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 10 day of August,
2009 (“Effective
Date”) between: GLAXOSMITHKLINE BIOLOGICALS, a company having its
principal office at 00 xxx xx x’Xxxxxxxx, 0000 Xxxxxxxxx, Xxxxxxx (“GSK BIO”); and 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”).
WHEREAS, the Parties entered
into that certain Master Agreement dated December 1, 2006 (the “Original Agreement Effective
Date”) (as amended on November 29, 2007, the “Original Agreement”);
and
WHEREAS, the Parties wish to
amend and restate in its entirety the Master Agreement as is set forth
herein.
NOW THEREFORE, in
consideration of the covenants and obligations expressed herein and for other
good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, and intending to be legally bound the Parties agree as
follows:
ARTICLE
I - DEFINITIONS AND INTERPRETATIONS
In this
Agreement the following expressions shall have the following
meanings:
“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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“Agreement” means this
Agreement between GSK BIO and RGI for the supply of Services by
RGI.
“Confidential Information”
shall mean any and all commercial and technical information relating to any of
the existing or planned products, businesses, research and/or development
activities, customers and suppliers of either Party whether in written, verbal
or any other form, tangible or intangible, which either Party may acquire or may
have access from time to time, provided such information is marked as “Confidential and Proprietary”
and provided that information which is orally disclosed shall be confirmed in
writing within thirty (30) days from oral disclosure. Confidential Information
includes and is not limited to: (a) any information
generated in connection with the provision of the Services (such as the results
or findings thereof and the contents of any report) under this Agreement, (b)
information concerning inventions, discoveries, concepts, ideas, techniques,
processes, designs, specifications, drawings, diagrams, models, samples, flow
charts, computer programs, algorithms, data, databases, studies, mathematical
calculations, finances and plans, customer lists, business plans, contracts,
marketing plans, production plans, distribution plans, system implementation
plans, business concepts, supplier information, business procedures and business
operations and all materials related thereto; (c) the existence, contents or
terms of this Agreement, (d) all know-how and intellectual property, (e) all
unpublished copyrightable material, (f) any use, variation, application,
reduction to practice, or any discussion and any other communication thereof
regarding or relating to the Information, and (g) any information concerning how
any part of the above information is related to and/or fits together with any
other part of the above information, or any other technology or business;
Notwithstanding the foregoing, the Parties agree that any and all
data, reports, laboratory work sheets, results, materials or information
provided by either Party or its Affiliates or Third Parties on behalf
of a Party and any other documents or information furnished to a Party, or to
which a Party is given access, by the other Party or its
Affiliates or such Third Parties in connection with the performance of this
Agreement, or prepared or generated by a Party in connection with
performing any and all Studies (as defined in Section 1.1.1. below) hereunder,
shall be deemed to be the Confidential Information of the
Party which owns such disclosed information.
“Effective Date” means the date
first given above.
“Party” shall mean GSK BIO or
RGI as the context requires and “Parties” shall mean both GSK
BIO and RGI.
“Person” and words signifying persons shall be construed as to
include individuals, firms, bodies corporate, joint ventures, governments,
states or agencies of state or any undertaking (whether or not having separate
legal personality and irrespective of the jurisdiction in or under the laws of
which it was incorporated or exists).
“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 24b-2 of the Securities Exchange Act of 1934.
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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 BIO.
“Services” means the services
to be provided by RGI pursuant to this Agreement at the request of GSK BIO (as
amended from time to time in accordance with the provisions of this Agreement)
and such other services as may from time to time be agreed upon by RGI and GSK
BIO, including Testing Services, consultation and tissue storage, in connection
with this Agreement and as further detailed and agreed upon in a SOW pursuant to
Article II below.
“Term” means that this
Agreement shall commence on the Original Agreement Effective Date and shall
continue until the later of: (i) 31. December 2011, (ii) or until the completion
of the recruitment phase of GSK BIO’s [***] or (iii) the provisions of Section
3.2 are satisfied, unless sooner terminated in accordance with the provisions
hereof.
“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.
“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 and exhibits are to the recitals and clauses of
and, if applicable, the schedules and exhibits
to, this Agreement. To the extent that there is conflict
between or ambiguity relating to any schedule or
exhibit to this Agreement and the remainder of this Agreement, the
wording of the schedule or exhibit shall
prevail.
Any
schedules and exhibits to this Agreement
form part of this Agreement and shall have the same force and effect as if
expressly set out in the body of the Agreement and any reference to the
Agreement shall include the schedules and
exhibits. Schedules and
exhibits may not be added to this Agreement except by the express written
consent of both Parties.
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 24b-2 of the Securities Exchange Act of 1934.
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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.
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.
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.
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.
The use
of the term “include” or “including” means “including but not limited
to”.
ARTICLE
II - STATEMENT OF WORK; STUDY DIRECTOR
2.1 Statement of
Work
(a) RGI
agrees to perform a study or studies which will involve Testing
Services (hereinafter referred to as “Study”) from time to time in
accordance with a Statement of Work in the form of Exhibit B attached hereto
(“SOW”), for
the benefit of GSK BIO or any Affiliate of GSK BIO. The Parties
hereby agree that the SOW’s attached hereto as Exhibit C are in effect as of
the Effective Date. Each SOW shall include as attachments (i) a
detailed protocol document (“Protocol”) which
shall be provided by GSK BIO or prepared by RGI under GSK BIO’s direction and
approved in writing by GSK BIO, and which shall be attached to each SOW as Schedule I, and (ii)
a pricing schedule in the form of Schedule II to the
SOW attached hereto (“Pricing
Schedule”). An SOW shall not be effective unless it has been
agreed upon in writing by both Parties.
(b) The
Pricing Schedule shall be based upon the Testing Services Fee Schedule set forth
in Exhibit A. Each SOW
shall specify the Study design, information desired, estimated duration of the
applicable Study, milestones and reporting (if applicable) and all other
relevant matters pertinent to completion of such Study (except for pricing), and
shall be deemed a part of this Agreement and is incorporated herein by
reference. Each Pricing Schedule attached to a SOW shall specify the
cost to GSK BIO of the Services RGI is to perform in connection with such Study
and shall be deemed a part of this Agreement and is incorporated herein by
reference.
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 24b-2 of the Securities Exchange Act of 1934.
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(c) If
requested by GSK BIO, RGI shall consult with GSK BIO to assist GSK BIO in
developing any Study design in a manner consistent with current regulatory
guidelines. RGI represents that any such Study design and/or the
results from any such Study shall satisfy the requirements of the U.S. Food and
Drug Administration (“FDA”) and the European Medicines Agency (“EMEA”) at the
time the Study design is completed.
2.2 Study
Director
(a) RGI
shall appoint a study director (“Study Director”) to
be responsible to oversee the completion of each Study by RGI. The
Study Director shall coordinate performance of the applicable Study with a
representative designated by GSK BIO (“GSK BIO
Representative”), which GSK BIO Representative shall have responsibility
over all matters relating to the performance of such Study on behalf of GSK
BIO.
