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EXHIBIT 10.27
*** TEXT OMITTED AND FILED SEPARATELY
PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST
UNDER 17 C.F.R. SECTION 200.80(b)(4)
AND RULE 406 UNDER THE SECURITIES
ACT OF 1933, AS AMENDED
CONFIDENTIAL
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (the "AGREEMENT") is made and
entered into as
of December 1, 2003 (the "EFFECTIVE DATE") by and between
STRUCTURAL GENOMIX,
INC. a Delaware corporation located at 10505 Roselle Street, San
Diego, CA
92121, U.S.A., ("SGX"), and UROGENE, S.A., a corporation
incorporated under the
laws of France with a principal place of business at 4 Rue
Pierre Fontaine -
Genopole, 91058 Evry, Cedex, France, ("UG"). SGX and UG may be
referred to
herein individually as a "Party" and collectively as the
"Parties".
BACKGROUND
WHEREAS, SGX has expertise in the field of structure directed
drug
discovery;
WHEREAS, UG has research and development programs in the area of
urology;
WHEREAS, the Parties wish to collaborate in the development of
therapeutic
products directed at inhibiting the protein kinase RON,
primarily for
application in the field of bladder cancer;
NOW, THEREFORE, in consideration of the foregoing and the
covenants and
promises contained in this Agreement, the Parties hereby agree
as follows:
1. DEFINITIONS
1.1 "Active Party" has the meaning ascribed to such term in
Section 6.1.
1.2 "Affiliate" means, with respect to a Party hereto, a
corporation,
company or other entity that is owned or controlled by such
Party by virtue of
such Party's direct or indirect ownership or control of fifty
percent (50%) or
more of the outstanding shares or securities (representing the
right to vote for
the election of directors or other managing authority) of such
corporation,
company or other entity, but such corporation, company or other
entity shall be
deemed to be an Affiliate only so long as such ownership or
control exists.
1.3 "Clinical Development" means development activities
conducted on a
Collaboration Product commencing upon the filing of an IND, up
to and including
generation of an International Registration Dossier.
1.4 "Collaboration" means the activities conducted by the
Parties under
the Research Plan and the Development Plan.
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1.5 "Collaboration Product" means any product that comprises or
contains
or is developed or manufactured based on a Safety Assessment
Candidate, and is
directed at inhibiting, modulating or altering the activity of
the Target.
Collaboration Products do not include SGX Products or UG
Products.
1.6 "Collaboration Technology" means Patent Rights and Know-How
which are
conceived or reduced to practice or otherwise developed by or on
behalf of UG or
SGX, or jointly by UG and SGX, in each case during and in the
performance of the
Collaboration, including without limitation, Collaboration
Products and
Information but excluding SGX Compounds, UG Compounds, SGX
Background
Technology, and UG Background Technology.
1.7 "Collaboration Term" means the period commencing on the
Effective Date
and ending on a Collaboration Product-by-Collaboration Product
and
country-by-country basis, upon Registration of each such
Collaboration Product.
1.8 "Competing Product" means a product developed outside of
the
Collaboration for application in the Therapeutic Field, which
has activity in an
[...***...] against the Target.
1.9 "Controls" or "Controlled" means possession of the ability
to grant
the licenses or sublicenses as provided for herein, without
violating the terms
of any agreement or other arrangement with a Third Party.
1.10 "Development Budget" has the meaning ascribed to such term
in Section
3.7.
1.11 "Development Plan" means, with respect to a particular
Collaboration
Product, the plan prepared by the JDC and approved by the
Parties pursuant to
Section 3.7 setting forth the detailed plan, Development Budget
and process for
the Parties' collaborative efforts to conduct development of,
and seek
Registration for, such Collaboration Product in the UG Territory
and SGX
Territory.
1.12 "Drug Candidate" means a Safety Assessment Candidate
selected by the
JDC for Clinical Development under Section 3.2(b).
1.13 "Excess Expenses" means, with respect to a particular
Collaboration
Product, the costs and expenses associated with such
Collaboration Product that
the Parties have agreed pursuant to Section 3.9 shall be
creditable against
certain royalty payments in accordance with Section 4.3.
1.14 "Expanded Therapeutic Field" means the Therapeutic Field,
[...***...]
cancer, [...***...] carcinomas, and [...***...] cancer.
