Exhibit 10.1

 

Portions of this Exhibit have been omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission pursuant to Rule
24b-2 under the Securities Exchange Act of 1934. Such portions are marked by
[***].

 

Confidential

 

SECOND AMENDED AND RESTATED MASTER SERVICES AGREEMENT

 

PREAMBLE

 

This confidential SECOND AMENDED AND RESTATED MASTER SERVICES AGREEMENT (the
“Master Agreement”) is dated as of July 26 2012 and made effective as of May 15,
2012 (“Effective Date”) between GLAXOSMITHKLINE BIOLOGICALS S.A. with offices
situated at 89 rue de l’Institut, 1330 Rixensart, Belgium, duly registered under
the Belgian Company Register with the number RPM Nivelles BE 440.872.918
(“GSK”), and RESPONSE GENETICS INC., a company incorporated in the State of
Delaware, whose principal place of business is situated at 1640 Marengo Street,
Suite 600, Los Angeles, CA 90033 (“RGI”).

 

WHEREAS, the Parties entered into that certain Master Agreement dated December
1, 2006 (as amended on November 29, 2007 and amended and restated in its
entirety on August 10, 2009 (the “Original Agreement Effective Date”) (as
amended with that certain First Amendment to the Original Agreement, dated as of
December 15, 2011 and as further amended with that certain Second Amendment to
the Original Agreement, dated February 22, 2012, the “Original Agreement”); and

 

WHEREAS, the Parties wish to amend and restate in its entirety the Original
Agreement as is set forth herein effective as of the Effective Date.

 

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:

 

DEFINITIONS

 

In this Master Agreement, the following initially capitalized terms shall have
the following meanings:

 

 

 

 

 

“Affiliate” with respect to a person shall mean any other person that directly,
or indirectly through one or more intermediaries, controls, is controlled by or
is under common control with such person; for the purposes of this definition
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, or
(b) the ownership, directly or indirectly, of at least fifty percent (50%) of
the voting securities or other ownership interest of a person.

 

“Analytical Plan” shall mean a formal authorized document that describes all
aspects of the Services to be performed by RGI at RGI’s Facility in the
framework of a Study.

 

“Applicable Laws” shall mean all applicable provisions of all statutes, laws,
rules, regulations, administrative codes, ordinances, decrees, orders,
decisions, injunctions, awards judgments, permits and licenses of or from
governmental authorities, including, without limitation, those relating to or
governing the use or regulation of the subject item.

 

“Assay-Related Data” shall mean any and all data and information that are
related to an assay or a GSK Assay that is performed by RGI within the framework
of the Services to be rendered under this Master Agreement as further described
in a Task Order. This includes, without limitation, all Raw Data, quality
control charts, technician certification documents, assay Procedures,
qualification or validation of assay protocol and report, documentation on
bridging of assays, QC panel protocol and report.

 

“Change Order” shall mean a specific form of amendment to a Task Order, to be
used when the Parties mutually agree to modify the scope of the Services or the
assumptions on which a Task Order is based. A Change Order form is attached to
this Master Agreement as Exhibit B.

 

“Critical” shall mean anything which has direct impact on the GSK Results or on
Samples from a Study.

 

“Effective Date” shall have the meaning set forth in the Preamble.

 

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“GSK Equipment” shall mean any equipment that will be provided to RGI by or on
behalf of GSK or its Affiliate, or (ii) that will be purchased by RGI on behalf
of and paid by GSK or its Affiliates during the term of this Master Agreement or
any Task Order to perform the Services hereunder and that shall be listed, if
applicable, in Schedule E attached to the relevant Task Order.

 

“Expiration Date” of this Master Agreement shall mean December 31, 2014 subject
to the provision set forth in Section 12 of this Master Agreement.

 

“Facility” shall mean premises of RGI including RGI’s subcontractor’s premises,
where the Services shall be carried out.

 

“GSK Assay” shall mean any analytical method, diagnostic, primer, probe, or
reagent, developed, qualified or validated by or on behalf of GSK which is
transferred to RGI to carry out the Services under the Master Agreement as
further described in a Task Order.

 

“GSK Confidential Information” shall mean all information (including, without
limitation, Study Protocols, case report forms, clinical data, other data,
reports, specifications, computer programs or models and related documentation,
know-how, trade secrets, including, without limitation, any technologies and
know-how pertaining to GSK Assay(s) or business or research plans) of GSK or
GSK’s Affiliates that are: (1) provided to RGI or RGI’s Affiliates in connection
with this Master Agreement or a Task Order, or in connection with a request for
proposals, proposals, or otherwise related to a project which potentially could
be the subject of a Task Order, whether or not a Task Order is ever executed; or
(2) created or developed by RGI, RGI’s Affiliates or a Third Party associated
with RGI (including, without limitation, RGI’s employees, agents, or
subcontractors), or by Study Investigators and staff, in connection with this
Master Agreement or a Task Order. This Master Agreement and the terms and
conditions herein shall be considered to be GSK Confidential Information.

 

“GSK Results” shall mean all discoveries, developments, inventions (whether
patentable or not), improvements, works of authorship, formulas, processes,
materials components, formulations, methods of use or delivery, clinical data,
Assay Related Data, materials, other data, reports, specifications, computer
programs or models and related documentation, know-how or trade secrets, which
are conceived or generated or first reduced to practice by GSK, its Affiliates
or RGI, its Affiliates or a Third Party associated with RGI or RGI’s Affiliates
(including, without limitation, RGI’s and RGI’s Affiliates’ employees, agents,
or subcontractors), or by Study Investigators and staff: (1) in connection with
performance of Services under this Master Agreement and in a Task Order, or (2)
which reflect or contain GSK Confidential Information, or (3) which relate to
Samples under study, including any results arising from the performance of
Samples Management Services, or (4) to Materials or GSK Assay(s) provided by GSK
under this Master Agreement or any Task Order.

 

- 3 -

 

 

 

“GSK Manager” shall be designated by GSK in writing to RGI within five (5)
business days of the date hereof, or such other representative which GSK may
subsequently designate in writing, who will liaise on the overall requirements
for the Services to be performed under this Master Agreement.

 

“GSK Representative” shall mean an individual designated by GSK to be
responsible for the performance of the Services as set forth in a Task Order.

 

“GxP” shall mean collectively Good Manufacturing Practices (GMP), Good
Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Clinical
Laboratory Practices (GCLP).

 

“Investigator” shall mean the individual responsible for the conduct of a Study
whose role is as defined by ICH GCP.

 

“Key Performance Indicators” or “KPIs” shall mean the metrics and measures that
will allow evaluation of the performance by RGI and its Affiliates of the
Services according to the terms of this Master Agreement and the specifications
set forth in the Task Orders(s). The KPIs shall be specified in Exhibit C of
this Master Agreement.

 

“Laboratory Services” shall mean any clinical testing activities that shall be
performed by RGI or its Affiliates within the framework of a Study as set forth
in a Task Order as further described in Section 2.2(b) and (ii) Samples
Management Services as further described in Section 2.2(c).

 

“Materials” shall mean active and raw materials, reagents, intermediates,
processing aids, ingredients or components, documentation and other materials,
including any materials relating to a GSK Assay that will be provided to RGI or
its Affiliates by GSK or its Affiliate during the term of this Master Agreement
to perform the Services hereunder and that shall be described in Schedule E
attached to the relevant Task Order.

 

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“Non Assay-Related Data” shall mean any and all data and information regarding
the Services performed by RGI or its Affiliates under this Master Agreement as
further described in a Task Order which are not directly related to an assay,
including a GSK Assay. This includes, without limitation, all records of
relevant personnel (e.g. training, CV, job description), transversal Procedures
and other transversal training documents, training records of employees involved
in the performance of the Services, documentation on equipment (including
computerized systems) validation and maintenance (IQ/OQ/PQ, qualification,
logbook, etc.), reagents, documentation and deviation reports.

 

“Operational Management Services” shall mean any activity pertaining to the
organization, the set-up and the management of a Study, including but not
limited to, Study project initiation, Study site services, Study project
management, Samples Management Services, as further described in Sections 2.2
(a) and (c) of this Master Agreement.

 

“Party” or “Parties” shall mean, when used in the singular, either GSK or RGI,
as the context requires, and, when used in the plural, shall mean GSK and RGI.

 

“Person” shall mean any natural person, corporation, unincorporated
organization, partnership, association, joint stock company, joint venture,
limited liability company, trust or government, or any agency or political
subdivision of any government, or any other entity.

 

“Procedure” shall mean any specificities or analytical methods pertaining to the
Services to be carried out by RGI or its Affiliates under a Task Order,
including, without limitation, the conditions under which the Services are to be
performed, which has been accepted by both RGI or its Affiliates and GSK or its
Affiliates and makes up an integral part of the Task Order.

 

“Raw Data” shall mean all original records and documentation, or verified copies
of these, generated by observations and activities carried out during the
performance of the Services and which have not been subject to processing or any
other manipulation. They are necessary for the reconstruction and evaluation of
the reported Study results. For the purposes of this guideline, “source data”
(ICH GCP) and “Raw Data” are the same.

 

 

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“RGI Confidential Information” shall mean all information (including, without
limitation, computer programs or models and related documentation, extraction
technology, assays, procedures, processes, techniques, resourcing, pricing, and
billing information, know-how or trade secrets related to clinical study
management, clinical testing, or business or research plans), financial
disclosures or general commercial information of RGI or RGI’s Affiliates that
are provided to GSK in connection with this Master Agreement or a Task Order, or
in connection with a request for proposals, proposals, or otherwise related to a
project which potentially could be the subject of a Task Order, whether or not a
Task Order is ever executed; provided, however RGI Confidential Information
shall not include any GSK Works, GSK Results or Assay-Related Data.

 

“RGI Results” shall mean all discoveries, developments, inventions (whether
patentable or not), improvements, works of authorship, processes, reports,
specifications, computer programs or models and related documentation, know-how,
technology, or trade secrets which are related to clinical study management,
data collection, data management, clinical testing or project management and
which are made by RGI or its Affiliates or subcontractors: (1) other than at the
specific request of GSK and at GSK’s cost under a Task Order, or (2) without
reference to or use of GSK Confidential Information or GSK Assay or GSK Results.

 

"RGI Manager" shall be designated by RGI in writing to GSK within five (5)
business days of the date hereofor such other representative which RGI may
subsequently designate in writing, who will liaise on the overall requirements
for the Services to be performed under this Master Agreement.

 

“RGI Monitor” shall mean an individual designated by RGI to be responsible for
the performance of the Services as designated in the Task Order.

 

“Samples Management Services” shall mean any services relating to the Samples
(other than clinical testing) as further described in Section 2.2(c)

 

“Samples” or “HBS” shall mean any human biological samples (including any
derivatives or progeny thereof) that shall be transferred to RGI or its
Affiliates under this Master Agreement or any Task Orders as well as Data
related thereto. “Data” in this definition shall mean information about the
human biological samples such as pathology information, and information
regarding the integrity of the biological materials.

- 6 -

 

 

 

“Services” shall mean any activities that RGI or its Affiliates will perform as
requested from time to time by GSK or its Affiliates and as set forth in a Task
Order. This includes, but is not limited to, the Operational Management
Services, Laboratory Services as well as any other services that RGI or its
Affiliates will perform under this Master Agreement, as further set forth in a
Task Order.

 

“Study” shall mean a clinical trial or an epidemiology study relating to GSK’s
cancer immunotherapies conducted by, or on behalf of GSK or its Affiliates, or
such a study or trial sponsored by a Third Party that receives support from GSK
or GSK’s Affiliates, within the framework of which the Parties agree then RGI or
its Affiliates shall perform the Services.

 

“Study Protocol” shall mean a statement of the rationale, objectives and
statistical design and methodology of a Study, including the conditions under
which the Study is to be performed, which has been accepted by both RGI and GSK
or their respective Affiliates.

 

“Study Records” shall mean Assay Related Data, Non Assay Related Data reference
materials, as well as any and all information pertaining to the Services carried
out under this Master Agreement and any Task Order(s) that has to be retained as
required by Applicable Laws or guidelines or upon GSK’s written request.

 

“Task Order” shall mean a written agreement, including any amendments or changes
in scope related to such an agreement, between the Parties or Affiliates which
incorporates by reference the terms of this Master Agreement and also contains
terms and conditions specifically applicable to the performance of Services by
RGI or its Affiliates with respect to a specific Study or Studies.

 

“Testing Services” shall mean RGI’s business of conducting molecular-based tumor
tissue profiling using a proprietary and patented process developed by RGI which
involves a complex molecular analysis of specific molecular markers that
provides valuable tumor specific gene expression information obtained from a
paraffin preserved fresh or frozen tissue sample, which can help the physician
choose the most appropriate therapy for a patient prior to starting treatment or
assist a pharmaceutical company in identifying the appropriate candidate patient
population suitable for a therapy in development.

 

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“Third Party” shall mean any Person other than GSK or RGI (or their respective
Affiliates).

 

The definitions of the terms in this Master Agreement shall apply equally to the
singular and plural forms of the terms defined. Whenever the context may
require, any pronoun shall include the corresponding masculine, feminine and
neuter forms. The words “include,” “includes” and “including” shall be deemed to
be followed by the phrase “without limitation” (regardless of whether it is
actually written there (and drawing no implication from the actual inclusion of
such phrase in some instances after such terms but not others)). The word “will”
shall be construed to have the same meaning and effect as the word “shall.”
Unless the context requires otherwise: (a) any definition of or reference to any
agreement, instrument or other document in this Master Agreement shall be
construed as referring to such agreement, instrument or other document as from
time to time amended, supplemented or otherwise modified (subject to any
restrictions on such amendments, supplements or modifications set forth in this
Master Agreement); (b) any reference in this Master Agreement to any person or
entity shall be construed to include the person’s or entity’s successors and
assigns; (c) the words “herein,” “hereof” and “hereunder” and words of similar
import, shall be construed to refer to this Master Agreement in its entirety and
not to any particular provision of this Master Agreement; and (d) all references
in this Master Agreement to Recitals, Articles, Sections or Exhibits shall be
construed to refer to the recitals, articles, sections and exhibits of this
Master Agreement.

