MASTER AGREEMENT FOR THE SUPPLY OF LABORATORY TEST SERVICES
THIS
MASTER LABORATORY TEST SERVICES AGREEMENT (the "Agreement")
is
made
the _17th day
of
January, 2006 ("Effective Date")
between:-
(1) |
SMITHKLINEBEECHAM
CORPORATION (d.b.a.
GlaxoSmithKline) a
corporation having its principal office at Xxx Xxxxxxxx Xxxxx,
Xxxxxxxxxxxx XX 00000, XXX ("GSK"); 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
is a 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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(C) |
In
reliance upon that skill, knowledge and experience, GSK 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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IT
IS HEREBY AGREED AS FOLLOWS:
DEFINITIONS
AND INTERPRETATIONS
101
Master
Laboratory Services Rev. 2 May 2001
for
GSK US
Entity Change
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.
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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1.2 |
"Agreement"
means
this Agreement between GSK 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 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 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.
2
1.4 |
"Effective
Date" means
the date first given above;
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1.5 |
1.1.5
"Party"
shall
mean GSK or RGI as the context requires and "Parties"
shall
mean both GSK and RGI;
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1.6 |
"Person"
and
words importing 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;
|
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.
3
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;
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1.9 |
"Services"
means the services to be provided by RGI pursuant to this Agreement
(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, 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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1.10 |
"Term"
means
that this Agreement shall commence on the Effective Date and shall
continue until the third (3rd)anniversary of the Effective Date ("Initial
Term"), unless sooner terminated in accordance with the provisions
hereof,
renewable at the option of, and upon the agreement of
both Parties in additional one (1) year increments ("Renewal Term"),;
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 are to the recitals
and
clauses of and, if applicable, the schedules to, this Agreement.
To the
extent
that there is conflict between or ambiguity relating to any schedules
to
this
Agreement and the remainder of this Agreement, the wording of the
schedules
shall prevail.
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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.
4
3 |
Any
schedules 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. Schedules
may
not
be added to this Agreement except by the express written consent
of both
Parties.
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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.
|
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 or any Affiliate of GSK. Each SOW shall
include as
attachments
(i) a detailed Protocol document ("Protocol")
which shall be provided by GSK or prepared by RGI under GSK's direction
and approved in writing by GSK, 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.
5
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 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, RGI shall consult with GSK to assist GSK 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
|
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
("GSK
Representative"),
which GSK Representative shall have responsibility over
all matters relating to the performance of such Study on behalf of
GSK.
|
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.
6
1.2.2 |
Unless
otherwise agreed to in the applicable SOW, or by the Study Director
and
GSK
Representative, all communications between RGI and GSK regarding
the
conduct
of each Study pursuant to a SOW shall be addressed to or routed directly
through the applicable Study Director and GSK Representative. RGI
may
substitute its Study Director and GSK may substitute the GSK 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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1.3
|
Corrective
Measures
|
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 mistake in conducting Testing Services, RGI agrees to
notify GSK
of such occurrence
in writing promptly following the day such discovery is made. Upon
receipt
of such notice, GSK will notify RGI in writing, within a reasonable
time,
whether
corrective measures which may include retesting are required to
ensure
validity
of results, and GSK will not be invoiced for any necessary corrective
measures.
RGI agrees to promptly implement necessary corrective measures.
The retest
data will be reported by RGI to GSK within a reasonable time from
the
receipt by RGI of notification from GSK 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. GSK shall have the right, but
not the
obligation,
to unilaterally extend the Term for up to two (2) one-year periods
("Renewal Term")
beyond the initial Term by providing at written notice to RGI at
least
thirty (30) days
prior to expiration of the Term. Further renewals shall be subject
to the
written agreement
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.
7
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
prior
to the expiration of the term of this Agreement, until all such Studies
have been completed, and the final report and any other pertinent
Study-related documents for such Studies have been received by and
completed to the reasonable satisfaction of GSK. All references in
this
Agreement to "Term of this Agreement" shall be deemed to include
both
the initial Term and any Renewal
Terms.
