Exhibit 10.35

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

AMENDED AND RESTATED DISTRIBUTION AND LICENSE AGREEMENT

This Amended and Restated Distribution and License Agreement (hereinafter, the
“Restated License Agreement”), which amends and restates the Distribution and
License Agreement, dated as of the 1st day of December, 2005 (hereinafter, as
amended to date pursuant to that certain First Amendment, dated as of the 15 th
day of May, 2009, the “Original 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”), is entered into and made
effective as of the 31st day of October, 2009 (the “Restatement Effective
Date”). Each of XenoPort and Astellas shall be a “Party” and, together, the
“Parties.”

RECITALS

A. XenoPort is developing a Transported Prodrug™ of gabapentin (as further
defined below, the “Product”) in the United States, for the treatment of
restless legs syndrome (“RLS”) and the management of neuropathic pain;

B. Astellas desires to further develop and commercialize the Product in Japan
and certain other countries (as further described below, the “Territory”), and
XenoPort desires to have the Product developed and commercialized in the
Territory by Astellas, in accordance with this Agreement;

C. The Parties have previously entered into the Original Agreement, pursuant to
which XenoPort has granted to Astellas certain exclusive distribution and
license rights for the Product in the Territory;

D. Astellas now wishes to be responsible for the manufacture of clinical and
commercial supplies of the Compound and/or Product and the Product Formulation
(as further defined below) for the development and commercialization of the
Product in the Territory; and

E. The Parties now wish to amend and restate in its entirety the Original
Agreement with this Restated License Agreement.

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NOW, THEREFORE, the Parties hereby agree as follows:

AGREEMENT

1. DEFINITIONS

1.1 “Affiliates” shall mean, in the case of a subject entity, another entity
that controls, is controlled by or is under common control with the subject
entity, for so long as such control exists. For purposes of this definition
only, “control” shall mean beneficial ownership (direct or indirect) of at least
fifty percent (50%) of the shares of the subject entity entitled to vote in the
election of directors (or, in the case of an entity that is not a corporation,
in the election of the corresponding managing authority). “Subsidiaries” of a
subject entity shall mean Affiliates that are controlled by such entity.

1.2 “Agreement” shall mean the Original Agreement, as in effect from the
Effective Date until the Restatement Effective Date, together with the Restated
License Agreement, which replaces the Original Agreement in its entirety as of
the Restatement Effective Date.

1.3 “Astellas Know-How” shall mean any and all scientific, medical, technical
and/or regulatory information relating to the Compound and/or the Product and
Data, which are owned or Controlled by Astellas as of the Effective Date or
during the term of this Agreement, which are needed by or reasonably useful to
XenoPort in order to develop and/or commercialize the Product outside the
Territory. Astellas Know-How shall include any developments and improvements
relating to the Compound and/or the Product made by Astellas during the term of
this Agreement. Notwithstanding the foregoing, Astellas Know-How shall not
include Astellas Manufacturing Know-How.

1.4 “Astellas Manufacturing Know-How” shall mean any and all scientific,
medical, technical and/or regulatory information and Data relating to
manufacture of the Compound, the Material and/or the Product, which are owned or
Controlled by Astellas as of the Effective Date or during the term of this
Agreement, which are needed by or reasonably useful to XenoPort in order to
manufacture the Product outside the Territory. Astellas Manufacturing Know-How
shall include any developments and improvements relating to manufacture of the
Compound, the Material and/or the Product made by Astellas during the term of
this Agreement.

1.5 “Batch” means a specific quantity of Compound comprised of a number of units
as set forth in the applicable master batch record(s), and that (a) is intended
to have uniform character and quality within its specifications and (b) is
produced according to a single production order during the same cycle of
production.

1.6 “Competitive Compound” shall mean any compound having as a primary mechanism
of action [… * …], other than the Compound. For avoidance of doubt, Competitive
Compound shall not include any compound that has a mechanism of action [… * …];
provided, however, that such compound [… * …] by either Party, including without
limitation RLS and painful diabetic neuropathy.

1.7 “Compound” shall mean that certain compound, referred to internally at
XenoPort as XP13512, the structure of which is set forth in Exhibit A, and all
isomers and/or mixtures of isomers thereof.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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1.8 “Control” shall mean possession of the ability to grant a license or
sublicense, of or within the scope set forth in this Agreement, without
violating the terms of any agreement or other arrangement with any Third Party.

1.9 “Data” shall mean all preclinical data, clinical data, clinical pharmacology
data and all regulatory filings and approvals submitted or obtained, together
with its supporting data and regulatory correspondence and rights to reference
the same, in each case pertaining to the Compound and/or the Product, which are
Controlled by each Party as of the Effective Date or during the term of this
Agreement.

1.10 “Diligent Efforts” shall mean the level of efforts required to carry out a
particular task or obligation in a sustained manner, consistent with the efforts
generally used by a Party with respect to its own compounds, with the same level
of peak sales potential, for which Marketing Approval is being sought as
expeditiously as practicable or for which Marketing Approval has been obtained,
as the case may be.

1.11 “Effective Date” shall mean December 1, 2005, the effective date of the
Original Agreement.

1.12 “First Commercial Sale” shall mean the first bona fide, arm’s length sale
of a Product in a country following receipt of Marketing Approval of such
Product in such country; provided that where such a first sale has occurred in a
country for which government pricing or government reimbursement approval is
needed and Astellas chooses to apply for such approval, then such sales shall
not be deemed a First Commercial Sale until such pricing or reimbursement
approval has been obtained.

1.13 “Field” shall mean any and all indications for human use.

1.14 “GSK” shall mean Glaxo Group Limited, a company existing under the laws of
England and Wales (d/b/a GlaxoSmithKline), having its registered office at Glaxo
Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, England, and its
Affiliates.

1.15 “GSK Agreement” shall mean the License and Services Agreement dated
September 24, 2009 between Astellas and GSK.

1.16 “IND” shall mean an Investigational New Drug application filed with the
U.S. Food and Drug Administration (“FDA”), or a comparable filing in the
Territory.

1.17 “Lonza” shall mean Lonza Ltd., a company existing under the laws of
Switzerland, having a place of business at Muenchensteinerstrasse 38, CH-4002
Basel, Switzerland, and its Affiliates, including Lonza Japan Ltd.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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1.18 “MAA” shall mean a New Drug Application filed with the FDA (or, in the
Territory, a marketing authorization application comparable to such New Drug
Application), including all supporting documentation and data required for such
application to be accepted for review, filed with the FDA or counterpart health
regulatory agency, requesting approval for commercialization of a product for a
particular indication in such country.

1.19 “Marketing Approval” shall mean, with respect to the United States or in
the Territory, approval by the health regulatory agency in such country that is
the counterpart of the FDA of the MAA for a product filed in such country. It is
understood that, as used herein, Marketing Approval does not include pricing or
reimbursement approval.

1.20 “Material” shall mean analogues, metabolites, impurities, degradates and
radio-labeled compounds and standard materials, i.e., defined, highly purified
compound for the purposes of conducting analytical, release and other studies.

1.21 “Net Sales” shall mean the gross amounts invoiced or otherwise received for
sales of the Product by Astellas, its Affiliates and Subdistributors to Third
Parties (but not including sales among Astellas, its Affiliates and their
respective Subdistributors) less deductions for: (a) customary trade, quantity
and cash discounts allowed and actually taken; (b) credits to customers on
account of return of Product; (c) [… * …] of such gross amount to cover outbound
transportation charges, including insurance, freight and packaging; and
(d) sales and excise taxes and duties and any other similar governmental charges
imposed upon the sale of Product to the customer. Notwithstanding the foregoing,
the amounts described in (c) and (d) above shall be deducted only to the extent
they are stated separately on the invoice and included within gross amounts
received from sales of the Product. If a Product is sold for consideration other
than solely cash, the monetary value of such other consideration shall be
included in the calculation of Net Sales.

1.22 “Patheon” shall mean Patheon Pharmaceuticals Inc, a Delaware corporation,
having a place of business at 2110 East Galbraith Road, Cincinnati, Ohio
45237-1625.

1.23 “Phase III Trial” shall mean human clinical trial(s), the principal purpose
of which is to establish safety and efficacy of the Product against the disease
being studied as required in 21 C.F.R. §312.21(c) or a similar clinical study in
a country other than the United States. For clarity, a Phase III Trial shall
also include any other human clinical trial intended as a pivotal trial for
filing an MAA, whether or not such trial is a traditional Phase III Trial.

1.24 “Product” shall mean (a) the pharmaceutical product containing the Compound
that is the subject of IND Nos. 68,341 and 71,352 (the “Existing Product”), and
(b) any changes to the formulation, dosage form or other aspects of the Existing
Product established by the Parties pursuant to Section 4.3 or otherwise,
provided that the result remains a pharmaceutical product containing the
Compound, alone or in combination with other active ingredients.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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1.25 “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;
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.

1.26 “Product Trademark” shall mean the trademark identified by XenoPort for the
Product in the Territory, or another mutually agreed trademark for the Product.

1.27 “Regulatory Authority” shall mean any national (e.g., the FDA or MHLW),
supra-national (e.g., the European Commission, the Council of the European Union
or the EMEA), or other governmental entity in any jurisdiction of the world
involved in the granting of Marketing Approval for pharmaceutical products.

1.28 “Subdistributor” shall mean an entity to whom Astellas has granted directly
or indirectly the right to market, distribute and/or promote, a Product in the
Territory in accordance with Section 2.3. For avoidance of doubt,
“Subdistributor” shall not include a wholesaler who is not primarily responsible
for marketing and promoting the Product for its respective territory or customer
group.

1.29 “Territory” shall mean Indonesia, Japan, Korea, Philippines, Taiwan and
Thailand.

1.30 “Third Party” shall mean any person or entity other than Astellas, XenoPort
and their Affiliates.

1.31 “Valid Claim” means (a) a claim of any issued, unexpired patent rights
which has not been revoked or held unenforceable or invalid by a decision of a
court or governmental agency of competent jurisdiction from which no appeal can
be taken, or with respect to which an appeal is not taken within the time
allowed for appeal, and which has not been disclaimed, denied or admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise; and (b) a
claim in any patent application pending with an administrative patent authority
unless the application has been (i) abandoned, or (ii) rejected by the relevant
patent authority and all options for appeal to the relevant administrative
patent authority for further prosecution of such claim have been exhausted.

1.32 “XenoPort Patent Rights” shall mean all issued, unexpired patents and all
reissues, renewals, re-examinations and extensions thereof, and patent
applications therefor, and any divisions or continuations, in whole or in part,
thereof, including those patents and applications set forth in Exhibit B, which
would, but for the license granted hereunder, be infringed by use, development,
manufacture, formulation, packaging, import, sale, distribution, promotion or
marketing of the Compound and/or the Product by

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Astellas, any of its Affiliates or Subdistributors in the Territory (and
countries outside the Territory, to the extent the Compound and/or the Product
is manufactured, formulated or packaged pursuant to Section 2.2 in such
countries, or where Astellas conducts or, requests XenoPort to conduct,
development activities in such countries pursuant to Section 4.7), to the extent
Controlled by XenoPort as of the Effective Date or during the term of this
Agreement.

1.33 “XenoPort Know-How” shall mean any and all scientific, medical, technical
and/or regulatory information relating to the Compound and/or the Product and
Data, which are owned or Controlled by XenoPort as of the Effective Date or
during the term of this Agreement, which are needed by or reasonably useful to
Astellas in order for Astellas to perform its obligations under this Agreement.
XenoPort Know-How shall include any developments and improvements relating to
the Compound and/or the Product made by XenoPort during the term of this
Agreement.

In addition, the following terms shall have the meaning described in the
corresponding section of this Agreement. Other terms may be defined throughout
the Agreement.

 

Term

  

Section

       

Term

  

Section

accepted    6.2.3       Infringement Action    10.3 Acquisition    2.4.2      
Infringing Product    10.4 Affected Area    16.2       JAMS    17.2 Annual Net
Sales    7.1       Joint Development Committee, JDC    3.2 Astellas    Preamble
      Joint Steering Committee, JSC    3.1 Astellas Development Plan    4.2.2   
   Liabilities    14.1 Astellas Indemnitees    14.2       M&A Acquired Product
   2.4.2 Change of Control    2.4.2       [… * …]    [… * …]          [… * …]   
Commercialization Plan    5.1.1       [… * …]    completion    6.2.2      
Original Agreement    Preamble Confidential Information    12.1       Party,
Parties    Preamble CMC Information    13.2.4       Panel    17.2.1 Damages   
10.3       Product Liability Claim    14.4 DMF    4.5       Product Materials   
16.2.5 Enforcement Action    10.4       Recall Costs    8.2 Existing Product   
1.24       [… * …]    Fault of Astellas    8.2       Restated License Agreement
   Preamble Fault of XenoPort    8.2       Restatement Effective Date   
Preamble FDA    1.16       RLS    Preamble Force Majeure    18.2       Royalty
Rate    7.1 Generic Product    7.3.3       second indication    6.2.7(a)
Improvements    10.1       Subsidiaries    1.1 Indemnitee, Indemnitor    14.3   
   third indication    6.2.7(b) Third Party Claim    14.1       Written
Disclosure    12.4 Third Party IP    2.5       XenoPort    Preamble Third Party
Royalties    7.3.1       XenoPort Indemnitees    14.1 Wind-down Period   
16.2.1(b)       [… * …]   

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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2. GRANT OF DISTRIBUTION RIGHTS AND LICENSE

2.1 Appointment. During the term of this Agreement, XenoPort appoints Astellas,
and Astellas hereby accepts such appointment, as the exclusive (even as to
XenoPort) distributor and marketer of the Product in the Territory.

