.

  	
  DISPUTE RESOLUTION

  	
  34

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  17.1

  	
  Arbitration

  	
  34

  	
   

  



 


 


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  18.

  	
  OPTION TO RENEW

  	
  35

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  18.1

  	
  Renewal

  	
  35

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  19.

  	
  GENERAL

  	
  35

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.1

  	
  Notices

  	
  35

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.2

  	
  Assignment

  	
  36

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.3

  	
  Independent Contractors

  	
  37

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.4

  	
  Severability

  	
  37

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.5

  	
  Communication

  	
  37

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.6

  	
  Governing Law

  	
  37

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.7

  	
  Currency

  	
  37

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.8

  	
  Successors and Assigns

  	
  37

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.9

  	
  No Waiver

  	
  37

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.10

  	
  Counterparts

  	
  38

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.11

  	
  Amendment

  	
  38

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.12

  	
  Confidential Information

  	
  38

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.13

  	
  Pricing Information to Customers

  	
  38

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.14

  	
  Public Announcements

  	
  38

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.15

  	
  Force Majeure

  	
  39

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.16

  	
  Talecris and Bayer Canada jointly and severally liable

  	
  39

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  19.17

  	
  Acknowledgement

  	
  40

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  EXECUTION FOR ASSIGNMENT

  	
  41

  	
   

  
	
  SCHEDULE “A” - COMMERCIAL PRODUCTS

  	
  42

  	
   

  
	
  SCHEDULE “B” - PLASMA PICK-UP SCHEDULE

  	
  44

  	
   

  
	
  SCHEDULE “C” - COMMERCIAL PRODUCT SPECIFICATIONS

  	
  45

  	
   

  
	
  SCHEDULE “D” - FRACTIONATION PRODUCTS AND PRICE ADJUSTMENTS FOR
  FRACTIONATION PRODUCTS

  	
  46

  	
   

  
	
  SCHEDULE “E” - CBS PRODUCTION INVENTORY TARGET LEVELS

  	
  47

  	
   

  
	
  SCHEDULE “F” - COLLECTION CENTRES

  	
  48

  	
   

  
	
  SCHEDULE “G” - INTENTIONALLY DELETED

  	
  49

  	
   

  
	
  SCHEDULE “H” - VIAL SIZES SUBSTITUTION / WASTAGE

  	
  50

  	
   

  



 


 


v of v

















 


ASSIGNMENT AND RESTATEMENT OF


PURCHASE AGREEMENT FOR


FRACTIONATION SERVICES AND COMMERCIAL PRODUCTS


 


THIS AGREEMENT effective as of the first of April, 2005
(hereinafter referred to as “Effective Date”) is made


 


	
  BETWEEN

  	
   

  
	
  AND AMONGST:

  	
   

  
	
   

  	
   

  
	
   

  	
  CANADIAN BLOOD SERVICES/

  
	
   

  	
  SOCIETE CANADIENNE DU SANG

  
	
   

  	
  1800 Alta Vista Drive

  
	
   

  	
  Ottawa, ON K1G 4J5

  
	
   

  	
  CANADA

  
	
   

  	
  (hereinafter referred to as “CBS”)

  
	
   

  	
   

  
	
  AND:

  	
   

  
	
   

  	
   

  
	
   

  	
  BAYER INC.

  
	
   

  	
  77 Belfield Road

  
	
   

  	
  Toronto, ON M9W 1G6

  
	
   

  	
  CANADA

  
	
   

  	
  (hereinafter referred to as “Bayer Canada”)

  
	
   

  	
   

  
	
  AND:

  	
   

  
	
   

  	
   

  
	
   

  	
  BAYER HEALTHCARE LLC

  
	
   

  	
  400 Morgan Lane

  
	
   

  	
  Westhaven, CT 06516-4175

  
	
   

  	
  USA

  
	
   

  	
  (hereinafter referred to as (“Bayer US”)

  
	
   

  	
   

  
	
  AND:

  	
   

  
	
   

  	
   

  
	
   

  	
  TALECRIS BIOTHERAPEUTICS, INC.

  
	
   

  	
  (F/K/A NPS BIOTHERAPEUTICS, INC.)

  
	
   

  	
  P. O. Box 13887

  
	
   

  	
  79 TW Alexander Drive

  
	
   

  	
  4101 Research Commons

  
	
   

  	
  Research Triangle Park

  
	
   

  	
  Raleigh, NC 27709

  
	
   

  	
  (hereinafter referred to as “Talecris”)

  
	
   

  	
   

  
	
   

  	
  (CBS, Bayer Canada and Talecris hereinafter collectively referred to
  as the “Parties”)

  



 


 


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WHEREAS:


 


1)                                      Bayer
US and Talecris have entered into that certain Joint Contribution Agreement,
dated as of December 10, 2004, pursuant to which Talecris acquired Bayer’s
plasma business;


 


2)                                      Bayer
Canada, Bayer US and CBS are parties to that certain Purchase Agreement for
Fractionation Services and Commercial Products dated as of April, 1, 2003,
which included Recombinant Hemophilia Products (as amended to date, the “Original
Agreement”);


 


3)                                      Bayer
Canada, Bayer US and CBS have amended the Original Agreement to split it into
two agreements: one with respect to Recombinant Hemophilia Products (the “RHP
Agreement”) and one with respect to the Fractionation Services and Commercial
Products other than Recombinant Hemophilia Products described in the Original
Agreement (the “Main Agreement”);


 


4)                                      Bayer
US wishes to terminate, as of the Effective Date of this Agreement, its ongoing
rights under the Main Agreement relating to activities after the Effective Date
of this Agreement, and Bayer Canada, Bayer US, Talecris and CBS wish to amend
and restate the Main Agreement to reflect Talecris’ acquisition of Bayer US’
manufacturing and fractionation facility in Clayton, North Carolina.


 


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


 


(c)                                 “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;


 


(d)                                “Collection
Centres” means those sites identified in Schedule “F”;


 


(e)                                 “Commercial
Products” means all products 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;


 


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


 


 


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(g)                                “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;


 


(h)                                “Effective
Date” means April 1, 2005;


 


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


 


(j)                                    “FPMS”
means the Fractionation Product Management System, a regulated database used by
CBS for national inventory management;


 


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


 


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


 


(m)                              “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;


 


(n)                                “Hema-Quebec”
and “HQ” means the blood management organization in the province of Quebec;


 


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


 


(p)                                “Industry
Canada” means Her Majesty the Queen in right of Canada as represented by the
federal Minister of Industry;


 


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


 


(r)                                   “Partnership
Fund” means the research fund supported by Bayer Canada and administered by
Bayer Canada, CBS and HQ whereby a research grant, based on merit, is for
research in the area of biologicals and blood products;


 


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


 


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


 


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


 


(v)                                “Product
Specifications” or “Specifications” includes the product monograph, all
labelling, package inserts and packaging for the Products as approved by Health
Canada and, for Commercial Products as set out in Schedule “C” as amended from
time to time;


 


(w)                              “Recall”
means any action ordered by Talecris or Bayer Canada 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;


 


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


 


(y)                                “Replacement
Fractionation Products” means products required by CBS pursuant to Sections
6.12, 7.2 and 7.3 and a Replacement Fractionation Product means any one of
them;


 


 


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(z)                                  “Replacement
Product” means products required by CBS pursuant to Sections 3.8, 3.9, 11.4 and
15.1 and a Replacement Product means any one of them;


 


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


 


(bb)                         “Shortage”
means that the total inventory of any Product, issuable and not subject to a
quarantine, Recall or Withdrawal, of Fractionation Products and/or Commercial
Products in the FPMS [***];


 


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


 


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


 


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


 


(ff)                               “Term”
means that period of time commencing on the Effective Date and ending at the
earlier of:


 


(a)                                  March
31, 2007; and


 


(b)                                 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;


 


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


 


(hh)                         “Warehouse”
means CBS’ primary warehouse at 1800 Alta Vista Drive, Ottawa, Ontario, Canada,
or such other warehouse as may be designated in writing by CBS to Bayer Canada
and consented to by Bayer Canada, which consent will not unreasonably be
withheld; and,


 


(ii)                                 “Withdrawal”
means any action ordered by Talecris, Bayer Canada or by CBS, 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                              Extended Meanings


 


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


 


1.3                              Schedules


 


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


 


Schedule “A” - Commercial Products;


Schedule “B” - 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” - CBS Product Inventory Target Levels;


Schedule “F” - Collection Centres;


Schedule “G” - Intentionally Deleted;


 


 






***
CONFIDENTIAL TREATMENT REQUESTED


 


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Schedule “H” - Vial Size Substitution / Wastage.