(b) Unless
otherwise agreed to in the applicable SOW, or by the Study Director and GSK BIO
Representative, all communications between RGI and GSK BIO regarding the conduct
of each Study pursuant to a SOW shall be addressed to or routed directly through
the applicable Study Director and GSK BIO Representative. RGI
may substitute its Study Director and GSK BIO may substitute the GSK BIO
Representative, as the case may be, during the course of a particular Study by
providing written notice thereof to the other Party.
2.3 Corrective
Measures If,
at any time during the term of this Agreement, RGI becomes aware that the
applicable SOW was not followed, or that RGI otherwise made a material error or
material mistake in conducting Testing
Services, RGI agrees to notify GSK BIO of such occurrence in writing
promptly following the day such discovery is made. Upon
receipt of such notice, GSK BIO will
notify RGI in writing, within a reasonable time, not to exceed two (2) business days, whether
corrective measures which may include retesting are required to ensure validity
of results, and GSK BIO will not be invoiced for any necessary corrective
measures. RGI agrees to implement necessary corrective measures promptly. The retest data will be
reported by RGI to GSK BIO within a reasonable time from the receipt by RGI of
notification from GSK BIO that retesting is required.
ARTICLE
III – APPOINTMENT
3.1 This
Agreement will commence with effect, as defined herein, from the Original
Agreement Effective Date and will continue for the Term, as defined in this
Agreement, or until terminated in accordance with the provisions of Article
X. Should GSK BIO wish to extend the term of this Agreement, the
Parties will discuss such extension in good faith.
3.2 Notwithstanding
the foregoing, however, such Term shall continue in force with respect to all
Studies being conducted under SOWs which have an effective date and have been received by RGI prior to the
expiration of the Term, until all such
Studies have been completed, and the final report and any other pertinent
Study-related documents for such Studies required
from RGI hereunder have been received by and completed to the reasonable
satisfaction of GSK BIO.
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 24b-2 of the Securities Exchange Act of 1934.
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ARTICLE
IV - COMPENSATION
4.1 GSK
BIO agrees to pay RGI according to the payment schedule set forth in the Pricing
Schedule as part of each SOW. The Pricing Schedule shall be based on
the unit pricing provided in Exhibit A and shall specify the timing of the
issuance of invoices applicable to the SOW. Absent an alternative
arrangement agreed upon by the Parties for a particular SOW, RGI may issue
invoices to GSK BIO on a monthly basis for
Services provided pursuant to the Agreement. All payments due
hereunder shall be paid by GSK BIO within sixty (60) days from the end of a
month in which an accurate, complete invoice is received by GSK BIO. Absent
terms in the SOW to the contrary, nothing in this Agreement shall be interpreted
to require RGI to initiate performance of
any SOW or to require GSK BIO to pay for work conducted pursuant to any
SOW prior to the execution of the relevant SOW by RGI. RGI shall be
entitled to interest at the prime rate as
published by Barclays Bank (London) from time to time plus one
percent (1%) per
annum for any payments not timely made to it under this
Agreement. In the event that GSK BIO contests the validity or
accuracy of amounts invoiced to it under the Agreement, no interest payments
shall be required for amounts later determined to have been inappropriately
invoiced.
4.2 Prices
and fees set forth in this Agreement will remain fixed during the
Term.
4.3 GSK
BIO will pay RGI in consideration of the Services performed pursuant to this
Agreement the following:
(a) For
microdissection of tumor or normal tissue and isolation of RNA or DNA, GSK BIO
shall pay a fee of €[***] per sample.
(b) For
other Services, GSK BIO shall pay according to the fee schedule set forth in
Exhibit A hereto.
(c) 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.
(d) Samples
will be provided by GSK BIO for analysis and shall meet mutually
agreed upon specified criteria for tumor content and slide preparation which
includes, but is not limited to, providing compliance with sample preparation
instructions, and compliance with packaging, delivery and shipping requirements
and instructions. RGI will make reasonable efforts to pre-screen the samples for
sufficiency prior to analysis and if RGI in its discretion eliminates
insufficient or deficient samples prior to performing any analysis, RGI will not
charge GSK BIO for that sample.
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 24b-2 of the Securities Exchange Act of 1934.
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(e) Samples,
for the purposes of this Agreement, may include samples from any GSK BIO-funded
source or sponsored samples deemed of interest to GSK BIO.
4.4 (a) The
Parties hereby agree that as of December 31, 2008 GSK BIO has accrued an
aggregate credit of €
[***](the “Existing Credit”) with RGI
towards Services that have yet to be rendered to GSK BIO. All other
amounts which previously have been paid to RGI will remain with RGI and are not
refundable or applicable to any future services or other activity under this
Agreement. The Existing Credit shall be allocated towards Services
rendered to GSK BIO during the remaining Term of the Agreement as set forth in
this Section 4.4
(b) In
2009 and the first two quarters of 2010, RGI shall apply €200,000 Euros of
the Existing Credit in each calendar quarter towards all Services rendered to
GSK BIO during such calendar quarter. In the event that the sum of all
Services rendered to GSK BIO in any such calendar quarter year exceeds €200,000,
then GSK BIO shall remit payment to RGI for such excess Services. In
the event the amount of Services rendered to GSK BIO in any such calendar
quarter does not exceed €200,000, the applicable portion of the Existing Credit
for the following calendar quarter shall be increased by such unused amount.
(c) If
GSK, in its sole discretion, determines that it wishes for RGI to continue to
provide GSK services under this Agreement for 2011 as well (and GSK shall notify
RGI in writing by July 31, 2010 as to such determination), the then-remaining
balance of the Existing Credit for shall be divided into six (6) equal quarterly
amounts spanning over the last two (2) quarters of 2010 and the four (4)
quarters of 2011 and utilized pursuant to the foregoing process. If
GSK determines that it does not wish RGI to provide such services in 2011, the
then-remaining balance of the Existing Credit would instead be divided into two
(2) equal quarterly amounts spanning over the last two (2) quarters of 2010 and
utilized pursuant to the foregoing process; provided any excess Existing Credit
remaining at the end of 2010 shall be rolled over to the following calendar
quarter(s) pursuant to the foregoing process for so long as RGI provides GSK
Services under this Agreement. Provided, in any event, if RGI ceases
for any reason to provide GSK services under this Agreement, then RGI shall
remit to GSK payment of all remaining Excess Credit within sixty (60) days after
the date on which RGI ceased to provide Services to GSK.
ARTICLE
V - PERFORMANCE OF THE SERVICES – SERVICE PROVISIONS
5.1 RGI
(either in its [***] Laboratory subject to the provisions of clause 5.16,
in its US-based laboratory or in any other laboratory RGI may set up in the
future, provided RGI’s selection (in RGI’s reasonable discretion) of a
laboratory aside from its Los Angeles, CA, USA facility shall in no way increase
the cost of, delay or compromise the services is provides GSK under this
Agreement) shall use its best efforts to
provide a turnaround time of five (5) business days for performance of
the Testing 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 24b-2 of the Securities Exchange Act of 1934.
