United States License and Co-Promotion Agreement [Amendment No. 1] - MedImmune Vaccines Inc. and Wyeth
FIRST AMENDMENT TO
UNITED STATES LICENSE AND CO-PROMOTION AGREEMENT
THIS FIRST AMENDMENT TO UNITED STATES LICENSE AND CO-PROMOTION AGREEMENT (the "Amendment"), is entered into as of October 23, 2002 (the "Amendment Effective Date"), by and between MEDIMMUNE VACCINES, INC. (formerly Aviron, Inc.), a Delaware corporation with its principal place of business at 297 North Bernardo Avenue, Mountain View, California 94043 ("MedImmune Vaccines"), and WYETH (formerly American Home Products Corporation), acting through its Wyeth Pharmaceuticals division, a Delaware corporation with its principal place of business at 5 Giralda Farms, Madison, New Jersey 07940 ("Wyeth"). MedImmune Vaccines and Wyeth are sometimes referred to herein individually as a "Party" and collectively as the "Parties."RECITALS
WHEREAS, MedImmune, Inc. acquired Aviron, Inc. ("Aviron") in January 2002, and Aviron survived such acquisition as a wholly-owned subsidiary of MedImmune, Inc., which subsidiary was renamed MedImmune Vaccines, Inc.; and
WHEREAS, American Home Products Corporation changed its corporate name to Wyeth in March 2002; and
WHEREAS, pursuant to that certain United States License and Co-Promotion Agreement dated January 11, 1999 by and between Aviron and American Home Products Corporation (the "U.S. Agreement"), the Parties are collaborating to develop, commercialize, market and promote MedImmune Vaccines's proprietary intranasally delivered cold-adapted vaccine formulation against influenza and influenza-associated illnesses, including otitis media infection, known as FluMist(R)or FluEnz(TM)(collectively, "FluMist") in the United States and its territories and possessions; and
WHEREAS, of even date herewith, Wyeth and MedImmune Vaccines have amended that certain FluMist(R)Supply Agreement dated January 11, 1999 (the "Supply Agreement") to modify the terms for the manufacture and supply of FluMist and the transfer price payments to be paid by Wyeth for supply of FluMist; and
WHEREAS, MedImmune Vaccines and Wyeth desire to amend the U.S. Agreement to: (a) change the Co-Promotion Term, and (b) modify one of the supply goal payments payable by Wyeth to MedImmune Vaccines for MedImmune Vaccines's supply of the frozen formulation of FluMist; and
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants and agreements contained herein, the Parties hereby agree as follows:
1. All capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the U.S. Agreement.
2. Each reference in the U.S. Agreement to "Aviron, Inc." shall be replaced by "MedImmune Vaccines, Inc." Each reference in the U.S. Agreement to "Aviron" shall be replaced by "MedImmune Vaccines".
3. Each reference in the U.S. Agreement to "American Home Products Corporation", "AHPC", "Wyeth-Ayerst Laboratories Division", and "Wyeth-Ayerst" shall be replaced with "Wyeth."
4. "First Full Flu Season" means the first Flu Season in which both (a) Regulatory Approval for the Product in the Territory has been obtained prior to June 30 of the first partial calendar year of such Flu Season; and (b) MedImmune is capable of manufacturing the lesser of (i) (CONFIDENTIAL TREATMENT REQUESTED) doses of the Product, or (ii) the JCC Forecast / Modified Forecast (as defined in the Second Amendment to the Supply Agreement), as applicable, for such Flu Season. The First Full Flu Season is the season following the Launch Date Flu Season. The Launch Date Flu Season is the season in which both (a) Regulatory Approval for the Product in the Territory has not been obtained prior to June 30 of the first partial calendar year of such Flu Season but has been obtained prior to the end of such Flu Season; and (b) MedImmune is capable of manufacturing the lesser of (i) (CONFIDENTIAL TREATMENT REQUESTED) doses of the Product, or (ii) the JCC Forecast/Modified Forecast, as applicable, for such Flu Season.
5. Section 1.16 of the U.S Agreement shall be deleted in its entirety and replaced with the following new Section 1.16:
"1.16 "Co-Promotion Term" means the period commencing on the Launch Date, extending through the Launch Date Flu Season , and terminating upon the earlier of (a) May 1 of the (CONFIDENTIAL TREATMENT REQUESTED) Flu Season following the First Full Flu Season or as extended pursuant to Section 19.8, or (b) termination of this Agreement pursuant to Section 19.2, 19.3, 19.4 or 19.5, or as otherwise agreed by the Parties in writing."