 


1.4                              Time


 


Time shall be of the essence.


 


1.5                              Entire Agreement


 


This Agreement, including the attached Schedules, and the SSA (as
defined in Section 15.4), constitutes the entire Agreement between and among
the Parties and Bayer US 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 and Bayer
US pertaining to the subject matter of this Agreement, including, without limitation,
the Main Agreement except with respect to obligations of Bayer US which by
their nature are required or are specifically stated to survive the termination
of the Main Agreement, including but not limited to Plasma picked up or to
Commercial Products and Fractionation Products manufactured or partially
manufactured prior to the Effective Date. 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 and
the SSA. No supplement, modification, amendment, or waiver of this Agreement
shall be binding unless executed in writing by all Parties.


 


1.6                              Lead


 


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


 


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


 


(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 labeling;


 


(iv)                              disposition
of Plasma Intermediates; and


 


(v)                                 the
provision to Bayer Canada of the Plasma and Fractionation Products Rolling
Forecasts of CBS and HQ and the four (4) month forecasts pursuant to Sections
5.1 and 5.2.


 


Talecris and Bayer Canada 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.


 


 


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1.7                              Role of Bayer US


 


CBS agrees that Bayer US shall have no further obligations under the
Main Agreement or this Agreement with respect to any activities from and after
the Effective Date of this Agreement and CBS shall look only to Bayer Canada or
to Talecris, for performance of obligations under this Agreement as set forth
herein. However, the obligations of Bayer US which by their nature are required
or are specifically stated to survive the termination of the Main Agreement,
shall survive. For greater certainty, these obligations shall include but not
be limited to the obligations of Bayer US and Bayer Canada with respect to
Plasma picked up by Bayer Canada or Bayer US or to Commercial Products and
Fractionation Products manufactured or partially manufactured by Bayer US prior
to the Effective Date. It is further acknowledged and agreed that Bayer US
shall have no ongoing rights or obligations under this Agreement except those
relating to the enforcement of or to seek damages from Talecris or Bayer Canada
relating to the assignment and assumption of its rights and obligations
described in this Section 1.7.


 


2.                                     PURCHASE AND SALE OF
GOODS/SERVICES


 


2.1                              Goods and Services


 


CBS shall purchase or obtain from Bayer Canada and Bayer Canada shall
sell or provide to CBS, 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.” In connection with the Fractionation Services,
Talecris will, unless otherwise permitted by the provisions of this Agreement,
use Plasma provided to Bayer Canada by CBS.


 


2.2                              Distribution of Products
in Canada


 


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


 


(b)                                CBS
further agrees to notify Bayer Canada in writing as soon as reasonably possible
if it suspects that any of the Products are being obtained from CBS 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


 


CBS shall provide Bayer Canada with an eighteen (18) month rolling
forecast (the “Rolling Forecast”) of its total monthly volume requirement for
Commercial Products by the fifth Business Day of each month (the “Forecast Day”).


 


3.2                              Prior Forecasts to be
Honoured


 


The Parties acknowledge that forecasts and commitments have been made
prior to the Effective Date under the Main Agreement which are applicable for
the first six (6) months of this Agreement. The Parties shall be bound by such
forecasts and commitments in accordance with the terms and conditions of this
Agreement.


 


 


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3.3                              Order for Commercial
Products


 


The forecast for each [***] immediately
following each Forecast Day in the Rolling Forecast shall be deemed as a
commitment by CBS to [***] of
Commercial Products referred to in the Rolling Forecast for the applicable
Forecast Day and may not be amended except by the agreement of the Parties (the
“Binding Forecast”). The forecast submitted [***]
after the Binding Forecast shall include the vial sizes of the Commercial
Products that are to be provided to [***] of
Commercial Product in the Binding Forecast and this forecast shall include specific
ordering instructions for vial sizes as well as quantities of each of the
Commercial Products.


 


3.4                              Annual Volume


 


(a)                                 The
volume of Commercial Products to be purchased by CBS during the first year of
the Agreement is set out in Schedule “A”. In the case of Commercial Product
IGIV and Fractionation Product IGIV to be purchased during the first year of
the Agreement, Bayer Canada shall permit CBS to deviate from this volume by
plus or minus [***] with no price increase or
decrease on a per unit or per gram basis. In the event that CBS purchases
during the first year of the Agreement volume of a Commercial Product that is
more than [***] below the amount provided for in
Schedule “A”, the Parties agree that the price for that Commercial Product
shall be renegotiated by CBS and Bayer Canada for that year. In the event that
CBS wishes to purchase Commercial Product volume in excess of [***] above the volume provided for in Schedule “A”, Bayer
Canada will provide the Commercial Product to CBS if it is available from
Talecris. The price for this excess volume of Commercial Product shall be
determined by CBS and Bayer Canada shall be determined by market conditions at
the time of such purchase.


 


(b)                                The
volume purchase commitment in Schedule “A” may be revised by the written
agreement of the Parties six (6) months prior to the start of each year of the
Agreement. [***]


 


3.5                              Delivery


 


Bayer Canada shall deliver the Commercial Products to CBS as set out in
this Agreement and at the times and in the quantities set out in the Binding
Forecast. In the event that CBS’ delivery requirements change during the Term
other than as required by the Binding Forecast, CBS shall notify Bayer Canada
in writing of the revised requirements. Talecris shall use its reasonable best
efforts to satisfy the revised requirements of CBS and Bayer Canada will
likewise use its reasonable best efforts to satisfy such revised requirements
of CBS. CBS and Bayer Canada shall agree in writing to the amended Delivery
Schedule.


 


3.6                              Late Deliveries


 


(a)                                 Should
it become apparent, prior to a projected delivery date set out in the Binding
Forecast or amended Delivery Schedule, that a delivery of a Commercial Product
cannot be made on time, Bayer Canada shall promptly notify CBS of such delay
and provide CBS with an estimate, by telephone and facsimile transmission, of
when the Commercial Product will be delivered.


 


 






*** CONFIDENTIAL TREATMENT REQUESTED


 


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(b)                                Bayer
Canada shall use its reasonable best efforts to locate Commercial Product to minimize
any delay and to ensure that such Commercial Product is delivered to CBS at no
additional cost to CBS. If the delay in delivery will result in, or is likely
to result in, a Shortage of any Commercial Product, the procedure set out in
Section 3.9 will apply.


 


(c)                                 Bayer
Canada shall be required to pay a late delivery fee of [***]
per equivalent unit on any portion of a scheduled delivery of each and every
Commercial Product that is four (4) or more weeks late. The late delivery fee
is payable only when there is no cost differential for Replacement Product
being paid on the late delivery. In the event that a late delivery fee is paid
by Bayer Canada, and the late delivery subsequently becomes the subject of a
cost differential payment as described in Subsection 3.9(c), the amount of the
cost differential payment will be reduced by the amount of any late delivery
fee paid. This amount shall be credited against invoices or paid to CBS in
cash, if there is insufficient Product remaining to be delivered to CBS
pursuant to this Agreement.


 


3.7                              Vial Size


 


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 “H” shall
govern.


 


3.8                              Commercial Product
Recalled, Withdrawn or Not Validly Distributed


 


Notwithstanding Section 3.6, CBS shall have the right to acquire
Replacement Product pursuant to Section 3.9 if there is 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 CBS; 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 CBS.


 


3.9                              Procedures for Alternate
Sourcing


 


(a)                                 In
the event of the occurrence of an event as described in Sections 3.8 and 3.10,
Bayer Canada shall respond in writing to CBS within two (2) Business Days, or
such longer time period if agreed to by CBS and Bayer Canada, 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 CBS,
CBS will so advise Bayer Canada and the supply of the Replacement Product shall
be governed by the terms of this Agreement.


 


 










*** CONFIDENTIAL TREATMENT
REQUESTED


 


8 of 51














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


 


(c)                                 If
Replacement Product is purchased by CBS from a third party with the consent of
Bayer Canada, or if it is subsequently determined that Bayer Canada’s refusal
to consent to the purchase was unreasonable, Bayer Canada shall compensate CBS
for the amount, if any, that the price CBS would have had to pay to Bayer
Canada 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 Bayer
Canada within fifteen (15) days of delivery by CBS of an invoice for such
amounts. Compensation by Bayer Canada of CBS pursuant to this paragraph shall
be the limit of Bayer Canada’s liability hereunder.


