AMENDED and RESTATED MASTER AGREEMENT FOR THE SUPPLY OF LABORATORY TEST SERVICES
AMENDED
and RESTATED MASTER AGREEMENT FOR THE SUPPLY OF LABORATORY TEST
SERVICES
THIS AMENDED AND RESTATED MASTER
LABORATORY TEST SERVICES AGREEMENT (the "Agreement") is made the 22th day
of December 2008 ("Effective Date") between:
1.
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SMITHKLlNE
XXXXXXX 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.
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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,
GSK and RGI entered into a Master Agreement for the Supply of Laboratory Test
Services dated January 17, 2006, and certain subsequent amendments thereto (the
“Master Agreement”); and
(A)
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GSK
is a global innovative pharmaceutical company with extensive research and
development capabilities.
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(B)
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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)
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In
reliance upon that skill, knowledge and experience, GSK wishes to engage
RGI as a preferred provider to provide services principally in relation to
profiling the expression of various genes from a range of human
malignancies and RGI agrees to accept preferred provider status and the
engagement on the following terms and
conditions.
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1.
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In
this Agreement the following expressions shall have the following
meanings:
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1.1
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"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
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"Agreement"
means this Agreement between GSK and RGI for the supply of Services by
RGI.
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1.3
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"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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1.4
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"Effective
Date" means the date first given
above;
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1.5
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"Party"
shall mean GSK or RGI as the context requires and "Parties" shall mean
both GSK and RGI;
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1.6
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"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
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"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
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"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
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"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, FISH/IHC testing
services, TLDA 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
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"Term"
means that this Agreement shall commence on the Effective Date and shall
continue until 17 January 2011 ("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.
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"Testing
Services" means RGl'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. Testing Services
includes TLDA Testing
Services.
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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
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1.12
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"Third
Party" shall mean any Person who is not a Party hereto or any of their
Affiliates, 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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1.13
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“FISH/IHC
Testing Services” means molecular-based tumor tissue profiling [***]
fluorescence in situ hybridization analysis of molecular markers of gene
expression obtained from a tissue sample. For the avoidance of
doubt, FISH/IHC Testing Services shall not be deemed part of “Testing
Services.
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1.14
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“Analytical
Services” means the evaluation and analysis of bioinformatics data,
including the analysis and interpretation of gene expression data or other
data, related to the performance or results related to the Testing
Services or FISH/IHC Testing
Services.
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1.15
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“TLDA
Testing Services” means RNA isolation using a proprietary and patented
extraction process developed by RGI from paraffin embedded tumor samples
or fresh frozen tumor samples and qRT-PCR analysis using the TLDA
system.
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1.16
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“Preferred
Provider” means RGI has met the preferred provider specifications
[***]
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2.
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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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3.
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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.
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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.
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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.
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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.
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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
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Statement
of Work
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1.1.1
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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 Il 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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1.1.2
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The
Pricing Schedule for the Testing Services shall be based upon the Testing
Services Fee Schedule set forth in Exhibit A. The Pricing Schedule for the
FISH/IHC Testing Services shall be based upon the FISH/IHC Testing
Services Fee Schedules set forth in Exhibit A-1. The Pricing Schedule for
the Analytical Testing Services shall be based upon the Analytical Testing
Services Fee Schedules set forth in Exhibit A-2. The Pricing for the TLDA
Testing Services shall be based upon the TLDA Testing Services Fee
Schedule set forth in Exhibit A-3. 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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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
1.1.3
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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
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Study
Director
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1.2.1
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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.
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1.2.2
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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
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Corrective
Measures
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1.3.1
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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
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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. The parties shall have the right, but not the obligation, to
extend the Term for one-year periods ("Renewal Term") beyond the initial
Term by mutually agreeing in writing prior to expiration of the
Term.
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2.2
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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
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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 Exhibits A, A1, A2 and A3 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, RGl 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. Prices and fees set
forth in this Agreement will remain fixed during the Initial
Term.
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3.2
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GSK
will pay RGI in consideration of the Services performed pursuant to this
Agreement the following;
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3.2.1
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For
microdissection of tumor or normal tissue and isolation of RNA or DNA, GSK
shall pay a fee of [***] per
sample.