1.15 "FTE" means a full time equivalent person year (consisting
of
[...***...] hours per year) of scientific or technical work
carried out by or on
behalf of SGX or UG under the Collaboration.
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1.16 "First Commercial Sale" means the first sale of a
Collaboration
Product to a Third Party in a Territory after all Registrations
required to
permit such sale have been granted, or such sale is otherwise
permitted by the
regulatory authority in such country.
1.17 "IND" means an Investigational New Drug application, as
defined in
the U.S. Food, Drug and Cosmetic Act ("FDCA") and the
regulations promulgated
thereunder or any corresponding foreign application,
registration or
certification.
1.18 "Inactive Party" has the meaning ascribed to such term in
Section
6.1.
1.19 "Information" means data specifically relating to
research,
development, Registration, manufacture, sale or use of
Collaboration Products,
including without limitation, pharmacological, toxicological and
clinical test
data, analytical and quality control data, regulatory
submissions,
correspondence and communications, and data relating to adverse
events.
1.20 "International Registration Dossier" means the collection
of
Information comprising the requirements for applications for
Registration of
Collaboration Products under the FDCA and any regulations
promulgated
thereunder, and as required by the Committee for Proprietary
Medicinal Products
representing the medicine authorities of the European Community
member states.
1.21 "Joint Research Committee" or "JRC" means the Joint
Research
Committee established pursuant to Section 2.4.
1.22 "Joint Development Committee or "JDC" means the Joint
Development
Committee established pursuant to Section 3.2.
1.23 "Know-How" means all ideas, data (including without
limitation data
from clinical and preclinical studies and test data including
pharmacological,
toxicological and clinical test data), inventions, information,
(including
without limitation information related to compounds and their
structure,
function and formulation, regulatory filings and submissions),
instructions,
designs, processes, formulas, software, materials, methods,
processes and
techniques.
1.24 "Lead Compound" means a compound with the properties
designated by
the JRC as required properties for a Lead Compound, which is
designated by the
JRC as a Lead Compound in accordance with Section 2.4(b)(v).
1.25 "Net Sales" means the total amount received by UG or SGX or
their
respective Affiliates or sublicensees, as the case may be, for
sales to third
parties (other than sublicensees) in arm's length transactions
of Products less:
(i) ordinary and customary prompt payment and other trade or
quantity discounts
actually allowed and taken; (ii) credits, rebates and returns
(including, but
not limited to, wholesaler and retailer returns) actually
extended and taken;
(iii) freight, postage and duties (including insurance premiums)
actually
incurred; (iv) excise taxes, other consumption taxes, customs
duties and
compulsory payments to governmental authorities actually paid
and separately
identified on the invoice or other documentation maintained in
the ordinary
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course of business. A "sale" shall include any transfer or other
disposition for
consideration, and Net Sales shall include the fair market value
of all other
consideration received by UG or SGX or their respective
Affiliates or
sublicensees in respect of any grant of rights to make, use,
sell or otherwise
distribute Products, whether such consideration is in cash,
payment in kind,
exchange or other form.
1.26 "NDA" means a New Drug Application, as defined in the U.S.
Food, Drug
and Cosmetic Act and the regulations promulgated thereunder, and
any
corresponding foreign application, registration or
certification.
1.27 "Patent Rights" means patent applications filed in any
country
worldwide, including provisionals, utilities, continuations (in
whole or in
part), divisionals, reissues, reexaminations and foreign
counterparts thereof,
any patents issued on such applications and any extensions of
term,
registrations or confirmations of such patents.
1.28 "Phase 1", "Phase 2", "Phase 3" and "Phase 4" means Phase
1, Phase 2,
Phase 3 and Phase 4 clinical trials, respectively, in each case
as prescribed by
the U.S. Food and Drug Administration or any successor entity
(the "FDA"), and
agencies of other governments of other countries having similar
jurisdiction
over the development, manufacturing and marketing of
pharmaceuticals.
1.29 "Phase 2A" means the Phase 2A or Phase 1/2 clinical trials,
as
prescribed by the FDA and agencies of other governments of other
countries
having similar jurisdiction over the development, manufacturing
and marketing of
pharmaceuticals, designed to evaluate efficacy and initial
clinical proof of
concept.
1.30 "Preclinical Development" means drug development activities
conducted
by the Parties from the nomination by the JRC of a Safety
Assessment Candidate
for Preclinical Development, and up to but not including filing
of an IND.