2.2 License. Subject to the terms and conditions of this Agreement, XenoPort
hereby grants to Astellas an exclusive 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; and
(b) develop, make, have made, use, 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 make, have made, formulate and have formulated the
Compound, formulate and have formulated the Product, and package and have
packaged the Product, outside the Territory, in each case solely for sale of the
resulting Product within the Territory. The rights and licenses in
Section 2.2(a) and 2.2(b) shall be exclusive even as to XenoPort, except with
respect to [… * …] in accordance with [… * …]

2.3 Subdistributors. Astellas shall have the right to engage its Subsidiaries as
Subdistributors of the Product, and may grant sublicenses under Section 2.2 to
such Subsidiaries solely for such purposes, solely for as long as such entity
remains a Subsidiary. Astellas may otherwise engage Subdistributors and grant
sublicenses only upon the approval of XenoPort, which approval shall not be
unreasonably withheld or delayed. In any event, Astellas shall ensure that all
of its Subdistributors are bound by a written agreement containing provisions as
protective of the Product and XenoPort as this Agreement. Without limiting the
foregoing, in the event that Products supplied by Astellas to a Subdistributor
are being directly or indirectly sold or used outside the Territory, Astellas
agrees that, upon becoming aware of such sale or use or otherwise upon the
request of XenoPort, it shall not supply further quantities of Products to such
Subdistributor.

2.4 No Conflict.

2.4.1 Competitive Compounds. In the event that Astellas and its Affiliates
shall, by themselves or through any Third Party(ies): (a) [… * …] (b) [… * …],
prior to [… * …] anywhere in the world [… * …] regarding a product containing
Competitive Compound(s), [… * …] with the Product, [… * …] XenoPort under this
Section 2.4.1 and XenoPort shall [… * …].

2.4.2 Notice of M&A Acquired Product. In the event of a Change of Control or
Acquisition, whereby [… * …] prior to such Change of Control [… * …] and whether
Astellas or its Affiliate [… * …] above. In the event Astellas [… * …] as the
case may be, shall not apply with respect to [… * …]. However, in such event,
unless XenoPort and Astellas [… * …] upon written notice,

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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which shall be [… * …] and XenoPort shall [… * …]. In the event Astellas [… * …]
fully apply with respect to [… * …]. As used herein, “Change of Control” means
(a) a merger involving Astellas, in which the shareholders of Astellas
immediately prior to such merger cease to control (as defined in Section 1.1)
Astellas after such merger, (b) a sale of all or substantially all of the assets
of Astellas to an acquiring entity or (c) a sale of a controlling (as defined in
Section 1.1) interest of Astellas to an acquiring entity. As used herein,
“Acquisition” means (a) a merger involving Astellas, in which the shareholders
of Astellas immediately prior to such merger does not cease to control (as
defined in Section 1.1) Astellas after such merger, or a merger involving an
Affiliate of Astellas in which the resulting entity remains an Affiliate of
Astellas after such merger, (b) an acquisition of all or substantially all of
the assets of an acquired entity by Astellas or an Affiliate or (c) a sale of a
controlling (as defined in Section 1.1) interest of an acquired entity to
Astellas or an Affiliate.

2.4.3 Ex-Territory; No Exploitation except as Licensed. Except as provided in
Section 2.2, neither Astellas nor its Affiliates will develop, file for
Marketing Approval with respect to, use, make, have made, market, import,
export, distribute, promote or sell the Compound and/or Product anywhere in the
world, except in 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.

2.4.4 Sale of Compounds Only as Part of Products. Astellas agrees that it shall
not, and shall ensure that its Affiliates and Subdistributors do not, sell or
otherwise make commercially available the Compound, other than as part of a
Product. This Section 2.4.4 shall not, however, prohibit sales of Compounds
among Astellas, its Affiliates and/or Subdistributors, provided that such
Compounds will be incorporated into Products for resale by such entities, nor
prohibit Astellas, its Affiliates and/or Subdistributors from exercising their
rights under Section 2.2 to “have” formulated or “have” packaged the Compound.

2.4.5 Wind-down Period. For avoidance of doubt, Sections 2.4.1 and 2.4.2 shall
not apply during the Wind-down Period with respect to the Affected Area.

2.5 XenoPort IP Acquired after the Effective Date. If, after the Effective Date,
XenoPort acquires from a Third Party subject matter within the XenoPort Patent
Rights and XenoPort Know-How (“Third Party IP”) that is subject to royalty or
other payment obligations to such Third Party, then the following shall apply.
The licenses granted under Section 2.2 above with respect to such Third Party IP
shall be subject to Astellas promptly reimbursing XenoPort for any milestones,
royalties or other amounts that become owing to such third party by reason of
Astellas’ exercise of rights granted in this Agreement with respect to the Third
Party IP. Upon request by Astellas, XenoPort shall disclose to Astellas a true,
complete and correct written description of such payment obligations, and
Astellas’ obligation to reimburse such amounts following such request shall be
limited to those payment obligations

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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as so disclosed by XenoPort. In the event Astellas does not promptly reimburse
XenoPort for such amounts upon request, then such Third Party IP shall
thereafter be deemed excluded from the XenoPort Patent Rights and XenoPort
Know-How hereunder. The reimbursement made by Astellas to XenoPort under this
Section 2.5 may then be treated by Astellas as Third Party Royalty payments
under Section 7.3.1 below.

2.6 No Other Rights; No License to Other Therapeutically Active Components.
Except for the rights and licenses expressly granted in this Agreement, each
Party retains all rights under its intellectual property, and no additional
rights shall be deemed granted to the other Party by implication, estoppel or
otherwise. The licenses and rights granted in this Agreement shall not be
construed to convey any licenses or rights under the XenoPort Patent Rights with
respect to any active ingredients other than the Compound.

3. GOVERNANCE

3.1 Joint Steering Committee. The Parties shall establish a committee (the
“Joint Steering Committee” or “JSC”) to oversee the Party’s collaboration
relating to the Product in the Territory. The JSC will consist of two
(2) representatives from each Party, each of whom shall be a senior executive of
a Party. In case a representative of a Party is unavailable for a scheduled JSC
meeting, upon reasonable notice to the other Party, such Party may substitute in
place of such representative for such meeting, a competent person who is
authorized by such Party to act on matters that will be presented to the JSC at
such meeting.

3.1.1 Meetings. The JSC shall meet at least once annually during the term of
this Agreement, unless otherwise agreed by the Parties. Such meeting(s) shall be
in person at least once per year, alternating between the facilities of each
Party unless otherwise mutually agreed, and the other meetings may be through
telephone or video conference or other mutually agreeable means. At the
discretion of each Party, other representatives of XenoPort or Astellas may
attend JSC meetings as non-voting observers. Each Party shall bear its own
personnel and travel costs and expenses relating to JSC meetings.

3.1.2 Responsibility. The JSC will (a) serve as a forum for keeping each Party
informed as to material matters in connection with the development,
manufacturing and commercialization of the Product in and outside of the
Territory, (b) provide strategic direction to the JDC, (c) resolve any disputed
matters submitted to the JSC by the JDC under Section 3.2.3 below, (d) review
and discuss the Commercialization Plan, any updates, modifications and additions
thereto submitted to the JSC pursuant to Section 5.1.1 below, and the progress
of Astellas thereunder and (e) undertake and/or approve such other matters as
are provided for the JSC under this Agreement, or otherwise agreed by the
Parties.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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3.1.3 Decisions. The objective of the JSC shall be [… * …] on the JSC. If the
JSC cannot reach agreement on any determination or decision for which it is
responsible within [… * …] after the date such matter was initially referred to
the JSC, the dispute shall be referred to [… * …] to resolve the dispute. If, […
* …] deciding vote with respect to [… * …], unless the matter (a) would
materially adversely affect [… * …], (b) would change [… * …], (c) would involve
[… * …] or [… * …], or (d) involves [… * …] for the Compound and/or Product in
the Territory. It is understood that the JSC shall [… * …]. If the Parties are
unable to resolve a dispute with respect to matters described in Sections
3.1.3(a), (b), (c) or (d), the Parties shall [… * …] and until such resolution,
neither Party shall proceed with a course of action that is claimed to fall
within Sections 3.1.3(a) through (d) above.

3.2 Joint Development Committee. The Parties shall establish a committee (the
“Joint Development Committee” or “JDC”) to oversee the development efforts
relating to the Product in the Territory. The JDC will consist of three
(3) representatives from each Party, at least one of whom shall be a senior
executive of each Party. In case a representative of a Party is unavailable for
a scheduled JDC meeting, upon reasonable notice to the other Party, such Party
may substitute in place of such representative for such meeting, a competent
person who is authorized by such Party to act on matters that will be presented
to the JDC at such meeting.

3.2.1 Meetings. The JDC shall meet once each calendar quarter until the first
filing of MAA with respect to the Product in the Territory, and twice annually
thereafter, during the term of this Agreement, unless otherwise agreed by the
Parties. Such meetings shall be in person at least twice per year until the
first filing of MAA with respect to the Product in the Territory, alternating
between the facilities of each Party unless otherwise mutually agreed, and the
other meetings may be through telephone or video conference or other mutually
agreeable means. With the consent of the JDC members, other representatives of
XenoPort or Astellas may attend JDC meetings as non-voting observers. Each Party
shall bear its own personnel and travel costs and expenses relating to JDC
meetings.

3.2.2 Responsibility. The JDC will (a) review and approve the Astellas
Development Plan, including the initial Astellas Development Plan pursuant to
Section 4.2.2 and any updates, modifications or additions thereto submitted to
the JDC pursuant to Section 4.2.3 below, (b) oversee the implementation of the
Astellas Development Plan, (c) review and approve protocols for any clinical
trials of Product in the Territory, (d) review and approve the translated
summaries of any regulatory filings for Products in the Territory (including the
precise wording of the label), which shall be provided by Astellas to the JDC in
the English language, (e) facilitate the exchange of Data and other information
and/or materials between the Parties, (f) review and approve manufacturing plans
for the Compound and the Product and (g) undertake and/or approve such other
matters as are provided for the JDC under this Agreement or otherwise agreed by
the Parties.

3.2.3 Decisions. Decisions of the JDC shall be by unanimous approval of its
members, with at least one (1) representative of each of Astellas and XenoPort
voting on the matter; provided, however, if the JDC cannot reach agreement on a
matter within [… * …] after the date such matter was initially referred to the
JDC, the dispute shall be referred to the JSC who shall meet promptly and
negotiate in good faith to resolve the dispute in accordance with Section 3.1.3
above.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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3.3 Limited Authority. Notwithstanding the creation of the JSC and JDC, each
Party shall retain the rights, powers and discretion granted to it hereunder,
and the JSC and JDC shall not be delegated or vested with such rights, powers or
discretion unless such delegation or vesting is expressly provided herein or the
Parties expressly so agree in writing. The JSC and JDC shall not have the power
to amend or modify this Agreement, and its decisions shall not be in
contravention of any terms and conditions of this Agreement. It is understood
and agreed that issues to be formally decided by the JSC and JDC are only those
specific issues that are expressly provided in this Agreement to be decided by
the JSC and JDC.

4. DEVELOPMENT

4.1 Development.

4.1.1 Subject to oversight by the JDC, Astellas shall be responsible for:
(a) conducting, and shall use Diligent Efforts to conduct, such clinical trials
and to obtain such regulatory approvals, including Marketing Approvals and
pricing and/or reimbursement approval, as may be necessary to commercialize the
Product in each country in the Territory, in accordance with the Astellas
Development Plan; and (b) manufacturing, and shall use Diligent Efforts to
manufacture, Compound and Product necessary to support such clinical trials and
regulatory approvals, including Marketing Approvals and pricing and/or
reimbursement approval, as may be necessary to commercialize the Product in each
country in the Territory. Without limiting the foregoing, Astellas agrees to use
Diligent Efforts to conduct such clinical trials and to obtain, as soon as
practical, Marketing Approval of the Product for RLS and painful diabetic
neuropathy in the Territory. Astellas agrees to keep XenoPort reasonably
informed as to the progress of its clinical development, manufacturing and
regulatory activities relating to the Product in the Territory, including its
correspondence and meetings with regulatory agencies, by way of updates to the
JDC at its meetings and as otherwise reasonably requested by XenoPort. Astellas
agrees to reasonably consider and promptly respond to any comments provided by
XenoPort with respect to such clinical development and regulatory activities. It
is understood and agreed that all development and manufacturing efforts for the
Product in the Territory shall be at the sole cost and expense of Astellas, and
shall be conducted in accordance with the Astellas Development Plan described
below.

4.1.2 XenoPort or its licensee(s) shall be responsible for all development,
manufacturing and regulatory activities of the Product outside the Territory.
XenoPort agrees to keep Astellas reasonably informed as to the progress of its
and/or [… * …] its other licensees’ clinical development, manufacturing and
regulatory activities relating to the Product outside the Territory, including
their correspondence and meetings with regulatory agencies, by way of updates to
the JDC at its meetings and as otherwise

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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reasonably requested by Astellas. XenoPort agrees to reasonably consider and
promptly respond to any comments provided by Astellas with respect to such
clinical development, manufacturing and regulatory activities. It is understood
and agreed that all development efforts for Product outside the Territory shall
be at the sole cost and expense of XenoPort, its Affiliates or its other
licensee(s), provided that any development efforts conducted for the Territory
requested by Astellas pursuant to Section 4.7 shall be at the sole cost and
expense of Astellas.

