EXHIBIT 10.9
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
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
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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
any other activity conducted by Pharmion, its Affiliates or Recognized
Agents under this Agreement which is the proximate cause of injury,
death or property damage to a thud parry; or (e) any failure of
Pharinion to comply with any recall of a Product or Pharmion Product
marketed, distributed or sold by Pharmion, its Affiliates or Recognised
Agents that is ordered by a governmental agency or required by it
confirmed failure of such product." "
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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 o f 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, Ph.D.
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Pharmion Corporation
By: /s/ Xxxxxxx X. Xxxxxxx
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