Geron Corporation / PAREXEL    

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

EXHIBIT 10.42

 

MASTER SERVICES AGREEMENT

This Master Services Agreement (this “Agreement”) is effective as of January 30,
2019 (the “Effective Date”), and is by and between Geron Corporation (“Client”),
a Delaware corporation with a principal place of business at 149 Commonwealth
Drive, Menlo Park, CA 94025, United States, and PAREXEL International (IRL)
Limited (“PAREXEL”), a corporation organized under the laws of Ireland with a
registered address at 70 Sir John Rogerson’s Quay, Dublin 2, Ireland.

BACKGROUND

PAREXEL is a contract research organization providing a full range of contract
research organization services for companies such as Client. Client and PAREXEL
wish to enter into this Agreement to provide the terms and conditions under
which Client may engage PAREXEL or its Affiliates (as defined below) from time
to time, upon execution of a Work Order (as defined below), to provide services
for Client’s studies or projects.

NOW THEREFORE, the parties agree as follows:

1.

DEFINITIONS

1.1.“Affiliate” means in relation to either party to this Agreement, any
company, partnership or other entity which directly or indirectly controls, is
controlled by, or is under common control with such party, or is managed by an
entity that is under common control with such party.  For purposes of this
definition, “control” means the beneficial ownership of more than fifty percent
(50%) of the issued voting shares or the legal power to direct or cause the
direction of the general management of the company, partnership or other entity
in question, and “controlled” shall be construed accordingly.

1.2.“Applicable Law” means any international, national, federal, state,
provincial, commonwealth, or local government law, statute, rule, requirement,
code, regulation, or ordinance that applies to either party or to a Project, the
Services, or this Agreement, including, without limitation: the Health Insurance
Portability and Accountability Act of 1996, and the regulations promulgated
pursuant thereto (“HIPAA”), to the extent applicable; the Federal Food, Drug and
Cosmetics Act (“FFDCA”) and its implementing regulations; the European Directive
2001/20/EC and the General Data Protection Regulation (EU) 2016/679  (the
“GDPR”) as well as the current good clinical practices guidelines of the
International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use Topic E6: Guidelines on Good
Clinical Practice (“ICH/GCP”), and applicable version(s) of the World Medical
Association Declaration of Helsinki, and, where applicable, rules governing
distribution practice, manufacturing practice and good laboratory practice, and
rules governing the collection and processing of personal data and the
collection and storage of human tissue samples and the performance of DNA
testing.

1.3. “Investigational Product” means a pharmaceutical form of an active
ingredient or placebo being tested or used as a reference in a Study.

1.4.“Investigator” means the person responsible for the conduct of a Study at a
Site. If a Study is conducted by a team of individuals at a Site, the
Investigator is the responsible leader of the team and may be called the
“Principal Investigator”.

 

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1.5.“Protocol” means a document that describes the objective(s), design,
methodology, statistical considerations, and organization of a clinical trial.

1.6.“Project” means a Study and/or such other project for Client with respect to
which PAREXEL provides Services pursuant to a Work Order.

1.7.“Regulatory Authority” means any supra-national, national or local agency,
authority, department, inspectorate, minister, ministry official, parliament or
public or statutory person (whether autonomous or not) of any government of any
country having jurisdiction over any of the activities contemplated by this
Agreement, including without limitation, the European Medicines Agency and the
United States Food and Drug Administration.

1.8.“Study” means an investigation in human subjects intended to discover or
verify the clinical, pharmacological and/or pharmacodynamics effects of an
investigational product(s), and/or to identify any adverse reactions to an
investigational product(s), and/or to study absorption, distribution,
metabolism, and excretion of an investigational product(s) with the object of
ascertaining its safety and/or efficacy.  As used herein, a “Study” has the
foregoing meaning and is conducted pursuant to a Protocol under a Work Order.

1.9.“Study Data” means all data generated through the direction, management or
performance of a Study or any Study-related Services.

1.10. “Study Materials” means the Investigational Product and other supplied
products and materials, including but not limited to an investigational or
marketed or other pharmaceutical product (other than an Investigational Product)
used as a reference in a Project.

1.11.“Subcontractor” means a particular provider of Services contracted directly
by PAREXEL, subject to Client’s prior written consent, except as expressly
permitted by this Agreement or the applicable Work Order(s), in connection with
the Services.

2.

SERVICES

2.1.PAREXEL will provide to Client the services set forth in the work order(s)
executed by both parties (“Work Order”), such Work Order(s) to be substantially
in the form of Attachment A hereto (“Services”).  PAREXEL shall perform the
Services in compliance with: (i) the Protocol, (ii) the terms and conditions of
this Agreement, (iii) the terms and conditions of the applicable Work Order,
(iv) PAREXEL’s standard operating procedures (“SOPs”), which shall have been
reviewed by Client, and (v) all Applicable Laws. If any term in a Work Order
conflicts with this Agreement, this Agreement will control except to the extent
that the Work Order expressly states that such conflicting term prevails over
this Agreement.  To the extent that any Services relate to scientific or
clinical trial matters, the Protocol will control the performance of such
Services, and will take precedence over all other Project documents for such
Services.  Notwithstanding anything to the contrary in this Agreement, neither
party nor its Affiliates shall have an obligation to order or provide Services
in the absence of an executed Work Order.

2.2Client and PAREXEL agree that any change to the details of a Work Order, the
assumptions upon which such Work Order is based or the scope of a Work Order may
require changes to the description of Services, budget, estimated timelines, or
payment schedule.  Client may, at Client’s discretion, reduce the scope of
Services set forth in any Work Order by notifying PAREXEL in writing, and the
parties will cooperate to modify the Work Order accordingly as set forth
herein.  Any such required changes shall be reflected in either (i) an approved
entry in a Change in Scope Log (“CIS Log”), in accordance with and in the form
set forth in Attachment B, or (ii) a written amendment to the Work Order (a
“Change Order”), in accordance with and in the form set forth in Attachment
C.  The parties to the Work Order agree to process such changes as follows:

 

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(a)For each Work Order related to clinical research services only, PAREXEL shall
generate and maintain a CIS Log showing all changes agreed by the parties to the
scope of Services and any associated proposed changes to the budget.  After each
new entry, PAREXEL shall forward the updated CIS Log to the appropriate
representative(s) of Client and Client shall review the CIS Log and request any
changes in writing within [*] of receipt of the CIS Log.  A Client
representative duly authorized, as set forth in the applicable Work Order and
subject to written update by Client as needed (the “GERON Representative”) to
approve new entries in the CIS Log shall promptly (but not later than [*] after
receipt) sign each applicable line item approved by Client.  Upon approval by
Client, the amended scope of Services and any associated changes to the budget
as reflected in signed CIS Log entries will be binding on both parties and shall
be implemented.  Once the aggregate amount of the CIS Log reaches a threshold
that will be specified in the applicable Work Order, or if regulatory reasons
demand it, then a formal Change Order will be prepared, and signed by both
parties.  A Change Order will be prepared irrespective of the threshold at the
end of every [*] or as otherwise agreed upon in the respective Work Order, as
well as the completion of Services.

(b)For all other Work Orders, the parties to the Work Order will negotiate and
execute a Change Order reflecting agreed-upon changes and any related terms.

(c)PAREXEL shall not be required to perform any services or incur any expenses
that are not specifically set forth in a Work Order unless and until a Change
Order is executed by the parties to the Work Order or a CIS Log is approved by
the Client as set forth above in this Section.

2.3If PAREXEL performs any changes in good faith upon the written request of the
GERON Representative before the applicable entries in the CIS Log are approved
or the applicable Change Order is executed, then Client will pay PAREXEL for the
performance of such changes and any expenses related thereto when the parties
have finalized the applicable mutually acceptable Change Order or approved the
applicable entries in the CIS Log.  In addition, subject to acceptance by Client
of the entries in the CIS Log or the terms and conditions of the applicable
mutually acceptable Change Order, including, but not limited to, any
corresponding changes in budget, if Client fails to approve a duly submitted CIS
Log entry within [*] after PAREXEL has submitted such request, and/or if the
parties fail to execute a formal Change Order within [*] after such formal
Change Order has been submitted by PAREXEL to Client, then PAREXEL reserves the
right, upon written notice to Client, to immediately terminate said activities.

2.4If PAREXEL provides any Services in good faith upon the written request of
the GERON Representative either (a) prior to execution by both parties of a
start-up Work Order for such Services at the start of PAREXEL’s engagement, or
(b) following expiration of the start-up Work Order but prior to execution by
both parties of a full Work Order for such engagement, then, in either such
case, Client shall pay PAREXEL for the performance of such Services and any
expenses related thereto in accordance with the terms of the applicable start-up
Work Order or Work Order, and upon execution of the applicable start-up Work
Order or Work Order, all terms and conditions of this Agreement shall apply to
such Services to the same extent as if such Services had been performed while
the applicable start-up Work Order (or full Work Order, as the case may be) was
executed and in full force and effect. In addition, Client acknowledges that
PAREXEL is under no obligation to provide Services under either scenario (a) or
(b) set forth in the preceding sentence, and Client agrees that PAREXEL may
immediately terminate said activities at any time prior to the execution by both
parties of the applicable start-up Work Order or full Work Order (as the case
may be).

2.5Each Work Order will identify certain key personnel reasonably acceptable to
Client (collectively, “Key Personnel”).  Key Personnel may include a Project
Manager (or comparable role, however titled), if applicable to the
Project.  PAREXEL recognizes that Client’s entry into this Agreement is based in
part on Client’s reliance upon the assignment of such Key Personnel to Client’s
Projects.  Subject to Section 15.3, PAREXEL agrees that it will not remove or
substitute any Key Personnel or materially reduce the time commitment of Key
Personnel without Client’s prior written consent, such consent not to be
unreasonably withheld, conditioned or delayed.  Notwithstanding the

 

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amended.

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foregoing, Client recognizes that Key Personnel may leave the employ of PAREXEL
for reasons beyond PAREXEL’s control or may be promoted to different roles
within PAREXEL. Whenever practicable, PAREXEL shall give Client at least [*]
notice prior to the departure of any Key Personnel from Client’s Projects, and
shall propose replacement personnel. Client shall have the right to approve or
reject any replacement Key Personnel at its reasonable discretion, such approval
not to be unreasonably withheld, conditioned or delayed; provided, however, that
PAREXEL shall not be liable for any delays caused by Client’s rejection of any
Key Personnel.  In addition, Client may request replacement of Key Personnel by
written notice to PAREXEL if Client reasonably believes that Key Personnel are
not performing Services to the reasonable satisfaction of Client. PAREXEL shall
submit the names and qualifications of proposed replacement Key Personnel to
Client, Client will [*].  If PAREXEL and Client [*], the parties may [*].

2.5.1The parties will establish an Executive Committee that comprises at least
one executive or corporate officer of each Party, as well as certain PAREXEL Key
Personnel and GERON Representatives (defined in 2.2 above).  The Executive
Committee will provide a functional mechanism for Client’s oversight of
PAREXEL’s Services in accordance with the Agreement, the applicable Work Orders,
and Applicable Law, including without limitation, as applicable, the
requirements of ICH E6(R2) Sections 5.2.1 and 5.2.2 as well as 21 CFR 312.52(a)
and (b).  The Executive Committee will function at a strategic relationship
level, across Projects and Studies for ongoing, overall assessment of PAREXEL’s
performance of Services to ensure compliance with regulatory requirements and
obligations under this Agreement and Work Orders, as well as identification and
resolution of project level and/or cross-project systemic issues.  The
composition of the Executive Committee and the scope and description of its
activities will be determined by Client and confirmed by mutual agreement of the
parties and may be documented in an ancillary document or plan.  The actions of
the Executive Committee will be subject at all times to the oversight and final
approval of Client.   

2.6Obligations transferred to PAREXEL under a Work Order in accordance with 21
C.F.R. 312.52 will be set forth in a “Transfer of Obligations under 21, C.F.R.
312.52 and Applicable Foreign Equivalents” (“TORO”). PAREXEL will assume
responsibility for transferred obligations set forth in the TORO and agrees to
diligently carry out such transferred obligations in accordance with this
Agreement and the applicable Work Order.  In addition, and without limiting the
foregoing, if called for by the Project and set forth in the Work Order, and
further subject to PAREXEL’s SOPs and standard tools and templates, PAREXEL will
ensure that all relevant requirements are met with respect to: (a) obtaining
informed consent from Study subjects in accordance with 21 C.F.R. Part 50, as
amended; (b) obtaining signed authorizations (including Data Privacy Notices)
for the collection, processing and transfer of the Personal Data of Data
Subjects (each as defined in Section 8.5 below); (c) obtaining both initial and
continuing ethics committee and investigational review board review and approval
in accordance with 21 C.F.R. Part 56, as amended; (d) obtaining from each Study
Investigator and providing to Client a fully completed and signed Form FDA 1572
and any other information required by 21 C.F.R. §312.53(c), as amended; and (e)
requiring that each Study Investigator abides by the Study-related commitments
and obligations he or she undertook by signing Form FDA 1572.

2.7PAREXEL may use its Affiliates to perform any of its obligations under this
Agreement or any Work Order.  In addition, any Affiliate of either party may
execute a Work Order pursuant to this Agreement.  Wherever an Affiliate of
either party enters into a Work Order, for the purposes of such Work Order, all
references in this Agreement to Client or PAREXEL, as the case may be, shall be
read as if they were a reference to that Affiliate only, and only that Affiliate
shall be deemed the party to this Agreement for the purpose of the Services
provided under such Work Order  and shall be bound as a party by all terms and
conditions of this Agreement with respect to such Services. [*], PAREXEL shall
[*].