1.31 "Product" means a Collaboration Product, SGX Product or UG
Product.
1.32 "Registration" means any approvals (including supplements,
amendments
and post-approvals and price approvals), licenses, registrations
or
authorizations of any national, supra-national (e.g., the
European Commission or
the Council of the European Union), regional or local regulatory
agency,
department, bureau, or other governmental entity, necessary for
the manufacture,
distribution, use, sale, pricing or reimbursement, of
Collaboration Products in
a regulatory jurisdiction.
1.33 "Research Plan" has the meaning ascribed to such term in
Section 2.1
1.34 "Safety Assessment Candidate" or "SAC" means a Lead
Compound with the
properties designated by the JRC as required properties for a
SAC, which is
designated by the JRC as a SAC in accordance with Section
2.4(b)(vi).
1.35 "SGX Background Technology" means all Patent Rights and
Know-How
which are: (a) owned or Controlled by SGX prior to the Effective
Date or during
the Collaboration Term; (b) developed by or on behalf of SGX (i)
outside the
Collaboration
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or (ii) within the Collaboration and comprise methodologies,
protocols or
technologies which have application to targets or compounds in
addition to the
Target and compounds the subject of the Collaboration; and (c)
necessary for the
conduct of the Collaboration.
1.36 "SGX Compounds" means all Patent Rights and Know-How which
are
conceived or reduced to practice or otherwise developed by or on
behalf of SGX
during and in the performance of the Collaboration, covering
compounds
identified and developed by SGX, which are not selected by the
JRC as Lead
Compounds.
1.37 "SGX Product" means any product that comprises or contains
or is
developed or manufactured based on or utilizing or is derived
from, a Lead
Compound or any part thereof which was selected by the JRC for
lead
optimization, and which has primary application in the SGX
Retained Field.
1.38 "SGX Retained Field" means kinase inhibitors (other than
MET)
developed for clinical indications other than the Expanded
Therapeutic Field.
1.39 "SGX Territory" means the United States, Canada and
Mexico.
1.40 "Sublicensee Information" has the meaning ascribed in
Section 4.6.
1.41 "Sublicensing Revenue" means all amounts (including,
without
limitation, payments received for the purchase of equity in
excess of the fair
market value of such equity, license fees, milestone and other
time or event
based payments and royalties on sales of products, but excluding
any research
funding payments received and actually used for such purpose)
received by a
Party under an agreement or license attributable to
Collaboration Products or
from sales of Collaboration Products to end users less any
withholding tax or
other tax related reductions.
1.42 "Target" means the human protein kinase RON.
1.43 "Territory" means UG Territory or SGX Territory.
1.44 "Therapeutic Field" means superficial and invasive bladder
cancer.
1.45 "Third Party" or "Third Parties" means any entity other
that UG or
SGX or their respective Affiliates.
1.46 "UG Background Technology" means all Patent Rights and
Know-How which
are: (a) owned or Controlled by UG prior to the Effective Date
or during the
Collaboration Term; (b) developed by or on behalf of UG (i)
outside the
Collaboration or (ii) within the Collaboration and comprises
methodologies,
protocols or technologies which have application to targets or
compounds in
addition to the Target and compounds that are the subject of the
Collaboration;
and (c) necessary for the conduct of the Collaboration.
1.47 "UG Compounds" means all Patent Rights and Know-How which
are
conceived or reduced to practice or otherwise developed by or on
behalf of UG
during
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and in the performance of the Collaboration, covering
compounds
identified and developed by UG, which are not selected by the
JRC as Lead
Compounds.
1.48 "UG Product" means any product that comprises or contains
or is
developed or manufactured based on or utilizing or is derived
from, a Lead
Compound or any part thereof which was selected by the JRC for
lead
optimization, and which has primary application in the UG
Retained Field.
1.49 "UG Retained Field" means non-kinase inhibitors developed
for
urological clinical application other than the Therapeutic
Field.
1.50 "UG Territory" means the countries listed in the attached
Exhibit A
("Europe")
1.51 "Valid Claim" means a claim of a pending patent application
within
the Patent Rights or an issued and unexpired patent within the
Patent Rights
which has not been held unenforceable or invalid by a court or
other
governmental agency of competent jurisdiction, and which has not
been disclaimed
or admitted to be invalid or unenforceable through
reexamination, reissue,
opposition, or otherwise.