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5.2 To
assist RGI to expeditiously perform the Testing Services, GSK BIO will use
reasonable efforts to transmit samples to
RGI for testing as follows:
(a) Regarding
samples from GSK’s [***] clinical studies GSK BIO will transmit these samples
according to the patient recruitment;
(b) Regarding
all other samples GSK BIO will transmit these in equal numbers each
quarter If samples for any one quarter are anticipated to exceed [***] (prospective and
retrospective), GSK BIO shall give written
notice to RGI of how many samples it
expects to deliver and of what mutually agreeable genes it will be requesting
analysis at least two
(2) quarters in advance so as to allow RGI
sufficient time to supplement resources (personnel, equipment, materials, etc.)
and/or to develop probes or primers, as
necessary, in order to analyze the samples expected. If GSK BIO
provides such notice to RGI, then GSK BIO shall use its best efforts to deliver to RGI for
testing samples equaling the projected
sample number.
5.3 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.
5.4 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.
5.5 GSK
BIO’s representatives may visit RGI’s laboratory and premises at reasonable
times, on reasonable prior notice, and with reasonable frequency during normal
business hours to observe the progress of any Study, and any and all information
and results derived therefrom. RGI shall assist GSK BIO in scheduling
such visits such as an audit of RGI by GSK QA/QC.
5.6 All
reports prepared by RGI hereunder shall be prepared in a
format specified in the applicable SOW and shall be considered to be
Confidential Information of GSK BIO. GSK BIO shall have access to all
documentation, records, raw data, specimens or other work product generated
as part of the performance of each
Study. RGI agrees to maintain appropriate records in paper or
magnetic form, in a manner which complies with regulatory
requirements.
5.7 In
its performance of the Services for GSK BIO hereunder and for SmithKline Xxxxxxx
Corporation under the RGI/SBC Agreement dated January 17, 2006 (as amended), RGI
agrees to dedicate the same level of priority to comparable Services requested
by GSK BIO and SmithKline Xxxxxxx Corporation for analysis of their respective
clinical samples.
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 24b-2 of the Securities Exchange Act of 1934.
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5.8 RGI
agrees to comply with all provisions of the Generic Drug Enforcement Act of
1992. RGI further agrees to submit to GSK BIO, upon request upon completion or
termination of the Testing Services, a certification that neither RGI nor any of
its employees has been debarred by the FDA under the provisions of the Act and
that RGI did not use in any capacity in connection with the Testing Services any
individual debarred by the FDA under the provisions of the above referenced
Act.
5.9 Should
applicable government regulatory requirements be changed during the term of this
Agreement, RGI shall make reasonable efforts to satisfy the new
requirements. In the event that compliance with such new regulatory
requirements necessitates a change in the SOW for a Study, RGI shall submit to
GSK BIO a revised technical and cost proposal for GSK BIO’s acceptance prior to
making any changes in the SOW for such Study.
5.10 In
the event of a conflict in government regulations, GSK BIO shall, upon request
by RGI, designate which regulations it
wishes RGI to follow in its
performance of a particular Study.
5.11
RGI agrees to use reasonable care in safeguarding, inventorying and
handling all SOW data, materials and supporting documentation (hereinafter
collectively termed “Study Archives”) originating from any SOW conducted under
this Agreement by RGI, whether written or physical (such as notebooks, original
or raw data, protocols, interim or final report copies). The Study
Archives shall be considered to be Confidential Information of GSK
BIO. RGI will maintain the samples provided to it for testing
under this Agreement in accordance with the usual and customary standards for
maintaining such materials. Upon request by GSK BIO, RGI will provide
sample materials to GSK BIO or a copy of documents from the Study Archives, at
GSK BIO’s expense. To the extent that samples are transferred to GSK
BIO, responsibility for maintaining such samples will then be undertaken by GSK
BIO. The samples and Study Archives are to be retained and archived
by RGI for a period of not less than ten (10) years following the completion of
the relevant SOW.
5.12
Following the end of the relevant ten (10) year retention period, RGI
further agrees that no samples or records originating from any Services
conducted under this Agreement and retained in RGI’s possession as Study
Archives will be permanently disposed of or destroyed by RGI without the prior
written permission of GSK BIO. GSK BIO agrees that such written
permission will not be unreasonably withheld; provided, however, that in lieu of
the granting of permission for such disposal, GSK BIO shall have the right at
the time such permission for disposal is requested by RGI to claim such
materials and to have RGI transmit such materials to GSK BIO, by a carrier of
GSK BIO’s choice and at GSK BIO’s expense. In the event RGI requests
such permission to dispose of the samples or Study Archives from GSK BIO under
the provisions of notice contained in this Agreement, and no response is
received from GSK BIO within four (4) weeks, RGI shall be deemed to have
received from GSK BIO permission for permanent disposal.
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 24b-2 of the Securities Exchange Act of 1934.
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5.13 GSK
BIO may,
at a reasonable time upon reasonable prior notice, obtain access to the samples
and Study Archives, provided that GSK BIO complies
with RGI’s reasonable access and control procedures relating to such
materials.
5.14 RGI
represents that each of its personnel, employees, agents, representatives,
subcontractors or invitees who shall perform any Study hereunder shall abide by
the provisions of Article 4 hereof while
performing Services. RGI agrees that each of its personnel,
employees, agents, representatives, subcontractors or invitees who shall perform
any Study hereunder shall be at least eighteen (18) years old or of legal age to
enter into a contract, whichever is older. Each Party agrees
to abide by the human rights provisions set forth in Exhibit D.
5.15 RGI
shall, commencing on the date that is [***] after the Effective Date, every
forty-five (45) days submit to GSK BIO [***]. Such statements shall
(i) contain the information set forth in Exhibit E, (ii) constitute RGI
Confidential Information, (iii) shall not be used for any purpose except to
evaluate and engage in discussion with RGI concerning this Agreement, and (iv)
will be disclosed only to GSK BIO employees who are required to have the
information in order to evaluate or engage in said discussions. GSK
BIO acknowledge that their employees who receive this information are aware that
the U.S. securities laws would prohibit any person who has material non-public
information about a company from purchasing or selling, directly or indirectly,
securities of such company (including entering into hedge transactions involving
such securities), or from communicating such information to any other person
under circumstances in which it is reasonably foreseeable that such person is
likely to purchase or sell such securities. GSK BIO agrees that they
will not use or permit any third party to use, and that they will use reasonable
efforts to assure that none of their employees will use or permit any third
party to use, any of the above information provided to them in contravention of
applicable laws. Upon request, GSK BIO will promptly redeliver to the
RGI or certify the destruction of all the written Confidential Information,
including any copies which have been made (provided GSK BIO may retain one copy
for the sole purposes of determining its obligations under this Agreement), and
will further deliver to RGI a duly authorized notice indicating that the
requirements of this sentence have been satisfied in full.
5.16 Upon
GSK BIO’s written request, the Parties shall in good faith negotiate an
amendment to this Agreement providing for RGI using commercially reasonable
efforts to develop a laboratory (with GSK bearing the reasonable costs
associated with developing said laboratory, including reimbursement to RGI for
its time and out-of-pocket expenses associated with such efforts and equipment
costs therefor, in each instance consistent with the provisions of Schedule 5.16) located in
[***] that is run by [***] (or another Third Party reasonably acceptable to GSK
BIO), with such laboratory performing Services in [***] for samples collected in
[***]; provided that the Existing Credit shall not be applicable towards
Services provided in such laboratory in [***].
