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.
DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT
THIS DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT (“ Agreement ”)
dated as of February 7, 2007 (“ Effective Date
”), is entered into between XenoPort, Inc., a Delaware
corporation having its principal place of business at 3410 Central
Expressway, Santa Clara, CA 95051 (“ XenoPort ”)
and Glaxo Group Limited, a company existing under the laws of
England and Wales, having its registered office at Glaxo Wellcome
House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, England
(“ GSK ”).
A. XenoPort
is developing a Transported Prodrug™ of gabapentin (as
further defined below, the “ Product ”) for the
treatment of restless leg syndrome (“ RLS ”) and
the management of neuropathic pain. XenoPort owns or controls
certain patents, know-how and other intellectual property relating
to such Product;
B. GSK
desires to co-develop and co-commercialize the Product with
XenoPort in the United States (as hereinafter defined), and to
further develop and commercialize the Product in other countries in
the Territory (as hereinafter defined), and XenoPort desires to
have the Product developed and commercialized in the Territory by
and with GSK, in accordance with this Agreement; and
C. GSK
desires to obtain from XenoPort certain distribution and license
rights for the Product in the Territory, and XenoPort is willing to
grant to GSK such rights on the terms and conditions set forth in
this Agreement;
NOW, THEREFORE, in
consideration of the foregoing premises and the mutual covenants
herein contained, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the
Parties (as hereinafter defined) hereby agree as
follows:
As used in this
Agreement, the following capitalized terms will have the meanings
set forth in this Article 1 when used in this
Agreement.
1.1 “
Affiliate ” of a Party shall mean any Person that,
directly or indirectly through one or more intermediaries,
controls, is controlled by or is under common control with such
Party, as the
case may be,
for as long as such control exists. As used in this
Section 1.1, “ control ” shall mean:
(a) to possess, directly or indirectly, the power to direct
the management and policies of such Person, whether through
ownership of voting securities or by contract relating to voting
rights or corporate governance; or (b) direct or indirect
beneficial ownership of at least fifty percent (50%) (or such
lesser percentage that is the maximum allowed to be owned by a
foreign corporation in a particular jurisdiction) of the voting
share capital in such Person. A “ Controlled Affiliate
” is an Affiliate that [... * ...] .
1.2 “
Annual Net Sales ” shall mean total Net Sales in a
country or countries in the Territory in a particular calendar
year.
1.3 “
Anti-Kickback Statute ” means the Medicare and
Medicaid Anti-Kickback Statute set forth at 42 U.S.C.
§1320a-7b(b).
1.4 “
Applicable Commercial Practices Policies ” means the
portions as identified by GSK of the Commercial Practices Policies
of GSK applicable (and as applied generally to GSK’s own
personnel) to the marketing, sale, promotion and detailing of
pharmaceutical products, as amended or supplemented by GSK from
time to time, a copy of which will be delivered to XenoPort prior
to XenoPort Co-Promoting and Detailing the Product and/or Detailing
the REQUIP™ Products in the United States and updated copies
will thereafter be delivered to XenoPort as and when amended or
supplemented.
1.5 “
Applicable Laws ” means the applicable provisions of
any and all national, supranational, regional, state and local
laws, treaties, statutes, rules, regulations, administrative codes,
guidances, ordinances, judgments, decrees, directives, injunctions,
orders, permits (including Marketing Approvals) of or from any
court, arbitrator, Regulatory Authority or governmental agency or
authority having jurisdiction over or related to the subject
item.
1.6 “
Asian Territory ” shall mean Indonesia, Japan, Korea,
Philippines, Taiwan and Thailand.
1.7 “
Astellas ” shall mean Astellas Pharma Inc. and its
Affiliates, and any other Third Parties to whom Astellas or
XenoPort has granted a right to sell, market, distribute and/or
promote a Product in a country in the Asian Territory. To the
extent Astellas’ rights in the Asian Territory terminate and
XenoPort grants rights to a Third Party, references herein to
Astellas shall be deemed to reference such Third Party.
1.8 “
Astellas Agreement ” shall mean the Distribution and
License Agreement dated December 1, 2005 between XenoPort and
Astellas.
1.9 “
Astellas Know-How ” shall mean any scientific,
medical, technical, marketing, regulatory and/or other information,
data and materials (including, preclinical data, clinical data,
clinical pharmacology data and regulatory filings and approvals
submitted or obtained, together with
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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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its supporting
data and regulatory correspondence and rights to reference the
same) primarily relating to the Compound and/or any Product, which
is Controlled by Astellas as of the Effective Date or during the
Term; provided, however, that [... * ...] .
1.10 “
Call ” shall mean a face-to-face meeting in an
individual, hospital or group setting between a Sales
Representative and one or more members of the Target
Audience.
1.11 “
Change of Control ” shall mean either: (a) a sale
of all or substantially all of the assets of a Party in one or a
series of integrated transactions not in the ordinary course of
business to a Third Party; or (b) the acquisition of a Party
by a Third Party by means of any transaction or series of related
transactions to which such Party is a party (including, any stock
acquisition, merger or consolidation). For clarity, a Change of
Control would not include any transaction or series of transactions
in which the holders of voting securities of a Party outstanding
immediately prior to such transaction continue to retain (either by
such voting securities remaining outstanding or by such voting
securities being converted into voting securities of the surviving
entity), as a result of shares in the Party held by such holders
prior to such transaction, fifty percent (50%) or more of the total
voting power represented by the voting securities of the acquiring
entity outstanding immediately after such transaction or series of
transactions.
1.12 “
Commercially Reasonable Efforts ” shall mean that
level of efforts and resources consistent with the usual practice
followed by a Party in the exercise of reasonable business
discretion relating to other pharmaceutical products owned by it or
to which it has exclusive rights, which is of similar market
potential and at a similar stage in development or product life,
taking into account issues of patent coverage, safety and efficacy,
product profile, the competitiveness of the marketplace, the
proprietary position of the compound or product, the regulatory
structure involved, the profitability of the products (including,
without limitation, pricing and reimbursement status achieved), and
other relevant factors, including without limitation technical,
legal, scientific, and/or medical factors.
1.13 “
Compound ” shall mean that certain compound, referred
to internally at XenoPort as XP13512, the structure of which is set
forth on Exhibit 1.13 , and all esters, hydrates,
metabolites [... * ...] , salts, solvates, isomers and/or
mixtures of isomers thereof.
1.14 “
Control ” (including any variations such as “
Controlled ” and “ Controlling ”),
in the context of intellectual property rights of a Party, shall
mean that such Party or its Controlled Affiliate owns or possesses
rights to intellectual property sufficient to grant the applicable
license under this Agreement, without violating the terms of an
agreement with a Third Party.
1.15 “
Co-Promotion ” (including any variations such as
“ Co-Promote ”) shall mean those promotional and
sales activities undertaken by a pharmaceutical company’s
sales force in concert with at least one other pharmaceutical
company’s sales force in a single territory to implement the
marketing and/or sales plans with respect to a particular
prescription pharmaceutical product under the same trademark in
such territory.
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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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1.16 “
Data ” shall mean any and all research data,
pharmacology data, preclinical data, clinical data and/or all
regulatory documentation, information and submissions pertaining
to, or made in association with an IND, Marketing Approval
Application, Marketing Approval or the like for the Product, in
each case that are Controlled by a Party or its Controlled
Affiliates as of the Effective Date or during the Term.
1.17 “
Detail ” (including any variations such as “
Detailing ”) shall mean that part of the activity
undertaken by a Sales Representative during a Call whereby a Sales
Representative, who has been trained with respect to the
REQUIP™ Products or the Product, as applicable, in accordance
with Section 5.4(c), makes a presentation: (a) describing
[... * ...] as applicable; (b) which may also include
[... * ...] ; and (c) in accordance with the [... *
...] , as applicable. [... * ...] , shall not constitute
a Detail. [... * ...] as applicable, shall not constitute a
Detail. As used herein, a [... * ...] in which [... *
...] (as consistent with industry norms) [... * ...]
.
1.18 “
EMEA ” shall mean the European Medicines Agency of the
European Union, or any successor entity thereto performing similar
functions.
1.19 “
Existing Phase III Studies ” shall mean those certain
Phase III clinical studies [... * ...]
1.20 “
FDA ” shall mean the United States Food and Drug
Administration, or any successor entity thereto performing similar
functions.
1.21 “
FD&C Act ” means the federal Food, Drug and
Cosmetic Act, as amended, and the regulations promulgated
thereunder from time to time.
1.22 “
Field ” shall mean the diagnosis, palliation,
treatment and/or prevention of any disease or health condition in
humans.