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ARTICLE I - TASK ORDERS

 

1.1            (a) In the event that, from time to time, GSK and RGI agree that
RGI will provide Services with respect to a Study, the Parties shall enter into
a Task Order under this Master Agreement, which shall define the scope and
timelines of RGI’s Services and otherwise set out the additional terms and
conditions applicable to RGI’s Services with respect to the Study. Where the
Study is sponsored by a Third Party that receives support from GSK or GSK’s
Affiliates and upon the written request of GSK (which request shall include
GSK’s authorization allowing RGI to perform the Services for such Third Party
and to use the applicable GSK Confidential Information, Materials, GSK Results,
GSK Equipment or GSK Assay in connection therewith), RGI shall provide the
Services directly to such Third Party sponsor (or its designate) via a
contractual arrangement entered into between such Third Party and RGI.

 

(b) The Parties hereby agree that as of the Effective Date all Statements of
Work (as defined in the Original Agreement) then in effect under the Original
Agreement shall automatically be converted into Task Orders under this Master
Agreement and all activities performed pursuant thereto shall be deemed to be
Services governed by and subject to the provisions of this Master Agreement. A
complete list of such Statements of Work is attached to this Master Agreement as
Exhibit I. For the avoidance of doubt, the Original Agreement’s terms and
conditions shall govern all activities undertaken thereunder up and until the
Effective Date.

 

1.2Each Task Order will incorporate by reference the terms of this Master
Agreement, but each Task Order shall be a unique agreement and shall stand alone
with respect to any other Task Order. A Task Order form is attached as Exhibit A
to this Master Agreement.

 

1.3GSK and RGI intend that their Affiliates may also execute Task Orders. Unless
the context requires otherwise, references to “GSK” or “RGI” in this Master
Agreement (and the related rights and obligations) as incorporated into such a
Task Order shall apply to the GSK Affiliate or RGI Affiliate that is a Party to
the Task Order.

 

 

 

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1.4Any Services shall be carried out by RGI upon the terms and conditions of
business set forth in this Master Agreement and under specific terms and
conditions set forth in each Task Order (hereinafter collectively referred to as
(the “Terms and Conditions”). These Terms and Conditions shall override and
exclude any other terms and conditions set forth (1) in any purchase order or
other order issued by GSK to require the performance of the Services by RGI or
(2) in any offer or other document issued by RGI with respect to the performance
of any Services, which terms and conditions could conflict in any way with the
Terms and Conditions. In addition, if any provisions of a Task Order are in
direct conflict with this Master Agreement so that the provisions of both cannot
be given effect, the terms of the Task Order shall govern the specific issue.

 

 

ARTICLE II – SERVICES

 

2.1RGI agrees to perform the Services, supplying any deliverables in accordance
with the timetable set out and turn-around time as specified in the respective
Task Order.

 

2.2Subject to the specific terms of the Task Order, the Services to be performed
by RGI shall generally consist of:

 

(a) Operational Management Services including:

 

i. Project management services, which are assured by a dedicated project
management team appointed by RGI. This project management team ensures the good
conduct of the Study in accordance with the requirements specified in the Task
Order and the mutually agreed Analytical Plan, including the specifications on
timelines. Project management also includes answering relevant questions related
to the Services at no charge to GSK or the Investigator. RGI shall also provide
sufficient project management resources to communicate with the Investigator in
a language understandable for Study site personnel, including the Investigator;

 

ii. Transportation system services, which may include maintaining a shipping
system, in compliance with all required regulatory bodies, by which Samples
collection supplies can be delivered to the Study sites, Samples can be shipped
from the Study sites, and reports can be delivered to recipients designated by
GSK; or

 

 

 

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iii. Samples tracking services which may include (a) shipment tracking of
Samples from pick-up from any location to any delivery location designated in
writing by GSK as set forth in the Task Order or (b) Samples tracking during the
handling, analysis and storage of these Samples by RGI or any Third Party, as
set forth in the Task Order.

 

(b) Laboratory Services such as:

i. Sample analysis for follow-up of Study subject, including but not limited to,
safety testing, screening for enrolment and disease progression evaluation;

 

ii. Sample analysis of the humoral or cellular immune response following
administration of a vaccine in the framework of a Study, including but not
limited to, immunochemistry, cell mediated immunology, functional immunology and
molecular biology typing of exogenous agents;

 

iii. assay development, qualification and validation; or

 

iv. Specific services in the framework of companion diagnostic assay
development, including but not limited to sample preparation and bridiging
testing.

 

(c) Samples Management Services such as the collection, shipment, dispatching,
receipt, preparation, tracking, storage, disposal or destruction of the Samples
obtained within the framework of a Study and provided to RGI or its Affiliates
pursuant to this Master Agreement or any Task Order.

 

(d) In performing Operational Management Services and Laboratory Services, RGI
shall also carry out:

 

i. Samples handling services, which shall include :

 

a. accepting transfer from GSK or Study sites of Samples with the understanding
that the Samples may have hazardous properties;

 

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b. handling the Samples in compliance with all Applicable Laws and regulations;
and

 

c. accepting sole responsibility for the handling, storage and disposal of all
waste products generated in the course of the performance of the Services by RGI
in compliance with all Applicable Laws, including laws governing disposal of
hazardous substances, and in accordance with the provisions set forth in Section
4.1 of this Master Agreement;

 

ii. Samples storage services in accordance with GSK specifications, as described
in Section 4.1 of this Master Agreement.

 

iii. Data services, including providing assay results and other data in
accordance with the data format and transmission as per GSK written
specifications set forth in the relevant Task Order.

 

2.3RGI agrees to perform Services in full compliance with:

 

(a) the Terms and Conditions of this Master Agreement;

 

(b) the terms, specifications and timelines established in the Task Order;

 

(c) the Study Protocol (if applicable), and any amendments to the Study
Protocol;

 

(d) RGI’s standard operating Procedures or GSK standard operating Procedures as
set forth in the relevant Task Order. A copy of the Procedures that have been
developed and validated by RGI shall be provided by RGI upon GSK’s request for
GSK’s (and its Affiliates’, designates, agents and subcontractors) use only in
connection with their use and exploitation of the GSK Results and GSK Works and
the GSK Gene Expression Values.

 

(e) Any analytical methods or other specific requirements laid down by GSK for
the Services, such as but not limited to, the corrective actions required by GSK
after the audit of RGI’s Facility in accordance with Section 8 of the Master
Agreement;

 

 

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(f) FDA regulations for clinical testing activities, being 21 CFR Part 11
(Electronic Records; Electronic Signatures), 21 CFR Part 58 (Good Laboratory
Practice for Nonclinical Laboratory Studies regulations), and 21 CFR Part 310,
312, 314 (Good Clinical Practices);

 

(g) To the extent required, CLIA, Clinical Laboratory Improvement Amendments, as
determined by the Centers of Medicare and Medicaid Services (CMS), regulating
clinical testing on humans in the USA;

 

(h) To the extent required, relevant EU Directives (Directive 2001/20/EC and
Directive 2005/28/EC (Good Clinical Practices), Directive 98/79/EC (IVD)),
applicable guidance and the Declaration of Helsinki as amended from time to
time;

 

(i) ICH Good Clinical Laboratory Practices guidelines Q2 and E6, or similar
guidelines which may apply in the country of performance of the Services or any
local standards which will be followed for regulatory purposes, including
without limitation, standards as required for Study data to be submitted to the
regulatory authority of the country in which the Study is conducted;

 

(j) all Applicable Laws, including applicable health and safety laws and
regulations and all Applicable Laws with respect to the handling and disposal of
infectious or hazardous waste;

 

(k) all applicable medical privacy laws and regulations; and

 

(l) any requirements specific to certain Services in the country of performance
of the Services, or to local standards which must be followed for regulatory
purposes, as specified in the Task Order; and

 

(k) Should applicable government regulatory requirements be changed during the
term of this Master 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 Task Order for a Study, RGI shall
submit to GSK a revised technical and cost proposal for GSK acceptance prior to
making any changes in the Task Order for such Study and

 

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(l) In the event of a conflict in government regulations, GSK shall, upon
request by RGI, designate which regulations it wishes RGI to follow in its
performance of a particular Study provided that RGI will be lawfully permitted
to comply only with the GSK designated regulations.

 

2.4RGI shall use its best commercial efforts to perform the Services in
accordance with the Key Performance Indicators set forth in Exhibit C of the
Master Agreement. GSK reserves the right to discuss, on a case-by-case basis,
the actions to be undertaken subsequent to a material failure by RGI to comply
with the agreed Key Performance Indicators in order to (re)assure the quality of
the Results generated in the performance of the Services. In the event, that
despite best efforts, the Parties fail to resolve such disagreement regarding
RGI’s non-compliance with Key Performance Indicators, GSK shall have the right
to terminate the affected Task Order(s) in accordance with the terms set forth
in Section 12.5 of this Master Agreement.

 

2.5RGI will assign a RGI Monitor as a Study Protocol administrator to coordinate
and monitor the Services rendered as set forth in the Task Order. A designated
GSK Representative will be responsible to overview the overall performance of
the Services. Both the RGI Monitor and the GSK Representative shall be
identified in each Task Order.

 

2.6RGI agrees that timely completion of each timeline for the performance of the
Services as set forth in the Task Order is an essential and critical business
requirement, and that time is of the essence regarding RGI’s performance under a
Task Order. RGI agrees that GSK must provide written acceptance of RGI’s
completion of each timeline for the performance of the Services within the
mutually-accepted timeframe set forth in each Task Order before that portion of
the Services may be considered completed under a Task Order. RGI shall inform
GSK in writing of the completion of the Services within three (3) working days
of the completion’s date. RGI shall notify GSK promptly (but in no event longer
than five (5) working days) upon becoming aware of any event or circumstance
which will, or which could reasonably be expected to cause a delay in the
completion of any Service. To avoid any issues with timelines, RGI will not
begin any activity set forth in a draft Task Order until a fully executed Task
Order has been negotiated and executed.

 

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2.7In the event of any actual or reasonably anticipated failure by RGI to
complete the Services in compliance with the GSK requirements as defined in the
Master Agreement or in any Task Order (including, without limitation, standards
for timely performance) (hereinafter collectively referred to as the
“Standards”) for any reason other than GSK’s acts or omissions or an event
described in Section 23.3 (Force majeure) of this Master Agreement that is not
capable of being cured by RGI within thirty (30) days of such date of completion
of Services, RGI shall immediately notify GSK in writing of such actual or
reasonably anticipated failure and GSK may at its sole discretion:

 

(a) require RGI to take reasonable corrective actions (including, if necessary,
immediately assigning such additional resources as may be required) so as to
complete Services so that Standards are met, at no additional cost to GSK;

 

(b) require RGI to re-perform Services so that Standards are met, at no
additional cost to GSK;

 

(c) perform affected Services itself or retain a Third Party to perform the
affected Services, and if in doing so GSK incurs internal and external costs RGI
agrees that GSK may deduct such costs from future payments due to RGI or be
reimbursed by RGI for such costs within sixty (60) days of GSK’s notification
related thereto; provided such deduction or reimbursement shall not be in excess
of the payment which would have been due to RGI under the relevant Task Order
had RGI completed the affected Services in compliance with the Standards.

 

Action or inaction by GSK as permitted under this Section 2.7 shall not limit
any other right that GSK may have under this Master Agreement or an applicable
Task Order, nor limit any right that GSK may have with respect to a breach by
RGI of this Master Agreement or the applicable Task Order.

 

2.8Except as GSK is specifically permitted by Section 2.7, any necessary
modifications to a Task Order, whether following a Study Protocol amendment,
procedure modification or not, shall be made only by a written Change Order
executed by both Parties. A Change Order form is attached as Exhibit B to this
Master Agreement. Each Party shall respond promptly to a request for a Change
Order made by the other Party. As part of a Change Order request or response,
RGI will propose, in writing, any necessary modifications to the milestone
dates, target dates and other timelines, fees, or costs described in the Task
Order.

 

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2.9RGI shall not subcontract any Services to another entity, including to RGI’s
Affiliates, without GSK's prior written approval. RGI agrees that any approved
subcontractor will be required to execute a written agreement which extends all
relevant obligations of RGI under this Master Agreement and the applicable Task
Order to the subcontractor. RGI shall also remain completely responsible for
ensuring the satisfactory performance of all subcontracted Services by
subcontractors selected by RGI and approved by GSK.

 

 

2.10RGI shall prepare reports (including any status interim reports) and submit
the same to GSK within the time period mutually agreed upon by the Parties in
the Task Order.

 

(a) All reports shall be transferred confidentially via a secure forum which
shall be compatible with GSK’s data transfer requirements. This secure system
can be installed by RGI or provided by GSK to RGI as mutually agreed upon by the
Parties in the Task Order.

 

(b) For the avoidance of doubt, the Parties agree that any secure forum provided
by GSK to RGI to transfer reports shall only be used by RGI to communicate with
GSK on the Services described in the Task Order, such as for providing a
validation report or reporting Study results.

 

(c) RGI shall make its staff reasonably available to GSK to respond to any
relevant questions relating to the provided reports, and shall provide GSK with
an updated report including any relevant additional information as may be
required by GSK without additional costs to GSK, unless the additional
information requires additional Services not included in the Task Order. GSK
shall notify RGI upon reasonable delay of its satisfaction with such reports and
updated reports.

 

 

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(d) In addition to any specific reporting requirements under a Task Order, RGI
agrees that all status interim reports provided by RGI shall refer to specific
milestones and completed tasks pursuant to the specifications set forth in the
Task Order, and any actual or anticipated delays with respect to the timelines
provided in the Task Order. To further improve the communication and project
management under a Task Order, upon RGI’s completion of an action, response, or
milestone, RGI will specify in its reports any required response or action from
GSK.