 


(d)                                Nothing
in this Section 3.9 shall limit the right of any party to terminate this
Agreement pursuant to Article 16 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


 


Talecris will supply to Bayer Canada for sale to CBS and HQ as follows:


 


(i)                                     In
the event that Talecris is able to produce two thirds (2/3) or more of Talecris’
planned global output, Bayer Canada will receive from Talecris for sale to CBS
and HQ their full Commercial Product delivery; or


 


(ii)                                  In
the event that Talecris produces less than two thirds (2/3) of Talecris’
planned global output, CBS and HQ will be protected from the full impact of a
shortage by Talecris providing to Bayer Canada for sale to CBS and HQ 50% more
of Talecris’ Commercial Product allocation from Talecris than CBS and HQ would
be proportionally entitled.


 


This is in addition to all other rights pursuant to this Agreement when
Talecris and Bayer Canada are unable to supply Commercial Product.


 


4.                                     COMMERCIAL PRODUCTS
SPECIFICATIONS


 


4.1                              Commercial Product
Specifications


 


Bayer Canada shall provide to CBS Commercial Products in accordance
with the Specifications.


 


 


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4.2                              Bayer Canada Determines
Commercial Products are Unsuitable


 


If, after any Commercial Products have been delivered to CBS, Bayer
Canada determines in its reasonable discretion that any Commercial Products are
unsuitable or defective in any manner or if Bayer Canada receives notification
from Talecris that Talecris has determined that any of the Commercial 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
Commercial Products, Bayer Canada shall give immediate notice by telephone and
facsimile transmission to CBS of any such deficiency. In the event that Bayer
Canada, acting reasonably, notifies CBS that Bayer Canada is Recalling or
Withdrawing any Commercial Products, or is taking any other action to remedy
any deficiencies in the Commercial Products, and requests that CBS co-operate
in any such Recall or Withdrawal, or take action to remedy any deficiency in
the Commercial Products (which request shall not be made unreasonably), CBS
shall reasonably co-operate in any such Recall or Withdrawal, or shall take
such action as is reasonably required by Bayer Canada to remedy any deficiency
in the Commercial Products. The costs of such Withdrawal, Recall or other
action, including the cost of repairing or replacing any Commercial Products,
shall be paid by the party to whom causation is attributable.


 


4.3                              CBS Determines Commercial
Products are Unsuitable


 


(a)                                 If
CBS determines, in its reasonable discretion, that any Commercial 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
Commercial Product, CBS shall immediately notify Bayer Canada, by telephone and
facsimile transmission, of such deficiency. In the event that CBS, acting
reasonably, notifies Bayer Canada, that it is proceeding with the Withdrawal or
quarantine of any Commercial Product, or is taking any other action to remedy
any deficiencies in the Commercial Product, Bayer Canada shall reasonably co-operate
in any such action as is required by CBS to remedy any deficiency. The costs of
such action, including the cost of repairing or replacing any Commercial
Products, shall be paid by CBS if it is the party to whom causation is
attributable or by Bayer Canada if Bayer Canada or Talecris is the party to
whom causation is attributable. For greater certainty, CBS is not required to
notify Bayer Canada of any defect or possible defect caused by CBS while the
Commercial Product is in CBS’ care and control and where there is no impact on
Talecris or Bayer Canada under this Agreement, unless otherwise required by any
regulatory authority.


 


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


 


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


and


 


(ii)                                  compensate
Bayer Canada for the direct costs to Talecris or Bayer Canada of such
Withdrawal or quarantine.


 


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4.4                              Significant Reduction in
Consumer Preference


 


(a)                                 A
significant reduction in Consumer preference for a Commercial Product occurs
when orders for a Commercial Product drop for [***],
together with evidence that the total market for the type of product in
question has not decreased. CBS shall be required to notify Bayer Canada as
soon as possible in writing in the event that CBS intends to implement this
Consumer preference clause. Such notification shall contain evidence of [***] in Commercial Products orders and evidence that the
total market for that type of product has not declined in a similar manner. CBS
will informally communicate to Bayer Canada as soon as it suspects that this
Consumer preference clause may need to be invoked to allow Bayer Canada 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 CBS shall exercise the recourse set out in Section 15.1.


 


(b)                                Following
written notice that CBS intends to invoke Subsection 4.4(a), Bayer Canada will
be granted:


 


(i)                                     [***];


 


(ii)                                  [***].


 


(c)                                 In
the event that Bayer Canada fails to restore orders as set out in Paragraphs
(i) and (ii) above, then the annual volume of the specific Commercial Product
forecast by CBS shall be adjusted to reflect the loss of demand for the
specific Commercial Product and the pricing shall be adjusted according to
Schedule “A” for those Commercial Products identified in the Pricing
Schedule-Consumer Preference Schedule and for those Commercial Products not
identified therein, the price shall be renegotiated by CBS and Bayer Canada.


 


(d)                                In
the event that Bayer Canada does restore orders for the Commercial Product as
provided for in this Section, [***] and the
time set out in Subsections 4.4(b)(i) and 4.4(b)(ii), if applicable, will be
deducted from the annual volume of Commercial Products forecast by CBS without
any increase in price.


 


5.                                     FRACTIONATION SERVICES


 


5.1                              Forecasting


 


CBS shall provide Bayer Canada with an eighteen (18) month rolling
forecast of the projected monthly supply of Plasma and the total monthly volume
requirement for Fractionation Products (“Plasma and Fractionation Products
Rolling Forecast”) by the fifth Business Day of each month (the “Plasma and
Fractionation Products Forecast Day”). CBS shall further provide Bayer Canada,
on a quarterly basis, with an estimate of the number of litres of Plasma to be
shipped to Bayer Canada for fractionation for the next two (2) calendar
quarters.


 


 










*** CONFIDENTIAL TREATMENT REQUESTED


 


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5.2                              Order for Fractionation
Products


 


The forecast for each four (4) month period immediately following each
Plasma and Fractionation Products Forecast Day in the Plasma and Fractionation
Products Rolling Forecast shall be deemed to be a commitment by CBS to purchase
from Bayer Canada, the Fractionation Products shown in the four (4) month
forecast and may not be amended except by the mutual written agreement of CBS
and Bayer Canada. This four (4) 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.


 


5.3                              Prior Forecasts to be
Honoured


 


The Parties acknowledge that forecasts and commitments have been made
prior to the Effective Date under the Main Agreement which are applicable to
the first six (6) months of this Agreement. Each Party shall be bound by such
forecasts and commitments in accordance with the terms and conditions of this
Agreement.


 


5.4                              Forecasting Continued to
Termination Date


 


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


 


5.5                              Survival of Orders after
Termination


 


Any Plasma picked up by Bayer Canada from CBS for fractionation by
Talecris into Fractionation Products prior to the termination or expiration of
this Agreement shall be fractionated by Talecris and delivered to Bayer Canada
for resale to CBS pursuant to this Agreement, and the rights and obligations of
the Parties hereto shall survive to the extent required to complete and pay for
the said Services.


 


6.                                     PLASMA COLLECTION AND PROCESSING


 


6.1                              Plasma Collection


 


CBS agrees that all Plasma it collects in Canada for pickup by Bayer
Canada for fractionation by Talecris 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 US Import for Export Regulations.


 


6.2                              Responsibility for Plasma
in CBS’ Possession


 


CBS 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, including
but not limited to any loss or damage resulting from the improper storage,
handling, packing, crating, blocking and/or transportation of the Plasma to the
Collection Centres, except as otherwise provided in this Agreement.


 


 


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6.3                              Notice of Plasma Pickup
by Bayer Canada


 


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


 


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


 


(ii)                                  such
other pertinent information as Bayer Canada and CBS agree will be provided. In
December of each year of the Term, an annual schedule for the following
calendar year for the pick-up of Plasma from the Collection Centres for
transport to Talecris’ fractionation facility will be agreed upon by Bayer
Canada and CBS, 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 by consent from time to time to account for
fluctuations in the volume of Plasma stored at the Collection Centres.


 


6.4                              Pickup, Transportation
and Storage of Plasma by Bayer Canada


 


Bayer Canada agrees to provide CBS with corrugated shipping containers,
at no cost to CBS, to be utilized for the storage and transportation of the
frozen Plasma. Bayer Canada shall be required at its own expense to pick up the
Plasma from the Collection Centres and arrange for storage if required. The
quality assurance department at Bayer Canada will audit the transportation
carrier and any storage facility used by Bayer Canada on a regular basis. Bayer
Canada reserves the right to select, in reasonable consultation with CBS, an
alternate carrier or storage facility at any time.


