exv10w27



 






	 	 	 	 	 	 	 
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Exhibit 10.27




Pharmion Corporation

2525 28th Street

Boulder, Colorado 80301




December 3, 2004




Celgene Corporation

7 Powder Horn Drive

Warren, New Jersey 07059



Attention: Sol J. Barer




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 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.




 









 











Celgene Corporation

December 3, 2004

Page 2




	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
	 
	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.




Please indicate your acceptance of, and agreement with, the foregoing by signing the enclosed
copy of this letter and returning it to us.











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Celgene Corporation

December 3, 2004

Page 3



Very truly yours,



Pharmion Corporation

Pharmion GmbH



	 	 	 	 	 
	By:

	 	/s/ Patrick J. Mahaffy
	 	 
	

	 	 	 	 
	

	 	Patrick J. Mahaffy

President and CEO	 	 






ACCEPTED AND AGREED:



Celgene Corporation



	 	 	 	 	 
	By:

	 	/s/ John W. Jackson
	 	 
	

	 	 	 	 
	

	 	John W. Jackson

Chairman and Chief Executive Officer	 	 






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