1.23 “
Filing ” of an MAA shall be deemed to occur on the
date of receipt of written notice of acceptance from the FDA in the
United States, or other relevant Regulatory Authority outside of
the United States, of such MAA for substantive review. Validation
of an MAA by the EMEA shall be deemed to constitute acceptance of
such MAA for substantive review in a Major Market (other than the
United States) and, if an MAA is submitted under the EU mutual
recognition procedure and validated by the relevant Regulatory
Authority in the reference member state, such MAA shall be deemed
to be accepted in a Major Market (other than the United States)
upon confirmation that the resulting approval in the reference
member state will serve as the basis for a mutual recognition
procedure in such Major Market (other than the United
States).
1.24 “
First Commercial Sale ” shall mean, on a
country-by-country basis and Product-by-Product basis, 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 for use or consumption by the general public of such
Product in such country. Sales of a Product for registration
samples, compassionate use sales,
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*
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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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named patient
use, inter-company transfers to Affiliates of a Party and the like
will not constitute a First Commercial Sale.
1.25 “
GSK Know-How ” shall mean all scientific, medical,
technical, marketing, regulatory and other information primarily
relating to the Product (including Data), which are Controlled by
GSK or its Controlled Affiliates during the Term, that are needed
by or reasonably useful to XenoPort in order for XenoPort to
exercise its rights or perform its obligations under this Agreement
and the Astellas Agreement; provided, however, that [... *
...] .
1.26 “
GSK Trademarks ” shall mean the Trademarks Controlled
by GSK or its Controlled Affiliates as of the Effective Date or
during the Term, which are used with the Products in the Field in
the Territory.
1.27 “
IND ” shall mean any Investigational New Drug
Application (including any amendments thereto) filed with the FDA
pursuant to 21 C.F.R. §321 before the commencement of clinical
trials of a Product, or any comparable filings with any Regulatory
Authority in any other jurisdiction.
1.28 “
Major Market ” shall mean the United States, France,
Germany, Italy, Spain and/or the United Kingdom.
1.29 “
Major Pharmaceutical Company ” shall mean a company
that is engaged in the business of selling pharmaceutical products,
whose revenues from such sales (on a consolidated basis in the last
full fiscal year prior to the closing of any Change of Control) was
in excess of [... * ...] . Any Affiliate of such company
shall be deemed to be a Major Pharmaceutical Company.
1.30 “
Marketing Approval ” shall mean all approvals,
licenses, registrations or authorizations of the Regulatory
Authority in a country, necessary for the manufacture, use,
storage, import, marketing and sale of a Product in such country.
For countries where governmental or other similar approval of
pricing and/or reimbursement is required for marketing in such
country, Marketing Approval shall not be deemed to occur until such
pricing or reimbursement approval is obtained. Notwithstanding the
foregoing, Marketing Approval shall be deemed to have occurred for
a particular indication for a Product in such jurisdiction upon the
First Commercial Sale of such Product in such jurisdiction with
labeling for such indication.
1.31 “
Marketing Approval Application ” (or “
MAA ”) shall mean a NDA submitted to the FDA in the
United States or a corresponding application for Marketing Approval
that has been submitted to a Regulatory Authority in any other
country in the Territory.
1.32 “
NDA ” shall mean a New Drug Application as defined in
Title 21 of the U.S. Code of Federal Regulations,
Section 314.50, et seq., which is filed with the FDA in order
to gain the FDA’s approval to commercialize a pharmaceutical
product in the United States for the indications set forth in the
New Drug Application.
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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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1.33 “
Net Sales ” shall mean the gross invoice price by GSK
or its Affiliates or Sublicensees, as the case may be, for all
Products sold by of GSK, its Affiliates or Sublicensees (“
Selling Party ”) under this Agreement in a country or
countries in the Territory in arm’s length sales to Third
Parties less the following deductions that are actually incurred,
allowed, paid, accrued or specifically allocated to the extent that
such amounts are deducted from gross invoiced sales amounts as
reported by the Selling Party in its financial statements in
accordance with the International Financial Reporting Standards
(“ IFRS ”), applied on a consistent
basis:
(a) trade,
quantity and cash discounts and allowances;
(b) credits,
rebates and charge backs or equivalents thereof (including those to
managed-care entities, national, state/provincial, local and other
governments, their agencies and purchasers, and to trade
customers);
(c) allowances
or credits to customers on account of rejection or returns
(including wholesaler and retailer returns), retroactive price
reductions affecting such Product or billing errors;
(d) freight,
postage and duties, and transportation charges relating to such
Product (including handling and insurance thereto) separately
identified on the invoice or other documentation maintained in the
ordinary course of business;
(e) sales
(such as value-added tax or its equivalent) and excise taxes, other
consumption taxes, customs duties and compulsory payments to
governmental authorities and any other governmental charges imposed
upon the sale of a Product to Third Parties;
(f) commissions
allowed or paid to Third Party wholesalers, or other similar Third
Party distributors, in each case who do not engage in marketing or
promotion of the Product;
(g) [...
* ...] bad debt reported [... * ...] in which [... *
...] or [... * ...] or [... * ...] in which
[... * ...] ; and
(h) any other
items actually deducted from (and therefore not included as) gross
invoiced sales amounts in determining revenue, and not otherwise
included as an item of income or the like, as reported by a Selling
Party in its financial statements in accordance with the IFRS,
applied on a consistent basis.
Sales between GSK
and its Affiliates or Sublicensees for resale shall be excluded
from the computation of Net Sales, and no payments will be payable
on such sales except where such Affiliates or Sublicensees are end
users. If a Product is sold or transferred for consideration other
than cash, the Net Sales from such sale or transfer shall be deemed
the then fair market value of such Product. [... *
...]
In the event that
[... * ...] the Net Sales [... * ...] shall be
[... * ...] during the applicable reporting period [... *
...] in which [... * ...] In the event that [... *
...] then Net Sales for purposes
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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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of [... *
...] shall be [... * ...] on the [... * ...]
shall not [... * ...] If [... * ...] as provided in
this paragraph, the matter shall be resolved in accordance with
Section 18.2 below.
1.34 “
Neuropathic Pain Indication ” shall mean an indication
for the Product involving [... * ...] .
1.35 “
Party ” shall mean XenoPort or GSK individually, and
“ Parties ” shall mean XenoPort and GSK
collectively.
1.36 “
Patent(s) ” shall mean any patents and patent
applications, together with all additions, divisions,
continuations, continuations-in-part, substitutions, reissues,
re-examinations, extensions, registrations, patent term extensions,
supplemental protection certificates and renewals of any of the
foregoing.
1.37 “
PDMA ” means the federal Prescription Drug Marketing
Act of 1987, as amended, and the regulations promulgated thereunder
from time to time.
1.38 “
Person ” means any individual, corporation,
partnership, firm, association, joint venture, joint stock company,
trust or other entity, or any government or regulatory
administrative or political subdivision or agency, department or
instrumentality thereof.
1.39 “
Phase I ” shall mean a human clinical trial, the
principal purpose of which is to demonstrate safety, tolerability
and pharmacokinetics of the Product in volunteer or patient
subjects, as further described in 21 C.F.R. §312.21(a)
(including, any such clinical study in any country other than the
United States).
1.40 “
Phase III ” shall mean a human clinical trial, the
principal purpose of which is to establish safety and efficacy of
the Product in patients with the disease being studied, as further
described in 21 C.F.R. §312.21(c) (including, any such
clinical study in any country other than the United States), which
is designed and intended to be of a size and statistical power
sufficient to serve as a pivotal study to support the filing of an
MAA for the indication being studied.
1.41 “
Phase IV ” shall mean a human clinical trial conducted
with respect to a Product: (a) after [... * ...] ;
(b) within the [... * ...] ; and (c) intended as
[... * ...] . Phase IV studies may include, for example,
[... * ...] , and the like. Phase IV studies shall not
include any human clinical trials: (i) [... * ...] ; and/or
(ii) from which [... * ...] for the purposes of:
[... * ...] or [... * ...] provided that in the case
of paragraph (ii), [... * ...] .
1.42 “
PhRMA Code ” means the PhRMA Code on Interactions with
Health Care Professionals, as amended.
1.43 “
Product ” shall mean any pharmaceutical product
containing the Compound, alone or in combination with one or more
other active pharmaceutical ingredients, in any dosage form or
formulation.
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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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1.44 “
Promotional Materials ” means all written, printed,
video or graphic advertising, promotional, educational and
communication materials [... * ...] for marketing,
advertising, promotion and sale of the Product or the REQUIP™
Products, as applicable, for use in the United States (a) [... *
...] .
1.45 “
Regulatory Authority ” shall mean the FDA, or a
regulatory body with similar regulatory authority in any other
jurisdiction within the Territory.
1.46 “
Regulatory Filing ” means all approvals, licenses,
registrations, submissions and authorizations made to or received
from a Regulatory Authority in a country necessary for the
development, manufacture and/or commercialization of a
pharmaceutical product in the Territory, including any INDs,
Marketing Approval Applications and Marketing Approvals.
