Exhibit 10.37
Pharmion Corporation
0000 00xx Xxxxxx
Xxxxxxx, Xxxxxxxx 00000
December 3, 2004
Celgene Corporation
0 Xxxxxx Xxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attention: Xxx X. Xxxxx
Gentlemen:
Pharmion GmbH ("Pharmion"), Pharmion Corporation ("Guarantor") and Celgene
Corporation ("Celgene") have previously entered into a License Agreement dated
November 16, 2001, as subsequently amended (the "License Agreement") pursuant to
which Celgene has granted to Pharmion a license for Thalidomide products,
including its Thalomid formulation. To further their mutual interests in
Pharmion obtaining regulatory approval for the marketing and sale of Thalomid in
the Territory (as defined in the License Agreement), Pharmion, Guarantor and
Celgene have previously established a working relationship relating to the
clinical development of Thalomid under a letter agreement dated April 2, 2003
("2003 Clinical Trials Agreement"). Subsequently, on the basis of advice from
the European Agency for the Evaluation of Medicinal Products ("EMEA") that it
would require additional clinical data for Thalomid before it could reach an
opinion on whether or not the drug should be approved as a treatment for
multiple myeloma, Pharmion withdrew its Thalomid application in Europe in order
to focus on preparing a new dossier with additional clinical data. Based on
discussions with each other, Pharmion and Celgene have come to recognize that
much of the research and development effort necessary for the regulatory
approval and commercialization of Thalomid, including clinical trials that would
support an EMEA submission, that each desires to be conducted is already being
planned and implemented by Celgene. In order to further coordinate these
development efforts, to insure continued consistency across US and European
centers, and to avoid unnecessary duplication of efforts, Pharmion, Guarantor
and Celgene hereby agree as follows:
1. The 2003 Clinical Trials Agreement shall remain in full force and
effect. Capitalized terms therein defined or otherwise defined in the
License Agreement shall have the same meaning in this letter agreement
as ascribed to such terms in such documents.
2. The Thalomid Clinical Development Committee ("TCDC") established under
the 2003 Clinical Trials Agreement as a forum to review the design,
development, enrollment and progress of Thalomid clinical trials funded
in part by Pharmion under the 2003 Clinical Trials Agreement shall also
function in a similar manner with respect to the clinical trials
Celgene Corporation
December 3, 2004
Page 2
contemplated by this agreement, and the provisions of the 2003 Clinical
Trials Agreement relating to the TCDC are incorporated herein by
reference in their entirety.
3. Celgene has shared with Pharmion its summary of, and budget for, its
003 Phase III multiple myeloma clinical trial plan for Thalomid for the
years 2005, 2006 and 2007 as currently contemplated by Celgene, and
also has advised Pharmion of certain other Phase II clinical studies
that are either underway or contemplated to evaluate the clinical
potential of Thalomid in treating other solid tumor and blood cancers.
Through the TCDC, Celgene shall, on a quarterly basis, keep Pharmion
apprised of the changes in the scope and direction of its currently
contemplated clinical development plans for Thalomid, the progress of
such trials, their provisions for compliance with Good Clinical
Practice requirements, and the data resulting from the such trials.
Celgene shall consider in good faith the views of Pharmion with respect
to the overall clinical development plan for Thalomid during the
forthcoming three calendar years and the suggestions that Pharmion may
make with regard to the mix of trials, other hematological or solid
tumor indications for Thalomid that would merit clinical development,
other new indications or other drug combinations for clinical trials.
Celgene shall also consider in good faith the views of Pharmion
concerning possible adjustments of any of the specific trials that may
be appropriate to address the requirements of the EMEA or other
regulatory authorities in connection with obtaining regulatory approval
or label expansion of Thalomid in the Territory. Notwithstanding
anything to the contrary in this agreement, Celgene shall have sole
authority with respect to, and control of, such clinical trials.
4. During the period commencing on January 1, 2005 and ending December 31,
2007, in addition to any remaining amounts payable by Pharmion to
Celgene under the 2003 Clinical Trials Agreement, Pharmion and
Guarantor, jointly and severally, shall reimburse Celgene for an
aggregate of $8 million (the "Funding") for the expenses and internal
costs incurred by Celgene for the conduct of Thalomid research and
development, including clinical trials ("Funded Expenses"). The Funding
shall be provided in installments of $666,666 each, payable on the last
day of each calendar quarter in 2005, 2006 and 2007. Celgene shall
present a statement of Funded Expenses within forty-five (45) days
after the end of each calendar quarter in the period from the date of
this letter agreement to December 31, 2007. Such statement shall
include a summary of expenses incurred for each clinical trial funded,
at least in part, by Pharmion. Celgene currently anticipates that the
total Funded Expenses in the three-year period ending December 31, 2007
to be well in excess of $8 million. However, if at any time during such
period, Celgene anticipates that the total Funded Expenses for such
period shall be less than $8 million, Celgene shall confer with
Pharmion regarding an appropriate adjustment of Pharmion's funding
obligations under this letter agreement.
5. To the extent there is any conflict between the terms of this letter
agreement and the License Agreement, this Agreement shall control.
6. This letter agreement shall be governed by and construed in accordance
with the laws of the State of New York.
Celgene Corporation
December 3, 2004
Page 3
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
-----------------------------------------
Xxxx X. Xxxxxxx
Chairman and Chief Executive Officer