2.8PAREXEL acknowledges that Client may, without the consent of PAREXEL,
designate or retain one or more other third-party contract research
organizations (“CROs”) or other designees to assist Client with any Project.  In
that case, PAREXEL agrees to reasonably cooperate with any such CROs or other
Client designees provided that (a) such CRO executes a confidentiality agreement
containing terms acceptable to PAREXEL and customary in the industry, (b) Client
manages

 

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such CRO and, unless otherwise agreed in the applicable Work Order, PAREXEL’s
SOPs apply to all of PAREXEL’s obligations under such Work Order, (c) such CRO
will not have access to PAREXEL’s SOPs and/or systems, and (d) PAREXEL will not
have any obligation to contract with, or provide any management or supervision
of, such CRO.   

2.9If, as part of the Services, PAREXEL provides online access to any software
tools (the “Software”), then the following terms and conditions shall apply:
Client shall not copy, modify, transcribe, translate, sell, lease, rent, share,
offer a subscription service or service bureau, or assign, or in any way
transfer the Software or access to the Software, or any interest thereto, or use
the Software for any purpose other than for Client’s business purposes relating
to the Project.  Client shall not reverse engineer, disassemble or decompile the
Software, except to obtain information necessary to provide programs
interoperable with the Software, and provided that Client first requests from
PAREXEL such information and PAREXEL is unable or unwilling to provide the
information within a reasonable period of time.  Client acknowledges that the
Software is PAREXEL Intellectual Property (as defined in Section 9.4).  PAREXEL
shall ensure that any Software owned by PAREXEL that collects, processes or
transfers of the Personal Data of Data Subjects is compliant with all Applicable
Laws.

2.10PAREXEL will perform its Services in accordance with PAREXEL’s SOPs, report
and file templates, and systems, unless specifically stated otherwise in the
applicable Work Order.  Notwithstanding the foregoing, Client may request to use
Client’s SOPs, or to deviate from PAREXEL’s SOPs, but Client acknowledges that
the use of Client’s SOPs, or deviations from PAREXEL’s SOPs may result in a
modification of the budget if the requested deviation would result in rework or
changes to the resource assumptions contained within the Study budget.

3.

StUDY mATERIALS

3.1Unless otherwise set forth in the applicable Work Order, Client shall provide
PAREXEL with a sufficient quantity of Study Materials which the Protocol
specifies Client shall deliver or which Client deems necessary to conduct the
Study.  All such Study Materials are and shall remain the sole property of
Client, and PAREXEL will use Study Materials only in connection with the
applicable Protocol and for no other purpose unless otherwise approved in
writing by Client. PAREXEL will ensure that Study Materials in its possession
and control are at all times handled, stored, and administered in full
compliance with Applicable Laws. Upon completion or termination of any Project,
any unused or expired Study Materials shall, at Client’s direction and expense,
be promptly returned to Client or its designee, or be disposed of in compliance
with Applicable Laws with written certification of same to Client.

3.2In no event shall PAREXEL or its Affiliates have any liability to Client for
loss, destruction or damage to Study Materials provided by Client caused by any
third party, except to the extent that any such third party is a [*] PAREXEL or
its Affiliates.  PAREXEL’s or its Affiliates liability to Client for damage,
destruction or loss to Study Materials provided by Client that is caused by
PAREXEL’s or its Affiliates’ [*] negligence or willful misconduct shall be
[*].  Unless otherwise agreed in the applicable Work Order, [*] shall be [*].

3.3Client shall provide to PAREXEL, in advance of the execution of a Work Order,
all information reasonably available to Client regarding known or reasonably
foreseeable hazards (in particular safety and toxicology data) associated with
any of the Study Materials, and thereafter any information reasonably available
to Client that PAREXEL may reasonably request as needed for the performance of
Services.

3.4In those cases where Services include clinical trial supplies and logistics
services (“CTSL Services”), the additional terms and conditions related to Study
Materials, set forth on Attachment D to this Agreement, shall also apply.  In
the event of any conflict between Attachment D and Section 3.1, above, with
respect to Study Materials, Attachment D shall control whenever the Services to
be performed include CTSL Services. Where applicable, information related to the
scope

 

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of the CTSL Services shall be set forth on an exhibit, incorporating the details
(as applicable) of Exhibit D of the template Work Order, and the applicable
budget for such CTSL Services shall also be set forth in an exhibit,
incorporating the details (as applicable) of Exhibit F, Table 2, of the template
Work Order.

4.

related agreements

4.1Client acknowledges and agrees that this Agreement does not cover certain
specialized services (“Specialized Services”) which PAREXEL may provide in
particular countries where a Project is conducted, such as, but not limited to,
serving as legal representative, local sponsor, agent, qualified person, or
senior scientific officer, and agrees that any such Specialized Services shall
require and be subject to the parties’ execution of a separate services
agreement with respect to such Specialized Services (each, a “Specialized
Services Agreement”).  The parties will use commercially reasonable efforts to
execute those Specialized Services Agreements determined by the parties to be
necessary or desirable to enable the performance of Client’s Projects promptly
following the determination that such Specialized Services Agreement is
necessary and/or following completion of any additional steps required
by  PAREXEL policies and procedures.  PAREXEL may, in its sole discretion, elect
not to perform such Specialized Services.  Client acknowledges and agrees that
if PAREXEL does perform such Specialized Services, such Specialized Services
will be at the cost and expense of Client, which costs shall be set forth in the
Work Order or the Specialized Services Agreement.

4.2Client and PAREXEL shall use commercially reasonable efforts to enter into a
mutually acceptable quality agreement (“Quality Agreement”), which shall be
incorporated by reference herein, promptly following execution hereof.  The
Quality Agreement shall set forth all mutually agreed quality assurance and
quality control terms and conditions between the parties, including, without
limitation, the quality oversight and standards for manufacturing, storing,
testing, releasing, shipping and receipt of Investigational Product and any
other applicable Study Materials, so as to allow Client or its designees to
transfer, and PAREXEL to receive, such Investigational Product and any other
applicable Study Materials.  In the event of any conflicts between this
Agreement and the Quality Agreement, this Agreement shall govern unless the
intent to supersede this Agreement is expressly stated in the Quality Agreement.

4.3Client and PAREXEL  agree that in those cases in which a Clinical
Pharmacology Unit of PAREXEL conducts a Project or provides Services, the
parties shall negotiate additional terms tailored to such Project or Services,
and shall agree upon such terms in an addendum hereto or in the applicable Work
Order.

5

THIRD-PARTY AGREEMENTS

5.1PAREXEL may use Subcontractors (defined in Section 1.11) and Specialty
Vendors, as each is defined below, for Services in support of a Study, subject
to Client’s prior written approval, which shall not be unreasonably withheld.
Subcontractors and Specialty Vendors set forth in a Work Order shall be deemed
approved upon execution of the Work Order. PAREXEL will [*].  [*], PAREXEL shall
be responsible and liable for its own negligence, omissions and/or intentional
misconduct, and that of its Affiliates.  Subject to the terms of such
agreements, PAREXEL will ensure that Client may audit the records of the
Services and inspect the facilities (if applicable) of its Subcontractors and
any Client-Designated Vendors and Specialty Vendors performing Services in
support of the Project where such Services are performed.  

5.2PAREXEL [*] shall ensure that any Subcontractors adhere to the terms and
conditions of this Agreement.  PAREXEL will maintain written agreements with
such Subcontractors containing terms substantially similar to those in this
Agreement, including with respect to compliance with Applicable Law, obligations
of confidentiality and non-use of Client Confidential Information, ownership of
Client Intellectual Property and indemnification obligations. If Client
reasonably objects to any Subcontractor contracted directly by PAREXEL for the
performance of a Project, PAREXEL will make reasonable efforts to promptly
replace the Subcontractor with a Subcontractor reasonably acceptable to Client.
Client shall have no liability for payments to Subcontractors, which shall be
the sole responsibility of PAREXEL.

 

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5.3If Client requires in writing that PAREXEL use a particular provider of
materials or services in connection with the Services and such provider is [*]
or [*] (a “Client-Designated Vendor”), then PAREXEL will contract with such
Client-Designated Vendor, unless PAREXEL [*], in which case Client may contract
directly with such Client-Designated Vendor.  Unless otherwise set forth in the
applicable Work Order, if PAREXEL contracts directly with such Client-Designated
Vendor, then payments to such Client-Designated Vendor shall be treated as a
Pass-Through Expense, and PAREXEL shall [*].

5.4  [*] (a “Specialty Vendor”), [*].  The parties agree that third party
vendors providing services that are administrative in nature and not unique to
the Project (such as courier or translation services) shall not need to be
identified in the Work Order.  The parties further agree that a Site will not be
deemed a Specialty Vendor. Any Specialty Vendor shall [*]. Any Specialty Vendor
[*]. PAREXEL will maintain written agreements with its Specialty Vendors
containing terms substantially similar to those in this Agreement with respect
to compliance with Applicable Law, obligations of confidentiality and non-use of
Client Confidential Information, ownership of Client Intellectual Property and
indemnification obligations. If Client reasonably objects to any proposed
Specialty Vendor, Client will promptly (prior to use) notify PAREXEL and PAREXEL
will make reasonable efforts to promptly propose a qualified replacement
Specialty Vendor, and will inform Client if it believes that identifying and
qualifying a replacement Specialty Vendor would impact Work Order timelines and
requirements. In no event shall PAREXEL be responsible for any delays caused by
Client’s rejection of a Specialty Vendor, or, per Section 5.4.1 below, rejection
of any medical reviewers employed by a Specialty Vendor.

5.4.1  [*], as well as confirmation that such Specialty Vendors are not debarred
and if agreed upon in the applicable work order, [*] for the prior [*] (or such
lesser period as may be available to PAREXEL), including a complete list of
inspection findings, if any, for Client’s review and approval prior to the start
of such medical imaging services.  Client may provide its approval via email.  

5.5If, pursuant to the applicable Work Order, Client expressly delegates to
PAREXEL the negotiation and execution of clinical trial related agreements
(including budgets) (“Clinical Trial Agreements”) with Investigators, hospitals
and/or research institutions (collectively, “Sites”) as part of the Services,
then Client hereby authorizes PAREXEL and PAREXEL Affiliates, if applicable, to
execute such Clinical Trial Agreements in PAREXEL’s own name or jointly with
Client, as mutually agreed with Client and subject to regulation or local
custom; provided, however, that Client shall cooperate with PAREXEL in the event
Client is required to execute a Clinical Trial Agreement or any documents
related thereto.  Client shall have the right to approve all Clinical Trial
Agreement templates for use and all finalized Clinical Trial Agreements prior to
execution.  Unless the form of Clinical Trial Agreement is mandated by
regulation, PAREXEL shall use the form of Clinical Trial Agreement mutually
agreed upon by Client and PAREXEL, and shall obtain Client’s approval of any
material modifications of such Clinical Trial Agreements. Upon award of a
Project, Client shall provide PAREXEL with written instructions regarding
negotiation parameters for the Clinical Trial Agreements.  If requested by
PAREXEL and to the extent required by Applicable Law or requested by the Sites,
Client agrees to provide letters of indemnification to Sites provided that the
terms and conditions of such letters of indemnification are acceptable to
Client. In the event the terms of such letters of indemnification are not
acceptable to Client, Client acknowledges that PAREXEL may not be able to
contract with such Site.

5.6Provided that PAREXEL has received adequate funds in advance from Client,
PAREXEL will administer and disburse payments to the Sites as described in the
applicable Work Order.  Client will provide adequate funds to PAREXEL in advance
for such payments in accordance with a schedule and budget to be mutually agreed
upon in advance between Client and PAREXEL.  Client will not be required to
provide funds exceeding the agreed budget for payments to Sites [*].  The budget
for payments to Sites will be modified in accordance with Section 2.2 if it
appears that payments to Sites will exceed the agreed budget. PAREXEL will not
be required to disburse payments to any

 

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amended.

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Sites if Client has not made sufficient advance funds available to PAREXEL to
cover such disbursements.  In the event the funds advanced by Client pursuant to
this Section are insufficient to cover such payments, Client will promptly pay
to PAREXEL the additional amounts required consistent with the budget for such
payments, in accordance with a schedule agreed upon by the parties, and if
Client does not provide such agreed funds in time to enable PAREXEL to make
timely payments, Client agrees to be liable for and to reimburse PAREXEL for any
interest and other charges, costs, fees and expenses incurred by PAREXEL because
of such late payment.  In no event will a Site be construed to be PAREXEL’s
employee, Subcontractor, agent, consultant, or representative, or be deemed to
be a vendor.  Provided that Client has supplied funds on a timely basis and  as
agreed between PAREXEL and Client for payments to Sites, Client will have no
liability to PAREXEL or any third party for PAREXEL’s late payment of, or
failure to pay, Sites.

6

PAYMENTS

6.1Client will pay to PAREXEL the Service fees specified in the applicable Work
Order, up to the amount of the budget set forth therein, as such budget for
Service fees may be modified by any applicable Change Order.  PAREXEL shall
deliver all deliverables under a Work Order [*].  For the avoidance of doubt,
PARAXEL shall deliver to Client all deliverables [*].  In addition to the
payment of Service fees, Client will reimburse PAREXEL for all reasonable
out-of-pocket expenses, including without limitation, printing, shipping, wire
transfer fees, telephone, travel and lodging, incurred by PAREXEL or its
Affiliates in providing the Services, and any other payments made by PAREXEL or
its Affiliates to third parties in connection with the Services (“Pass-Through
Expenses”), provided that PAREXEL shall supply appropriate supporting
documentation consistent with PAREXEL’s standard documentation with respect to
any Pass-Through Expenses as to which PAREXEL requests reimbursement.  Client
will not be required to provide funds exceeding the agreed budget for
Pass-Through Expenses [*], provided, however, that in the event [*], PAREXEL
shall [*].  The budget for Pass-Through Expenses will be modified in accordance
with Section 2.2 if it appears that payments to Sites will exceed the agreed
budget. In addition, PAREXEL shall keep Client reasonably informed of estimated
prospective Pass-Through Expenses on a regular basis to be set forth in the
applicable Work Order.  

