GlaxoSmithKline MASTER AGREEMENT FOR THE Biological s.a. Rue de I'lnstitut, 89 SUPPLY OF LABORATORY TEST SERVICES B-1330 Rixensart Belgium Tel. +32 (0) 2 656 81 11 Fax. +32 (0) 2 656 80 00 www.gsk-bio.com
GlaxoSmithKline
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GlaxoSmithKline
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MASTER
AGREEMENT FOR THE
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Biological
x.x.
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Xxx
de I'lnstitut, 89
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SUPPLY
OF LABORATORY TEST SERVICES
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X-0000
Xxxxxxxxx
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Xxxxxxx
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Tel.
x00 (0) 0 000 00 00
Fax.
x00 (0) 0 000 00 00
xxx.xxx-xxx.xxx
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THIS
MASTER LABORATORY TEST SERVICES AGREEMENT (the "Agreement")
is
made
the
1st
day of
December, 2006 ("Effective Date")
between:
(1) |
GLAXOSMITHKLINE
BIOLOGICALS, a company having its principal office at 00 xxx xx
X'Xxxxxxxx, 0000 Xxxxxxxxx, Xxxxxxx ("GSK
BIO");
and
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(2) |
RESPONSE
GENETICS INC., a company incorporated in the State of Delaware,
whose
principal place of business is situated at 0000 Xxxxxxx Xxxxxx,
Xxxxx 000,
Xxx Xxxxxxx, XX 00000 ("RGI").
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WHEREAS:
(A) |
GSK
BIO is a leading vaccine global innovative pharmaceutical company
with
extensive research and development capabilities
.
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(B) |
RGI
is engaged, inter
alia, in
the business of supplying Testing Services, as that is defined
herein, in
relation to the pharmaceutical industry and related industries
and has
considerable skill and knowledge in that
field.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
1 of
40
(C) |
RGI
and SmithKline Xxxxxxx Corporation (d.b.a. GlaxoSmithKline) have
entered
into a Master Agreement for the Supply of Laboratory Test Services
dated
January 17, 2006 (the "RGI/SBC Agreement") under which RGI has
agreed to
provide testing services to SmithKline Xxxxxxx
Corporation.
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(D) |
In
reliance upon RGI's skill, knowledge and experience, GSK BIO also
wishes
to engage RGI to provide services, principally in relation to profiling
the expression of various genes from a range of human malignancies
and RGI
agrees to accept the engagement on the following terms and
conditions.
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(E) |
RGI
plans to set up a laboratory within the European Union (hereinafter
referred to as the 'European Laboratory') within [***] of the
Effective
Date where the Services can be performed and for this purpose
plans to
invest a minimum amount of USD [***] of its own funds into
the
establishment of such
laboratory.
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IT
IS HEREBY AGREED AS FOLLOWS:
DEFINITIONS
AND INTERPRETATIONS
1 |
In
this Agreement the following expressions shall have the following
meanings:
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1.1 |
"Affiliate"
with
respect to a person shall mean any other person that directly, or
indirectly through one of more intermediaries, controls, is controlled
by
or is under common control with such person; for the purposes of
this
clause 1.1 only, "control" and, with correlative meanings, the terms
"controlled by" and "under common control with", shall mean (a) the
possession, directly or indirectly, of the power to direct the management
or policies of a person, whether through the ownership of voting
securities, by contract or otherwise, and/or (b) the ownership, directly
or indirectly, of at least fifty percent (50%) of the voting securities
or
other ownership interest of a
person.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
2 of
40
1.2
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"Agreement"
means
this Agreement between GSK BIO and RGI for the supply of Services
by
RGI.
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1.3 |
"Confidential Information"
shall
mean any and all commercial and technical information relating to
any of
the existing or planned products, businesses, research and/or development
activities, customers and suppliers of either Party whether in written,
verbal or any other form, tangible or intangible, which either Party
may
acquire or may have access from time to time, provided such information
is
marked as "Confidential
and Proprietary" and
provided that information which is orally disclosed shall be confirmed
in
writing within thirty (30) days from oral disclosure. Confidential
Information includes and is not limited to: (a) any information generated
in connection with the provision of the Services (such as the results
or
findings thereof and the contents of any report) under this Agreement,
(b)
information concerning inventions, discoveries, concepts, ideas,
techniques, processes, designs, specifications, drawings, diagrams,
models, samples, flow charts, computer programs, algorithms, data,
databases, studies, mathematical calculations, finances and plans,
customer lists, business plans, contracts, marketing plans, production
plans, distribution plans, system implementation plans, business
concepts,
supplier information, business procedures and business operations
and all
materials related thereto; (c) the existence, contents or terms of
this
Agreement, (d) all know-how and intellectual property, (e) all unpublished
copyrightable material, (f) any use, variation, application, reduction
to
practice, or any discussion and any other communication thereof regarding
or relating to the Information, and (g) any information concerning
how any
part of the above information is related to and/or fits together
with any
other part of the above information, or any other technology or business;
Notwithstanding the foregoing, the Parties agree that any and all
data,
reports, laboratory work sheets, results, materials or information
provided by either Party or its Affiliates
or Third Parties on behalf of a Party and any other documents or
information furnished to a Party, or to which a Party is given access,
by
the other Party or its Affiliates or such Third Parties in connection
with
the performance of this Agreement, or prepared or generated by a
Party in
connection with performing any and all Studies (as defined in Section
1.1.1. below) hereunder, shall be deemed to be the Confidential
Information of the Party which owns such disclosed
information.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
3 of
40
1.4 |
"Effective
Date" means
the date first given above;
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1.5 |
1.1.5
"Party"
shall
mean GSK BIO or RGI as the context requires and
"Parties"
shall
mean both GSK BIO and RGI;
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1.6 |
"Person"
and
words signifying persons shall be construed as to include individuals,
firms, bodies corporate, joint ventures, governments, states or
agencies
of state or any undertaking (whether or not having separate legal
personality and irrespective of the jurisdiction in or under the
laws of
which it was incorporated or exists);
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1.7 |
"Purpose"
shall
mean the provision of the Services pursuant to this Agreement and
the
evaluation by the Parties of whether to add other projects and
services to
this Agreement;
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1.8 |
"Relevant
Staff' shall
mean employees and sub-contractors involved in providing the Services
and
named in the relevant Schedule or otherwise agreed to in writing
by GSK
BIO;
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1.9 |
"Services"
means
the services to be provided by RGI pursuant to this Agreement at
the
request of GSK BIO (as amended from time to time in accordance
with the
provisions of this Agreement) and such other services as may from
time to
time be agreed upon by RGI and GSK BIO, including Testing Services,
consultation and tissue storage, in connection with this Agreement
and as
further detailed and agreed upon in a SOW pursuant to Article 1
below;
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
4 of
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1.10 |
"Term"
means
that this Agreement shall commence on the Effective Date and
shall
continue until the 31. December 2010 or until the completion
of the
recruitment phase of GSK BIO's [***] whichever is later, unless
sooner
terminated in accordance with the provisions hereof
and
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1.11 |
"Testing
Services"
means RGI's business, among other things, of conducting molecular-based
tumor tissue profiling using a proprietary and patented process
developed
by RGI which involves a complex molecular analysis of specific
molecular
markers that provides valuable tumor specific gene expression
information
obtained from a paraffin preserved fresh or frozen tissue sample,
which
can help the physician choose the most appropriate therapy for
a patient
prior to starting treatment or assist a pharmaceutical company
in
identifying the appropriate candidate patient population suitable
for a
therapy in development.