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ARTICLE
3
COMPENSATION
3.1 |
GSK
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 on a quarterly
basis
for Services
provided pursuant to the Agreement. All payments due hereunder
shall be
paid
by GSK net thirty (30) days upon receipt by GSK of an accurate,
complete
invoice. Absent terms in the SOW to the contrary, nothing in
this
Agreement shall be interpreted to
require RGI to initiate any SOW or to require GSK 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 rate of prime plus one percent for any payments
not
timely made to it under this Agreement. In the event that GSK
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.
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Prices
and fees set forth in this Agreement will remain fixed during the initial
Term.
3.2 |
GSK
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
shall [***] per
sample.
|
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.
8
3.2.2 |
For
other Services, GSK shall pay according to the fee schedule set
forth in
Exhibit
A hereto.
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3.2.3 |
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 |
Samples
provided for analysis must 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 for that sample. Assuming that the samples
provided by
GSK for analysis meet agreed upon specified criteria, RGI
agrees to
extract RNA from at least [***]% of the samples, calculated
on an annual basis. If RGI is unable to extract RNA from
at
least [***]%
of the samples that meet RGI's criteria, calculated on an
annual basis,
GSK shall not be charged for those samples from which RGI
was unable to
extract
RNA. If RGI is able to extract RNA from at least [***]% of
the samples
that
meet RGI's criteria, calculated on an annual basis, GSK shall
nevertheless
be
charged for all samples if the non-conformance to RGI criteria
could not
have reasonably been determined by RGI without having performed
the
analysis first.
|
3.2.5 |
Samples,
for the purposes of this Agreement, may include samples
from any
GSK-funded
source or sponsored samples deemed of interest to
GSK.
|
3.3 |
GSK
agrees to make a non-refundable upfront payment of two million
US dollars
($ 2,000,000) within two weeks from the Effective Date ("Upfront
Payment"). This payment shall be credited against future
work undertaken
in the initial Term of this Agreement,
in the following
manner:
|
Year 1 credit: | $ | [***] | ||
Year
2 credit:
|
$ | [***] | ||
Year 3 credit: |
$
|
[***]
|
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.
9
3.4 |
In
addition to the Upfront Payment, GSK agrees to make minimum payments
of
$[***]
annually during each year of the Term. Such additional minimum
payments
are above and beyond the work credited against the Upfront Payment
referenced in Section 3.3, and are hereinafter referred to as
the Annual
Minimum. GSK agrees to pay within thirty (30) days after each
anniversary
from the Effective Date the amount corresponding
to the shortfall to reach the Annual Minimum payment (a) if GSK
failed in
that
year to submit to RGI a sufficient number of samples for that
year to
generate payment obligations (above and beyond the amount credited
in that
year against the Upfront
Payment) meeting the Annual Minimum and (b) provided that RGI
has not
materially
breached its obligations under this Agreement, including but
not limited
to the
minimum Service levels set forth herein such as the Service levels
and
Service requirements
set forth in Section 3.2.4 and Article4. If GSK submits to RGI
in a
particular
year samples which generate payment obligations exceeding both
the work
credited against the Upfront Payment and the Annual Minimum payment
for
that year, the excess payments may be applied against the Annual
Minimum
payment required for
the following contract year (in the event and to the extent that
work
generated in that following contract year does not meet or exceed
the
amount credited against the Upfront
Payment and the Annual Minimum payment for that
year).
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3.5 |
If
GSK and RGI mutually agree to extend the Agreement for a Renewal
Term, the
Agreement shall be extended on the same terms and with the same
Annual
Minimum payment
amount ($[***]) and terms. If the Agreement is not renewed beyond
the Initial Term, then unused credit against upfront and minimum
payments
made by GSK to RGI under Section 3.3 may be applied to work under
any SOW
agreed upon prior to expiration of the Agreement ("Rollover Credit"),
subject to the following conditions: (1) All such work must be
scheduled
so that it is completed within one year of the expiration of
the initial
Term of the Agreement; (2) The pricing provisions set forth in
this
Agreement and as referenced in the pricing schedule shall not
be binding
on RGI, and RGI may specify new pricing for its services; (3)
The Rollover
Credit amount shall not exceed
$[***].
|
3.6 |
If
GSK provides samples in excess of the amounts needed to meet
the
Annual
Minimum set forth in 3.3 above, the excess (the "Excess") shall be
invoiced to GSK and
shall be subject to a [***]% discount on the cost per sample
set forth
in 3.1. Notwithstanding
the foregoing, if GSK applies any of the Excess to its minimum
payment
obligations in the following contract year, then the discounted
amounts on
the Excess shall be refunded to RGI at that
time.