2. RESEARCH COLLABORATION.
2.1 Research Collaboration. Subject to the terms and conditions
of this
Agreement UG and SGX will use commercially reasonable efforts to
perform under
the Research Plan attached to this Agreement as Exhibit B
("Research Plan"),
based on the budget attached as Exhibit B1 ("Research Budget").
Research Plan
activities will be overseen by the JRC. The JRC will review the
Research Plan on
an ongoing basis and may make changes to the Research Plan then
in effect,
provided that the JRC may not increase the applicable Research
Budget without
the written approval of each Party. On an annual basis
commencing on the first
anniversary of the Effective Date and continuing until the
conclusion of the
Parties' activities under the Research Plan, the JRC shall
review the Research
Budget to ensure that the number of full time equivalent
personnel (FTEs) of
each Party engaged under the Research Plan and the other costs
of the Research
Plan activities, are being shared between the Parties on a 50/50
basis, and
shall make adjustments to each Party's responsibilities under
the Research Plan
in order to effect such sharing to the greatest extent possible,
taking into
account each Party's experience and expertise in the various
Research Plan
activities.
2.2 Performance Standards; Records. Each Party shall conduct
its
activities under the Collaboration in good scientific manner,
and in compliance
in all material respects with the requirements of applicable
laws and
regulations, to attempt to achieve its objectives efficiently
and expeditiously.
Each Party shall maintain laboratories, offices and other
facilities reasonably
necessary to carry out the activities to be performed by such
Party pursuant to
the Collaboration. In conformity with standard pharmaceutical
and biotechnology
industry practices and the terms and conditions of this
Agreement, each Party
shall prepare and maintain, or shall cause to be prepared and
maintained,
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complete and accurate written records, accounts, notes, reports
and data with
respect to activities conducted pursuant to the Research Plan
and Development
Plan and all results (including without limitation any
inventions, discoveries
and developments) made pursuant to its efforts under the
Collaboration, and,
upon the other Party's written request, shall send legible
copies of the
aforesaid to the other Party. Such records shall be complete and
accurate and
shall fully and properly reflect all work done and results
achieved in the
performance of the Collaboration in sufficient detail and in
good scientific
manner. Upon reasonable advance notice, each Party agrees to
make its employees
and non-employee consultants reasonably available at their
respective places of
business to consult with the other Party on issues arising in
connection with
any request from any regulatory agency with respect to
activities under this
Agreement, including, without limitation, regulatory,
scientific, technical and
clinical testing issues. At least quarterly during the
performance of the
Research Plan, the Parties shall have the obligation to prepare
and provide to
the JRC written reports summarizing the progress of the work
performed by such
Party in connection with the Research Plan during the preceding
quarter.
2.3 Provision of Materials and Know-How. In the course of
the
Collaboration, the Parties will provide each other, promptly
upon request, with
materials and data within Collaboration Technology, as required
for each Party
to perform its respective obligations under the Research Plan
and Development
Plan. Neither Party will have the right to transfer or disclose
materials
received from the other Party to any Third Party other than
permitted
sublicensees or approved Third Party contractors under the
Research Plan,
without the other Party's prior written consent.
2.4 Joint Research Committee
(a) Membership; Decisions. SGX and UG will establish a JRC
to
oversee, review and recommend direction of the Research Plan.
The JRC shall be
comprised of six (6) members, with three (3) members being
appointed by SGX and
three (3) members being appointed by UG. Additional
representatives of each
Party (for example the members of the individual project teams
or consultants)
may attend JRC meetings at the election of each Party. The
Parties may
subsequently agree to change the size of the JRC as appropriate
to meet the
needs of the Parties' collaborative efforts under this
Agreement. Each Party may
replace its JRC representatives at any time, with written notice
to the other
Party. Each representative of SGX and UG shall have one vote on
the JRC, which
vote may be cast by proxy. Decisions of the JRC shall be made by
unanimous vote.
Any matter upon which the JRC is unable to agree shall be
submitted to a senior
executive officer designated by each Party for such purpose.