6. Section 8.3 of the U.S. Agreement shall be replaced, in its entirety, with the following new Section 8.3:
"8.3 Supply Goal Payments. Wyeth shall pay the following amounts to MedImmune Vaccines no later than fifteen (15) days after the occurrence of the following events:
(a) Wyeth shall pay to MedImmune Vaccines (CONFIDENTIAL TREATMENT REQUESTED) upon the first commercial sale of the Frozen Formulation in the Territory, excluding any sales in the 2002-03 Flu Season, provided that both of the following two conditions are met: (i) Regulatory Approval for such Frozen Formulation in the Territory was obtained on or prior to June 30 of the year of the applicable Flu Season in which such first commercial sale occurred, and (ii) the JCC Forecast for such Flu Season is at least (CONFIDENTIAL TREATMENT REQUESTED) doses;
(b) Wyeth shall pay to MedImmune Vaccines (CONFIDENTIAL TREATMENT REQUESTED) upon receiving written notice from MedImmune Vaccines that MedImmune Vaccines has supplied and Wyeth has accepted, pursuant to Section 6.3(a) of the Supply Agreement, at a minimum, the lesser of (i) (CONFIDENTIAL TREATMENT REQUESTED) doses, or (ii) the JCC Forecast for the Frozen Formulation for the third Flu Season."
7. Section 12.2 of the U.S. Agreement shall be replaced, in its entirety with the following new Section 12.2: "12.2 Royalty Reports and Payments. No later than the tenth (10th) working day in January, April, July and October, Wyeth shall provide MedImmune Vaccines with a written report summarizing the number of doses of Frozen Product sold in the U.S., and an estimate of average Net Sales per dose, based on Wyeth's best estimates. Within thirty (30) days after the first day of January, April, July and October of each year during the Co-Promotion Term, Wyeth shall deliver to MedImmune Vaccines a true and accurate report of Net Sales of Product, if any, sold by Wyeth, its Affiliates, and sublicensees in the Territory during the preceding three (3) month period in the Territory, accompanied by all royalties due under Section 12.1 and all payments due to MedImmune Vaccines under Section 7.6 for the period covered by such report. Such report shall also include the information necessary for MedImmune Vaccines to calculate "Net Sales", including actual and accrued estimates for freight, cash discounts, rebates and returns. If there are no Net Sales during such period, the report shall so state. If any amount is payable by MedImmune Vaccines to Wyeth, MedImmune Vaccines shall pay such amounts to Wyeth within thirty (30) days of receipt of such report in U.S. dollars by wire transfer to a bank account designated by Wyeth."
8. Section 20.1(b) of the U.S. Agreement shall be amended by deleting "President of Wyeth-Ayerst Global Pharmaceuticals" and inserting in its place "President of Wyeth Pharmaceuticals".
9. The Parties' addresses for notices in Section 21.5 of the U.S. Agreement shall be replaced with the following:
|If to MedImmune Vaccines:||MedImmune, Inc.|
35 West Watkins Mill Road
Gaithersburg, Maryland 20878
Attention: Chief Executive Officer
Telephone: (301) 527-4256
Facsimile: (301) 527-4201
|If to Wyeth:||Wyeth Pharmaceuticals|
555 Lancaster Avenue
St. Davids, Pennsylvania
Attention: Sr. Vice President
Global Business Development
Telephone: (610) 688-5809
Facsimile: (610) 688-9498
|With copies to:||Wyeth|
Five Giralda Farms
Madison, New Jersey 07940
Attention: Executive Vice President and General Counsel
Telephone: (973) 660-6040
Facsimile: (973) 660-7155
10. Except as amended hereby, all terms and conditions of the U.S. Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, MedImmune Vaccines and Wyeth have caused this Amendment to be executed as of the date first written above by their respective officers thereunto duly authorized.
|WYETH||MEDIMMUNE VACCINES, INC.|
|By: /s/ Ronald Alice||By: /s/ Melvin D. Booth|
|Name: Ronald Alice||Name: Melvin D. Booth|
|Title: Vice President, Law Department||Title: President, Chief Operating Officer|