6.2All invoiced amounts for Services performed in accordance with the terms and
conditions of this Agreement and any Work Order and any related Pass-Through
Expenses (including Investigator fees) are due net [*] from the date of receipt
by Client of PAREXEL’s electronic invoice, together with appropriate supporting
documentation (as set forth in Section 6.1 above).  If Client identifies items
in an invoice which are disputed, Client will notify PAREXEL in writing, noting
its objection to the disputed item(s) with specificity, within [*] of the date
of the invoice.  All items that are not disputed by Client in writing within
such period shall be deemed to have been approved by Client.  All disputes of
which Client notifies PAREXEL in accordance with this Section shall be addressed
as set forth in Section 20 below.  Client will pay any undisputed portions of
any invoice per the agreed upon payment terms.  Client will pay interest on any
unpaid invoice (including any undisputed portion of a disputed invoice) at the
rate of [*] until such invoice(s) is paid in full.  Payments will be made to
PAREXEL in accordance with the instructions set forth in the applicable Work
Order or such other written instructions as may be provided by PAREXEL from time
to time.

6.3Each party will be responsible for any taxes based on its own net
income/profits. All other taxes and duties incurred by PAREXEL or its Affiliates
with respect to a Project, including those pertaining to PAREXEL’s Service fees,
Pass-Through Expenses or incurred on the movement of Client’s Study Materials
(“Taxes”), will be the responsibility of Client and such Taxes are not included
in any such fees or expenses.    PAREXEL shall be entitled to invoice Client in
respect of such Taxes without mark-up and Client shall reimburse PAREXEL for
such Taxes in accordance with Section 6.2.  PAREXEL will reasonably cooperate
with requests by Client to provide information or documents within PAREXEL’s
control, at Client’s expense, to enable to Client to recover Taxes related to
the Services provided under a Work Order to the extent permitted by law.

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

6.4All payments due hereunder in accordance with the payment schedule of the
applicable Work Order shall be made by Client in the currency that is used in
the applicable Work Order (the “Work Order Currency”).  The parties to the Work
Order acknowledge and agree that all amounts set forth in the Work Order shall
be in Work Order Currency.  In determining the amount payable by Client under a
Work Order for Pass-Through Expenses incurred by PAREXEL in a currency other
than the Work Order Currency, PAREXEL will use a rate of exchange based on the
www.oanda.com exchange rate on the date such Pass-Through Expenses are incurred
by PAREXEL.

6.5In addition to the requirement that Client advance adequate funds for
payments to Sites as set forth in Section 5.6, to the extent that PAREXEL has
agreed to act as payment agent for Client with respect to any other third
parties, or to the extent that PAREXEL has agreed to advance any payments to
third parties in respect of Pass-Through Expenses, Client will provide adequate
funds to PAREXEL in advance for such payments in accordance with a schedule and
budget to be mutually agreed upon in advance between Client and PAREXEL, and
PAREXEL shall only be obligated to make such payments to third parties to the
extent that Client has provided adequate funds to PAREXEL for such payments in
advance.  In the event the funds advanced by Client are insufficient to cover
such payments, Client will promptly pay to PAREXEL the additional amounts
required consistent with the budget (excluding all Taxes) for such payments, and
if Client does not provide funds in time to enable PAREXEL to make timely
payments, Client agrees to be liable for and to reimburse PAREXEL for any
interest and other charges, costs, fees and expenses incurred by PAREXEL because
of such late payment.

7

TERM AND TERMINATION

7.1This Agreement will commence on the Effective Date and will expire on the
fifth (5th) anniversary of the Effective Date unless earlier terminated in
accordance with this Agreement, or unless extended in accordance with the
following sentence.  Any Work Order, the duration of which extends beyond the
expiration or termination of this Agreement, will continue to be performed for
the term of such Work Order, and will continue to be governed by the terms of
this Agreement, which terms shall remain in effect beyond the expiration or
termination of this Agreement solely with respect to such Work Order.

7.2Either party to this Agreement and/or any individual Work Order(s) may
immediately terminate this Agreement and/or such individual Work Order(s),
and/or PAREXEL may suspend performance of Services, for a material breach of
this Agreement or the applicable Work Order(s) by the other party (the
“Breaching Party”), if the Breaching Party fails to cure such material breach
within [*] (or [*] for payment breaches) after receipt of written notice
specifying in reasonable detail the nature of such material breach.

7.3Either party to this Agreement and/or any individual Work Order(s) may
terminate this Agreement and/or such individual Work Order upon [*] written
notice to the other party upon the happening of any of the following events: (a)
PAREXEL may terminate any individual Work Order(s) if PAREXEL reasonably
believes, based on documented serious adverse events in a Study, that
continuation of the Services under the applicable Work Order(s) would pose a
serious safety risk to the health and/or wellbeing of a Project participant in
violation of Applicable Law, (b) if any certificate, authorization, approval or
exemption from a Regulatory Authority required for the conduct of the Services
is revoked, suspended, or expires without renewal, (c) if such party is of the
reasonable opinion that the continuation of the Services would be in violation
of Applicable Law, or (d) upon the other party’s becoming insolvent and/or
unable to pay all material debts when due, including without limitation if the
other party files a petition in bankruptcy, or enters into an agreement with its
creditors, or applies for or consents to the appointment of a receiver or
trustee, or makes an assignment for the benefit of creditors, or suffers or
permits the entry of any order adjudicating it to be bankrupt or insolvent.

7.4Client may terminate this Agreement and/or any individual Work Order(s)
without cause upon [*] prior written notice to PAREXEL.

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

7.5Upon receipt of notice of termination of this Agreement and/or any Work
Order(s) by a party to this Agreement or such Work Order: (a) in compliance with
Applicable Laws and with due care for the safety of Study subjects, the parties
will cooperate to establish a reasonable and mutually acceptable wind-down plan
for Services, and PAREXEL will, as soon as reasonably practicable, discontinue
providing the applicable Services, except to the extent reasonably required to
safely close out a Project (“Closeout Services”), and (b) PAREXEL will terminate
existing third party obligations to the extent practicable and cancelable.  Upon
expiration and/or termination of this Agreement and/or any Work Order, Client
will pay PAREXEL for, or PAREXEL will apply any remaining advance payments to,
all mutually agreed and undisputed (1) Services, (2) non-cancelable costs and
(3) all Pass-Through Expenses actually incurred by PAREXEL up to and including
the completion of Closeout Services, provided that in no event will Client be
obligated to pay Pass-Through Expenses exceeding those set forth in a budget
established in accordance with the applicable Work Order.  Thereafter, any final
payment still owed to PAREXEL, or any refund due Client (including with respect
to any unused advance, Site fees, Pass-Through Expenses or other third party
costs advanced by Client), pursuant to this Section, will be made by Client or
PAREXEL, as applicable, within [*] of the final reconciliation invoice(s) from
PAREXEL.

7.6Termination of this Agreement or of a Work Order for any reason shall not
affect the rights of the parties that have accrued on or before
termination.  Termination of one or more Work Order(s) shall not affect any
other Work Order or this Agreement.

8

CONFIDENTIALITY AND PRIVACY COMPLIANCE

8.1 “Confidential Information” means information that relates to the business,
operations, products, or plans of a party that either is marked as
“Confidential,” “Proprietary” or the substantial equivalent at the time of
disclosure or that a reasonable person would believe to be confidential and/or
proprietary based on the circumstances of its disclosure.  The terms of this
Agreement and any Work Order, including without limitation, pricing, constitute
the Confidential Information of both parties and may not be disclosed by either
party except in accordance with this Article 8 or the other party’s prior
written consent.  PAREXEL Intellectual Property (as defined in Section 9.4)
shall be the Confidential Information of PAREXEL.  Confidential Information will
not include information that (a) is or becomes part of the public domain through
no fault of the recipient; (b) was in the recipient’s rightful possession prior
to disclosure by discloser; (c) is rightfully disclosed to the recipient by a
third party with the right to disclose the information; or (d) is independently
developed by the recipient without use of the discloser’s Confidential
Information.

8.2In the event the receiving party (a) is required by Applicable Law to
disclose the disclosing party’s Confidential Information, including, without
limitation, in accordance with (i) securities laws or regulations and the
applicable rules of any public stock exchange or (ii) to defend or prosecute
litigation or (b) receives a subpoena, other validly issued administrative or
judicial order, or a request pursuant to regulatory audit, requesting
Confidential Information of the disclosing party, then in any such case the
receiving party may, to the limited extent necessary to comply with the
requirements of subsection (a) and/or (b), disclose the other party’s
Confidential Information.  In such event, to the extent practicable and
permitted by Applicable Law or the requesting government agency, the receiving
party shall promptly and prior to any such disclosure, notify the disclosing
party in writing of such request and provide reasonable assistance to the
disclosing party, at the disclosing party’s expense, if the disclosing party
wishes to seek a protective order or similar relief. In the event such
protective order is not granted, the receiving party may disclose only that
information which is legally required to be disclosed as evidenced by the
written opinion of its outside legal counsel. PAREXEL acknowledges and agrees
that Client may be required to publicly disclose certain terms of this Agreement
or a Work Order by Applicable Law, or by regulation or rule of any stock
exchange, such as in Forms 8-K, 10-Q and 10-K (each such disclosure a “Public
Disclosure”), and nothing herein shall preclude Client from doing so to the
extent required by Applicable Law; provided that Client will seek confidential
treatment from the SEC regarding such Public Disclosures to the extent
practicable and permitted by Applicable Law, and will provide advance notice to
PAREXEL of such anticipated Public

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

Disclosure, to the extent permitted by Applicable Law.  To the extent
practicable, Client will reasonably take into consideration PAREXEL’s input with
respect to any confidential treatment request made by Client to the Securities
and Exchange Commission (the “SEC”) requesting that certain information
contained in this Agreement or any Work Order(s) be afforded “confidential
treatment” and thus redacted from Client’s Public Disclosure, to the extent
permitted by Applicable Law.

8.3 Any disclosure of Confidential Information by PAREXEL to institutional
review boards, ethics committees and any Regulatory Authority shall be made (i)
in accordance with the scope of Services expressly permitted under a Work Order,
(ii) as required by Applicable Law and in accordance with the process outlined
in Section 8.2 above, or (iii) as permitted by this Section 8.3. If PAREXEL
reasonably believes [*] the parties will in good faith discuss the [*]. Client
will [*] for discussion [*].  Other than [*], no disclosure [*] prior written
consent.

8.4Client and PAREXEL may use the other party’s Confidential Information only in
connection with its rights and obligations under this Agreement.  Except as
expressly permitted herein, each party will maintain in confidence and will not
disclose the other party’s Confidential Information, using the same degree of
care, but no less than reasonable care, as it uses to protect its own
confidential information of a similar nature.  The receiving party may disclose
the disclosing party’s Confidential Information only to the receiving party’s
Affiliates and its and their respective employees, Board members, vendors,
prospective vendors, Sites, independent contractors, outside consultants
(including its legal counsel, its insurance carriers and agents, investment
bankers, and its financial and accounting advisers) and actual and potential
investors, lenders, acquirors, development and/or commercialization partners and
collaborators who (a) have a need to know such Confidential Information, (b) are
made aware of the Confidential Information’s confidential and/or proprietary
nature and (c) are under an obligation to protect confidential and/or
proprietary information no less restrictive than the obligations set forth
herein.  PAREXEL’s SOP’s constitute PAREXEL’s Confidential Information. If
requested by Client, PAREXEL will provide Client [*] of SOP’s used in the
performance of the Services and online or electronic access to any such SOP’s
requested by Client for review in accordance with PAREXEL’s policies and
procedures.

8.5PAREXEL and Client will comply with all Applicable Laws relating to
collection, processing, transfer and protection of any information relating to
an identified or identifiable natural person (“Personal Data”) such as, but not
limited to, Personal Data of its own employees, employees of the other party,
Study subjects, Site Investigators and research site staff, as such Applicable
Laws relate to the protection of the Personal Data of inhabitants of the
European Economic Area (EEA).  With respect to Personal Data that is received,
collected or Processed in connection with a Project, Client and/or its
Affiliates, PAREXEL agrees to comply, pursuant to its SOPs, with the Data
Privacy Addendum set forth on Attachment E.

8.6The terms and conditions of this Agreement shall apply to any Confidential
Information made available to either party (or its Affiliates) by the other
party (or its Affiliates) during the term of this Agreement and for a period of
[*] thereafter, or such longer period as may otherwise be required by Applicable
Law, including Confidential Information exchanged by the parties or their
Affiliates before, during or after a bid defense or a request for a proposal.  

9

OWNERSHIP

9.1PAREXEL understands and agrees that all right, title and interest in and to
(i) all intellectual property (including without limitation, patents,
copyrights, trademarks, trade secrets, know-how, software, inventions, designs,
utilities, tools, models, methodologies, programs, systems, and specifications)
and all tangible property rights that are owned, developed, or licensed by,
and/or on behalf of, Client and/or its Affiliates prior to, or independent of,
this Agreement or any Work Order, or that are the subject of the Study,
including but not limited to all rights in the Investigational Product and/or
its applications (alone or in combination with other pharmaceutical ingredients,
products, or devices), Study Materials, or the Study (collectively “Pre-Existing
Intellectual Property”), as well as (ii) any improvements, modifications or
enhancement thereto, derived as a direct or indirect result of

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

the performance of the Services, whether generated by Client, PAREXEL, its
Affiliates or Subcontractors, non-administrative Specialty Vendors, or
Client-Designated Vendors, or its or their respective agents or employees,
either solely or jointly with others, but excluding any PAREXEL Intellectual
Property (such improvements referred to herein as “CLIENT Improvements”), are
the sole property of Client.   Collectively, Pre-Existing Intellectual Property
and CLIENT Improvements are referred to herein as “CLIENT Intellectual
Property”.   PAREXEL hereby assigns, and shall require that its Affiliates and
Subcontractors assign, to Client all right, title, and interest it or they may
have or obtain in any such Client Intellectual Property, and acknowledges that
Client Intellectual Property shall be considered Client’s Confidential
Information.  PAREXEL and its employees, agents, Subcontractors, Affiliates and
its and their related personnel, shall upon Client’s request and at Client’s
reasonable expense, execute such documents and take such other actions as Client
deems reasonably necessary for Client to perfect such ownership and to apply
for, secure, and maintain patent or other proprietary protection of CLIENT
Intellectual Property.  PAREXEL shall ensure that each of its employees, agents,
personnel, and any Affiliates and Subcontractors performing any part of the
Services shall have a contractual obligation to assign to Client all CLIENT
Improvements so that PAREXEL can comply with its obligations hereunder, and
PAREXEL shall promptly obtain such assignments.