4.2 Astellas Development Plan.

4.2.1 An initial, preliminary development plan for Astellas’ development of the
Product in the Territory is set forth in Exhibit C. For avoidance of doubt, such
initial, preliminary development plan is not intended to create or constitute
any legally binding obligation among the Parties.

4.2.2 Within [… * …] after the Effective Date, the JDC shall discuss and approve
the plan for Astellas’ development of the Product in the Territory (the
“Astellas Development Plan”). Astellas acknowledges and agrees that each Party
desires that Astellas commit to conduct development of the Compound and/or
Product in the Territory for both the RLS and painful diabetic neuropathy
indications, in a manner to be described by the JDC in the Astellas Development
Plan; and the JDC shall, during the discussion of such development, take into
account an expected selling price of the Product, expected launch time for
respective indications, communications with the Regulatory Authority in the
Territory, advice of the experts in the Territory, possibility of bridging use
of the Data obtained by XenoPort from its pre-clinical studies and/or clinical
trials of the Product outside the Territory for development in the Territory and
any other relevant regulatory and business matters.

4.2.3 Astellas agrees to provide to the JDC for its review and approval, which
approval shall not be unreasonably withheld or delayed, updated versions of the
Astellas Development Plan at least annually, and any modification or addition to
the Astellas Development Plan within a reasonable period of time prior to
adoption and implementation thereof.

4.3 Change in Formulation. Before modifying or creating a new formulation or
dosage form of the Product, or developing the Compound in combination with
another active ingredient, Astellas shall discuss the proposed modifications or
development with XenoPort at the JSC and obtain the approval of the JSC, which
approval shall not be unreasonably withheld or delayed. Subject to
Section 3.1.3(b), XenoPort agrees that Astellas may conduct formulation studies
on the Compound that were so discussed and approved by the JSC for the purpose
of developing and commercializing pharmaceutical formulations of the Compound as
a sole active ingredient.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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4.4 Exchange of Data and Know-How. Promptly after the Effective Date, XenoPort
shall provide Astellas with any and all XenoPort Know-How that XenoPort
considers as necessary or reasonably useful for Astellas to develop and/or
commercialize the Product in the Territory, including but not limited to, any
and all Data from any and all clinical trials and preclinical studies of the
Compound and/or Product that are completed as of the Effective Date. During the
term of this Agreement, each Party shall provide to the other Party all Data
(and, in case of XenoPort, any and all additional XenoPort Know-How, and in the
case of Astellas, any and all Astellas Know-How and Astellas Manufacturing
Know-How) Controlled by such Party, (a) that such Party considers as necessary
or reasonably useful for the other Party to develop and/or commercialize the
Product in the Territory (in the case of Astellas) or outside the Territory (in
the case of XenoPort), in a timely fashion and as promptly as possible or
(b) upon the reasonable request of the other Party; in each case, for use by
such other Party in accordance with this Section 4.4. Promptly after May 15,
2009, XenoPort shall disclose to Astellas any and all undisclosed Data and
XenoPort Know-How relating to manufacture of the Compound, the Material and the
Product and 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 Territory and under
reasonable and customary confidentiality restrictions.

4.4.1 Use; Disclosure. Astellas will use and disclose Data, XenoPort Know-How
and XenoPort Manufacturing Know-How to its Affiliates or Third Parties only as
required to obtain Marketing Approval for the Product in the Territory and/or as
may be necessary in performing its obligations and exercising its rights under
this Agreement (including, but not limited to, the use of such Data, XenoPort
Know-How and XenoPort Manufacturing Know-How to manufacture clinical and
commercial supplies of Compound and/or Product pursuant to Section 8 and to
design development activities outside the Territory for Section 4.7), in each
case solely to the extent necessary for development and commercialization of the
Product in the Territory and under reasonable and customary confidentiality
restrictions. Astellas may not use any Data, XenoPort Know-How or XenoPort
Manufacturing Know-How (or permit any Affiliates or Third Party to use Data,
XenoPort Know-How or XenoPort Manufacturing Know-How) outside the Territory
(other than pursuant to Sections 4.7 and 8.1), nor for any products other than
the Product. XenoPort may only use, and disclose to Affiliates and Third
Parties, Data, Astellas Know-How and Astellas Manufacturing Know-How provided by
Astellas as is reasonably necessary or useful for developing, manufacturing
and/or commercializing the Product outside the Territory, including for
cross-referencing drug master files or other regulatory filings by XenoPort, its
Affiliates or Third Parties, provided that the disclosure of such Data, Astellas
Know-How and Astellas Manufacturing Know-How to a non-governmental Third Party
is made under reasonable and customary confidentiality restrictions, and
complies with Section 4.4.2 below.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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4.4.2 Other Licensee(s). XenoPort shall [… * …] under this Section 4.4 [… * …]
to the extent that [… * …]. It is understood that [… * …], shall not be [… * …].
However, XenoPort agrees [… * …] except to the extent [… * …]. Promptly after
May 15, 2009, XenoPort shall use [… * …] that is [… * …] and under [… * …].
Promptly after the Restatement Effective Date, XenoPort shall use [… * …] that
are [… * …] and under [… * …]. It is understood that [… * …], shall not be [… *
…].

4.5 Regulatory Matters. Subject to Section 16.2.2 below, all regulatory filings
for the Product, including the MAA and Marketing Approvals, in the Territory
shall be in the name of Astellas in Japan, or its Affiliate(s) or
Subdistributor(s) in countries other than Japan. Astellas shall, or shall cause
its Affiliate(s) or its Subdistributor(s) to, be responsible for the filing
thereof, the payment of fees and all other associated costs, for monitoring
clinical experiences and filing associated reports and fulfilling all of its
regulatory obligations throughout the development and commercialization of the
Product in the Territory. Notwithstanding the foregoing, XenoPort may, and if
elected by XenoPort shall be responsible to, file and keep a Drug Master File
(“DMF”) in the Territory at its expense in its own name or in the name of its
suppliers with respect to the bulk supply of the Compound and shall permit
Astellas, its Affiliates and its Subdistributors to cross-reference such DMF in
their regulatory filings for the Product in the Territory.

4.6 Development within the Territory. Astellas shall commence, promptly after
the Effective Date, its development of the Product in Japan in accordance with
this Section 4. The Parties recognize, however, that Astellas’ development and
commercialization of the Product in countries of the Territory other than Japan
may not be achieved, if ever, until a later date as is customary for
pharmaceutical launches in Asia, and may depend upon (a) whether the Data
obtained by XenoPort and/or by Astellas from their respective pre-clinical
studies and/or clinical trials of the Product may be used for obtaining
Marketing Approval of the Product in such country(ies) and (b) whether
commercialization of the Product in such country(ies) would be commercially
feasible under the terms and conditions of this Agreement. Subject to the
foregoing, a decision by Astellas not to develop and/or commercialize a Product
in a country of the Territory other the Japan shall not by itself be deemed a
breach of its obligations to use Diligent Efforts under this Agreement with
respect to such country, provided that Astellas can and does promptly terminate
this Agreement with respect to such country pursuant to Section 15.2 below.

4.7 Cooperation in Development. The Parties acknowledge that, from time to time,
Astellas may, or may request XenoPort to, conduct activities outside the
Territory (for example, to conduct certain clinical trials in the United States
on Japanese subjects) for use in obtaining Marketing Approval of the Product in
the Territory. Any activities outside the Territory conducted or requested by
Astellas pursuant to this Section 4.7 shall be subject to the consent of
XenoPort, which consent shall not be unreasonably withheld or delayed. Subject
to such consent, XenoPort shall cooperate as mutually agreed to perform such
activities, the cost of which shall be reimbursed by Astellas (including without
limitation payment of the supply price of the clinical supplies used in such
activities, in accordance with any supply agreement between the Parties then in
effect).

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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4.8 Astellas Know-How and Astellas Manufacturing Know-How. All results, data,
information, know-how and technology obtained by Astellas or its Affiliates in
the course of development or manufacturing activities with respect to the
Compound and/or the Product conducted by Astellas or any of its Affiliates shall
be solely owned by Astellas or such Affiliates. Subject to Section 2.3(a) of the
GSK Agreement and Sections 4.4 and 10.1 of this Agreement, during the term of
this Agreement, Astellas shall solely own or Control all right, title and
interest in and to the know-how and technology owned or Controlled by Astellas
which Astellas may decide to use for manufacturing the Compound and Product or
modifying or creating a new formulation or dosage form of the Product in
accordance with Section 4.3.

5. COMMERCIALIZATION

5.1 Commercialization.

5.1.1 Subject to oversight by the JSC, Astellas shall be responsible for:
(a) launching and commercializing, and shall use Diligent Efforts to launch and
commercialize, the Product in each country in the Territory in accordance with a
commercialization plan submitted by Astellas to the JSC (“Commercialization
Plan”); and (b) manufacturing, and shall use Diligent Efforts to manufacture,
the Compound and Product necessary to support the launching and
commercialization of the Product in each country in the Territory in accordance
with the Commercialization Plan. Without limiting the foregoing, Astellas agrees
to use Diligent Efforts to launch the Product as soon as practicable in the
Territory, and thereafter to manufacture, market, promote and sell such Product
and to maximize the Net Sales of the Product in the Territory. Astellas agrees
to provide to the JSC updated versions of the Commercialization Plan at least
annually, and any material modification or addition to the Commercialization
Plan within a reasonable period of time prior to adoption and implementation
thereof. Astellas shall keep XenoPort reasonably informed as to the progress of
its launch, manufacturing and commercialization activities relating to the
Product in the Territory, by way of updates to the JSC at its meetings and as
otherwise reasonably requested by XenoPort. It is understood and agreed that,
subject to oversight by the JSC, and consistent with the other provisions of
this Agreement, all commercialization and manufacturing efforts for the Product
in the Territory shall be at the sole discretion and expense of Astellas, its
Affiliates or Subdistributors.

5.1.2 XenoPort or its licensee(s) shall be responsible for launching,
manufacturing and commercializing the Product outside the Territory. XenoPort
shall keep Astellas reasonably informed as to the progress of its and/or [… * …]
its other licensees’ launch, manufacturing and commercialization activities
relating to Product outside the Territory, by way of updates to the JSC at its
meetings and as otherwise reasonably requested by Astellas but no more often
than once annually other than at the JSC meeting. It is understood and agreed
that all manufacturing and commercialization efforts for the Product outside the
Territory shall be at the sole discretion and expense of XenoPort, its
Affiliates or its other licensees.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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5.2 Marketing Materials. Any marketing and promotional materials created or used
by Astellas, its Affiliates and Subdistributors for the Product shall be
appropriate to the Marketing Approval for the Product in the respective country
and consistent with XenoPort’s worldwide profile for the Product, provided that
XenoPort shall respect local marketing needs in the Territory regarding such
materials (e.g., the size of letters in such materials). In addition, it is
understood that any claim, message or other material part of promotional
materials, samples, advertising and materials for training sales representatives
with respect to Product shall be consistent with Marketing Approval and comply
with applicable laws.

5.3 Reporting Adverse Drug Reactions/Experiences. Promptly following the
Effective Date, the Parties will prepare a standard operating procedure
governing the collection, investigation, reporting and exchange of information
concerning adverse drug reactions, Product quality and Product complaints,
sufficient to permit each Party to comply with its legal obligations. The
standard operating procedure will be promptly updated if required by changes in
legal requirements. Each Party shall keep the other Party informed about any
adverse drug reactions of which such Party becomes aware or is informed
regarding the use of a Product in or outside the Territory. As between the
Parties, Astellas shall be responsible for reporting all adverse drug
reactions/experiences to the appropriate regulatory authorities in countries in
the Territory, and XenoPort shall be responsible for reporting all adverse drug
reactions/experiences to the appropriate regulatory authorities in countries
outside the Territory, in accordance with the appropriate laws and regulations
of the relevant countries and authorities. Astellas shall ensure that its
Affiliates and Subdistributors comply with such reporting obligations in the
Territory, and XenoPort shall ensure that its Affiliates and licensees (other
than Astellas, its Affiliates and Subdistributors) comply with such reporting
obligations outside the Territory. These reporting obligations shall apply to
non-serious adverse events as well, which shall mean adverse events occurring
from Product overdose or from Product withdrawal, as well as any toxicity,
sensitivity, failure of expected pharmacological action or laboratory
abnormality that is, or is thought by the reporter to be, serious or associated
with relevant clinical signs or symptoms. Each Party will designate a regulatory
affairs liaison to be responsible for communicating with the other Party
regarding the reporting of adverse drug reactions/experiences. The details of
such exchange shall be separately discussed and agreed upon in writing by and
between such regulatory affairs liaisons within a reasonable period after
execution of this Agreement.

6. INITIAL PAYMENT AND MILESTONES

6.1 Initial Payment. In partial consideration of the costs incurred by XenoPort
in connection with the research and development of the Product and in exchange
for the exclusive rights granted herein, Astellas shall pay XenoPort Twenty Five
Million Dollars (US $25,000,000) within [… * …] after execution of this
Agreement.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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6.2 Milestones. In further consideration of the costs incurred by XenoPort in
connection with the research and development of the Product and in exchange for
the exclusive rights granted herein:

6.2.1 Initiation of U.S. Phase III Trial. Upon the first dosing of a human
patient in a Phase III Trial of the Compound and/or Product in the United States
by or under authority of XenoPort, the date of which XenoPort shall inform
Astellas in writing, Astellas shall pay XenoPort Ten Million Dollars (US
$10,000,000).

