Document:

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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Exhibit 10.28

Celgene Corporation

7 Powder Horn Drive

Warren, New Jersey 07059

December 3, 2004

Pharmion Corporation

2525 28th Street

Boulder, Colorado 80301

Pharmion GmbH

Aeschenvorstadt 71

P.O. Box 605

4010 Basel

Switzerland

Gentlemen:

Reference is made to that certain License Agreement, dated as of November 16, 2001, as amended by
Amendment No. 1, dated March 3, 2003, as further amended by Amendment No. 2, dated April 8, 2003,
and as further amended by that letter agreement, dated August 18, 2003, by and among Pharmion GmbH,
Pharmion Corporation (“Pharmion”) and Celgene Corporation (“Celgene”) (the “License Agreement”).
Except as otherwise indicated, capitalized terms used herein have the meaning ascribed to them in
the License Agreement.

Since the date of the License Agreement, Celgene has continued, and continues, to make a
substantial investment in the development of world-wide intellectual property rights to the use of
Thalidomide in oncology.

Against that background, Pharmion GmbH, Pharmion and Celgene hereby agree as follows:

1. The Territory is hereby expanded to include Hong Kong, Korea and Taiwan. Accordingly, the term
“Territory” under the definitions set forth in Article I of the License Agreement is hereby amended
in its entirety to read as follows:

“Territory” shall mean all the countries of the world, except the United States, Canada,
Mexico, Japan, and all provinces of China other than Hong Kong).”

In addition, Section 3.10 of the License Agreement is hereby deleted in its entirety.

2. In consideration of the parties’ mutual interest in extending and expanding their relationship
as a result of Pharmion’s substantial investment in building a distribution infrastructure for
Thalidomide sales in key markets in the Territory, its substantial investment seeking regulatory
approval in such markets, and Pharmion’s demonstrated success in distributing Thalidomide in
certain major markets in the Territory, and in view of the unanticipated delay in obtaining UK
Regulatory Approval, (i) Section 9.3(b) of the License

 

 

Agreement is hereby amended to eliminate clause (i) in its entirety, with the subsequent clauses of Section 9.3(b) being appropriately
renumbered and cross-references thereto being appropriately revised, and (ii) Section 9.4 of the
License Agreement is hereby amended to eliminate clause (a) in its entirety, with the subsequent
clauses of Section 9.4 being appropriately renumbered and cross-references thereto being
appropriately revised.

3. In consideration of the amendments set forth in Sections 1 and 2 above, contemporaneously with
the execution and delivery of this letter agreement, Pharmion shall pay to Celgene U.S. $3,000,000
by wire transfer of immediately available funds,

4. In the interest of accurately reflecting the agreement of the parties to the License Agreement
with respect to royalties thereunder, Section 3.5 of the License Agreement is amended in its
entirety to read as follows:

“3.5 Royalties. In consideration of the license and rights granted by Celgene to Pharmion
pursuant to this Article 3, Pharmion shall pay to Celgene a royalty with respect to each
country in the Territory, equal to eight percent (8%) of Net Sales following the First
Commercial Sale in such country, payable as provided below.”

5. Except as expressly modified by this letter agreement, all terms and conditions of the License
Agreement shall remain in full force and effect.

6. This letter agreement may be executed in two or more counterparts, each of which shall be deemed
to be an original but all of which, together, shall constitute one and the same agreement.

	 	 	 	 	 	 	 
	 	 	Sincerely,	 	 
	 
	 	 	 	 	 	 
	 	 	Celgene Corporation
	 
	 	 	 	 	 	 
	

	 	By:
	 	/s/
	 	Sol J. Barer
	 	 	 	 	 
	

	 	 	 	 	 	Sol J. Barer

President and Chief Operating Officer

Agreed:

Pharmion Corporation

Pharmion GmbH

	 	 	 	 	 	 	 
	By:

	 	/s/
	 	Patrick J. Mahaffy	 	 
	 	 	 	 	 
	

	 	 	 	Patrick J. Mahaffy

President and Chief Executive Officer	 	 

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