 


6.5                              Maximizing Transportation
Efficiency


 


(a)                                 [***]


 


(b)                                [***]:


 


(i)                                     [***];


 


(ii)                                  [***];  and


 


(iii)                               [***].


 


6.6                              Bayer Canada Responsible
for Exportation of Plasma


 


Bayer Canada is responsible for all costs incurred for the exportation
of Plasma to the United States of America including transportation, duty,
excise, brokerage fees and customs in addition to insuring documentation is
prepared and available as required for exportation.


 


 










***
CONFIDENTIAL TREATMENT REQUESTED


 


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6.7                              Shipping Documents and
Exportation of Plasma


 


Other than as set out in the SSA (as defined in Section 15.4), prior to
each Plasma shipment from the storage facility, Bayer Canada will receive from
CBS:


 


(i)                                     consolidated
Plasma shipment summary document;


 


(ii)                                  statement
of value for customs purposes; and


 


(iii)                               copies
of Collection Centres Plasma shipment summaries.


 


Donor detail lists (bleed sheets listing testing and acceptance) shall
be shipped directly to fractionation facility concurrent with the consolidated
Plasma shipment from the storage facility.


 


6.8                              Responsibility for Plasma
in Talecris’ or Bayer Canada’s Possession


 


Bayer Canada 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
Talecris or Bayer Canada. 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. Each of Talecris
and Bayer Canada 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.


 


6.9                              Talecris to Inspect
Plasma


 


Immediately prior to the pooling of Plasma at Talecris’ US
fractionation facility, Talecris shall inspect the Plasma or otherwise
ascertain that it conforms to the requirements of the appropriate regulatory
authorities. For greater certainty, other than as set out or to be set out in
the Supplemental Services Agreement for B19 Testing, Talecris has no duty to
test the Plasma and this provision does not apply to latent defects or
deficiencies and shall not release CBS from its liabilities or responsibility
with respect to such Plasma.


 


6.10                       CBS Determines Plasma Delivered
to Bayer Canada is Unsuitable


 


If, after any Plasma has been picked up by Bayer Canada, CBS
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
Fractionation Products, CBS shall immediately notify Bayer Canada by telephone
and facsimile transmission and shall provide instructions for amelioration,
return to CBS, destruction or other disposition of the Plasma. All rejected
Plasma or Plasma Intermediates shall be held at the expense and risk of CBS
until, at its cost, CBS retakes possession of them or otherwise directs their
disposition. However, if such circumstance is due to the negligence or wilful
misconduct of Talecris or Bayer Canada, such costs shall be borne by Bayer
Canada.


 


6.11                       Right of Talecris and Bayer
Canada to Reject CBS Plasma


 


(a)                                 Talecris
and Bayer Canada shall have the right, at any time while the Plasma is in
Talecris’ or Bayer Canada’s 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 CBS, with notice of any such deficiency to be
provided to Bayer Canada pursuant to Section 6.10, or


 


 


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(ii)                                  do
not meet the standards set out in Section 6.1, or


 


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


 


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


 


(b)                                Bayer
Canada shall immediately notify CBS by telephone and facsimile transmission of
any such rejection by Bayer Canada or by Talecris. CBS shall co-operate with
Bayer Canada 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
Talecris at the sole cost and expense of CBS with CBS’ consent, except in the
case of rejected Plasma or Plasma Intermediates which are the responsibility of
Talecris or Bayer Canada as provided for in Section 6.12. All rejected Plasma
or Plasma Intermediates shall be held at the expense and risk of CBS until, at
its cost, CBS retakes possession of them or otherwise directs their disposition.
However, if such circumstance is due to the negligence or wilful misconduct of
Talecris or Bayer Canada, all such costs shall be paid by Bayer Canada.


 


6.12                       Plasma Rendered Unusable by
Talecris or Bayer Canada


 


(a)                                 If
any Plasma is rendered unusable while it is in the care, custody and control of
Talecris or Bayer Canada, Bayer Canada shall replace Fractionation Products
that were to result from the fractionation of such Plasma with equivalent
products manufactured by Talecris (“Replacement Fractionation Products”). These
Replacement Fractionation Products are to be supplied to CBS at the same cost
as CBS would have been required to pay for Fractionation Products had Talecris
or Bayer Canada not rendered the Plasma unusable. The availability of
Replacement Fractionation Products from Bayer Canada for the purpose of this
Section shall be determined at the sole discretion of Bayer Canada acting
reasonably. Bayer Canada shall supply and deliver Replacement Fractionation
Products on the date scheduled for the delivery of the Fractionation Products.


 


(b)                                In
the event that Bayer Canada is unable to supply Replacement Fractionation
Products as set out above CBS may begin the procedures set out in Subsections
3.9(b) and (c).


 


6.13                       Quarterly Meetings


 


The Parties will, with HQ, which organization also has an agreement
with Talecris and Bayer Canada, meet quarterly, beginning in the first quarter
after the Effective Date. The purpose of these quarterly 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. Quarterly meetings may be
cancelled if CBS, HQ, Talecris and Bayer Canada agree. CBS, Talecris or Bayer
Canada may call a special meeting by giving written notice to the other party
or parties and HQ. 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. For greater clarity, Bayer Canada shall provide to CBS in writing, a
complete reconciliation report of Plasma and Products prior to each quarterly
meeting, provided that the quarterly meeting is scheduled at least six (6)
weeks following the end of the prior quarter.


 


 


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6.14                       Change to CBS Standard Operating
Procedures


 


(a)                                 In
the event that CBS 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, CBS must inform Bayer Canada 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 CBS will notify Bayer Canada as soon as reasonably possible. CBS will work
with and Bayer Canada to evaluate the consequences of any such change on the
Services.


 


(b)                                Bayer
Canada shall submit to CBS the 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. CBS will notify Bayer Canada if
it accepts such costs. The Parties recognize that any changes in the SOP that
affect Fractionation Services could not be anticipated at the time the pricing
of the Fractionation Services was agreed between the Parties, and that changing
SOP could materially affect the cost and viability of the Fractionation
Services.


 


6.15                       Work in Process 


 


Effective
from April 1, 2006;


 


(a)                                 The
amount of Work in Process Inventory as measured by the volume in litres of
Plasma held and in process, shall not exceed the volume of Plasma picked up by
Bayer Canada from CBS and Hema-Quebec in the previous eight (8) months for IGIV
and ten (10) months for 25% Albumin unless the excess volume is caused directly
or indirectly by CBS or Hema-Quebec. Neither Talecris nor Bayer Canada shall be
responsible for disruption in processing caused by insufficient Plasma
available for pickup from CBS and Hema-Quebec.


 


(b)                                Work
in Process Inventory includes all Plasma provided by CBS and Hema-Quebec that
has been picked up by Bayer Canada for Fractionation Services. It also includes
all Fractionation Products, not yet released for distribution by Health Canada,
processed from Plasma provided by CBS and Hema-Quebec in the possession of
Talecris or Bayer Canada.


 


(c)                                 Work
in Process Inventory does not include Plasma collected by CBS and Hema-Quebec
held in Canada awaiting pick up by Bayer Canada unless delay in processing is
due to Bayer Canada’s failure to pick up Plasma.


 


7.                                     DELIVERY OF FRACTIONATION
PRODUCTS AND RECORDS


 


7.1                              Delivery Schedule and
Report on Status of Fractionation Product Delivery


 


Talecris and Bayer Canada shall use reasonable best efforts to deliver
Fractionation Products in accordance with the four-month forecast described in
Section 5.2, and Bayer Canada shall be required to provide monthly written
updates to CBS, which shall include delivery status plans and a list confirming
the Fractionation Products to be delivered for the upcoming six (6) week period
(“Projected Delivery”).


 


 


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7.2                              Notice of Delay in
Delivery of Fractionation Products


 


(a)                                 Except
as provided for in Section 7.3, should it become apparent prior to a projected
delivery date that a delivery of Fractionation Products cannot be made on time,
Bayer Canada shall promptly notify CBS of such delay and provide CBS with an
estimate, by telephone and facsimile transmission, of when Fractionation
Product will be delivered. If the delay in delivery will result in, or is
likely to result in, a Shortage of any Fractionation Product, Bayer Canada
shall be required, whenever possible, to provide Replacement Fractionation
Products to CBS at the same price at which Bayer Canada would have provided
Fractionation Products pursuant to this Agreement. The availability of
Replacement Fractionation Products from Bayer Canada for the purpose of this
Section shall be determined at the sole discretion of Bayer Canada acting
reasonably.


 


(b)                                In
the event that Bayer Canada is unable to supply Replacement Fractionation
Products as set out above, CBS may begin the procedures set out in Subsections
3.9 (b) and (c).