9.2PAREXEL understands and agrees that all materials, data, information,
reports, records, documentation and/or results (including, without limitation,
Study Data, deliverables under the applicable Work Order (“Deliverables”),
project management documentation, documents submitted to and received from
regulatory authorities, case report forms, project data bases, site regulatory
documentation related to a Study, etc.) generated, prepared or obtained by
PAREXEL as a result of conducting a Project under this Agreement (collectively,
the “Service Records”) shall be the sole and exclusive property of Client;
provided, however, Deliverables and Service Records will not include any PAREXEL
Intellectual Property (as defined below). PAREXEL shall provide any or all
Deliverables and Service Records (including originals thereof) to Client upon
Client’s written request, unless the applicable Work Order provides for an
alternate disposition thereof. Client shall have the right to use Deliverables
and Service Records for any lawful purpose without additional compensation to
PAREXEL beyond the agreed budget amount set forth in the applicable Work Order
for Services actually performed by PAREXEL.

9.3PAREXEL will retain all Client Intellectual Property, Deliverables and
Service Records in confidence and in accordance with all Applicable Laws.  In
particular, and without limitation, PAREXEL will ensure that all electronic
records, as defined in 21 C.F.R. §11.3(a)(6), as amended, are maintained
consistent with the requirements of 21 C.F.R. Part 11, as amended.

9.4Notwithstanding anything to the contrary contained in this Agreement or any
Work Order, PAREXEL retains exclusive ownership of all rights, title and
interest in and to all intellectual property (including without limitation,
patents, copyrights, trademarks, trade secrets, know-how, software, inventions,
designs, utilities, tools, models, methodologies, programs, systems, and
specifications) that is owned, developed, or licensed by, and/or on behalf of,
PAREXEL or its Affiliates prior to, or independent of, PAREXEL’s performance
under this Agreement or any Work Order, even if utilized to provide the Services
(the “PAREXEL Pre-Existing Intellectual Property”), as well as all improvements,
modifications or enhancements to such PAREXEL Pre-Existing Intellectual Property
developed in the course of performing the Services (each a “PAREXEL
Improvement”), provided that in no event shall any such PAREXEL Pre-Existing
Intellectual Property or PAREXEL Improvement [*]. Client hereby assigns to
PAREXEL all right, title, and interest it may have or obtain in any such PAREXEL
Improvements, including, without limitation, any and all intellectual property
rights arising therefrom or related thereto.  The PAREXEL Pre-Existing
Intellectual Property, together with any PAREXEL Improvements, shall
collectively be referred to as “PAREXEL Intellectual Property.”

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

9.5Prior to completion of Services under any Work Order, [*] the retention and
storage of Project documents (including Deliverables, prior to their provision
to Client, and Service Records) according to Applicable Law.  Unless the parties
agree on the terms and conditions under which PAREXEL may provide ongoing
storage services to Client, PAREXEL will return to Client for archiving all
documents relating to the Services performed (according to the Applicable Law of
the participating countries) upon completion of the Services under any Work
Order (or at any earlier point in time when requested to do so by Client in
writing) at Client’s reasonable expense, and thereafter Client will be
responsible for the archiving of such documents.  PAREXEL may retain one copy of
the Project documents, including Confidential Information, if any, to satisfy
regulatory and audit requirements [*]. In addition to the foregoing, to the
extent permitted by Applicable Laws (including GDPR), PAREXEL may store and
process information relating [*]  in the United States or other countries where
PAREXEL conducts business for as long as necessary to comply with PAREXEL’s
legal obligations or business needs.  Any such storage or processing shall be
conditioned upon the express, prior written consent [*].  Client shall have no
responsibility or liability to PAREXEL, its Affiliates or Subcontractors, or any
third party for [*] pursuant to this Section 9.5, except to the extent
specifically set forth in the applicable Work Order to enable the performance of
the Services.  

10

INSURANCE

10.1Each of Client and PAREXEL shall bind and maintain, at its sole expense,
with financially sound and reputable insurers, insurance coverage at the
following minimum limits covering the conduct of its business during the term of
this Agreement and any Work Order, and for a period of [*] following the
termination of this Agreement or any Work Order (whichever is longer).  The
limits below are in United States dollars and may be satisfied when in
currencies other than United States dollars equivalent to the limits stated
below:

(a)Commercial General Liability: [*] per occurrence and [*] in the
aggregate.  Client hereby warrants that the policy includes clinical trials
coverage and does not exclude coverage for any product or compound subject to
any Project.

(b)If Client has marketed products: Product Liability [*] per occurrence (Client
only)

(c)Errors and Omissions: [*] per claim and in the aggregate.  (PAREXEL only)

(d)Client and PAREXEL shall bind and maintain all other statutory insurance
coverage as required by local laws in each country of operation.

10.2In addition, to the fullest extent required in any particular jurisdiction
under Applicable Law, Client will maintain in full force and effect during the
term of the applicable Work Order, insurance coverage for all subjects who have
been enrolled into any Project and/or in whom Project-related procedures are
undertaken as specified in the applicable Protocol, i.e., “clinical trial
insurance”.  PAREXEL will inform Client of those jurisdictions involved in a
Study where such additional insurance is required, if any.

10.3Unless otherwise set forth in the applicable Work Order, Client shall be
responsible for insuring Study Materials provided by Client against loss or
damage, except in the case of negligence or willful misconduct by PAREXEL, its
Affiliates [*].  

10.4Client and PAREXEL will, upon written request from the other party, provide
certificates of insurance evidencing the above required coverage, and showing
the expiration date of each such policy.

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

11

AUDIT

11.1Subject to Section 11.2 below, during the term of this Agreement, upon
reasonable written notice and at times mutually agreed upon by the parties
during PAREXEL’s normal business hours, but no more frequently than [*] every
[*] (except that one additional permitted “follow-on” audit (“Follow-on Audit”)
shall be permitted at no additional cost in the event of material negative
findings in the initial annual audit), Client may, without disruption to
PAREXEL’s normal business operations, audit PAREXEL’s, its Affiliates’, [*]
facilities used to perform the Services, including Project documentation and
Pass-Through Expenses that relate directly to the Services.  As permitted by
Applicable Law and related directly to Services, PAREXEL, its Affiliates, [*]
will provide all information and records reasonably requested by Client to
permit  Client to conduct the audit to Client’s reasonable satisfaction,
including, without limitation, information and records related to PAREXEL’s and
its Affiliates’ oversight and audits of its [*]; any material deficiencies or
weaknesses identified with respect to [*] related to Services; any regulatory
findings or citations, including, but not limited to, U.S. FDA Form 483 notices
or observations; any refusal to file, rejection or warning letters, and the
basis therefor; and any corrective action plans implemented as a result
thereof.  Any such audit results shall be deemed Confidential Information of
PAREXEL hereunder and will be subject to the confidentiality obligations set
forth in this Agreement.  Client will make reasonable efforts to provide a
written report detailing the results of such audit to PAREXEL within [*] after
completion of the audit. If PAREXEL, its Affiliates, [*] receives any regulatory
findings or citations, including but not limited to U.S. FDA Form 483 notices or
observations; or any refusal to file, rejection or warning letters, or similar
notices, affecting or relating to a Study or the Services and/or the facilities
in which the Services are or were conducted, Client shall be entitled conduct a
for-cause audit and inspection of PARAXEL, the applicable Affiliate [*].

11.2Notwithstanding anything to the contrary contained in this Agreement, no
third party auditor used by Client to conduct an audit under this Agreement
(“Third Party Auditor”) will be (a) a competitor of PAREXEL or any of its
Affiliates, or (b) permitted to access or to examine any information, materials
or facilities, until such Third Party Auditor has entered into a reasonable
non-disclosure agreement with PAREXEL, containing terms and conditions
acceptable to the Third Party Auditor and Client and customary in the
industry.  Affiliates of Client shall not be considered Third Party
Auditors.  If the audit is to be conducted by an Affiliate of Client, Client
shall obligate such Affiliate to comply with confidentiality obligations with
respect to such audit that are no less restrictive than the confidentiality
obligations set forth in Section 8 of this Agreement, and shall be liable for
any breach by its Affiliate of those obligations.  Client, its Affiliates, and
its Third Party Auditors will have the right to conduct audits having the scope
of, and according to the processes set forth in, Section 11.1; provided,
however, Client, its Affiliates,  and Third Party Auditors will not be given
access to the confidential information of any third party.

11.3PAREXEL will permit any Regulatory Authority to (a) inspect any of its
facilities where the Services are performed; (b) monitor and/or audit the
conduct of the Project; or (c) inspect, audit and/or copy any and all Project
documents, source documents, work product and required licenses, certificates
and accreditations.  PAREXEL shall, and shall cause its Affiliates, [*], and its
and their employees to, cooperate with any of the foregoing activities and shall
provide timely access to requested documentation and facilities.  PAREXEL will
notify Client promptly if any Regulatory Authority conducts such an inspection
related to Services, audit or visit, whether scheduled or unscheduled, of
PAREXEL, its Affiliates, [*], and to the extent permitted by Applicable Law,
Client will have the right to be present at the opening and closing meeting of
any inspection, audit or visit by a Regulatory Authority that pertains to any
Study or Services conducted by PAREXEL on behalf of Client.  PAREXEL will
provide Client with [*] of any inspection, audit or visit by a Regulatory
Authority that pertains to any Study or Services, and will promptly provide a
detailed written summary of any such inspection, audit or visit related to a
Study or the Services, including, without limitation any regulatory findings or
citations such as  U.S. FDA Form 483 notices, and any refusal to file, rejection
or warning letters, and the basis therefor, and any corrective actions to be
implemented by PAREXEL in response

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

to such findings or citations.  Client will not bear any fees or costs incurred
by PAREXEL for any inspections, audits or visits conducted by a Regulatory
Authority, unless such inspection, audit or visit is conducted solely for the
purpose of auditing Services conducted by PAREXEL on behalf of Client and no
other client, in which case [*] in such fees or costs.  

11.4PAREXEL Service fees and Pass-Through Expenses associated with audits
performed by Client or on behalf of Client, except for Follow-on Audits, are
considered outside the scope of Services, unless specifically defined otherwise
in a Work Order.  Any Service fees or Pass-Through Expenses with respect to
Client audits will be billed at reasonable hourly rates to be agreed upon in
advance by PAREXEL and Client.

12

DEBARMENT

12.1PAREXEL represents that, consistent with Section 306(a) and Section 306(b)
of the Federal Food, Drug and Cosmetic Act (21 U.S.C.  § 335a (a) and 335a (b)),
neither it nor any of its Affiliates, nor its or its Affiliates’ employees
engaged in the performance of Services, is debarred, sanctioned, excluded or
otherwise ineligible to participate in a general healthcare program
(collectively “Debarred” or “Debarment”) and PAREXEL will not knowingly hire any
Debarred individual or entity to perform Services. If PAREXEL, any of its
Affiliates, or Subcontractors, or PAREXEL’s, its Affiliates’ or Subcontractors’
employees or any individuals contracted thereby to perform Services, is Debarred
or receives notice of an action or threat of action of Debarment, PAREXEL shall
immediately notify Client.  The debarment of PAREXEL, its Affiliates, or
Subcontractors, or PAREXEL, its Affiliates’ or Subcontractors’ employees or
individuals retained thereby to perform Services remains in place for a period
of [*] shall be deemed to be a material breach of this Agreement.

13

INDEMNIFICATION

13.1PAREXEL will defend, indemnify and hold harmless Client, its Affiliates and
their respective directors, officers, and employees (“Client Indemnitees”) from
and against all damages, liabilities, judgments, settlements, penalties, and
costs and expenses (including without limitation, reasonable fees and
disbursements of counsel and costs and expenses associated with subpoenas,
document production and testimony) (collectively, “Costs”) incurred by Client
Indemnitees arising out of or in connection with any third party (including
without limitation, government agencies) claims, suits, actions, proceedings,
investigations and/or demands (“Third Party Claims”) arising out of (a) the
material breach of this Agreement or the applicable Work Order(s) by PAREXEL,
its Affiliates or Subcontractors, and/or (b) any negligence or willful
misconduct on the part of PAREXEL, its Affiliates or Subcontractors; provided,
however, that PAREXEL shall have no obligation of indemnity hereunder with
respect to any Third Party Claim to the extent Client is required to indemnify
any PAREXEL Indemnitee (as defined below) for such Third Party Claim as set
forth in Section 13.2 below.

13.2Client will defend, indemnify and hold harmless PAREXEL, its Affiliates, and
their respective directors, officers, and employees (“PAREXEL Indemnitees”) from
and against all Costs incurred by PAREXEL Indemnitees arising out of or in
connection with any Third Party Claims arising out [*], (b) the material breach
of this Agreement or the applicable Work Order(s) by Client, and/or (c) Client’s
negligence and/or willful misconduct; provided, however, that Client shall have
no obligation of indemnity hereunder with respect to any Third Party Claim to
the extent PAREXEL is required to indemnify any Client Indemnitee for such Third
Party Claim as set forth in Section 13.1 above.