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 24b-2 of the Securities Exchange Act of 1934.
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5.17 (a) Upon
GSK BIO’s written request, RGI shall in good faith and without delay, commence
and complete the activities outlined in Exhibit F relating to the
bridging of the assays/diagnostic tests to the Third Party(ies) that is(are)
developing and will manufacture and sell the commercial diagnostic test(s) to be
used with GSK BIO’s [***]. Additionally, subject to the provisions of
Section 5.17(c), upon GSK BIO’s written request, RGI shall in good faith and
without delay, commence and complete the activities outlined in Exhibit F relating to the
transfer of the assays/diagnostic tests to a Third Party of GSK’s
choosing. GSK BIO shall accept responsibility for the
bridging/transfer activities and RGI makes no representations or warranties,
express or implied, that the assays and/or diagnostic tests will not infringe
any Third Party patent or other proprietary rights. RGI shall grant
to GSK (and such Third Party(ies) a covenant not-to-xxx for its intellectual
property (including patents and know-how) that are necessary for GSK (or its
designated Third Party) to practice such assays/diagnostic tests on terms and
conditions that are reasonable and customary in the industry. GSK BIO
shall reimburse RGI for its time and out-of-pocket expenses associated with such
bridging/transfer activities pursuant to the fee schedule included in Exhibit F.
(b) To
the extent RGI has any contracts or agreements with any Third Parties that are
necessary or useful for the ongoing performance of such assays/diagnostic tests
performed as part of the Services associated with the existing SOW’s related to
GSK BIO’s [***] (including to the extent applicable, for the avoidance of doubt,
the RGI agreement [***], then RGI shall use its commercially reasonable efforts
to (upon GSK’s request) provide rights (either via sublicense, assignment or
transfer of such agreement as GSK and RGI may agree) under such contracts or
agreements (or the relevant portion thereof) to GSK BIO (or such Third Party, as
GSK BIO may request) solely as part of such bridging/transfer
activities. Notwithstanding the foregoing if Third Party consent is
required prior to such provision of rights, then RGI shall use its good faith
efforts to obtain such consents. Upon the transfer, assignment or
sublicense of such agreements, GSK BIO agrees to abide by any and all
obligations under such transferred, assigned or sublicensed agreements,
including all financial obligations arising out of such agreements which relate
to the bridging and transfer obligations, and GSK BIO further agrees to require
its Third Party designees to abide by any and all obligations under such
agreements.
(c) Notwithstanding
the foregoing, RGI shall not be obligated to undertake any of the aforementioned
bridging or transfer activities solely to the extent it believes in good faith
that such activities could breach one or more then-existing Third Party
agreements. In such circumstances, RGI shall consult in good faith
with GSK BIO regarding the issues, including providing GSK BIO (under
confidence) with true and correct copies of the applicable Third Party
agreement(s) (and any amendments thereto and other relevant materials), if
permitted to do so. If, after consulting with GSK BIO, RGI is unwilling to
proceed for materially adverse good faith reasons, then it shall not be obliged
to proceed with such bridging or transfer activities. For the
avoidance of doubt, RGI shall perform all aspects of the aforementioned bridging
or transfer activities that are not subject to this Section 5.17(c)
(d) If
after reviewing the aforementioned Third Party agreements (and any amendments
thereto and other relevant materials) GSK BIO maintains its request to RGI to
continue with such bridging or transfer activities and RGI is not unwilling to
proceed with such bridging or transfer activities for materially adverse good
faith reasons, then [***].
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 24b-2 of the Securities Exchange Act of 1934.
Page 11
of 39
(e) The
obligations set forth in this clause 5.17 shall survive the termination of this
Agreement until the time the provisions of Section 3.2 are
satisfied.
ARTICLE
VI – CONFIDENTIALITY
6.1 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:
(a) 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
(b) to
maintain the confidentiality of the Confidential Information and not to disclose
it directly or indirectly to any other company, organization, individual or
Third Party other than in the case of GSK BIO, to an Affiliate, save as
permitted by clause 5.2; and
(c) 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.
6.2 Notwithstanding
clause 6.1, 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:
(a) is
made aware of the obligations contained in this Agreement prior to such
disclosure; and
(b) agrees
to abide by such terms of this Agreement as if it were a Party to
it.
6.3 Nothing
in clause 6.1 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.
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 24b-2 of the Securities Exchange Act of 1934.
Page 12
of 39
6.4 The
provisions of clause 5.1 shall not apply to any Confidential Information
which:
(a) 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
(b) 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
(c)
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
(d) 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.
6.5 The
obligations of each Party in this Article VI shall survive for a period of ten
(10) years from the date of disclosure of such information. Each of
the Parties agrees that damages may not be an adequate remedy for breach of this
Article VI and that, accordingly, each Party shall be entitled to seek
injunctive or other equitable relief.
ARTICLE
VII - INTELLECTUAL PROPERTY
7.1 Except
as otherwise provided herein, all title to any and all inventions, improvements
and data, whether or not patentable, and copyrightable works, which result from
the performance of any Study hereunder shall reside with GSK BIO, subject to the
remaining provisions of this Article VII.
7.2 RGI
shall promptly disclose to GSK BIO all inventions and improvements (whether
patentable or not) and all copyrightable works made by it which are governed by
this clause 7.1. RGI agrees, upon GSK BIO’s written request, to
cooperate at GSK BIO’s expense in formally assigning title to GSK BIO to such
inventions, improvements and copyrightable works, and to assist GSK BIO in
obtaining patent or copyright protection to such intellectual
property.
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 24b-2 of the Securities Exchange Act of 1934.
Page 13
of 39
7.3 Subject
to the remaining provisions of this Article VII, RGI agrees that all original works of authorship prepared by or
for RGI in the performance of any Study hereunder shall be works for hire, and
GSK BIO shall own such works and all copyrights therein. For any
original such works of authorship that, under the copyright laws of the United
States, may not be considered works for hire, RGI agrees to reasonably cooperate
with GSK BIO in protecting its rights in such works. Such works shall
be deemed to be the property of GSK BIO, and shall be included in the
Confidential Information of GSK BIO under this Agreement.
7.4 Subject
to this clause 7.4. RGI owns, and GSK BIO acknowledges RGI’s ownership of, (i)
the Testing Services, including RGI’s proprietary process for analyzing the
samples and producing the gene expression values, and all of the materials which
comprise same, and any accompanying patent information owned by RGI, (ii) all
intellectual property associated therewith (the “Intellectual Property”), and
(iii) any algorithms or scales created and used by RGI in producing or
developing the gene expression values (“algorithms”), and agrees that it shall
not do or suffer to be done any act or thing or undertake any action anywhere
that in any manner might infringe, or impair the validity, scope, or title of
RGI in the Testing Services, algorithms or Intellectual Property which may be
owned by RGI at any time. It is understood that neither GSK BIO nor
any Affiliate shall acquire or claim title to the Testing Services, algorithms,
research and development, or the Intellectual Property by virtue of this
Agreement. However, any improvements or modifications thereto which are
developed during the course of RGI’s performance of the Services under the
Agreement, will be jointly owned by the Parties and GSK BIO may, at its
discretion and expense, seek patent protection for such jointly owned
inventions. In case GSK BIO does not wish to seek such patent protection, it
shall inform RGI thereof and RGI may seek patent protection at its own
expense.