 


(c)                                 Bayer
Canada shall reimburse CBS for any reasonable out-of-pocket expenses incurred
by CBS in connection with any delay described in Section 7.2(a) above,
including, without limitation, expenses relating to communications with
Consumers, hospitals and clinics.


 


7.3                              Delay in Delivery of
Fractionation Products due to CBS


 


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


 


7.4                              Records


 


Talecris and Bayer Canada shall maintain accurate records from the time
that Talecris and Bayer Canada, 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 CBS upon reasonable request.


 


 


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8.                                     DELIVERY OF PRODUCTS


 


8.1                              Product Shelf Life


 


Bayer Canada shall ensure that all Products shipped to CBS pursuant to
this Agreement shall have a remaining minimum shelf life of twelve (12) months.
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, Bayer Canada shall be entitled to deliver to CBS the
Product with Bayer Canada’s agreement to take back any unused Product remaining
in CBS’ inventory at the time of outdating. Where the only Product available
has less than six (6) months remaining shelf life, Bayer Canada and CBS must
agree to the shortened shelf life in writing and Bayer Canada agrees to take
back any unused Product remaining in CBS’ inventory at the time of outdating,
all at Bayer Canada’s cost.


 


8.2                              Delivery of Products


 


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


 


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


 


(c)                                 When
Products are available for shipment to CBS, a shipment notification shall be
sent by Bayer Canada, by facsimile to CBS 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)                                Bayer
Canada 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 Bayer Canada to the Warehouse. In the event that
CBS changes the location of its Warehouse during the Term:


 


(i)                                     where
there are additional costs associated with the change of location, CBS shall be
responsible for such additional costs and liabilities 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, CBS shall
be entitled to a price reduction for such decrease in costs and liabilities
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 Bayer Canada will, at the request of CBS, deliver
Products to destinations other than the Warehouse. Any additional costs and
liabilities resulting from such change in delivery shall be the responsibility
of CBS; unless said emergency and/or extenuating circumstances arise directly
or indirectly from the actions, whether negligent or not, omissions or
misconduct of Talecris, Bayer Canada, Bayer Canada’s carrier or its permitted
assigns. In this event, Bayer Canada shall be liable for all such costs.


 


 


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8.3                              Responsibility for
Products


 


Bayer Canada shall be responsible for and bear all risk of loss or
damage to the Products to be delivered by Bayer Canada to the Warehouse while
the Products are in Talecris’ or Bayer Canada’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 Bayer Canada. For the purpose
of this section, the time during which the Products are in transit from
Talecris’ facility to the Warehouse, or other reasonable destination designated
by CBS, shall be deemed to be a period during which the Products are in the
care, custody and control of Bayer Canada. For greater certainty, the Products
shall be f.o.b. the Warehouse.


 


8.4                              Duty of Inspection


 


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


 


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


 


 


9.                                     INVOICES AND PAYMENT


 


9.1                              Invoices


 


Bayer Canada shall include a packing slip with all deliveries of
Products. Within  [***]
Bayer Canada shall deliver to CBS an invoice, in duplicate, for the Products
delivered. All invoices shall be in  [***] 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 Bayer Canada’s GST
registration number if applicable.


 


9.2                              Price


 


The prices for Commercial Products to be charged to CBS by Bayer
Canada, during the [***] of the
Term are in [***] in accordance with Schedule “A”.
The prices to be charged to CBS for the Services during the [***] of the Term are in [***]
and charged according to Fractionation Products produced in accordance with
Schedule “D”.


 


9.3                              Price Adjustments


 


(a)                                 Annual


 


Prices for all Products may increase at the start of each Agreement
year (April 1) by up to the maximum of the average increase in CPI over the
previous calendar year.


 


 










***
CONFIDENTIAL TREATMENT REQUESTED


 


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(b)                                Improvements
Mandated by Regulator - Products


 


Where Talecris is directed by the regulator with authority, to make an
Improvement which will result in a price increase for a Product, Bayer Canada
shall provide CBS with notice in accordance with Section 10.2 and shall
substantiate the proposed price increase. Bayer Canada and CBS shall negotiate
in good faith the amount and timing of any proposed price increase to CBS. If
CBS does not agree to accept the price or timing, then Bayer Canada and CBS
have the right to terminate the Agreement with respect to the Product,
immediately upon notice to the other party without any cost or penalty.


 


(c)                                 Talecris
Initiated Improvements - Commercial Products


 


With respect to an Improvement initiated by Talecris for a Commercial
Product which will result in a price increase to CBS, Bayer Canada shall notify
CBS by June 30 of the prior year. Bayer Canada shall substantiate the price
increase and Bayer Canada and CBS shall negotiate in good faith the amount and
timing of any proposed price increase to CBS which, for greater clarity, will
not be implemented prior to April 1 of the following year. If CBS does not
agree to accept the price from Bayer Canada, then Bayer Canada or CBS has the
right to terminate the Agreement with respect to the Commercial Product,
immediately upon notice to the other Party, without any cost or penalty.


 


(d)                                Talecris
Initiated Improvements - Fractionation Products


 


With respect to an Improvement initiated by Talecris for a
Fractionation Product, Bayer Canada shall notify CBS in accordance with Section
10.2, and;


 


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


 


9.4                              Payment Terms


 


[***].


 


9.5                              Value added


 


(a)                                 In
consideration of the Products and Services purchased pursuant to this
Agreement, Bayer Canada will provide from Talecris:


 


 










*** CONFIDENTIAL TREATMENT REQUESTED


 


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(i)                                     a
contribution of [***] Canadian funds per year to
the Partnership Fund if a minimum of [***] equivalent
of Intravenous Immunoglobulin (combined Commercial Product and Fractionation
Products and combined forecast of CBS and HQ) is purchased in the year. For
further clarification, the reference to [***] Canadian
funds in this Subsection refers to total contribution to the Partnership Fund
and not [***] Canadian funds to each of CBS and
HQ;


 


(ii)                                  a
contribution of [***] Canadian funds to CBS for
each year Fractionation Services are provided pursuant to this Agreement. These
funds are to be used for educational purposes, in CBS’ sole discretion, and CBS
agrees to recognize Talecris’ contribution to each project supported by this
fund.


 


(iii)                               a
contribution of [***] related to the transfer of
business to Talecris, payable immediately upon execution of this Agreement.


 


(b)                                In
the event Talecris sells its business or any portion thereof, Talecris agrees
to continue to make the contributions set out in Section 9.5(a), based on the
total volume of Products set out in Subsection 9.5(a)(i) and the Services
specified in Subsection 9.5(a)(ii) pursuant to any assignment of any portion of
the Agreement.


 


9.6                              Pricing Not Affected by
Remedies


 


In the event that CBS exercises any right or remedy as a result of
supply problems caused or to the extent contributed by Talecris or Bayer Canada
that reduces the amount of any Product delivered to CBS by Bayer Canada under
this Agreement, the annual volume for that Product shall be reduced by such
amount but the pricing for that Product shall remain at the level determined by
Schedule “A” as if the annual volume were not so reduced.


 


10.                              REGULATORY AND QUALITY ASSURANCE
MATTERS


 


10.1                       Regulatory Condition of Supply


 


Bayer Canada shall obtain and submit a copy of the Notice of Compliance
issued by Health Canada to CBS in order to show that the Products to be
supplied meet the requirements of Health Canada.


 


10.2                       Improvements


 


(a)                                 In
the event that Talecris makes or plans to make an Improvement, Bayer Canada
shall advise CBS 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 Quarterly
Fractionation meetings.


 


(b)                                Subject
to Section 15.3 and with CBS’ agreement, in the event that the Improvement will
require CBS to change CBS process for fractionation, Bayer Canada shall provide
CBS with six (6) months advance notice to enable it to make the change,
validate it and apply to Health Canada for amendment to its license.


 


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


 


 










*** CONFIDENTIAL TREATMENT REQUESTED


 


 


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


 


(e)                                 If
Talecris makes any Improvement to the Commercial Products in the United States
of America, and unless the Parties otherwise agree, Talecris and Bayer Canada
shall use all reasonable efforts to include such Improvement in the Commercial
Products being supplied under this Agreement. Talecris and Bayer Canada will at
the time of, or within a reasonable timeframe and no longer than six (6) months
after filing the submission for the improved or changed Commercial Product in
the United States of America, apply for approval of Health Canada for the Improvement.
Should the Improvement not be permitted due to Health Canada requirements,
Bayer Canada will advise CBS.