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1.12 |
"Third Party" shall
mean any Person who is not a Party hereto or any of their
Affiliates
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2 |
References
to recitals, clauses and, if applicable, schedules and exhibits
are to the
recitals and clauses of and, if applicable, the schedules and exhibits
to,
this Agreement. To the extent that there is conflict between or
ambiguity
relating to any schedule or exhibit to this Agreement and the remainder
of
this Agreement, the wording of the schedule or exhibit shall
prevail.
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3 |
Any
schedules and exhibits to this Agreement form part of this Agreement
and
shall have the same force and effect as if expressly set out in
the body
of the Agreement and any reference to the Agreement shall include
the
schedules and exhibits. Schedules and exhibits may not be added
to this
Agreement except by the express written consent of both
Parties.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
5 of
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4 |
Words
denoting the singular shall include the plural and vice versa and
words
denoting any gender shall include all genders unless the context
otherwise
requires.
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5 |
A
reference to any Party shall include a reference to the legal successors
to the whole or a substantial part of its undertaking and its permitted
assignees.
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6 |
References
to any statute or statutory provision shall, unless the context
otherwise
requires, be construed as a reference to that statute or provision
as from
time to time amended, consolidated, modified, extended, re-enacted
or
replaced.
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7 |
The
headings preceding the text of the various provisions of this Agreement
are for convenience of reference only and are not intended to,
nor do
they, define, limit or in any other way describe the scope of this
Agreement or the intent of the provisions
hereof.
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ARTICLE
1
STATEMENT
OF WORK; STUDY DIRECTOR
1.1 |
Statement
of Work
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1.1.1 |
RGI
agrees to perform a study or studies which will involve Testing Services
(hereinafter referred to as "Study") from time to time in accordance
with
a Statement of Work in the form of Exhibit
B attached
hereto ("SOW"),
for the benefit of GSK BIO or any Affiliate of GSK BIO. Each SOW
shall
include as attachments (i) a detailed protocol document ("Protocol")
which shall be provided by GSK BIO or prepared by RGI under GSK BlO's
direction and approved in writing by GSK BIO, and which shall be
attached
to each SOW as Schedule
I,
and (ii) a pricing schedule in the form of Schedule
II
to
the SOW attached hereto ("Pricing
Schedule").
An SOW shall not be effective unless it has been agreed upon in writing
by
both Parties.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
6 of
40
1.1.2 |
The
Pricing Schedule shall be based upon the Testing Services Fee Schedule
set
forth in Exhibit
A.
Each SOW shall specify the Study design, information desired, estimated
duration of the applicable Study, milestones and reporting (if applicable)
and all other relevant matters pertinent to completion of such Study
(except for pricing), and shall be deemed a part of this Agreement
and is
incorporated herein by reference. Each Pricing Schedule attached
to a SOW
shall specify the cost to GSK BIO of the Services RGI is to perform
in
connection with such Study and shall be deemed a part of this Agreement
and is incorporated herein by
reference.
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1.1.3 |
If
requested by GSK BIO, RGI shall consult with GSK BIO to assist GSK
BIO in
developing any Study design in a manner consistent with current regulatory
guidelines. RGI represents that any such Study design and/or the
results
from any such Study shall satisfy the requirements of the U.S. Food
and
Drug Administration ("FDA") and the European Medicines Agency ("EMEA")
at
the time the Study design is
completed.
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1.2 |
Study
Director
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1.2.1 |
RGI
shall appoint a study director ("Study
Director")
to be responsible to oversee the completion of each Study by RGI.
The
Study Director shall coordinate performance of the applicable Study
with a
representative designated by GSK BIO ("GSK
BIO Representative"),
which GSK BIO Representative shall have responsibility over all matters
relating to the performance of such Study on behalf of GSK
BIO.
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1.2.2 |
Unless
otherwise agreed to in the applicable SOW, or by the Study Director
and
GSK BIO Representative, all communications between RGI and GSK BIO
regarding the conduct of each Study pursuant to a SOW shall be addressed
to or routed directly through the applicable Study Director and GSK
BIO
Representative. RGI may substitute its Study Director and GSK BIO
may
substitute the GSK BIO Representative, as the case may be, during
the
course of a particular Study by providing written notice thereof
to the
other Party.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
7 of
40
1.3 |
Corrective
Measures
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1.3.1 |
If,
at any time during the term of this Agreement, RGI becomes aware
that the
applicable SOW was not followed, or that RGI otherwise made a material
error or material mistake in conducting Testing Services, RGI agrees
to
notify GSK BIO of such occurrence in writing promptly following the
day
such discovery is made. Upon receipt of such notice, GSK BIO will
notify
RGI in writing, within a reasonable time, not to exceed two (2) business
days, whether corrective measures which may include retesting are
required
to ensure validity of results, and GSK BIO will not be invoiced for
any
necessary corrective measures. RGI agrees to implement necessary
corrective measures promptly. The retest data will be reported by
RGI to
GSK BIO within a reasonable time from the receipt by RGI of notification
from GSK BIO that retesting is
required.
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ARTICLE
2
APPOINTMENT
2.1 |
This
Agreement will commence with effect, as defined herein, from the
Effective
Date and will continue for the Term, as defined in this Agreement,
or
until terminated in accordance with the provisions of Article 9.
Should
GSK BIO wish to extend the term of this Agreement, the Parties will
discuss such extension in good
faith.
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2.2 |
Notwithstanding
the foregoing, however, such Term shall continue in force with respect
to
all Studies being conducted under SOWs which have an effective date
and
have been received by RGI prior to the expiration of the Term, until
all
such Studies have been completed, and the final report and any other
pertinent Study-related documents for such Studies required from
RGI
hereunder have been received by and completed to the reasonable
satisfaction of GSK BIO.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
8 of
40
ARTICLE
3
COMPENSATION
3.1 |
GSK
BIO agrees to pay RGI according to the payment schedule set forth
in
the Pricing
Schedule as part of the SOW. The Pricing Schedule shall be based
on the
unit pricing provided in Exhibit A and shall specify the timing of
the
issuance of
invoices applicable to the SOW. Absent an alternative arrangement
agreed upon
by the Parties for a particular SOW, RGI may issue invoices to GSK
BIO on
a monthly basis for Services provided pursuant to the Agreement.
All payments
due hereunder shall be paid by GSK BIO within thirty (30) days
from the
end of a month in which an accurate, complete invoice is received
by
GSK BIO.
Absent terms in the SOW to the contrary, nothing in this Agreement
shall be
interpreted to require RGI to initiate performance of any SOW or
to
require GSK
BIO to pay for work conducted pursuant to any SOW prior to the
execution of
the relevant SOW by RGI. RGI shall be entitled to interest at the
prime
rate as
published by Barclays Bank (London) from time to time plus one percent
per annum
for any payments not timely made to it under this Agreement. In
the event
that GSK BIO contests the validity or accuracy of amounts invoiced
to
it under
the Agreement, no interest payments shall be required for amounts
later determined
to have been inappropriately invoiced.