6.2.2 Completion of U.S. Phase III Trial. Upon the first completion of a Phase
III trial of the Compound and/or Product in the United States by or under
authority of XenoPort, Astellas shall pay XenoPort Five Million Dollars (US
$5,000,000). As used herein, “completion” of a Phase III trial shall be deemed
to occur upon the earliest of (a) receipt by XenoPort of the final report for
such Phase III trial, (b) filing of an MAA for the Product or (c) first issuance
of a press release by XenoPort or its licensee announcing completion of a Phase
III trial of the Compound and/or Product in the United States, the date of which
XenoPort shall inform Astellas in writing.

6.2.3 MAA Filing in the United States. Upon first acceptance of a filing of an
MAA for the Compound and/or Product in the United States by or under authority
of XenoPort, the date of which XenoPort shall inform Astellas in writing,
Astellas shall pay XenoPort Three Million Dollars (US $3,000,000). As used
herein, an MAA shall be deemed “accepted” upon the earlier of: (a) the
expiration of the period specified in applicable regulations for any notice by
the FDA that such MAA will not be accepted for review, without XenoPort or its
designee having received such notice from such agency; or (b) the receipt by
XenoPort or its designee from such agency that the MAA will be accepted for
review; provided that in any case, if no such period or acceptance is provided
for in the applicable regulations, then the MAA shall be deemed “accepted” on
the date such MAA was filed.

6.2.4 MAA Filing in Japan. Upon first acceptance of a filing of an MAA for the
Compound and/or Product in Japan by or under authority of Astellas, Astellas
shall pay XenoPort [… * …].

6.2.5 Marketing Approval in the United States. Upon obtaining the first
Marketing Approval of the Compound and/or Product for the first indication in
the United States by or under authority of XenoPort, the date of which XenoPort
shall inform Astellas in writing, Astellas shall pay XenoPort [… * …].

6.2.6 Marketing Approval in Japan. Upon obtaining the first Marketing Approval
of the Compound and/or Product in Japan for the first indication by or under
authority of Astellas, Astellas shall pay XenoPort [… * …].

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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6.2.7 Additional Indications.

(a) Second Indication. Upon first acceptance of a filing of an MAA for the
Compound and/or Product for a second indication in Japan by or under authority
of Astellas, Astellas shall pay XenoPort [… * …]. Upon obtaining the first
Marketing Approval of the Compound and/or Product for a second indication in
Japan by or under authority of Astellas, Astellas shall pay XenoPort [… * …]. As
used herein, a “second indication” shall mean any indication for which Marketing
Approval is obtained, other than the indication triggering payment under
Section 6.2.6 above.

(b) Third Indication. Upon first acceptance of a filing of an MAA for the
Compound and/or Product for a third indication in Japan by or under authority of
Astellas, Astellas shall pay XenoPort [… * …]. Upon obtaining the first
Marketing Approval of the Compound and/or Product for a third indication in
Japan by or under authority of Astellas, Astellas shall pay XenoPort [… * …]. As
used herein, a “third indication” shall mean any indication for which Marketing
Approval is obtained, other than the indications triggering payment under
Section 6.2.6 and 6.2.7(a) above.

(c) Subsequent Indications. Astellas shall not be obligated to make any
milestone payments with respect to Marketing Approval for the fourth and
subsequent indications of the Compound and/or Product. It is understood that,
for purposes of this Section 6.2.7, a single MAA or Marketing Approval may
include more than one indication, e.g. both the first and second indications, or
the second and third indications, as the case may be.

6.2.8 Timing of Payment. Each payment provided in Sections 6.2.4, 6.2.6 and
6.2.7 above shall be due within thirty (30) days following the occurrence of
each event triggering such payment, and each payment provided in Sections 6.2.1,
6.2.2, 6.2.3 and 6.2.5 shall be due within thirty (30) days following XenoPort’s
notice to Astellas of the event triggering such payment.

7. ROYALTY

7.1 Royalty. In further consideration for the exclusive rights granted herein,
during the term of this Agreement, Astellas shall, subject to the reduction of
royalty rate pursuant to Section 7.3 below, pay to XenoPort the royalties as
calculated in this Section 7.1 (as determined below, the “Royalty Rate”) on the
Net Sales of the Product in the Territory. Such Royalty Rate shall be determined
[… * …]. The Royalty Rate to be applied to Annual Net Sales shall be calculated
as follows:

[… * …]

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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For illustrative purposes only:

[… * …]

For the sake of clarity, subject to Section 7.3: (i) in no event will [… * …];
and (ii) [… * …].

As used herein, “Annual Net Sales” of the Product shall mean the Net Sales of
Product(s) sold in the Territory by or under authority of Astellas in each
calendar year.

In the event that the Product [… * …], for the purposes of determining royalty
payments, shall be [… * …]. In the event that
[… * …], such agreement not to be unreasonably withheld or delayed. This
paragraph shall apply to both this Section 7.1 and Section 7.1.1 below.

7.1.1 Non-Japanese Marketing Approval. In the event that the Product receives
Marketing Approval in one or more countries in the Territory before receiving
Marketing Approval in Japan, Astellas shall, subject to the reduction of royalty
rate pursuant to Section 7.3 below, pay to XenoPort the following running
royalties on the Net Sales of the Product in the Territory until the Product
receives Marketing Approval in Japan:

 

Annual Net Sales in the Territory    Royalty That portion of Annual Net Sales in
the Territory up to and including [… * …]    [… * …] of such Net Sales That
portion of Annual Net Sales in the Territory above [… * …] and up to and
including [… * …]    [… * …] of such Net Sales That portion of Annual Net Sales
in the Territory above [… * …]    [… * …] of such Net Sales

7.1.2 If the Product subsequently does receive Marketing Approval in Japan, upon
such Marketing Approval in Japan, the Royalty Rate calculation as set forth in
Section 7.1 shall apply in lieu of Section 7.1.1.

7.2 Intentionally Omitted.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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7.3 Certain Reductions to Royalties.

7.3.1 Third Party Royalties. In the event Astellas or its Affiliates is required
to pay to a Third Party royalties or any other amounts under agreements for
patent rights, trade secrets or other intellectual property or technology
covering the Compound and/or Product (“Third Party Royalties”), then Astellas
may deduct [… * …] of the Third Party Royalties from those royalties owed to
XenoPort pursuant to Section 7.1; provided the royalties paid to XenoPort will
not be so reduced to less than [… * …] of the royalties otherwise due pursuant
Section 7.1, and further provided that neither Sections 7.3.2 nor 7.3.3 applies
at the time. For the purposes of Section 7.1 and this Section 7.3, any Third
Party royalties or any other amounts under agreements for patent rights, trade
secrets or other intellectual property or technology covering the Compound
and/or Product required to be paid by Astellas or its Affiliates [… * …].

7.3.2 Loss of Exclusivity. On a Product-by-Product and country-by-country basis,
after the later of the expiration of (or if there are no) (a) XenoPort Patent
Rights or patent rights Controlled by Astellas containing Valid Claims, which
absent a license thereunder, would be infringed by a Third Party selling such
Product in such country and/or (b) regulatory exclusivity with respect to such
Product, in such country, then the royalties payable pursuant to Section 7.1
with respect to such Product sold in such country shall thereafter be reduced by
[… * …], provided that Section 7.3.3 below does not apply at the time. For
avoidance of doubt, clause (a) above shall be deemed satisfied when all the
patents described in subparagraph (i) below are expired even if any of the
patents described in subparagraph (ii) below are unexpired at that time, as
applied on a Product-by-Product and country-by-country basis (i.e., with respect
to the Net Sales of such particular Product in such particular country):

(i) in the event of expiration of the patents included in XenoPort Patent Rights
or patent rights Controlled by Astellas containing Valid Claims, which absent a
license thereunder, would be infringed by a Third Party selling such Product in
such country, or if there are no such patent rights in such country, even if

(ii) there are unexpired patents included in XenoPort Patent Rights or patent
rights Controlled by Astellas containing Valid Claims, which absent a license
thereunder, would NOT be infringed by a Third Party selling such Product in such
country.

7.3.3 Introduction of Generic Products. On a Product-by-Product and
country-by-country basis, in the event that after the occurrence of both clause
(a) and (b) of Section 7.3.2 above, one or more Generic Product(s) are being
marketed for an approved indication of such Product in such country; and such
Generic Product(s) represent a total number of units of at least [… * …] of such
Product and such Generic Product(s) for all indications, in the aggregate, in
such country in any calendar year, determined by the number of units of such
Product and such Generic Product(s) sold to Third Parties, in the aggregate,
during such calendar year (as measured by IMS data or other data agreed upon by
the Parties), and Astellas reasonably determines that Astellas is not likely to
recover such lost market share; then the royalties payable pursuant to
Section 7.1 with respect to such Product sold in such country shall thereafter
be reduced by [… * …]. “Generic Product” shall mean a [… * …] being sold in such
country in the Territory, which [… * …], and is [… * …].

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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7.3.4 Reductions Not Cumulative. The reductions set forth in this Section 7.3
shall not be cumulative. Notwithstanding anything to the contrary in this
Section 7.3, at any time, at most one of Sections 7.3.1, 7.3.2 or 7.3.3 shall
apply with respect to any Product in any country. Unless Section 7.3.3 applies,
the royalty payable under this Section 7 shall not be reduced by this
Section 7.3 below [… * …] of the royalties otherwise due pursuant only to
Section 7.1 (i.e., without taking into account any of this Section 7.3). In case
Section 7.3.3 applies, the royalties payable under this Section 7 shall not be
reduced by this Section 7.3 to below [… * …] of the royalties otherwise due
pursuant to Section 7.1 (i.e., without taking into account any of this
Section 7.3). In case Sections 7.3.1 and 7.3.2 apply simultaneously, only
Section 7.3.2 shall apply, and in case all three of Sections 7.3.1, 7.3.2 and
7.3.3 apply simultaneously, only Section 7.3.3 shall apply.

7.4 Discounting. Astellas, its Affiliates and Subdistributors shall set prices
and discounts for the Product in the Territory solely in the interest of the
commercial success of the Product in the Territory and not for the interest of
its other products and services. However, the foregoing shall not be construed
to dictate to Astellas, its Affiliates or Subdistributors any resale prices for
the Products in the Territory.

7.5 Quarterly Reports. Commencing with the first occurrence of Net Sales of
Product in the Territory, within sixty (60) days after each
March 31, June 30, September 30 and December 31 thereafter, Astellas shall
deliver to XenoPort a true and accurate report, giving such particulars of the
business conducted by Astellas, its Affiliates and its Subdistributors during
the preceding three (3) calendar months as are pertinent to account for payments
under this Section 7. Simultaneously with the delivery of each such report,
Astellas shall pay to XenoPort the total amounts, if any, due to XenoPort
pursuant to this Section 7 for the period of such report.

8. COMPOUND/PRODUCT SUPPLY

8.1 Manufacturing and Supply Responsibilities. Contemporaneously with the
execution of the Restated License Agreement, the Amended and Restated
Non-Commercial Supply Agreement, dated as of May 15, 2009, by and between the
Parties, shall terminate and no longer be in effect. Upon the Restatement
Effective Date, subject to the terms and conditions of this Agreement, Astellas
shall have the exclusive right and responsibility to manufacture or have
manufactured (including packaging) the Compound, the Material and the Products
for both clinical use and commercial distribution in the Territory; except that
[… * …] the Compound, the Material and the Products [… * …] the Territory [… *
…]. For the avoidance of doubt, it is understood and agreed that: (i) Astellas
shall [… * …]; (ii) XenoPort shall have no obligation to: (A) [… * …]; (B) [… *
…]; or (C) [… * …]; (iii) Astellas shall [… * …]; and (iv) [… * …] with respect
to the manufacture of the Compound and Products for distribution [… * …].

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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8.2 Recalls. To the extent (a) any governmental or regulatory authority issues a
request, directive or order that the Product be recalled or withdrawn in the
Territory, (b) a court of competent jurisdiction orders a recall or withdrawal
of the Product in the Territory or (c) either Party determines, after
consultation with the other Party, that the Product should be recalled or
withdrawn in the Territory, the Parties shall recall or withdraw the Product as
set forth in this Section 8.2. As between the Parties, Astellas shall control
and coordinate, including making all contacts with regulatory authorities, all
activities it deems necessary in connection with such recall or withdrawal in
the Territory. All out-of-pocket expenses related to the execution of any recall
or withdrawal of the Product (“Recall Costs”) shall be shared equally between
the Parties, provided that in the case of (c) above, if the Parties do not
mutually agree on having the Product recalled or withdrawn, then the Party
requesting the recall or withdrawal shall bear initially the entire expense of
such recall or withdrawal; but in each case subject to the final allocation
between the Parties as follows. In the event that it is finally determined, or
agreed between the Parties, that such recall or withdrawal is caused by:
(a) breach of the representations and warranties of XenoPort set forth in
Section 13.2 below, or the gross negligence or willful misconduct of XenoPort,
or the failure by XenoPort to comply with applicable laws and regulations
(collectively, the “Fault of XenoPort”) XenoPort shall be responsible for Recall
Costs to extent of such Fault of XenoPort, (b) the failure of Astellas to
properly perform the manufacturing, formulation or packaging of the Compound
and/or Products, or the gross negligence or willful misconduct of Astellas, or
the failure by Astellas to comply with applicable laws and regulations,
including its failure to properly file for Marketing Approval of the Products in
the Territory (collectively, the “Fault of Astellas”), Astellas shall be
responsible for Recall Costs to the extent of such Fault of Astellas and (c) in
all other cases, the Recall Costs shall be shared by the Parties as follows: […
* …] shall be borne by Astellas and [… * …] shall be borne by XenoPort.