 


(f)                                   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.


 


10.3                       Special Access Program


 


(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 CBS for release pursuant
to SAP (“SAP Commercial Product”). CBS agrees that it will only carry 40% of
Target Level inventory for SAP Commercial Product unless Bayer Canada and CBS
otherwise agree.


 


(b)                                Notwithstanding
Subsection 10.3(a), if Health Canada requires CBS to move to a licensed product
produced by any other manufacturer, Bayer Canada shall reimburse CBS for any
inventory of SAP product(s) upon return of such SAP product. In this event, CBS
will have the option to terminate this Agreement with respect to such SAP
Commercial Product(s).


 


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


 


10.4                       Communications


 


Bayer Canada shall promptly advise CBS and provide CBS with copies of
the following correspondence with Health Canada regarding the Commercial
Products, Replacement Products manufactured by Talecris, Fractionation
Products, Replacement Fractionation Products manufactured by Talecris, their
manufacture, the processing of Plasma into Fractionated Product, and/or the
inspection of any of Talecris’ 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;


 


(ii)                                  Notices
Of Compliance;


 


(iii)                               Product
Monographs approved by Health Canada;


 


 


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(iv)                              Health
Canada Exit Notices and Talecris’ Responses;


 


(v)                                 FDA
483’s and Talecris’ Responses;


 


(vi)                              Recall/Withdrawal
information and correspondence ; and


 


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


 


Other documents regarding regulatory issues will be provided to CBS by
agreement of Bayer Canada, on a case by case basis.


 


10.5                       Talecris and Bayer Canada
Information


 


Bayer Canada, shall, upon execution of this Agreement, notify CBS in
writing, of the name of its and Talecris’ senior regulatory person. In the
event of a change of either designated person during the Term, Bayer Canada
shall immediately notify CBS, in writing, of such change.


 


10.6                       Compliance Audit


 


CBS shall be entitled to audit Talecris’ and Bayer Canada’s facilities
and quality systems, the books and records of Talecris and Bayer Canada in
respect of production and quality assurance matters arising from the Agreement;
provided that such audit is at the expense of CBS, and 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. Talecris and Bayer Canada shall provide responses
including corrective measures to audit observations in a timely manner. Talecris
and Bayer Canada shall use their best efforts to implement said measures within
a reasonable time frame.


 


11.                              PRODUCT WITHDRAWALS/RECALLS


 


11.1                       Recall / Withdrawal


 


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


 


(b)                                Talecris
and Bayer Canada must provide supporting information or documentation to CBS
for dissemination within twenty-four (24) hours by telephone and facsimile of a
decision to Recall/Withdraw any of the Commercial Products, or Fractionation
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 CBS if the causation is
attributable to CBS or by Bayer Canada if the causation is attributable to Talecris
or Bayer Canada.


 


(d)                                Subject
to Subsection 11.1(e), Bayer Canada 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 CBS.


 


(e)                                 Any
news release or disclosure relating to a removal from the market, quarantine,
Recall or Withdrawal of a Product and referencing CBS must be reviewed and
approved by CBS prior to release by Bayer Canada or Talecris.


 


 


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(f)                                   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 Talecris or Bayer Canada must be reviewed and approved by Bayer
Canada prior to release by CBS.


 


11.2                       Patient Notification System


 


Talecris and Bayer Canada understand that the Patient Notification
System (PNS) was created to provide a fast, confidential method to provide
information to Consumers on Recall or Withdrawal events. Talecris and Bayer
Canada each 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 CBS.


 


11.3                       Adverse Event Reporting


 


In accordance with Health Canada regulations, CBS will promptly notify
Bayer Canada by facsimile of any adverse drug reactions potentially associated
with the use of the Products reported to it. Bayer Canada shall provide written
reports on investigation within ninety (90) days of receipt of CBS’ written
notification.


 


11.4                       Replacement Products and
Replacement Fractionation Products


 


Any Replacement Products or Replacement Fractionation Products proposed
by Bayer Canada under Sections 3.8, 3.9, 6.12, 7.2 and 7.3 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.


 


12.                              REPRESENTATIONS, WARRANTIES AND
INSPECTION


 


12.1                       Representations and Warranties
of the Parties


 


Each of the Parties represents and warrants 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 CBS 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.


 


 


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(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.


 


(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.


 


12.2                       Applicable Laws and Notice of
Compliance


 


12.2.1                  Talecris
and Bayer Canada represent and warrant to CBS that the Products have been and
are manufactured in accordance with Canadian regulations and all other
applicable laws and regulations and comply therewith. Talecris and Bayer Canada
further represent and warrant that, if required, valid Health Canada approvals
have been issued and are in good standing. Bayer Canada shall notify CBS
immediately upon any notice of deficiencies or requests for submissions with
respect to any of the Products.


 


12.2.2                  Bayer
US represents and warrants with respect to Plasma picked up and to Commercial
Products and Fractionation Products manufactured or partially manufactured
prior to the Effective Date (“Existing Products”), that such Existing Products
have been stored and/or manufactured in accordance with Canadian regulations
and all other applicable laws and regulations and comply therewith. Bayer US
further represents and warrants that, if required, valid Health Canada approvals
have been issued and are in good standing. Bayer Canada shall notify CBS
immediately upon any notice of deficiencies or requests for submissions with
respect to any of the Existing Products. Notwithstanding anything to the
contrary above, Bayer US’ representations and warranties only relate to its
handling of the Plasma and its manufacturing or partial manufacturing of the
Commercial Products and Fractionation Products prior to the Effective Date. Any
handling of the Plasma and manufacturing or partial manufacturing of the
Commercial Products and Fractionation Products on or after the Effective Date
is represented and warranted by Talecris and Bayer Canada as per Section 12.2.1
above.


 


12.3                       Title and Warranty on the
Products


 


Talecris and Bayer Canada hereby warrant: (i) title in and to the
Commercial Products; (ii) the Products’ conformance to any specification,
description or design furnished by Talecris in any product inserts or
labelling; and (iii) that the Products shall conform to the Product Specifications
and/or that the Products shall comply with all laws, regulations or codes in
force in Canada. Talecris and Bayer Canada further warrant that the Products
shall be transported to CBS in a manner in which their quality, safety and
efficacy are not compromised.


 


 


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12.4                       Guaranteed Yield


 


(a)                                 Talecris
and Bayer Canada guarantee that the minimum annual IGIV yield from Plasma
processed through the chromatography process shall be [***].


 


(b)                                Once
Talecris has fractionated [***]
(excluding reprocessed lots), Talecris and Bayer Canada agree that the minimum
guarantee yield shall be adjusted to [***] of these
lots, effective immediately.


 


(c)                                 Talecris
and Bayer Canada guarantee that the minimum yield for [***].


 


(d)                                If
the yield falls below the above stated amounts for either [***],
Bayer Canada will provide additional Commercial Product to make up the
deficiency, at the lesser of the price CBS pays for Fractionation Products or
Commercial Products.


 


12.5                       Current Information


 


Talecris and Bayer Canada represent and warrant that the information
currently provided to CBS and which will, from time to time, be amended or
further provided with the Products, including without limit, any regulatory
filings, circulars and package inserts, are current, accurate and fulfill any
regulatory requirements for the Products.


 


12.6                       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 inspection or
pre-testing conducted by or on behalf of CBS or any third party, except as
expressly provided for herein.


 


12.7                       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.


 


13.                              PATENT PROTECTION


 


13.1                       No Infringement


 


Talecris and Bayer Canada hereby represent and warrant to the best of
their knowledge to CBS 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.


 


 






*** CONFIDENTIAL TREATMENT REQUESTED


 


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13.2                       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,
Talecris and Bayer Canada shall, in addition to the indemnity provided in
Section 14.3, 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 CBS at Bayer Canada’s expense, the right to continue to use the Commercial
Products, or Fractionation Products manufactured by the infringing process.


 


14.                              INSURANCE AND INDEMNIFICATION


 


14.1                       Talecris’ and Bayer Canada’s
Insurance


 


Talecris and Bayer Canada shall each 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 five million dollars
($5,000,000) and product liability insurance shall have limits no less than
five million dollars ($5,000,000) per incident and five million dollars
($5,000,000) per annum in the aggregate.


 


(a)                                 Bayer
Canada shall provide CBS with proof of valid insurance coverage for both
Talecris and Bayer Canada. A certificate of insurance issued by the insurer
shall be acceptable to CBS as proof of coverage.


