EXHIBIT 10.10
Pharmion Corporation
0000 00xx Xxxxxx
Xxxxxxx, Xxxxxxxx 00000
April 2, 2003
Celgene Corporation
0 Xxxxxx Xxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attention: Xxxx X. Xxxxxxx
Gentlemen:
On March 3, 2003, Pharmion GmbH ("Pharmion"), Pharmion Corporation ("Guarantor")
and Celgene Corporation ("Celgene") entered into Amendment No.1 (the
"Amendment") to the License Agreement among such parties dated November 16, 2001
(as amended, the "License Agreement"). Capitalized terms that are not defined
herein shall have the meaning ascribed thereto in the License Agreement.
Celgene, Pharmion and Guarantor mutually acknowledge and agree that the further
clinical development of Thalomid, including registration studies for, among
other indications, newly diagnosed multiple myeloma, is in the interest of the
parties, and that it is also in the interest of the parties that such studies
should include centers in the Territory. In order to insure that such studies
are consistent across centers in the United States and the Territory, and are
designed to enroll patients as rapidly as possible, Pharmion, Guarantor and
Celgene hereby agree as follows:
(1) Promptly following the execution of this letter agreement, Celgene and
Pharmion shall establish a Thalomid Clinical Development Committee
("TCDC") consisting of an equal number of representatives from both
parties, which will meet (in person, telephonically or via
videoconference) quarterly and, as may be agreed upon by Celgene and
Pharmion from time to time, at other times, to review the design,
development, enrollment and progress of Thalomid clinical trials in the
Territory (the "Trials"). Through TCDC, Celgene and Pharmion each shall
(a) afford the other the opportunity to confer concerning the
initiation and conduct of Trials, including matters relating to the
oversight of the clinical sites involved in Trials, (b) keep apprised
on a regular basis concerning the progress of Trials, and (c) consider
in good faith the views of the other with respect to Trials, including
the views concerning possible adjustments of any Trials that may be
appropriate to address the requirements of regulatory authorities in
connection with obtaining Regulatory Approval of Thalomid. If requested
by either Celgene or Pharmion, any material matter as to which the
parties' representatives on the TCDC have opposing views shall be
referred to the chief executive officer of Pharmion and the chief
operating officer of Celgene for consideration by them. Notwithstanding
anything to the contrary in this letter agreement, the party initiating
a Trial shall have sole authority with respect to, and control of, such
Trial.
Celgene Corporation
April 2, 2003
Page 2
(2) During the period commencing on the date of this letter agreement and
ending December 31, 2005, Pharmion shall provide Celgene an aggregate
of $8 million (the "Funding") for the expenses and internal costs
incurred and/or to be incurred by Celgene for the conduct of Trials.
The Funding shall be provided as follows: (a) in 2003 in three
installments of $1 million each, payable upon execution of this letter
agreement, September 30, 2003 and December 31, 2003; (b) in 2004 in
four installments of $750,000 each, payable on the last day of each
calendar quarter in 2004; and (c) in 2005 in four installments of
$500,000 each, payable on the last day of each calendar quarter in
2005. Celgene shall, within 45 days after the end of each calendar
quarter in the period from the date of this letter to December 31,
2006, provide Pharmion copies of invoices and other documentation
available to Celgene reflecting up to $8 million of expenses and
internal costs incurred by Celgene with respect to clinical trials of
Thalomid.
(3) To the extent there is any conflict between the terms of this letter
agreement and the License Agreement, this Agreement shall control.
(4) This letter agreement shall be governed by and construed in accordance
with the laws of the State of New York.
Please indicate your acceptance of, and agreement with, the foregoing by signing
the enclosed copy of this letter and returning it to us.
Very truly yours,
Pharmion Corporation
Pharmion GmbH
By: /s/ Xxxxxxx X. Xxxxxxx
---------------------------------
Xxxxxxx X. Xxxxxxx
President and CEO
ACCEPTED AND AGREED:
Celgene Corporation
By: /s/ Xxxx X. Xxxxxxx
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Xxxx X. Xxxxxxx
Chairman and Chief Executive Officer