13.3The party seeking indemnification for any Third Party Claim covered by this
Section (“Covered Claim”) will promptly notify the indemnifying party in writing
of such Covered Claim.  The indemnifying party will have sole control of the
defense, settlement or compromise of the Covered Claim and the indemnified party
will cooperate with the indemnifying party, at the indemnifying party’s expense,
in the defense, settlement or compromise of the Covered Claim.  Neither party
will settle any Covered Claim without the other party’s prior written consent,
which consent will not be unreasonably

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

withheld, conditioned or delayed.  The failure of an indemnified party to
promptly notify the indemnifying party of any Covered Claim will not relieve the
indemnifying party of its obligations under this Section unless and to the
extent the indemnifying party is materially prejudiced by such failure to
provide notice.  If the indemnifying party fails to inform the indemnified party
of its intent to assume responsibility for the defense of a Covered Claim within
a reasonable time period, and in any event before any response or other action
is required to be made by the indemnified party, the indemnified party shall
have the right to assume such responsibility, at the indemnifying party’s
expense.  

13.4Notwithstanding anything to the contrary contained in this Agreement, if a
conflict of interest exists between the parties with respect to the Third Party
Claim, or if the assumption and conduct of the defense by the indemnifying party
would adversely affect the indemnified party in any manner or prejudice its
ability to conduct a successful defense, then the indemnified party may be
separately represented with respect to such Third Party Claim by legal counsel
reasonably acceptable to the indemnifying party and at the indemnifying party’s
expense.

14

DISCLAIMER AND LIMITATION OF LIABILITY

14.1PAREXEL MAKES NO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO [*].

14.2[*], the aggregate liability of each party and its Affiliates to the other
party, regardless of the theory of liability, for any claim, breach or default
under this Agreement, will be limited to [*] and, except as set forth in Section
3.2, shall not exceed [*].  In no event will either party or its Affiliates be
liable for any lost profits, or for any special, incidental, punitive,
exemplary, consequential or other indirect damages, regardless of whether a
party has been advised of the possibility of such damages.  The aforementioned
limitations shall not apply to the extent such limitations are prohibited by
Applicable Law or in connection with either party’s indemnification obligations
under this Agreement.

15

DELAYS

15.1PAREXEL’s performance under this Agreement or any Work Order may be
contingent upon the performance of obligations by another party, including, but
not limited to, Client itself, Client-Designated Vendors and other third parties
who are not PAREXEL Affiliates or Subcontractors.  To the extent that PAREXEL is
delayed or unable to perform its obligations under this Agreement or any Work
Order as a result of a failure by Client, or a third party who is not an
Affiliate or Subcontractor of PAREXEL, to perform its material obligations, such
delay or failure to perform by PAREXEL, to the limited extent solely
attributable to  such other party’s failure to perform, will not be deemed a
breach by PAREXEL.  In that case, the parties to the Work Order will promptly
cooperate in good faith to either update a CIS Log or negotiate and enter into a
Change Order, as the case may be, pursuant to Section 2 above with respect to
any required changes or additions to the description of Services, budget,
estimated timelines, or payment schedule, or Client may terminate this Agreement
or the applicable Work Order in accordance with Section 7.4.

15.2Neither party to this Agreement and/or any Work Order will be responsible
for any default under this Agreement or such Work Order by reason of strikes,
riots, wars, acts of terrorism, fire, acts of God, acts in compliance with any
Applicable Law, or any other cause beyond its reasonable control, provided that
the affected party shall promptly give notice thereof to the other party, and
shall take commercially reasonable steps to overcome the effects of such event
as soon as possible, and such party’s delay in performance shall be excused only
for the period of delay caused by such event.

15.3If Client delays or suspends the Services to be provided for a period of [*]
or longer and desires to maintain Key Personnel or other staff assigned to the
Services, the parties to the Work Order will agree in writing that certain
PAREXEL staff, including Key Personnel, will continue to be

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

assigned to perform such Services.  In such event, during the period of delay or
suspension, Client will pay a monthly maintenance fee in an amount to be
mutually agreed by the parties.  If such delay or suspension lasts [*], then the
parties will seek to amend the respective Work Order on mutually agreed terms to
accommodate such delay or suspension,  or either party will have the right to
terminate the respective Work Order on [*] prior written notice.

16

PUBLICITY

16.1Except as permitted under Section 8 or as necessary to perform the Services
hereunder (including without limitation for purposes of recruitment of Study
subjects or registration of clinical trials), Client and PAREXEL agree that they
will obtain the other party’s prior written approval before using each other’s
name, symbols and/or marks in any form of publicity.

INDEPENDENT CONTRACTOR

17.1The relationship of the Client and PAREXEL to each other is that of
independent contractors, and nothing contained herein will be construed to
constitute, create, or in any way be interpreted as, a joint venture,
partnership, or business organization of any kind.  Except as expressly provided
for in this Agreement, under no circumstances will the employees or agents of
one party be considered employees or agents of the other party.

18

NON-SOLICITATION

18.1During the term of this Agreement and for a period of [*] following any
termination or expiration of this Agreement, [*] agrees, on behalf of itself and
its Affiliates, not to solicit for employment, employ or otherwise retain any
employee or consultant of the other party or its Affiliates providing (or who
has provided) Services under any Work Order; provided that it will not be a
violation of this Section if an employee or consultant of [*] responds to an
indirect solicitation (e.g., advertisements in media of general circulation).

19

ASSIGNMENT

19.1Either Client or PAREXEL may assign this Agreement without the other party’s
prior written consent to an Affiliate or a successor in interest by reason of
merger, acquisition, partnership, license agreement or otherwise; provided that
no assignment to a direct competitor of the other party will be permitted
without such other party’s prior written consent; and further provided that the
assigning party shall, [*].  Except as expressly permitted by this Agreement or
the applicable Work Order(s), neither party will have the right to assign this
Agreement or any of its rights or obligations hereunder without the prior
written consent of the other party, which consent will not be unreasonably
withheld, conditioned or delayed.  Any attempt at assignment in violation of
this Section shall be null and void.  

20

DISPUTE RESOLUTION

20.1With the exception of any claim for equitable relief or a breach of Article
6 (Confidentiality and Privacy Compliance), if a dispute, claim or controversy
arises between the parties relating to this Agreement or any Work Order or
Exhibit hereto (a “Dispute”), the parties to this Agreement or such Work Order
will promptly meet in the presence of at least one executive or corporate
officer from each party, and attempt to resolve the Dispute in good faith.  All
such efforts at resolution shall be confidential and shall be treated as
compromise and settlement negotiations for purposes of applicable rules of
evidence.  In the event the Dispute is not resolved through negotiation within
[*] after said meeting, the parties will submit to confidential, non-binding
mediation in accordance with the [*] then currently in effect.  Unless the
parties agree otherwise, the mediator will be selected from the [*].  Each party
will designate at least one corporate officer with full authority to resolve the
dispute

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

who will attend and participate in the mediation.  If the Dispute is not
resolved within [*] of the written request for mediation, there is no further
obligation to mediate.

20.2If the Dispute remains unresolved [*] after the written request for
mediation, the Dispute shall be submitted, at the request of either party, to
binding arbitration in accordance with the Commercial Arbitration Rules of the
American Arbitration Association (“AAA Rules”) then currently in effect, by a
sole arbitrator to be appointed jointly by the Parties.  If the parties cannot
agree upon a sole arbitrator within [*] after commencement of the arbitration,
the arbitrator shall be selected by the American Arbitration Association. Such
arbitration shall be conducted in English at [*]. Judgment upon the award
rendered by the arbitrator shall be binding and may be entered in any court
having jurisdiction thereof.  The award shall be rendered in US currency.

21

GENERAL

21.1Notice.  Any notice or communication required or permitted hereunder shall
be in writing and shall be deemed received (a) on the date received if delivered
by a reputable international overnight delivery service, or (b) [*] after the
date postmarked if sent by first class, registered or certified mail, with
return receipt requested.  Notice given under this Section shall be sent to the
parties at the following addresses (or such other address as the applicable
party may provide by written notice):

 

To PAREXEL:

 

PAREXEL International (IRL) Limited

One Kilmainham Square

Inchicore Road

Kilmainham

Dublin 8, Ireland

ATTN: Legal Department

 

With copy to:

 

PAREXEL International

195 West Street

Waltham, MA 02451

U.S.A.

ATTN: [*]

 

To Client:

 

Geron Corporation

149 Commonwealth Drive

Menlo Park, CA 94025

ATTN: [*]

 

 

With a copy to:

Geron Corporation

149 Commonwealth Drive

Menlo Park, CA 94025

U.S.A.

ATTN: Legal Department

Email:  [*]

 

Failure to give notice in accordance with the terms set forth in this Section
where notice in such form is expressly required by this Agreement shall result
in such notice being deemed null and void.

21.2Entire Agreement.  This Agreement, including any Work Order(s) and
attachments hereto, constitutes the entire understanding of Client and PAREXEL
with respect to the subject matter hereof and supersedes and replaces all prior
contracts, agreements, and understandings relating to the same subject matter,
whether written or oral, including without limitation that certain (1) Letter of
Agreement by and between Client and PAREXEL International LLC (“PAREXEL
International”), an Affiliate of PAREXEL, dated August 1, 2018 (the “LOA”) and
(2) Mutual Confidential Disclosure Agreement, by and between Client and PAREXEL
International dated March 21, 2018 (the “CDA”). The parties acknowledge and
agree that the terms and conditions of this Agreement will apply to all Services
performed by PAREXEL under the LOA.  No waiver, consent, change or modification
to this Agreement will be binding, unless in writing and signed by duly
authorized representatives of PAREXEL and Client.  

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Geron Corporation / PAREXEL    

 

21.3Severability.  If any term of this Agreement is declared unenforceable, then
the unenforceability thereof will not affect the remaining terms of this
Agreement.

21.4Waiver.  Failure to enforce any of the terms or conditions of this Agreement
will not constitute a waiver of any such terms or conditions, then or in the
future, or of any other terms or conditions.

21.5Governing Law and Forum; Compliance with Law.  This Agreement will be
governed by and construed in accordance with the laws of the state of New York,
U.S.A. without regard to its conflict of laws provisions.  Unless otherwise
mutually agreed by the parties, Client and PAREXEL hereby consent to the
exclusive jurisdiction of the courts located in New York, New York.  Client and
PAREXEL shall comply with all Applicable Law relating to the Projects and
Services.

21.6Good Faith.  Both parties shall act only in good faith in the performance of
their respective obligations and the exercise of their respective rights under
this Agreement.

21.7Survival.  The following Sections of this Agreement shall survive the
expiration or termination of this Agreement: 5.6, 6, 7, 8, 9, 10 (with respect
to tail coverage), 11.3, 13, 14, 16, 18, 20 and 21.1 and 21.5, as well as any
other provision that, in order to give proper effect to its intent, should
survive such expiration or termination.

21.8Counterparts.  This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original and all of which shall together be
deemed to constitute one agreement.  The parties agree that execution of this
Agreement by industry standard electronic signature software and /or by
exchanging PDF signatures shall have the same legal force and effect as the
exchange of original signatures, and that in any proceeding arising under or
relating to this Agreement, each party hereby waives any right to raise any
defense or waiver based upon execution of this Agreement by means of such
electronic signatures or maintenance of the executed agreement electronically.

[Signatures on following page]

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement through
their duly authorized representatives effective as of the Effective Date.

 

Geron Corporation

 

PAREXEL International (IRL) Limited

By:

 

/s/ Andrew J. Grethlein

 

By:

/s/ Maria King

Name:  

 

Andrew J. Grethlein, Ph.D.

 

Name:

Maria King

Title:  

 

Executive Vice President, Development and Technical Operations

 

Title:

Senior Director

Date:

 

30 Jan 2019

 

Date:

Jan 30, 2019

 

 

 

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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ATTACHMENT A
FORM OF WORK ORDER

{24 pages omitted}

[*]

 

 

Attachment A: Work Order

Page 1

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

ATTACHMENT B
FORM OF CHANGE IN SCOPE LOG

Change In Scope Client Signature Page

 

 

 

 

 

 

 

 

 

 

Protocol No.

0

 

 

 

 

 

 

Client Name

0

 

 

 

 

 

 

PAREXEL Project No.

0

 

 

 

 

 

 

Project Manager

0

 

 

 

 

 

 

CIS No.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Item#

Date Requested and Requestor

CIS Task description

Service Fee (Contract Currency)

Investigator Fees

Pass Through Costs

Date Approved

Client Signature / Title

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Attachment B: CIS Log

Page 1

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 

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ATTACHMENT C
FORM OF CHANGE ORDER

Client Name:

 

Drug Name or Number:

 

Protocol Number:

 

PAREXEL Project Number:

 

Change Order Number:

 

Change Order Date:

 

PAREXEL Project Manager:

 

PAREXEL and Client signed a Work Order dated ______ [as amended].  The parties
wish to amend said Work Order as applicable and hereby agree as follows:

1.The items listed on Change Log #_______, attached as Attachment 1 to this
Change Order, dated  Date shall be incorporated in said Work Order

2.The total contract value changes as follows:

 

Previous Contract Value

Change Order Value

New Contract Value

Service Fees

 

 

 

Estimated Investigator Fees

 

 

 

Estimated Pass-Through Expenses

 

 

 

3.The Payment Schedule shall be replaced in its entirety by the following
Payment Schedule: / The following terms shall be added to the Payment Schedule:

No term or condition other than the above shall be amended by this Change
Order.  