9. PAYMENTS; BOOKS AND RECORDS

9.1 Payment Method. All payments under this Agreement shall be made by bank wire
transfer in immediately available funds to an account designated by the Party to
which such payments are due. All dollar amounts specified in this Agreement are
in U.S. dollars. Any payments due under this Agreement that are not paid by the
date such payments are due under this Agreement shall bear interest to the
extent permitted by applicable law at the prime rate publicly announced by
Citibank on the date such payment is due, plus [… * …], computed on the basis of
a three hundred sixty (360) day year, actual days elapsed. The applicable
interest rate shall be adjusted each time there shall be a change in the prime
rate announced by Citibank. This Section 9.1 shall in no way limit any other
remedies available to the Parties. All amounts owed by Astellas to XenoPort
hereunder shall be paid by a Japanese entity from either a bank account in Japan
or the United States.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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9.2 Taxes. If laws or regulations require withholding by Astellas of any taxes
imposed upon XenoPort on account of any royalties, initial or milestone payments
paid under this Agreement, such taxes shall be deducted by Astellas as required
by law from such payment and shall be paid by Astellas to the proper taxing
authorities. Official receipts of payment of any withholding tax shall be
secured and sent to XenoPort as evidence of such payment. The Parties will
exercise their reasonable efforts to ensure that any withholding taxes imposed
are reduced as far as possible under the provisions of any applicable tax
treaty, and shall cooperate in filing any forms required for such reduction.
Both Parties agree that under the applicable tax treaty as of the Effective
Date, no withholding taxes are due on any amounts due hereunder provided that
the appropriate forms have been filed with the tax authorities in Japan.

9.3 U. S. Dollars. All sums due under this Agreement shall be payable in U.S.
dollars. Monetary conversion from the currency of a foreign country, in which
Product is sold, into United States currency shall be calculated at the actual
average of the buying and selling rates of exchange for a calendar quarter in
which such sales were made as such rates are reported, as of the last business
day of such calendar quarter, by Bank of Tokyo-Mitsubishi.

9.4 Records; Inspection.

9.4.1 Astellas. Astellas shall keep, and require its Affiliates and
Subdistributors to keep, complete, true and accurate books of accounts and
records for the purpose of determining the amounts payable to XenoPort pursuant
to this Agreement. Such books and records shall be kept for at least three
(3) years following the end of the calendar quarter to which they pertain. Such
records will be open for inspection during such three (3) year period by an
independent auditor chosen by XenoPort and reasonably acceptable to Astellas for
the purpose of verifying the amounts payable by Astellas hereunder. Such
inspections may be made no more than once each calendar year, at reasonable
times and on reasonable prior written notice. Such records for any particular
calendar quarter shall be subject to no more than one inspection. The
independent auditor shall be obligated to execute a reasonable confidentiality
agreement prior to commencing any such inspection. Inspections conducted under
this Section 9.4.1 shall be at the expense of XenoPort, unless a variation or
error producing an underpayment in amounts payable exceeding [… * …] of the
amount paid for any period covered by the inspection is established in the
course of any such inspection, whereupon all costs relating to the inspection
for such period and any unpaid amounts that are discovered shall be paid by
Astellas, together with interest on such unpaid amounts at the rate set forth in
Section 9.1 above. The Parties will endeavor in such inspection to minimize
disruption of Astellas’ normal business activities to the extent reasonably
practicable.

9.4.2 XenoPort. XenoPort shall keep complete, true and accurate books of
accounts and records for the purpose of determining payments due from Astellas
pursuant to this Agreement. Such books and records shall be kept for at least
three (3) years following the end of the calendar quarter to which they pertain.
Such records will be open for inspection during such three (3) year period by an
independent auditor chosen by Astellas and reasonably acceptable to XenoPort for
the purpose of verifying the amounts

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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payable by Astellas hereunder. Such inspections may be made no more than once
each calendar year, at reasonable times and on reasonable prior written notice.
Such records for any particular calendar quarter shall be subject to no more
than one inspection. Astellas’ independent auditor shall be obligated to execute
a reasonable confidentiality agreement prior to commencing any such inspection.
Inspections conducted under this Section 9.4.2 shall be at the expense of
Astellas, unless a variation or error producing an overpayment in amounts
payable exceeding [… * …] of the amount paid for any period covered by the
inspection is established in the course of any such inspection, whereupon all
costs relating to the inspection for such period and any overpaid amounts that
are discovered shall be paid by XenoPort, together with interest on such
overpaid amounts at the rate set forth in Section 9.1 above. The Parties will
endeavor in such inspection to minimize disruption of XenoPort’s normal business
activities to the extent reasonably practicable.

10. INTELLECTUAL PROPERTY

10.1 Ownership of Inventions. Title to all inventions and other intellectual
property made solely by Astellas personnel in connection with this Agreement
shall be owned by Astellas. Title to all inventions and other intellectual
property made solely by XenoPort personnel in connection with this Agreement
shall be owned by XenoPort. Title to all inventions and other intellectual
property made jointly by personnel of XenoPort and Astellas in connection with
this Agreement shall be jointly owned by Astellas and XenoPort. Prosecution of
any patent applications and patents with respect to such jointly owned
inventions and intellectual property shall be solely as mutually agreed. Except
as expressly provided in this Agreement, it is understood that neither Party
shall have any obligation to obtain any approval of nor pay a share of the
proceeds to the other Party to exploit or enforce such jointly owned inventions
or intellectual property, and that neither Party shall, without obtaining the
approval of the other Party, license or assign the same to a Third Party other
than its licensees of (or an assignee of all or substantially all of its assets
or business in any country pertaining to) the Compound and/or the Product or
Subdistributors. For clarity, each Party shall have the right, without having to
obtain the approval of, nor to pay a share of the proceeds to, the other Party,
to license and/or assign such jointly owned intellectual property to any
licensee of the Compound and/or Product or Subdistributor or to an assignee of
all or substantially all of its assets or business pertaining to the Compound
and/or Product in any country. Astellas hereby grants to XenoPort a
non-exclusive, worldwide, irrevocable, fully paid-up license, with the right to
sublicense, under any Improvements to make, have made, use, sell, offer for
sale, import, practice and otherwise exploit the same for the Compound and/or
the Product, subject to the exclusive rights granted to Astellas under this
Agreement with respect to the Product in the Territory. As used herein,
“Improvements” means any patent rights or other intellectual property made by or
under authority of Astellas in connection with manufacturing, developing and/or
commercializing the Product that is applicable to the Compound, Product or
transported prodrugs thereof or the manufacture, use or formulation thereof.
Notwithstanding anything to the contrary contained herein, subject to
Section 2.7 of the GSK Agreement, XenoPort shall not have the right to
sublicense or disclose to GSK any Astellas Manufacturing Know-How and/or
Improvements relating to manufacturing the Compound, the Material and/or the
Product inside or outside the Territory until the expiration or earlier
termination of this Agreement in all countries of the Territory pursuant to
Section 15.2 or 15.3 below or Section 2.4 above.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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10.2 Prosecution and Maintenance of Patents.

10.2.1 Filings. As between Astellas and XenoPort, XenoPort shall have
responsibility for the filing, prosecution and maintenance of all XenoPort
Patent Rights in the Territory at XenoPort’ expense. Astellas shall have the
right to review pending patent applications and make recommendations to XenoPort
concerning the foregoing. XenoPort will consider in good faith all reasonable
suggestions of Astellas with respect thereto. XenoPort agrees to keep Astellas
generally informed of the course of patent prosecution or other proceedings with
respect to the XenoPort Patent Rights within the Territory, including those
patents and patent applications relating to the Compound and/or the Product in
the Territory which shall not be listed in Exhibit B as of the Effective Date.

10.2.2 Extensions. XenoPort shall, [… * …], file for extensions of the terms of
any and all of the XenoPort Patent Rights if legally possible in any country of
the Territory with respect to the Product and shall be responsible for
prosecuting any required actions for such extensions at its own expense.

10.3 Third Party Infringement Claims. If the production, sale or use of any
Compound or Product in the Territory pursuant to this Agreement results in a
claim, suit or proceeding alleging patent infringement against XenoPort or
Astellas (or their respective Affiliates or Subdistributors) (collectively,
“Infringement Actions”), such Party shall promptly notify the other Party hereto
in writing. The Party subject to such Infringement Action shall have the right
to direct and control the defense thereof (including the conclusion of a
potential settlement, but limited to the rights granted pursuant to this
Agreement) using counsel reasonably acceptable to the other Party, and the
Infringement Action shall be at the expense of the Party subject to such
Infringement Action; provided, however, that the other Party may participate in
the defense and/or settlement thereof at its own expense with counsel of its
choice. In any event, the Party that is subject to the Infringement Action
agrees to keep the other Party hereto reasonably informed of all material
developments in connection with any such Infringement Action. Astellas agrees
not to settle any Infringement Action, or make any admissions or assert any
position in such Infringement Action, in a manner that would adversely affect
the Product or the manufacture, use or sale thereof in or outside the Territory,
without the prior written consent of XenoPort. XenoPort agrees not to settle any
Infringement Action in a manner that would adversely affect the Product or the
manufacture, use or sale thereof in the Territory, without the prior written
consent of Astellas. Astellas may treat its Damages from such Infringement
Action as Third Party Royalties under Section 7.3.1 above, and XenoPort may
treat its Damages from such Infringement Action as payments for Third Party IP
under Section 2.5 above. As used herein, “Damages” shall mean out-of-pocket
costs incurred by a Party, including reasonable attorney’s fees, damages and
other liabilities that are part of any final judgment awarded against such
Party, and any amounts paid by such Party in a settlement of the action that is
approved by the other Party, such approval not to be unreasonably withheld or
delayed.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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10.4 Enforcement. Subject to the provisions of this Section 10.4, in the event
that Astellas reasonably believes that any XenoPort Patent Rights in the
Territory is infringed or misappropriated by a third party or is subject to a
declaratory judgment action in the Territory arising from such infringement, in
each case with respect to the manufacture, sale or use within the Field in the
Territory of a product comprising a prodrug of gabapentin (an “Infringing
Product”), Astellas shall promptly notify XenoPort. XenoPort shall have the
initial right (but not the obligation), at its own expense, to enforce the
XenoPort Patent Rights with respect to such infringement or defend any
declaratory judgment action with respect thereto in the Territory (for purposes
of this Section 10.4, an “Enforcement Action”). Astellas shall, at its expense,
have the right to join in as a party plaintiff and to give reasonable assistance
to such Enforcement Action. XenoPort shall keep Astellas reasonably informed of
the progress of any such Enforcement Action. XenoPort agrees not to settle any
Enforcement Action, or make any admissions or assert any position in such
Enforcement Action, in a manner that would materially adversely affect Astellas’
rights or interests in the Territory, without the prior written consent of
Astellas, which shall not be unreasonably withheld or delayed.

10.4.1 Initiating Enforcement Actions. In the event that XenoPort fails to
initiate an Enforcement Action to enforce the XenoPort Patent Rights against a
commercially significant infringement by a third party in a country in the
Territory, which infringement consists of the manufacture, sale or use of an
Infringing Product in the Field in such country, within [… * …] of a request by
Astellas to initiate such Enforcement Action, Astellas may initiate an
Enforcement Action against such infringement at its own expense. Upon [… * …],
provided that [… * …]. Astellas shall keep XenoPort reasonably informed of the
progress of any such Enforcement Action. XenoPort shall, at its expense, have
the right to join in as a party plaintiff and to give reasonable assistance to
such Enforcement Action. Astellas agrees not to settle any Enforcement Action,
or make any admissions or assert any position in such Enforcement Action, in a
manner that would materially adversely affect the validity, enforceability or
scope of the XenoPort Patent Rights in or outside the Territory, without the
prior written consent of XenoPort, which shall not be unreasonably withheld or
delayed.

10.4.2 Recoveries. Any damages or other monetary awards recovered from an
Enforcement Action shall be allocated first to reimburse the costs and expenses
of Party who initiates the Enforcement Action and, if the other Party joins as a
party plaintiff, then the costs and expenses of the other Party. Any amounts
remaining shall be shared [… * …] to Astellas and
[… * …] to XenoPort.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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10.5 Third Party Rights. The obligations of XenoPort and the rights of Astellas
under Sections 10.2 and 10.4 above shall be subject to, and limited by, any
agreements pursuant to which XenoPort acquired or licensed any particular
XenoPort Patent Rights, Data or other subject matter. With respect to the
prosecution or enforcement of XenoPort Patent Rights licensed by XenoPort from a
Third Party, to the extent XenoPort has the right to do so, XenoPort shall
cooperate with Astellas to prosecute and enforce such XenoPort Patent Rights in
the same manner as set forth in Sections 10.2 and 10.4 above. As between
XenoPort and Astellas, any recoveries from enforcement of such XenoPort Patent
Rights licensed from a Third Party (including any amounts that XenoPort receives
from the Third Party licensor as a result of such enforcement) shall be shared
in accordance with Sections 10.4.2, after deducting from such recoveries any
amounts owed to the Third Party licensor for such enforcement; provided that any
Enforcement Actions initiated by the Third Party licensor shall be deemed
initiated by XenoPort for purposes of Section 10.4.2 above, and the costs and
expenses incurred by XenoPort in such Enforcement Action shall include the costs
and expenses reimbursed or required to be reimbursed by XenoPort to the Third
Party licensor in such Enforcement Action.

