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,...
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
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
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1. |
DEFINED TERMS AND INTERPRETATION |
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1.1 |
Definitions |
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1.2 |
Extended Meanings |
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1.3 |
Schedules |
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1.4 |
Time |
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1.5 |
Entire Agreement |
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1.6 |
Lead |
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2. |
PURCHASE AND SALE OF GOODS/SERVICES |
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2.1 |
Goods and Services |
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2.2 |
Distribution of Products in Canada |
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3. |
DELIVERY OF COMMERCIAL PRODUCTS |
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3.1 |
Forecasting |
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3.2 |
Prior Forecasts to be Honoured |
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3.3 |
Order for Commercial Products |
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3.4 |
Annual Volume |
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3.5 |
Delivery |
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3.6 |
Late Deliveries |
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3.7 |
Vial Size |
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3.8 |
Commercial Product Recalled, Withdrawn or Not Validly Distributed |
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3.9 |
Procedures for Alternate Sourcing |
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3.10 |
Minimum Supply Guarantee to Further Protect Canadians |
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4. |
COMMERCIAL PRODUCTS SPECIFICATIONS |
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4.1 |
Commercial Product Specifications |
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4.2 |
Bayer Canada Determines Commercial Products are Unsuitable |
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4.3 |
CBS Determines Commercial Products are Unsuitable |
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4.4 |
Significant Reduction in Consumer Preference |
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i of v
5. |
FRACTIONATION SERVICES |
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5.1 |
Forecasting |
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5.2 |
Order for Fractionation Products |
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5.3 |
Prior Forecasts to be Honoured |
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5.4 |
Forecasting Continued to Termination Date |
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5.5 |
Survival of Orders after Termination |
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6. |
PLASMA COLLECTION AND PROCESSING |
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6.1 |
Plasma Collection |
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6.2 |
Responsibility for Plasma in CBS’ Possession |
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6.3 |
Notice of Plasma Pickup by Bayer Canada |
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6.4 |
Pickup, Transportation and Storage of Plasma by Bayer Canada |
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6.5 |
Maximizing Transportation Efficiency |
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6.6 |
Bayer Canada Responsible for Exportation of Plasma |
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6.7 |
Shipping Documents and Exportation of Plasma |
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6.8 |
Responsibility for Plasma in Talecris’ or Bayer Canada’s Possession |
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6.9 |
Talecris to Inspect Plasma |
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6.10 |
CBS Determines Plasma Delivered to Bayer Canada is Unsuitable |
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6.11 |
Right of Talecris and Bayer Canada to Reject CBS Plasma |
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6.12 |
Plasma Rendered Unusable by Talecris or Bayer Canada |
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6.13 |
Quarterly Meetings |
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6.14 |
Change to CBS Standard Operating Procedures |
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6.15 |
Work in Process |
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7. |
DELIVERY OF FRACTIONATION PRODUCTS AND RECORDS |
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7.1 |
Delivery Schedule and Report on Status of Fractionation Product Delivery |
16 |
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7.2 |
Notice of Delay in Delivery of Fractionation Products |
17 |
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7.3 |
Delay in Delivery of Fractionation Products due to CBS |
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7.4 |
Records |
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ii of v
8. |
DELIVERY OF PRODUCTS |
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8.1 |
Product Shelf Life |
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8.2 |
Delivery of Products |
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8.3 |
Responsibility for Products |
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8.4 |
Duty of Inspection |
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9. |
INVOICES AND PAYMENT |
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9.1 |
Invoices |
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9.2 |
Price |
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9.3 |
Price Adjustments |
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9.4 |
Payment Terms |
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9.5 |
Value added |
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9.6 |
Pricing Not Affected by Remedies |
21 |
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10. |
REGULATORY AND QUALITY ASSURANCE MATTERS |
21 |
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10.1 |
Regulatory Condition of Supply |
21 |
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10.2 |
Improvements |
21 |
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10.3 |
Special Access Program |
22 |
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10.4 |
Communications |
22 |
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10.5 |
Talecris and Bayer Canada Information |
23 |
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10.6 |
Compliance Audit |
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11. |
PRODUCT WITHDRAWALS/RECALLS |
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11.1 |
Recall / Withdrawal |
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11.2 |
Patient Notification System |
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11.3 |
Adverse Event Reporting |
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11.4 |
Replacement Products and Replacement Fractionation Products |
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iii of v
12. |
REPRESENTATIONS, WARRANTIES AND INSPECTION |
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12.1 |
Representations and Warranties of the Parties |
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12.2 |
Applicable Laws and Notice of Compliance |
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12.3 |
Title and Warranty on the Products |
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12.4 |
Guaranteed Yield |
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12.5 |
Current Information |
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12.6 |
No Waiver |
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12.7 |
Survival of Representations and Warranties |
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13. |
PATENT PROTECTION |