 

2.11RGI agrees that it will not, without the prior written consent of GSK, which
consent shall not be unreasonably withheld or delayed, change any Procedure,
assay methodology, reagent, or reference range for the duration of the
applicable Study (as defined) under the applicable Task Order (a “Change”). RGI
shall give GSK prior written notice of any such Change at least one (1) month
before its implementation and shall promptly make available to GSK upon GSK’s
written request all available comparison data without additional charge so that
GSK can assess the impact of such Change on the Services performed or on the
Study.

 

2.12RGI shall at its own expense:

 

(a) provide and maintain RGI Facility of sufficient size and quality, with an
appropriate security level and all labour, plant, machinery, equipment to enable
RGI to fulfill all its obligations under this Master Agreement and the Task
Order(s), regardless of whether any of such equipment aforesaid have been
acquired from GSK; and

 

(b) maintain all RGI premises including RGI’s Facility, RGI’s equipment and
RGI’s materials in reasonably good working condition and in compliance with all
relevant regulatory requirements and Applicable Laws; and

 

(c) provide adequate insurance for all such RGI premises including RGI Facility,
machinery and equipment as necessary to address the risks inherent to RGI’s
activities under the Master Agreement and any Task Order(s).

 

 

 

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ARTICLE III - RGI STAFF AND RESOURCES

 

3.1RGI agrees that only appropriately qualified and experienced staff of RGI
will perform the Services under a Task Order.

 

3.2If GSK requests in writing the replacement of any RGI staff due to reasonable
and documented concerns regarding the performance of the Services, RGI will
immediately remove that person from the performance of the Services or project
and assign an appropriately qualified and experienced replacement, at no
additional cost to GSKand the Parties shall in good faith discuss and adjust in
writing the timeline of any Services or project affected by such change of
personnel, provided RGI shall take reasonable steps to mitigate any negative
effects to such timeline.

 

3.3RGI may replace RGI staff providing Services under this Master Agreement or a
specific Task Order; provided that:

 

(a) GSK shall be given prompt written notice (at least three (3) working days,
to the extent possible) of the staff RGI proposes to replace, and information
regarding RGI’s proposed replacement staff; and

 

(b) replacement of the staff shall be at no additional cost to GSK and shall not
adversely affect the timely and quality performance of the Services,

 

(c) if RGI notifies GSK that such staffing changes have not been anncounced
within RGI, GSK shall maintain such information in confidence until it has been
announced within RGI.

 

ARTICLE IV - SAMPLES – MATERIALS – EQUIPMENT

 

4.1Any Samples, Materials or GSK Equipment supplied by GSK to RGI for the
purpose of carrying out Services under a Task Order shall be listed in the
Schedule E of the relevant Task Order. These Samples, Materials and GSK
Equipment will be Delivered Duty Paid (DDP). With regard to the Samples:

 

 

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(a) RGI agrees that any Samples provided by GSK shall not be transferred to any
Third Party without the prior written consent of GSK or unless specified
otherwise in the relevant Task Order.

 

(b) RGI shall be responsible for the storage and disposal of the Samples in
accordance with RGI’s Procedures and written instructions provided by GSK in the
applicable Task Order and all Applicable Laws.

 

(c) Samples shall only be used by RGI for the sole purpose of the performance of
the Services in accordance with the terms set forth in the Task Order(s). For
the avoidance of doubt, no modifications of Samples or use other than the
performance of the Services as provided in the Task Order will be permitted
without GSK’s prior written agreement. The terms set forth in this Section shall
survive termination or expiration of the Master Agreement and any Task Orders.
Within one (1) working day after receipt of Samples, RGI shall record each
Sample provided under this Master Agreement and any Task Order in an appropriate
tracking system (the “Tracking Records”). RGI shall maintain the Tracking
Records to reflect any changes in tracked information and any Samples’ transfer
as well as record complete consumption or disposal of each and every Sample
received under this Master Agreement and any Task Orders. Any Samples and
non-used or remaining Samples provided by or on behalf of GSK to RGI in the
course of this Master Agreement or any Task Orders as well as any Samples
derivatives, aliquots or pools shall be recorded in the Tracking Records and
shall be stored under appropriate conditions in RGI’s premises that are secure
and clean to maintain Samples’ biological integrity.

 

(d) RGI shall be responsible for the storage and disposal of the Samples before,
during and after the Services, in accordance with RGI’s Procedures, written
instructions provided by GSK, as applicable, as well as with the provisions set
forth in Section 6 of this Master Agreement and in the applicable Task Order.
RGI shall provide adequate storage facility for Samples to be maintained under
appropriate conditions as specified in the Schedule A of each Task Order. RGI
agrees to establish a contingency plan that guarantee the quality of the stored
Samples. Sample storage areas must be monitored where controlled conditions are
required to maintain Samples biological integrity.

 

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(e) Except as set forth in Section 23.3 (Force Majeure), upon receipt of any
Samples by RGI, RGI shall be solely responsible for the use, storage and
shipment of those Samples and shall compensate GSK for any lost of, or damages
to, any such Samples that may occur when Samples are under the custody of either
RGI or any RGI’s subcontractors or agents. Where applicable, the related
compensation shall be calculated according to certain criteria that will be set
forth in the relevant Task Order. RGI will handle the Samples in compliance with
all Applicable Laws.

 

(f) RGI shall be solely responsible for any waste material generated by RGI in
connection with the Services, and warrants that all such waste material will be
handled, stored and disposed of by RGI in compliance with all Applicable Laws.

 

(g) RGI agrees that any Samples provided by GSK under this Master Agreement and
any Task Orders:

i. understood to be experimental in nature and may have hazardous properties;

 

ii. shall be used in compliance with all Applicable Laws, rules and regulations;

 

iii. shall not be used in human subjects; and

 

iv. will not be administered to man or to animals and will not be used for any
reason whatsoever to conduct experiments on animals.

 

(h) RGI will notify GSK in writing of any adverse effects experienced by persons
handling Samples. RGI will promptly notify GSK in writing of any assay results
or other information which suggest: (i) a significant risk for humans, (ii)
mutagenicity, (iii) teratogenicity or (iv) carcinogenicity.

 

4.2.Materials and Equipment.

 

(a) RGI shall provide the material and equipment necessary to perform its
obligations relating to the Services at the RGI Facilities. In the event that
the Parties agree that RGI should (i) acquire additional equipment, or (ii)
modify existing equipment or RGI Facility to carry out the Services, or (iii)
that GSK will loan GSK Equipment to RGI to enable RGI to carry out the Services,
such acquisition or modification or loan shall be discussed and agreed to by the
Parties before incurring any expenses related thereto. In the event GSK
transfers GSK Equipment to RGI for the purpose of performing specific Services
under a particular Task Order, any such GSK Equipment provided by GSK shall be
listed in the Schedule E of the relevant Task Order. Unless otherwise stated in
a Task Order, any such GSK Equipment transferred by GSK to RGI under this Master
Agreement or any Task Order(s) shall remain at all times, the exclusive property
of GSK, provided risk of loss as to such equipment remains with RGI while in
RGI’s possession.

 

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(b) RGI agrees that it will only use in collecting, analyzing or otherwise
handling data and performing Services for GSK, reagents, Procedures and
equipment, including but not limited, to computer, hardware or software systems,
which have been qualified or validated for use within the context of relevant
GxP compliance, and are maintained in a suitable state of performance and
calibration. Any exceptions to the aforesaid requirements shall be subject to
the prior written agreement of GSK. RGI agrees at GSK's request to provide such
evidence of validation as GSK reasonably requires.

 

(c) With respect to the GSK Equipment or the Materials provided by GSK to RGI
under the Master Agreement or any Task Order, RGI hereby agrees that:

 

i. RGI staff which will operate the GSK Equipment will make themselves available
for training in using the GSK Equipment;

 

ii. only qualified and duly trained RGI staff shall have the right to operate
the GSK Equipment;

 

iii. the Materials and GSK Equipment will be used only by RGI to carry out the
Services and in accordance with written directions provided by GSK under the
Master Agreement or the relevant Task Order;

 

iv. the Materials and GSK Equipment will be kept in a safe and secure location,
and will be used only by RGI staff designated by RGI as responsible for carrying
out the activities on the GSK Equipment;

 

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v. RGI will take suitable precautions and measures to prevent theft, damage or
loss to the Materials and GSK Equipment;

 

vi. RGI shall at its own expense insure the Materials and GSK Equipment through
“All Risks” coverage at its full reinstatement value; and

 

vii. upon expiration or termination of the Master Agreement or any Task Order
under which GSK has transferred Materials or GSK Equipment to RGI for the
performance of the Services, RGI shall return to GSK any unused Materials and
shall, as agreed upon by the Parties, either (i) return to GSK the GSK Equipment
and all system related training materials and documentation provided to RGI or
(ii) buy the GSK Equipment or part of it at a price to be agreed to by the
Parties at that time, provided however, that the purchase price shall in no
event be lower than the residual value of the purchased GSK Equipment to be
based on the fair market value.

 

(d) Unless otherwise stated in a Task Order, GSK shall be responsible for, and
pay the related costs for, the regular maintenance of the GSK Equipment in
accordance with the contracts for maintenance entered into by GSK and its
suppliers regarding the said GSK Equipment (the “Contract(s) for Maintenance”).
A copy of the Contract(s) for Maintenance (and any subsequent amendments)
pertaining to the GSK Equipment shall be provided by GSK to RGI upon request of
RGI. Notwithstanding the foregoing provision, RGI shall ensure the day-to-day
maintenance of the GSK Equipment according to GSK specifications or the
customary standard of care applicable to the GSK Equipment.

 

(e) To allow due regular maintenance of the GSK Equipment, RGI shall provide
reasonable access to GSK subcontractors/suppliers to RGI premises, including RGI
Facility, upon reasonable notice.

 

(f) Notwithstanding foregoing Section 4.2(d) of this Master Agreement, it is
understood that GSK’s obligations with respect to the maintenance of the GSK
Equipment shall not extend beyond the maintenance obligations set forth in the
related Contract(s) for Maintenance. In particular, GSK shall in no event be
responsible for any breakdown or defect of the GSK Equipment arising out of the
improper use, operation or neglect on the part of RGI or its staff.

 

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ARTICLE V - INFORMATION TO BE PROVIDED BY GSK

 

5.1GSK shall provide such information reasonably necessary to enable RGI to
perform the Services. This may include any of the following:

(a) Information to uniquely identify each Sample to be assayed or information
pertaining to the Materials provided by GSK to RGI to carry out the Services;

 

(b) Information on the content of any reference control Samples supplied by GSK
to RGI to carry out the Services;

 

(c) Detailed analytical methods, or, if these are available in the public
domain, a reference to their publication;

 

(d) Stability storage protocols with respect to the Samples or Materials
provided by GSK to RGI to carry out the Services;

 

(e) Specifications or other quality limits to which Samples to be assayed are
expected to comply with, or, if these are available in the public domain, a
reference to their publication; and

 

(f) Listings of required validation parameters and acceptance criteria for any
assay validations to be carried out by RGI. In the event RGI determines itself
the parameters and the criteria to be used to perform the Services, RGI shall
seek prior approval from GSK for any such parameters and criteria selected by
RGI to carry out such Services.

 

ARTICLE VI - SAMPLES AND DATA RETENTION

 

6.1The Parties agree that upon completion of the Services set forth in a Task
Order, RGI shall retain any unused Samples or remaining Samples as well as any
and all Study Records as required by any and all Applicable Laws and guidelines
for a period of at least fifteen (15) years after the last relevant assay run
within the framework of each related Study (the “Retention Period”). During such
Retention Period, RGI shall, upon the written agreement or request by GSK:

 

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(a)Either return to GSK (reasonable shipping costs being borne by GSK) :

 

i. unused or remaining Samples; or

 

ii. original Assay-Related Data in case the Services have been performed using a
GSK Assay; or

 

iii. original Raw Data and certified copies of other Assay-Related Data, in case
the Services have been performed using an assay other than a GSK Assay; or

 

iv. certified copies of Non Assay-Related Data in case the Services have been
performed using an assay other than a GSK Assay; or

 

v. original documentation pertaining to the GSK Equipment validation and
maintenance as well as reagents provided by GSK: or

 

(b)destroy unused or remaining Samples (related costs being borne by RGI).

 

6.2In any event, upon expiration of the Retention Period, prior to disposing of
any such remaining or unused Samples or Study Records (including the original
Study Records), RGI shall notify GSK in advance, and if GSK so requests, shall
deliver such remaining or unused Samples and Study Records to GSK, at GSK’s
costs, rather than dispose of them.

 

6.3RGI agrees to provide GSK with original Study Records, without additional
charge. RGI further agrees to ensure these Study Records are available, at any
time, for inspection by Health or Regulatory Authorities such as FDA, WHO, EMA,
or by authorized GSK personnel upon reasonable notice.

 

ARTICLE VII - QUALITY ASSURANCE

 

7.1RGI agrees and shall ensure that all results arising from the performance of
the Laboratory Services have been generated in accordance with the terms of this
Master Agreement or the specific terms and specifications set forth in the
relevant Task Order. RGI shall use its best efforts to ensure that those results
are free from any laboratory errors, using RGI‘s or GSK’s Procedures for review
and approval of such results.

 

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7.2RGI shall be responsible for comparing any such results with all
specifications, quality limits or acceptance criteria provided by GSK.

 

7.3In the event RGI’s quality system does not comply with GCLP guidelines or
GSK’s specific quality requirements, an action plan will then be defined and
agreed to by the Parties to remediate potential identified gaps in RGI’s quality
system (the “Action Plan”). As the case may be, such Action Plan shall be
attached to this Master Agreement as Exhibit G which shall form an integral part
of this Master Agreement. The Parties acknowledge that quality is critical in
performing the Services and therefore, the Parties agree that in case RGI fails
to comply in all respects with the Action Plan within the agreed timelines set
forth in the Exhibit G, GSK shall have the right to terminate the Master
Agreement and any and all executed Task Orders immediately upon written notice
RGI subject to the terms set forth in Section 13.2 of this Master Agreement.