[Insert Client Legal Name]

PAREXEL International (IRL) Limited

By:

By:

Name:

Name:

Title:

Title:

Date:

Date:

 

Attachment C: Change Order

Page 1

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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ATTACHMENT D
Additional Terms for CTSL Services

The parties hereto agree that in those cases where PAREXEL is to provide
clinical trial supplies and logistics services (“CTSL Services”) to Client, the
provision of such CTSL Services shall be governed (i) the applicable provisions
of the Agreement; (ii) the additional provisions as set forth in this Attachment
D; and (iii) the provisions set forth in an exhibit to the Work Order containing
those details (as and if applicable) set forth in Exhibit D of the template Work
Order.

1.

DEFINITIONS

The defined terms used in the Agreement apply to this Attachment D and in
addition:

“Facility” means PAREXEL’s facility(ies) used for the storage and/or
distribution of Study Materials, as further identified in the applicable Work
Order.

“Manufacture/Manufacturing” means the processing or manufacturing of the Study
Materials pursuant to such specifications as set out in the applicable Work
Order.

“Package/Packaging” means the packaging and/or labelling of the Study Materials
pursuant to such Specifications as set out in the applicable Work Order.

“Territory” means the countries set out in the applicable Work Order.

"Waste" means Pharmaceutical Waste as defined in Section 2.3 of the World Health
Organization Handbook on Safe management of wastes from health-care activities
(the “Handbook”).

2.

SERVICES

2.1.PAREXEL will provide to Client the CTSL Services set forth in the applicable
Work Order, which shall include, but not be limited to: specific details of the
CTSL Services to be provided; the Territory; the anticipated volume of Study
Materials subject to the CTSL Services; and the applicable fees for the CTSL
Services.  In the event of any conflict between the documents comprising this
Agreement, the parties will seek to harmonize the applicable documents to
reflect the intent of the parties, but otherwise this Attachment D, together
with the applicable Work Order exhibit incorporating the details (as and if
applicable) of Exhibit D of the template Work Order, shall take precedence in
respect of the CTSL Services but the Agreement shall take precedence in respect
of any other Service.  

2.2.For the avoidance of doubt, as set forth in Section 3.1 and Article 9 of the
MSA, all right, title and interest in and to all of Client’s Study Materials,
whether in the possession of PAREXEL, its Affiliates, Subcontractors, Specialty
Vendors or Client-Designated Vendors, shall at all times remain the sole
property of Client. PAREXEL shall hold, and shall ensure that each of the
foregoing entities holds, such Study Materials on a fiduciary basis as Client’s
bailee. In particular, PAREXEL shall ensure that all the Study Materials are
stored separately  and securely, and clearly distinguished from other stocks and
supplies held by PAREXEL on behalf of itself or other customers. Unless required
by Applicable Law to perform the CTSL Services hereunder, PAREXEL shall not
destroy, deface or obscure any identifying mark or packaging on or relating to
the Study Materials without Client’s prior written consent.

 

Attachment D: Additional Terms for CTSL Services

Page 1

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

2.3.If PAREXEL has not performed agreed upon CTSL Services at all or has not
performed any part of the agreed upon CTSL Services in accordance with the
requirements set out in this Agreement or an applicable Work Order, Client shall
notify PAREXEL in writing within [*] of becoming aware of the non-performance or
the faulty performance (as the case may be) and, if PAREXEL becomes aware of
such non-performance or faulty performance by PAREXEL, PAREXEL shall notify
Client in writing within [*] thereof.   On receipt of such notification from or
to Client, PAREXEL, may, [*]. Client may decline, in its sole discretion, to
have PAREXEL [*], in which case the parties will [*].  If PAREXEL is in good
faith unable to perform the CTSL Services, in whole or in part, for [*], if
appropriate, any CTSL Services that were commenced. In the event of any of the
foregoing circumstances, [*].  PAREXEL will effect such [*] within [*] of the
termination of CTSL Services.

2.4.Where PAREXEL is acting as importer of record or exporter of record in
connection with the CTSL Services, PAREXEL may use its preferred Subcontractors
or Vendors and will reasonably consider, upon Client’s request, but shall not be
obligated to use, Client-Designated Vendors.

2.5.In the event that Client requires that PAREXEL use a Client-Designated
Vendor in connection with any CTSL Service,  and as a consequence, PAREXEL is
required to qualify such Client-Designated Vendor, then Client will bear the
commercially reasonable cost for the qualification by PAREXEL of such
Client-Designated Vendor.  

3.

DELIVERY, ACCEPTANCE AND STORAGE OF PRODUCTS

3.1.Unless otherwise specified in a Work Order, Client shall deliver Study
Materials to the Facility or Study Site(s) mutually agreed by PAREXEL and
Client, in accordance with the Incoterms (“Incoterms 2010”) as specified in the
Work Order.  In the event the CTSL Services involve PAREXEL purchasing Study
Materials on behalf of Client, PAREXEL shall be responsible for obtaining the
delivery of such Study Materials to the relevant Facility in accordance with the
Incoterms 2010 established between PAREXEL and the seller, and Client shall
reimburse PAREXEL for the costs and the expense of such Study Materials and
shipment. If PAREXEL purchases Study Materials, in no event shall Client be
[*].  

3.2.In the event PAREXEL purchases Study Materials on behalf of the Client, any
transfer of legal and economic ownership of such Study Materials shall transfer
to Client upon allocation of such Study Materials to a Project under the
applicable Work Order.  Client shall retain all right, title and interest in and
to Study Materials purchased by PAREXEL on behalf of Client, and except with
respect to the responsibilities and obligations of PAREXEL set forth herein and
in the applicable Work Order, responsibility for all costs, including applicable
taxes and duties, and insurance associated with shipment of such items to the
Facility shall be Client’s responsibility.   For the avoidance of doubt, with
regards to the transfer of Study Materials to Client and any subsequent shipment
of the Study Materials made in accordance with the Agreement and/or the
applicable Work Order, Client shall (i) pay directly to the relevant tax
authority, or (ii) reimburse PAREXEL for, any and all taxes and duties and
insurance incurred in relation to such transfer of such Study Materials.

3.3.All deliveries of Study Materials by Client to PAREXEL shall be supported by
delivery receipts or other documentation provided by Client indicating the
following:

 

(a)

a complete and comprehensive description of the Study Materials and the quantity
of such Study Materials;

Attachment D: Additional Terms for CTSL Services

Page 2

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

(b)

manufacturer information, customs value, applicable codes, quantities, batch
numbers, and expiration dates of the Study Materials as well as identification
of whether the Study Materials are classified as dangerous goods;

 

(c)

all other information, instructions and documents reasonably available to Client
and necessary for PAREXEL to perform its CTSL Services with respect to the Study
Materials under the applicable Work Order.

3.4.Client shall notify PAREXEL in writing prior to any delivery of Study
Materials to PAREXEL’s Facility for storage. The written notice shall state the
expected date and time at which the Study Materials will be delivered to
PAREXEL’s Facility.

3.5.PAREXEL will visually inspect all Study Materials for damage or loss in
transit, ascertain the quantities received, and if applicable, stop temperature
monitoring devices, download readings and check the packaging of physical Study
Materials against specifications in order to verify that the Study Materials
appear to meet the requirements set forth in the applicable Work Order, and that
no temperature excursions or other deviations have occurred in transit. In the
event that any of the Study Materials do not appear to comply with the
requirements or specifications, or appear to have experienced a temperature
excursion or other deviation, PAREXEL shall promptly (but in no event more than
[*]) notify Client in writing thereof and provide any other information
reasonably requested by Client with respect to such Study Materials. Client will
respond promptly (but in no event more than [*]) to PAREXEL with any questions
regarding PAREXEL’s assessment, and PAREXEL will cooperate with Client’s
requests for information and documents to enable Client to assess the status of
the Study Materials.  If Client  concurs with PAREXEL’s conclusion that such
Study Materials are non-compliant, Client will promptly provide instructions as
to any follow-up measures to be taken in connection with any such non-compliant
Study Materials.  If Client does not agree with PAREXEL’s conclusion, the
parties will promptly use commercially reasonable efforts to resolve such
disagreement, commencing with efforts by the Executive Committee. If the
Executive Committee is unsuccessful in resolving the disagreement as to whether
a particular Study Material complies with the requirements set forth in the
applicable Work Order, the dispute resolution provisions set forth  Article 20
of this Agreement will apply.   

3.6.PAREXEL acknowledges that some Study Materials may subsequently be sent to
designated Sites for the performance of a Study.   Unless otherwise stated in
the applicable Work Order, at such time as requested by Client, PAREXEL shall
ship the Study Materials as designated by Client in writing to the relevant
location, and such shipment of the Study Materials shall be in accordance with
Applicable Laws and this Agreement. The method of transport for shipments shall
be determined and agreed to by the parties in an exhibit to the applicable Work
Order incorporating the provisions (if and as applicable) of Exhibit D in the
template Work Order. PAREXEL shall ensure that the Study Materials are properly
prepared for shipment and delivered in a timely manner.

Attachment D: Additional Terms for CTSL Services

Page 3

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

3.7.During the term of the applicable Work Order, PAREXEL shall:

 

(a)

keep all Study Materials properly and securely stored against loss, damage or
theft at its Facility in accordance with Applicable Laws and cGXPs and the
conditions specified in the Work Order and as otherwise required by this
Agreement and instructed by Client in the applicable Work Order;

 

(b)

maintain accurate inventory and tracking records with respect to all Study
Materials;

 

(c)

be responsible for all the costs associated with maintaining and occupying the
Facility;

 

(d)

if required by the Work Order, collect Study Materials from Sites and return
them to the Facility or other facility as may be advised in writing by Client,
for storage until a written request is received from Client for their (a)
subsequent destruction as Waste as per Section 4.1 of this Attachment D, (b)
return to Client or (c) delivery to Client’s agent; and

 

(e)

comply with Applicable Laws and all specifications with respect to such Study
Materials and production thereof stated in the Work Order to the extent that the
CTSL Services include processing, Manufacturing, Packaging, storing, delivering,
transferring or distributing Study Materials.

4.

PRODUCT SECURITY

4.1.Waste.  To the extent the CTSL Services include the handling or disposal of
Waste as set out in the applicable Work Order, the following shall apply:

 

(a)

Waste shall be destroyed by PAREXEL within a reasonable time (without
jeopardizing the CTSL Services) and in accordance with Applicable Law, the terms
of the Work Order and the instructions of Client. Until destruction has taken
place, the Waste shall be stored and handled in a manner designed to prevent
unauthorized access and possible misuse. If Client requires certain security
measures to be taken with respect to Waste, they shall be discussed in advance
and agreed to in the Work Order.

 

(b)

All records and certificates concerning Waste shall be kept for a period of at
least [*] (or longer if requested by Client and at Client’s expense) and made
available to Client upon request.

 

(c)

If PAREXEL requests, in writing, from Client direction with respect to disposal
of any inventories of Study Materials, and PAREXEL is unable to obtain a
response from Client within a reasonable time period after making reasonable
efforts to do so in accordance with the terms of the Agreement (such period not
less than [*] after notice from PAREXEL), then PAREXEL shall be entitled in its
sole discretion to (i) dispose of all such items in accordance with Applicable
Law and guidance, including the Handbook, and (ii) offset all expenses incurred
by and due to PAREXEL or any of its Affiliates from Client against any credits
Client may hold with PAREXEL or any of its Affiliates. PAREXEL has the right,
but not the obligation, to destroy all expired or obsolete Study Materials after
giving written notice to Client of PAREXEL’s intention to do so, if PAREXEL is
unable to obtain a response from Client within a reasonable time period (not
less than [*] after such written notice) after making reasonable efforts to do
so in accordance with the terms of the Agreement.

Attachment D: Additional Terms for CTSL Services

Page 4

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

4.2.Security.

 

(a)

During the term of the applicable Work Order, PAREXEL shall employ all
reasonable and necessary security measures and policies to safeguard the
integrity, accessibility and confidentiality of the Study Materials and
establish and maintain all necessary disaster and emergency recovery plans so as
to avoid any disruption to the CTSL Services.  Upon Client’s reasonable request,
PAREXEL will provide Client with copies of all relevant documentation of its
security measures and policies as well as disaster and emergency recovery and
response plans, including any material updates thereto, and will address in good
faith any requests by Client for additional information.

 

(b)

PAREXEL may only deliver the Study Materials to such persons who are authorized
to receive the relevant Study Materials, as designated in writing by
Client.  PAREXEL may, however, transfer Study Materials to and among its
Affiliates (including its depots), and to its Subcontractors and Specialty
Vendors (if any) performing CTSL Services, to facilitate the CTSL Services and
delivery of Study Materials to their ultimate destination as set forth in the
applicable Work Order provided that PAREXEL provides Client with its written
plan for such transfer to any Facility.  During the term of the applicable Work
Order, PAREXEL will maintain insurance coverage adequate to protect against loss
or damage to Study Materials arising from negligence or willful misconduct by
PAREXEL, its Affiliates or any Subcontractor or Specialty Vendor.

4.3.Rejected and Returned Study Materials.

 

(c)

Any Study Materials that PAREXEL is considering rejecting on the basis of
non-compliance with the requirements of the Applicable Work Order, and any
rejected, surplus, obsolete or out of date Study Materials or those returned to
PAREXEL shall be appropriately identified and kept physically separate in
quarantine in a dedicated area, so as to avoid confusion with other goods and
prevent the Study Materials being sent to any other person.  At Client’s
request, such Study Materials shall be returned to Client or Client’s designee.

 

(d)

Where PAREXEL has any doubt about the compliance of Study Materials with the
requirements set forth in the applicable Work Order, the parties will adhere to
the process set forth in Section 3.5 to establish the compliance or
non-compliance of the Study Materials.  Obsolete or expired Study Materials
shall, if not returned to Client or Client’s designee by PAREXEL pursuant to
Client’s request, be destroyed by PAREXEL in accordance with this Agreement and
Applicable Law in such way that eliminates the possibility of re-use, documents
the destruction, and shall be kept in a secure manner until they have been
destroyed.