1.47 “
REQUIP™ Products ” shall mean those certain
pharmaceutical products Controlled by GSK or its Affiliates as of
the Effective Date, which contain ropinirole HCL as an active
ingredient and are known as of the Effective Date as REQUIP CR and
REQUIP XL 24h.
1.48 “
REQUIP™ Trademarks ” shall mean shall mean the
Trademarks Controlled by GSK or its Affiliates as of the Effective
Date and during the Term, which are used with the REQUIP™
Products in the Field in the Territory.
1.49 “
RLS Indication ” shall mean an indication for the
Product involving RLS.
1.50 “
Sales Representative ” shall mean a professional
pharmaceutical sales representative engaged or employed by either
Party to conduct sales activities and other promotional efforts
with respect to a Product and/or the REQUIP™
Products.
1.51 “
Samples ” shall mean individual physician sample units
of the Product or the REQUIP™ Products, as
applicable.
1.52 “
Sublicensee ” shall mean a Third Party to whom GSK has
granted a right to sell, market, distribute and/or promote a
Product in the Territory pursuant to Section 2.2 and “
Sublicense ” shall mean an agreement or arrangement
between GSK and a Sublicensee granting such rights. As used in this
Agreement, “Sublicensee” shall not include a wholesaler
or reseller of a Product who does not market or promote such
Product.
1.53 “
Target Audience ” means those health care
professionals legally permitted to prescribe the Product or the
REQUIP™ Products, as applicable, or issue hospital orders for
the Product or the REQUIP™ Products, as applicable, in each
case in the United States, or those other allied professionals that
are part of the treatment team and who are recognized for this
purpose in the Co-Promotion Plan or the REQUIP™ Sales Plan,
as applicable.
1.54 “
Territory ” shall mean worldwide, except for the Asian
Territory.
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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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1.55 “
Third Party ” shall mean any Person other than
XenoPort, GSK and their respective Affiliates.
1.56 “
Trademarks ” means registered and unregistered
trademarks, including words and logos, and any applications for
registrations thereof, and intellectual property rights residing in
such trademarks, including copyrights and design rights.
1.57 “
United States ” or “ U.S. ” means
the fifty (50) states of the United States of America and the
District of Columbia.
1.58 “
XenoPort Know-How ” shall mean all scientific,
medical, technical, regulatory and other information primarily
relating to the Compound and the Product (including the Data),
which are Controlled by XenoPort or its Controlled Affiliates as of
the Effective Date or during the Term, that were generated or
utilized by XenoPort or its Controlled Affiliates in developing or
producing the Product or are otherwise reasonably necessary for GSK
to exercise its rights or perform its obligations under this
Agreement; provided, however, that [... * ...] .
1.59 “
XenoPort Patents ” shall mean: (a) the Patents
Controlled by XenoPort or its Controlled Affiliates listed on
Exhibit 1.59 , together with all additions, divisions,
continuations, substitutions, re-issues, re-examinations,
extensions, registrations, patent term extensions, supplemental
protection certificates and renewals of any such Patents; and
(b) all [... * ...] .
1.60 “
XenoPort Trademarks ” shall mean the Trademarks
Controlled by XenoPort or its Controlled Affiliates and reflected
in Exhibit 1.60 hereto, the applications for which have
been filed in the name of XenoPort, or another mutually agreed
Trademark Controlled by XenoPort or its Affiliates, in each case
for use with the Products in the Field in the Territory.
1.61 Additional
Definitions. Each of the following terms shall have the meaning
described in the corresponding section of this Agreement indicated
below:
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Term
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Section
Defined
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Term
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Section
Defined
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9.1(d)
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Infringement
Actions
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12.4
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Exhibit
6.5
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JAMS
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18.2
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Additional Sales Representatives
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5.2(e)
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Joint
Commercialization Committee / JCC
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3.3(a)
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Introduction
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Joint
Development Committee / JDC
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3.2(a)
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3.7
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Joint
P&L
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6.5(c)
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Asian Territory Agreement
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8.4(a)(ii)
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[... *
...]
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6.2(c)(v)
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7.4(a) /
7.4(b)
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Liabilities
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17.1
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Clinical Studies and Activities
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4.3(a)
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[... *
...]
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Exhibit
6.5
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1.33
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[... *
...]
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5.2(d)(ii)
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5.1(b)
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3.4(a)
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[... *
...]
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5.2(e)
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*
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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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Term
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Section
Defined
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Term
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Section
Defined
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6.2(c)(i)
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More
Favorable
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8.4(c)
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Negotiation
Period
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8.4(a)(ii)
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12.3(a)
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[... *
...]
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4.6(a)
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6.2(c)(ii)
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Operating
Profit/Loss Percentage
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6.5(c)
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11.1
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Operating
Profits or Loss
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Exhibit
6.5
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8.4(d)(ii)
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[... *
...]
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Exhibit
6.5
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9.1(d)
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Payment
Report
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6.3(c)
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11.5
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[... *
...]
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1.34
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Personnel
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5.4(h)
|
|
|
|
5.5
|
|
[... *
...]
|
|
1.34
|
|
|
|
5.2(a)
|
|
[... *
...]
|
|
6.2(c)(vi)
|
|
|
|
5.2(b)
|
|
Product
Materials
|
|
15.2(g)
|
|
|
|
|
|
Prosecution and
Maintenance
|
|
12.2(a)
|
|
|
|
5.2(d)(i)
|
|
Re-Offer
Notice
|
|
8.4(a)(iii)(A)
|
|
|
|
Exhibit
6.5
|
|
Requesting
Party
|
|
11.5
|
|
|
|
12.4
|
|
REQUIP™
Materials
|
|
15.2(i)
|
|
|
|
4.1(a)
|
|
REQUIP™
Sales Plan
|
|
5.3(b)
|
|
|
|
6.2(c)(iii) /
6.2(c)(iv)
|
|
|
|
|
|
|
|
18.1
|
|
Reversion
Notice
|
|
8.4(a)(i)
|
|
|
|
19.2
|
|
Revised
Terms
|
|
8.4(a)(iii)(A)
|
|
|
|
|
|
RLS
|
|
Recitals
|
|
|
|
Introduction
|
|
[... *
...]
|
|
Exhibit
6.5
|
|
|
|
8.4(a)(ii)
|
|
Selling
Party
|
|
1.33
|
|
|
|
3.6
|
|
[... *
...]
|
|
3.6
|
Executive
Steering
Committee / ESC
|
|
3.1(a)
|
|
Subcommittee
|
|
3.1(c)
|
|
|
|
|
|
Sublicense
|
|
1.52
|
|
|
|
19.2
|
|
Supply
Transition Date
|
|
10.1
|
|
|
|
6.4(c)
|
|
Supply
Transition Plan
|
|
10.1
|
|
|
|
6.4(c)
|
|
Term
|
|
14.1
|
|
|
|
Introduction
|
|
Third Party
Claim
|
|
17.1
|
|
|
|
17.2
|
|
Third Party
Royalties
|
|
6.4(a)
|
GSK Prosecuted XP Patents
|
|
12.2(a)
|
|
[... *
...]
|
|
2.3(c)
|
|
|
|
6.5(c)
|
|
Wind-down
Period
|
|
15.2(a)(ii)
|
|
|
|
19.1
|
|
Withdrawal
Notice
|
|
3.4(b)
|
|
|
|
19.1
|
|
[... *
...]
|
|
6.2(c)(vii)
|
|
|
|
19.1
|
|
XenoPort
|
|
Introduction
|
|
|
|
1.33
|
|
XenoPort House
Marks
|
|
13.3
|
|
|
|
12.1
|
|
XenoPort
Indemnitees
|
|
17.1
|
|
|
|
12.1
|
|
XenoPort
Operating Expenses
|
|
6.5(c)
|
|
|
|
17.3
|
|
XenoPort
Prosecuted Patents
|
|
12.2(b)
|
|
|
|
17.3
|
|
XenoPort
Trademarks Option
|
|
13.2
|
|
|
|
12.3(a)
|
|
|
|
|
|
|
|
|
|
*
|
|
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 .
|
- 10 -
2.1 License
. Subject to the terms and conditions of this Agreement, XenoPort
hereby grants to GSK an exclusive license, with the right to grant
sublicenses as provided in Section 2.2, under the XenoPort
Patents and XenoPort Know-How to develop, use, make, have made,
offer for sale, sell, import, market, distribute and promote the
Compound and Products, in each case solely in the Field in the
Territory. The rights and licenses in this Section 2.1 shall
be exclusive even as to XenoPort, except with respect to: (a)
[... * ...] in accordance with [... * ...] (b)
[... * ...] in accordance with [... * ...] (c)
[... * ...] in accordance with [... * ...] (d)
[... * ...] and (e) [... * ...] .