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13.1 |
No Infringement |
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13.2 |
Infringement by a Product or Process |
27 |
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14. |
INSURANCE AND INDEMNIFICATION |
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14.1 |
Talecris’ and Bayer Canada’s Insurance |
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14.2 |
CBS Insurance |
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14.3 |
Indemnity |
29 |
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14.4 |
Approval of Counsel |
30 |
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15. |
CHANGE |
30 |
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15.1 |
Technological Change |
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15.2 |
Dispute Resolution |
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15.3 |
Intentionally Omitted |
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15.4 |
Parvovirus B19 Testing and the Change to the Caprylate/Chromatography Process |
31 |
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16. |
TERMINATION |
32 |
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16.1 |
Termination of Agreement |
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16.2 |
Talecris Event of Default |
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16.3 |
CBS Event of Default |
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16.4 |
Bayer Canada Event of Xxxxxxx |
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00. |
DISPUTE RESOLUTION |
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17.1 |
Arbitration |
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iv of v
18. |
OPTION TO RENEW |
35 |
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18.1 |
Renewal |
35 |
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19. |
GENERAL |
35 |
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19.1 |
Notices |
35 |
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19.2 |
Assignment |
36 |
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19.3 |
Independent Contractors |
37 |
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19.4 |
Severability |
37 |
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19.5 |
Communication |
37 |
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19.6 |
Governing Law |
37 |
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19.7 |
Currency |
37 |
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19.8 |
Successors and Assigns |
37 |
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19.9 |
No Waiver |
37 |
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19.10 |
Counterparts |
38 |
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19.11 |
Amendment |
38 |
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19.12 |
Confidential Information |
38 |
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19.13 |
Pricing Information to Customers |
38 |
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19.14 |
Public Announcements |
38 |
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19.15 |
Force Majeure |
39 |
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19.16 |
Talecris and Bayer Canada jointly and severally liable |
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19.17 |
Acknowledgement |
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EXECUTION FOR ASSIGNMENT |
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SCHEDULE “A” - COMMERCIAL PRODUCTS |
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SCHEDULE “B” - PLASMA PICK-UP SCHEDULE |
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SCHEDULE “C” - COMMERCIAL PRODUCT SPECIFICATIONS |
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SCHEDULE “D” - FRACTIONATION PRODUCTS AND PRICE ADJUSTMENTS FOR FRACTIONATION PRODUCTS |
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SCHEDULE “E” - CBS PRODUCTION INVENTORY TARGET LEVELS |
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SCHEDULE “F” - COLLECTION CENTRES |
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SCHEDULE “G” - INTENTIONALLY DELETED |
49 |
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SCHEDULE “H” - VIAL SIZES SUBSTITUTION / WASTAGE |
50 |
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v of v
ASSIGNMENT AND RESTATEMENT OF
FRACTIONATION SERVICES AND COMMERCIAL PRODUCTS
THIS AGREEMENT effective as of the first of April, 2005 (hereinafter referred to as “Effective Date”) is made
BETWEEN |
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AND AMONGST: |
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CANADIAN BLOOD SERVICES/ |
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SOCIETE CANADIENNE DU SANG |
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0000 Xxxx Xxxxx Xxxxx |
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Xxxxxx, XX X0X 0X0 |
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XXXXXX |
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(hereinafter referred to as “CBS”) |
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AND: |
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BAYER INC. |
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00 Xxxxxxxx Xxxx |
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Xxxxxxx, XX X0X 0X0 |
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XXXXXX |
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(hereinafter referred to as “Bayer Canada”) |
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AND: |
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BAYER HEALTHCARE LLC |
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000 Xxxxxx Xxxx |
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Xxxxxxxxx, XX 00000-0000 |
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XXX |
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(hereinafter referred to as (“Bayer US”) |
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AND: |
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TALECRIS BIOTHERAPEUTICS, INC. |
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(F/K/A NPS BIOTHERAPEUTICS, INC.) |
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P. O. Box 13887 |
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79 XX Xxxxxxxxx Drive |
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4101 Research Commons |
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Xxxxxxxx Xxxxxxxx Xxxx |
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Xxxxxxx, XX 00000 |
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(hereinafter referred to as “Talecris”) |
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(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 0000 Xxxx Xxxxx Xxxxx, Xxxxxx, Xxxxxxx, Xxxxxx, 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
4 of 51
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
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(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.
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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:
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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.
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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.
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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.
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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
0000 Xxxx Xxxxx Xxxxx
Xxxxxx, XX X0X 0X0 XXXXXX
Attention: Director,
Plasma Products and Services
Telephone: (000)
000-0000
Facsimile: (000)
000-0000
(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: (000)
000-0000
Facsimile: (000)
000-0000
(iii) where the matter relates to a business or financial issue, a copy to:
Attention: Director,
Supply Management
Telephone: (000)
000-0000
Facsimile: (000)
000-0000
(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: (000)
000-0000
Facsimile: (000)
000-0000
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in the case of Talecris to:
Talecris
Biotherapeutics, Inc.