 

(e)

PAREXEL shall have in place and comply with a system that meets the requirements
of Applicable Laws and including a written procedure to recall promptly and
effectively Study Materials known or suspected to be defective, with a
designated person(s) responsible for recalls. PAREXEL shall cooperate with
Client in conducting any recall, and Client shall provide PAREXEL with written
authorization to recall any Study Material. In the event of a recall, PAREXEL
shall ensure that all recalled Study Materials at a PAREXEL-controlled site, or
supplied by a Facility, are reconciled and shall provide Client with all
requested information regarding the storage and warehousing of recalled Study
Materials.  PAREXEL shall ensure that recalled Study Materials under PAREXEL’s
control (including the control of its Affiliates and Subcontractors), are
secured and are

Attachment D: Additional Terms for CTSL Services

Page 5

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

subsequently destroyed if required or otherwise handled in accordance with this
Agreement and Client’s instructions.

5.

PAYMENTS

5.1.In addition to all of the payments otherwise required under this Agreement,
exclusive of any taxes imposed upon PAREXEL’s net income, Client shall pay any
and all taxes, duties, or excises, including but not limited to those taxes,
duties or excises imposed upon (a) the CTSL Services, (b) the Study Materials or
their Manufacture, Packaging, testing, production, storage, inventory, sale,
distribution, import/export, transportation, delivery, use, or consumption, and
(c) any payments made by PAREXEL hereunder to any Regulatory Authority,
including without limitation any sales, use, service, value-added, withholding
or similar taxes without any mark-up.  PAREXEL will reasonably cooperate with
requests by Client to provide information or documents within PAREXEL’s control,
at Client’s expense, to enable to Client to recover Taxes related to the
Services provided under a Work Order to the extent permitted by law.

6.

TERM AND TERMINATION

6.1.Within [*] of termination of or expiration of the applicable Work Order,
PAREXEL shall, as requested by Client, destroy, return to or transport to a
location designated by Client all Study Materials. Any Study Materials returned
or destroyed due to the expiration or termination of the applicable Work Order
or at Client’s express request shall be returned or destroyed at Client’s cost
and expense, unless termination was due to PAREXEL’s default.

7.

REPRESENTATIONS AND WARRANTIES

7.1.Client represents and warrants to PAREXEL that as of the commencement of
CTSL Services under the applicable Work Order:

 

(a)

Prior to delivery, it has, [*], provided to PAREXEL, all safe handling
instructions, health and environmental information and Material Safety Data
Sheets of Client applicable to the Investigational Product as well as to any
Study Materials [*];

 

(b)

It has produced, or had produced on its behalf, the Investigational Product in
compliance with all Applicable Laws, and  the Investigational Product shall
comply with all applicable specifications, and shall not be adulterated,
misbranded or mislabeled within the meaning of any Applicable Law prior to
delivery to PAREXEL; and

 

(c)

[*], it has provided accurate and complete information for all Study Materials
to facilitate import/export activities, including but not limited to product
description, customs values, manufacturer information and other applicable
information provided by Client  (collectively, “Trade Compliance Information”)
to facilitate import/export activities that will be conducted by PAREXEL
pursuant to this Agreement and the applicable Work Order.  Client acknowledges
and agrees that PAREXEL will rely on such Trade Compliance Information in its
communications with Regulatory Authorities.

 

Attachment D: Additional Terms for CTSL Services

Page 6

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

ATTACHMENT E
DATA PRIVACY ADDENDUM

 

This Data Privacy Addendum (the “Addendum”) forms part of the Master Service
Agreement entered on January 30, 2019 (the “MSA”) by and between Geron
Corporation (“Geron”), a Delaware corporation with a principal place of business
at 149 Commonwealth Drive, Menlo Park, CA 94025, United States, acting on its
own behalf and as agent for any Geron Affiliate, and PAREXEL International (IRL)
Limited (“PAREXEL”), a corporation organized under the laws of Ireland with a
registered address at 70 Sir John Rogerson’s Quay, Dublin 2, Ireland.  

 

If the provisions of this Addendum and the MSA conflict, then the provisions of
this Addendum shall control with respect to the personal data protection matters
addressed herein.  Capitalized terms not otherwise defined herein shall have the
meaning given to them in the MSA.

 

1.Definitions

In this Addendum, the following terms shall have the meanings set out below and
cognate terms shall be construed accordingly:

1.1“Affiliate” means, with respect to a party, an entity that owns or controls,
is owned or controlled by or is or under common control or ownership with such
party, where control is defined as the possession, directly or indirectly, of
the power to direct or cause the direction of the management and policies of an
entity, whether through ownership of voting securities, by contract or
otherwise.

1.2“Contracted Processor” means PAREXEL, a PAREXEL Affiliate, or a
Sub-Processor;

1.3“Data Protection Laws” means all applicable laws (including decisions and
guidance by relevant Supervisory Authorities) and regulations relating to data
protection, the Processing of personal data and privacy applicable to PAREXEL
and Geron in respect of the Processing of Subject Personal Data under the MSA
and any Work Order, including the GDPR and any other laws and regulations of the
European Union, the EEA and their member states relating to data protection.

1.4“Data Subject Request” means a data subject's request to exercise that
person’s rights under applicable law in respect of that person’s personal data,
including, without limitation, the right to access, correct, amend, transfer,
obtain a copy of, object to the Processing of, restrict the Processing of or
delete such personal data.

1.5“EEA” means the European Economic Area;

1.6“EU” means the European Union;

1.7“GDPR” means Regulation 2016/679 of the European Parliament and of the
Council on the protection of natural persons with regard to the processing of
Personal Data and on the free movement of such data, and references to
“Controller”, “Data Subjects”, “Processor”, “Process”, “Processed” and
“Processing” and “Supervisory Authority” shall have the meanings set out in, and
will be interpreted in accordance with GDPR and any data protection legislation
in a member country introduced to adopt, clarify and/or supplement GDPR from
that date.

Attachment E: Data Privacy Addendum

Page 1

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

1.8 “Personal Data” means any information relating to an identified or
identifiable natural person; an identifiable natural person is one who can be
identified, directly or indirectly, in particular by reference to an identifier
such as a name, an identification number, location data, an online identifier or
to one or more factors specific to the physical, physiological, genetic, mental,
economic, cultural or social identity of that natural person;

1.9“Privacy Shield” means, collectively, the EU-U.S. Privacy Shield Framework
and Swiss-U.S. Privacy Shield Framework self-certification programs operated by
the U.S. Department of Commerce and approved by the European Commission pursuant
to Decision C (2016)4176 dated July 12, 2016 and by the Swiss Federal Council on
January 11, 2017 respectively.

1.10“Regulator” means any regulatory, governmental or supervisory authority,
including, without limitation, any European Supervisory Authority, with
authority over all or any part of (a) the provision or receipt of the Services,
(b) the Processing of personal data in connection with the Services or (c) a
Contracted Processor’s business or personnel relating to the Services.

1.11“Restricted Transfer” means:

1.11.1a transfer of Subject Personal Data from Geron to a Contracted Processor,
or by a Contracted Processor to Geron; or

1.11.2an onward transfer of Subject Personal Data from a Contracted Processor to
a Contracted Processor, or between two establishments of a Contracted Processor,
in each case, where such transfer would be prohibited by Data Protection Laws
(or by the terms of data transfer agreements put in place to address the data
transfer restrictions of Data Protection Laws) in the absence of a legally
accepted transfer mechanism covered in Chapter V of the GDPR;

1.12“Security Incident” means any Contracted Processors’ personal data breach
(as defined in GDPR) or other incident that has resulted, in any accidental,
unauthorized or unlawful destruction, loss, alteration, disclosure of, access to
or encryption of personal data.

1.13“Services” means the services and other activities to be supplied to
Geron  by PAREXEL or by a Contracted Processor on behalf of PAREXEL, pursuant to
the MSA;

1.14“Standard Contractual Clauses” or “SCC” means the EU standard contractual
clauses for Data Processors established in countries pursuant to the European
Commission Decision (2010/87/EC) under the EU Directive (95/46/EC) for the
transfer of personal data from an EEA established controller to processors
established in third countries which do not ensure an adequate level of data
protection, as set out in Schedule 2 or as may be updated or replaced from time
to time.  

1.15“Subject Personal Data” means any Personal Data provided to a Contracted
Processor by or on behalf of Geron in connection with the Services, or that is
acquired, collected, generated or otherwise Processed by a Contracted Processor
on behalf of Geron pursuant to or in connection with the MSA or any applicable
Work Order;

1.16“Sub-Processor” means any person or entity (including any third party and
any PAREXEL Affiliate or Subcontractor) contracted with PAREXEL, or with any
PAREXEL Affiliate, to perform Services involving the Processing of Subject
Personal Data on behalf of Geron in connection with the MSA or any applicable
Work Order; and

Attachment E: Data Privacy Addendum

Page 2

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

1.17The word “include” shall be construed to mean include without limitation,
and cognate terms shall be Processing of Personal Data.

2.Roles of the Parties. The parties acknowledge and agree that with regard to
the Processing of Personal Data to provide Services in connection with the MSA
and any applicable Work Order, Geron (and its Affiliates, where applicable) is
the Controller, PAREXEL (and its Affiliates, where applicable) are the
Processors and that PAREXEL or its Affiliates may engage Sub-Processors pursuant
to the requirements set forth in Section 6 “Sub-Processors” below.

 

Processing of Subject Personal Data.

3.1Each Contracted Processor shall comply with all applicable Data Protection
Laws in the Processing of Subject Personal Data; shall treat Subject Personal
Data as Confidential Information in accordance with the terms of the MSA and
shall only Process Subject Personal Data on behalf of Geron, and in accordance
with Geron’s documented instructions for the following purposes: (i) Processing
in accordance with the MSA and applicable Work Order and (ii) Processing to
comply with other documented reasonable instructions provided by Geron (e.g.,
via email) where such instructions are consistent with the terms of the MSA
and/or the applicable Work Order. Contracted Processors shall not perform
Services in a manner that causes Geron to violate Data Protection Laws.

3.2PAREXEL and its Affiliates shall notify Geron in writing [*] if they believe
that any instruction given by Geron infringes Data Protection Laws.

3.3Contracted Processors will maintain reasonably detailed records of all
Processing activities.

3.4Other than as expressly permitted by the MSA or required by law, no
Contracted Processor shall disclose personal data to any third parties without
Geron’s prior consent.

 

4.Details of the Processing. The subject-matter of Processing of Subject
Personal Data by PAREXEL is the performance of the Services pursuant to the MSA
and the applicable Work Order. The duration of the Processing, the nature and
purpose of the Processing, the types of Subject Personal Data and categories of
Data Subjects Processed, as well as the location of the Processing performed
under this Addendum are further specified in respective Work Orders with an
attachment similar to Schedule 1 (Details of Processing Activities) attached to
this Addendum.

 

5.Rights of Data Subjects.

 

5.1Data Subject Requests. PAREXEL or its Affiliates (if applicable) shall
promptly (in any event without undue delay) notify Geron if any Contracted
Processor receives a request from a Data Subject to exercise the Data Subject's
right of access, right to rectification, restriction of Processing, erasure
(“right to be forgotten”), data portability, object to the Processing, or its
right not to be subject to an automated individual decision making, each such
request being a “Data Subject Request”.  No Contracted Processor shall respond
to such a request except on the documented written instruction of Geron or the
relevant Geron Affiliate or as required by Applicable Laws or Regulator, in
which case PAREXEL or its Affiliate shall inform Geron of that legal requirement
before any Contracted Processor responds to the request.  In addition, PAREXEL
and its Affiliates shall, and shall cause any Sub-processors to, upon Geron’s
request provide such reasonable cooperation and assistance, and take such action
as Geron may reasonably request (including assistance by appropriate technical
and organizational measures) to allow Geron to fulfill its obligations to Data
Subjects or under Data Protection Laws, in respect of such requests or
complaints, including, without limitation, meeting any deadlines imposed by such
obligations.   To the extent legally

Attachment E: Data Privacy Addendum

Page 3

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

permitted, Geron shall be responsible for any reasonable costs arising from
PAREXEL’s provision of such assistance.

 

6.

Processor Personnel.

 

6.1Confidentiality. PAREXEL and each PAREXEL Affiliate shall ensure that all
personnel of any Contracted Processor engaged in the Processing of Subject
Personal Data are informed of the confidential nature of the Subject Personal
Data, have received appropriate training on their responsibilities and have
executed written confidentiality agreements or are subject to professional or
statutory obligations of confidentiality, and that such confidentiality
obligations survive the termination of the personnel engagement.

 

6.2Reliability. PAREXEL shall take commercially reasonable steps to ensure the
reliability of any Contracted Processor personnel engaged in the Processing of
Subject Personal Data.

 

6.3Limitation of Access. PAREXEL and its Affiliates shall ensure that access to
Subject Personal Data is limited to those personnel performing Services who need
to know/access the relevant Subject Personal Data, strictly as necessary for the
purposes of and in accordance with the MSA or the applicable Work Order.

 

6.4Data Protection Officer. PAREXEL and its Affiliates have appointed a data
protection officer. The appointed person may be reached at: Mr. Uwe Fiedler,
Chief Privacy Officer & VP, Data Protection & Privacy; Business phone: [*].  

 

7.

Sub-Processors.

 

7.1Contracting with Sub-Processors. Geron acknowledges and agrees that, subject
to the provisions set forth herein: (a) PAREXEL’s Affiliates may be retained as
Sub-Processors to perform PAREXEL’s obligations to perform Services under the
MSA and applicable Work Orders; and (b) PAREXEL and PAREXEL’s Affiliates
respectively may contract with third-party Sub-Processors to perform PAREXEL’s
obligations to perform Services under the MSA and applicable Work Orders.
PAREXEL or a PAREXEL Affiliate shall enter into a written agreement with each
Sub-Processor containing data protection obligations not less protective than
those in this Addendum with respect to the protection of Subject Personal Data
to the extent applicable to the nature of the Services provided by such
Sub-Processor.