(a) GSK shall
have the right to sublicense its rights under this Agreement:
(i) in any country in the Territory to its Affiliates;
(ii) to a Third Party in a particular country in the Territory
if neither GSK nor any of its Affiliates have direct sales
operations in such country; and (iii) to Third Parties to
permit such Third Parties to provide services to and on behalf of
GSK relating to the manufacturing or development of the Product, in
each case of (i) through (iii) without the consent of
XenoPort. GSK may sublicense its rights as provided in this
Section 2.2(a) to such Affiliates solely for so long as such
Person remains an Affiliate.
(b) Except as
otherwise provided in Section 2.2(a), GSK may engage
Sublicensees and grant Sublicenses in any country in the Territory
[... * ...] To the extent that [... * ...] In
addition, [... * ...] to the same extent [... * ...]
. Promptly following the execution of each Sublicense as provided
in this Section 2.2(b), [... * ...] .
2.3 Activities
Outside the Territory.
(a) GSK
agrees that neither it, nor any of its Controlled Affiliates, will
sell or provide the Compound or the Products to any Third Party if
GSK or its relevant Controlled Affiliate knows, or has reason to
believe, that the Compound and/or the Products, as the case may be,
sold or provided to such Third Party would be sold or transferred,
directly or indirectly, for use in the Asian Territory.
(b) XenoPort
agrees that it and its Affiliates will not, and that it will use
Commercially Reasonable Efforts to exercise its rights under any
agreements with Astellas (including the Astellas Agreement) to
cause Astellas not to, sell or provide the Compound or
the
|
|
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|
|
*
|
|
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 .
|
- 11 -
Product to any
Third Party if XenoPort, its relevant Affiliate or Astellas knows,
or has reason to believe, that the Compound and/or the Products, as
the case may be, sold or provided to such Third Party would be sold
or transferred, directly or indirectly, for use in the Territory;
provided, however, that nothing in this Agreement (including this
Section 2.3(b)) shall be deemed to [... * ...] ; and
provided, further, that: (i) XenoPort shall [... * ...]
; and (ii) XenoPort will [... * ...] and/or [... *
...] to the extent that [... * ...] and provided that
[... * ...] .
(c) Subject
to [... * ...] with respect to [... * ...] , XenoPort
agrees to keep GSK reasonably informed through the JDC of [... *
...] relating to [... * ...] to the extent XenoPort
[... * ...] XenoPort represents to GSK that XenoPort [...
* ...] In addition, XenoPort agrees to [... * ...] or
the [... * ...] and/or [... * ...] and/or [... *
...] .
2.4 No Other
Rights . Except for the rights and licenses expressly granted
in this Agreement, XenoPort retains all rights under its
intellectual property, and no additional rights shall be deemed
granted to GSK by implication, estoppel or otherwise. For clarity,
the licenses and rights granted in this Agreement shall not be
construed to convey any licenses or rights under the XenoPort
Patents with respect to any active pharmaceutical ingredient other
than the Compound.
3.1 Executive
Steering Committee .
(a)
Establishment . Within thirty (30) days following the
HSR Clearance Date, XenoPort and GSK shall establish an Executive
Steering Committee (“ Executive Steering Committee
” or “ ESC ”) to oversee, review and
coordinate the activities of the Parties under this Agreement,
including, the development of the Product for registration, and the
marketing, commercialization and distribution of Products, in the
Field in the Territory, subject to the provisions of this
Article 3.
(b)
Duties . The ESC shall:
(i) Review
and approve material changes to the Development Plan;
(ii) Review
and approve material changes to the Commercialization Plan for the
United States in the event that XenoPort has exercised the
Co-Promotion Option as provided in Section 5.2(a);
(iii) Review
the Commercialization Plan for each Major Market country
(including, in the event that XenoPort has not exercised the
Co-Promotion Option as provided in Section 5.2(a), 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 .
|
- 12 -
(iv) Provide
a forum for the Parties to exchange information and coordinate
their respective activities with respect to matters pertaining to
the development, manufacture, marketing and distribution of the
Products in the Territory, and matters pertaining to Regulatory
Filings for the Product in the Territory;
(v) Provide
a forum for resolving matters to be decided by the JDC or JCC under
this Agreement;
(vi) Provide
a forum to review with XenoPort decisions by GSK regarding material
development, regulatory, manufacturing and commercial matters
pertaining to the Product in the Territory that are not decided by
the JDC or the JCC; and
(vii) Perform
such other duties as are specifically assigned to the ESC in this
Agreement.
(c)
Subcommittees . From time to time, the ESC may establish
subcommittees to oversee particular projects or activities within
the scope of authority of the ESC, as it deems necessary or
advisable (each, a “ Subcommittee ”). Each
Subcommittee shall consist of such number of representatives of
each Party as the ESC determines is appropriate from time to time.
Each Subcommittee shall meet with such frequency as the ESC shall
determine. Each Subcommittee shall operate by unanimous vote in all
decisions, with each Party having one (1) vote and with at
least one (1) representative from each Party participating in
such vote. If, with respect to a matter that is subject to a
Subcommittee’s decision-making authority, the Subcommittee
cannot reach unanimity, the matter shall be referred to the ESC,
which shall resolve such matter in accordance with
Section 3.6.
3.2 Joint
Development Committee .
(a)
Establishment . Within thirty (30) days following the
HSR Clearance Date, GSK and XenoPort shall establish a joint
development committee (“ Joint Development Committee
” or “ JDC ”) to plan, oversee and
coordinate the conduct of the development activities for the
Product in the Territory.
(b)
Duties . The JDC shall:
(i) Subject
to oversight by the ESC, determine the Development Plan in
accordance with Section 4.1;
(ii) Subject
to and within the parameters of the Development Plan:
(A) Oversee
the implementation of the Development Plan, allocate
responsibilities to each Party in connection with executing the
Development Plan and review each Party’s execution of its
responsibilities under the Development Plan (including review of
the clinical trials conducted by each Party pursuant to the
Development Plan); 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 .
|
- 13 -
(B) Approve
certain regulatory matters as provided in Section 4.7
below;
(iii) Present
any proposed revisions or amendments to the Development Plan, and
the results of development efforts, to the ESC as needed, but no
less frequently than once each calendar half-year;
(iv) Oversee
XenoPort’s conduct of the Clinical Studies and Activities;
and
(v) Perform
such other duties as are specifically assigned to the JDC in this
Agreement or delegated to the JDC by the ESC.
3.3 Joint
Commercialization Committee .
(a)
Establishment . Within thirty (30) days after
XenoPort’s election to exercise its Co-Promotion Option under
Section 5.2(a) below, GSK and XenoPort shall establish a joint
commercialization committee (“ Joint Commercialization
Committee ” or “ JCC ”) to oversee the
conduct of the commercialization, marketing and Co-Promotion
activities for Products in the United States.
(b)
Duties . The JCC shall:
(i) Subject
to oversight by the ESC, review and approve the Commercialization
Plan for the United States developed by GSK in accordance with
Section 5.1(b);
(ii) Review
and approve the Co-Promotion Plan developed in accordance with
Sections 5.2(b) and 5.2(c); and
(iii) Perform
such other duties as are specifically assigned to the JCC in this
Agreement or delegated to the JCC by the ESC.
3.4 Committee
Membership .
(a)
Membership . Subject to Section 3.4(b), the ESC, JDC
and JCC (each, a “ Committee ”) shall each be
composed of an equal number of representatives from each of GSK and
XenoPort, selected by such Party. Unless the Parties otherwise
agree, the exact number of representatives for each of GSK and
XenoPort shall be: (a) with respect to the ESC, subject to
Section 3.4(b), two (2) representatives, at least one
(1) of whom shall be [... * ...] , or a delegate of
such [... * ...] (or representative of [... * ...] );
provided that such delegate shall [... * ...] ; and (b) with
respect to the JDC and the JCC, three (3) representatives, at
least one (1) of whom shall [... * ...] , or a delegate
of such [... * ...] (or representative of [... * ...]
); provided that such delegate shall be [... * ...] . Either
Party may replace its respective Committee representatives at any
time with prior written notice to the other Party; provided that
the criteria for composition of each Committee set forth in the
preceding sentence continues to be satisfied following any
such
|
|
|
|
|
*
|
|
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 .
|
- 14 -
replacement of
a Party’s representative on any such Committee. Each
Committee will be chaired by a GSK representative and GSK may, from
time to time and in its sole discretion, change the representative
who serves as the chairperson on any Committee with prior written
notice to XenoPort.