Prices
and fees set forth in this Agreement will remain fixed during the
Term.
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3.2 |
GSK
BIO will pay RGI in consideration of the Services performed pursuant
to
this Agreement the following:
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3.2.1 |
For
microdissection of tumor or normal tissue and isolation of RNA or
DNA, GSK
BIO shall pay a fee of €[***] per
sample.
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3.2.2 |
For
other Services, GSK BIO shall pay according to the fee schedule set
forth
in Exhibit A hereto.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
9 of
40
3.2.3
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Samples
may include pre- and post-treatment biopsies as well as adjacent
normal
tissue excised from samples sent for analysis. Pre- Post- and Normal
are
considered three different types of
samples.
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3.2.4
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Samples
will be provided by GSK BIO for analysis and shall meet mutually
agreed
upon specified criteria for tumor content and slide preparation
which
includes, but is not limited to, providing compliance with sample
preparation instructions, and compliance with packaging, delivery
and
shipping requirements and instructions. RGI will make reasonable
efforts
to pre-screen the samples for sufficiency prior to analysis and
if RGI in
its discretion eliminates insufficient or deficient samples prior
to
performing any analysis, RGI will not charge GSK BIO for that
sample.
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3.2.5
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Samples,
for the purposes of this Agreement, may include samples from
any GSK
BIO-funded source or sponsored samples deemed of interest to
GSK
BIO.
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3.3 |
GSK
BIO agrees to make an upfront payment of two million Euros (EUR
2,000,000)
within four weeks from the Effective Date ("Upfront Payment").
This
payment shall be refundable only under the circumstances described
in 9.4.
of this Agreement and shall be credited against the Annual Minimum
Payment
defined in 3.4. below, in the following
manner:
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Year
2
credit: EUR
[***]
Year
3
credit: EUR
[***]
3.4 |
GSK
BIO agrees to make minimum payments of EUR [***] annually during
the years
2007, 2008 and 2009. Such annual minimum payments are hereinafter
referred
to as the Annual Minimum. The Upfront Payment shall be credited
against
the Annual Minimum Payment as defined under 3.3.
above.
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GSK
BIO
will pay the Annual Minimum in monthly instalments of EUR [***] Euros
and
[***] cent) each, starting in January 2007. The Annual Minimum (as reduced
by
crediting the Upfront Payment as defined under 3.3. above) is fully
creditable against work undertaken by RGI under this Agreement during the
year
in which it is paid. If, in any one of the years 2007, 2008 or 2009, GSK
BIO
submits to RGI work which generates payment obligations below the Annual
Minimum
the difference between the Annual Minimum (as reduced by crediting the Upfront
Payment as defined under 3.3. above) and the value of the work submitted
can be
credited against Services ordered by GSK Bio under this Agreement between
January 1st
2010 and
the end of the Term.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
10
of 40
3.5 |
The
Parties will conduct regular reviews of the fees set forth in
the fee
schedule in Exhibit A in March of each year. The price reviews
will
include, but not be limited to, a review of RGI's overhead costs
for the
performance of the Services. If the review shows that the overhead
cost
item per sample has decreased, the fees will be reduced accordingly.
If
the review shows that the overhead cost item per sample has increased
by
more than [***]%, the Parties will enter into good faith discussions
to
optimize the cost/price structure. If the Parties cannot agree
on a new
cost/price structure, the existing fees shall continue to
apply.
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ARTICLE
4
PERFORMANCE
OF THE SERVICES – SERVICE
PROVISIONS
4.1 |
RGI,
either in its European Laboratory, in its US-based laboratory
or in any
other laboratory RGI may set up in the future –
as may be
requested by GSK BIO shall use its best efforts to provide a
turnaround
time of five (5) business days for performance of the Testing
Services.
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4.2 |
To
assist RGI to expeditiously perform the Testing Services, GSK
BIO will use
reasonable efforts to transmit samples to RGI for testing as
follows:
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· |
Regarding
samples from GSK's [***] clinical studies GSK BIO will transmit
these
samples according to the patient
recruitment;
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· |
Regarding
all other samples GSK BIO will transmit these in equal numbers
each
quarter. If samples for any one quarter are anticipated to exceed
[***]
[***] (prospective and retrospective), GSK BIO shall give written
notice
to RGI of how many samples it expects to deliver and of what mutually
agreeable genes it will be requesting analysis at least two (2)
quarters
in advance so as to allow RGI sufficient time to supplement resources
(personnel, equipment, materials, etc.) and/or to develop probes
or
primers, as necessary, in order to analyze the samples expected.
If GSK
BIO provides such notice to RGI, then GSK BIO shall use its best
efforts
to deliver to RGI for testing samples equalling the projected sample
number.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
11
of 40
4.3 |
RGI
will perform the Testing Services in accordance with good laboratory
art.
RGI also will comply with the applicable laws, regulations, and
guidelines
governing the performance of the Testing Services, including
those
relating to Good Laboratory Practices. RGI further will comply
with all
laws, regulations and guidelines applicable to the care and use
of
experimental animals. In addition, all animals used in projects
covered by
this Agreement shall be provided humane care and treatment in
accordance
with acceptable current veterinary
practices.
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4.4 |
RGI
shall use reasonable efforts to provide facilities, supplies
and staff
necessary to complete each Study as provided in the applicable
SOW, as it
may be modified as provided herein, and in accordance with the
terms of
this Agreement.
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4.5 |
GSK
BIO's representatives may visit RGI's laboratory and premises
at
reasonable times, on reasonable prior notice, and with reasonable
frequency during normal business hours to observe the progress
of any
Study, and any and all information and results derived therefrom.
RGI
shall assist GSK BIO in scheduling such visits such as an audit
of RGI by
GSK QA/QC.
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4.6 |
All
reports prepared by RGI hereunder shall be prepared in a format
specified
in the applicable SOW and shall be considered to be Confidential
Information of GSK BIO. GSK BIO shall have access to all documentation,
records, raw data, specimens or other work product generated
as part of
the performance of each Study.
RGI agrees to maintain appropriate records in paper or magnetic
form, in a
manner which complies with regulatory
requirements.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
12
of 40
4.7 |
In
its performance of the Services for GSK BIO hereunder and for
SmithKline
Xxxxxxx Corporation under the RGI/SBC Agreement, RGI agrees to
dedicate
the same level of priority to Services requested by GSK BIO and
SmithKline
Xxxxxxx Corporation for analysis of their respective clinical
samples.
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4.8 |
RGI
agrees to comply with all provisions of the Generic Drug Enforcement
Act
of 1992. RGI further agrees to submit to GSK BIO, upon request upon
completion or termination of the Testing Services, a certification
that
neither RGI nor any of its employees has been debarred by the FDA
under
the provisions of the Act and that RGI did not use in any capacity
in
connection with the Testing Services any individual debarred by the
FDA
under the provisions of the above referenced
Act.
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4.9 |
Should
applicable government regulatory requirements be changed during
the term
of this Agreement, RGI shall make reasonable efforts to satisfy
the new
requirements. In the event that compliance with such new regulatory
requirements necessitates a change in the SOW for a Study, RGI
shall
submit to GSK BIO a revised technical and cost proposal for GSK
BIO's
acceptance prior to making any changes in the SOW for such
Study.