(b) Responsibilities. The JRC will review, direct and supervise
the
performance of the Research Plan. The JRC will be responsible
for (i)
coordinating, monitoring and reporting research progress and
ensuring open
exchange between the Parties with respect to Collaboration
activities; (ii)
determining the research strategy, budget and time lines for the
Research Plan;
(iii) determining whether to obtain licenses from Third Parties
with respect to
intellectual property useful for the conduct of the Research
Plan; (iv)
determining the required properties for compounds to be
deemed
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Lead Compounds, including without limitation, potency,
selectivity, in vivo
efficacy and bioavailability; and (v) selecting Lead Compounds
for entry into
lead optimization; provided that no more than four (4) Lead
Compound series will
be pursued in lead optimization under the Collaboration at any
one time; and
(vi) determining the required properties for Lead Compounds to
be deemed Safety
Assessment Candidates and selecting Safety Assessment Candidates
for entry into
Preclinical Development.
(c) Meetings. During the term during which the Parties are
performing under the Research Plan, the JRC shall meet
quarterly, in person or
via video-conference, or as the JRC may otherwise agree, to
discharge its
responsibilities, with the expectation that meetings will
alternate between
appropriate offices of each Party. Each Party will be
responsible for paying its
own expenses in connection with participating in the meetings of
the JRC. The
JRC shall prepare written minutes of each meeting and a written
record of all
JRC decisions, whether made at a JRC meeting or otherwise.
3. DEVELOPMENT
3.1 Overview. SGX and UG agree that they will collaborate on
development
of Collaboration Products pursuant to the terms of this
Agreement, in a
coordinated international program aimed at producing an
International
Registration Dossier and obtaining Registration of Collaboration
Products in the
UG Territory and SGX Territory. All such collaborative
development efforts of
the Parties, or either Party, shall be in accordance with the
Development Plan
for each Collaboration Product. Except as otherwise provided in
this Agreement,
each Party agrees that neither Party may conduct Preclinical
Development or
Clinical Development on a Collaboration Product for sale or
distribution, or
license any Third Party to do so, except collaboratively with
the other Party or
as permitted by this Agreement. However, as discussed further in
Article 6, it
is agreed that, if one Party determines that it does not wish to
proceed with
such joint development of a particular Collaboration Product,
the other Party
shall be permitted to do so on its own pursuant to the terms of
Article 6.
3.2 Joint Development Committee. On a Collaboration
Product-by-
Collaboration Product basis, once a Safety Assessment Candidate
is selected by
the JRC for progression to Preclinical Development, the Parties
shall form a JDC
for the development of such SAC, comprised of six (6) members,
with three (3)
members being appointed and replaced by SGX and three (3)
members being
appointed and replaced by UG. Additional representatives of each
Party (for
example members of the individual project teams or consultants)
may attend JDC
meetings at the election of each Party. The Parties may
subsequently agree to
change the size of each JDC, as appropriate to meet the needs of
the Parties in
managing the joint efforts under this Agreement. The JDC shall
(a) prepare the
Development Plan for the Preclinical Development of the SAC, and
modify or amend
it as appropriate, based on the results of the development
efforts on such SAC,
during the development process; (b) select one or more SACs for
Clinical
Development and prepare the Development Plan for such Clinical
Development, (c)
determine whether and when to commence Phase 1, Phase 2 and
Phase 3 for each
Collaboration Product; (d) oversee the Parties' activities under
the Development
Plan, including supervision of
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regulatory activities and (e) perform such other duties and
obligations as the
Parties specifically delegate to it in writing by mutual written
agreement of
the Parties.
3.3 JDC Meetings. JDC meetings shall take place at such
mutually
convenient times and places as determined by the JDC, with the
expectation that
meetings will alternate between appropriate offices of each
Party. Each Party
will be responsible for paying its own expenses in connection
with participating
in JDC meetings. The JDC shall determine the frequency of its
meetings and how
such meetings will be conducted and recorded.
3.4 Decision-Making and Issue Resolution. All decisions of the
JDC shall
be unanimous by the members of such committee. If the JDC fails
to reach
unanimous agreement on an issue needing resolution, the matter
shall be referred
for good faith discussion and resolution by a senior executive
officer
designated by each Party for such purpose.