(b)
Withdrawal from Committees . At any time during the Term and
for any reason, XenoPort shall have the right to withdraw from
participation in the Committees upon written notice to GSK, which
notice shall be effective immediately upon receipt (“
Withdrawal Notice ”). Following the issuance of a
Withdrawal Notice and subject to this Section 3.4(b),
XenoPort’s representatives to the Committees shall not
participate in any meetings of the Committees, nor shall XenoPort
have any right to vote on decisions within the authority of the
Committees. If, at any time, following the issuance of a Withdrawal
Notice, XenoPort wishes to resume participation in the Committees,
XenoPort shall notify GSK in writing and, thereafter,
XenoPort’s representatives to the Committees shall be
entitled to attend any subsequent meeting of the Committees and to
participate in the activities of, and decision-making by, the
Committees as provided in this Article 3 as if a Withdrawal
Notice had not been issued by XenoPort pursuant to this Section
3.4(b). Following XenoPort’s issuance of a Withdrawal Notice
pursuant to this Section 3.4(b), unless and until XenoPort
resumes participation in the Committees in accordance with this
Section 3.4(b): (i) all meetings of the Committees shall be
held at GSK’s facilities; (ii) GSK shall have the right
to make the final decision on all matters within the scope of
authority of the Committees; and (iii) XenoPort shall have the
right to continue to receive the minutes of Committee meetings, but
shall not have the right to approve the minutes for any Committee
meeting held after XenoPort’s issuance of a Withdrawal
Notice.
3.5 Committee
Meetings . The ESC shall meet at least once each calendar
half-year, or more or less often as otherwise agreed to by the
Parties. The JDC and, from and after such time as is appropriate,
the JCC shall meet at least once each calendar quarter, or more or
less often as otherwise agreed to by the Parties. All Committee
meetings may be conducted by telephone, video-conference or in
person as determined by the applicable Committee; provided,
however, that each Committee shall meet in person at least twice
each calendar year, unless the Parties mutually agree to meet by
alternative means. Unless otherwise agreed by the Parties, all
in-person meetings for each Committee shall be held on an
alternating basis between XenoPort’s facilities and
GSK’s facilities. Each Party shall bear its own personnel and
travel costs and expenses relating to Committee meetings. With the
consent of the Parties (not to be unreasonably withheld or
delayed), other employee representatives of the Parties may attend
any Committee meeting as non-voting observers. Minutes of each
Committee meeting will be prepared by the chairperson and
distributed to the members of the applicable Committee for review
and comment within twenty (20) days after each meeting of the
applicable Committee, and will be approved as the first order of
business at the immediately succeeding Committee
meeting.
3.6
Decision-Making . Subject to Section 3.4(b), decisions
of each Committee shall be [... * ...] . In the event the
JDC or the JCC [... * ...] with respect to a particular
matter within its authority, then upon request by either Party such
matter shall be referred to the ESC for
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|
*
|
|
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 .
|
- 15 -
resolution. In
the event that the ESC [... * ...] with respect to a
particular matter [... * ...] as requested by [... *
...] . The Parties’ [... * ...] to resolve such
matter; provided, however that with respect to [... * ...] .
If, [... * ...] are unable to resolve such matter [... *
...] .
3.7 Alliance
Managers . Within thirty (30) days following the HSR
Clearance Date, each Party shall appoint a representative (“
Alliance Manager ”) to facilitate communications
between the Parties (including coordinating the exchange of Data
and Know-How of each Party as required under this Agreement) and to
act as a liaison between the Parties with respect to such other
matters as the Parties may mutually agree in order to maximize the
efficiency of the collaboration. Each Party may replace its
Alliance Manager with an alternative representative satisfying the
requirements of this Section 3.7 at any time with prior
written notice to the other Party.
3.8 Scope of
Governance . Notwithstanding the creation of the ESC, JDC and
JCC, each Party shall retain the rights, powers and discretion
granted to it hereunder, and no Committee shall be delegated or
vested with rights, powers or discretion unless such delegation or
vesting is expressly provided herein, or the Parties expressly so
agree in writing. No Committee shall have the power to amend or
modify this Agreement, and no decision of any Committee shall be in
contravention of any terms and conditions of this Agreement. It is
understood and agreed that issues to be formally decided by the
ESC, JDC and JCC, as applicable, are only those specific issues
that are expressly provided in this Agreement to be decided by the
ESC, JDC and JCC, as applicable.
DEVELOPMENT AND REGULATORY
ACTIVITIES
(a)
Initial Development Plan . An initial development plan for
the collaboration is attached to this Agreement as
Exhibit 4.1 (“ Development Plan ”)
and sets out separately the development activities to be conducted
by each Party. Within [... * ...] the HSR Clearance Date,
the JDC shall review and finalize the details of the Development
Plan, which shall be consistent with the Development Plan in
Exhibit 4.1 .
(b)
Changes to a Development Plan . The JDC shall review the
Development Plan on an ongoing basis, and in no event less
frequently than [... * ...] . The JDC may propose to the ESC
revisions to the then-current Development Plan; provided, however,
the [... * ...] .
4.2 Development
Activities of GSK .
(a)
Conduct of Development Activities . Except as provided in
Section 4.3 below, GSK shall, at its expense, use Commercially
Reasonable Efforts to carry out all clinical development and other
activities required to obtain Marketing Approvals for the Product
in the Territory. GSK
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|
|
*
|
|
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 .
|
- 16 -
shall carry out
all such activities in accordance with the then-current Development
Plan and the provisions of this Agreement.
(b)
Diligence . GSK shall use Commercially Reasonable Efforts to
achieve the goals of the then-current Development Plan in
accordance with the timelines specified therein and to realize the
commercial opportunity for the Product in other
indications.
4.3 Development
Activities of XenoPort .
(a)
Conduct of Development Activities . Except as otherwise
mutually agreed, XenoPort shall, at its expense and with oversight
by the JDC, continue to conduct the Existing Phase III Studies and
those other clinical studies and activities listed on
Exhibit 4.3 to this Agreement (collectively, the
“ Clinical Studies and Activities ”). XenoPort
shall make reasonable modifications to the protocols for such
Clinical Studies and Activities, as requested by GSK from time to
time; provided, however, that [... * ...] . Notwithstanding
the foregoing, [... * ...] Existing Phase III Study [...
* ...] of such modifications. In addition, XenoPort shall
[... * ...] Clinical Studies and Activities [... *
...] Existing Phase III Studies, [... * ...]
.
(b)
Diligence . XenoPort shall use Commercially Reasonable
Efforts to conduct and complete the Clinical Studies and Activities
in order to achieve the goals of the then-current Development Plan
in accordance with the timelines specified therein.
4.4 Change in
Formulation. Before [... * ...] , GSK shall discuss the
proposed [... * ...] with XenoPort at the ESC and [... *
...] . Subject to the foregoing, XenoPort agrees that GSK may
[... * ...] that were so discussed [... * ...] by the
ESC.
4.5 Conduct of
Activities . Each Party shall conduct those activities
allocated to such Party under the Development Plan in compliance in
all material respects with all Applicable Laws and in accordance
with good scientific and clinical practices, applicable under the
Applicable Law of the country in which such activities are
conducted.
(a)
Assignment of Regulatory Filings . At a reasonable time
[... * ...] , XenoPort shall assign or cause to be assigned
to GSK all Regulatory Filings for the Compound in the Territory;
provided, however, that, [... * ...] XenoPort shall maintain
[... * ...] . Notwithstanding the foregoing, it is
understood that XenoPort may [... * ...] and/or [... *
...] provided that [... * ...] For such purposes,
[... * ...] at which XenoPort [... * ...]
.
(b)
Responsibility for Regulatory Filings . Except for [... *
...] , GSK shall be responsible, at its expense, for filing,
obtaining and maintaining all Regulatory Filings for the Compound
and each Product in the Territory. [... * ...] . GSK shall
also obtain any export approvals required by the FDA to import or
export the Product to any country within the Territory. All
such
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*
|
|
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 .
|
- 17 -
filings will be
in the name of GSK, except where otherwise required by Applicable
Law in any country within the Territory.
4.7
Regulatory Cooperation . [... * ...] , GSK shall be
responsible for liaising with and managing all interactions with
Regulatory Authorities in the Territory, including with respect to
all Regulatory Filings for Product in the Territory, other than
[... * ...] , and XenoPort shall be entitled to participate
in such interactions as provided in this
Section 4.7.
(a)
Involvement of XenoPort . To the extent relating to the
Product within the [... * ...] or [... * ...] , GSK
shall provide XenoPort with:
(i) reasonable
advanced notice [... * ...] of substantive meetings with the
[... * ...] that are either scheduled with, or initiated by
or under the authority of, GSK or its Affiliates;
(ii) an
opportunity to have [... * ...] representatives attend, and
[... * ...] , all substantive meetings with [... *
...] ; and in any case, GSK shall keep the JDC informed as to
all material interactions with Regulatory Authorities;
and
(iii) a
copy of any material documents, information and correspondence
submitted to [... * ...] relating to Regulatory Filings for
the Product as soon as reasonably practicable, together with
English translations and summaries thereof, to the extent such
translations and summaries exist.