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4.10 |
In
the event of a conflict in government regulations, GSK BIO shall,
upon
request by RGI, designate which regulations it wishes RGI to
follow in its
performance of a particular
Study.
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4.11 |
RGI
agrees to use reasonable care in safeguarding, inventorying and
handling
all SOW data, materials and supporting documentation (hereinafter
collectively termed "Study Archives") originating from any SOW
conducted
under this Agreement by RGI, whether written or physical (such
as
notebooks, original or raw data, protocols, interim or final
report
copies). The Study Archives shall be considered to be Confidential
Information of GSK BIO. RGI will maintain the samples provided
to it for
testing under this Agreement in accordance with the usual and
customary
standards for maintaining such materials. Upon request by GSK
BIO, RGI
will provide sample materials to GSK BIO or a copy of documents
from the
Study Archives, at GSK BlO's expense. To the extent that samples
are
transferred to GSK BIO, responsibility for maintaining such samples
will
then be undertaken by GSK BIO. The samples and Study Archives
are to be
retained and archived by RGI for a period of not less than ten
(10) years
following the completion of the relevant
SOW.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
13
of 40
4.12 |
Following
the end of the relevant ten (10) year retention period, RGI
further agrees
that no samples or records originating from any Services
conducted under
this Agreement and retained in RGI's possession as Study Archives
will
be permanently
disposed of or destroyed by RGI without the prior written
permission of
GSK BIO. GSK BIO agrees that such written permission will not
be unreasonably
withheld; provided, however, that in lieu of the granting of permission
for such disposal, GSK BIO shall have the right at the time
such permission
for disposal is requested by RGI to claim such materials and
to
have RGI
transmit such materials to GSK BIO, by a carrier of GSK BlO's
choice
and at
GSK BlO's expense. In the event RGI requests such permission
to dispose
of the
samples or Study Archives from GSK BIO under the provisions of
notice contained
in this Agreement, and no response is received from GSK BIO
within four
(4) weeks, RGI shall be deemed to have received from GSK BIO
permission for
permanent disposal.
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4.13 |
GSK
BIO may, at a reasonable time upon reasonable prior notice, obtain
access
to the samples and Study Archives, provided that GSK BIO complies
with
RGI's reasonable access and control procedures relating to such
materials.
|
4.14 |
RGI
represents that each of its personnel, employees, agents, representatives,
subcontractors or invitees who shall perform any Study hereunder
shall
abide by the provisions of Article 4 hereof while performing
Services. RGI
agrees that each of its personnel, employees, agents, representatives,
subcontractors or invitees who shall perform any Study hereunder
shall be
at least eighteen (18) years old or of legal age to enter into
a contract,
whichever is older.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
14
of 40
ARTICLE
5
CONFIDENTIALITY
5.1 |
Save
as otherwise provided in this Agreement, any Confidential Information
which is disclosed by or on behalf of either Party (the "Disclosing
Party") to the other Party (the "Receiving Party") at any time after
the
date of this Agreement shall remain the property of the Disclosing
Party
and the Receiving Party hereby
undertakes:-
|
5.1.1 |
to
use the Confidential Information received from the Disclosing
Party and
subject to the provisions of Section 6 hereto, solely and exclusively
for
the Purpose; and
|
5.1.2 |
to
maintain the confidentiality of the Confidential Information
and not to
disclose it directly or indirectly to any other company, organization,
individual or Third Party other than in the case of GSK BIO,
to an
Affiliate, save as permitted by clause 5.2;
and
|
5.1.3 |
at
the request of the Disclosing Party to return, delete or destroy
all
copies of the Confidential Information, in whatever form it is
held,
provided that the Receiving Party may retain one copy of the
Confidential
Information for the sole purpose of determining its obligations
under this
Agreement but may make no further use of such Confidential Information
whatsoever.
|
5.2 |
Notwithstanding
clause 5.1, if RGI is the Receiving Party, it may disclose Confidential
Information to any of its Relevant Staff who need to know the Confidential
Information in order to fulfil the Purpose, provided that RGI shall
procure that each such person to whom or which Confidential Information
is
to be disclosed:
|
5.2.1 |
is
made aware of the obligations contained in this Agreement prior
to such
disclosure; and
|
5.2.2 |
agrees
to abide by such terms of this Agreement as if it were a Party to
it.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
15
of 40
5.3 |
Nothing
in clause 5.1 shall preclude disclosure of any Confidential Information
required by any governmental, quasi-governmental or regulatory agency
or
authority or court entitled by law to disclosure of the same, or
which is
required by law to be disclosed. The Receiving Party shall promptly
notify
the Disclosing Party when such requirement to disclose has arisen
to
enable the Disclosing Party to seek an appropriate protective order
and to
make known to the said agency or authority or court the proprietary
nature
of the Confidential Information and to make any applicable claim
of
confidentiality in respect thereof. The Receiving Party agrees to
co-operate in any appropriate action which the Disclosing Party may
decide
to take. If the Receiving Party is advised to make a disclosure in
accordance with this clause 5.3 it shall only make a disclosure to
the
extent to which it is obliged.
|
5.4
|
The
provisions of clause 5.1 shall not apply to any confidential information
which:-
|
5.4.1
|
the
Receiving Party can demonstrate by its written records, was already
in the
possession of the Receiving Party and at its free use and disposal
or
generally and conveniently available to the public prior to its disclosure
by the Disclosing Party hereunder (through in each case no fault
of the
Receiving Party or any of its Affiliates or no breach of this Agreement
by
the Receiving Party); or
|
5.4.2
|
is
purchased or otherwise legally acquired by or becomes available to
the
Receiving Party at any time from a Third Party which is not prohibited
from disclosing such Confidential Information;
or
|
5.4.3
|
comes
into the public domain-
otherwise than through the fault of the Receiving Party or at the
time of
disclosure is in the public domain;
or
|
5.4.4
|
the
Receiving Party can demonstrate by its written records was developed
by or
for the Receiving Party independently of the disclosure of Confidential
Information by the Disclosing Party or its
Affiliates.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
16
of 40
5.5
|
The
obligations of each Party in this clause 5 shall survive for a period
of
ten (10) years from the date of disclosure of such
information.
|
5.6
|
Each
of the Parties agrees that damages may not be an adequate remedy
for
breach of this Article 5 and that, accordingly, each Party shall
be
entitled to seek injunctive or other equitable
relief.
|
ARTICLE
6
INTELLECTUAL
PROPERTY
6.1
|
Except
as otherwise provided herein, all title to any and all inventions,
improvements and data, whether or not patentable, and copyrightable
works,
which result from the performance of any Study hereunder shall reside
with
GSK BIO, subject to the remaining provisions of this Article
6.
|
6.2
|
RGI
shall promptly disclose to GSK BIO all inventions and improvements
(whether patentable or not) and all copyrightable works made by it
which
are governed by this clause 6.1. RGI agrees, upon GSK BIO's written
request, to cooperate at GSK BIO's expense in formally assigning
title to
GSK BIO to such inventions, improvements and copyrightable works,
and to
assist GSK BIO in obtaining patent or copyright protection to such
intellectual property.