7.5 For
the avoidance of doubt, the gene expression values produced and/or developed by
the Testing Services (“gene expression values”), as well as all designs,
developments, ideas, discoveries, inventions and information designed,
developed, discovered, invented, produced or originated by GSK BIO independent
of RGI in the course of or as a result of GSK BIO’s use or analysis of the gene
expression values provided to GSK BIO by RGI pursuant to this Agreement shall be
the sole property of GSK BIO. All such designs, developments, ideas,
discoveries, inventions and information shall be part of the Confidential
Information of GSK BIO. In the event GSK BIO decides, at its
discretion, to seek patent, copyright or other protection (whether in the United
States or elsewhere) in relation to any of same, or to publish the gene
expression values, GSK BIO shall acknowledge RGI’s ownership of the property set
forth in clause 7.4, as appropriate, that the Testing Services and process by
which the gene expression values were produced are proprietary to RGI, and that
the gene expression values were produced using RGI’s proprietary process, as the
case may be. .RGI shall
reasonably cooperate with GSK BIO in the filing of any necessary applications
and in otherwise applying for, obtaining or maintaining patent, copyright or
other protection subject to GSK BIO’s acknowledgement, as set forth in this
paragraph, and to GSK BIO bearing all necessary costs and expenses in relation
thereto.
7.6 If
any of the Intellectual Property owned by RGI is necessary in order to reasonably use the gene expression
values owned by GSK BIO according to this Agreement, RGI will grant GSK BIO a
non-exclusive, fully paid up, irrevocable, world wide license with the right to
sublicense to use such Intellectual Property solely for the purpose of using GSK BIO’s gene
expression values.
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 24b-2 of the Securities Exchange Act of 1934.
Page 14
of 39
7.7 RGI
shall be entitled to utilize the gene expression values (although GSK BIO
retains ownership of the gene expression values) only for the purposes of this
Agreement, and any designs,
developments, ideas, discoveries, inventions and information designed,
developed, discovered, invented, produced or originated by RGI independent of
GSK BIO in the course of or as a result of RGI’s use of the gene expression
values provided to GSK BIO by RGI pursuant to this Agreement shall be the sole
and absolute property of GSK BIO. All such designs, developments,
ideas, discoveries, inventions and information shall be part of the Confidential
Information of GSK BIO. RGI shall reasonably cooperate with GSK BIO in the
filing of any necessary applications and in otherwise applying for, obtaining or
maintaining patent, copyright or other protection with regard to any such
designs, developments, ideas, discoveries, inventions and information, subject
to GSK BIO’s bearing all necessary costs
and expenses in relation thereto.
7.8 The
Parties shall observe all copyrights in written material, including
computer software, belonging to the other Party or any Third Party and will not
make any unauthorized copies of such material or software.
7.9 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.
7.10 GSK
BIO shall provide RGI with sufficient amounts of all compounds, materials,
samples or other substances (collectively, the “Test Materials”) with
which to perform each Study, as well as sufficient
and comprehensive data as may be reasonably required by RGI concerning the
stability, proper storage and safety requirements with respect to such Test
Materials. Such Test Materials shall remain the property of GSK BIO at all times
and shall be properly stored by RGI in accordance with the SOW or as otherwise
agreed by the Parties.
7.11 Upon
completion of any Study, upon request by GSK BIO, any remaining untested samples
of the Test Materials provided for such Study shall be returned to GSK BIO for
retention in compliance with applicable regulatory
requirements.
ARTICLE
VIII - RELATIONSHIP OF THE PARTIES
8.1 It
is understood that in the performance of this Agreement RGI will be acting in
the capacity of an independent contractor and that nothing in this Agreement
shall be construed as creating any contract of employment or relationship of
principal and agent between GSK BIO and RGI or GSK BIO or any of the Relevant
Staff.
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 24b-2 of the Securities Exchange Act of 1934.
Page 15
of 39
8.2 RGI
shall perform this Agreement solely as an independent contractor, and as such
shall select, engage and discharge its employees and otherwise direct and
control the performance of the Studies. Neither RGI nor anyone
employed by it shall be, represent, act, or purport to act as, or be deemed to
be, the agent, representative, employee, or servant of GSK BIO nor shall GSK BIO
nor anyone employed by it be, represent, act, or purport to act as, or be deemed
to be, the agent, representative, employee, or servant of RGI.
8.3 Neither
GSK BIO nor RGI shall have authority to make any statement, representation, or
commitment of any kind or to take any action binding upon the other Party
without the other Party's prior written authorization.
ARTICLE
IX- REPRESENTATION AND WARRANTIES – INDEMNIFICATION
9.1 RGI
represents and warrants that RGI and the Relevant Staff:
(a) have
the appropriate level of expertise and qualifications and the necessary ability
to undertake the work required under this Agreement; and
(b) are
not prevented or restricted by any obligations owed to a Third Party or
otherwise in any way from performing the Services; and
(c) owns
and/or controls all the necessary rights, including patent rights, for the
performance of the Services in accordance with this Agreement.
9.2 In
addition RGI represents that all members of the Relevant Staff are contractually
bound to assign to RGI all inventions, improvements and any other intellectual
property rights that may be developed or conceived by the Relevant Staff or that
may otherwise arise during the performance of the Services under this Agreement
and that none of the Relevant Staff have any rights thereto that could impair or
jeopardize the applicability or enforcement of the provisions laid down in
Article VII above.
9.3 Each
Party represents and warrants that it has the right to enter into this Agreement
and is not in conflict with any Third Party obligation during the performance of
the Study under this Agreement.
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 24b-2 of the Securities Exchange Act of 1934.
Page 16
of 39
9.4 In
addition to any other indemnification provided herein, RGI agrees to indemnify,
defend and hold GSK BIO and its affiliates, shareholders, officers, directors,
employees, agents, successors and assigns harmless from and against any and all
Third Party claims, suits, actions, liabilities, losses, costs, reasonable
attorneys' fees, expenses, judgments or damages, whether ordinary, special or
consequential (collectively, the “Indemnified Amounts”), arising out of (i)
RGI's negligence in the performance of any Study and/or Services, (ii) any
wrongful acts or omissions in the performance by RGI of any Study and/or
Services hereunder, whether such actions are of RGI, its
employees, agents, representatives, subcontractors or invitees, or (iii) any
material breach of this Agreement by RGI, its employees, agents,
representatives, subcontractors or invitees.
9.5 In
addition to any other indemnification provided herein, GSK BIO agrees to
indemnify, defend and hold RGI and its affiliates, shareholders, officers,
directors, employees, agents, successors and assigns harmless from and against
any and all Indemnified Amounts arising out of (i) GSK BIO's
negligence in the conduct of the activities to be performed by GSK BIO under
this Agreement, (ii) any wrongful acts or omissions in the conduct of the
activities to be performed by GSK BIO under this Agreement, whether such actions
are of GSK BIO, its employees, agents, representatives, subcontractors or
invitees, or (iii) any material breach of this Agreement by GSK BIO, its
employees, agents, representatives, subcontractors or invitees.