10.6 Patent Marking. Astellas agrees to mark and have its Affiliates and
Subdistributors mark all patented Products they sell or distribute pursuant to
this Agreement in accordance with the applicable patent statutes or regulations
in the country or countries of manufacture and sale thereof.

11. TRADEMARKS

11.1 Display. All packaging materials, labels and promotional materials for the
Product in the Territory shall display the Product Trademark to the extent such
packaging materials, labels and promotional materials have enough space for such
display. Astellas shall include in its packaging materials, labels and
promotional materials a statement, of reasonable size and prominence approved by
XenoPort, acknowledging that the Product is sold under license from XenoPort to
the extent such packaging materials, labels and promotional materials have
enough space for such statement. The Astellas trade dress and style of packaging
with respect to each Product may be determined by Astellas so as to be
consistent with Astellas’ standard trade dress and style, but shall, so far as
is reasonable, be consistent with XenoPort’s worldwide branding strategy for the
Product, provided that XenoPort shall respect local marketing needs in the
Territory regarding trade dress and style.

11.2 License. XenoPort hereby grants to Astellas an exclusive (even as to
XenoPort), royalty-free license to use the Product Trademark solely in
connection with formulation, packaging, marketing, promoting, distributing and
selling the Product in the Territory in accordance with this Agreement. The
ownership and all goodwill from the use of the Product Trademark shall vest in
and inure to the benefit of XenoPort.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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11.3 Registration. XenoPort agrees to file, register and be responsible to
maintain a registration for the Product Trademark in Japan (and in countries of
the Territory outside Japan, upon notice from Astellas that an MAA for the
Product is being filed in such country), for the term of this Agreement, for use
with the Product. The costs of filing and maintaining such registrations in the
Territory shall be borne by XenoPort.

11.4 Ownership. Astellas hereby acknowledges XenoPort’s exclusive ownership
rights in the Product Trademark, and accordingly agrees that at no time during
the term of this Agreement or for [… * …] thereafter to challenge or assist
others to challenge the Product Trademark or the registration thereof, nor
during the term of this Agreement to attempt to register any trademarks, marks
or trade names confusingly similar to such Product Trademark.

11.5 Recordation. In those countries where a trademark license must be recorded,
XenoPort will provide and record a separate trademark license for the Product
Trademark, at XenoPort’s sole expense. Astellas shall cooperate in the
preparation and execution of such documents.

11.6 Approval of Promotional Materials. Astellas shall submit representative
samples of promotional materials, packaging and Product using the Product
Trademark to XenoPort for XenoPort’s reasonable approval, which approval shall
not be unreasonably withheld or delayed, prior to their first use and prior to
any subsequent change or addition to such promotional materials, provided that
if XenoPort has not responded within four (4) weeks after receiving such
submissions, XenoPort’s approval will be deemed to have been received.

11.7 Termination. Astellas’ right to use the Product Trademark shall terminate
in each country of the Territory in which Astellas’ rights to distribute the
Product are terminated in accordance with this Agreement. Astellas shall
cooperate in the cancellation of any trademark licenses recorded or entered into
in such countries.

12. CONFIDENTIALITY

12.1 Confidential Information. Except as expressly provided in this Agreement,
the Parties agree that the receiving Party shall not publish or otherwise
disclose and shall not use for any purpose any information furnished to it by
the other Party hereto pursuant to this Agreement (collectively, “Confidential
Information”). Notwithstanding the foregoing, Confidential Information shall not
include information that, in each case as demonstrated by written documentation:

12.1.1 was already known to the receiving Party, other than under an obligation
of confidentiality, at the time of disclosure or, as shown by
written documentation, was developed by the receiving Party independent of
disclosure by the disclosing Party;

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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12.1.2 was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the receiving Party;

12.1.3 became generally available to the public or otherwise part of the public
domain after its disclosure and other than through any act or omission of the
receiving Party in breach of this Agreement;

12.1.4 was subsequently lawfully disclosed to the receiving Party by a person
other than the disclosing Party, and who did not directly or indirectly receive
such information from disclosing Party; or

12.1.5 is developed by the receiving Party without use of or reference to any
information or materials disclosed by the disclosing Party.

12.2 Permitted Disclosures. Notwithstanding the provisions of Section 12.1
above, each Party hereto may disclose the other Party’s Confidential Information
to its Affiliates, licensees, Subdistributors and any other Third Parties to the
extent such disclosure is reasonably necessary to exercise the rights granted to
it, or reserved by it, under this Agreement (including the right to grant
sublicenses, as applicable), prosecuting or defending litigation, complying with
applicable governmental laws or regulations, submitting information to tax or
other governmental authorities or conducting clinical trials hereunder with
respect to the Product. If a Party is required by law or regulations to make any
such disclosure of the other Party’s Confidential Information, to the extent it
may legally do so, it will give reasonable advance notice to the latter Party of
such disclosure and, save to the extent inappropriate in the case of patent
applications or otherwise, will use its good faith efforts to secure
confidential treatment of such Confidential Information prior to its disclosure
(whether through protective orders or otherwise). For any other disclosures of
the other Party’s Confidential Information, including to Affiliates, licensees,
Subdistributors and other Third Parties, a Party shall ensure that the recipient
thereof is bound by a written confidentiality agreement as materially protective
of such Confidential Information as this Section 12. If the Party whose
Confidential Information is to be disclosed has not filed a patent application
with respect to such Confidential Information, it may require the other Party to
delay the proposed disclosure (to the extent the disclosing Party may legally do
so), for up to ninety (90) days, to allow for the filing of such an application.

12.3 Terms of this Agreement. Each Party agrees [… * …], except [… * …] pursuant
to clause (a) above, the [… * …]

12.4 Publicity. Subject to Section 12.3 above, neither Party shall originate any
written publicity, news release or other announcement or statement relating to
this Agreement (collectively, a “Written Disclosure”), without the prompt prior
review and written approval of the other Party, which approval shall not be
unreasonably withheld or delayed. Notwithstanding the foregoing,

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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either Party may make any public Written Disclosure it believes in good faith
based upon the advice of counsel is required by applicable law, rule or
regulation or any listing or trading agreement concerning its or its Affiliates’
publicly traded securities. In addition, the Parties shall agree upon a press
release to announce the execution of this Agreement, together with a
corresponding Question & Answer outline for use in responding to inquiries about
the Agreement; thereafter, Astellas and XenoPort may each disclose to third
parties the information contained in such press release and Question & Answer
outline without the need for further approval by the other.

12.5 Prior Non-Disclosure Agreements. Upon execution of this Agreement, the
terms of this Section 12 shall supersede any prior non-disclosure, secrecy or
confidentiality agreement between the Parties. Any information disclosed under
such prior agreements shall be deemed disclosed under this Agreement.

12.6 Publication of Product Information. Prior to publishing, publicly
presenting and/or submitting for written or oral publication a manuscript,
abstract or the like that includes Data or other information relating to Product
that has not previously published pursuant to this Section 12.6, a Party shall
provide the other Party a copy thereof in English for its review for at least
thirty (30) days (unless such Party is required by law to publish such
information sooner). Such Party shall consider in good faith any comments
provided by the other Party during such thirty (30) day period. In addition,
such Party shall, at the request of the other Party, remove any Confidential
Information of the other Party therefrom, except each Party shall have the right
to publicly disclose any information, including Confidential Information,
pertaining to safety or efficacy of the Compound and/or Product that such Party
believes in good faith it is obligated or appropriate to disclose. The
contribution of each Party shall be noted in all publications or presentations
by acknowledgment or coauthorship, whichever is appropriate.

13. REPRESENTATIONS AND WARRANTIES

13.1 Mutual Warranty. Each Party represents and warrants to the other that this
Agreement is a legal and valid obligation binding upon such Party and
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by such Party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it is bound, nor, to such Party’s knowledge, violate any law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it.

13.2 XenoPort Warranties. XenoPort represents and warrants to Astellas that, as
of the Effective Date:

13.2.1 it has the full right and authority to enter into this Agreement and
grant the rights and licenses as provided herein;

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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13.2.2 it has not previously granted any right, license or interest in or to the
XenoPort Patent Rights, or any portion thereof, that is in conflict with the
rights or licenses granted to Astellas under this Agreement;

13.2.3 XenoPort has not knowingly withheld from Astellas any material
information in the possession of XenoPort related to the safety or efficacy of
the Compound and/or the Product (a) that has been requested by Astellas, or
(b) that XenoPort considered to be reasonably material to Astellas’ evaluation
of the safety and/or efficacy of the Compound and/or Product;

13.2.4 XenoPort has not knowingly withheld from Astellas any material CMC
Information in the possession of XenoPort regarding the Existing Product
(a) that has been requested by Astellas, or (b) that XenoPort considered to be
reasonably material to Astellas’ evaluation of the quality of the Compound
and/or Product. As used herein, “CMC Information” means information of the type
required to appear in Section 7.0 of IND Nos. 68,341 and 71,352;

13.2.5 to its best knowledge, there are no actual, pending, alleged or
threatened action, suits, claims, interference or governmental investigations
involving the Compound and/or the Product, the XenoPort Patent Rights, the
XenoPort Know-How or the Product Trademark by or against XenoPort, or any of its
Affiliates or other licensees in or before any court, governmental or regulatory
authority. In particular, to its best knowledge, there is no pending or
threatened product liability action nor intellectual property right litigation
in relation to the Compound and/or the Product;

13.2.6 all necessary consents, approvals and authorizations of all governmental
authorities and other persons or entities required to be obtained by XenoPort in
order to enter into this Agreement have been obtained;

13.2.7 to its best knowledge, there are no actual, pending, alleged or
threatened infringement by a Third Party of any of the XenoPort Patent Rights or
the XenoPort Know-How;

13.2.8 to its best knowledge, none of the issued XenoPort Patent Rights are
invalid or unenforceable.

13.2.9 there are no XenoPort Patent Right that are licensed by XenoPort from any
Third Party, which would, but for the license granted hereunder, be infringed by
use, development, formulation, packaging, import, sale, distribution, promotion
or marketing of the Compound and/or the Product by Astellas, any of its
Affiliates or Subdistributors in accordance with this Agreement. There are no
Data licensed by XenoPort from any Third Party relating to the Compound and/or
the Product.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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13.2.10 XenoPort has not granted a lien or other encumbrances on any of the
subject matter of this Agreement or on any of XenoPort’s rights, benefits or
obligations hereunder or on any of the XenoPort Patent Rights, which would
conflict with the rights or licenses of Astellas hereunder.

13.2.11 Notwithstanding the foregoing, it is understood that substantial
information has been published in XenoPort’s SEC filings and in its scientific
publications regarding the Compound and/or the Product, and is available to the
public. Accordingly, for purposes of this Section 13.2, Astellas shall be deemed
to be on notice of and to have received disclosures of such information, and the
representations and warranties set forth in this Section 13.2 shall be subject
to such disclosures.

13.3 XenoPort Covenants. XenoPort covenants to Astellas that, during the term of
this Agreement (a) it shall not grant any right, license or interest in or to
the XenoPort Patent Rights, or any portion thereof, that is in conflict with the
rights or licenses granted under this Agreement, and (b) it shall not grant a
lien or other encumbrances on any of the subject matter of this Agreement or on
any of XenoPort’s rights, benefits or obligations hereunder or on any of the
XenoPort Patent Rights, which would conflict with the rights or licenses of
Astellas hereunder.

13.4 Astellas Warranties. Astellas represents and warrants to XenoPort that, as
of the Effective Date: (a) it has the full right and authority to enter into
this Agreement and grant the rights granted herein; (b) Astellas and its
Affiliates have not initiated any human clinical trials with respect to, and are
not commercializing, any products containing the Compound or any Competitive
Compound, and are not engaged in contract negotiations with respect to
in-licensing or acquiring any specific product or technology relating to the
Compound or any Competitive Compound(s); (c) all necessary consents, approvals
and authorizations of all governmental authorities and other persons or entities
required to be obtained by Astellas in order to enter into this Agreement have
been obtained; and (d) Astellas does not have any knowledge that any of
XenoPort’s representations and warranties set forth in Section 13.2 above are
inaccurate.

13.5 DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND
EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OR VALIDITY
OF ANY PATENTS ISSUED OR PENDING.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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13.6 LIMITATION OF LIABILITY. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR
OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY
SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT,
SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING,
WITHOUT LIMITATION, LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF
BUSINESS) EXCEPT IN THE CASE OF (A) BREACH OF SECTION 2.4.3 BY ASTELLAS OR ITS
AFFILIATES, (B) BREACH OF SECTION 12, (C) SUCH DAMAGES OWED TO THIRD PARTIES
PURSUANT TO SECTION 14 OR (D) BREACH OF ASTELLAS’ OBLIGATION TO USE DILIGENT
EFFORTS TO DEVELOP AND/OR COMMERCIALIZE THE PRODUCT PURSUANT TO SECTIONS 4.1.1
AND 5.1.1, PROVIDED IT IS UNDERSTOOD THAT IN THE CASE OF (D) DAMAGES SHALL BE
CALCULATED BASED ON LOSS OF ROYALTIES AND OTHER AMOUNTS OWED TO XENOPORT
HEREUNDER AS A RESULT OF SUCH BREACH, AND NOT BASED ON THE LOSS OF NET SALES
RECEIVED BY ASTELLAS.