 


(b)                                All
of the aforementioned certificates provided by the insurer to Talecris and
Bayer Canada shall certify the following:


 


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


 


(ii)                                  that
CBS has been added to the certificate as an additional named insured with
respect to the general liability insurance referred to in Section 14.1;


 


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


 


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


 


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


 


(c)                                 Bayer
Canada shall provide CBS 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 Talecris or Bayer Canada. In no case shall
Talecris or Bayer Canada materially alter, cancel or allow to lapse any
stipulated insurance while CBS 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 Talecris and
Bayer Canada 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 Talecris or Bayer Canada, as applicable, at its own expense.


 


 


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


 


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


 


14.2                       CBS Insurance


 


CBS 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 five million dollars ($5,000,000) per incident
and five million dollars ($5,000,000) per annum in the aggregate.


 


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


 


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


 


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


 


(ii)                                  that
Bayer Canada has been added to a certificate as an additional named insured
with respect to the general liability insurance referred to in Section 14.2;


 


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


 


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


 


(v)                                 a
waiver of subrogation in favour of Bayer Canada.


 


(c)                                 CBS
shall provide Bayer Canada 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 CBS 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 CBS 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
CBS at its own expense.


 


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


 


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


 


 


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14.3                       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)                                CBS
hereby agrees to indemnify and hold Talecris and Bayer Canada, and their
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:


 


(i)                                     the
negligence of, or an intentional act or failure to act by Talecris or Bayer
Canada; or,


 


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


 


(iii)                               any
unauthorized or false warranty made by Talecris or Bayer Canada.


 


(c)                                 Talecris
and Bayer Canada hereby agree to indemnify and hold CBS 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 CBS or,


 


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


 


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


 


(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.


 


 


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(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.


 


14.4                       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.


 


15.                              CHANGE


 


15.1                       Technological Change


 


(a)                                 If
CBS 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;


 


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


 


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


 


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


 


(b)                                If
CBS 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 CBS Plasma pursuant to this Agreement; or


 


(ii)                                  the
Fractionation Products are obsolete;


 


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


 


 


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If Bayer Canada agrees with CBS, CBS may immediately proceed to
contract with alternative source(s) for the purchase of fractionation services.
If an alternative source of service is obtained by CBS the portion of the
Agreement relating to Fractionation Services or particular Fractionation
Products shall be terminated, subject to Section 5.5.


 


If Bayer Canada fails to respond to CBS within fifteen (15) days, then
CBS shall have the right to cancel the Agreement with respect to the Services,
subject to Section 5.5.


 


15.2                       Dispute Resolution


 


(a)                                  For
the purposes of Section 15.1 only, if Bayer Canada 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;


 


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


 


In the event that CBS and Bayer Canada cannot resolve a dispute under
this Section within the thirty (30) day period, the matter may be referred to
arbitration by Bayer Canada pursuant to the provisions of Article 17.


 


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


 


15.3                       Intentionally Omitted


 


15.4                       Parvovirus B19 Testing and the
Change to the Caprylate/Chromatography Process


 


The Parties have entered into a Supplemental Services Agreement (the “SSA”),
effective April 1, 2005. All Plasma picked up on or after April 1, 2005 will be
tested for high levels of parvovirus B19, and the terms of the SSA shall govern
this.


 


 


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16.                              TERMINATION


 


16.1                       Termination of Agreement


 


CBS or Talecris, 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 16.2,
16.3 or 16.4 as applicable) occurs (other than, in the case of CBS, an Event of
Default with respect to itself, or in the case of Talecris, an Event of Default
with respect to itself or with respect to Bayer Canada), by giving the other
Parties 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.


 


16.2                       Talecris Event of Default


 


A Talecris “Event of Default” shall mean:


 


(a)                                  the
failure by Talecris 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
CBS, or any material breach by Talecris 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 CBS;


 


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


 


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


 


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


 


(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 Talecris or any filing by or against Talecris 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


 


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


 


An Event of Default shall, for the events described in Subsections
16.2(a) and (b) above, take effect thirty (30) days after notice being given by
CBS to Bayer Canada, specifying the default or breach, during which time
Talecris shall be entitled to cure the noted default.


 


16.3                       CBS Event of Default


 


A CBS “Event of Default” shall mean:


 


(a)                                  any
misrepresentation herein contained resulting in a material adverse effect on
Talecris or Bayer Canada or any material breach by CBS 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 Talecris or Bayer Canada;


 


 


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


 


(c)                                  the
making of a general assignment by CBS 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 CBS;


 


(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 CBS or any filing by or against CBS 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 CBS which
petition is not dismissed, vacated, set aside or stayed within forty-five (45)
days; or


 


(g)                                 CBS,
or its successor, ceases to coordinate or loses the authority to coordinate the
national blood supply program for Canada, excluding the province of Quebec.


 


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


 


16.4                       Bayer Canada Event of Default


 


A Bayer Canada “Event of Default” shall mean:


 


(a)                                  the
failure by Bayer Canada 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
CBS, or any material breach by Bayer Canada 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 on CBS;


 


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


 


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


 


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


 


(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 Bayer Canada, or any proceedings under the
Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C.-36, as amended; or


 


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


 


An Event of Default shall, for the events described in Subsections
16.4(a) and (b) above, take effect thirty (30) days after notice being given by
CBS, specifying the default or breach, during which time Bayer Canada shall be
entitled to cure the noted default.


 


 


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17.                              DISPUTE RESOLUTION


 


17.1                       Arbitration


 


(a)                                  The
Parties agree that in the event of any dispute or claim between CBS and
Talecris or between CBS and Bayer Canada arising under or in connection with
this Agreement other than described in Section 15.1, or any order issued
pursuant to this Agreement, 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. Any dispute between
Talecris and Bayer Canada shall be resolved in accordance with the agreement
between them, and CBS will have no obligation to participate in any such
resolution.


 


(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 Article.


 


(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) CBS, and (ii) Bayer
Canada and Talecris 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 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 Article, 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.


 


 


34 of 51

















 


18.                              OPTION TO RENEW


 


18.1                       Renewal


 


The Term may be extended for one (1) one-year term from April 1, 2007,
upon written agreement of Talecris and CBS; provided that Bayer Canada shall
have no obligations under this Agreement for any such extended term without its
express written consent.


 


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


 


19.                              GENERAL


 


19.1                       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; or


 


(iii)                               sent
by facsimile.


 


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


 


(i)                                     in
all cases to:


 


Canadian Blood
Services

1800 Alta Vista Drive

Ottawa, ON K1G 4J5 CANADA


 


Attention:                                         Director,
Plasma Products and Services

Telephone:                                    (613)
739-2390

Facsimile:                                            (613)
739-2025


 


(ii)                                  where
the matter relates to regulatory issues including Quality Assurance, Quality
Control or Quality Systems, a copy to:


 


Attention:                                         Vice-President,
Quality Assurance and Regulatory Affairs

Telephone:                                    (613)
739-2036

Facsimile:                                            (613)
739-2505


 


(iii)                               where
the matter relates to a business or financial issue, a copy to:


 


Attention:                                         Director,
Supply Management

Telephone:                                    (613)
739-2350

Facsimile:                                            (613)
739-2025


 


(iv)                              where
the matter relates to an alleged breach by CBS, notice to be given to:


 


Attention:                                         Vice
President General Counsel and Corporate Secretary

Telephone:                                    (613)
739-2121

Facsimile:                                            (613)
739-2099


 


 


35 of 51

















 


in the case of Talecris to:


 


Talecris
Biotherapeutics, Inc.

P. O. Box 13887

79 TW Alexander Drive

4101 Research Commons

Research Triangle Park

Raleigh, NC 27709

USA


 


Attention:                                         General
Legal Counsel

Telephone:                                    (919)

Facsimile:                                            (919)
316-6669


 


in the case of Bayer Canada to:


 


Bayer Inc.
Biological Products

77 Belfield Road

Toronto, ON M9W 1 G6


 


Attention:                                         Vice
President, Biological Products

Telephone:                                    (416)
240-5965

Facsimile:                                            (416)
248-0907


 


in the case of Bayer US to:


 


address


 


Attention:

Telephone:

Facsimile:


 


Any party may from time to time change its address by written notice to
the other Parties and/or Bayer US 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.


 


19.2                       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.


 


 


36 of 51

















 


19.3                       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.


 


19.4                       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.


 


19.5                       Communication


 


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


 


19.6                       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 Article 17. The Parties agree that the United Nations
Convention on contracts for the International Sale of Goods shall not apply to
this Agreement.


 


19.7                       Currency


 


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


 


19.8                       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.


 


19.9                       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.


 


 


37 of 51

















 


19.10                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.