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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.
10
ARTICLE
4
PERFORMANCE
OF THE SERVICES - SERVICE PROVISIONS
4.1 |
RGI
shall provide a turnaround time of seven (7) business days for
performance
of RT- PCR Testing Services (up to 6 genes plus a housekeeping
gene) for
up to a maximum of
[***] [***] prospective samples delivered to RGI in that time period.
If
more than [***] [***]
prospective samples are provided in any seven (7) business day
time
period, RGI shall
turnaround the excess above [***] in the next 7 business day period.
Such
excess samples
shall be included in the [***] sample maximum for the next 7 business
day
period.
RGI shall provide a turnaround time of two (2) months for performance
of
Testing Services for retrospective samples delivered to RGI in
that time
period, subject to
the conditions set forth in 4.2
herein.
|
4.2 |
To
assist RGI to expeditiously perform the Testing Services, GSK will
use
reasonable efforts to evenly distribute samples sent to RGI for
testing
throughout each quarter and year. If samples for any one quarter
will
exceed [***] (prospective and retrospective), GSK shall provide
RGI notice
of how many samples it expects to deliver and of what mutually
agreeable
genes it will be requesting analysis of at least two (2) quarters
in
advance to allow RGI sufficient time to supplement resources (personnel,
equipment, materials, etc.) or to develop probes or primers, as
necessary,
in order to analyze the samples
expected. If GSK provides such notice to RGI, then GSK shall make
best
efforts
to deliver to RGI for testing samples equalling the estimated sample
number. If GSK does not provide such samples for testing, RGI and
GSK
shall discuss and negotiate in good faith to compensate RGI for
any unused
investments RGI made in anticipation of such
samples.
|
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.
|
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.
11
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.
|
4.5 |
GSK'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 in scheduling such
visits.
|
4.6 |
All
reports prepared by RGI hereunder shall be prepared in a format
specified
in the applicable
SOW. GSK shall have access to all documentation, records, raw data,
specimens
or other work product generated during the performance of each
Study.
RGI
agrees to maintain appropriate records in paper or magnetic form,
in a
manner which complies with regulatory
requirements.
|
4.7 |
RGI
agrees to comply with all provisions of the Generic Drug Enforcement
Act
of 1992. RGI
further agrees to submit to GSK, 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.
|
4.8 |
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 a revised technical and cost proposal for GSK's acceptance
prior to making any changes in the SOW for such Study.
|
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.
12
4.9 |
In
the event of a conflict in government regulations, GSK shall, upon
request
by RGI, designate
which regulations shall be followed by RGI in its performance of
a
particular Study.
|
4.10 |
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. 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, RGI will provide sample materials
to GSK
or a copy of documents from the Study Archives, at GSK's expense.
To the
extent that samples are transferred
to GSK, responsibility for maintaining such samples will then be
undertaken by
GSK. 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.
|
4.11 |
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. GSK agrees
that such
written
permission will not be unreasonably withheld; provided, however,
that in
lieu of the granting of permission for such disposal, GSK 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, by a
carrier of GSK's choice and at GSK's expense. In the event RGI
requests
such permission to dispose of the samples or Study Archives from
GSK under the provisions of notice contained in this Agreement,
and no
response is received from GSK within four (4) weeks, RGI shall
be deemed
to have received from GSK
permission for permanent disposal.
|
4.12 |
GSK
may, at a reasonable time upon reasonable prior notice, obtain
access to
the samples
and Study Archives, provided that GSK complies with RGI's reasonable
access and control procedures relating to such
materials.
|
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.
13
4.13 |
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. 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 legal age, whichever
is
older.
|
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, 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 fulfill 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
|
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.
14
5.2.2 |
agrees
to abide by such terms of this Agreement as if it were a Party
to
it.
|
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.
|
5.5 |
The
obligations of each Party in this clause 5 shall survive for a
period of
ten years from
the date of disclosure of such
information.
|
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.