3.5 Joint Development. For each SAC selected by the JRC for
joint
development as a Collaboration Product hereunder by mutual
written agreement,
SGX and UG agree that they will collaborate to generate an
International
Registration Dossier, and will conduct, or have conducted, all
Preclinical
Development and Clinical Development on such Collaboration
Product in accordance
with the Preclinical and Clinical Development Plans developed by
the JDC for
such Collaboration Product. The Parties will work together to
develop a common
brand name for each Collaboration Product to be marketed under
worldwide. Each
Party agrees not to incur any expenses or costs in excess of the
Development
Budget (as defined below) within such Development Plan except as
mutually agreed
in writing by the Parties. The collaborative development program
will follow the
most expeditious path to the production of an International
Registration Dossier
and Registration of Collaboration Products in the UG Territory
and SGX
Territory, provided however it is understood that unless
otherwise agreed by the
Parties, all commercialization activities with respect to such
Collaboration
Product once Registration has been obtained, will be conducted
by the Parties
independently, in each Party's respective Territory for such
Collaboration
Product and that each Party will bear its own costs of such
commercialization
activities. On a Collaboration Product-by-Collaboration Product
basis, each
Party will be primarily responsible for regulatory activities in
its applicable
Territories after Registration in such Territory, comprising
regulatory
compliance, safety surveillance, adverse event reporting and all
other necessary
support services, however the Parties will keep each other
informed of such
activities and will work together in the conduct of such
activities where
necessary or useful. The Parties will mutually agree on (i)
the
commercialization strategy for countries outside of the
Territories, including
outlicensing as necessary; and (ii) the engagement of a Third
Party(ies) to
manufacture and supply bulk drug substance for Collaboration
Product
development, and Collaboration Products for commercialization
purposes, in the
Territories.
3.6 Access to Information. During the term of this Agreement
each Party
(the "Providing Party") will provide the other Party (the
"Recipient") in
English, for use in the Recipient's development and
commercialization efforts
relating to a Collaboration
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Product, all Information that the Providing Party owns or
Controls regarding
such Collaboration Product (including, without limitation,
Sublicensee
Information), necessary or useful for making regulatory filings
and seeking and
maintaining Registration, for Collaboration Products in the
Recipient's
Territory for such Collaboration Product, as such Information
becomes available.
The Recipient will have a right of access, and the right to use
and incorporate
all Information provided by the Providing Party in regulatory
filings for such
Collaboration Products in the Recipient's Territory. The Parties
will report and
take other actions in relation to, adverse events with
Collaboration Products,
to each other in accordance with a reporting protocol in a form
to be agreed by
the JDC. Each Party will be entitled to receive copies of all
correspondence
with regulatory authorities and will be entitled to be present
at all meetings
with regulatory authorities in any Territory related to
Collaboration Products.
3.7 Development Plans and Budgets. Promptly after the selection
by the JRC
of a SAC for development as a Collaboration Product by the
Parties, the JDC
shall prepare and provide to each Party for final approval a
development plan
for such SAC (the "Development Plan"). The Development Plan
shall include all
needed details regarding the Preclinical and Clinical
Development, and other
work to be undertaken to develop and produce the International
Registration
Dossier for such Collaboration Product, including an allocation
of all such work
as appropriate to each Party (or to selected Third Party
contractors, as
agreed), and shall establish a budget (the "Development Budget")
for all costs
and expenses to be incurred by each Party in conducting the work
allocated to it
under such Development Plan. The budget will be based on (i) an
allocation of
Full Time Equivalent (FTE) personnel of each Party working under
the Development
Plan, with each FTE costed at an annualized rate of
U.S.$[...***...] (which rate
will be increased on each anniversary of the Effective Date by
[...***...]%);
(ii) the actual extraordinary direct costs approved by the JDC,
and (iii) the
actual costs of work performed by Third Parties as approved by
the JDC. Each
Party shall diligently review the proposed Development Plan and
shall either
approve the plan or provide the JDC any requested changes and
comments. If a
Party provides such requested changes or comment to a proposed
Development Plan,
the JDC shall review the proposed changes within thirty (30)
days, and as
appropriate, thereafter prepare a revised draft of the
Development Plan,
accommodating such changes and comments, and resubmit such
revised Development
Plan for approval by the Parties as provided above. Once the
Parties have agreed
on the Development Plan proposed by the JDC, such Development
Plan shall be
effective and shall control and govern the Parties' development
effort with
respect to the applicable Product, subject to any subsequent
amendments or
modifications to such Development Plan as provided below. From
time to time
during the development of such Collaboration Product, the JDC
shall review the
Development Plan in light of the results of the development work
and any other
relevant Information and shall amend or modify the Development
Plan as
appropriate, provided that the JDC may not increase the
applicable Development
Budget without the written approval of each Party. At least
sixty (60) days
prior to January 1 of any year in which the Parties are
developing a particular
Collaboration Product hereunder, the JDC shall review the
applicable Development
Budget for such Collaboration Product and shall submit a revised
and updated
Development Budget for the coming calendar year to each of the
Parties for
approval as provided above. Upon such approval, the Development
Budget shall be
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effective for the development of such Collaboration Product
during such calendar
year, subject further to amendment of the applicable Development
Plan.