14. INDEMNIFICATION

14.1 Indemnification of XenoPort. Astellas shall indemnify and hold harmless
each of XenoPort, its Affiliates and the directors, officers and employees of
such entities and the successors and assigns of any of the foregoing (the
“XenoPort Indemnitees”), from and against any and all liabilities, damages,
penalties, fines, costs, expenses (including, without limitation, reasonable
attorneys’ fees and other expenses of litigation) (“Liabilities”) from any
claims, actions, suits or proceedings brought by a Third Party (a “Third Party
Claim”) incurred by any XenoPort Indemnitee, arising from, or occurring as a
result of: (a) the use, marketing, distribution or sale of any Product by
Astellas, its Affiliates or Subdistributors in the Territory (and manufacturing,
formulation and packaging activities by or under authority of Astellas inside or
outside the Territory pursuant to Section 2.2 or development activities by
Astellas or requested by Astellas outside the Territory pursuant to 4.7),
including, without limitation, any Products Liability Claim (subject to and
shared in accordance with the mechanism set forth in Section 14.4 below) and
Third Party infringement claims (subject to Section 10.3 above), or (b) any
material breach of any representations, warranties or covenants by Astellas in
Section 13 above; except to the extent such Third Party Claims fall within the
scope of XenoPort’s indemnification obligations set forth in Section 14.2 below.

14.2 Indemnification of Astellas. XenoPort shall indemnify and hold harmless
each of Astellas, its Affiliates and Subdistributors and the directors, officers
and employees of Astellas, its Affiliates and Subdistributors and the successors
and assigns of any of the foregoing (the “Astellas Indemnitees”), from and
against any and all Liabilities from any Third Party Claims incurred by any
Astellas Indemnitee, arising from, or occurring as a result of: (a) the use,
marketing, distribution or sale of any Product by XenoPort or its licensee
outside the Territory (other than manufacturing, formulation and packaging
activities by or under authority of Astellas outside the Territory pursuant to
Section 2.2 and development activities by Astellas or requested by Astellas
outside the Territory pursuant to 4.7), (b) any material breach of any
representations, warranties or covenants by XenoPort in Section 13 above, or
(c) subject to and shared in accordance with the mechanism set forth in
Section 14.4 below, any Product Liability Claim asserted against the Astellas
Indemnitees.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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14.3 Procedure. Except with respect to Third Party infringement claims subject
to Section 10.3 above, and Product Liability Claims subject to Section 14.4
below, a Party that intends to claim indemnification under this Section 14 (the
“Indemnitee”) shall promptly notify the other Party (the “Indemnitor”) in
writing of any Third Party Claim, in respect of which the Indemnitee intends to
claim such indemnification, and the Indemnitor shall have sole control of the
defense and/or settlement thereof. The indemnity arrangement in this Section 14
shall not apply to amounts paid in settlement of any action with respect to a
Third Party Claim, if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld or delayed unreasonably. The
failure to deliver written notice to the Indemnitor within a reasonable time
after the commencement of any action with respect to a Third Party Claim, if
prejudicial to its ability to defend such action, shall relieve such Indemnitor
of any liability to the Indemnitee under this Section 14, but the omission to so
deliver written notice to the Indemnitor shall not relieve the Indemnitor of any
liability that it may have to any Indemnitee otherwise than under this
Section 14. The Indemnitee under this Section 14 shall cooperate fully with the
Indemnitor and its legal representatives in the investigation of any action with
respect to a Third Party Claim covered by this indemnification.

14.4 Products Liability Claims. Each Party shall notify the other Party as
promptly as practicable if any Third Party Claim is commenced or threatened
against such Party alleging product liability, product defect, design,
manufacturing, packaging or labeling defect, failure to warn, or any similar
action relating to the formulation, manufacture, use or safety of those Products
sold by or under authority of Astellas in the Territory hereunder (“Product
Liability Claim”). Each Party shall cooperate with the other Party in connection
with any such Product Liability Claim that is commenced or threatened against
the other Party. If a Product Liability Claim is asserted against both Parties,
each Party will have the right to designate counsel to defend itself in the
Product Liability Claim. If a Product Liability Claim is brought against one
Party but not the other Party, the named Party shall control the defense and/or
settlement thereof at its own expense with counsel of its choice, subject to
this Section 14.4. In such case, the other Party may participate in the defense
and/or settlement thereof at its own expense with counsel of its choice. In any
event, the Party that is subject to the Product Liability Claim (if not asserted
against both Parties) agrees to keep the other Party hereto reasonably informed
of all material developments in connection with any such Product Liability
Claim. Astellas agrees not to settle any Product Liability Claim, or make any
admissions or assert any position in such Product Liability Claim, in a manner
that would adversely affect the Product or the manufacture, use or sale thereof
in or outside the Territory, without the prior written consent of XenoPort.
XenoPort agrees not to settle any Product Liability Claim, or make any
admissions or assert any position in such Product Liability Claim, in a manner
that would adversely affect the Product or the manufacture, use or sale thereof
in the Territory, without the prior written consent of

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Astellas. To the extent a Product Liability Claim is caused by: (a) the Fault of
XenoPort (as defined in Section 8.2 above), XenoPort shall bear all Liabilities
from such Product Liability Claim to the extent of its Fault, (b) the Fault of
Astellas (as defined in Section 8.2 above), Astellas shall bear all Liabilities
from such Product Liability Claim to the extent of its Fault and (c) neither the
Fault of XenoPort nor the Fault of Astellas, the Parties shall share the
Liabilities from such Product Liability Claim as follows: [… * …] shall be borne
by Astellas, and [… * …] shall be borne by XenoPort.

14.5 Insurance. Each Party shall secure and maintain in effect during the term
of this Agreement and for a period of [… * …] thereafter insurance policy(ies)
underwritten by a reputable insurance company in a form and having limits
standard and customary for entities in the biopharmaceutical industry for
exposures related to the Product. Such policies shall include coverage for
clinical trial liability and products liability. Upon request by the other Party
hereto, certificates of insurance evidencing the coverage required above shall
be provided to the other Party.

15. TERM AND TERMINATION

15.1 Term. This Agreement shall become effective as of the Effective Date and,
shall continue, on a country-by-country basis, until terminated pursuant to
Section 15.2 or 15.3 below or Section 2.4 above.

15.2 Termination By Astellas. Astellas may terminate this Agreement for any
reason under this Section 15.2 without any penalty, consequence, termination
compensation, loss of profits, goodwill indemnity or otherwise solely by reason
of such termination (i.e., without prejudice to any remedies XenoPort may have
for a breach of this Agreement by Astellas), as a whole or on a
country-by-country basis with respect to countries in the Territory upon written
notice to XenoPort; provided that such notice is given after the third
anniversary of the Effective Date. In the event Astellas elects to terminate
this Agreement under this Section 15.2 with respect to Japan, Astellas shall
have elected to terminate this Agreement in whole. Without limiting the other
provisions of this Agreement, if, at any time after the First Commercial Sale of
a Product in a country, [… * …] with respect to such country (if a country in
the Territory other than Japan), or as a whole (if such country is Japan); and
this Agreement shall so terminate upon such notice by XenoPort without any
penalty, consequence, termination compensation, loss of profits, goodwill
indemnity or otherwise solely by reason of such deemed termination.

15.3 Termination for Cause. In the event a Party fails to pay any amount due
under this Agreement or otherwise materially breaches any obligation, covenant
or warranty under this Agreement, the other Party shall have the right to
terminate this Agreement upon written notice, provided that such breach is not
cured within [… * …] (if a failure to pay), or within [… * …] (if any other
material breach), after notice thereof specifying such breach.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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16. EFFECT OF TERMINATION

16.1 Accrued Obligations. Termination of this Agreement for any reason shall not
release any Party hereto from any liability that, at the time of such
termination, has already accrued to the other Party or that is attributable to a
period prior to such termination nor preclude either Party from pursuing all
rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement.

16.2 Rights on Termination. This Section 16.2 shall apply upon any termination
of Astellas’ rights under this Agreement in whole or with respect to a
particular country, excluding only termination of this Agreement pursuant to
Section 15.3 for XenoPort’s breach. As used herein, the “Affected Area” shall
mean the Territory in case of termination of this Agreement as a whole, or the
terminated country(ries) in case of termination of this Agreement with respect
to such country(ries).

16.2.1 Wind-down Period.

(a) Development. In the event there are any on-going clinical trials of the
Product in an Affected Area, at XenoPort’s request, Astellas agrees to either
promptly transition such clinical trials to XenoPort, or continue to conduct
such clinical trials (i) in the case of termination by XenoPort pursuant to
Section 15.3 or 2.4, or termination by Astellas pursuant to Section 15.2, at
Astellas’ own expense and (ii) in the case of any other termination, at
XenoPort’s expense for a period requested by XenoPort up to a maximum of [… * …]
after such termination.

(b) Commercialization. In case of termination by XenoPort pursuant to
Section 15.3 or 2.4, or termination by Astellas pursuant to Section 15.2,
Astellas and its Subdistributors shall continue to distribute Products in each
country of the Affected Area for which Marketing Approval therefor has been
obtained, in accordance with the terms and conditions of this Agreement, for a
period requested by XenoPort not to exceed [… * …] from such termination (for
purposes of this Section 16.2, the “Wind-down Period”); provided that XenoPort
may terminate the Wind-down Period upon [… * …] written notice to Astellas.
Notwithstanding any other provision of this Agreement, during the Wind-down
Period, Astellas’ and its Subdistributors’ rights with respect to the Compound
and the Product in the Affected Area shall be non-exclusive, and XenoPort shall
have the right to engage one or more other distributor(s) and/or sublicensee(s)
of the Product in all or part of the Affected Area. Any Products sold or
disposed by Astellas in the Affected Area during the Wind-down Period shall be
subject to royalties under Section 7 above. Within [… * …] of expiration or
termination of the Wind-down Period, Astellas shall notify XenoPort of any
quantity of the Products remaining in Astellas’ inventory and Astellas shall
transfer all right, title and interest in and to any such quantities of the
Products to XenoPort for no consideration.

16.2.2 Assignment of MAA and Marketing Approvals. Astellas shall assign or cause
to be assigned to XenoPort (or if not so assignable, Astellas shall take all
reasonable actions to make available to XenoPort the benefits of) all regulatory
filings and

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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registrations (including INDs, MAAs and Marketing Approvals) for the Product in
the Affected Area, including any such regulatory filings and registrations made
or owned by its Affiliates and/or Subdistributors. In each case, unless
otherwise required by any applicable law or regulation, the foregoing assignment
(or availability) shall be made within [… * …] after termination of the Affected
Area. In addition, Astellas shall promptly provide to XenoPort a copy of all
Data, Astellas Know-How and Astellas Manufacturing Know-How pertaining to the
Product to the extent not previously provided to XenoPort.

16.2.3 Supply. Astellas shall use Diligent Efforts to transition to XenoPort
upon XenoPort’s request any arrangements with any contractor from which Astellas
had arranged to obtain a supply of the Compound or Products. In the event that
such materials are manufactured by Astellas, then, upon request by XenoPort,
Astellas shall continue to provide XenoPort with such materials [… * …];
provided that XenoPort shall use commercially reasonable efforts to obtain such
alternative source as soon as practicable. In addition, Astellas shall promptly
provide to XenoPort a copy of all Data, the Astellas Know-How and the Astellas
Manufacturing Know-How pertaining to the manufacture of the Compound and the
Products to the extent not previously provided to XenoPort during the term of
this Agreement or pursuant to Section 16.2.2, and XenoPort shall have the right,
subject to Section 10.1, to use (and authorize the use of) and to disclose all
such Data, Astellas Know-How and Astellas Manufacturing Know-How pertaining to
the manufacture of the Compound and the Products following termination of this
Agreement.

16.2.4 Transition. Astellas shall use Diligent Efforts to cooperate with
XenoPort and/or its designee to effect a smooth and orderly transition in the
development and sale of the Product in the Affected Area during the Wind-down
Period. Without limiting the foregoing, Astellas shall, upon written request
from XenoPort, provide XenoPort copies of customer lists, customer data and
other customer information relating to the Product in the Affected Area (except
as prevented by the applicable laws and regulations relating to the protection
of personal information), which XenoPort shall have the right to use and
disclose for any purpose after termination of this Agreement. In addition,
Astellas shall refer all inquiries after the Wind-down Period (or after the
termination of this Agreement, in case there is no Wind-down Period) regarding
the Product in the Affected Area to XenoPort or any newly appointed
distributors.

16.2.5 Return of Materials. Except for any Product in Astellas’ inventory that
is transferred to XenoPort as set forth in Section 16.2.1(b), within fifteen
(15) days after the end of the Wind-down Period (or after the termination of
this Agreement, in the event there is no Wind-down Period), Astellas shall
destroy all tangible items comprising, bearing or containing trademarks, marks,
tradenames, patents, copyrights, designs, drawings, formulas or other Data,
photographs, samples, literature, sales and promotional aids (“Product
Materials”) and Confidential Information of XenoPort, that is in Astellas’
possession, and provide written certification of such destruction, or prepare
such tangible items of Product Materials and Confidential Information for
shipment to XenoPort, as

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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XenoPort may direct, at XenoPort’s expense; provided that Astellas may retain
copies of Product Materials and Confidential Information relating to countries
in the Territory outside the Affected Area as reasonably necessary for its
continued promotion, marketing, sale and distribution of the Product in such
countries under this Agreement. Effective upon the end of the Wind-down Period
(or upon termination of this Agreement, in the event there is no Wind-down
Period), Astellas shall cease to use all trademarks and trade names of XenoPort
in the Affected Area, and all rights granted to Astellas hereunder with respect
to the Product in the Affected Area shall terminate.