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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
3.2.2
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For
Services, GSK shall pay according to the fee schedule set forth in
Exhibits A, X-0, X-0 and A-3
hereto.
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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
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 RGl'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 RGl'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.
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3.2.5
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Samples,
for the purposes of this Agreement, may include samples from any
GSK-funded source or sponsored samples deemed of interest to
GSK.
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3.3
GSK
agrees to make a non-refundable Upfront Payment of $1,300,000 on or before
December 31, 2008. This payment of $1,300,000 may be credited against
future work undertaken in the period beginning on January 1, 2009 and
ending on December 31, 2010. (the “Credit Period”. If GSK
submits samples to RGI during the Credit Period which generate payment
obligations exceeding the Upfront Payment, then GSK shall make payment to
RGI in the amount which exceeds the Upfront Payment. If GSK
sends samples to RGI during the Credit Period which do not generate
payment obligations sufficient to meet the amount of the Upfront Payment,
RGI shall retain the excess amount.
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ARTICLE
4
PERFORMANCE
OF THE SERVICES - SERVICE PROVISIONS
4.1
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RGI
shall provide a turnaround time of no longer than 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. If requested in advance by GSK, 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, on the condition that any such samples shall be subject to
a [***] surcharge over the fees set forth in Exhibit A. 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, and the [***]
surcharge shall also apply to such samples. Such excess samples
shall be included in the [***] sample maximum for the next 7 business
day period.
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4.2
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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 anyone quarter will
exceed [***] 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 equaling 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.
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4.3
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RGI
will perform the Testing Services. in compliance with the
applicable laws, regulations, and guidelines governing the performance of
the Testing Services, including those relating to Good Laboratory
Practices, CAP and CLIA.
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4.4
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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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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
4.5
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GSK's
representatives may visit RGl'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. RG I shall assist GSK in
scheduling such visits.
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4.6
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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.
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4.7
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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.
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4.8
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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.
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4.9
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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.
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4.10
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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.
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4.11
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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 RGl'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.
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4.12
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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.
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4.13
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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.
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4.14
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GSK
hereby appoints RGI as a preferred provider for the services which are
subject to this agreement.
[***]
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ARTICLE
5
CONFIDENTIALITY
5.1
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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:
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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.
6
5.1.1
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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
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5.1.2
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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
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5.1.3
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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 sale purpose of determining its obligations under this
Agreement but may make no further use of such Confidential Information
whatsoever.
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5.2
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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:
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5.2.1
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is
made aware of the obligations contained in this Agreement prior to such
disclosure; and
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5.2.2
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agrees
to abide by such terms of this Agreement as if it were a Party to
it.
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5.3
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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.
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5.4
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The
provisions of clause 5.1 shall not apply to any Confidential Information
which:-
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5.4.1
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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
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5.4.2
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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
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5.4.3
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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
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5.4.4
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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.
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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.
|
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.
|
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
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 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 RGl's ownership of, (i) the Testing Services,
including RGl'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.
|
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.
|
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, shall be
used by RGI solely for purposes of performing this Agreement and shall be
properly stored by RGI in accordance with the SOW or as otherwise agreed
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.
8
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 that 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.
|
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,
representatives, subcontractors or invitees or (iii) any material breach
of this Agreement by RGI, its employees, agents, representatives,
subcontractors or invitees.
|
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 compiete 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
|
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; or (b) the
other Party ceases to exist as a going concern as a result of bankruptcy
or insolvency.
|
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
9.2
|
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. In the event of termination, any remaining credit
from the Upfront Payment shall remain with
RGI.
|
9.3
|
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.
|
9.4
|
Articles
5, 6, 7, 12, 13, 15, and 17 shall survive termination of this Agreement
for whatever reason.
|
9.5
|
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 endeavors, 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 endeavors 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.
|
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;
|
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
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.
|
11.1.6
|
The
initial details for the purposes of clause 11.1
are:
|
For
GSK
[***]
[***]
[***]
[***]
(tel)
[***]
(fax)
[***]
With a
copy to
GSK
Attn:
R&D General Counsel
[***]
[***]
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
With a copy to:
Xxxxxx X. XxXxxxx, Esq.
Vice President and General
Counsel
-and-
XXXXXXX
XXXX & XXXXXXXXX LLP
Attn:
Xxxxxx Xxxxxx, Esq.
