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.
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. Modification, notwithstanding
the provisions of Section 4.1(k) of the Agreement, Laphal and Pharmion, as its
parent company, shall have the right to continue to utilize the Laphal safety
and distribution system in connection with sales of Thalidomide in lieu of
S.T.E.P.S.; and
(d) The waivers of the provisions of the Agreement contained in paragraph
(b) above shall be effective for a period commencing on the Acquisition Date and
shall extend until the earlier of (x) the effectiveness of the Formulation
Modification, or (y) the receipt by Pharmion of its first Regulatory Approval in
the European Union for the sale of Thalidomide, including Regulatory Approval by
the EMEA. The waivers of the provisions of the Agreement contained in paragraph
(c) above shall be effective for a period commencing on the Acquisition Date and
shall extend until the earlier of (x) the effectiveness of the S.T.E.P.S.
Modification, or (y) the receipt by Pharmion of its first Regulatory Approval in
the European Union for the sale of Thalidomide, including Regulatory Approval by
the EMEA.
(e) Pharmion will sublicense its rights under Section 3.1 of the Agreement
to Laphal pursuant to Section 10.12 of the Agreement.
(f) All net sales of Laphal's formulation of Thalidomide under its ATUs
shall constitute Net Sales of Product within the meaning of Section 3.5 of the
Agreement, and
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Pharmion shall comply with the provisions of Sections 3.6 through 3.8 with
respect to such sales and royalties.
4. GRUNENTHAL WITHDRAWAL FROM THE MARKET. Pharmion has been advised that
the Grunenthal Group (i) has for several years been distributing Thalidomide in
Europe through various ATUs and other temporary, specials or named-patient
authorizations (collectively, "Special Authorizations"), utilizing its original
stock of product, and (ii) will cease to distribute Thalidomide on or about
April 30, 2003. It is anticipated that the withdrawal of Grunenthal product from
the market will create a demand for an alternative source of the product.
Pharmion intends to work with regulatory authorities in Europe to provide
Thalidomide to this patient population on a compassionate use basis under some
form of Special Authorizations, and to do so utilizing the S.T.E.P.S. system.
Any sales of Product under such Specials Authorizations shall constitute
Net Sales of Product within the meaning of Section 3.5 of the Agreement, and
Pharmion shall comply with the provisions of Sections 3.6 through 3.8 with
respect to such sales and royalties.
5. OTHER COMPLIANCE. In connection with the sales of Laphal's formulation
of Thalidomide and the provision of Thalidomide to patients as described in
paragraph 4 above (any such Thalidomide product, a "Pharmion Product"), Pharmion
and Guarantor shall, and cause their respective Affiliates to, comply with the
provisions of Sections 4.1(c), (f), (h) and (j) of the Agreement, which for the
purposes of this paragraph 5 shall be deemed to refer to the Pharmion Products
rather than "the Products".
6. ACCESS TO DATA. Pharmion shall provide Celgene and its designees access
to any clinical trials data of Pharmion or any of its Affiliates with respect to
the Products or any other formulation of Thalidomide.
7. INDEMNIFICATION. Section 8.1 of the Agreement is hereby amended to read
in its entirety as follows:
"8.1. PHARMION INDEMNITY OBLIGATIONS. Pharmion shall defend, indemnify and
hold Celgene, its Affiliates and their respective employees, officers,
directors, counsel and agents harmless from all claims, losses, damages or
expenses (including, without limitation, reasonable attorneys' fees and
expenses and costs of investigation) arising as a result of: (a) the breach
by Pharmion of any covenant, representation or warranty contained in this
Agreement; (b) actual or asserted violations of any applicable law or
regulation by Pharmion, its Affiliates or Recognized Agents by virtue of
which any Product or Pharmion Product distributed, marketed or sold shall be
alleged or determined to be adulterated, misbranded, mislabeled or otherwise
not in compliance with any applicable law or regulation; (c) claims for
bodily injury, death or property damage attributable to the distribution,
marketing or sale of the Product or any Pharmion Product by Pharmion, its
Affiliates or Recognized Agents; (d) any negligent act or omission of
Pharmion, its Affiliates or Recognized Agents in the distribution, marketing
and sale of any Product or Pharmion Product or
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any other activity conducted by Pharmion, it's Affiliates or Recognized
Agents under this Agreement which is the proximate cause of injury, death or
property damage to a third party, or (e) any failure of Pharmion to comply
with any recall of a Product or Pharmion Product marketed, distributed or
sold by Pharmion, its Affiliates or Recognized Agents that is ordered by a
governmental agency or required by a confirmed failure of such Product."
8. TERMINATION. Section 9.3(b)(i) of the Agreement is hereby amended by
replacing the words "within three (3) years after the date of this Agreement"
with the words "within five (5) years after the date of this Agreement".
9. UNMODIFIED PROVISIONS. The provisions of this Amendment No. 1 shall be
deemed to be incorporated in the Agreement and except as expressly modified by
this Amendment, all terms and conditions of the Agreement shall remain in full
force and effect.
10. GOVERNING LAW; CHOICE OF FORUM. The parties agree that this Agreement
shall be governed by and construed in accordance with the laws of the State of
New York.
11. CAPTIONS. All captions herein are for convenience only and shall not
be interpreted as having any substantive meaning.
IN WITNESS WHEREOF, the parties have caused this Amendment No. 1 to be
duly executed by their authorized representatives, in duplicate on the dates
written herein below.
Pharmion GmbH Celgene Corporation
By: /s/ Xxxxxxx X. Xxxxxxx By: /s/ Xxx X. Xxxxx
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Pharmion Corporation
By: /s/ Xxxxxxx X. Xxxxxxx
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EXHIBIT A
Form of Acquisition Agreement
for the acquisition of
Gophar S.A.S.
the parent corporation
of
Laphal Developpement S.A.