 


19.11                Amendment


 


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


 


19.12                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,


 


(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.


 


19.13                Pricing Information to Customers


 


(a)                                 Talecris
and Bayer Canada agree that CBS has the right to provide detailed pricing or
cost information to its Members, the provincial and territorial Ministers of
Health and their delegates.


 


(b)                                Talecris
and Bayer Canada agree that CBS may provide a range (not to be less than [***] of the actual specific price of any Commercial
Products) to customers upon request.


 


(c)                                 CBS
agrees that any request (other than as set out in Subsection 19.13(a) above)
for the specific cost of any Commercial Products will be referred to Bayer
Canada.


 


(d)                                Bayer
Canada will consult with CBS prior to Talecris or Bayer Canada releasing any
pricing or cost information relating to any Fractionation Products.


 


19.14                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 party
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.


 


 










*** CONFIDENTIAL TREATMENT
REQUESTED


 


38 of 51





















 


19.15                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.


 


19.16                Talecris and Bayer Canada jointly and
severally liable


 


Talecris and Bayer Canada shall be held jointly and severally liable
for the obligations set out in this Agreement.


 


 


39 of 51


















 


19.17                Acknowledgement


 


IN WITNESS WHEREOF Talecris, Bayer Canada and CBS have executed this
Agreement, each on the date indicated.


 


 


	
  CANADIAN BLOOD SERVICES

  	
   

  	
   

  	
   

  
	
   

  	
   

  
	
  BY:

  	
  /s/ Ian Mumford

  	
   

  	
  BY: 

  	
  /s/ Authorized Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NAME:

  	
  Ian Mumford

  	
   

  	
  NAME:

  	
  Authorized Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TITLE:

  	
  Chief Operating Officer

  	
   

  	
  TITLE:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  DATE:

  	
   

  	
   

  	
  DATE:

  	
  2005/04/07

  	
   

  
	
   

  	
   

  
	
  AND

  	
   

  
	
   

  	
   

  
	
  BY:

  	
  /s/ Marcel Leclair

  	
   

  	
   

  
	
   

  	
   

  
	
  NAME:

  	
  Marcel Leclair

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  TITLE:

  	
  Executive Director & A/CFO

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  DATE:

  	
  April 6/2007

  	
   

  	
   

  
	
   

  	
   

  
	
  BAYER INC.

  	
   

  
	
   

  	
   

  
	
  BY:

  	
  /s/ Authorized Signatory

  	
   

  	
  BY:

  	
  /s/ Authorized Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NAME:

  	
  Authorized Signatory

  	
   

  	
  NAME: 

  	
  Authorized Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  TITLE:

  	
  President

  	
   

  	
  TITLE:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  DATE:

  	
   

  	
   

  	
  DATE:

  	
   

  	
   

  
	
   

  	
   

  
	
  TALECRIS BIOTHERAPEUTICS, INC.

  	
   

  
	
   

  	
   

  
	
  BY:

  	
  /s/ Lawrence D. Stern

  	
   

  	
  BY:

  	
  /s/ Authorized Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NAME:

  	
  Lawrence D. Stern

  	
   

  	
  NAME:

  	
  /s/ Authorized Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  TITLE:

  	
  Chairman & CEO

  	
   

  	
  TITLE:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  DATE:

  	
   

  	
   

  	
  DATE:

  	
   

  	
   

  
																													



 


 


40 of 51

















 


 


Bayer Healthcare LLC is executing this Agreement for the sole purpose
of assigning to Talecris and Bayer Canada all of its rights under the Main
Agreement relating to activities after the Effective Date of this Agreement. Bayer
Healthcare LLC is not a party to and has no other rights under this Agreement
relating to activities after the Effective Date of this Agreement other than
the right to enforce or seek damages from Talecris or Bayer Canada relating to
such assignment. For greater clarity, Bayer Healthcare LLC shall remain
responsible and liable for Existing Products as defined in Section 12.2.2.


 


	
  BAYER HEALTHCARE LLC

  	
   

  
	
   

  	
   

  
	
  BY:

  	
  /s/ Authorized Signatory

  	
   

  	
  BY:

  	
  /s/ Paul R. Berry

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NAME:

  	
  Authorized Signatory

  	
   

  	
  NAME:

  	
  Paul R. Berry

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  TITLE:

  	
   

  	
   

  	
  TITLE:

  	
  Senior Vice President General Counsel and Secretary

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  DATE:

  	
   

  	
   

  	
  DATE:

  	
   

  	
   

  
									



 


41 of 51

















 


SCHEDULE “A” - COMMERCIAL PRODUCTS


 


	
   

  	
   

  	
  2005-2006 Volume

  	
   

  	
  Price

  
	
  Product

  	
   

  	
  Total

  	
   

  	
  CBS

  	
   

  	
  Héma-Québec

  	
   

  	
  (2005-2006)*

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 






[***]


 


	
  Product

  	
   

  	
  Combined CBS/HQ Volume

  	
   

  	
  Price

  (2005-2006)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 






*** CONFIDENTIAL TREATMENT REQUESTED


 


42 of 51

















SCHEDULE “A” COMMERCIAL PRODUCTS (continued)


 


Pricing Schedule - Consumer Preference Section 4.4 (b)


 


	
  Product

  	
   

  	
  Combined CBS/HQ Volume

  	
   

  	
  (2005-2006 Pricing)*

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


[***]

[***]








*** CONFIDENTIAL TREATMENT REQUESTED


 


43 of 51

















 


SCHEDULE “B” - PLASMA PICK-UP SCHEDULE


 


CBS


 


	
  Centre Name

  	
   

  	
  Address

  	
   

  	
  Min Pick up Frequency

  	
   

  	
  Ann Vol.

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


HQ


 


	
  Centre Name

  	
   

  	
  Address

  	
   

  	
  Min Pick up Frequency

  	
   

  	
  Ann Vol.

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  



 






*** CONFIDENTIAL TREATMENT REQUESTED


 


44 of 51

















 


SCHEDULE “C” - COMMERCIAL PRODUCT SPECIFICATIONS


 


	
  Product

  	
   

  	
  Specifications

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  



 






*** CONFIDENTIAL TREATMENT REQUESTED


 


45 of 51

















 


SCHEDULE “D” - FRACTIONATION PRODUCTS AND PRICE ADJUSTMENTS FOR
FRACTIONATION PRODUCTS


-Volume Of Plasma Picked Up


 


Fractionation Products


 


	
  Product

  	
   

  	
  Unit of Measure

  	
   

  	
  2005-2006 Index

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***] 

  	
   

  	
  [***]

  



 


 


Price Adjustments for Fractionation - Volume of Plasma Picked-Up


 


	
   

  	
   

  	
  Price Adjustment/Volume 

  (2005-2006 Prices)

  
	
  Product

  	
   

  	
  Unit of Measure

  	
   

  	
  120,000 - 140,000

  	
   

  	
  >140,000

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


[***]


 










*** CONFIDENTIAL TREATMENT REQUESTED


 


46 of 51

















 


SCHEDULE “E” - CBS PRODUCT INVENTORY TARGET LEVELS


 


	
  Product

  	
   

  	
  Target Inventory Level

  (weeks)

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  



 






*** CONFIDENTIAL TREATMENT REQUESTED


 


47 of 51

















 


SCHEDULE “F” - COLLECTION CENTERS


 


CBS


 


	
  Centre Name

  	
   

  	
  Address

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  



 


HQ


 


	
  Centre Name

  	
   

  	
  Address

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  



 






*** CONFIDENTIAL TREATMENT REQUESTED


 


48 of 51

















 


SCHEDULE “G” - DELIVERY SCHEDULE


 


Tables Intentionally Deleted.


 


49 of 51

















 


SCHEDULE “H” - VIAL SIZES SUBSTITUTION / WASTAGE


 


[***]


 






*** CONFIDENTIAL TREATMENT REQUESTED


 


50 of 51

















 


Schedule
H (continued) vial size Substitution Clause Example 


 


[***]


 


 


	
   

  	
   

  	
  May

  	
   

  	
  June

  	
   

  	
  July

  	
   

  	
  Aug

  	
   

  	
  Sept

  	
   

  	
  Oct

  	
   

  	
  Nov

  	
   

  	
  Dec

  	
   

  	
  Jan-03

  	
   

  	
  Feb

  	
   

  	
  Mar

  	
   

  	
  Apr

  	
   

  	
  May

  	
   

  	
  Jun

  	
   

  	
  July

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
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Compensation example


 


	
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*** CONFIDENTIAL TREATMENT REQUESTED


 


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