EXHIBIT 10.37
Amendment No. 1 to
License Agreement
This
Amendment No. 1, dated March 3, 2003, to the License Agreement,
dated
as of November 16, 2001 by and among Pharmion GmbH, a Swiss limited
liability
company ("Pharmion"), Pharmion Corporation, a Delaware corporation
("Guarantor")
and Celgene Corporation, a Delaware corporation ("Celgene").
WHEREAS,
Pharmion, Guarantor and Celgene are parties to License
Agreement,
dated November 16, 2001, (the "Agreement"); and
WHEREAS,
promptly following the execution and delivery of this
Agreement,
Pharmion, or one of its Affiliates, will enter into an agreement
(the
"Acquisition Agreement") substantially in the form annexed hereto
as Exhibit A
with the owners of Gophar S.A.S. to acquire, or cause one of its
Affiliates to
acquire, 100% of the outstanding capital stock of Gophar S.A.S.,
the holder of
100% of the issued and outstanding share capital of Laphal
Developpement S.A.
("Laphal"); and
WHEREAS,
Laphal currently sells Thalidomide in France and Belgium under
two French ATUs (AUTORISATION TEMPORAIRE D'UTILISATION) and, in
addition, sells
Thalidomide in various other countries on a specials or named
patient basis,
based upon such ATUs; and
WHEREAS,
Laphal purchases its requirements of Thalidomide from Laphal
Industrie ("Industrie"), a company under common ownership with
Laphal that will
not be acquired by Pharmion or one of its Affiliates; and
WHEREAS,
on or prior to the closing of the Acquisition Agreement, Laphal
will enter into an agreement substantially in the form annexed
hereto as Exhibit
B with Industrie providing for the supply of Thalidomide by
Industrie to Laphal;
and
WHEREAS,
Pharmion and Celgene wish to amend the Agreement as provided
below in order to accommodate the acquisition of Laphal by Pharmion
and to
reflect the existing circumstances surrounding the sale of
Thalidomide in
various markets within the Territory (as defined in the
Agreement);
NOW,
THEREFORE, in consideration of the premises and the mutual
covenants
contained herein, Celgene and Pharmion hereby agree that the
Agreement be
amended as follows:
1.
DEFINITIONS. All terms not otherwise expressly defined in this
Amendment shall have the meanings ascribed to such terms in the
Agreement.
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2. LAPHAL
SAFETY AND DISTRIBUTION SYSTEM. Attached hereto as Exhibit C is
Pharmion's summary description of the safety and distribution
system that Laphal
has established with respect to its sales of Thalidomide under the
ATUs that it
has in France, which system Pharmion understands has been approved
as part of
such ATUs by the appropriate French regulatory authorities. Exhibit
C also
contains Pharmion's comparison of the Laphal system with
S.T.E.P.S.
3.
ACQUISITION RELATED CHANGES. If Pharmion or one of its
Affiliates
acquires all of the outstanding capital stock of Laphal pursuant to
the
agreement referred to in the second recital above on or prior to
June 30, 2003,
then, effective upon the closing of such acquisition (the
"Acquisition Date"),
the following amendments to the Agreement shall take effect:
(a)
Following the acquisition of Laphal by Pharmion, Pharmion will
use
commercially reasonable efforts to introduce S.T.E.P.S. to the
French regulatory
authorities and to seek to modify such ATUs as promptly as possible
to allow a
shift from Laphal's safety and distribution system to a full
implementation of
S.T.E.P.S. (the "S.T.E.P.S. Modification"). In addition, Pharmion
will use
commercially reasonable efforts to change the formulation of
Thalidomide that
Laphal has authority to distribute under such ATUs from Laphal's
formulation to
Product produced under the Celgene Patent Rights and Celgene
Technology (the
"Formulation Modification").
(b)
Pending effectiveness of the Formulation Modification,
notwithstanding
the provisions of Section 4.1(e) and 4.2 of the Agreement, Pharmion
shall have
the right to permit Laphal to continue to sell its formulation of
Thalidomide,
and notwithstanding Section 3.3 of the Agreement, Laphal shall have
the right to
purchase its requirements of Thalidomide from Industrie.
(c)
Pending effectiveness of the S.T.E.P.S. Modi