3.8 Costs of the Collaboration. All costs and expenses incurred
or
expended by a Party hereunder under the Research Budget and
Development Budget
("Collaboration Costs") shall initially be borne by the Party
incurring such
costs and expenses, subject to creditability of Excess Expenses
as provided in
Section 4.3, provided however, on a Collaboration
Product-by-Collaboration
Product basis, the costs of any country specific regulatory
requirement (outside
of the International Registration Dossier and any Phase 4
studies required by a
regulatory body in a Territory), will be borne by the Party
whose Territory for
such Collaboration Product includes such country. Each Party
shall calculate and
maintain records of all the Collaboration Costs incurred or
expended by the
Party during its performance of development on a Collaboration
Product, in
accordance with generally accepted accounting procedures
consistently applied
throughout such Party's organization and such other procedures
to be agreed upon
between the Parties. Commencing on the formation of the JDC,
each Party shall
report quarterly to the other on the Collaboration Costs it has
incurred in each
calendar quarter, on a Collaboration Product-by- Collaboration
Product basis,
and the purpose (referencing the activities within the
applicable Development
Plan) for which such costs were incurred or expended, with such
reports to be
submitted within sixty (60) days after the end of each of the
first three (3)
calendar quarters and ninety (90) days after the end of the
calendar year. The
Parties shall seek to resolve promptly and in good faith any
questions or issues
related to such accounting statements, and in any event within
ninety (90) days
following receipt.
3.9 Excess Expenses.
(a) For each particular calendar year during which
Collaboration
Costs are incurred hereunder, and promptly following the First
Commercial Sale
of each Collaboration Product hereunder, each Party shall review
the
Collaboration Costs report submitted by the other Party and
compare such
submission to the applicable Research Budget and Development
Budget. The Parties
will then meet, if necessary, via designated senior officers
from each Party
with financial accounting responsibility, to discuss the reports
and reach
agreement on the total amount of Collaboration Costs that each
Party may
properly apply to the Collaboration activities hereunder. It is
understood and
agreed that a Party will not be entitled to obtain credit for
any Collaboration
Costs incurred by the Party in excess of the amount set forth in
the applicable
Research Budget or Development Budget for accomplishing the
relevant task or
objective unless approved by the JRC or JDC. If such officers
cannot reach
agreement promptly, the matter will be submitted to senior
executive officers of
each Party for prompt resolution, with the understanding that
each Party will
provide access to any information relating to the Collaboration
activities
undertaken by such Party, and the actual calculation of costs
and expenses
incurred therefor, with respect to Collaboration Products during
such calendar
year for which such Party seeks credit hereunder for the related
Collaboration
Costs .
(b) UG and SGX will share the total amount of Collaboration
Costs
incurred by the Parties within the applicable Research Budget
and Development
Budget
11
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CONFIDENTIAL
for each Collaboration Product, up to and including the costs of
Clinical
Development, on a 50/50 basis. Any Collaboration Costs incurred
by a Party in
excess of [...***...]% of the total amount of Collaboration
Costs incurred by
both Parties, will be deemed Excess Expenses of such Party (the
"First Party")
and in the event that the Party which has not incurred Excess
Expenses (the
"Second Party") does not elect to pay the First Party the amount
of the Excess
Expenses in cash within [...***...] ([...***...]) months of the
First Commercial
Sale of a Collaboration Product, the First Party may credit such
Excess Expenses
in accordance with Section 4.3.
3.10 Audit Rights. Each Party shall have the right to have an
independent
accounting firm audit the other Party's relevant records to
determine the
accuracy of the Collaboration Costs reported by such other Party
under Section
3.8 above. Such audit right shall be exercised under the terms
of the audit
provisions set forth in Section 4.11 below.