The JDC shall
approve the overall strategy and positioning of all [... *
...] Regulatory Filings with [... * ...] , based upon
reasonably detailed reports and summaries of such submissions and
filings presented to the JDC by GSK. In connection with such
review, [... * ...] .
(b)
Involvement by GSK . With respect to the Regulatory Filings
maintained by XenoPort under Section 4.6(a) and Regulatory
Filings relating to the trials permitted to be conducted by
XenoPort in the Territory under Section 2.3(b) above, XenoPort
shall provide GSK with:
(i) reasonable
advanced notice [... * ...] of substantive meetings with the
[... * ...] that are either scheduled with, or initiated by
or under the authority of, XenoPort or its Affiliates relating to
such Regulatory Filings;
(ii) an
opportunity to have [... * ...] representatives attend, and
[... * ...] , all substantive meetings with [... *
...] relating to such Regulatory Filings; and in any case,
XenoPort shall keep the JDC informed as to all material
interactions with Regulatory Authorities relating to such
Regulatory Filings; and
(iii) a
copy of any material documents, information and correspondence
submitted to [... * ...] relating to such Regulatory Filings
as soon as reasonably practicable, together with English
translations and summaries thereof, to the extent such translations
and summaries exist.
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*
|
|
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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(c)
Assistance by XenoPort . XenoPort will provide reasonable
cooperation and assistance to GSK in the event that GSK must
respond to questions from Regulatory Authorities in the Territory
concerning development activities conducted by or on behalf of
XenoPort with the Compound or Product, including the Clinical
Studies and Activities.
(d) Other
Regulatory Matters . Each Party will promptly provide the other
Party with copies of all material documents, information and
correspondence received from a Regulatory Authority (including a
written summary of any material communications in which such other
Party did not participate) within the Territory and, upon
reasonable request, with copies of any other documents, reports and
communications from or to any Regulatory Authority within the
Territory relating to the Compound, the Product and/or activities
under this Agreement.
4.8 Exchange of
Data and Know-How .
(a) By
XenoPort . Promptly following the HSR Clearance Date, XenoPort
will make available to GSK, at no cost or expense to GSK, all
XenoPort Know-How that is necessary, or materially useful, for GSK
to develop and/or commercialize the Compound and Products in the
Territory, including all Data from any and all clinical trials
(including the Clinical Studies and Activities) and preclinical
studies and non-clinical development work for the Compound and
Products that have been obtained by XenoPort as of the Effective
Date.
(b) By
Either Party . During the Term, each Party shall provide to the
other Party all such Party’s Know-How (i.e., in case of
XenoPort, XenoPort Know-How, and in the case of GSK, all GSK
Know-How) and that has not previously been provided hereunder, in
each case promptly upon request by the other Party. The Party
providing such Party’s Know-How shall provide the same in
electronic form to the extent the same exists in electronic form,
and shall provide copies as reasonably requested and an opportunity
for the other Party or its designee to inspect (and copy) all other
materials comprising such Know-How (including for example, original
patient report forms and other original source data). The Parties
will cooperate and reasonably agree upon formats and procedures to
facilitate the orderly and efficient exchange of the XenoPort
Know-How and the GSK Know-How. [... * ...] ; provided that
[... * ...] or [... * ...] . For the avoidance of
doubt, [... * ...] . Accordingly, and consistent with the
proviso in the fourth sentence of this Section 4.8(b),
XenoPort shall [... * ...] .
(c)
Provision of Data to JDC . Upon request by the JDC, each
Party shall promptly provide the JDC with summaries in reasonable
detail of all Data generated or obtained in the course of such
Party’s performance of activities under a Development
Plan.
4.9 Sharing of
Regulatory Filings. Without limiting Section 4.8 above,
each Party shall permit the other to access, and shall provide the
other Party with sufficient rights to reference and use in
association with exercising its rights and performing its
obligations under this Agreement [... * ...] , all of such
Party’s, its Affiliates’ and, to the extent it has the
right to do so, its Sublicensees’ Data, Regulatory Filings
and regulatory communications associated with any
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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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submissions of
MAAs or other approvals for the Product respectively in the
Territory. Without limiting the foregoing, XenoPort shall permit
GSK to access and shall provide GSK with sufficient rights to
reference and use, in support of MAAs filed and Marketing Approvals
received by or on behalf of GSK, the IND of XenoPort for the
Compound in the Territory. Notwithstanding the foregoing, GSK shall
be obligated to [... * ...] .
(a)
Inspection by Astellas . To the extent any Regulatory
Authority [... * ...] requests an audit of the clinical
trial sites and, if GSK supplies Compound or Product to Astellas
during the Term, manufacturing sites in the Territory [... *
...] , GSK shall permit such Regulatory Authority [... *
...] to enter the all relevant clinical trial sites and, if
applicable, manufacturing sites of GSK and its Affiliates during
normal business hours and upon reasonable advance notice to inspect
and verify compliance with applicable regulatory requirements. GSK
shall, at XenoPort’s expense, provide reasonable assistance
for a full and correct carrying out of the inspection. Such
inspection shall not relieve GSK of any of its obligations under
this Agreement.
(b)
Diligence . GSK shall use Commercially Reasonable Efforts to
secure the rights set forth in Section 4.10(a) from
GSK’s Sublicensees, trial sites and other contractors for the
Product. In the event GSK is unable to secure such inspection
rights from any of its Sublicensees, trial sites or contractors,
GSK agrees to secure such rights for itself and [... * ...]
GSK shall exercise such rights [... * ...] and fully report
the results thereof to XenoPort and Astellas.
4.11 Clinical
Trial Register. Notwithstanding anything in this Agreement to
the contrary, including Article XI, GSK shall have the right
to publish in its clinical trial register the results or summaries
of the results of all clinical trials for the Compound and Products
conducted: (a) by either Party in the Territory pursuant to
this Agreement; and (b) by [... * ...] provided,
however, that [... * ...] . The Parties will discuss the
process for [... * ...] .
4.12 Reporting;
Adverse Drug Reactions .
(a)
Pharmacovigilance Agreement . Within ninety (90) days
after the HSR Clearance Date, the Parties shall enter into a
pharmacovigilance agreement on terms no less stringent than those
required by ICH guidelines, including: (i) providing detailed
procedures regarding the maintenance of core safety information and
the exchange of safety data relating to the Compound and the
Products for the Territory within appropriate timeframes and in an
appropriate format to enable each Party to meet both expedited and
periodic regulatory reporting requirements; and (ii) ensuring
compliance with the reporting requirements of all applicable
Regulatory Authorities on a worldwide basis for the reporting of
safety data in accordance with standards stipulated in the ICH
Guidelines, and all applicable regulatory and legal requirements
regarding the management of safety data.
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Certain Confidential
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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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(b)
Adverse Event Reporting . As between the Parties:
(i) XenoPort shall be responsible for [... * ...]
(ii) GSK shall be responsible for [... * ...] and
(iii) XenoPort or Astellas shall be responsible for [... *
...] all in accordance with the Applicable Laws of the relevant
countries and regulatory authorities. GSK shall ensure that its
Affiliates and Sublicensees comply with such reporting obligations
in the Territory, and XenoPort [... * ...]
(c)
Global Safety Database . GSK shall maintain the global
safety database with respect to the Product for the Territory and
[... * ...] XenoPort agrees to [... * ...] enable GSK
to maintain such global safety database for [... * ...]
.
COMMERCIALIZATION AND
PROMOTION
5.1 GSK
Commercialization of Product .
(a)
GSK’s Responsibility . Except as provided below, GSK
shall have sole responsibility for the commercialization,
distribution, marketing and promotion of the Products in the Field
in the Territory. Further, regardless of whether XenoPort exercises
the Co-Promotion Option as provided in Section 5.2 below,
during the Term, GSK will have the exclusive right and
responsibility in the Territory for the following:
(i) establishing
pricing and reimbursement for Product;
(ii) managed
care contracting for Product;
(iii) receiving,
accepting and filling orders for Product from customers;
(iv) distributing
Product to customers;
(v) controlling
invoicing, order processing and collecting accounts receivable for
sales of Product; and
(vi) recording
sales of Product in the Territory in its books of account for
sales.