9.6 Where
claims relate to those by third Parties and in the event either Party incurs, or
expects to incur expenses, damages, claims or liability for which it is entitled
hereunder to seek indemnification from the other Party, the Party claiming
indemnification (the “Indemnitee”) shall
promptly notify the other Party (the “Indemnitor”) and
shall permit the Indemnitor, at the Indemnitor’s sole discretion, to settle any
such claim or suit and agrees to the complete control of the defense or
settlement of such claim or suit by the Indemnitor, and the Indemnitor shall not
be responsible for any legal fees or other costs incurred other than as provided
in this Agreement provided, however, that the
Indemnitor may not settle such claim or suit in any manner that would require
payment by the Indemnitee, or would materially adversely affect the rights
granted to the Indemnitee hereunder, or would materially conflict with the terms
of this Agreement, or adversely affect other of its products, without first
obtaining the Indemnitee’s prior written consent, which consent shall not be
unreasonably withheld. The Indemnitee, its employees, consultants and
agents, shall cooperate fully with the Indemnitor and its legal representatives
in the investigation and defense of any claims or suits covered by the
indemnification provisions of this Agreement. Neither Party will be liable
for any loss of actual or anticipated income or profits or for any special,
indirect or consequential loss or damages.
9.7 Nothwithstanding
anything to the contrary in this Agreement or the Original Agreement, RGI (and
its Affiliates and shareholders) hereby releases and forever hold GSK BIO (and
its Affiliates) harmless from any and all claims, losses or damages related to
or arising out of RGI having opened, operated, and subsequently closed that
certain laboratory in the [***].
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 24b-2 of the Securities Exchange Act of 1934.
Page 17
of 39
ARTICLE
X – TERMINATION
10.1 GSK
BIO shall have the absolute and unconditional right, in its sole judgment and
discretion, to terminate this Agreement and/or any Study performed under this
Agreement for any reason, with or without cause, such termination to be
effective on the next anniversary date of the Effective Date provided at least
ninety (90) days prior written notice is given to RGI.
10.2
Either Party (“the Non-Defaulting Party”) may
terminate this Agreement by notice in writing if (a) the other Party commits or
permits a material breach of this Agreement which is incapable of remedy, or if
capable of remedy, the breaching Party fails to cure that breach within ninety
(90) days after receiving written notice
thereof from the Non-Defaulting Party; or
(b) the other Party ceases to exist as a going concern as a result of bankruptcy
or insolvency proceedings.
10.3 Subject
to clause 7.5. above, if GSK BIO terminates this Agreement pursuant to clause
10.1 above, GSK BIO shall be permitted to use the technology used by RGI in
performance of the Services solely for the purpose of completing any unperformed
services pursuant to any then outstanding and
pending SOW during the remainder of the existing Term (with no renewals
permitted). To the extent that GSK BIO requests RGI’s assistance in
such use of the technology, and RGI agrees to provide such assistance, then GSK
BIO shall provide appropriate compensation to RGI for such
assistance.
10.4
In the event of termination of this Agreement and/or any Study performed under
this Agreement, RGI shall use all reasonable efforts to minimize any further
costs and RGI shall be reimbursed only for the Services actually performed and
the expenses actually and reasonably incurred as of the effective date of such
termination. RGI will within sixty (60) days after the date of such
termination reimburse any amounts overpaid by GSK BIO (including any remaining
Existing Credit).
10.5
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.
10.6
(a) Expiration
or termination of this Agreement or the Term for any reason shall terminate all
outstanding obligations and liabilities between the Parties arising from this
Agreement except that the provisions of Articles I, IV,VI, VII, VIII, X, XII,
and Sections 3.2, 5.6, 5.11, 5.12, 5.17 and 9.4 through 9.7 shall survive
such expiration or termination for the time period specified in such provisions
or if no such time period is specified, five (5) years after the date of
expiration or termination.
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 24b-2 of the Securities Exchange Act of 1934.
Page 18
of 39
(b) Termination
or expiration of this Agreement for whatever reason in accordance with the
provisions hereof shall not affect the accrued rights of the Parties, and shall
not limit remedies that may be otherwise available in law or
equity.
10.7 The
Parties may terminate this Agreement at any time by mutual agreement in writing,
executed by both Parties.
ARTICLE
XI – FORCE MAJEURE
11.1 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”).
11.2 Subject
to clause 11.3, 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. 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 11.3 and
11.4, 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.
11.3 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.
11.4 If
either Party is prevented from performance of its obligations for a continuous
period in excess of three (3) months due to force majeure, the other Party may
terminate this Agreement forthwith on service of written notice upon the Party
so prevented, in which case neither Party shall have any liability to the other
except that rights and liabilities which accrued prior to such termination shall
continue to subsist.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
Page 19
of 39
11.5 Notwithstanding
anything in this Article 11 to the
contrary, no Force Majeure Condition shall relieve GSK BIO of the obligation to
pay for Testing Services which have already been completed by RGI.
ARTICLE
XII – MISCELLANEOUS
12.1 Notice.
(a) Any
notice required by this Agreement to be given to either Party shall be in
writing and shall be served by being addressed to the address of the other Party
stated in this Agreement or such other address as may from time to time have
been notified by a notice given in accordance with this clause. Any
notice or other document to be given under this Agreement shall be deemed to
have been duly given if left at or sent to the address, or if more than one is
designated by a Party, to the addresses,
referred to in clause 12.2 by: hand or courier; first class post, express or
other fast postal service (airmail if abroad); or registered post; or facsimile
or other electronic media.
(b) Any
such notice or other document shall be deemed to have been received by the
addressee five (5) working days following the date of dispatch of
the notice or other document by or, where the notice or other document is sent
by hand or courier or is given by facsimile or other electronic media,
simultaneously with the delivery or transmission. To prove the giving
of a notice or other document it shall be sufficient to show that it was
dispatched.
|
(c)
|
The initial details for the purposes of clause
12.1 are:
|
For GSK BIO
GlaxoSmithKline
Biologicals S.A.
Parc de la Noire Epine
Xxxxxx Xxxxxxx 0/0
X-0000 Xxxxx
Xxxxxxx
Attn: Vice President,
Procurement
With copies to:
GlaxSmithKline
Biologicals S.A.
Parc de la Noire Epine
Xxxxxx Xxxxxxx 0/0
X-0000 Xxxxx
Xxxxxxx
Attn: Vice President and General
Counsel, Legal Department
For
RGI
Attn:
Xxxxxxxx Xxxxxxxxx
0000
Xxxxxxx Xxxxxx Xxxxx 000
Xxx
Xxxxxxx, XX 00000
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 24b-2 of the Securities Exchange Act of 1934.
Page 20
of 39
12.2 Governing
Law And Jurisdiction.
This
Agreement will be governed by and construed in accordance with the laws of
Belgium, without regard to its conflict of laws or choice of laws
principles. The Parties agree that any disputes arising under this
agreement shall be presented exclusively before the courts of the State of
California in the United States in cases RGI is the respondent, and in Nivelles,
Belgium, in cases GSKBIO is the respondent. 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.
12.3
Entire Agreement, Amendment
Or Variation.
(a)
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.