 

7.4Services performed by RGI shall be compliant with the GSK or RGI’s standard
operating Procedures, as indicated in the relevant Task Order. This shall be
analyzed in a written document (i.e. Analytical Plan or similar) and provided to
GSK for approval before Services are started.

 

7.5RGI will immediately notify GSK of any Critical deviation by sending a
completed deviation document, which includes at a minimum the root cause
analysis justifying and explaining the Critical deviation and the suggested
action(s) to be taken to remedy to this deviation.

 

7.6Assay, equipment and computer system validation, assay transfer and assay
control used by RGI to carry out the Services shall comply with GxP and other
applicable regulations. RGI shall have procedures in place with respect to any
Critical equipment used to carry out the Services which describes the use,
maintenance, cleaning, testing, calibration of this Critical equipment and what
to do in case of failure. All equipment and each analytical method used in the
analysis of Study Materials must be appropriately documented, validated,
controlled and approved. Records demonstrating the validity and suitability of
such equipment and assays within the RGI Facility must be retained.

 

 

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7.7Critical changes to an assay used to perform the Services shall be controlled
and validated in agreement with GSK before its implementation, and shall result
in the issue of a further version of the assay description. Analytical
platforms/assays shall not be changed or modified during the course of the
performance of the Services, without prior consultation and agreement with GSK.
Such changes must be controlled, documented and appropriately authorized and may
result in the need for further assay validation.

 

7.8For the avoidance of doubt the Parties agree that all GSK Assay-Related Data
shall be the sole property of GSK. RGI further undertakes that all GSK Assay
Related Data shall be recorded and kept to comply with the foregoing provisions
into note books or files, retrievable for GSK and not accessible to any other
person than RGI.

 

ARTICLE VIII - AUDITS AND INSPECTIONS

 

8.1GSK or its authorized representatives may, in its sole discretion, conduct
on-site compliance audits of RGI to verify areas of RGI’s premises, including
RGI Facility or RGI’s equipment, Materials and GSK Equipment or RGI’s Procedures
and data connected with the Services as well as Study Records, or any
laboratories or agencies subcontracted by RGI. RGI shall be responsible for
gaining the agreement of the subcontracted sites that GSK shall conduct a
compliance audit. RGI shall receive reasonable notice of any such audit, and RGI
relevant personnel shall attend any audit, deemed appropriate by GSK, at no
additional cost to GSK. For the avoidance of doubt, RGI shall not charge any
additional costs to GSK with respect to the conduct of any such
on-site-compliance audit.

 

8.2RGI agrees to provide GSK with original Study Records, without additional
charge except for reasonable copying and shipping charges, upon reasonable
notice provided such notice is received during the Retention Period subject to
Section 6.2. RGI further agrees to ensure these Study Records are available, at
any time, for inspection by government or regulatory authorities such as FDA,
WHO, EMEA, or for audit by authorized GSK personnel upon reasonable notice
provided that such notice is received during the Retention Period subject to
Section 6.2.

 

 

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8.3RGI will permit representatives of governmental or regulatory authorities to
inspect areas of RGI’s premises, including RGI Facility or RGI’s equipment,
Materials and GSK Equipment or RGI’s Procedures connected with the Services. To
the extent possible, RGI shall receive reasonable written notice of any such
inspection, and GSK personnel may attend any inspection as it deems appropriate.
RGI agrees that RGI’s relevant personnel shall attend any such inspection at no
additional cost to GSK. For the avoidance of doubt, RGI shall not charge any
additional costs to GSK in connection with any inspection performed by any such
governmental or regulatory authorities.

 

8.4In the event that any governmental or regulatory authorities gives notice to
RGI of its intention to conduct an inspection at a site(s) at which a Service is
being performed or take any other regulatory action with respect to Services
provided to GSK, then RGI will, upon receipt of such notice, promptly give GSK
notice thereof, and GSK shall have the right to be present at any such
inspection or regulatory action. In the event that such an inspection or
regulatory action is performed without notice, RGI shall notify GSK as soon as
practicably possible thereafter. RGI will provide GSK with copies of any
documentation issued by the governmental/regulatory authority and its proposed
response thereto, which response will be subject to approval by GSK prior to
issuance, the approval of GSK not to be unreasonably withheld.

 

8.5In the event that the audit carried out by GSK or its authorized
representatives or the inspection conducted by governmental or regulatory
authorities or their respective nominated representatives reveals evidence of
poor management, failure to comply with the terms of this Master Agreement or of
a Task Order, which cause Critical alerts or alert findings, provided any such
alerts or failure or default have not been resolved, or corrective actions
requested by GSK have not been implemented, by RGI within thirty (30) days after
GSK’s notification thereof, then GSK shall be entitled to terminate the Master
Agreement and related Task Order for breach by giving notice of such termination
to take effect immediately.

 

8.6If RGI becomes aware of any material issues related to the performance of a
Study Investigator, including without limitation, (i) any governmental or
regulatory authority notification to a Study Investigator that it will inspect
the Study Investigator’s records, facilities, equipment, or Procedures, or (ii)
any action taken by any governmental or regulatory authorities with respect to a
Study, RGI shall notify GSK as soon as is practicable (to the extent possible,
within two (2) business days prior to the occurrence of the inspection or
action), and will cooperate with GSK regarding responsive action.

 

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8.7During the term of the Master Agreement, RGI will promptly notify GSK in
writing of:

(i) any material action taken by any governmental or regulatory authority with
respect to RGI, and provide GSK with copies of any reports issued by such
governmental or regulatory authorities; and

 

(ii) any action taken by any governmental or regulatory authority with respect
to RGI involving a GSK Study or any Services, and provide GSK with copies of any
reports issued by such governmental or regulatory authorities.

 

 

ARTICLE IX - REGULATORY

 

9.1During the term of this Master Agreement and any Task Order and any renewals
thereof, RGI shall secure and maintain any and all licenses required by
Applicable Laws and regulations which are or may become applicable to RGI in
connection with the Services to be performed by RGI under the Master Agreement
or any Task Order, including without limitation, compliance with all applicable
licensing requirements, if any, relating to the collection of Samples or removal
and disposal of applicable chemical, biological or medical waste.

 

 

ARTICLE X - CHANGES IN PREMISES, EQUIPMENT, INFORMATION OR PROCEDURES

 

10.1RGI shall not perform Services in any other facility or Facility without
first receiving the prior written approval of GSK with respect to the use of
such new facility or Facility.

 

10.1RGI will notify GSK within five (5) working days of any Critical changes
occurring in the premises, including RGI Facility, equipment, reagents used to
carry out the Services, RGI or GSK’s Procedures used for the performance of the
Services, and, where practicable, will seek GSK’s written agreement prior to the
change being introduced.

 

 

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10.2GSK will ensure that RGI is informed within five (5) working days of any
changes to any of the information supplied to RGI regarding the Services, as
stated in the respective Task Order. In the event, RGI incurs additional costs
in implementing these changes, the additional costs shall be discussed in good
faith by the Parties and if mutually agreed to by the Parties, shall be
reimbursed to RGI by GSK.

 

10.3Without prejudice to Section 2.1, changes to agreed timelines by either RGI
or GSK must be notified in accordance with Section 2.7 and accepted in advance
and revised timelines agreed by the Parties, acting in good faith.

 

ARTICLE XI – COMPENSATION

 

11.1 (a) In consideration for its performance of Services under a Task Order,
GSK shall pay RGI in accordance with the terms of the relevant Task Order,
including any milestone and payment schedule set forth in the Task Order, and in
accordance, if applicable, with any discounts, rebates, or other pricing terms
as set forth in Exhibit D attached to and incorporated by reference as part of
this Master Agreement and according to the budget set forth in Schedule B
attached to the relevant Task Order (hereinafter referred to as the “Budget”).
GSK shall have no obligation to make payments for any portion of the Services
that is not completed pursuant to the terms and conditions of the Master
Agreement or in accordance with the specifications set forth in the relevant
Task Order or for Services that are not covered by a Task Order or a written
amendment executed by both Parties, including a Change Order, or any other cost
to which GSK has not specifically agreed to in writing in advance, including,
without limitation, any cost incurred by RGI to satisfactorily complete the
Services which exceeds the amount GSK has agreed to pay for the performance of
the Services under the Task Order concerned.

 

(b) Any significant change to the scope of the Services shall result in an
adjustment to the related Budget by amendment and shall be subject to a Change
Order. The fixed costs or reimbursable costs payable to RGI as indicated above
may increase or decrease, consistent with the increase or decrease in the scope
of Services or the Budget specifications noted in the Task Order or the related
Budget.

 

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(c) No changes to the scope of the Services can be implemented by RGI without
prior written approval from GSK Representative. It will be RGI's responsibility
to proactively identify additional services outside the original scope of the
Services that need to be performed in furtherance of the implementation of such
change. RGI shall submit to the GSK Representative the costs associated with the
performance of such additional activities for initiating Change Order to the
relevant Task Order and this prior to implementation.

 

11.2GSK’s payment obligation is also conditioned upon RGI submitting proper
invoices. RGI shall submit invoices as provided for in the milestones and
payments schedule and with any information requirements contained in the
applicable Task Order, within sixty (60) days of completion of the relevant
portion of the Services or achievement of relevant milestone, to the attention
of:

 

Accounting Department

GlaxoSmithKline Biologicals SA

Rue de l’Institut, 89

1330 Rixensart

Belgium

 

The following information must be indicated on each invoice:

 

(a) Invoice number;

(b) Study Protocol number, e-track number (as appropriate);

(c) GSK Affiliate for which Services are provided (as appropriate);

(d) Invoice date;

(e) Effective Date of this Master Agreement and the applicable Task Order;

(f) GSK’s internal Contract Reference Number, i.e. PO number (to be provided by
GSK);

(g) Dates on which Services were provided;

(h) Total amount of fees for the Services performed during the invoiced period;

(i) Payee name and address (for Services provided within U.S., name and address
must match the W-9 form submitted by RGI); and

(j) Tax ID/VAT number (for Services provided within U.S., tax ID number must
match the W-9 form submitted by RGI).

 

 

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Failure to provide the required information will delay approval and the invoice
may be returned for revisions. All invoices shall become payable at the end of
the month following sixty (60) days from the receipt by GSK.

 

11.3Any discrepancy between the amount invoiced to GSK and the Services actually
performed by RGI during the invoiced period will be notified by GSK to RGI.
Regularization of the incorrect invoice by RGI shall only be made via a credit
note referring to the initial invoice, and such corrections shall not be deemed
to be a delay in payment.

 

11.4All sums payable by GSK in respect of the Services are exclusive of VAT and
any other similar duties or taxes. Such sums shall however include all handling,
packing, delivery and customs charges unless agreed otherwise in writing in the
Task Order.

 

ARTICLE XII – TERM AND TERMINATION

 

12.1This Master Agreement shall take effect on the Effective Date and shall
continue until the Expiration Date unless earlier terminated as provided below.
Each Task Order shall take effect as of the effective date designated in the
Task Order. Termination of this Master Agreement or of any Task Order shall not
affect any other Task Order; each Task Order shall continue in full force and
effect unless specifically terminated in accordance with the terms of this
Master Agreement or the terms of that Task Order. Termination of this Master
Agreement shall not (unless otherwise agreed in writing between the Parties)
terminate any Task Order which shall continue for the term specified in the Task
Order (and the Parties shall continue to perform their obligations thereunder)
unless terminated earlier in accordance with this Master Agreement. The Master
Agreement shall continue to apply in relation to any surviving Task Order for
the duration of that Task Order, notwithstanding its termination.

 

12.2GSK may terminate this Master Agreement, without cause, upon providing
ninety (90) days written notice to RGI. RGI may terminate this Master Agreement,
without cause, upon providing one year’s prior written notice to GSK.

 

12.3Either Party may terminate this Master Agreement or any Task Order
immediately upon written notice if the other Party becomes insolvent, or if
proceedings are instituted against the other Party for reorganization or other
relief under any bankruptcy law, or if any substantial part of the other Party’s
assets come under the jurisdiction of a receiver or trustee in an insolvency
proceeding authorized by law. All rights and licenses granted under or pursuant
to this Agreement by RGI to GSK are, and shall otherwise be deemed to be, for
purposes of Article 365(n) of the U.S. Bankruptcy Code, licenses of rights to
“intellectual property” as defined under Article 101(52) of the U.S. Bankruptcy
Code. The Parties agree that each Party, as a licensee of such intellectual
property rights under this Agreement, shall retain and may fully exercise all of
its rights and elections under the U.S. Bankruptcy Code.

 

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12.4GSK may terminate this Master Agreement or any Task Order immediately upon
written notice to RGI if there is a change in control of RGI by the acquisition
by any person or entity, directly or indirectly, of more than fifty percent
(50%) of the total voting capital stock of RGI (or such lesser amount by whuch
the acquiring party gains control over RGI), or by any sale, lease, exchange or
other disposition by RGI of all or substantially all of its assets.

 

12.5GSK may terminate this Master Agreement or a Task Order immediately upon
written notice to RGI, if RGI fails to remedy a material breach of this Master
Agreement within sixty (60) days after written notice by GSK to RGI of the
breach.

 

12.6GSK may terminate any Task Order, in whole or in part, without cause, upon
providing written notice to RGI.

 

12.7RGI may terminate this Master Agreement or any Task Order immediately upon
written notice to GSK, if GSK fails to remedy a material breach of this Master
Agreement or the relevant Task Order within sixty (60) days after written notice
by RGI to GSK of the breach.

 

 

ARTICLE XIII - EFFECT OF TERMINATION OR EXPIRATION

 

13.1Upon notice of termination of a Task Order by or to RGI, RGI shall use
commercially reasonable efforts to conclude or transfer any uncompleted Service,
as directed by GSK, as expeditiously as possible. RGI shall not undertake
further work, incur additional expenses, or enter into further commitments with
regard to any Services, except as mutually agreed upon in writing by the
Parties.