(b)
Commercialization Plan . At least [... * ...] , GSK
shall prepare [... * ...] a plan setting forth the strategic
plan for the marketing, promotion and commercialization of the
Products in such [... * ...] , which plan shall be in
reasonable scope and detail (the “ Commercialization
Plan ”); provided, however, that [... * ...] ;
provided further that [... * ...] with respect thereto,
[... * ...] . Each Commercialization Plan for [... *
...] shall be presented by GSK to the ESC or the JCC [... *
...] , as applicable. The ESC and the JCC [... * ...]
shall review the Commercialization Plans for [... * ...] on
an ongoing basis, and in no event less frequently than once each
calendar year. Subject to Section 5.2, GSK shall carry out all
marketing, promotion and
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Certain Confidential
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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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commercialization of the Products in the
Territory in accordance with the then-current Commercialization
Plan and the provisions of this Agreement.
5.2
Co-Promotion Option of XenoPort .
(a)
Exercise of Co-Promotion Option . XenoPort shall have a
non-sublicensable option to Co-Promote the Product with GSK in the
United States (“ Co-Promotion Option ”) in
accordance with the terms and conditions of this Article 5. To
facilitate such Co-Promotion Option, GSK shall notify XenoPort of
its right to exercise the Co-Promotion Option [... * ...] .
To exercise the Co-Promotion Option, XenoPort shall notify GSK in
writing [... * ...] ; provided that [... * ...] . In
the event that XenoPort exercises the Co-Promotion Option as
provided in this Section 5.2(a), XenoPort will have an exclusive
right to Co-Promote and Detail the Product with GSK in the United
States until [... * ...] . In the event that XenoPort does
not exercise the Co-Promotion Option as provided in this
Section 5.2(a) or if XenoPort does not provide written notice
to GSK that it is exercising the Co-Promotion Option [... *
...] , XenoPort will have no right to Co-Promote or Detail the
Product with GSK in the United States, and GSK will have no further
obligation with respect to the Co-Promotion Option.
(b)
Co-Promotion Plan . In the event that XenoPort exercises the
Co-Promotion Option, GSK shall prepare, in consultation with
XenoPort and the JCC, the tactical plan for promoting and marketing
the Product in the United States, consistent with the
Commercialization Plan for the United States (“
Co-Promotion Plan ”), which shall be reviewed and
approved by the JCC [... * ...] . The Co-Promotion Plan
shall set out in reasonable detail: (i) [... * ...] in
connection with the Co-Promotion [... * ...] (ii) [... *
...] (iii) [... * ...] and (iv) [... * ...]
.
(c)
Changes to the Co-Promotion Plan . After the submission of
the initial Co-Promotion Plan, the JCC shall review and amend if
necessary the Co-Promotion Plan on an ongoing basis and in no event
less frequently than [... * ...] .
(i) The
Parties shall each use Commercially Reasonable Efforts to
Co-Promote and Detail the Product in the United States pursuant to
the terms and conditions hereof and the then-current Co-Promotion
Plan. The JCC will agree upon and monitor each Party’s
Co-Promotion and Detailing activities for each Co-Promotion Year.
“ Co-Promotion Year ” shall mean, for the
calendar year in which the Parties are first engaged in
Co-Promotion, the portion of the calendar year remaining beginning
upon the date of the First Commercial Sale in the United States,
and shall mean the relevant January 1 through December 31
calendar year, or pro rata portion thereof, for all subsequent
calendar years until the expiration or earlier termination of
XenoPort’s right to Co-Promote the Product as provided
herein.
(ii) During
any Co-Promotion Year, XenoPort shall use Commercially Reasonable
Efforts to [... * ...] the Co-Promotion Plan approved by the
JCC [... * ...] .
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Certain Confidential
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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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(iii) The
Co-Promotion Plan approved by the JCC for each Co-Promotion Year
shall: (A) specify [... * ...] to be provided [... *
...] the number of Sales Representatives [... * ...] (B)
[... * ...] in a manner that ensures [... * ...] to
be provided [... * ...] and (C) to the extent [... *
...] Sales Representatives that [... * ...] .
(e) Sales
Efforts of XenoPort . At the time XenoPort exercises the
Co-Promotion Option, it shall notify GSK of the number of Sales
Representatives that XenoPort elects to deploy initially for the
Product, provided that [... * ...] . Promptly after such
exercise of the Co-Promotion Option, XenoPort will [... *
...] of Sales Representatives that XenoPort so elects, [...
* ...] in accordance with the Co-Promotion Plan [... *
...] . XenoPort shall, as requested by GSK, within [... *
...] ; provided that, subject to [... * ...] Sales
Representatives that XenoPort deploys [... * ...] . In the
event that XenoPort desires to increase the number of XenoPort
Sales Representatives who Detail and Co-Promote Product [... *
...] in accordance with the Co-Promotion Plan, [... *
...] Co-Promoting and Detailing the Product as provided herein
[... * ...] . In the event that GSK does not agree to using
such Additional Sales Representatives in the Co-Promotion and
Detailing of the Product, XenoPort will [... * ...]
.
(f) Costs
of Co-Promotion . If XenoPort exercises its Co-Promotion Option
as provided in Section 5.2(a), the Parties shall [... *
...] . Notwithstanding the foregoing GSK shall [... *
...] in accordance with the Co-Promotion Plan [... *
...] . Such [... * ...] .
(g)
Co-Promotion Coordination . GSK shall be responsible for
developing the strategies and programs to carry out the
Co-Promotion activities, including the assignment of sales
activities in accordance with the Commercialization Plan for the
United States and Co-Promotion Plan.
5.3
Non-exclusive Right to Detail the REQUIP™ Products
.
(a)
Commencement of Right to Detail the REQUIP™ Products .
If XenoPort exercises the Co-Promotion Option for the Product,
XenoPort shall also obtain a non-sublicensable, non-exclusive right
to Detail the REQUIP™ Products in the United States on and
from the date on which XenoPort exercises its Co-Promotion Option,
to the extent such REQUIP™ Products are approved for
commercialization in the United States. Such right shall continue
until [... * ...] . If GSK (or its Affiliate) has not
obtained the approvals required to commercialize the REQUIP™
Products in the United States at the time that XenoPort exercises
the Co-Promotion Option, the Parties [... * ...]
.
(b) The
REQUIP™ Sales Plan . GSK shall prepare and
determine, in consultation with XenoPort, the tactical plan for
XenoPort’s Detailing of the REQUIP™ Products by
XenoPort Sales Representatives in the United States (the “
REQUIP™ Sales Plan ”) and shall provide the
REQUIP™ Sales Plan to XenoPort [... * ...] . The
REQUIP™ Sales Plan shall set out in reasonable detail: (i)
[... * ...] in connection with [... * ...] and (ii)
[... * ...] under such REQUIP™ Sales Plan, [... *
...] and which is [... * ...] . XenoPort shall be
entitled to dedicate a number of Sales
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Certain Confidential
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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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Representatives
elected by XenoPort, up to [... * ...] , to Detail the
REQUIP™ Products in the United States. XenoPort’s right
to deploy such Sales Representatives shall commence [... *
...] .
(c)
Coordination . GSK shall be responsible for developing
strategies and programs to carry out in an optimal fashion
Detailing activities of the Parties with respect to the
REQUIP™ Products, including the assignment of Detailing
activities in accordance with the REQUIP™ Sales
Plan.
(d)
Reimbursement . GSK shall reimburse XenoPort for each Detail
provided by the XenoPort Sales Representatives Co-Promoting the
REQUIP™ Products in the United States in accordance with the
REQUIP™ Sales Plan in an amount equal to: (i) [... *
...] and/or [... * ...] and (ii) [... * ...] .
Such reimbursements shall be made to XenoPort [... * ...]
.
(e)
GSK’s Exclusive Responsibilities for the REQUIP™
Products . During the period that XenoPort is Detailing the
REQUIP™ Products in the United States as provided herein, GSK
will have the exclusive right and responsibility in the United
States for the following:
(i) establishing
pricing and reimbursement for the REQUIP™
Products;
(ii) managed
care contracting for the REQUIP™ Products;
(iii) receiving,
accepting and filling orders for the REQUIP™ Products from
customers;
(iv) distributing
the REQUIP™ Products to customers;
(v) controlling
invoicing, order processing and collecting accounts receivable for
sales of the REQUIP™ Products;
(vi) all
marketing and promotion activities relating to the REQUIP™
Products other than Detailing; and
(vii) recording
sales of the REQUIP™ Products in the Territory in its books
of account for sales.
5.4 XenoPort
Sales Representatives .
(a)
Qualifications . All XenoPort Sales Representatives
Co-Promoting and Detailing Product and/or Detailing the
REQUIP™ Products shall be required to have comparable
educational qualifications and experience as GSK requires for its
own Sales Representatives. Such XenoPort Sales Representatives
shall be subject to a reasonable proficiency examination relevant
to the Product or the REQUIP™ Products in the same manner as
GSK’s Sales Representatives.
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Certain Confidential
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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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(b) No
Contract Sales Force . XenoPort shall not be permitted to use a
contract sales force to fulfill its Co-Promotion and Detailing
responsibilities with respect to the Product and/or Detailing
responsibilities with respect to the REQUIP™ Products under
this Agreement.