000
Xxxxxxx Xxxxxx
Xxx Xxxx,
XX 00000-0000
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.
11
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.
|
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. RGI may report to the U.S. Securities
and Exchange Commission (“SEC”) any information regarding this Agreement
which it reasonably deems advisable or
necessary.
|
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
|
RG
I 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.
12
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.
|
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.
|
Signed
for and on behalf of SmithKline Xxxxxxx Corporation by
|
Signature
|
Date
|
|
||
Name:
|
|||||
Title:
|
|||||
SmithKline
Xxxxxxx Corporation
|
|||||
Signed
for and on behalf of Response Genetics Inc. by
|
|||||
|
Signature
|
Date
|
|
||
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.
13
Response
Genetics List of Services
EXHIBIT A
TESTING
SERVICES FEE SCHEDULE
Research Service [***]
|
Cost/[***]
|
Explanation of
Service
|
[***]
[***]
|
[***]
|
[***]
[***]
|
[***]
[***]
|
[***]
|
[***]
|
[***]
|
||
[***] |
[***]
|
[***] |
[***]
|
[***]
[***]
|
[***]
[***]
|
[***] | [***] | |
[***] | [***] | [***] |
[***] | [***] |
[***]
[***]
[***]
|
[***] |
[***]
[***]
[***]
|
|
[***]
|
- | - |
[***]; A [***]% surcharge on all processing fees apply for expedited
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.
14
EXHIBIT
A-1
FISH/IHC
TESTING SERVICES FEE SCHEDULE
FISH/IHC
|
Cost
|
Explanation
of Services
|
[***] | [***] | [***] |
[***] | [***] | [***] |
[***] | [***] | [***] |
[***] | [***] | [***] |
[***] | [***] | [***] |
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
EXHIBIT
A-2
ANALYTICAL
SERVICES FEE SCHEDULE
GSK
will compensate RGI for Analytical Services performed by RGI at the rate of
[***] per hour, not to exceed [***] per day.
[***]
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
EXHIBIT
A-3
[***] TESTING
SERVICES FEE SCHEDULE
[***] Services
|
Cost
|
Explanation
of Service
|
[***]
|
[***]
$[***]/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.
17
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 Sjv1ITHKLlNE XXXXXXX CORPORATION, a
Pennsylvania corporation, d/b/a GlaxoSmithKline, ("GSK") and Response Genetics,
Inc.("RGI").
terms
defined therein are used herein as defined therein unless otherwise defined
herein); and
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 A 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 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.
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. Amendment. Any amendments to this
Statement of Work of the Schedules attached hereto shall be documented by
written amendment signed by authorized representatives of both Parties and shall
be attached hereto.
RGI
|
SMITHKLlNE
XXXXXXX CORPORATION
|
|||
(d.b.a.
GlaxoSmithKline
|
||||
By:
|
|
By:
|
|
|
[Signature]
|
[Signature]
|
|||
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.
19
SCHEDULE
I
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:
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.
20
SCHEDULE
II
PAYMENT
SCHEDULE AND INVOICING INSTURCTIONS
PAYMENT
SCHEDULE
Milestone
|
Payments
(US
$)
|
Approx.
% of total
|
Projected
date
|
For
Admin
use
only
|
[***] | ||||
[***] | ||||
[***] | ||||
[***]
|
INVOICING
INSTRUCTIONS
GSK shall
pay Response Genetics, Inc. within thirty (30) days following receipt of an
original invoice as detailed below. The following shall be clearly
noted on all invoices
submitted for processing:
1.
“INVOICE” stated
at the top
|
|
2.
Supplier/Vendor’s Invoice Number and Date
|
|
3. GlaxoSmithKline
GSK Information
[***]
[***]
[***]
[***]
[***]
|
|
4.
For electronic payment*: Bank Account Name/Address and Routing
details
|
|
5.
Tax ID number or SS# **
|
|
6.
Detailed description of Services or Contract
Milestone***
|
|
7.
Amount of invoice
|
|
[***]
[***]
[***]
|
All checks shall be made payable
to:
Response
Genetics, Inc.
0000
Xxxxxxx Xxxxxx, 0xx Xxxxx
Xxx
Xxxxxxx, XX 00000
|
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