 

 

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13.2Upon the effective date of termination of a Task Order, RGI shall invoice
GSK for payments due for Services already preformed prior to the effective date
of such termination and, if termination was by GSK without cause under Section
12.6, for reimbursement for all expenses incurred in accordance with the Task
Order prior to such termination date, provided in each instance GSK shall not be
obligated to remit payment to RGI for any Services that is the subject of an RGI
breach. This invoice and any payment obligation of GSK are subject to Section 11
of this Master Agreement. If, upon the effective date of termination, GSK has
advanced funds which are unearned by RGI, RGI shall repay such funds to GSK
within sixty (60) days after the effective date of termination.

 

13.3Within thirty (30) days or as soon as practicably possible thereafter, or
such other period of time mutually agreed to in writing by the Parties, after
the effective date of termination of this Master Agreement or a Task Order, RGI
shall deliver to GSK all materials, data, and information pertaining either to
the Study or to the Services which are GSK’s property as defined in Article IV
of this Master Agreement or the relevant Task Order. RGI agrees that this
obligation is not conditioned upon GSK’s prior payment of amounts due or
agreement to pay any amounts in dispute.

 

13.4Compliance with this Section 13 does not limit or waive either Party’s
potential remedies for a breach of this Master Agreement or a relevant Task
Order. Termination of this Master Agreement or a Task Order shall not release
either Party from any obligation or right which accrued to that Party prior to
the effective date of termination or which later accrues from an act or omission
which occurred prior to the effective date of termination.

 

13.5Upon termination or expiration of this Master Agreement or any Task Order,
the following provision of this Master Agreement shall survive expiration or
termination for the time period specified in such provisions or if no such time
period is specified, indefinitely: “Definitions” (for interpretation purposes),
Articles VI (Samples and Data Retention, XIII (Effect of Termination), XIV
(Confidentiality), XV (Intellectual Property), XIX (Indemnification), XX
(Insurance), XXI (Damages) and XXIII (Miscellaneous), and Sections 1.1(b), 1.2,
1.4, 2.10(b), 2.10(c) (for a one year period after the delivery date of the
applicable report(s), 4.2(a)(last sentence), 4.2(c) through 4.2(f), 8.2, 8.7
(only with regard to actions relating to GSK Studies or Services), 11.2 and 11.4
(for any outstanding payments), 12.1, and 16.6.

 

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13.6In the event of termination of this Agreement by GSK pursuant to Sections
12.3 or 12.4 or 12.5, or by RGI pursuant to Section 12.2, GSK shall receive the
following items (after submitting a request in writing within thirty (30) days
after the effective date of such termination and at no cost to GSK), solely to
the extent reasonably necessary for GSK to continue (or have continued by its
Affiliates or a Third Party the development, commercialization, manufacture and
supply of any diagnostic test developed as part of the Services, and to be able
to perform any services (including laboratory testing services) that were
conducted as part of the Services:

(a) full access and transfer of a copy in electronic form of the data,
information, and materials owned or controlled by RGI regarding the development,
commercialization, manufacturing and supply of the Services to GSK (with RGI
using its commercially reasonable efforts to provide such data, information and
materials to GSK by thirty (30) days after the receipt of such notice); and

 

(b) To the extent permitted by law, the transfer of all Regulatory Approvals (or
applications therefore) held by RGI its Affiliates or permitted sublicensees
related specifically to the Services, if any, (with RGI using its commercially
reasonable efforts to undertake such actions within thirty (30) days after the
receipt of such notice of); and

 

(c) a non-exclusive, royalty-free worldwide license, with the right to
sublicense (to the extent RGI has the right to sublicense), RGI’s rights in its
intellectual property and the RGI Confidential Information to the extent such
intellectual property has been used for, or is necessary for GSK to continue (or
have continued by its Affiliates or a Third Party), the development,
commercialization, manufacture or supply of the Services .

 

(d) RGI’s obligations under this Agreement to manufacture, supply and
commercialize the Services (on commercially reasonable and standard terms to be
negotiated and agreed to by both Parties in writing) shall survive termination
of this Agreement until the date on which GSK (or its Affiliate or a third Party
acting on GSK’s behalf) is able to perform the Services in a manner
substantially equivalent to the Services provided by RGI in all material
respects provided that GSK shall pay RGI for such continued Services pursuant to
the agreed fees.

 

 

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(e) Notwithstanding anything to the contrary set forth in this Master Agreement,
with respect to any license or rights granted to GSK to RGI intellectual
property or RGI Confidential Information pursuant to Sections 13.6(a), 13.6(c),
15.6 or 16.6, GSK shall make reasonable best efforts to ensure that the use of
such RGI intellectual property rights or RGI Confidential Information by any GSK
Affiliate or any Third Party shall be limited to the scope of the license or
other rights granted to GSK hereunder and such RGI intellectual property rights
or RGI Confidential Information is only used as necessary for GSK to continue
the Services or exploit the Services (including obtaining appropriate written
covenants to such effect from any Third Party sublicensees).

 

ARTICLE XIV - CONFIDENTIALITY

 

14.1As of and after the Effective Date, all Confidential Information disclosed,
revealed or otherwise made available by one Party (“Disclosing Party”) to the
other Party (“Receiving Party”) under, or as a result of, this Master Agreement
is furnished to the Receiving Party solely to permit the Receiving Party to
exercise its rights, and perform its obligations, under this Master Agreement.
The Receiving Party shall not use any of the Disclosing Party’s Confidential
Information for any other purpose, and shall not disclose, reveal or otherwise
make any of the Disclosing Party’s Confidential Information available to any
other Person without the prior written authorization of the Disclosing Party.

 

14.2In furtherance of the Receiving Party’s obligations under Section 14.1
hereof, the Receiving Party shall take reasonable steps, and shall implement
reasonable safeguards, to prevent the unauthorized use or disclosure of any of
the Disclosing Party’s Confidential Information. Without limiting the generality
of this Section 14.2, the Receiving Party shall disclose any of the Disclosing
Party’s Confidential Information only to those of its officers, employees,
licensees, sublicensees, consultants, attorneys and financial investors that
have a need to know the Disclosing Party’s Confidential Information, in order
for the Receiving Party to exercise its rights and perform its obligations under
this Agreement, and only if such officers, employees, licensees, sublicensees,
consultants, attorneys and financial investors have executed appropriate
non-disclosure agreements containing substantially similar terms regarding
confidentiality as those set out in this Agreement or are otherwise bound by
obligations of confidentiality effectively prohibiting the unauthorized use or
disclosure of the Disclosing Party’s Confidential Information. The Receiving
Party shall promptly furnish the Disclosing Party with written notice of any
known unauthorized use or disclosure of any of the Disclosing Party’s
Confidential Information by any officer, employee, licensee, sublicensees,
consultants, attorneys or financial advisors of the Receiving Party, and shall
take all actions that the Disclosing Party reasonably requests in order to
prevent any further unauthorized use or disclosure of the Disclosing Party’s
Confidential Information.

 

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14.3The Receiving Party’s obligations under Sections 14.1 and 14.2 hereof shall
not apply to the extent that the Receiving Party can prove by written evidence
that any of the Disclosing Party’s Confidential Information:

 

(a) passed into the public domain, or becomes generally available to the public
through no breach of this Master Agreement or the Original Agreement by the
Receiving Party;

 

(b) was known to the Receiving Party prior to disclosure hereunder by the
Disclosing Party;

 

(c) is disclosed, revealed or otherwise made available to the Receiving Party by
a Third Party that, to the Receiving Party’s knowledge, is under no obligation
relating to the subject item of non-disclosure and/or non-use to the Disclosing
Party; or

 

The Receiving Party may disclose Confidential Information as is required to be
disclosed under Applicable Law, or in connection with any application by the
Receiving Party for any Regulatory Approvals; provided, however, that, subject
to Section 14.6 below, the Receiving Party shall furnish the Disclosing Party
with as much prior written notice of such disclosure requirement as reasonably
practicable, so as to permit the Disclosing Party, in its sole discretion, and
at its sole expense, to take appropriate action, including seeking a protective
order, in order to prevent the Disclosing Party’s Confidential Information from
passing into the public domain or becoming generally available to the public.

 

14.4Subject to Sections 6.1 and 13.6, upon expiration or termination of this
Master Agreement for any reason whatsoever, the Receiving Party shall cease all
use of and return to the Disclosing Party (or destroy, if the Disclosing Party
specifies in writing) all copies of all documents and other materials that
contain or embody any of the Disclosing Party’s Confidential Information (and
irrevocably delete all electronic copies of such documents and materials),
except to the extent that the Receiving Party is required by Applicable Law to
retain such documents and materials, or if the entire document or material does
not contain the Disclosing Party’s Confidential Information, then the document
or material shall be redacted to remove entirely the Disclosing Party’s
Confidential Information. Within thirty (30) days after the date of expiration
or termination of this Agreement, the Receiving Party shall furnish the
Disclosing Party with a certificate, duly executed by an officer of the
Receiving Party, confirming that the Receiving Party has complied with its
obligations under this Section 14.4.

 

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14.5All of the Receiving Party’s obligations under Sections 14.1 and 14.2
hereof, with respect to the protection of the Disclosing Party’s Confidential
Information, shall for a period of ten (10) years survive the expiration or
termination of this Master Agreement for any reason whatsoever.

 

14.6No public announcement concerning the existence of, terms, or subject matter
of this Agreement shall be made, either directly or indirectly, by either Party,
without first obtaining the prior written approval of the other Party and
agreement upon the nature and text of such public announcement which such
agreement and approval shall not be unreasonably withheld. Notwithstanding the
foregoing, if, in the opinion of legal counsel for the Party desiring to make
such public announcement, such disclosure is required under Applicable Law, the
Party required to make such public announcement shall inform the other Party of
the proposed announcement or disclosure in reasonably sufficient time prior to
public release, which shall be not less than ten (10) business days (or such
shorter period as may be required under Applicable Law) prior to release of such
proposed public announcement, and shall provide the other Party with a written
copy thereof in order to allow such other Party to comment upon such public
announcement. The Receiving Party shall reasonably cooperate with Disclosing
Party (at the Disclosing Party’s expense) with respect to all disclosures
regarding this Master Agreement required under Applicable Law, including
requests for confidential treatment of proprietary information of the Disclosing
Party included in any such disclosure. For the avoidance of doubt, RGI hereby
agrees that (after consultation with its legal advisors confirming that no such
disclosure is required) it shall not issue any press release or other public
disclosure of this Master Agreement without GSK’s prior consent provided that
GSK hereby acknowledges RGI may be required to make certain disclosures pursuant
to the Securities Exchange Act of 1934, as amended from time to time, and that
the content of such disclosures is reasonably agreed by the Parties in advance
thereof.

 

 

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14.7Applicable Law. Nothing in this Agreement shall be construed as preventing
or in any way inhibiting either Party from complying with Applicable Law
governing activities and obligations undertaken pursuant to this Master
Agreement, in any manner which it reasonably deems appropriate, including, for
example, by disclosing to Regulatory Authorities confidential or other
information received from the other Party, subject to Sections 14.3 and 14.6.

 

14.8Non-Use of Names. Neither Party (or its Affiliates) shall use, either
directly or indirectly, the logo, name, housemarks or trademarks of the other
Party (or its Affiliates), or any of their officers, employees or board members
in any publicity, marketing advertising or other documents (or other
disclosures) without the prior written consent of the other Party (in its sole
discretion). Each Party will use commercially reasonable efforts to review and
approve any proposed disclosure within ten (10) business days of its receipt
from the other Party of a copy or transcript of the proposed disclosure. If a
Party approves the other Party’s usage of its names, trademarks, etc. in
accordance with this Section 14.8, the other Party shall comply with any usage
guidelines or requirements imposed by the approving Party.

 

14.9Publication. Publication in a journal, paper, magazine or any other such
similar disclosure by RGI describing activities undertaken under this Master
Agreement or mentioning the name of GSK in relation to this Agreement will not
take place without the prior written agreement of GSK. GSK shall have the sole
right to publish any results arising from the Services. RGI will be acknowledged
in all such publications or other public disclosures by co-authorship or
acknowledgment, whichever is appropriate.

 

ARTICLE XV - INTELLECTUAL PROPERTY

 

15.1RGI will disclose promptly to GSK in writing any GSK Results. Subject to
Section 13.6(e) hereof, RGI agrees that GSK Results shall be the sole property
of GSK. Without limiting the foregoing, and without additional consideration,
RGI hereby also assigns to GSK all rights, title, and interest RGI may have in
any GSK Results upon the future creation of such GSK Results. RGI agrees to
obtain written agreements with RGI employees, agents, and subcontractors which
assign, without additional consideration, all rights, title and interests in GSK
Results to GSK or to RGI by which RGI can then assign to GSK.

 

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15.2“GSK Works” shall mean all original works of authorship prepared by or for
or on behalf of GSK in connection with the performance of this Master Agreement
or any Task Order. All GSK Works shall be “works made for hire,” and GSK will
own all GSK Works and all copyrights in GSK Works. For any GSK Works that, under
the copyright laws of the United States, may not be considered “works made for
hire,” RGI agrees to assign to GSK all rights, title, and interest in such GSK
Works, without payment of any additional compensation to RGI. At GSK’s request
and expense, RGI shall also reasonably assist GSK in obtaining or perfecting
GSK’s rights, title, and interest in such GSK Works.

 

15.3If GSK requests, RGI will execute and will cause its employees, agents, or
subcontractors to execute any instruments or testify as GSK deems necessary for
GSK to obtain patents or otherwise to protect GSK's interest in a GSK Result.
GSK will reasonably compensate RGI for the time devoted to such activities and
will reimburse RGI for reasonable and necessary expenses incurred.