|
6.3
|
Subject
to the remaining provisions of this Article 6, RGI agrees that all
original works of authorship prepared by or for RGI in the performance
of
any Study hereunder shall be works for hire, and GSK BIO shall own
such
works and all copyrights therein. For any original such works of
authorship that, under the copyright laws of the United States, may
not be
considered works for hire, RGI agrees to reasonably cooperate with
GSK BIO
in protecting its rights in such works. Such works shall be deemed
to be
the property of GSK BIO, and shall be included in the Confidential
Information of GSK BIO under this
Agreement.
|
6.4
|
Subject
to this Article 6.4. RGI owns, and GSK BIO acknowledges RGI's ownership
of, (i) the Testing Services, including RGI's proprietary process
for
analyzing the samples and producing the gene expression values, and
all of
the materials
which comprise same, and any accompanying patent information owned
by RGI,
(ii) all intellectual property associated therewith (the "Intellectual
Property"), and (iii) any algorithms or scales created and used by
RGI in
producing or developing the gene expression values ("algorithms"),
and
agrees that it shall not do or suffer to be done any act or thing
or
undertake any action anywhere that in any manner might infringe,
or impair
the validity, scope, or title of RGI in the Testing Services, algorithms
or Intellectual Property which may be owned by RGI at any time. It
is
understood that neither GSK BIO nor any Affiliate shall acquire or
claim
title to the Testing Services, algorithms, research and development,
or
the Intellectual Property by virtue of this Agreement. However, any
improvements or modifications thereto which are developed during
the
course of RGI's performance of the Services under the Agreement,
will be
jointly owned by the Parties and GSK BIO may, at its discretion and
expense, seek patent protection for such jointly owned inventions.
In case
GSK BIO does not wish to seek such patent protection, it shall inform
RGI
thereof and RGI may seek patent protection at its own
expense.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
17
of 40
6.5
|
For
the avoidance of doubt, the gene expression values produced and/or
developed by the Testing Services ("gene expression values"), as
well as
all designs, developments, ideas, discoveries, inventions and information
designed, developed, discovered, invented, produced or originated
by GSK
BIO independent of RGI in the course of or as a result of GSK BIO's
use or
analysis of the gene expression values provided to GSK BIO by RGI
pursuant
to this Agreement shall be the sole property of GSK BIO. All such
designs,
developments, ideas, discoveries, inventions and information shall
be part
of the Confidential Information of GSK BIO. In the event GSK BIO
decides,
at its discretion, to seek patent, copyright or other protection
(whether
in the United States or elsewhere) in relation to any of same, or
to
publish the gene expression values, GSK BIO shall acknowledge RGI's
ownership of the property set forth in clause 6.4, as appropriate,
that
the Testing Services and process by which the gene expression values
were
produced are proprietary to RGI, and that the gene expression values
were
produced using RGI's proprietary process, as the case may be. RGI
shall
reasonably cooperate with GSK BIO in the filing of any necessary
applications and in otherwise applying for, obtaining or maintaining
patent, copyright or other protection subject to GSK BIO's
acknowledgement, as set forth in this paragraph, and to GSK BIO bearing
all necessary costs and expenses in relation
thereto.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
18
of 40
If
any of
the Intellectual Property owned by RGI is necessary in order to reasonably
use
the gene expression values owned by GSK BIO according to this Agreement, RGI
will grant GSK BIO a non-exclusive, fully paid up, irrevocable, world wide
license with the right to sublicense to use such Intellectual Property solely
for the purpose of using GSK BIO's gene expression values.
6.6 |
RGI
shall be entitled to utilize the gene expression values (although
GSK BIO
retains ownership of the gene expression values) only for the purposes
of
this Agreement, and any designs, developments, ideas, discoveries,
inventions and information designed, developed, discovered, invented,
produced or originated by RGI independent of GSK BIO in the course
of or
as a result of RGI's use of the gene expression values provided to
GSK BIO
by RGI pursuant to this Agreement shall be the sole and absolute
property
of GSK BIO. All such designs, developments, ideas, discoveries, inventions
and information shall be part of the Confidential Information of
GSK BIO.
RGI shall reasonably cooperate with GSK BIO in the filing of any
necessary
applications and in otherwise applying for, obtaining or maintaining
patent, copyright or other protection with regard to any such designs,
developments, ideas, discoveries, inventions and information, subject
to
GSK BIO's bearing all necessary costs and expenses in relation
thereto.
|
6.7 |
The
Parties-shall observe all copyrights in written material, including
computer software, belonging to the other Party or any third
Party and
will not make any unauthorised copies of such material or
software.
|
6.8 |
Each
Party acknowledges that the other Party owns certain inventions,
processes, know-how, trade secrets, improvements and other intellectual
property which have been independently developed by each Party
and which
relate to that Party's business or operations. It is acknowledged
that the
intellectual property owned by either Party on the date of this
Agreement
will remain the exclusive property of the owning
Party.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
19 of
40
6.8.1 |
GSK
BIO shall provide RGI with sufficient amounts of all compounds, materials,
samples or other substances (collectively, the "Test
Materials")
with which to perform each Study, as well as sufficient and comprehensive
data as may be reasonably required by RGI concerning the stability,
proper
storage and safety requirements with respect to such Test Materials.
Such
Test Materials shall remain the property of GSK BIO at all times
and shall
be properly stored by RGI in accordance with the SOW or as otherwise
agreed by the Parties.
|
6.8.2 |
Upon
completion of any Study, upon request by GSK BIO, any remaining untested
samples of the Test Materials provided for such Study shall be returned
to
GSK BIO for retention in compliance with applicable regulatory
requirements.
|
ARTICLE
7
RELATIONSHIP
OF THE PARTIES
7.1 |
It
is understood that in the performance of this Agreement RGI will
be acting
in the capacity of an independent contractor and that nothing
in this
Agreement shall be construed as creating any contract of employment
or
relationship of principal and agent between GSK BIO and RGI or
GSK BIO or
any of the Relevant
Staff.
|
7.2 |
RGI
shall perform this Agreement solely as an independent contractor,
and as
such shall select, engage and discharge its employees and otherwise
direct
and control the performance of the Studies. Neither RGI nor anyone
employed by it shall be, represent, act, or purport to act as,
or be
deemed to be, the agent, representative, employee, or servant
of GSK BIO
nor shall GSK BIO nor anyone employed by it be, represent, act,
or purport
to act as, or be deemed to be, the agent, representative, employee,
or
servant of RGI.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
20 of
40
7.3 |
Neither
GSK BIO nor RGI shall have authority to make any statement,
representation, or commitment of any kind or to take any action binding
upon the other Party without the other Party's prior written
authorization.
|
ARTICLE
8
REPRESENTATION
AND WARRANTIES - INDEMNIFICATION
8.1 |
RGI
represents and warrants that RGI and the Relevant
Staff:
|
8.1.1
|
have
the appropriate level of expertise and qualifications and the necessary
ability to undertake the work required under this Agreement;
and
|
8.1.2
|
are
not prevented or restricted by any obligations owed to a third Party
or
otherwise in any way from performing the
Services.
|
8.1.3
|
owns
and/or controls all the necessary rights, including patent rights,
for the
performance of the Services in accordance with this
Agreement.