16.2.6 Subdistributors. Any contracts with Subdistributors of the Product in the
Affected Area engaged by Astellas other than Astellas’ Affiliates shall, at the
request of XenoPort in its discretion, be assigned to XenoPort to the furthest
extent possible, provided that such assignment is accepted by the
Subdistributor(s) for such Affected Area. In the event such assignment is not
requested by XenoPort or is not accepted by such Subdistributor(s), then the
rights of such Subdistributors with respect to the Product in the Affected Area
shall terminate upon termination of Astellas’ rights with respect to such
Affected Area. Astellas shall ensure that its Affiliates and such
Subdistributors (if not assigned to XenoPort pursuant to this Section 16.2.6)
shall transition the Product back to XenoPort in the manner set forth in this
Section 16.2 as if such Affiliate or Subdistributor were named herein.

16.3 No Renewal, Extension or Waiver. Acceptance of any order from, or sale or
license of, any Product to Astellas after the effective date of termination of
this Agreement shall not be construed as a renewal or extension hereof, or as a
waiver of termination of this Agreement.

16.4 Survival. Upon termination of this Agreement in whole, all rights and
obligations of the parties under this Agreement shall terminate except:
(a) Sections [… * …], and (b) those provisions of this Agreement [… * …]. For
clarity, in the event this Agreement is terminated with respect to one or more
countries, but not the entire Territory, then the Affected Area shall thereafter
cease to be within the Territory for all purposes of this Agreement, but
Sections [… * …] shall survive such termination with respect to the Affected
Area.

17. DISPUTE RESOLUTION

17.1 Disputes. In the event of any dispute between the Parties arising out of or
in connection with this Agreement, either Party may, by written notice to the
other, have such dispute referred to the CEO of XenoPort and the CEO of Astellas
for attempted resolution by good faith negotiations within thirty (30) days
after such notice is received, and, in such event, each Party shall cause its
representative to meet and be available to attempt to resolve such issue.
Notwithstanding the foregoing, neither Party shall be obligated to negotiate for
more than thirty (30) days. If the Parties should resolve such dispute or claim,
a memorandum setting forth their agreement will be prepared and signed by both
Parties if requested by either Party.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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17.2 Arbitration. Any dispute, controversy or claim with respect to the breach,
interpretation or enforcement of this Agreement, including disputes relating to
termination of this Agreement that cannot be resolved pursuant to Section 17.1
(or which this Agreement directs shall be resolved pursuant to this
Section 17.2) shall be settled by binding arbitration in the manner described in
this Section 17. The arbitration shall be conducted by the Judicial Arbitration
and Mediation Services, Inc. (“JAMS”) under its rules of arbitration then in
effect. Notwithstanding those rules, the following provisions shall apply to the
arbitration hereunder:

17.2.1 Arbitrators. The arbitration shall be conducted by a single JAMS
arbitrator; provided that at the request of either Party, the arbitration shall
be conducted by a panel of three (3) arbitrators, with one (1) JAMS arbitrator
chosen by each of Astellas and XenoPort and the third appointed by the other two
(2) arbitrators. If the Parties are unable to agree upon a single arbitrator, or
the other two arbitrators are unable to agree upon the third arbitrator in case
of a panel of three (3), such single or third arbitrator (as the case may be)
shall be appointed in accordance with the rules of JAMS. In any event, the
arbitrator or arbitrators selected in accordance with this Section 17.2.1 are
referred to herein as the “Panel” and shall be comprised of arbitrators who are
familiar with worldwide research and business development in the pharmaceutical
industry, unless otherwise agreed.

17.2.2 Proceedings. Except as otherwise provided herein, the Parties and the
arbitrators shall use their best efforts to complete the arbitration within one
(1) year after the appointment of the Panel under Section 17.2.1 above, unless a
Party can demonstrate to the Panel that the complexity of the issues or other
reasons warrant the extension of one or more of the time tables. In such case,
the Panel may extend such time table as reasonably required. The Panel shall, in
rendering its decision, apply the substantive law of the State of New York,
without regard to its conflicts of laws provisions, except that the
interpretation and enforcement of this Section 17 shall be governed by the U.S.
Federal Arbitration Act. The proceeding shall take place in San Francisco,
California, United States of America. The arbitral proceedings and all
pleadings, responses and evidence shall be in the English language. If so
requested by the arbitrator(s), any evidence originally in a language other than
English shall be submitted with an English translation accompanied by an
original or true copy thereof. The decision and/or award rendered by the
arbitrator(s) shall be written, final and non-appealable, and judgment on such
decision and/or award may be entered in any court of competent jurisdiction. If
the Panel determines that it is reasonable to do so, the fees of the Panel shall
be paid by the losing Party, which Party shall be designated by the Panel.
Otherwise, the fees of the Panel shall be split equally between the Parties.
Each Party shall bear the costs of its own attorneys’ and experts’ fees;
provided that the Panel may in its discretion award the prevailing Party all or
part of the costs and expenses incurred by the prevailing Party in connection
with the arbitration proceeding.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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17.2.3 Interim Relief. Notwithstanding anything in this Section 17.2 to the
contrary, Astellas and XenoPort shall each have the right to apply to any court
of competent jurisdiction for a temporary restraining order, preliminary
injunction or other similar interim or conservatory relief, as necessary,
pending resolution under the above described arbitration procedures. Nothing in
the preceding sentence shall be interpreted as limiting the powers of the
arbitrators with respect to any dispute subject to arbitration under this
Agreement. The Panel may award injunctive relief.

18. MISCELLANEOUS

18.1 Governing Law, Venue. This Agreement and any dispute arising from the
performance or breach hereof shall be governed by, and construed and enforced in
accordance with, the laws of the State of New York, U.S.A., without reference to
conflicts of laws principles. The U.N. Convention on the Sale of Goods shall not
apply to this Agreement.

18.2 Force Majeure. Nonperformance of any Party, except for failure to pay
amounts due hereunder, shall be excused to the extent that performance is
prevented by strike, fire, earthquake, flood, acts of terrorism, governmental
acts or orders or restrictions, failure of suppliers or any other reason where
failure to perform is beyond the reasonable control of the nonperforming Party
(“Force Majeure”). In such event, Astellas or XenoPort, as the case may be,
shall promptly notify the other Party of such inability and of the period for
which such inability is anticipated to continue. Without limiting the foregoing,
the Party subject to such inability shall use reasonable efforts to minimize the
duration of any Force Majeure event.

18.3 No Implied Waivers; Rights Cumulative. No failure on the part of XenoPort
or Astellas to exercise and no delay in exercising any right under this
Agreement, or provided by statute or at law or in equity or otherwise, shall
impair, prejudice or constitute a waiver of any such right, nor shall any
partial exercise of any such right preclude any other or further exercise
thereof or the exercise of any other right.

18.4 Independent Contractors. Nothing contained in this Agreement is intended
implicitly, or is to be construed, to constitute XenoPort or Astellas as
partners in the legal sense. No Party hereto shall have any express or implied
right or authority to assume or create any obligations on behalf of or in the
name of any other Party or to bind any other Party to any contract, agreement or
undertaking with any third party. This Agreement does not create a partnership
for United States federal income tax purposes (as defined in Section 761 of the
United States Internal Revenue Code), for any state or local jurisdiction in the
United States or in any country other than the United States. Therefore, except
for filing regarding withholding tax which, if not filed, shall be imposed upon
royalties and milestone payments paid under this Agreement, there is no
requirement to file Form 1065, United States Partnership Return of Income, any
similar state or local income tax return or any similar document with tax
authorities in any country other than the United States.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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18.5 Notices. All notices, requests and other communications hereunder shall be
in writing and shall be personally delivered or sent by registered or certified
airmail, return receipt requested, postage prepaid, in each case to the
respective address specified below, or such other address as may be specified in
writing to the other Parties hereto:

 

Astellas:    Astellas Pharma Inc.    3-11, Nihonbashi-Honcho 2-chome   
Chuou-ku, Tokyo, 103-8411, Japan    Attn: Vice President, Licensing, Corporate
Strategy    Fax: +81-3-5203-7164 With a copy to:    Astellas Pharma Inc.   
3-11, Nihonbashi-Honcho 2-chome    Chuou-ku, Tokyo, 103-8411, Japan    Attn:
Vice President, Legal, Corporate Administration    Fax: +81-3-3244-5811
XenoPort:    XenoPort, Inc.    3410 Central Expressway    Santa Clara,
California 95051,    United States of America    Attn: CEO    Fax: +1 (408)
616-7211 with a copy to:    Wilson Sonsini Goodrich & Rosati    650 Page Mill
Road    Palo Alto, California 94304-1050    United States of America    Attn:
Kenneth A. Clark, Esq.    Fax: +1 (650) 493-6811

18.6 Assignment. This Agreement shall not be assignable by either Party to any
Third Party hereto without the written consent of the other Party hereto; except
either Party may assign this Agreement without the other Party’s consent to an
entity that acquires substantially all of the business or assets of the
assigning Party, whether by merger, acquisition or otherwise, provided that the
acquiring Party assumes this Agreement in writing or by operation of law. In
addition, either Party shall have the right to assign this Agreement to a
Subsidiary upon written notice to the non-assigning Party; provided that the
assigning Party guarantees the performance of this Agreement by such Subsidiary,
and further provided that if the non-assigning Party reasonably believes such
assignment could result in material adverse tax consequences to the
non-assigning Party, such assignment shall not be made without the non-assigning
Party’s consent. Subject to the foregoing, this Agreement shall inure to the
benefit of each Party, its successors and permitted assigns. Any assignment of
this Agreement in contravention of this Section 18.6 shall be null and void.

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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18.7 Modification. No amendment or modification of any provision of this
Agreement shall be effective unless in writing signed by all Parties hereto. No
provision of this Agreement shall be varied, contradicted or explained by any
oral agreement, course of dealing or performance or any other matter not set
forth in an agreement in writing and signed by all Parties.

18.8 Severability. If any provision hereof should be held invalid, illegal or
unenforceable in any jurisdiction, the Parties shall negotiate in good faith a
valid, legal and enforceable substitute provision that most nearly reflects the
original intent of the Parties and all other provisions hereof shall remain in
full force and effect in such jurisdiction and shall be liberally construed in
order to carry out the intentions of the Parties hereto as nearly as may be
possible. Such invalidity, illegality or unenforceability shall not affect the
validity, legality or enforceability of such provision in any other
jurisdiction. In the event a Party seeks to avoid a provision of this Agreement
by asserting that such provision is invalid, illegal or otherwise unenforceable,
the other Party shall have the right to terminate this Agreement upon sixty (60)
days’ prior written notice to the asserting Party, unless such assertion is
eliminated and the effect of such assertion is cured within such sixty (60) day
period. Any termination in accordance with the foregoing sentence shall be
deemed an election by Astellas to terminate pursuant to Section 15.2 if XenoPort
exercises its right to terminate under this Section 18.8, and a termination for
the breach of XenoPort pursuant to Section 15.3 if Astellas exercises its right
to terminate under this Section 18.8.

18.9 Counterparts. This Agreement may be executed in two counterparts, each of
which shall be deemed an original, and all of which, together, shall constitute
one and the same instrument.

18.10 Headings. Headings used herein are for convenience only and shall not in
any way affect the construction of, or be taken into consideration in
interpreting, this Agreement.

18.11 Export Laws. Notwithstanding anything to the contrary contained herein,
all obligations of XenoPort and Astellas are subject to prior compliance with
United States and foreign export regulations and such other United States and
foreign laws and regulations as may be applicable, and to obtaining all
necessary approvals required by the applicable agencies of the governments of
the United States and foreign jurisdictions. XenoPort and Astellas shall
cooperate with each other and shall provide assistance to the other as
reasonably necessary to obtain any required approvals.

[continued on next page]

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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18.12 Entire Agreement. This Restated License Agreement, together with all the
Exhibits thereto, constitute the entire agreement, both written or oral, with
respect to the subject matter hereof, and supersede all prior or contemporaneous
understandings or agreements, whether written or oral, between XenoPort and
Astellas with respect to such subject matter on and after the Restatement
Effective Date. The Original Agreement shall govern the rights and obligations
between the Parties prior to the Restatement Effective Date, and this Restated
License Agreement shall govern the rights and obligations between the Parties on
and after the Restatement Effective Date.

IN WITNESS WHEREOF, the Parties hereto have caused this Restated License
Agreement to be duly executed and delivered in duplicate originals as of the
Restatement Effective Date.

 

XENOPORT, INC.     ASTELLAS PHARMA, INC. By:   

/s/ Ronald W. Barrett

    By:  

/s/ Chihiro Yokota

Name:   

Ronald W. Barrett

   

Name:

 

Chihiro Yokota

Title:   

Chief Executive Officer

    Title:  

Vice President, Licensing and Alliances

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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EXHIBIT A

COMPOUND

[… * …]

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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EXHIBIT B

XENOPORT PATENT RIGHTS

[… * …]

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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EXHIBIT C

INITIAL DEVELOPMENT PLAN

[… * …]

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.