 

15.4GSK acknowledges RGI’s ownership of, (i) the Testing Services, including
RGI’s proprietary process for extracting nucleic acid and 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 “RGI Intellectual Property”),
and (iii) any algorithms or scales created and used by RGI in producing or
developing the gene expression values (“algorithms”). If GSK directly challenges
the validity of any claim within an issued patent within the RGI Intellectual
Property licensed under section 15.6 by filing in any country a lawsuit,
interference action or the like, then the license in that country to the patent
under section 15.6 of this Agreement shall terminate. With respect to RGI
Intellectual Property expressly identified herein, if GSK learns of an
infringement, unauthorized use, misappropriation or threatened infringement by a
Third Party of such RGI Intellectual Property, GSK shall promptly notify RGI. It
is understood that neither GSK nor any Affiliate shall acquire or claim title to
the Testing Services, algorithms, research and development, or the RGI
Intellectual Property by virtue of this Master Agreement, subject to the
provisions of Section 13.6 and 16.6. However, any improvements or modifications
thereto which are developed during the course of RGI’s performance of the
Services under the Master Agreement, will be jointly owned by the Parties and
GSK may, at its discretion and expense, seek patent protection for such jointly
owned inventions. In case GSK does not wish to seek such patent protection, it
shall inform RGI thereof and RGI may seek patent protection at its own expense.

 

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15.5For 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 Master Agreement shall
be the sole property of GSK . All such designs, developments, ideas,
discoveries, inventions and information shall be part of the GSK Confidential
Information. 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, and to GSK bearing all necessary costs
and expenses in relation thereto.

 

15.6RGI hereby grants to GSK a non-exclusive, fully paid up, irrevocable,
worldwide license with the right to sublicense to intellectual property owned by
RGI solely as is necessary for GSK to exercise its rights under this Agreement,
including to use the gene expression values owned by GSK according to this
Master Agreement.

 

15.7RGI shall be entitled to utilize the gene expression values (although GSK
retains ownership of the gene expression values) only for the purposes of this
Master 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 Master
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’s bearing all necessary costs and expenses in relation thereto.

 

 

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15.8The 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.

 

15.9Each Party acknowledges that the other Party owns certain inventions,
processes, know-how, trade secrets, improvements and other intellectual property
which has 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.

 

15.10For the avoidance of doubt, RGI hereby acknowledges and agrees that the
probes and primers for the [***] antigens that were subject to or arising from
services being performed under the Original Agreement shall be solely owned by
GSK. Without limiting the foregoing and without additional consideration, RGI
hereby also assigns to GSK all rights, title, and interest RGI may have in the
probes and primers developed by RGI exclusively on behalf of GSK during the term
of the Original Agreement, including probes and primers for the [***] antigens.
RGI agrees to obtain written agreements with RGI employees, agents, and
subcontractors which assign, without additional consideration, all rights, title
and interests in the probes and primers for the [***] antigens that were subject
to or arising from services being performed under the Original Agreement to GSK
or to RGI by which RGI can then assign to GSK.

 

 

ARTICLE XVI - REPRESENTATIONS, WARRANTIES AND COVENANTS

 

16.1RGI represents and warrants that RGI is not bound by any other agreement
under which there would be a default or a breach or conflict with as a result of
the execution and performance of this Master Agreement or a Task Order.

 

16.2RGI represents and warrants that any computer, hardware, software systems,
and any equipment used by RGI in connection with Services under a Task Order has
been validated by RGI for use as required by Applicable Laws or guidelines. RGI
agrees to provide evidence of such validation as GSK may reasonably require.

 

 

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16.3RGI represents and warrants that procedures which are compatible with the EU
Data Protection Directive (95/46/EC) (the “Directive”) or the Applicable Laws or
regulations of EU Member States, will be employed so that the processing and
transfer (as defined in the Directive) of personal data, relating to any and all
Study data subjects, from an EU Member State to a third country which may not or
does not have data protection legislation at least equivalent to that of the EU,
will not be impeded by any action initiated on the basis of the Directive or
corresponding Member State legislation or regulations. RGI further represents
and warrants that GSK will at all times be recognized and, where appropriate
(for example, informed consents for Study subjects), identified as the Data
Controller within the meaning of the Directive or the applicable Member State
legislation. Without limiting the above RGI agrees that it will not provide to
GSK any names of, or initials of any Study subjects.

 

16.4RGI represents and warrants that RGI and any employees, agents, and
subcontractors in connection with this Master Agreement and any Task Order have
not been debarred under the provisions of the Generic Drug Enforcement Act of
1992, 21 U.S.C. § 335a (a) and (b); disqualified as a clinical testing facility
under the provisions of 21 C.F.R. Part 58, Subpart K; or disqualified as a
clinical Investigator under the provisions of 21 C.F.R. § 312.70. RGI shall
notify GSK of any notice to any of the above of an action with respect to
debarment or disqualification. The notification obligations of this Section
shall survive termination of this Master Agreement and any applicable Task
Order.

 

16.5RGI represents and warrants that RGI will require all employees, agents, and
subcontractors in connection with this Master Agreement and any Task Order to
comply with the provisions of this Master Agreement and the applicable Task
Order.

 

16.6           (a) Upon GSK’s written request, RGI shall in good faith and
without delay, commence and complete the activities outlined in Exhibit H
relating to the bridging of the assays/diagnostic tests used or created as part
of the Services to the Third Party(ies) that is(are) developing and will
manufacture and sell the commercial diagnostic test(s) to be used with GSK
immunotherapies. Additionally, upon GSK’s written request, RGI shall in good
faith and without delay, commence and complete the activities outlined in
Exhibit H relating to the transfer of the assays/diagnostic tests to a Third
Party of GSK’s choosing. GSK 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. Subject to Section 13.6(e)
hereof, RGI shall grant to GSK (and such Affilitates or Third Party(ies) to
which GSK may disclose or sublicense intellectual property owned by RGI pursuant
to this Master Agreement, a covenant not-to-sue 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 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 H.

 

 

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(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 Task Orders (including to the extent applicable, for the avoidance of
doubt, the RGI agreement with [***]), 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 (or
such Third Party, as GSK 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 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 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 regarding the issues, including providing GSK (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, 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 16.6(c).

 

 

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(d) If after reviewing the aforementioned Third Party agreements (and any
amendments thereto and other relevant materials) GSK maintains its request to
RGI to continue with such bridging or transfer activities and RGI is willing to
proceed with such bridging or transfer activities for materially adverse good
faith reasons, then GSK shall pursuant to Article XIX of this Agreement
indemnify, defend, and hold harmless RGI, its officers, agents and employees
against any and all Third Party claims, demands, suits, judgments, expenses and
costs, solely arising from or relating to any aspect of the bridging or transfer
activities. The indemnification shall not apply to any activities which RGI
conducts outside the scope of the bridging or transfer activities contemplated
by Section 16.6 that are not requested by GSK or its Third Party designee.

 

16.7RGI shall provide GSK with a courtesy copy of its quarterly reports filed
under Section 13 of the Securities Exchange Act of 1934, including financial
information provided in Item 1, Part I on Form 10Q. RGI will provide this report
to GSK on the same day it files with the United States Securities and Exchange
Commission (SEC). In the event RGI cease being publicly listed, then RGI shall
on a quarterly basis provide GSK with copies of its then-current financial
reports that substantially contain the same information that was contained in
the aforementioned quarterly reports. Should GSK reasonably have questions as to
the content of quarterly reports, RGI shall reasonably comply with such requests
and promptly provide GSK with the requested answers.

 

 

ARTICLE XVII - ETHICAL STANDARDS AND HUMAN RIGHTS

 

17.1Unless otherwise required or prohibited by Applicable Laws, RGI warrants, to
the best of its knowledge, that in relation to the supply of Services under the
terms of the Master Agreement and any Task Order:

 

(a) it does 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;

 

 

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(b) it does not use forced labor in any form (prison, indentured, bonded or
otherwise) and its employees are not required to lodge papers or deposits on
starting work;

 

(c) it provides a safe and healthy workplace, presenting no immediate hazards to
its employees. Any housing provided by RGI to its employees is safe for
habitation. RGI provides access to clean water, food, and emergency healthcare
to its employees in the event of accidents or incidents at RGI's workplace;

 

(d) it does not discriminate against any employees on any ground (including
race, religion, disability or gender).

 

(e) it does not engage in or support the use of corporal punishment, mental,
physical, sexual or verbal abuse and does not use cruel or abusive disciplinary
practices in the workplace;

 

(f) it pays each employee at least the minimum wage, or a fair representation of
the prevailing industry wage, (whichever is the higher) and provides each
employee with all legally mandated benefits;

 

(g) it complies with the Applicable Laws on working hours and employment rights
in the countries in which it operates; and

 

(h)it is respectful of its employees right to freedom of association.

 

17.2RGI agrees that it is responsible for controlling its own supply chain and
that it shall reasonably encourage compliance with ethical standards and human
rights by any subsequent supplier of goods and services that are used by RGI
when performing its obligations under this Master Agreement and any Task Order.

 

17.3RGI shall ensure that it has ethical and human rights policies and an
appropriate complaints procedure to deal with any breaches of such policies.

 

17.4GSK reserves the right upon reasonable notice during normal business hours
(unless audit is for cause, in which case no notice shall be necessary) to enter
upon the RGI's premises including RGI Facility to monitor compliance by RGI of
the warranties set out in the Section above and RGI shall, subject to compliance
with Applicable Laws, furnish GSK with any relevant documents reasonably
requested by GSK in relation thereto.

 

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ARTICLE XVIII - ANTI-BRIBERY AND CORRUPTION

 

18.1RGI acknowledges receipt of the ‘Prevention of Corruption – Third Party
Guidelines’, which are attached as Exhibit F attached to this Master Agreement,
and agrees to perform its obligations under the Master Agreement in accordance
with the principles set out therein.

 

18.2RGI shall comply fully at all times with all Applicable Laws, including but
not limited to applicable anti-corruption laws, of the territory in which RGI
conducts business with GSK.

 

18.3RGI agrees that it has not, and covenants that it will not, in connection
with the performance of this Master Agreement or any Task Order, promise,
authorize, ratify or offer to make, or take any act in furtherance of any
payment or transfer of anything of value, directly or indirectly: (i) to any
individual including Government Officials (as defined below); or (ii) to an
intermediary for payment to any individual including Government Officials; or
(iii) to any political Party. It is the intent of the Parties that no payments
or transfers of value shall be made, promised, authorized, ratified or offered
with the purpose or effect of public or commercial bribery, acceptance of or
acquiescence in extortion, kickbacks or other unlawful or improper means of
securing an improper advantage or obtaining or retaining business.

 

For the purpose of this Section “Government Official" means: (i) any officer or
employee of a government or any department, agency or instrument of a
government; (ii) any person acting in an official capacity for or on behalf of a
government or any department, agency, or instrument of a government; (iii) any
officer or employee of a company or business owned in whole or part by a
government; (d) any officer or employee of a public international organization
such as the World Bank or United Nations; (iv) any officer or employee of a
political Party or any person acting in an official capacity on behalf of a
political Party; or (v) any candidate for political office.

 

 

- 46 -

 

 

 

18.4RGI shall not contact, or otherwise meet with any Government Official with
respect to any transactions required under this Master Agreement or any Task
Order, without the prior written approval of GSK and, when requested by GSK,
only in the presence of a GSK designated representative.

 

18.5RGI represents that it has not been convicted of or pleaded guilty to a
criminal offence, including one involving fraud, corruption, or moral turpitude,
that it is not now, to the best of its knowledge, the subject of any government
investigation for such offenses, and that it is not now listed by any government
agency as debarred, suspended, proposed for suspension or debarment, or
otherwise ineligible for government programs.

 

18.6RGI represents and warrants that except as disclosed in writing: (1) it does
not have any interest which directly or indirectly conflicts with its proper and
ethical performance of this Master Agreement and any Task Order(s); and (2) it
shall maintain arms length relations with all Third Parties (including
Government Officials) with which it deals in performance of this Master
Agreement or any Task Order.

 

18.7GSK shall have the right during the term of this Master Agreement to conduct
an investigation and audit of RGI to monitor compliance with the terms of this
Section 18. RGI shall reasonably cooperate with such investigation or audit, the
scope, method, nature and duration of which shall be at the sole reasonable
discretion of GSK.

 

18.8RGI shall ensure that all transactions under the Master Agreement and any
Task Order are properly and accurately recorded in all material respects on its
books and records and each document upon which entries such books and records
are based is complete and accurate in all material respects. RGI must maintain a
system of internal accounting controls reasonably designed to ensure that it
maintains no off-the-books accounts.

 

18.9RGI agrees that GSK may make full disclosure of information relating to a
possible violation of the terms of this Master Agreement at any time and for any
reason to any competent government bodies and its agencies, and to whomsoever
GSK determines in good faith has a legitimate need to know.

 

- 47 -

 

 

 

18.10GSK shall be entitled to terminate this Master Agreement and any Task Order
immediately on written notice to RGI, if RGI fails to perform its obligations in
accordance with this Section 18. RGI shall have no claim against GSK for
compensation for any loss of whatever nature by virtue of the termination of
this Master Agreement or any Task Orders in accordance with this Section 18.

 

 

ARTICLE XIX - INDEMNIFICATION

 

19.1GSK shall indemnify, defend and hold RGI and its officers, directors,
trustees, agents, employees and its Affiliates (individually or collectively
referred to herein as an “RGI Party”) harmless from and against any and all
losses, liabilities, damages, expenses (but excluding indirect, incidental,
special, consequential or punitive losses or damages) or fees (but only
reasonable attorneys fees and expenses and costs of litigation pertaining to
such RGI Claim) paid or payable by RGI or a RGI Party to a Third Party
(collectively, “RGI Losses”) to the extent that such RGI Losses result from or
arise in connection with a claim, suit or other proceeding made or brought by a
Third Party against RGI or a RGI Party (a “RGI Claim”) based on, resulting from,
or arising in connection with:

 

(a) the breach of any material obligation, covenant, agreement, representation
or warranty of GSK or a GSK Party contained in this Master Agreement or any Task
Order; or

 

(b) any material violation of Applicable Laws by GSK, or a GSK Party, in
connection with the performance of GSK’s obligations under this Master Agreement
or any Task Order.