|
8.2 |
In
addition RGI represents that all members of the Relevant Staff
are
contractually bound to assign to RGI all inventions, improvements
and any
other intellectual property rights that may be developed or conceived
by
the Relevant Staff or that may otherwise arise during the performance
of
the Services under this Agreement and that none of the Relevant
Staff have
any rights thereto that could impair or jeopardize the applicability
or
enforcement of the provisions laid down in Article 6
above.
|
8.3 |
Each
Party represents and warrants that it has the right to enter
into this
Agreement and is not in conflict with any third Party obligation
during
the performance of the Study under this
Agreement
|
8.4 |
In
addition to any other indemnification provided herein, RGI agrees
to
indemnify, defend and hold GSK BIO and its affiliates, shareholders,
officers, directors, employees, agents, successors and assigns
harmless
from and against any and all claims, suits, actions, liabilities,
losses,
costs, reasonable attorneys' fees, expenses, judgments or damages,
whether
ordinary, special or consequential (collectively, the "Indemnified
Amounts"),
arising out of (i) RGI's negligence in the performance of any
Study and/or
Services, (ii) any wrongful acts or omissions in the performance
by RGI of
any Study and/or Services hereunder, whether such actions are
of RGI, its
employees, agents, representatives, subcontractors or invitees
or (iii)
any material breach of this Agreement by RGI, its employees,
agents,
representatives, subcontractors or
invitees.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
21 of
40
8.5 |
In
addition to any other indemnification provided herein, GSK BIO
agrees to
indemnify, defend and hold RGI and its affiliates, shareholders,
officers,
directors, employees, agents, successors and assigns harmless
from and
against any and all Indemnified Amounts arising out of (i) GSK
BIO's
negligence in the conduct of the activities to be performed by
GSK BIO
under this Agreement, (ii) any wrongful acts or omissions in
the conduct
of the activities to be performed by GSK BIO under this Agreement,
whether
such actions are of GSK BIO, its employees, agents, representatives,
subcontractors or invitees or (iii) any material breach of this
Agreement
by GSK BIO, its employees, agents, representatives, subcontractors
or
invitees.
|
8.6
|
Where
claims relate to those by third Parties and in the event either Party
incurs, or expects to incur expenses, damages, claims or liability
for
which it is entitled hereunder to seek indemnification from the other
Party, the Party claiming indemnification (the "Indemnitee")
shall promptly notify the other Party (the "Indemnitor")
and shall permit the Indemnitor, at the indemnitor's sole discretion,
to
settle any such claim or suit and agrees to the complete control
of the
defense or settlement of such claim or suit by the Indemnitor, and
the
Indemnitor shall not be responsible for any legal fees or other costs
incurred other than as provided in this Agreement. The Indemnitee,
its
employees, consultants and agents, shall cooperate fully with the
Indemnitor and its legal representatives in the investigation and
defense
of any claims or suits covered by the indemnification provisions
of this
Agreement. Neither Party will be liable for any loss of actual or
anticipated income or profits or for any special, indirect or
consequential loss or damages.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
22
of 40
ARTICLE
9
TERMINATION
9.1
|
GSK
BIO shall have the absolute and unconditional right, in its sole
judgment
and discretion, to terminate this Agreement and/or any Study performed
under this Agreement for any reason, with or without cause, such
termination to be effective on the next anniversary date of the Effective
Date provided at least ninety (90) days prior written notice is given
to
RGI.
|
9.2 |
Either
Party ("the
Non-Defaulting Party") may
terminate this Agreement by notice in writing if (a) the other Party
commits or permits a material breach of this Agreement which is incapable
of remedy, or if capable of remedy, the breaching Party fails to
cure that
breach within ninety (90) days after receiving written notice thereof
from
the Non-Defaulting Party; or (b) the other Party ceases to exist
as a
going concern as a result of bankruptcy or insolvency; or (c) due
to loss
of Key Personnel. "Key Personnel" for the purposes of this Agreement
means
Xxxxxxxx Xxxxxxxxx. RGI warrants that all intellectual property rights
of
Xxxxxxxx Xxxxxxxxx that are necessary for the performance of Services
hereunder have been assigned to
RGI.
|
9.3 |
Subject
to clause 6.5. above, if GSK BIO terminates this Agreement pursuant
to
clause 9.1 above, GSK BIO shall be permitted to use the technology
used by
RGI in performance of the Services solely for the purpose of completing
any unperformed services pursuant to any then outstanding and pending
SOW
during the remainder of the existing Term (with no renewals permitted).
To
the extent that GSK BIO requests RGI's assistance in such use of
the
technology, and RGI agrees to provide such assistance, then GSK BIO
shall
provide appropriate compensation to RGI for such
assistance.
|
9.4 |
In
the event of termination of this Agreement and/or any Study performed
under this Agreement, RGI shall use all reasonable efforts to minimize
any
further costs and RGI shall be reimbursed only for the Services actually
performed and the expenses actually and reasonably incurred as of
the
effective date of such termination. RGI will reimburse any amounts
overpaid by GSK BIO.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
23
of 40
In
case
GSK BIO terminates this Agreement for a breach committed by RGI according to
clause 9.2. (a) above or in case RGI terminates this Agreement, except if such
termination is for a breach committed by GSK BIO according to 9.2. (a), RGI
shall refund the part of the Upfront Payment that has not yet been credited
against work performed by RGI according to clause 3.4.
In
case
GSK BIO at any time during the calendar year 2007 terminates this Agreement
due
to its decision to terminate its [***] RGI shall refund 50% of the Upfront
Payment that has not yet been credited against work performed by RGI according
to clause 3.4.
9.5
|
Upon
termination of this Agreement, if requested by the other Party, each
Party
shall immediately deliver up to the other Party or, if the other
Party
agrees, destroy all copies of and other embodiments of any of the
Confidential Information and all other correspondence, documents,
specifications, and any other property belonging to the other Party
which
may be in its/his/her possession. One archival copy of such materials
may
be maintained in the possession of legal counsel for the
Party.
|
9.6
|
Clauses
5, 6, 7, 8, 12 and 17 shall survive termination of this Agreement
for
whatever reason.
|
9.7
|
The
Parties may terminate this Agreement at any time by mutual agreement
in
writing, executed by both Parties.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
24
of 40
ARTICLE
10
FORCE
MAJEURE
10.1 |
In this
Agreement, "force majeure" shall mean any cause preventing either
Party
from performing any or all of its obligations which arises from
or is
attributable to acts, events, omissions or accidents beyond the
reasonable
control of the Party so prevented including, without limitation,
strikes,
lock-outs or other industrial disputes (whether involving the workforce
of
the Party so prevented or of any Third Party), act of God, war,
terrorism,
riot, civil commotion, malicious damage, compliance with any law
or
Governmental order, rule, regulation or direction, accident, breakdown
of
plant or machinery, fire, flood or storm (each a "Force Majeure
Condition"). Subject to clause 10.3, each Party shall be released
from its
obligations under this Agreement to the extent that its performance
hereunder is delayed, hindered or prevented by force
majeure.