(c)
Training . GSK shall provide the same sales training on the
Product and on the REQUIP™ Products for XenoPort Sales
Representatives who will be Co-Promoting and Detailing the Product
and/or promoting the REQUIP™ Products, as applicable, as the
training on the Product and the REQUIP™ Products that GSK
provides to its own Sales Representatives who promote and Detail
the Product and/or the REQUIP™ Products, as applicable, in
the United States. XenoPort shall be responsible for causing its
Sales Representatives to attend and successfully complete the GSK
training program prior to such Sales Representatives Co-Promoting
and Detailing Product and/or Detailing the REQUIP™ Products
in the United States. The Parties acknowledge and agree that in
order for a XenoPort Sales Representative to be deemed to have
successfully completed the training, such XenoPort Sales
Representative must demonstrate thorough knowledge of the medical
and technical aspects of the Product and/or the REQUIP™
Products, as applicable, the Applicable Commercial Practices
Policies and must achieve scores on certifications for the Product
and the REQUIP™ Products, as applicable, at similar rates to
those required for GSK sales representatives who are Co-Promoting
and Detailing the Product and/or Detailing the REQUIP™
Products, as applicable. XenoPort Sales Representatives will be
entitled to attend those sections of national and regional sales or
plan of action meetings for GSK Sales Representatives, except
[... * ...] . The costs of such sales training for XenoPort
Sales Representatives for the Product and attendance at meetings
shall [... * ...] .
(d)
Timing . XenoPort and GSK shall cooperate to have the
XenoPort Sales Representatives hired and trained as provided in
this Agreement prior to [... * ...] .
(e)
Compensation and Bonus System for Sales Representatives .
The Parties acknowledge that in order to attract and retain
professional Sales Representatives, there may be a degree of
discrepancy between the compensation and bonus incentive structure
for GSK’s Sales Representatives and the compensation and
bonus incentive structure for XenoPort’s Sales
Representatives. To ensure consistency of efforts between the Sales
Representatives of the Parties, each Party agrees that in designing
such Party’s compensation and bonus incentive structure, each
Party will give due consideration to the effect that such
Party’s compensation and bonus structure may have on the
other Party’s sales force, provided that [... * ...]
.
(f)
XenoPort Salaries and Wages . XenoPort acknowledges and
agrees that it will be solely responsible for paying all salaries,
wages, benefits and other compensation that its employees,
including XenoPort Sales Representatives, may be entitled to
receive in connection with providing services under this
Agreement.
(g)
Support . Except as otherwise agreed, XenoPort shall be
solely responsible for providing its own equipment, automobiles,
offices and fixtures, working facilities, and such other
facilities, services and support as may be required for XenoPort
Sales Representatives Co-Promoting
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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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and Detailing
Product and/or Detailing the REQUIP™ Products as provided in
this Agreement and pursuant to the Co-Promotion Plan or
REQUIP™ Sales Plan, as applicable.
(h) No
Employment by GSK . For the avoidance of doubt, XenoPort Sales
Representatives will not be, and will not be considered or deemed
to be, employees of GSK for any purpose. GSK is engaging XenoPort
hereunder, and XenoPort will perform its obligations hereunder,
strictly as an “independent contractor.” Sales
Representatives and any other employee or agent that is involved in
performing XenoPort’s obligations under this Agreement
(collectively, “ Personnel ”) will not be, and
will not be considered or deemed to be, employees of GSK for any
purpose. GSK will not have any responsibility for the hiring,
termination, compensation, benefits or other conditions of
employment or engagement of the Personnel of XenoPort.
(i) GSK
Benefit Plans . Personnel of XenoPort are not eligible to
participate in any benefit programs offered by GSK to its
employees, or in any pension plans, profit sharing plans, insurance
plans or any other employee benefit plans offered from time to time
by GSK to its employees. XenoPort acknowledges and agrees that GSK
does not, and will not, maintain or procure any workers’
compensation or unemployment compensation insurance for or on
behalf of the XenoPort’s employees, including, without
limitation, XenoPort Sales Representatives. Personnel of XenoPort
are not eligible to participate in any benefits programs offered by
GSK to its employees, or in any pension plans, profit sharing
plans, insurance plans or any other employee benefits plans offered
from time to time by GSK to its employees.
(j)
Management of Sales Representatives . XenoPort will be
responsible for supervising its Sales Representatives. In
connection therewith, at all times that XenoPort is Co-Promoting
and Detailing the Product and/or Detailing the REQUIP™
Products, XenoPort will provide a sufficient number of full time
employees to serve as district managers. XenoPort may, but will not
be obligated to, designate one (1) or more full time employees
to serve as regional directors having the responsibility for
supervising a group of its district managers in a particular
geographic region of the United States. XenoPort will provide GSK
with contact information for its district managers and regional
directors, and will update that information periodically or as
requested by GSK from time to time. XenoPort acknowledges and
agrees that it comply with this Section 5.4 in the hiring and
employment of all district managers and regional directors, and
that the provisions in this Section 5.4 will apply to all such
district managers and regional directors.
5.5
Co-Promotion Agreement . Promptly following XenoPort’s
exercise of its Co-Promotion Option for the Product in accordance
with Section 5.2(a), for the purposes of permitting GSK to
comply with its obligations under Applicable Law, GSK and XenoPort
shall enter into a co-promotion agreement setting out such
obligations of XenoPort, including with respect to the activities
of its Sales Representatives, in the Co-Promotion and Detailing of
the Product and the Detailing of the REQUIP™ Products and
containing terms substantially similar to the terms set out on
Exhibit 5 and which is consistent with the terms and
conditions of this Agreement (“ Co-Promotion Agreement
”). Notwithstanding the foregoing, the obligations imposed on
XenoPort, including with respect to the activities of its Sales
Representatives, in the Co-Promotion and
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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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Detailing of
the Product and the Detailing of the REQUIP™ Products,
including the terms of the Co-Promotion Agreement to be executed by
GSK and XenoPort as provided in this Section 5.5, shall be
[... * ...] . It is understood that XenoPort may continue to
exercise its rights under this Article 5 pending completion of
such Co-Promotion Agreement, provided however, that [... *
...] .
5.6 Promotional
Materials .
(a) Subject
to Article XIII, GSK will own all right, title and interest in
and to all Promotional Materials during and after the Term,
including any intellectual property rights (including Trademarks)
in the Promotional Materials other than the XenoPort
Trademarks.
(b) The
determination of the content of the Promotional Materials shall be
the sole responsibility of GSK. The quantity and method of
distribution of the Promotional Materials in the United States for
the XenoPort Sales Representatives shall be as set forth in the
Co-Promotion Plan or the REQUIP™ Sales Plan, as
applicable.
(c) With
respect to the Co-Promotion of the Product, XenoPort will cause its
Sales Representatives to utilize only the Promotional Materials
relating to Product provided to them by GSK, and will not utilize
any other promotional, advertising, educational or communication
materials or other materials relating to or referring to the
Product. With respect to the Detailing of the REQUIP™
Products, XenoPort Sales Representatives will utilize only the
Promotional Materials relating to the REQUIP™ Products
provided to them by GSK, and will not utilize any other
promotional, advertising, educational or communication materials or
other materials relating to or referring to the REQUIP™
Products. XenoPort Sales Representatives will conduct only those
promotional and other sales activities relating: (i) to the
Product that have been approved in advance in accordance with the
Co-Promotion Plan; and (ii) to the REQUIP™ Products that
have been approved in advance in accordance with the REQUIP™
Sales Plan. XenoPort Sales Representatives shall not modify, change
or alter the Promotional Materials provided by GSK in any way
whatsoever, without the express prior written consent of GSK.
XenoPort Sales Representatives shall use such Promotional Materials
solely for the purpose of performing their obligations under this
Agreement.
5.7 Reports and
Audit Rights .
(a) XenoPort
will keep accurate records in sufficient detail of the
XenoPort’s Sales Representatives’ Detailing activities
relating to the Product and/or the REQUIP™ Products to
determine the amounts owed by GSK to XenoPort hereunder. XenoPort
shall keep such records regarding such Sales Representatives’
Detailing activities during the period during which XenoPort is
Co-Promoting the Product and/or the REQUIP™ Products, as
applicable, and for a period of [... * ...]
(b) During
normal business hours and with not less than [... * ...]
advance written notice to XenoPort, XenoPort will permit GSK or its
authorized representatives to (i) have
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Certain Confidential
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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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access to the
records of XenoPort Sales Representative Detailing activities
maintained by XenoPort for purposes of verifying the accuracy of
the invoices presented by XenoPort hereunder, and (ii) audit
such records; provided, however that [... * ...] . Any and
all audits undertaken by GSK pursuant
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