3.11 Diligence. Each Party shall use commercially reasonable
diligent
efforts to (i) develop and bring Safety Assessment Candidates
nominated by the
JRC for Preclinical Development, to the market as Collaboration
Products in such
Party's applicable Territory as soon as reasonably practicable,
(ii) obtain such
Registrations as may be necessary to market such Collaboration
Products in such
Territory, and (iii) after obtaining Registration for any such
Collaboration
Products, launch such Collaboration Products and promote and
meet the market
demand therefore. In connection with the above, each Party shall
use efforts not
less than those efforts made by similarly situated companies in
the
biotechnology industry with respect to comparable products of
comparable
commercial potential, stage of development and patent
protection.
3.12 Lack of Diligence. In the event that either Party fails to
use or
continue to use diligent efforts to actively develop and
commercialize a
Collaboration Product in accordance with Section 3.11 above (the
"First Party"),
and the First Party fails to initiate diligent efforts within
sixty (60) days of
receipt of notice from the other Party (the "Second Party") of
such failure,
then the Second Party may terminate the First Party's rights
under this
Agreement with respect to such Collaboration Product and, in
such event, the
Second Party shall have the exclusive right to commercialize any
such
Collaboration Product in the First Party's Territory and the
Second Party shall
make payments to the First Party in accordance with Section
6.3.
3.13 Competing Products. During the period from the Effective
Date to the
tenth anniversary of the Effective Date, each Party agrees not
to, and to cause
its Affiliates not to, directly or indirectly, develop and
commercialize a
Competing Product in any country in the other Party's Territory
for the
applicable Collaboration Product. In the event that a Party (an
"Acquiring
Party") purchases or otherwise takes control of a Third Party
("Acquisition")
which has developed or commercialized (and is continuing to
produce or sell), or
is developing or commercializing a Competing Product (directly
or indirectly) in
any such case, within the other Party's Territory for the
applicable
Collaboration Product, the Parties will negotiate in good faith
to agree on the
appropriate sharing between the Parties of the Acquiring Party's
rights and
obligations in connection with the development and
commercialization of the
Competing Product, and in the event
12 ***CONFIDENTIAL TREATMENT REQUESTED
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CONFIDENTIAL
that such agreement is not reached within twelve months after
such Acquisition,
the Acquiring Party shall divest, or cause its applicable
Affiliate to divest,
the Competing Product.
4. ROYALTY PAYMENTS
4.1 Royalties on Net Sales of Collaboration Products. No later
than six
(6) months prior to the filing of the International Registration
Dossier for the
first Collaboration Product, the Parties will negotiate in good
faith a
commercialization plan for Collaboration Products including an
agreement on the
appropriate royalty payments and shares of Sublicensing Revenue
due to each
Party, recognizing the guiding principle of a 50/50
collaboration with equal
sharing of expenses and returns. In the event that no agreement
is reached by
the Parties by the date that is six (6) months prior to the
First Commercial
Sale of the first Collaboration Product, (i) UG will pay to SGX
a royalty of
[...***...]% of Net Sales of Collaboration Products by or on
behalf of UG in the
UG Territory or [...***...]% of Sublicensing Revenue received by
UG in
connection with Collaboration Products; and (ii) SGX will pay to
UG a royalty of
[...***...]% of Net Sales of Collaboration Products by or on
behalf of SGX in
the SGX Territory or [...***...]% of Sublicensing Revenue
received by SGX in
connection with Collaboration Products.
4.2 Royalties on Net Sales of UG Products and SGX Products.
In
consideration of the rights granted hereunder:
(a) SGX shall pay to UG [...***...]% of Net Sales of SGX
Products by
or on behalf of SGX in the SGX Territory or [...***...]%] of
Sublicensing
Revenue received by SGX in connection with SGX Products; and
(b) UG shall pay to SGX [...***...]% of Net Sales of UG Products
by
or on behalf of UG worldwide or [...***...]% of Sublicensing
Revenue received by
UG in connection with UG Products.
4.3 Creditable Payments. Each Party may credit any Excess
Expenses
(including interest calculated at the rate equal to the prime
rate as reported
by the Chase Manhattan Bank, New York, New York, plus
[...***...] percent
([...***...]%), compounded annually) it has incurred, as
determined in
accordance with Section 3.9, against any royalty payments it is
required to make
under Section 4.1, up to a maximum of [...***...]% of the
royalties due from
such Party in any calendar quarter. In the event that a
Collaboration Product
has been registered in one Party's Territory but the First
Commercial Sale of a
Collaboration Product in the other Party's Territory is delayed
or likely to be
delayed by more than twelve (12) months,
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