15
5.6 |
Each
of the Parties agrees that damages may not be an adequate remedy
for
breach of this clause 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, subject to the remaining provisions
of this Article 6.
|
6.2 |
RGI
will make reasonable efforts to disclose to GSK all inventions
and
improvements (whether
patentable or not) and all copyrightable works made by it which
are
governed by
this Section 6.1. RGI agrees, upon GSK's written request, to cooperate
at
GSK's expense
in formally assigning title to GSK to such inventions, improvements
and
copyrightable
works, and to assist GSK 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 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 in protecting
its rights in such works. Such works shall be deemed to be the
property of
GSK, and shall be included in the Confidential Information of GSK
under
this Agreement.
|
6.4 |
RGI
owns, and GSK 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 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, including any
improvements or modifications thereto which are developed during
the
course of RGI's performance under the Agreement, the Parties intending
that all utilization of the Testing Services, algorithms and
relating Intellectual Property by GSK shall at all times inure
to the
exclusive benefit 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.
16
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 independent of RGI in the course
of or as a
result
of GSK's use or analysis of the gene expression values provided
to GSK by
RGI pursuant
to this Agreement shall be the sole property of GSK. All such designs,
developments, ideas, discoveries, inventions and information shall
be part
of the Confidential
Information of GSK. In the event GSK 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 shall
acknowledge
RGI's ownership of the property set forth in clause 6.4, 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. RGI shall reasonably cooperate with GSK in the filing
of any
necessary
applications and in otherwise applying for, obtaining or maintaining
patent, copyright
or other protection subject to GSK's acknowledgement, as set forth
in this
paragraph,
and to GSK bearing all necessary costs and expenses in relation
thereto.
|
6.6 |
RGI
shall be entitled to utilize the gene expression values (although
GSK
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 in
the
course of or as a result of RGI's use of the gene expression values
provided to GSK
by RGI pursuant to this Agreement shall be the sole and absolute
property
of GSK.
All such designs, developments, ideas, discoveries, inventions and
information shall be part of the Confidential Information of GSK.
RGI
shall reasonably cooperate with GSK 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 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.
17
6.7 |
The
Parties will observe all copyright in written material, including
computer
software, belonging to the other Party or any third Party, 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.
|
6.8.1 |
GSK
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 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, any remaining untested
samples of the Test Materials provided for such Study shall be returned
to
GSK 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 and RGI or GSK or any of the Relevant
Staff.
|
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.
18
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 nor shall GSK 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.
|
7.3 |
Neither
GSK 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.
|
8.2 |
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
|
8.3 |
In
addition to any other indemnification provided herein, RGI agrees
to
indemnify, defend and hold GSK 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,
(ii)
any wrongful acts or omissions in the performance by RGI of any
Study,
whether such actions are of RGI, its employees, agents, representives,
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.
19
8.4 |
In
addition to any other indemnification provided herein, GSK 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's negligence in the conduct of the activities
to be
performed
by GSK under this Agreement, (ii) any wrongful acts or omissions
in the
conduct of the activities to be performed by GSK under this Agreement,
whether such actions are of GSK, its employees, agents, representatives,
subcontractors or invitees or
(iii) any material breach of this Agreement by GSK, its employees,
agents,
representatives,
subcontractors or invitees.
|
8.5 |
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 intends 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.
|
ARTICLE
9
TERMINATION
9.1 |
GSK
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.
|
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.
20
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 of receiving written notice thereof
from
the Non- Defaulting Party; (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
|
9.3 |
If
GSK terminates this Agreement pursuant to 9.1
above, GSK shall be permitted to use
the technology used by RGI in performance of the Services solely
for the
purpose of
completing any unperformed services for the remainder of the existing
Term
(with no renewals
permitted). To the extent that GSK requests RGI's assistance in such
use
of the technology, and RGI agrees to provide such assistance, then
GSK
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,
unless
the parties agree
or RGI is otherwise obliged to provide Services after such termination.
If
GSK terminates this Agreement pursuant to the provisions of Section
9.1,
the Annual Minimum
for the year in which the notice of termination is issued shall still
apply. If GSK terminates the Agreement pursuant to a breach covered
by
Section 9.2, then the Annual Minimum for that year shall not
apply.
|
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.
|
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.
21
9.6 |
Clauses
5, 6, 7,12,13,15,
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.
|
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.
|
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.
