COMMERCIAL SUPPLY AGREEMENT

        This Commercial Supply Agreement (this "Agreement") is entered into and effective as of the 1st day of June 2002 ("Effective Date") by and between Baxter Pharmaceutical Solutions LLC ("BAXTER"), a Delaware limited liability company having a place of business at 927 South Curry Pike, Bloomington, Indiana 47403, and IDEC Pharmaceuticals Corporation ("CLIENT"), a Delaware corporation having a place of business at 3030 Callan Road, San Diego, CA 92121.

RECITALS

        1.     CLIENT is engaged in the development, bulk production, formulation, sale and distribution of pharmaceutical products;

        2.     BAXTER is engaged in the filling, labeling and packaging of pharmaceutical products;

        3.     CLIENT and BAXTER desire to have BAXTER fill, package, inspect, label, and test a certain pharmaceutical product known as Ibritumomab Tiuxetan ("Zevalin") for distribution and sale by CLIENT.

        NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the parties agree as follows:

Article 1, DEFINITIONS

        As used in this Agreement, the following words and phrases shall have the following meanings:

1


2


3


Article 2, PRODUCT MASTER PLAN

4


ARTICLE 3, PURCHASE AND SUPPLY OF PRODUCT

5


6


Article 4, FORECASTS, ORDERS, AND CAPACITY

7


8


Article 5, PRICE

Article 6, SHIPMENT AND INVOICING

9


Article 7, ACCEPTANCE OF PRODUCT

10


Article 8, TERM AND TERMINATION

11


12


Article 9, PRODUCTION OF PRODUCT

13


14


Article 10, REGULATORY

15


Article 11, TRADEMARKS

Article 12, REPRESENTATIONS AND WARRANTIES

16


Article 13, LIMITATION OF LIABILITY, WAIVER OF SUBROGATION AND REPLACEMENT OF BULK CONJUGATED ANTIBODY AND OTHER CLIENT SUPPLIED COMPONENTS

17


18


Article 14, INDEMNIFICATION

19


Article 15, INSURANCE

20


Article 16, RECALL OF PRODUCT

21


 
  Recall Class
Number of Consignees

  I
  II
  III
[CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED]

Article 17, INTELLECTUAL PROPERTY

22


Article 18, CONFIDENTIAL INFORMATION, NONDISCLOSURE AND PUBLICITY

23


Article 19, FORCE MAJEURE

24


Article 20, NOTICES

If to BAXTER: Baxter Pharmaceutical Solutions LLC
927 South Curry Pike
Bloomington, Indiana 47403
  Attn:Alisa K. Wright, Vice President of Business Affairs

 

 

Telefax No.

 

812-332-3079
  Telephone No. 812-333-0887

With a copy to:

 

Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, Illinois 60015-4633
  Attn:General Counsel

 

 

Telefax No.

 

(847) 948-2450
  Telephone No. (847) 948-2600

If to CLIENT:

 

IDEC Pharmaceuticals Corporation
3030 Callan Road
San Diego, California 92121
  Attn:President

 

 

Telefax No.

 

(858) 431-8755
  Telephone No. (858) 431-8500

With a copy to:

 

IDEC Pharmaceuticals Corporation
3030 Callan Road
San Diego, California 92121
  Attn:Company Secretary

 

 

Telefax No.

 

(858) 431-8755
  Telephone No. (858) 431-8500

25


Article 21, APPLICABLE LAW

Article 22, ASSIGNMENT

Article 23, ALLIANCES

Article 24, TAXES

Article 25, SUCCESSORS AND ASSIGNS

Article 26, ENTIRE AGREEMENT

26


Article 27, SEVERABILITY

Article 28, WAIVER AND MODIFICATION OF AGREEMENT

Article 29, INDEPENDENT CONTRACTORS

        IN WITNESS WHEREOF, the parties have caused this Commercial Supply Agreement to be signed by their duly authorized representatives as of the Effective Date written above.

  "BAXTER"   "CLIENT"

BAXTER PHARMACEUTICAL SOLUTIONS LLC

 

IDEC PHARMACEUTICALS CORPORATION

By:

 

/s/  ALISA K. WRIGHT      

 

By:

 

/s/  WILLIAM ROHN      

Name: Alisa Wright

 

Name: William Rohn

Title: Vice President, Business Affairs

 

Title: President and COO

27



Exhibit 1

Cancellation Fees

Timing

  Cancellation Fee
Cancellation of any batch within [CONFIDENTIAL TREATMENT REQUESTED] of the scheduled fill date [CONFIDENTIAL TREATMENT REQUESTED]
Cancellation of any batch within [CONFIDENTIAL TREATMENT REQUESTED] of the scheduled fill date [CONFIDENTIAL TREATMENT REQUESTED]
Cancellation of any batch within [CONFIDENTIAL TREATMENT REQUESTED] of the scheduled fill date [CONFIDENTIAL TREATMENT REQUESTED]


Exhibit 2

Product Specifications for Release Testing of Product Kits

        Labeled and released components will be assembled into the Zevalin radiolabeling kit (111-Indium or 90-Yttrium).