 

7.2List of Current Sub-Processors.  Each Work Order will identify any
Sub-Processors to be used in connection with the Services provided therein.
Without limitation to the terms and conditions of the MSA granting Geron the
right to [*], and subject further to Sections 7.4 and 7.5 below, PAREXEL and its
Affiliates may continue to use those Sub-Processors set forth in a Work Order
and such Sub-Processors shall be deemed approved upon execution of the Work
Order .

 

7.3Notification/Objection Right for New Sub-Processors.  PAREXEL shall give
Geron [*] prior written notice of the desire to contractually engage any new
Sub-Processor, including full details of the Processing to be undertaken by the
Sub-Processor.  Geron may object to PAREXEL’s use of a new Sub-Processor by
notifying PAREXEL promptly in writing within [*] after receipt of PAREXEL’s
notice. In the event Geron objects to a new Sub-Processor, as permitted in the
preceding sentence, PAREXEL will work with Geron in good faith to provide the
Services which avoids the use of that proposed Sub-Processor without
unreasonably burdening Geron, or PAREXEL may propose another new Sub-Processor
in accordance with this provision.  If PAREXEL is unable to make available such
change within a reasonable

Attachment E: Data Privacy Addendum

Page 4

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

period of time, which shall not exceed [*] after PAREXEL’s receipt of Geron’s
objection notice, Geron may, notwithstanding anything to the contrary in the MSA
or the applicable Work Order, [*] with respect to those Services which cannot be
provided by PAREXEL without the use of the objected-to new Sub-Processor, or in
its entirety if the Work Order cannot be performed without such Services, [*]
(other than fees due and owing) to PAREXEL or its Affiliate for Services
performed [*], by providing written notice to PAREXEL. PAREXEL will refund Geron
any prepaid fees covering the remainder of the term of such Work Order following
the [*].

 

7.4With respect to each and every Sub-Processor, PAREXEL, or the relevant
PAREXEL Affiliates shall:

 

7.4.1before the Sub-Processor first Processes Subject Personal Data, carry out
adequate due diligence to ensure that the Sub-Processor is capable of providing
the level of protection for Subject Personal Data required by this Addendum;

7.4.2ensure that the arrangement between on the one hand (a) PAREXEL., or (b)
the relevant PAREXEL Affiliate, and on the other hand, the Sub-Processor, is
governed by a written contract including terms which offer at least the same
level of protection for Subject Personal Data as those set out in this Addendum
and which meet the requirements of Article 28(3) of the GDPR;

7.4.3if that arrangement involves a Restricted Transfer, ensure that PAREXEL’s
or its Affiliate’s Privacy Shield applies.

 

7.5Liability. PAREXEL and its Affiliates shall be [*] for the acts and omissions
of any Sub-Processor to the [*] were performed by PAREXEL or its Affiliates.

 

8.

Security.

 

8.1Controls for the Protection of Subject Personal Data. PAREXEL (and its
Affiliates and approved Sub-Processors) shall maintain and monitor appropriate
technical and organizational measures for protection of the security (including
protection against unauthorized or unlawful Processing and against accidental or
unlawful destruction, loss or alteration or damage, unauthorized disclosure of,
or access to, Subject Personal Data), confidentiality and integrity of Subject
Personal Data, to ensure a level of security appropriate to that risk,
including, as appropriate, access control to systems, access control to data,
disclosure control, input control, job control, availability control, and
segregation control.  PAREXEL shall not (and shall require that its Affiliates
and approved Sub-Processors do not) materially decrease the overall security
given to Subject Personal Data at any time during the performance of the
Services. Without limiting the generality of the foregoing, PAREXEL and its
Affiliates shall comply, and shall require any Sub-Processors to comply with the
requirements set out in Attachment 2 (Security Terms), including its obligation
to notify Geron of any Security Incident.

 

8.2Audits. Subject to Section 11 (“Audit”) of the MSA and upon Geron’s written
request at reasonable intervals, and subject to the confidentiality obligations
set forth in the MSA, PAREXEL and its Affiliates and any Sub-Processors
providing Services) shall make available to Geron all information necessary to
demonstrate compliance with this Addendum, and shall allow for audits, including
inspections, by Geron (or Geron’s authorized independent, third-party auditor
which is not a competitor of PAREXEL and has executed proper confidentiality
agreement before audits) in relation to the Processing of the Subject

Attachment E: Data Privacy Addendum

Page 5

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

Personal Data by the Contracted Process. Geron and its authorized third party
auditors shall treat such information as confidential, and Contracted Processor
may redact information that explicitly identifies any other Contracted Processor
customer in order to preserve its confidentiality obligation to any such
customer.

 

9.

Security Incident Management and Notification.

PAREXEL shall notify Geron without undue delay of when PAREXEL, its Affiliate or
Sub-Processor becomes aware of any Security Incident, and further, shall provide
Geron with sufficient information to allow Geron to meet any statutory
obligations to report or inform Data Subjects and/or Regulators of the Security
Incident under the Data Protection Laws.  The notification of the Security
Incident to Geron shall be by e-mail to the email address(es) identified by
Geron within the MSA or the applicable Work Order. Such notification shall
include, where possible, the categories and approximate number of Data Subjects
concerned, and approximate number of personal data records concerned, the likely
consequences of the Security Incident, and the proposed corrective action taken
by PAREXEL, its Affiliates or Sub-Processors.  PAREXEL (and its Affiliates and
Sub-Processors, as applicable) shall co-operate with Geron and take such
reasonable commercial steps as are directed by Geron to assist in the
investigation, mitigation and remediation of each such Security Incident.

10.

Return and Deletion of Subject Personal Data.

 

 

10.1

Intentionally Omitted.

 

10.2Geron may by written notice to PAREXEL, within [*] of the Cessation Date
require PAREXEL, and each PAREXEL Affiliate (and Sub-Processor, as applicable)
to (a) return a complete copy of all Subject Personal Data to Geron by secure
file transfer in such format as is reasonably notified by Geron to PAREXEL; and
(b) delete and procure the deletion of all other copies of Subject Personal Data
Processed by any Contracted Processor.  PAREXEL, and each PAREXEL Affiliate
shall comply with any such written request within [*] of receipt of such notice,
to the extent allowed by applicable Data Protection Laws.  Each Contracted
Processor may retain Subject Personal Data to the extent required by applicable
Data Protection Laws and only to the extent and for such period as required by
applicable Data Protection Laws and always provided that PAREXEL, and each
PAREXEL Affiliate shall ensure the confidentiality of all such Subject Personal
Data and shall ensure that such Subject Personal Data is only Processed as
necessary for the purpose(s) specified in the Applicable Laws requiring its
storage and for no other purpose.

 

11.

Co-operation with Regulators and Conduct of Claims

11.1PAREXEL and its Affiliates shall, and shall cause any approved
Sub-Processors to, promptly and to the extent permitted by Applicable Law,
notify Geron without undue delay upon receipt of any inquiry or request from a
Regulator that any Contracted Processor receives which relates to the Processing
of Subject Personal Data, the provision or receipt of the Services or either
party's obligations under the MSA, any Work Order or this Addendum, unless
prohibited from doing so by Applicable Law or by the Regulator.  If any
Contracted Processor or Geron receives such an inquiry or request from a
Regulator, PAREXEL and its Affiliates (and any Sub-Processors, as applicable)
shall promptly without undue delay provide Geron with such information as Geron
may reasonably request to satisfy such inquiry or request.

11.2Unless Geron notifies PAREXEL or its Affiliate (or an approved
Sub-Processor, as applicable) that they will be responsible for handling a
particular communication or correspondence with a Regulator or a Regulator
requests in writing to engage directly with PAREXEL or its Affiliate (or
approved

Attachment E: Data Privacy Addendum

Page 6

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

Sub-Processor, as applicable), Geron will handle all communications and
correspondence relating to Subject Personal Data or the Services.

11.3Geron shall have the right, at its sole discretion, to assume control of the
defense and settlement of any governmental or regulatory proceeding or
third-party claim that relates to the Processing of personal data, including
claims against PAREXEL or its Affiliate (or approved Sub-Processor, as
applicable), provided that Geron shall not enter into any compromise or
settlement of such claim or compromise any such claim without the prior written
consent of the Contracted Processor, which consent shall not be unreasonably
withheld or delayed. Geron’s exercise of such right under this clause 11.3 shall
(a) not be construed to require Geron to bear the costs of such defense and
settlement and (b) be without prejudice to its contractual, legal, equitable or
other rights to seek recovery of such costs.    

11.4Where a Contracted Processor interacts directly with a Regulator in
accordance with clause 11.2, it shall do so in an open and co-operative way at
mutually agreed expense and in consultation with Geron.  With respect to such
interaction with a Regulator, such Contracted Processor shall (and shall cause
its Personnel and any Sub-contractors to):

11.4.1make itself readily available for meetings with the Regulator as
reasonably requested;

11.4.2subject to clause 11.4.3 below, answer the Regulator’s questions
truthfully, fully and promptly; and provide the Regulator with such information
and co-operation as the Regulator may require; and

11.4.3where permitted by law, notify Geron of any Regulator’s request for
information relating to Geron or the personal data Processed by Contracted
Processors and before disclosing such requested information, co-operate with
Geron’s efforts to prevent the disclosure of, or obtain protective treatment
for, such information, and comply with Geron’s reasonable instructions regarding
the response to such request.

11.5Data Protection Impact Assessment.  Prior to processing, if Geron reasonably
believes that a Data Protection Impact Assessment per GDPR Article 35, and/or a
Prior Consultation per GDPR Article 36 is/are necessary before processing, or
Geron is required by Supervisory Authority to perform either one or both, Geron
shall immediately notify PAREXEL in writing. Geron and PAREXEL shall discuss in
good faith and reach agreement in respective Work Orders about reasonable
service scope of such cooperation and its corresponding costs before
processing.  According to the WO, PAREXEL shall provide reasonable cooperation
and assistance to Geron with any data protection impact assessments, and
consultations with Regulators or other competent data privacy authorities, which
Geron reasonably considers to be required of Geron by Article 35 or 36 of the
GDPR or equivalent provisions of any other Data Protection Law.  

 

12.

Transfers Outside of the EEA.

 

12.1Restrictions on Transfer.   PAREXEL and its Affiliates (and any approved
Sub-Processor, as applicable) shall not permit Subject Personal Data to be
Processed outside the United States or EEA without Geron’s prior written
consent.  PAREXEL and its Affiliates (and any approved Sub-Processor, as
applicable) shall ensure that any processing of Subject Personal Data outside
the United States or the EEA to which Geron consents complies with Section 12.2.

 

13.Indemnity.  The terms and conditions of Article 13 of the MSA will apply to
indemnification hereunder.

14.Liability.   The terms and conditions of Section 14.2 of the MSA will apply
to limitations of liability hereunder.

Attachment E: Data Privacy Addendum

Page 7

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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15.Term and Termination.

15.1Any breach by a Contracted Processors of this Addendum shall be deemed a [*]
of the MSA.

15.2Upon any termination or expiration of the MSA, PAREXEL, its Affiliates, and
any approved Sub-Processors shall cease all operation on Subject Personal Data
and shall, at Geron’s written direction, return or delete and procure the
deletion, of all copies of Subject Personal Data.

15.3The obligations of PAREXEL, its Affiliates and any approved Sub-Processors
under this Addendum shall expressly survive termination or expiration of the
MSA, for so long as PAREXEL Processes Subject Personal Data.

 

16.

General Terms

 

16.1Governing Law and Jurisdiction. The parties to this Addendum hereby submit
to the choice of jurisdiction stipulated in the MSA with respect to any disputes
or claims howsoever arising under this Addendum, including disputes regarding
its existence, validity or termination or the consequences of its nullity; and
this Addendum and all non-contractual or other obligations arising out of or in
connection with it are governed by the laws of the country or territory
stipulated for this purpose in the MSA.

16.2Order of Precedence. Nothing in this Addendum reduces PAREXEL’s or any
PAREXEL Affiliate’s obligations under the MSA in relation to the protection of
Subject Personal Data or permits PAREXEL, or any PAREXEL Affiliate to Process
(or permit the Processing of) Subject Personal Data in a manner which is
prohibited by the MSA.  Subject to the foregoing, with regard to the subject
matter of this Addendum, in the event of inconsistencies between the provisions
of this Addendum and any other agreements between the parties, including the MSA
and including (except where explicitly agreed otherwise in writing, signed on
behalf of the parties) agreements entered into or purported to be entered into
after the date of this Addendum, the provisions of this Addendum shall prevail.

16.3

Changes in Data Protection Laws.  

16.3.1PAREXEL may, with at least [*] written notice to Geron, from time to time
make any variations to the Standard Contractual Clauses, as they apply to
Restricted Transfers which are subject to a particular Data Protection Law,
which are required, as a result of any change in, or decision of a competent
authority under, that Data Protection Law, to allow those Restricted Transfers
to be made (or continue to be made) without breach of that Data Protection Law;
and

16.3.2Either Geron or PAREXEL may propose any other variations to this Addendum
which such party reasonably considers to be necessary to address the
requirements of any Data Protection Law.

Severance.  Should any provision of this Addendum be invalid or unenforceable,
then the remainder of this Addendum shall remain valid and in force. The invalid
or unenforceable provision shall be either (i) amended as necessary to ensure
its validity and enforceability, while preserving the parties’ intentions as
closely as possible or, if this is not possible, (ii) construed in a manner as
if the invalid or unenforceable part had never been contained therein.

Attachment E: Data Privacy Addendum

Page 8

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.