 

provided, however, that GSK shall not be obligated to indemnify, defend or hold
harmless RGI or a RGI Party under this Section from any RGI Claim or for any RGI
Losses to the extent arising out of or attributable to: (A) a material breach by
RGI, or any RGI Party of any obligation, covenant, agreement, representation or
warranty of RGI, or any RGI Party contained in this Master Agreement or any Task
Order, or (B) any material violation of Applicable Laws by RGI, or a RGI Party,
in connection with the performance of RGI’S obligations under this Master
Agreement or any Task Order, (C) any act or omission by RGI or a RGI Party,
which constitutes recklessness, gross negligence, or willful misconduct on the
part of RGI or a RGI Party, or (D) RGI Claims to the extent RGI is responsible
for indemnifying, defending and holding GSK and GSK Parties harmless for such
claims as set forth in Section 19.2.

 

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19.2RGI shall indemnify, defend and hold GSK and their respective Affiliates,
and its and their employees, agents, officers, and directors (individually or
collectively referred to hereinafter as a “GSK Party”) harmless from and against
any and all losses, liabilities, damages, expenses (but excluding indirect,
incidental, special, consequential or punitive losses or damages) or fees (but
only reasonable attorneys fees and expenses and costs of litigation pertaining
to such GSK Claim) paid or payable by GSK or a GSK Party to a Third Party
(collectively, “GSK Losses”) to the extent that such GSK Losses result from or
arise in connection with a claim, suit or other proceeding made or brought by a
Third Party against GSK or a GSK Party (a “GSK Claim”) based on, resulting from,
or arising in connection with:

 

(a) the breach of any material obligation, covenant, agreement, representation
or warranty of RGI or a RGI Party contained in this Master Agreement or any Task
Order; or

 

(b) any material violation of Applicable Laws by RGI, or a RGI Party, in
connection with the performance of RGI’s obligations under this Master Agreement
or any Task Order.

 

provided, however, that RGI shall not be obligated to indemnify, defend or hold
harmless GSK or a GSK Party from any GSK Claim or for any GSK Loss incurred by
GSK or a GSK Party to the extent arising out of, or attributable to, (A) a
material breach by GSK or any GSK Party of any obligation, covenant, agreement,
representation or warranty of GSK or a GSK Party contained in this Master
Agreement or any Task Order; or (B) any material violation of Applicable Law by
GSK, or a GSK Party, in connection with the performance of GSK’s obligations
under this Master Agreement or any Task Order, (C) any act or omission by GSK,
or a GSK Party, which constitutes recklessness, gross negligence, or willful
misconduct on the part of GSK, or a GSK Party, or (D) GSK Claims to the extent
GSK is responsible for indemnifying, defending and holding RGI and RGI Parties
harmless for such claims as set forth in Section 19.1.

 

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19.3Indemnification Procedures.

 

(a) Each indemnified Party shall notify (in English) the indemnifying Party in
writing (and in reasonable detail) of the Claim within ten (10) business days
after receipt by such indemnified Party of notice of the GSK Claim or RGI Claim,
as the case may be, or otherwise becoming aware of the existence or threatened
existence thereof (such GSK Claim or RGI Claim being referred to as a “Claim”).
Failure to give such notice shall not constitute a defense, in whole or in part,
to any claim by an indemnified Party hereunder except to the extent the rights
of the indemnifying Party are materially prejudiced by such failure to give
notice. The indemnifying Party shall notify (in English) the indemnified Party
of its intentions as to defense of the Claim or potential Claim in writing
within ten (10) business days after receipt of notice of the Claim. If the
indemnifying Party assumes the defense of a Claim against an indemnified Party,
an indemnifying Party shall have no obligation or liability as to any Claim for
which settlement or compromise of such Claim or an offer of settlement or
compromise of such Claim is made by an indemnified Party without the prior
written consent of the indemnifying Party, which consent shall not be
unreasonably withheld.

 

(b) The indemnifying Party shall assume exclusive control of the defense and
settlement (including all decisions relating to litigation, defense and appeal)
of any such Claim; provided, however, that the indemnifying Party may not settle
such Claim in any manner that would require payment by the indemnified Party, or
would materially adversely affect the rights granted to the indemnified Party
hereunder, or would materially conflict with the terms of this Master Agreement,
or adversely affect other products, without first obtaining the indemnified
Party’s prior written consent, which consent shall not be unreasonably withheld.

 

(c) The indemnified Party shall reasonably cooperate with the indemnifying Party
in its defense of the Claim at the indemnifying Party’s expense. If the
indemnifying Party assumes defense of the Claim, an indemnified Party may
participate in, but not control, the defense of such Claim using attorneys of
its choice and at its sole cost and expense. If an indemnifying Party does not
agree to assume the defense of the Claim asserted against the indemnified Party,
or if the indemnifying Party assumes the defense of the Claim yet fails to
defend or take other reasonable, timely action, in response to such Claim
asserted against the indemnified Party, the indemnified Party shall have the
right to defend or take other reasonable action to defend its interests in such
proceedings, and shall have the right to litigate, settle or otherwise dispose
of any such Claim; provided, however, that no Party shall have the right to
settle a Claim in a manner that would materially conflict with this Master
Agreement, or would require a payment by the Party, or adversely affect the
Party (its Affiliates) or its products, without the prior written consent of the
Party entitled to control the defense of such Claim.

 

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19.4Neither Party nor its Affiliates, nor any of its or their respective
directors, officers, employees or agents shall have any liability for any
special, incidental or consequential damages, including but not limited to the
loss of opportunity, loss of use, or loss of revenue or profit in connection
with or arising out of this Master Agreement or any Task Order even if such
Party shall have been advised of the possibility of such damages.

 

Article XX – INSURANCE

 

20.1 (a) RGI hereby represents that it has insurance (or is self-insured) for
product liability and general liability, and that it has and will maintain such
coverage for the term of this Master Agreement and for a period of two (2) years
after the expiration of this Master Agreement or the earlier termination
thereof. Such insurance is in an amount which is reasonable and customary in the
global development and services industry for companies of comparable size and
activities. RGI shall provide a written statement of the existence of such
insurance to GSK upon request.

 

(b) GSK hereby represents that it is self-insured for product liability and
general liability, and that it has and will maintain such coverage for the term
of this Master Agreement and for a period of two (2) years after the expiration
of this Master Agreement or the earlier termination thereof. Such self-insurance
is in an amount which is reasonable and customary in the global pharmaceutical
industry for companies of comparable size and activities. GSK shall provide a
written statement of the existence of such insurance to RGI upon request.

 

ARTICLE XXI - DAMAGES

 

- 51 -

 

 

 

21.1The Parties agree that a failure by RGI to complete Services in a timely
manner, as measured by any milestone or timeline agreed to in a Task Order, for
any reason other than GSK’s acts or omissions or an event described in Section
23 is a material breach of the relevant Task Order; and that such failure would
result in damage to GSK but that determining the precise extent of that damage
would be difficult. Accordingly, the Parties agree that, in the event of such a
failure by RGI, GSK may in addition to any other remedies available to it,
deduct from payments as reasonable liquidated damages, in light of the
anticipated or actual loss caused by the breach and the difficulties of proof of
loss, and not as a penalty, the following amounts, in addition to any costs
assessed to RGI under Section 2.7(c):

 

(a) [***] per cent ([***]%) of the value of the appropriate milestone payment
for the first full or part of a week that the stated milestone is delayed beyond
the relevant performance date; and

 

(b) [***] per cent ([***]%) of the value of the appropriate milestone payment
for each full or part of a week thereafter that the stated milestone is further
delayed beyond the relevant performance date;

 

(c) up to a maximum of [***] per cent ([***]%) of the appropriate milestone
payment.

 

21.2Except as specifically provided in this Section, nothing in this Master
Agreement or any Task Order shall be interpreted as a limitation of liability or
waiver by either Party of any legal or equitable remedy which may be available
to that Party.

 

ARTICLE XXIII - MISCELLANEOUS

 

23.1INDEPENDENT CONTRACTORS.

(a) The relationship of the Parties is that of independent contractors. Neither
Party is the partner, joint venturer, or agent of the other and neither Party
has authority to make any statement, representation, commitment, or action of
any kind which purports to bind the other without the other's prior written
authorization.

 

- 52 -

 

 

 

(b) RGI agrees that no employee or independent contractor of RGI shall be
considered an employee of GSK or entitled to any benefits or eligible for
participation in any benefits plans provided to employees of GSK. RGI
acknowledges and agrees that RGI is solely responsible for any wages or
compensation payable to employees or independent contractors of RGI, as well as
any and all applicable witholdings of federal, state, or local contributions and
taxes in connection with any compensation paid to employees or independent
contractor’s of RGI.

 

23.2WAIVER AND RELEASE. Notwithstanding anything to the contrary in this
Agreement or the Original Agreement, RGI (and its Affiliates and shareholders)
hereby releases and forever hold GSK (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 United Kingdom.

 

23.3FORCE MAJEURE. Notwithstanding anything to the contrary set forth in this
Master Agreement, neither Party shall lose any rights hereunder or be liable to
the other Party for damages or losses on account of failure of performance by
the defaulting Party, other than a failure to make payment, if the failure is
occasioned by government action, war, terrorism, fire, explosion, flood, strike,
lockout, embargo, shortage of materials or utilities, vendor failure to supply,
act of God, or any other cause beyond the control and without the fault or
negligence of the defaulting Party, provided that the Party claiming force
majeure has exerted all reasonable efforts to avoid or remedy such force majeure
and that in no event shall a Party be required to settle any labor dispute or
disturbance. Such excuse shall continue as long as the condition preventing the
performance continues. Upon cessation of such condition, the affected Party
shall promptly resume performance hereunder. Each Party agrees to give the other
Party prompt written notice of the occurrence of any such condition, the nature
thereof, and the extent to which the affected Party will be unable to perform
its obligations hereunder. Each Party further agrees to use all reasonable
efforts to correct the force majeure condition as quickly as possible and to
give the other Party prompt written notice when it is again fully able to
perform its obligations hereunder; provided if such event of force majeure
continues for a period of in excess of three (3) months, then either Party may
terminate this Master Agreement or any affected Task Order upon providing the
other Party prior written notice.

 

- 53 -

 

 

 

23.4NOTICES.

 

(a) All notices under this Master Agreement or a Task Order shall be sent by
registered or certified mail, postage prepaid, or by overnight courier service.
Notices may be sent by facsimile or e-mail, if confirmed by also sending as
described above.

 

(b) Notices pertaining to this Master Agreement shall be sent to:

 

If to RGI:

Attn: Chief Executive Officer

Address:

1640 Marengo Street,

Los Angeles, CA 90033

USA

 

Copy to:

RGI Legal Department

103 S, Carroll Street

Frederick, MD 21701

 

If to GSK:

Attn: VP Diagnostics, Immunotherapeutics

Address:

Rue de l’Institut, 89

1330 Rixensart

BELGIUM

 

Copy to:

GSK Biologicals Legal Department

Ave Fleming 20

1300-B Wavre, Belgium

 

Each party may designate to the other in writing an email address for notice
purposes pursuant to this Section 23.4.

 

(c) Notices pertaining to a Task Order shall be sent to GSK Representatives
identified in the Task Order.

 

23.5ASSIGNMENT. GSK may assign its rights and duties under this Master Agreement
or any Task Order without RGI’s consent; GSK shall notify RGI of any such
assignment. Any assignment by RGI is valid only upon the prior written consent
of GSK. To the extent permitted above, this Master Agreement or any Task Order
shall be binding upon and inure to the benefit of the Parties and their
permitted successors and assigns.

 

23.6SEVERABILITY. If any provision(s) of this Master Agreement or a Task Order
should be illegal or unenforceable in any respect, the legality and
enforceability of the remaining provisions of this Master Agreement or the Task
Order shall not in any way be affected.

 

- 54 -

 

 

 

23.7WAIVER; MODIFICATION OF AGREEMENT. No waiver, amendment, or modification of
any of the terms of this Master Agreement or a Task Order shall be valid unless
in writing and signed by authorized representatives of both Parties. Failure by
either Party to enforce any rights under this Master Agreement or a Task Order
shall not be construed as a waiver of such rights nor shall a waiver by either
Party in one or more instances be construed as constituting a continuing waiver
or as a waiver in other instances.

 

23.8GOVERNING LAW; VENUE. This Master 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 Delaware in the United States in cases RGI is the respondent, and
in Nivelles, Belgium, in cases GSK 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.

 

23.9COUNTERPARTS. This Master Agreement and any Task Order may be executed in
one or more counterparts including facsimile or PDF copies transmitted
electronically,each of which shall be deemed an original and all of which shall
constitute the same instrument.

 

23.10ENTIRE AGREEMENT. This Master Agreement, in conjunction with individual
Task Orders entered into under this Master Agreement, as well as all schedules
and exhibits to this Master Agreement and any Task Orders constitute the entire
agreement and understanding between the Parties with respect to the subject
matter hereof and supersedes any prior agreement, understanding or arrangement
between the Parties, whether oral or in writing as of the Effective Date. No
representation, undertaking or promise shall be taken to have been given or be
implied from anything said or written in negotiations between the Parties prior
to this Master Agreement except as expressly stated in this Master Agreement.

 

- 55 -

 

 

 

23.11FURTHER ASSURANCES. The Parties shall do and execute all such further acts
and things as are reasonably required to give full effect to the rights given
and the transactions contemplated by this Master Agreement.

 

23.12INTERNATIONAL SALE OF GOODS ACT. The Parties acknowledge and agree that the
International Sale of Goods Act and the United Nations Convention on Contracts
for the International Sale of Goods have no application to this Agreement.

 

23.13COSTS. Except as is otherwise expressly set forth herein, each Party shall
bear its own expenses in connection with the negotiation of this Agreement.

 

 

SIGNATURE PAGE TO FOLLOW

 

- 56 -

 

 

 

IN WITNESS whereof the hands of the Parties or their duly authorised
representatives on the date first above written.