|
10.2 |
If
either Party is prevented or delayed in the performance of any of
its
obligations under this Agreement by force majeure, that Party shall
forthwith serve notice in writing on the other Party specifying the
nature
and extent of the circumstances giving rise to force majeure, and
shall
subject to service of such notice and to clauses 10.3 and 10.4, have
no
liability in respect of the performance of such of its obligations
as are
prevented by the force majeure event during the continuation of such
events, and for such time after they cease as is necessary for that
Party,
using all reasonable endeavours, to recommence its affected operations
in
order for it to perform its
obligations.
|
10.3 |
The
Party claiming to be prevented or delayed in the performance
of any of its
obligations under this Agreement by reason of force majeure shall
use all
reasonable endeavours to bring the force majeure event to a close
or to
find a solution by which the Agreement may be performed despite
the
continuation of the force majeure
event.
|
10.4 |
If
either Party is prevented from performance of its obligations
for a
continuous period in excess of three (3) months due to force
majeure, the
other Party may terminate this Agreement forthwith on service
of written
notice upon the Party so prevented, in which case neither Party
shall have
any liability to the other except that rights and liabilities
which
accrued prior to such termination shall continue to
subsist.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
25 of
40
10.5 |
Notwithstanding
anything in this Article 10 to the contrary, no Force Majeure Condition
shall relieve GSK BIO of the obligation to pay for Testing Services
which
have already been completed by RGI.
|
ARTICLE
11
NOTICE
11.1 |
Any
notice required by this Agreement to be given to either Party shall
be in
writing and shall be served by being addressed to the address of
the other
Party stated in this Agreement or such other address as may from
time to
time have been notified by a notice given in accordance with this
clause.
Any notice or other document to be given under this Agreement shall
be
deemed to have been duly given if left at or sent to the address,
or if
more than one is designated by a Party, to the addresses, referred
to in
clause 11.2 by:
|
11.1.1 |
hand
or courier;
|
11.1.2 |
first
class post, express or other fast postal service (airmail if abroad);
or
|
11.1.3 |
registered
post; or
|
11.1.4 |
facsimile
or other electronic media.
|
11.1.5 |
Any
such notice or other document shall be deemed to have been received
by the
addressee five (5) working days following the date of dispatch
of the
notice or other document by or, where the notice or other document
is sent
by hand or courier or is given by facsimile or other electronic
media,
simultaneously with the delivery or transmission. To prove the
giving of a
notice or other document it shall be sufficient to show that
it was
dispatched.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
26 of
40
11.1.6 |
The
initial details for the purposes of clause 11.1
are:
|
For
GSK BIO
Attn:
General Counsel
Rue
de
I'Institut 89
X-0000
Xxxxxxxxx
Xxxxxxx
Facsimile:
+ 32 –
2656 - 8144
For
RGI
Attn:
Xxxxxxxx Xxxxxxxxx
0000
Xxxxxxx Xxxxxx Xxxxx 000
Xxx
Xxxxxxx, XX 00000
Fax:
000-000-0000
ARTICLE
12
GOVERNING
LAW AND JURISDICTION
12.1 |
This
Agreement will be governed by and construed in accordance with the
laws of
Belgium, without regard to its conflict of laws or choice of laws
principles. The Parties agree that any disputes arising under this
Agreement shall be presented exclusively before the Courts of Nivelles,
Belgium. Each Party hereby submits itself to the personal jurisdiction
and
venue of such courts in connection with any such proceedings, and
agrees
to accept service of process by
mail.
|
ARTICLE
13
ENTIRE
AGREEMENT, AMENDMENT OR VARIATION
13.1 |
This
Agreement sets out the entire agreement and understanding between
the
Parties regarding the subject matter of this Agreement and supersedes
all
prior discussions, arrangements and agreements, whether oral
or in writing
or which may be inferred from the conduct of the
Parties.
|
13.2 |
No
other terms and conditions including any standard terms and conditions
of
GSK BIO, RGI or their Affiliates) shall apply in relation to
this
Agreement or the provision of the Services or of any other Services
by RGI
to GSK BIO, save for any additional terms and conditions specifically
agreed to in writing hereafter by the
Parties.
|
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
27 of
40
13.3 |
Any
amendment or modification to this Agreement shall be made in writing
and
signed by both Parties.
|
ARTICLE
14
VALIDITY/SEVERABILITY
14.1 |
The
invalidity or unenforceability of any provision of this Agreement
shall
not affect the validity or enforceability of any other provision,
which
shall remain in full force and effect. The Parties shall use their
reasonable efforts to achieve the purpose of the invalid provision
by a
new legally valid stipulation.
|
ARTICLE
15
ASSIGNMENT
15.1 |
Either
Party may assign this Agreement in whole or in part, provided that,
if RGI
wishes to assign this Agreement in whole or in part, it shall first
obtain
the prior written consent of GSK BIO,
which shall not be unreasonably withheld.
|
ARTICLE
16
WAIVER
16.1 |
The
failure of either Party to exercise any right or remedy under this
Agreement shall not be deemed to be a waiver of such right or remedy.
Any
waiver in respect of any breach of any provision of this Agreement
which
is made in writing shall be valid but shall not be construed to be
a
waiver of any succeeding breach of such a
provision.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
28
of 40
ARTICLE
17
ANNOUNCEMENTS
17.1
|
Neither
Party shall publish the existence or subject matter of this Agreement
without the prior written consent of the other Party, such consent
not to
be unreasonably withheld or
delayed.
|
17.2
|
No
oral or written release of any statement, information, advertisement
or
publicity matter having any reference to either GSK BIO or RGI, express
or
implied, shall be used by the other Party or on the other Party's
behalf,
unless and until such matter shall have first been submitted to and
received the approval in writing of the Party whose name is being
used.
|
ARTICLE
18
PERMITS
18.1 |
RGI
shall obtain and pay for all permits, governmental fees, and licenses
necessary for it to perform the Studies hereunder and shall obtain
all
required inspections, authorizations and approvals prior to commencement
of any Study hereunder.
|
ARTICLE
19
RECORDS
19.1 |
RGI
agrees to maintain for a period of two (2) years after the termination
or
expiration of this Agreement adequate records of, and copies of all
receipts for expenses incurred in connection with, the performance
of the
Services and allow access to GSK BIO and its authorised representatives
to
inspect such records and receipts upon reasonable
notice.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
29
of 40
ARTICLE
20
LABORATORY
VISITS
20.1 |
GSK
BIO's representatives may visit RGI's facilities at reasonable times,
on
reasonable prior notice, and with reasonable frequency, during normal
business hours to observe the progress of the Testing Services. RGI
will
assist GSK BIO in scheduling such
visits.
|
ARTICLE
21
FDA/EMEA
VISITS
21.1
|
At
GSK BIO's request, a representative of RGI shall accompany GSK BIO
to
FDA/EMEA to explain or discuss any and all aspects of the Testing
Services. Such visit or visits to the FDA/EMEA shall be arranged
at times
mutually agreeable to GSK BIO and RGI. All reasonable travel and
living
expenses incurred by RGI in connection with such visits shall be
reimbursed by GSK BIO.
|
21.2
|
RGI
shall notify GSK BIO of any request from FDA/EMEA, other federal
or state
agencies or any other Third Party to inspect or otherwise gain access
to
the information, gene expression values, clinical samples, or materials
pertaining to the Services performed by RGI under this Agreement.