22
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.
|
10.5 |
Notwithstanding
anything in this provision 10 to the contrary, no Force Majeure
Condition
shall relieve GSK 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
listed, 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 two (2) working days following the date of dispatch
of the
notice or
other document by post (five (5) working days, if sent
by airmail) 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.
23
11.1.6 |
The
initial details for the purposes of clause 11.1 are:
|
For
GSK
Attn:
Xxxxx
Xxxxxxxx, MD
Senior
Vice President,
Oncology
Medicine Development Center
GlaxoSmithKline
Tel:
[***]
Fax:
[***]:
For
RGI
Attn:
Xxxxxxxx Xxxxxxxxx
President
and CEO
Response
Genetics, Inc.
0000
Xxxxxxx Xxxxxx Xxxxx 000
Xxx
Xxxxxxx, XX 00000
Tel:
000-000 0000
Fax:
000-000-0000
-and-
XXXXXX
& XXXXXX
Attn:
Xxxxxx Xxxxxx, Esq.
Xxx
Xxxxxxxx
Xxx
Xxxx,
XX 00000
Tel:
000-000-0000
FAX:
(000) 000-0000
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.
24
ARTICLE
12
GOVERNING
LAW AND JURISDICTION
12.1 |
This
Agreement will be governed by and construed in accordance with
the laws of
the State
of New York, 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 State Courts for the State of New York or the Federal
District
Courts
of New York. 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, 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, save for any additional
terms and
conditions specifically agreed to in writing hereafter by the
Parties.
|
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.
|
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.
25
ARTICLE
15
ASSIGNMENT
15.1 |
Either
Party may assign this Agreement in whole or in
part.
|
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.
|
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 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 the
Studies to be performed hereunder and shall obtain all required
inspections, authorizations and approvals prior to commencement
of any
Study hereunder.
|
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.
26
ARTICLE
19
RECORDS
19.1 |
RGI
agrees to maintain for a period of two 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
and its
authorised representatives to inspect such records and receipts
upon
reasonable notice.
|
ARTICLE
20
LABORATORY
VISITS
20.1 |
GSK'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 in scheduling
such
visits.
|
ARTICLE
21
FDA
VISITS
21.1 |
At
GSK's request, a representative of RGI shall accompany GSK to FDA
to
explain or discuss
any and all aspects of the Testing Services. Such visit or visits
to the
FDA shall be
arranged at times mutually agreeable to GSK and RGI. All reasonable
travel
and living
expenses incurred by RGI in connection with such visits shall be
reimbursed by GSK.
|
21.2 |
RGI
shall notify GSK of any request from FDA, 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 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 and as otherwise
required by law. During such inspections, RGI shall provide appropriate
scientific and quality
assurance support. RGI shall promptly send GSK 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.
27
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.
|
ARTICLE
23
EXHIBITS
23.1 |
Any
Exhibit or SOW to this Agreement is hereby incorporated into and
made a
part of this
Agreement. In the event of a conflict between the provisions contained
in
this Agreement
and any such Exhibit or SOWs, the terms of the Agreement shall
prevail
over
the Exhibit or SOW, except to the extent an Exhibit or SOW specifically
states that
one of its provisions supersedes a similar provision in the
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.
28
IN
WITNESS whereof
the Parties have executed this Agreement on the date above written.
Signed
for and on behalf of SmithKline Xxxxxxx Corporation by
/s/ | Signature | Date 01-17-2006 | ||
|
||||
Name:
Xxxxx Xxxxxxxx, MD
Title: Senior Vice President,
|
||||
Oncology Medicien Development Center
SmithKline Xxxxxxx Corporation
|
18 JAN 06 |
Signed
for and on behalf of Response Genetics Inc. by
/s/ | Signature | Date 01-19-2006 | ||
Xxxxxxxx Xxxxxxxxx |
||||
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.
29
sponse
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.
A-1
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.
A-2
EXHIBIT
B
SAMPLE
STATEMENT
OF WORK NO. 01 TO MASTER
LABORATORY SERVICES AGREEMENT
THIS
STATEMENT OF WORK is entered into as of the (»»»»») 1st day of (...............)
(the
"Effective
Date")
by and
between SMITHKLINE XXXXXXX CORPORATION, a Pennsylvania
corportion, d/b/a GlaxoSmithKline, ("GSK")
and
(,,,,,,,,,,,,,,,,)("RGI").
