Exhibit 10.35.1
C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS
FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24 B
-2 OF THE
S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
May 15, 2009
Astellas Pharma Inc.
3-11, Nihonbashi-Honcho 2-chome
Chuo-ku, Tokyo, 103-8411, Japan
Attn: Corporate Executive, Vice President,
Business Development
Fax: +81-3-3244-3245
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Re:
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The Distribution and License
Agreement, dated as of December 1, 2005 (the “
Agreement ”), between XenoPort, Inc., a Delaware
corporation having a place of business at 3410 Central Expressway,
Santa Clara, CA 95051, United States of America (“
XenoPort ”), and Astellas Pharma Inc., a Japanese
corporation having a place of business at 3-11, Nihonbashi-Honcho
2-chome, Chuo-ku, Tokyo, 103-8411, Japan (“ Astellas
”).
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Dear Sir:
This letter agreement (hereinafter,
this “ Amendment ”) is to confirm the agreement
between Astellas and XenoPort effective as of the 15th day of May,
2009 (the “ Amendment Effective Date ”), with
respect to certain modifications to the Agreement as set out in
Paragraphs 1 – 11 below. Each of XenoPort and Astellas shall
be hereinafter referred to as a “ Party ,” and
together as the “ Parties .” Astellas and
XenoPort agree that, effective the Amendment Effective Date, the
Agreement shall be amended as follows:
RECITALS
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A.
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The Parties have previously
entered into the Agreement, pursuant to which XenoPort has granted
to Astellas certain exclusive distribution and license rights for
the Product in the Territory;
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B.
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The Parties desire to amend and
restate that certain Non-Commercial Supply Agreement, dated as of
April 2, 2007, between the Parties (the “
Non-Commercial Supply Agreement ”), by executing the
Amended and Restated Non-Commercial Supply Agreement between the
Parties, effective as of the Amendment Effective Date,
contemporaneously with the execution of this Amendment (as
executed, the “ Amended and Restated Non-Commercial Supply
Agreement ”);
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*
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C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS
FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24 B
-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
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C.
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Under the Non-Commercial Supply
Agreement, XenoPort has been responsible for: (1) all
activities necessary to supply Astellas with Compound and the
Material (as defined in the Non-Commercial Supply Agreement), in
the form of drug substance with XP13512 as the active
pharmaceutical ingredient; and (2) the Product Formulation (as
hereinafter defined);
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D.
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XenoPort has utilized Patheon
Pharmaceuticals Inc. (“ Patheon ”) for certain
of the Product Formulation under an agreement dated as of
October 27, 2006 by and between XenoPort and Patheon (the
“ Patheon Agreement ”) and supplied such Product
to Astellas pursuant to the Non-Commercial Supply Agreement as
Non-Commercial Supplies (as defined in the Non-Commercial Supply
Agreement); and
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E.
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Astellas wishes to be responsible
for all of the Product Formulation for both the development and
commercialization of the Product in the Territory, and XenoPort
desires to transfer to Astellas its responsibility for the Product
Formulation under the Agreement, under the terms and conditions
hereinafter set forth.
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AGREEMENT
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1.
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Definitions
: Capitalized terms used but not
defined herein shall have the respective meanings assigned to such
terms in the Agreement.
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2.
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Agreement Revised
Definitions .
Section 1.6 of the Agreement shall be amended and completely
replaced with the following:
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“1.6 “ Cost of
Goods ” shall mean the [… * …]
meeting the specifications mutually agreed by the Parties,
[… * …] for calculating cost of
goods, which shall include [… * …] . Cost of
Goods shall not include [… * …] . It is
understood that the [… * …] . In addition, the
[… * …] . As used in this Section 1.6,
[… * …] in Sections 8.2 and 8.3
below.”
New Section 1.18 shall be added
to the Agreement as follows (and all subsequent definitions in
Section 1 and related section references shall be deemed
renumbered accordingly):
“1.18 “ Product
Formulation ” shall mean all processes and activities
typically engaged in by a person or entity in the pharmaceutical
industry for formulation and packaging of: (a) placebo
tablets; and (b) the Product from the Compound supplied
(directly or indirectly) by XenoPort; including, without
limitation, vendor selection, contract negotiation, vendor
management, scheduling, manufacturing process and formulation
development, validation and scale-up, coating, packaging, labeling
and shipping, storage, quality control and assurance, release
testing, process improvement and support for
inspections.”
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*
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C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS
FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24 B
-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
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3.
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License
: Section 2.2 of the Agreement
shall be amended and completely replaced with the
following:
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“2.2 License . Subject
to the terms and conditions of this Agreement, XenoPort hereby
grants to Astellas an exclusive (even as to XenoPort) license
during the term of this Agreement under the XenoPort Patent Rights
and XenoPort Know-How to: (a) formulate, have formulated,
package and have packaged the Product using the Compound supplied
by XenoPort; and (b) use, develop, market, import, export,
sell, distribute and promote the Compound and the Product; in each
case for use in the Field. Such license shall be limited solely to
the Territory, except that Astellas has the non-exclusive right to
formulate and have formulated the Compound, and package and have
packaged the Product, outside the Territory, in each case solely
for sale of the resulting Product within the Territory. It is
understood and agreed that the licenses set forth in this
Section 2.2 exclude the right to manufacture or have
manufactured Compounds.”
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4.
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Ex-Territory
. Section 2.4.3 of the
Agreement shall be amended and completely replaced with the
following:
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“2.4.3 Ex-Territory; No
Exploitation except as Licensed . Neither Astellas nor its
Affiliates will develop, file for Marketing Approval with respect
to, use, market, import, export, distribute, promote or sell the
Product anywhere in the world, except in the Territory (provided
that Astellas may formulate or have formulated the Compound and
package and have packaged Product outside the Territory, solely for
sale of the resulting Product within the Territory), and, within
the Territory, only in accordance with and under this Agreement.
Astellas agrees that it and its Affiliates shall not use nor
otherwise exploit XenoPort Patent Rights, XenoPort Know-How and the
Product Trademark, except as licensed in this
Agreement.”
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5.
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Information
Exchange : A new
sentence shall be added to the end of Section 4.4 of the
Agreement as follows:
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“Promptly after the Amendment
Effective Date, XenoPort shall disclose to Astellas any and all
undisclosed Data and XenoPort Know-How relating to Product
Formulation that is Controlled by XenoPort (the “XenoPort
Manufacturing Know-How”). XenoPort shall grant Astellas, its
Affiliates or Third Parties the right to use the XenoPort
Manufacturing Know-How for the sole purpose of developing and
commercializing the Product in the
