William M. Burns F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel, Switzerland
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Exhibit 10.40
Xxxxxxx X. Xxxxx
X. Xxxxxxxx-Xx Xxxxx Ltd
Xxxxxxxxxxxxxxxxx 000
XX-0000
Xxxxx, Xxxxxxxxxxx
X. Xxxxxxxx-Xx Xxxxx Ltd
Xxxxxxxxxxxxxxxxx 000
XX-0000
Xxxxx, Xxxxxxxxxxx
August 17, 2007
Re: | Support of CellCept® activities outside the U.S. (the “ROW”) between Aspreva Pharmaceuticals SA (“Aspreva”), and X. Xxxxxxxx-Xx Xxxxx Ltd and Xxxxxxxx-Xx Xxxxx Inc. (collectively, “Roche”) |
Dear Xx. Xxxxx,
As a follow up to our recent discussions with you and your team
regarding our
CellCept®
Collaboration and Promotion Agreement dated July 18, 2003,
as amended (“Collaboration Agreement”), this letter
(“Letter Agreement”) sets forth certain understandings
and agreements reached by Aspreva and Roche with respect to
activities undertaken by Roche to develop and commercialize
CellCept for autoimmune indications (“ROW
Activities”). The ROW Activities consist of the following:
1. Clinical Development. Through its
local affiliate in China, Roche elected to perform several
clinical trials for the treatment of lupus nephritis using
CellCept (“Clinical Trials”). Activities performed by
such affiliate included recruitment, study management, liaising
with local CRO’s and investigators, and product
distribution. Such activities are described in more detail in
Exhibit A.
2. ROW Commercialization. In addition to
Xxxxxxx’s worldwide efforts to prepare for the
commercialization of CellCept in autoimmune indications, Roche
has undertaken certain activities to prepare for the
commercialization of CellCept in autoimmune indications in
territories outside the US, Canada and the major five EU
countries. Activities performed by Roche included
non-promotional pre-market preparation, educational programs,
medical product related training, and market assessment. Such
activities are described in more detail in Exhibit A.
3. General. Roche has provided Aspreva or
Aspreva’s affiliates with guidance on clinical development,
drug safety, product manufacturing and patent expiry strategies
relating to CellCept.
Xxxxxxx agrees to reimburse Roche for certain expenses incurred
by Roche in connection with the ROW Activities by making a
one-time payment to Roche of twenty million dollars
(US$20,000,000). Such payment shall be non-refundable and
non-creditable. Such payment shall be made no later than thirty
(30) days after the date of this letter by wire transfer to
an account designated by Roche. Aspreva shall have no further
obligations to Roche with respect to the ROW Activities, and
nothing herein is intended to alter the allocation between Roche
and Aspreva of costs incurred in connection with
CellCept-related activities (other than the ROW Activities) that
is set forth in the Collaboration Agreement.
Aspreva Pharmaceuticals SA | Tel:x00 (0)00 000 0000 | |
Rue des Beaux-Arts 8 | Fax:x00 (0)00 000 0000 | |
Case postale 1611 | ||
2001 Neuchâtel, Switzerland | VAT Registration Nr. 622 567 | |
xxx.xxxxxxx.xxx |
[ * ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to
Rule 24b-2
of the Securities Exchange Act of 1934, as amended.
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In consideration for Aspreva’s agreement to make the
payment specified above, Roche will provide Aspreva with access
to, and copies of, all resulting data from the Clinical Trials
for use by Aspreva (or its affiliates) in its permitted
activities under the Agreement. Any such Clinical Trial
information shall be deemed Roche Confidential Information under
the Collaboration Agreement.
This Letter Agreement sets forth the entire agreement and
understanding of the parties relating to the subject matter
hereof, and supersedes all prior oral and written, and all
contemporaneous oral agreements, understandings and
arrangements. For the avoidance of doubt, the Collaboration
Agreement shall continue in full force and effect. No
modification of or amendment to this Letter Agreement shall be
effective unless signed by the parties. If any provision of this
Letter Agreement is held to be invalid by a court of competent
jurisdiction, then the remaining provisions shall remain in full
force and effect. This Letter Agreement is to be interpreted and
enforced in accordance with the laws of the State of New York,
without regard for any conflicts of law principles that would
provide for application of the laws of any jurisdiction outside
New York.
If the foregoing captures our agreements and understandings on
these matters, please have this Letter Agreement signed below
where indicated and return the duplicate original to Aspreva.
Aspreva Pharmaceuticals SA
By: |
/s/ Xxxx
X. Xxxxxxxxx
|
Name: Xxxx X. Xxxxxxxxx
Title: VP Finance
X. Xxxxxxxx-Xx Xxxxx Ltd
By: |
/s/ Xxxxxx
Xxxxxx
|
Name: Xxxxxx Xxxxxx
Title: | Attorney at Law |
X. Xxxxxxxx-Xx Xxxxx Ltd
By: |
/s/ X.
X. Xxxxx
|
Name: X. X. Xxxxx
Title: | CEO Pharma Division, Roche |
Xxxxxxxx-Xx Xxxxx Inc.
By: |
/s/
Xxxx X. Xxxxxxxx
|
Name: Xxxx X. Xxxxxxxx
Title: | V. P. Commercial Operations |
8/28/07
[ * ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to
Rule 24b-2
of the Securities Exchange Act of 1934, as amended.
2
![](https://www.sec.gov/Archives/edgar/data/1314026/000094523407000653/o38269o3826900.gif)
Exhibit A
[ * ]
[ * ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to
Rule 24b-2
of the Securities Exchange Act of 1934, as amended.
3