AMENDMENT NO. 5
TO THE
ENBREL ® SUPPLY
AGREEMENT
This Amendment
No. 5 (this “ Amendment No. 5 ”) is
made as of this 30th day of August, 2005 (the “ Amendment
No. 5 Effective Date ”) by and among Immunex
Corporation, a Washington corporation having its principal place of
business at One Amgen Center Drive, Thousand Oaks, California 91320
(together with its Affiliates, “ Immunex ”),
Wyeth (formerly, “American Home Products Corporation”),
a Delaware corporation having its corporate headquarters at Five
Giralda Farms, Madison, New Jersey 07940, acting through its Wyeth
Pharmaceuticals Division (together with its Affiliates, “
Wyeth ”), and Boehringer Ingelheim Pharma GmbH &
Co. KG, a German corporation having a place of business at
Birkendorfer Straße 65, 88397 Biberach an der Riss, Federal
Republic of Germany (“ BIP ”), and amends the
Enbrel® Supply Agreement effective as of November 5,
1998, as amended by Amendment No. 1 effective June 27,
2000, Amendment No. 2 effective June 3, 2002, Amendment
No. 3 effective December 18, 2002 and Amendment
No. 4 effective May 21, 2004 (the “
Agreement ”).
WHEREAS, Immunex,
Wyeth, and BIP have entered into the Agreement for BIP’s
supply of Enbrel ® (etanercept) to Immunex and
Wyeth; and
WHEREAS, the
Parties have determined that in addition to the rights and
obligations set forth in the Agreement, they wish to have BIP
manufacture and supply Immunex and Wyeth with syringes filled with
the Product; and
WHEREAS, Immunex
and BIP have entered into a Letter of Intent dated as of
March 2, 2005 regarding the Syringe Project (as defined
therein); and
WHEREAS, Immunex,
Wyeth and BIP have entered into a Syringe Project Letter Agreement,
concurrently herewith, relating to BIP’s undertaking to
complete its syringe fill and finish facility.
NOW, THEREFORE, in
consideration of the mutual covenants contained herein, and for
other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties hereto, each
intending to be legally bound, hereby agree as follows:
1.1 General
. All initially capitalized terms used herein and not defined shall
have the meanings set forth in the Agreement.
1.2
Syringe(s) shall mean syringes meeting the standards and
specifications set forth in the attached Exhibit J.
1
2. Drug
Product and Finished Product including 25 mg. and 50 mg. Syringe
Forms.
Beginning on
the Amendment No. 5 Effective Date, and unless specifically
named and separated, all reference to Drug Product or Finished
Product in the Agreement shall include syringes containing
twenty-five (25) mg. and fifty (50) mg. of specifically
formulated Bulk Drug Substance. Exhibit B and Exhibit C
attached to the Agreement shall be stricken and replaced with the
revised Exhibit B and Exhibit C attached to this
Amendment No. 5.
3.
Maximum, Minimum and Pricing for Syringe Fill and Finish
Services.
The Maximum,
Minimum and pricing terms for the manufacture and supply of
Syringes are set forth in Exhibit I attached hereto and
incorporated herein. For avoidance of doubt, the Parties hereby
acknowledge and agree that Wyeth and Immunex’s obligation to
satisfy the Minimum Syringe quantity requirement set forth in
Exhibit I (including both purchases of Syringes and the
payment of any Shortfall Payment) shall be credited toward
satisfying, but shall not otherwise alter, the Parties’
rights and obligations set forth in Section 3.1(a)(2) of the
Agreement, and the Parties agree that Section 3.1(a)(2) of the
Agreement refers and applies only to the baseline “Annual
Minimum” runs per Sections 5.10(a) and (b) of the
Agreement (i.e. currently 84 runs per year of either liquid or
lyophilized Product) and the Baseline Accepted Unused Capacity runs
per Section 5.10(a)(4) of the Agreement (currently 10 runs per
year of either liquid or lyophilized Product) but not to any
additional Bulk Drug Substance Runs. BIP shall fill all orders for
Syringes that are placed by Immunex or Wyeth in accordance with the
terms of this Amendment No. 5 and the relevant provisions of
the Agreement.
4. Term
of Obligation to Fill and Finish Syringes.
The
Parties’ rights and obligation with respect to BIP
manufacturing and supplying Immunex and Wyeth with Syringes filled
with the Product pursuant to this Amendment No. 5
(“Amendment No. 5 Rights and Obligations”) shall
continue until the end of the year 2009. Thereafter, the Amendment
No. 5 Rights and Obligations shall automatically continue for
two (2) year periods unless terminated by any Party by
providing eighteen (18) months prior written notice to the
other Parties. For the avoidance of doubt, the Amendment No. 5
Rights and Obligations shall automatically terminate upon
expiration or termination of the Agreement.
Notwithstanding
the foregoing and in addition to any termination rights pursuant to
the Agreement, Imm
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