RGI
shall notify GSK BIO of such request prior to permitting any Third
Party
access, unless prior notice is not reasonably
feasible.
|
21.3
|
RGI
agrees to permit inspection of such information, gene expression
values,
clinical samples, or other materials by authorized representatives
of
FDA/EMEA and as otherwise required by law. During such inspections,
RGI
shall provide appropriate scientific and quality assurance support.
RGI
shall promptly send GSK BIO a copy of any inspection reports received
by
RGI as a result of any such
inspection.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
30
of 40
ARTICLE
22
COUNTERPARTS
22.1 |
This
Agreement may be executed in any number of counterparts, each of
which
shall be deemed an original but all of which together shall constitute
one
and the same instrument.
|
SIGNATURE
PAGE FOLLOWS
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
31 of
40
IN
WITNESS
whereof
the Parties have executed this Agreement on the date above written.
Signed
for and on behalf of GlaxoSmithKline
Biologicals SA
by
Signature |
Date
|
XX December 06 | |
Name:
Jean Stephenne
Title:
President General Manager
|
Signature |
Date
|
14 December 06 | |
Name:
Xxxx-Xxxx Prieels
|
|||
Title:
Senior Vice President
Research
& Development
|
Signed for and on behalf of Response
Genetics Inc. by
Signature |
Date
|
15 December 06 | |
Name:
Xxxxxxxx
Xxxxxxxxx
|
|||
Title: Chief
Executive Officer
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
32 of
40
Response
Genetics List of Services
Exhibit
A
TESTING
SERVICES FEE
SCHEDULE
RGI
Services
|
Cost
|
Explanation
of Service
|
||
[***]
|
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
[***]
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
33 of
40
RGI
Services
|
Cost
|
Explanation
of Service
|
|
||
[***]
|
[***]
|
|
|
||
|
|
|
|||
[***]
|
[***]
|
[***]
|
|
||
|
|
|
|||
[***]
|
[***]
|
[***]
|
|
||
[***]
|
[***]
|
[***]
|
|
||
[***]
|
[***]
|
[***]
|
|
||
|
|
||||
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
34 of
40
EXHIBIT
B
FORM
TASK ORDER/STATEMENT OF WORK AND SCHEDULES
TASK
ORDER/STATEMENT OF WORK REFERENCE NUMBER _______
This
TASK
ORDER/STATEMENT OF WORK is effective ______________, 200_
(the
"Effective Date") between
_____________________
("Contractor"), with offices located at
________________________________________, and
GlaxoSmithKline
Biologicals SA, with offices located rue de I'lnstitut 89, X-0000 Xxxxxxxxx,
Xxxxxxx ("GSK").
BACKGROUND
GSK
and
Contractor are parties to a Master Agreement (or are Affiliates of the
parties to the Master Agreement) with an effective date of
__________.
The
terms
and
conditions of that Master Agreement are used by GSK and Contractor, by executing
this Task Order/Statement of Work, to contract for the laboratory research
services described in this Task Order/Statement of Work.
The
following shall apply in this Task Order/Statement of Work and to the Study
which is the subject of this Task Order/Statement of Work:
CONTRACTOR'S
NAME: Response Genetics, inc.
CONTRACTOR'S
ADDRESS: 0000 Xxxxxxx Xx., #000, Xxx Xxxxxxx, XX 00000
CONTRACTOR'S
TELEPHONE NO.: x0-000-000-0000
CONTRACTOR'S
TAX ID #:000000000
TEST
NAME:
STUDY
TITLE (if applicable):
GSK
PROTOCOL NUMBER (if applicable):
CONTRACTOR
MONITOR :
GSK
REPRESENTATIVE :
Period
of
Performance of the Services : From [day]
[month] [year]
To
[day]
[month] [year]
1.
THE
SERVICES
Contractor
agrees to perform the Services as described in the Protocol, task description,
and/or Study proposal in Schedule A, attached and incorporated by reference
as
part of this Task Order/Statement of Work, and in accordance with the terms
of
the Master Agreement.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
35 of
40
2.
COMPENSATION
In
consideration for its performance of Services under this Task Order/Statement
of
Work, GSK shall pay Contractor in accordance with the payment schedule as
documented in Schedule B, attached and incorporated by reference as part of
this
Task Order/Statement of Work.
3. ARCHIVING
SPECIFICATIONS
Anticipated
date of Study completion of work as detailed in schedule A :
4. TERM:
TERMINATION
This
Task
Order/Statement of Work shall continue until the Services are completed or
until
terminated as provided in the Master Agreement. The performance schedule is
summarized below with the major milestones and delivery dates (modify as
needed):
Start
date:
First
sample delivered
Final
sample delivered
Final
assay complete
Final
Report:
5.
INCORPORATION
BY REFERENCE
The
terms
and conditions of the Master Agreement are hereby incorporated by reference
into
and made a part of this Task Order/Statement of Work. All defined terms within
the Master Agreement shall have the same meaning when used in this Task
Order/Statement of Work. If any provisions of this Task Order/Statement of
Work
are in direct conflict with this Master Agreement so that the provisions of
both
cannot be given effect, the terms of this Task Order/Statement of Work shall
govern the specific issue.
6.
NOTICE.
In
addition to the recipients of notice listed in the Master Agreement, notices
applicable to this Task Order/Statement of Work Agreement shall be sent to
(list
all relevant contacts at both Contractor and GSK including study director
below):
If
to Contractor:
|
If
to GSK:
|
Name:
|
Name:
|
Address:
|
Address:
|
Facsimile:
|
Facsimile:
|
Copy
to:
|
Copy
to:
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
36 of
40
7.
ADDITIONAL
TERMS.
Include
any additional project-specific terms.]
8.ENTIRE
AGREEMENT.
This
Task
Order/Statement of Work, including the incorporated terms of the Master
Agreement, represents the entire and integrated agreement between Contractor
and
GSK-Biologicals and supersedes all prior negotiations, representations or
agreements, either written or oral, regarding the Study.
GLAXOSMITHKLINE BIOLOGICALS
SA
|
CONTRACTOR'S NAME | ||
By: | By: | ||
|
|
||
Title: | Title: | ||
Date:
|
Date: | ||
|
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
37 of
40
TASK
ORDER/STATEMENT OF WORK
SCHEDULE
A
DESCRIPTION
OF THE SERVICES
The
Contractor shall perform _______ According
agreed Standard _____ as
detailed
below.
Test
Performance Assessment
· |
Screening
Step
|
· |
Technical
Bridge
|
· |
Clinical
Bridge
|
Test
name
Contractor
or GSK Standard Operating Procedure
number
Validation
plan
Specific
Quality Standard (if negative)
Reporting
Timings
Prices
(see schedule B)
Archiving
Responsibility
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
38
of 40
Test
Routine
Test
name
Contractor
or GSK Standard Operating Procedure
number
Study
title
Planned
number samples
Timings:
· |
Turnaround
time
|
· |
Timetable
|
Archiving
Prices
(see schedule B)
Reporting
Responsibility
Specific
Quality Standard (if negative)
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
39
of 40
TASK
ORDER/STATEMENT OF WORK
SCHEDULE
B
PAYMENT/PAYMENT
SCHEDULE
Payment
schedule should be generally cost neutral throughout study period
Invoices
should be dispatched regularly at monthly intervals throughout the course of
the
analyses.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
40
of 40