P. O. Box 13887
79 XX Xxxxxxxxx Drive
4101 Research Commons
Research Triangle Park
Raxxxxx, XX 00000
XXX
Attention: General
Legal Counsel
Telephone: (919)
Facsimile: (000)
000-0000
in the case of Bayer Canada to:
Bayer Inc.
Biological Products
77 Xxxxxxxx Xxxx
Xxxxxxx, XX X9W 1 G6
Attention: Vice
President, Biological Products
Telephone: (000)
000-0000
Facsimile: (000)
000-0000
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.
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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.
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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.
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19.17 Acknowledgement
IN WITNESS WHEREOF Talecris, Bayer Canada and CBS have executed this Agreement, each on the date indicated.
CANADIAN BLOOD SERVICES |
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BY: |
/s/ Xxx Xxxxxxx |
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BY: |
/s/ Authorized Signatory |
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Xxx Xxxxxxx |
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NAME: |
Authorized Signatory |
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TITLE: |
Chief Operating Officer |
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TITLE: |
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2005/04/07 |
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AND |
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/s/ Xxxxxx Xxxxxxx |
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NAME: |
Xxxxxx Xxxxxxx |
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TITLE: |
Executive Director & A/CFO |
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DATE: |
April 6/2007 |
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BAYER INC. |
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BY: |
/s/ Authorized Signatory |
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BY: |
/s/ Authorized Signatory |
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NAME: |
Authorized Signatory |
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NAME: |
Authorized Signatory |
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TITLE: |
President |
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TITLE: |
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TALECRIS BIOTHERAPEUTICS, INC. |
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/s/ Xxxxxxxx X. Xxxxx |
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/s/ Authorized Signatory |
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Xxxxxxxx X. Xxxxx |
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/s/ Authorized Signatory |
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Chairman & CEO |
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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 |
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/s/ Authorized Signatory |
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/s/ Xxxx X. Xxxxx |
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Authorized Signatory |
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NAME: |
Xxxx X. Xxxxx |
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TITLE: |
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Senior Vice President General Counsel and Secretary |
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41 of 51
SCHEDULE “A” - COMMERCIAL PRODUCTS
|
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2005-2006 Volume |
|
Price |
||||
Product |
|
Total |
|
CBS |
|
Héma-Québec |
|
(2005-2006)* |
[***] |
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[***] |
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[***] |
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[***] |
|
[***] |
[***] |
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[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
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[***] |
[***]
Product |
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Combined CBS/HQ Volume |
|
Price |
[***] |
|
[***] |
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[***] |
[***] |
|
[***] |
|
[***] |
[***] |
|
[***] |
|
[***] |
[***] |
|
[***] |
|
[***] |
*** 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 |
|
Xxx Vol. |
[***] |
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[***] |
|
[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
HQ
Centre Name |
|
Address |
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Min Pick up Frequency |
|
Xxx Vol. |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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*** CONFIDENTIAL TREATMENT REQUESTED
44 of 51
SCHEDULE “C” - COMMERCIAL PRODUCT SPECIFICATIONS
Product |
|
Specifications |
[***] |
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[***] |
[***] |
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[***] |
[***] |
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[***] |
[***] |
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[***] |
[***] |
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[***] |
*** CONFIDENTIAL TREATMENT REQUESTED
45 of 51
SCHEDULE “D” - FRACTIONATION PRODUCTS AND PRICE ADJUSTMENTS FOR FRACTIONATION PRODUCTS
-Volume Of Plasma Picked Up
Fractionation Products
Product |
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Unit of Measure |
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2005-2006 Index |
[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
Price Adjustments for Fractionation - Volume of Plasma Picked-Up
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Price Adjustment/Volume |
||||
Product |
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Unit of Measure |
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120,000 - 140,000 |
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>140,000 |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***]
*** CONFIDENTIAL TREATMENT REQUESTED
46 of 51
SCHEDULE “E” - CBS PRODUCT INVENTORY TARGET LEVELS
Product |
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Target Inventory Level |
[***] |
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[***] |
[***] |
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[***] |
[***] |
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[***] |
[***] |
|
[***] |
*** CONFIDENTIAL TREATMENT REQUESTED
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SCHEDULE “F” - COLLECTION CENTERS
CBS
Centre Name |
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Address |
[***] |
|
[***] |
[***] |
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[***] |
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*** CONFIDENTIAL TREATMENT REQUESTED
48 of 51
SCHEDULE “G” - DELIVERY SCHEDULE
Tables Intentionally Deleted.
49 of 51
SCHEDULE “H” - VIAL SIZES SUBSTITUTION / WASTAGE
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*** CONFIDENTIAL TREATMENT REQUESTED
50 of 51
Schedule H (continued) vial size Substitution Clause Example
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*** CONFIDENTIAL TREATMENT REQUESTED
51 of 51