(b)
No other terms and conditions (including any standard terms and conditions of
GSK BIO, RGI or their Affiliates) shall apply in relation to this Agreement or
the provision of the Services or of any other Services by RGI to GSK BIO, save
for any additional terms and conditions specifically agreed to in writing
hereafter by the Parties.
(c) Any
amendment or modification to this Agreement shall be made in writing and signed
by both Parties.
12.4 Validity/Severability. 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.
12.5 Assignment. Either Party may
assign this agreement in whole or in part, provided that, if RGI wishes to
assign this agreement in whole or in part, it shall first obtain the prior
written consent of GSK BIO, which shall not be
unreasonably withheld.
12.6 Waiver. 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.
12.7 Announcements. 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. No oral or written release of
any statement, information, advertisement or publicity matter having any
reference to either GSK BIO or RGI, express or implied, shall be used by the
other Party or on the other Party's behalf, unless and until such matter shall
have first been submitted to and received the approval in writing of the Party
whose name is being used.
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 24b-2 of the Securities Exchange Act of 1934.
Page 21
of 39
12.8 Permits. RGI shall obtain
and pay for all permits, governmental fees, and licenses necessary for it to
perform the Studies hereunder and
shall obtain all required inspections, authorizations and approvals prior to
commencement of any Study hereunder.
12.9 Records. RGI agrees to
maintain for a period of two (2) years after the termination or expiration of
this Agreement adequate records of, and copies of all receipts for expenses
incurred in connection with, the performance of the Services and allow access to
GSK BIO and its authorized representatives to inspect such records and receipts
upon reasonable notice.
12.10
Laboratory
Visits. GSK BIO’s
representatives may visit RGI’s facilities at reasonable times, on reasonable
prior notice, and with reasonable frequency, during normal business hours to
observe the progress of the Testing Services. RGI will assist GSK BIO
in scheduling such visits.
12.11
FDA.EMEA
Visits.
(a) At
GSK BIO’s request, a representative of RGI shall accompany GSK BIO to FDA/EMEA
to explain or discuss any and all aspects of the Testing
Services. Such visit or visits to the FDA/EMEA shall be arranged at
times mutually agreeable to GSK BIO and RGI. All reasonable travel
and living expenses incurred by RGI in connection with such visits shall be
reimbursed by GSK BIO.
(b) RGI
shall notify GSK BIO of any request from FDA/EMEA, other federal or state
agencies or any other Third Party to inspect or otherwise gain access to the
information, gene expression values, clinical samples, or materials pertaining
to the Services performed by RGI under this Agreement. RGI shall
notify GSK BIO of such request prior to permitting any Third Party access,
unless prior notice is not reasonably feasible.
(c) RGI
agrees to permit inspection of such information, gene expression values,
clinical samples, or other materials by authorized representatives of FDA/EMEA
and as otherwise required by law. During such inspections, RGI shall
provide appropriate scientific and quality assurance support. RGI
shall promptly send GSK BIO a copy of any inspection reports received by RGI as
a result of any such inspection.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
Page 22
of 39
12.12
Counterparts. This Agreement
may be executed in any number of counterparts, each of which shall be deemed an
original but all of which together shall constitute one and the same
instrument.
SIGNATURE
PAGE
FOLLOWS
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
Page 23
of 39
IN WITNESS whereof the Parties
have executed this Agreement on the date above written.
Signed
for and on behalf of GlaxoSmithKline Biologicals SA
by
/s/ Xxxxxx Xxxxxxxxx |
Signature
|
Date
|
01/09/2009 | |
Name:
Xxxxxx Xxxxxxxxx
|
||||
Title: Vice
President Procurement
|
||||
Signed
for and on behalf of Response Genetics Inc.
by
|
||||
/s/ Xxxxxxxx Xxxxxxxxx |
Signature
|
Date
|
07/09/2009 | |
Name
: Xxxxxxxx Xxxxxxxxx
|
||||
Title
: Chief Executive Officer
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
Page 24
of 39
Response Genetics List of
Services
EXHIBIT
A
TESTING
SERVICES FEE SCHEDULE
RGI
Services
|
Cost
|
Explanation
of Service
|
||
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
Page 25
of 39
RGI
Services
|
Cost
|
Explanation
of Service
|
||
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
Page 26
of 39
EXHIBIT
B
FORM TASK
ORDER/STATEMENT OF WORK AND SCHEDULES
TASK
ORDER/STATEMENT OF WORK REFERENCE NUMBER ………….
This TASK ORDER/STATEMENT OF WORK is
effective ____________, 200__ (the “Effective Date”)
between
__________________
(“Contractor”), with offices located
at _______________________,
and
GlaxoSmithKline
Biologicals SA, with offices located rue de l’Xxxxxxxx 00, X-0000 Xxxxxxxxx,
Xxxxxxx (“GSK”).
BACKGROUND
GSK and Contractor are parties to a
Master Agreement (or are Affiliates of the parties to the Master Agreement) with
an effective date of __________. The terms and conditions of that
Master Agreement are used by GSK and Contractor, by executing this Task
Order/Statement of Work, to contract for the laboratory research services
described in this Task Order/Statement of Work.
The following shall apply in this Task
Order/Statement of Work and to the Study which is the subject of this Task
Order/Statement of Work:
CONTRACTOR’S NAME: Response Genetics,
Inc.
CONTRACTOR’S
ADDRESS: 0000 Xxxxxxx Xx.,#000, Xxx Xxxxxxx, XX 00000
CONTRACTOR’S TELEPHONE
NO.:x0-000-000-0000
CONTRACTOR’S TAX ID
#:000000000
TEST
NAME:
STUDY
TITLE (if applicable):
GSK
PROTOCOL NUMBER (if applicable) :
CONTRACTOR
MONITOR :
GSK
REPRESENTATIVE :
Period of
Performance of the Services : From [day] [month]
[year] To [day] [month]
[year]
1. THE
SERVICES
Contractor agrees to perform the
Services as described in the Protocol, task description, and/or Study proposal
in Schedule A, attached and incorporated by reference as part of this Task
Order/Statement of Work, and in accordance with the terms of the Master
Agreement.
Page 27
of 39
2. COMPENSATION
In consideration for its performance of
Services under this Task Order/Statement of Work, GSK shall pay Contractor in
accordance with the payment schedule as documented in Schedule B, attached and
incorporated by reference as part of this Task Order/Statement of
Work.
3. ARCHIVING
SPECIFICATIONS
Anticipated date of Study completion of
work as detailed in schedule A :
4. TERM;
TERMINATION
This Task Order/Statement of Work shall
continue until the Services are completed or until terminated as provided in the
Master Agreement. The performance schedule is summarized below with
the major milestones and delivery dates (modify as needed):
Start
date:
First
sample delivered
Final
sample delivered
Final
assay complete
Final
Report:
5. INCORPORATION BY
REFERENCE
The terms and conditions of the Master
Agreement are hereby incorporated by reference into and made a part of this Task
Order/Statement of Work. All defined terms within the Master
Agreement shall have the same meaning when used in this Task Order/Statement of
Work. If any provisions of this Task Order/Statement of Work are in
direct conflict with this Master Agreement so that the provisions of both cannot
be given effect, the terms of this Task Order/Statement of Work shall govern the
specific issue.