        Each kit component (2B8-MX-DTPA Conjugated Antibody, 50 mM Sodium Acetate, Formulation Buffer and Reaction vial) is individually tested and released based upon pre-determined release specifications.

        Kits are tested for adequacy of the packaging materials (labels, tray, package insert, overlabels and carton), printing of lot number and expiration date, and identity of the kit components is verified using the following methods:

[CONFIDENTIAL
TREATMENT
REQUESTED]
 [CONFIDENTIAL
TREATMENT
REQUESTED]
 [CONFIDENTIAL
TREATMENT
REQUESTED]

[CONFIDENTIAL
TREATMENT
REQUESTED]

 

[CONFIDENTIAL
TREATMENT
REQUESTED]

 

[CONFIDENTIAL
TREATMENT
REQUESTED]

[CONFIDENTIAL
TREATMENT
REQUESTED]

 

[CONFIDENTIAL
TREATMENT
REQUESTED]

 

[CONFIDENTIAL
TREATMENT
REQUESTED]

[CONFIDENTIAL
TREATMENT
REQUESTED]

 

[CONFIDENTIAL
TREATMENT
REQUESTED]

 

[CONFIDENTIAL
TREATMENT
REQUESTED]

[CONFIDENTIAL TREATMENT REQUESTED]




Exhibit 3

Kit Component Specifications
for Release Testing of 2B8-MX-DTPA Conjugated Antibody

 
  Test Name
  Specification
Safety Tests/
Process Related Impurities
 Pre-filtration Bioburden [CONFIDENTIAL TREATMENT REQUESTED]
  Particulate Matter [CONFIDENTIAL TREATMENT REQUESTED]
  Bacterial Endotoxins [CONFIDENTIAL TREATMENT REQUESTED]
  Sterility (Bulk) [CONFIDENTIAL TREATMENT REQUESTED]
  Sterility (Finished Product) [CONFIDENTIAL TREATMENT REQUESTED]
Identity Potency Tests [CONFIDENTIAL TREATMENT REQUESTED]
Strength Protein Concentration [CONFIDENTIAL TREATMENT REQUESTED]
Quality Appearance, Color, Clarity [CONFIDENTIAL TREATMENT REQUESTED]
Potency CD20 Binding Activity [CONFIDENTIAL TREATMENT REQUESTED]
  Radiochemical Purity [CONFIDENTIAL TREATMENT REQUESTED]
Purity/
Product Related Impurities
 Percent Monomer by SEC-HPLC [CONFIDENTIAL TREATMENT REQUESTED]
  Chelates per Antibody [CONFIDENTIAL TREATMENT REQUESTED]
  SDS-PAGE, Silver Stain [CONFIDENTIAL TREATMENT REQUESTED]
General Tests Fill Volume [CONFIDENTIAL TREATMENT REQUESTED]
  pH Determination [CONFIDENTIAL TREATMENT REQUESTED]

[CONFIDENTIAL TREATMENT REQUESTED]




Kit Component Specifications
for Release Testing of 50 mM Sodium Acetate

 
  Test Name
  Specification
Safety Tests/
Process Related Impurities
 Pre-filtration Bioburden [CONFIDENTIAL TREATMENT REQUESTED]
  Particulate Matter [CONFIDENTIAL TREATMENT REQUESTED]
  Bacterial Endotoxins [CONFIDENTIAL TREATMENT REQUESTED]
  Sterility (Bulk) [CONFIDENTIAL TREATMENT REQUESTED]
  Sterility (Finished Product) [CONFIDENTIAL TREATMENT REQUESTED]
Identity Sodium Identification [CONFIDENTIAL TREATMENT REQUESTED]
  Acetate Identification [CONFIDENTIAL TREATMENT REQUESTED]
Strength Sodium Acetate Concentration [CONFIDENTIAL TREATMENT REQUESTED]
Quality Appearance, Color, Clarity [CONFIDENTIAL TREATMENT REQUESTED]
General Tests Fill Volume [CONFIDENTIAL TREATMENT REQUESTED]


Kit Component Specifications
for Release Testi