 

 

GLAXOSMITHKLINE BIOLOGICALS SA RESPONSE GENETICS INC.             By: /s/ Jamila
Louahed By: /s/ Thomas A. Bologna     Name: Jamila Louahed Name: Thomas A.
Bologna     Title: VP Research & Development, Title: CEO Immunotherapeutics    
Date: July 26, 2012 Date: July 26, 2012       By: /s/ Emmanuel Hannon      
Name: Emmanuel Hannon       Title: Senior VP, Head of Vaccines Discovery   and
Development       Date: July 26, 2012       By: /s/ Sophie Lelong       Name:
Sophie Lelong       Title: Senior Manager Procurement       Date: July 26, 2012
 

 

- 57 -

 

 

EXHIBIT A - FORM TASK ORDER AND SCHEDULES

PO number

to be inserted on each invoice

 

TASK ORDER RGI-XXX

 

This TASK ORDER is effective as of the ……. Day of …………. (the “Effective Date”)
between RESPONSE GENETICS INC., a company incorporated in the State of Delaware,
whose principal place of business is situated at 1640 Marengo Street, Suite 600,
Los Angeles, CA 90033 and GLAXOSMITHKLINE BIOLOGICALS SA, with offices located
at 89 rue de l’Institut, 1330 Rixensart, BELGIUM (“GSK”).

 

BACKGROUND

 

GSK and RGI are Parties to a second Amended and Restated Master Agreement
(hereinafter referred to as the “Master Agreement”) with an effective date of
<INSERT DATE>.

 

 

TASK ORDER EFFECTIVE DATE: <INSERT DATE> GSK PROJECT NAME : <INSERT PROJECT
NAME> STUDY TITLE: <INSERT STUDY TITLE> ASSAY NAME: <INSERT ASSAY NAME> RGI
Monitor: <INSERT NAME> GSK  Representative: <INSERT NAME lab coordinator> TASK
ORDER EXPIRATION DATE: <INSERT DATE>

 

 

1.THE SERVICES

 

RGI agrees to perform the Services as outlined in Schedule A and if appropriate,
in Schedule C, attached and incorporated by reference as part of this Task
Order, and in accordance with the terms of the Master Agreement.

 

2.COMPENSATION

 

In consideration for its performance of Services under this Task Order, GSK
shall pay RGI in accordance with the payment schedule as documented in Schedule
B, attached and incorporated by reference as part of this Task Order.

 

- 58 -

 

 

 

3.SAMPLE STORAGE

 

The Samples provided by GSK to RGI are listed in Schedule E of this Task Order
and are to be stored in accordance to section 4.1 and 6 of the Master Agreement.

 

3.TERM; TERMINATION

 

This Task Order shall continue until the Services are completed in accordance
with the timelines set forth in Schedule A attached to this Task Order or until
terminated as provided in the Master Agreement.

 

4.INCORPORATION OF MASTER AGREEMENT BY REFERENCE

 

The Terms and Conditions of the Master Agreement are hereby incorporated by
reference into and made a part of this Task Order. Unless otherwise stated in
this Task Order, all defined terms within the Master Agreement shall have the
same meaning when used in this Task Order. If any provisions of this Task Order
are in direct conflict with the Master Agreement so that the provisions of both
cannot be given effect, the terms of this Task Order shall govern the specific
issue.

 

5.NOTICE.

 

In addition to the recipients of notice listed in the Master Agreement, notices
applicable to this Task Order Agreement shall be sent to:

 

6.APPLICABLE STANDARDS.

 

 

- 59 -

 

[INSERT ANY APPLICABLE STANDARDS TO WHICH THE WORK SHOULD BE PERFORMED, CLIA, EU
Directives, ETC]

 

RGI Monitor:

Name: <INSERT NAME>

 

Address :

<INSERT ADDRESS>

 

 

Email address: <INSERT E-MAIL ADDRESS>

Copy to:

GSK representative:

Name: <INSERT NAME lab coordinator>

Address :

Rue de l’Institut, 89

1330 Rixensart

BELGIUM

Email address: <INSERT E-MAIL ADDRESS>

Copy to: <INSERT NAME contract manager>

 

 

7.ENTIRE AGREEMENT.

 

This Task Order, including the incorporated Terms and Conditions of the Master
Agreement, represent the entire and integrated agreement between RGI and GSK and
supersedes all prior negotiations, representations or agreements, either written
or oral, regarding the Services subject of this Task Order.

 

 

GLAXOSMITHKLINE BIOLOGICALS SA

 

By: ____________________________

 

Name:

 

Title:

 

Date: _________________

RESPONSE GENETICS INC.

 

By: ___________________________

 

Name:

 

Title:

 

Date: _________________

 

- 60 -

 

 

SCHEDULE A – DESCRIPTION OF SERVICES

 

-Reference to Study Protocol (if applicable)

-Analytical Plan or similar

oStudy

oSerology or assay

oGoal of Services

oMilestone schedule with timing

oDeliverables

oReporting schedule (regular reporting, milestone reports,..)

-Key contact persons at GSK and RGI side

-KPI specific on activity

 

 

- 61 -

 

 

 

SCHEDULE B – BUDGET RELATING TO THE SERVICES

 

Payment schedule should be generally cost neutral throughout performance period,
i.e. payments will be made according to the Services actually achieved during
the invoiced period.

 

Invoices should be dispatched regularly at least every two (2) months throughout
the course of the Master Agreement.

The invoices should mention the purchase order (PO) to be provided by GSK
(usually noted on the first page of the original Task Order document).

All payments will be made within sixty (60) days from the end of month from the
date of receipt of the invoice.

 

Total budget

-Including cost of all requested Services

-on basis of the (estimated) number of Samples to be tested and price per
(final) result

 

 

- 62 -

 

 

 

SCHEDULE C – PROCEDURES AND PROTOCOLS

 

Procedures

In light of the Services described in Schedule A, a controlled copy of all
Procedures and policies mentioned below was sent to RGI at the indicated dates.

 

RGI is required to follow the Procedures from GSK, listed below.

If Procedures from RGI are used, a copy shall be provided to GSK and the
reference and title of these Procedures are mentioned below. Any changes to a
Procedure used for the Services need to be agreed and approved by both Parties
in written before implementation of such change.

  

Procedures GSK :

-1

-2

 

Procedures RGI :

-1

-2

 

- 63 -

 

 

 

SCHEDULE D – PRICING TERMS

 

DISCOUNT / REBATE / PRICING TERMS SPECIFICALLY AGREED TO FOR THIS TASK ORDER (IF
APPLICABLE)

 

Breakdown of unit prices

-Agreed price proposal

-milestone price for assay development

-price per final result for routine

 

- 64 -

 

 

 

SCHEDULE E – SAMPLES, MATERIALS & GSK EQUIPMENT

 

Samples:

Description of Samples that will be provided to RGI by GSK or its Affiliate
during the term of this Master Agreement to perform the Services hereunder,
indicating a scale of value.

 

-1

-2

 -

 

Materials :

List of active and raw materials, reagents, intermediates, processing aids,
ingredients or components, documentation and other materials that will be
provided to RGI by GSK or its Affiliate during the term of this Master Agreement
to perform the Services hereunder :

 

-1

-2

 -

 

All Materials to be provided by GSK will be shipped to the following shipping
address:

<INSERT SHIPPING ADDRESS RGI>

 

GSK Equipment :

List of equipment that will be provided to RGI by GSK or its Affiliate during
the term of this Task Order to perform the Services described in Schedule A :

if applicable

 

- 65 -

 

 

 

 

EXHIBIT B – CHANGE ORDER FORM

 

CHANGE ORDER

 

1.All Change Orders shall be identified by

 

Change Order number: ____________ date submitted: ____________ application date:
____________ Task Order(s) to amend: ____________

 

2.Describe and motivate changes, modifications, or additions to the Services.

  

 

3.These modifications were requested by

[_] GSK [_] RGI

 

4.Impact on

-Cost: (if applicable)

oinitial cost of Study :

ochanges in cost :

onew final cost of Study :

-Timing / Schedule: (if applicable)

oTask Order will remain effective until __________

-any other requirement: (if applicable)

 

 

 

- 66 -

 

 

SIGNATURE PAGE TO FOLLOW

5.Change Order Is:

 

Approved and Accepted________                 ______________________ __________
__________ _____   Signature of GSK Date   Name :     Title :          
______________________ __________ __________ _____   Signature of RGI Date  
Name :    Title :          

 

- 67 -

 

 

EXHIBIT C – KEY PERFORMANCE INDICATORS

[***]

[***]

[***]

[***]

 

KPI specific on activity will be specified in TO

 

 

- 68 -

 

 

EXHIBIT D – RATE CARD / PRICE SCHEDULE/DISCOUNT

 

  Service Explanation of service Fee per sample
Expedited Reporting Fee per sample
Non-expedited Reporting
(can be Batched) Extraction by “tumor cells” technique
1 [***] [***] [***] [***]
2 [***] [***] [***] [***]
3 [***] [***] [***] [***] Extraction by “tumor area” technique
4 [***] [***] [***] [***]
5 [***] [***] [***] [***]
6 [***] [***] [***] [***] Analysis activities
7 [***] [***] [***] [***]
8 [***] [***] [***] [***]
9 [***] [***] [***] [***]
10 [***] [***] [***] [***]
11 [***] [***] [***] [***]
12 [***] [***] [***] [***]

 

 

- 69 -

 

 

 

  Service Explanation of service Fee per sample
Expedited Reporting Fee per sample
Non-expedited Reporting
(can be Batched)
13 [***] [***] [***] [***]
14 [***] [***] [***] [***]
15 [***] [***] [***] [***]
16 [***] [***] [***] [***]
17 [***] [***] [***] [***]
18 [***] [***] [***] [***]
19 [***] [***] [***] [***] Other Activities
20 [***] [***] [***] [***]
21 [***] [***] [***] [***]

  

 

[***]

 

 

 

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EXHIBIT F - PREVENTION OF CORRUPTION – THIRD PARTY GUIDELINES

 

The GSK Anti-Bribery and Corruption Policy (POL-GSK-007) requires compliance
with the highest ethical standards and all anti-corruption laws applicable in
the countries in which GSK (whether through a Third Party or otherwise) conducts
business. POL-GSK-007 requires all GSK employees and any Third Party acting for
or on behalf of GSK to ensure that all dealings with Third Parties, both in the
private and government sectors, are carried out in compliance with all relevant
laws and regulations and with the standards of integrity required for all GSK
business. GSK values integrity and transparency and has zero tolerance for
corrupt activities of any kind, whether committed by GSK employees, officers, or
Third Parties acting for or on behalf of the GSK.

 

Corrupt Payments – GSK employees and any Third Party acting for or on behalf of
GSK, shall not, directly or indirectly, promise, authorise, ratify or offer to
make or make any “payments” of “anything of value” (as defined in the glossary
section) to any individual (or at the request of any individual) including a
“government official” (as defined in the glossary section) for the improper
purpose of influencing or inducing or as a reward for any act, omission or
decision to secure an improper advantage or to improperly assist the company in
obtaining or retaining business.

 

Government Officials – Although GSK´s policy prohibits payments by GSK or Third
Parties acting for or on its behalf to any individual, private or public, as a
“quid pro quo” for business, due to the existence of specific anticorruption
laws in the countries where we operate, this policy is particularly applicable
to “payments” of “anything of value” (as defined in the glossary section), or at
the request of, “government officials” (as defined in the glossary section).

 

Facilitating Payments – For the avoidance of doubt, facilitating payments
(otherwise known as “greasing payments” and defined as payments to an individual
to secure or expedite the performance of a routine government action by
government officials) are no exception to the general rule and therefore
prohibited.

 

GLOSSARY

 

The terms defined herein should be construed broadly to give effect to the
letter and spirit of the ABAC Policy. GSK is committed to the highest ethical
standards of business dealings and any acts that create the appearance of
promising, offering, giving or authorising payments prohibited by this policy
will not be tolerated.

 

Anything of Value: this term includes cash or cash equivalents, gifts, services,
employment offers, loans, travel expenses, entertainment, political
contributions, charitable donations, subsidies, per diem payments, sponsorships,
honoraria or provision of any other asset, even if nominal in value.

 

- 71 -

 

 

 

Payments: this term refers to and includes any direct or indirect offers to pay,
promises to pay, authorisations of or payments of anything of value.

Government Official shall mean:

 

·Any officer or employee of a government or any department, agency or instrument
of a government;

 

·Any person acting in an official capacity for or on behalf of a government or
any department, agency, or instrument of a government;

 

·Any officer or employee of a company or business owned in whole or part by a
government;

 

·Any officer or employee of a public international organisation such as the
World Bank or United Nations;

 

·Any officer or employee of a political Party or any person acting in an
official capacity on behalf of a political Party; or

 

·Any candidate for political office.

 

 

- 72 -

 

 

 

EXHIBIT G – LABORATORY QUALITY ASSESSMENT ACTION PLAN

 

 

NA

 

- 73 -

 

 

 

EXHIBIT H – TECHNOLOGY TRANSFER PROVISIONS

 

 

[***]

[***]

•[***]

•[***]

•[***]

•[***]

•[***]

[***]

•[***]

•[***]

•[***]

•[***]

[***]

•[***]

•[***]

•[***]

•[***]

[***]

•[***]

•[***]

•[***]

•[***]

[***]

·[***]

 

- 74 -

 

 

 

EXHIBIT I – STATEMENTS OF WORK

 

[***] [***]     [***]     [***]     [***]   [***] [***]     [***]     [***]  
[***] [***]     [***]     [***]   [***] [***]     [***]     [***]   [***] [***]
    [***]     [***]   [***] [***]     [***]     [***]   [***] [***]     [***]  
  [***]   [***] [***]     [***]     [***]   [***] [***]     [***]     [***]  
[***] [***]     [***]     [***]   [***] [***]     [***]     [***]  

 

- 75 -