6. NOTICE. In addition to
the recipients of notice listed in the Master Agreement, notices applicable to
this Task Order/Statement of Work Agreement shall be sent to (list all relevant
contacts at both Contractor and GSK including study director
below):
Page 28
of 39
If
to Contractor:
Name:
Address:
Facsimile:
Copy
to:
|
If
to GSK:
Name:
Address:
Facsimile:
Copy
to:
|
7. ADDITIONAL
TERMS. Include any additional
project-specific terms.]
8. ENTIRE
AGREEMENT. This Task
Order/Statement of Work, including the incorporated terms of the Master
Agreement, represents the entire and integrated agreement between Contractor and
GSK-Biologicals and supersedes all prior negotiations, representations or
agreements, either written or oral, regarding the Study.
GLAXOSMITHKLINE
BIOLOGICALS SA
|
CONTRACTOR’S
NAME
|
|||
By:
|
By:
|
|||
Name:
|
Name:
|
|||
Title:
|
Title:
|
Date: |
|
Date:
|
Page 29
of 39
TASK
ORDER/STATEMENT OF WORK
EXHIBIT
A
DESCRIPTION
OF THE SERVICES
The
Contractor shall perform ………. According agreed Standard ……as detailed
below.
Test Performance
Assessment
Screening
Step
Technical
Bridge
Clinical
Bridge
Test
name
Contractor
or GSK Standard Operating Procedure number
Validation
plan
Specific
Quality Standard (if negative)
Reporting
Timings
Prices
(see schedule B)
Archiving
Responsibility
Test
Routine
Test
name
Contractor
or GSK Standard Operating Procedure number
Study
title
Planned
number samples
Timings:
Turnaround
time
Timetable
Archiving
Prices
(see schedule B)
Reporting
Responsibility
Specific
Quality Standard (if negative)
Page 30
of 39
TASK
ORDER/STATEMENT OF WORK
EXHIBIT
B
PAYMENT/PAYMENT
SCHEDULE
Payment
schedule should be generally cost neutral throughout study period
Invoices
should be dispatched regularly at monthly intervals throughout the course of the
analyses.
Page 31
of 39
EXHIBIT
C
SOW’s
In Effect as of the Effective Date
Study
title/Description
TO
|
Task Order
reference
|
PO#
|
TO amount
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
|||
[***]
|
[***]
|
[***]
|
[***]
|
Page 32
of 39
Exhibit
D
HUMAN
RIGHTS
|
(A)
|
Each
Party shall not employ engage or otherwise use any child labor in
circumstances such that the tasks performed by any such child labor could
reasonably be foreseen to cause either physical or emotional impairment to
the development of such child in all countries in which it operates or
sources goods;
|
|
(B)
|
Each
Party shall not use forced labor in any form (prison, indentured, bonded
or otherwise) and staff are not required to lodge papers or deposits on
starting work;
|
|
(C)
|
Each
Party shall comply with all applicable environment, safety and health
regulations and provide a safe and healthy workplace, presenting no
immediate risks to its staff. Any housing provided by a Party
to its workers is safe for habitation. Each party shall provide
access to clean water, food, and emergency healthcare to its workers in
the event of accidents or incidents at the Contractor’s
workplace;
|
|
(D)
|
within
the customs and practices of the countries in which each Party operates,
each Party shall not discriminate against any worker on any ground
(including race, religion, disability or gender). Each Party
shall not engage in or support the use of corporal punishment, mental,
physical, sexual or verbal abuse and does not use cruel or unusual
disciplinary practices in the
workplace;
|
|
(E)
|
Each
Party shall pay each employee at least the minimum wage, or the prevailing
industry wage, (whichever is the higher) and provide each employee with
all legally mandated benefits;
|
|
(F)
|
Each
Party shall comply with the laws on working hours and employment rights in
the countries in which it operates;
|
|
(G)
|
Each
Party has identified all the hazardous or toxic waste that it or its
contractors or agents produce, and it is confident that all waste is
disposed of by competent bodies via authorized disposal routes;
and
|
|
(H)
|
Each
Party shall not engage in any activities which may cause harm
to either those living in the vicinity to its operations or the
environment.
|
Each
Party shall upon request furnish the other with any documents reasonably
requested in relation to the above.
Page 33
of 39
EXHIBIT
E
FORM
OF [***]
SLIDE
1
[***]
SLIDE
2
[***]
Page 34
of 39
SLIDE
3
[***]
SLIDE
4
[***]
Page 35
of 39
EXHIBIT
F
BRIDGING
AND TRANSFER ACTIVITIES
Cost
|
Explanation
|
||
Equipment
and Supplies
|
|||
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
Testing
Services
|
|||
[***]
|
[***]
|
[***]
|
|
Consulting
Fees
|
|||
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
Training
|
|||
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
Travel
|
|||
[***]
|
[***]
|
[***]
|
Page 36
of 39
SCHEDULE
5.16
Cost
|
Explanation
|
||
Equipment
and Related Expenses
|
|||
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
Bridging/Testing
Services
|
|||
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
Consulting
Fees
|
|||
[***]
|
[***]
|
[***]
|
|
Training
and Travel
|
|||
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
Document
Translation
|
|||
[***]
|
[***]
|
[***]
|
Page 37
of 39
TRAVEL
AND EXPENSE REIMBURSEMENT GUIDELINES
1.
|
GSK
will, to the extent provided for under its written agreement with
Supplier, reimburse Supplier for out-of-pocket expenses actually and
reasonably incurred by Supplier’s personnel in connection with
GSK-authorized travel and for lodging, car rental and meals while away
from home performing services directly on behalf of
GSK.
|
2.
|
Local
travel expenses should not exceed $[***] per session for occasion when
facilitators are utilized who will have Local Travel expenses and $[***]
for occasions when facilitators are utilized who will have Non-Local
travel expenses.
|
3.
|
All
Supplier expenses for which reimbursement is sought must be approved in
advance by GSK.
|
4.
|
All
expenses over $[**] must be accompanied by a written receipt and an
explanation as to why the expenses were
incurred.
|
5.
|
Reimbursement
of Supplier’s expenses is subject to the following
conditions:
|
(a)
|
Air
and train travel only by economy (coach) class or actual fare, whichever
is less;
|
(b)
|
Lodging
at hotels that are generally considered medium cost (i.e.,Marriott,
Ramada, etc.);
|
(c)
|
When
rental cars are required, economy or compact class rental
automobiles are
to be used;
|
(d)
|
Meals
at restaurants are generally considered medium priced, taking into
account
that no more than $50 will be allowed for any day that a Supplier’s
staff
member is required to perform work on behalf of GSK when a
overnight stay
is required; and
|
Page 38
of 39
(e)
|
Any
other expenses specifically authorized under Supplier’s agreement with
GSK
or expressly agreed to in writing by GSK’s
Representative.
|
6.
|
Expenses
incurred in excess of the above, or otherwise not permitted hereunder,
shall be borne by Supplier unless authorized by GSK in
writing. Expenses related to general Supplier overhead and back
office work, such as administrative efforts, general management expenses
and any other expenses not directly related to GSK’s work, will not be
reimbursable by GSK.
|
Page 39
of 39