WIINESSEIH:
WHEREAS,
GSK and RGI have entered into a Master Laboratory Services Agreement
dated
as
of (...............)
(as
amended or modified from time to time, the "Agreement":
terms
defined therein are used herein as defined therein unless otherwise defined
herein); and
WHEREAS,
RGI has agreed to perform Studies from time to time for GSK on the terms
of
the
Agreement and the applicable Protocol, Statement of Work and Pricing Schedule;
and
WHEREAS,
this Statement of Work is one of the Statements of Work referred to in the
Agreement;
NOW,
THEREFORE, in consideration of the premises and any sums to be paid, the
Parties
hereby agree to the following terms, conditions and specifications in connection
with the
Study
to be conducted hereunder:
1. Statement
of Work.
RGI
agrees to conduct the study entitled " (»»»»»»»»)
(the "Protocol")
attached hereto as Schedule
I
and made
a part hereof.
2. Study
Director.
The
Study will be conducted under the direction (,,,,,,,,,,,,,,,,),.
as the
study
director (the "Study
Director").
By
signing this Statement of Work, the Study Director agrees to be bound by the
terms and conditions of this Statement of Work and the Agreement to
the
extent that such terms and conditions relate to the Study Director. The Study
Director hereby
acknowledges receiving and reading a copy of the Agreement.
3. Payment.
In
consideration of conducting the Study hereunder, GSK shall pay RGI
in
accordance with the budget and payment schedule set forth in the Pricing
Schedule attached hereto as Schedule
II
and made
a part hereof.
4. Term.
Unless
the Study is terminated earlier in accordance with the provisions of
the
Agreement, the term of this Statement of Work shall commence on the Effective
Date and shall continue in force until the Study has been completed, and all
reports and other documents
as required by the Protocol, including without limitation the final report,
have
been received
by and completed to the reasonable satisfaction of GSK. RGI shall use its best
efforts to deliver to GSK of all reports and documents referenced in this
Section
4,
within
30 days
of
completion of Study
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.
B-1
5. Material
Transfer Agreement.
In the
event the Test Materials are to be provided by GSK to RGI for the Study, they
shall be transferred to RGI under the terms of the Material Transfer Agreement
attached hereto as Schedule III.
6. Incorporation
by Reference.
The
terms and conditions of this Statement of Work
and
all Schedules hereto are hereby incorporated into and made a part of the
Agreement.
7. Amendment.
Any
amendments to this Statement of Work or the Schedules attached
hereto shall be documented by written amendment signed by authorized
representatives of both Parties and shall be attached hereto.
IN
WITNESS WHEREOF, the Parties hereto have duly executed this Statement of
Work
as
of the Effective Date by their authorized representatives.
RGI | SMITHKLINE XXXXXXX CORPORATION(d.b.a. GlaxoSmithKline) | |||
By: | By: | |||
|
|
|||
Name:______________________________ |
Name:______________________________
|
|||
[Print] | [Print] | |||
Title:_______________________________ | Title:_______________________________ | |||
Date:_______________________________ | Date:_______________________________ |
AGREED
AND ACCEPTED:
Study
Director
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.
B-2
SCHEDULE
PROTOCOL
Protocol
Date
1.0 |
Title:
|
2.0 |
Study
Numbers:
|
3.0 |
Purpose:
|
4.0 |
Testing
Facility:
Study Director.
|
5.0 |
Client:
Client
Representative:
|
6.0 |
Proposed
Study Dates:
Study Start Date:
Study Termination
Date:
|
7.0 |
Sample
Type:
Type of Samples:
Number
of Samples:
Precautions:
Test
System
Justification:
|
8.0 |
Chain
of Custody Procedure: To
ensure end-to-end chain-of-custody, the following procedures
have been established and will be followed for all human
blood
samples:
|
9.0 |
Results
Report and
Final
Report:
|
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.
I-1
10.0 |
Good
Laboratory Practice: This
study will be conducted under the guidelines of Good Laboratory
Practice
as promulgated by the Food and Drug Xxxxxxxxxxxxxx 00 XXX
00.
|
11.0 |
Approvals
|
Client Representative Date |
|
Study Director 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.
I-2
SCHEDULE
II
PRICING
SCHEDULE TO STATEMENT OF WORK NO.
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.
II-1