Document:

Exhibit 10.8

 

Exhibit 10.8

January 10, 2007

Office of Technology Management

University of Massachusetts Medical School

333 South Street, Suite 400

Shrewsbury, MA 01545

Attention: Executive Director

			
	Re:	 	License Agreements between the University of Massachusetts (the “University”) and RXi
Pharmaceuticals, Inc. (the “Company”) dated as of January 10, 2007 (the “License Agreements”)

Ladies and Gentlemen:

     In consideration of the University’s cooperation in the establishment of the Company, the
grant of the licenses by the University to the Company pursuant to the License Agreements, and
other valuable consideration acknowledged by CytRx Corporation (“CytRx”) and the University, CytRx
hereby covenants with University as follows (all capitalized terms not otherwise defined shall have
the meaning set forth in the License Agreements):

1. From the period beginning upon the closing of the Initial Financing and continuing
through the term of the License Agreements, CytRx agrees that it will not vote its shares of
capital stock of the Company or otherwise take steps to elect or have elected individuals
who are (i) employees, officers or directors of CytRx, (ii) employees, officers or directors
of any entity that has a contractual business relationship with CytRx, or (iii) employees,
officers, directors of any entity that has a contractual business relationship with any
officer or director of CytRx (collectively, (i), (ii), and (iii) are “Affiliates”) to
constitute a majority of the Company’s Board of Directors, and, in the event that Affiliates
are elected to hold a majority of the seats of the Company’s Board of Directors, CytRx shall
use reasonable efforts to cause a sufficient number of its Affiliates to resign from their
position as directors of the Company or to cause a sufficient number of independent
directors to be added to the Company’s Board of Directors, so that Affiliates do not
constitute a majority of the Company’s Board of Directors.

2. If at any time following the Initial Financing, CytRx holds a majority of the outstanding
voting power of the Company, it will use reasonable efforts without delay to transfer or
otherwise dispose of a sufficient number of shares of the Company’s voting stock to bring
its ownership of the total outstanding shares of the Company’s voting stock below fifty
percent (50%), subject to the rules and regulations of the Securities and Exchange
Commission and applicable state securities laws.

     The University and the Company agree that the provisions of this letter will become effective
as of the date of this letter.

 

 

			
	UMass Medical School 

Office of Technology Management 

January 10, 2007

Page 2 of 2
	 	UMass Agreement No.: UMMC 07-U-201

     This letter is governed by and construed in accordance with the laws of the Commonwealth of
Massachusetts irrespective of any conflicts of law principles. The parties may only bring legal
action that arises out of or in connection with this Agreement in the Massachusetts Superior Court
in Suffolk County.

     This letter may be executed in counterparts, each of which when executed and delivered shall
be deemed to be an original and all of which when taken together shall constitute but one and the
same instrument.

	 	 	 	 	 	 	 
	 	 	CYTRX CORPORATION	 	 
	 
	 	 	 	 	 	 
	 

	 	By:	 	 	 	 
	 

	 	 	 	 

	 	 
	 

	 	Name:
	 	Steven Kreigsman	 	 
	 

	 	Title:
	 	President & CEO	 	 

	 	 	 	 	 
	AGREED, ACKNOWLEDGED AND ACCEPTED:	 	 
	 
	 	 	 	 
	UNIVERSITY OF MASSACHUSETTS	 	 
	 
	 	 	 	 
	By:
	 	 	 	 
	 

	 	 

	 	 
	Name:

	 	James P. McNamara, Ph.D.	 	 
	Title:

	 	Executive Director	 	 
	 

	 	Office of Technology ManagementExhibit 10.9

 

Exhibit 10.9

Master Agreement for 

Clinical Trials Management Services

This Master Agreement for Clinical Trials Management Services (the “Agreement”) is made and entered
into this 30th day of November, 2006, by and between CytRx Corporation, a corporation of
California with offices at 11726 San Vicente Blvd., Los Angeles, CA 90049 (hereinafter referred to
as “Sponsor”) and Pharmaceutical Research Associates, Inc., a corporation of the Commonwealth of
Virginia, together with its Affiliates with offices at 12120 Sunset Hills Road, Suite 600, Reston,
Virginia 20190 (hereinafter referred to as “PRA”), both hereinafter referred as “Parties”

PRA is engaged in the business of providing services related to the design, management and
implementation of clinical development programs for the pharmaceutical, biotechnology and medical
device industries; and

Sponsor desires to engage PRA to perform such Services in connection with Sponsor’s proposed
maximum tolerated dose study and Phase IIb clinical trial for arimoclomol;

Therefore, in consideration of the premises and mutual promises and undertakings herein,
the receipt and sufficiency of which are hereby acknowledged, the parties intending to be legally
bound do hereby agree as follows:

	1.0	 	Definitions

	 	a.	 	Affiliates: With respect to either party, an Affiliate is any entity
that is controlled by, controls, or is under common control with the party named above.
	 
	 	b.	 	Amendment: A written specification of changes to a Task Order that are
agreed to by the parties and authorized by signature of each party’s authorized
representative(s), in a format substantially similar to Appendix B attached hereto.
	 
	 	c.	 	Authorized Sponsor Representative: An officer of Sponsor who, is
authorized to represent Sponsor and among other things, will maintain regular contact
with the PRA Project Manager in order to follow the progress of the Services, notify
PRA of any changes to the Project Specifications or other components of a Task Order,
and review and approve Amendments.
	 
	 	d.	 	Budget Estimate for Services: A component of a Task Order that
outlines the estimated cost of the Services based upon the Project Specifications.
	 
	 	e.	 	Key Personnel: The key PRA personnel assigned to the Services
including the Project Manager and others as agreed to by the parties.
	 
	 	f.	 	Milestone: An event associated with a specific date, for which a
payment will be due, as set out in the Payment Schedule of any Task Order.
	 
	 	g.	 	Pass-Through Budget: A component of a Task Order that outlines the
estimated costs of pass-through expenses for goods and services incurred by PRA on
behalf of

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	 	 	 	Sponsor, in connection with the performance of the Services, including but not limited
to expenses related to investigator meetings, IRB fees, central laboratory fees,
dedicated or dial-up data connections between PRA and Sponsor, travel, overnight mail
service, telephone usage fees and materials.

	 	h.	 	Payment Schedule: A component of a Task Order that describes the
timing of payments due to be made for Services delivered and pass through costs
incurred.
	 
	 	i.	 	PRA Project Manager: The PRA representative assigned to lead the PRA
project team, act as the principal liaison between PRA and Sponsor, and provide general
oversight in the delivery of Services with regard to a specific Task Order.
	 
	 	j.	 	Project Schedule: A component of a Task Order that outlines the
project milestones, estimated timelines and completion date for the Services based upon
the Project Specifications.
	 
	 	k.	 	Project Specifications: A component of a Task Order that outlines the
specific Services to be provided, assumptions used in preparing the Budget Estimate for
Services, Pass-Through Budget and Project Schedule, and assignment of project-related
responsibilities between the parties.
	 
	 	l.	 	Services: The services to be provided by PRA and its subcontractors
(if applicable) under this Agreement as specifically outlined in a Task Order or
otherwise authorized in writing by Sponsor.
	 
	 	m.	 	Task Order: A written specification of Services to be performed by PRA
under this Agreement, including the Project Specifications, Project Schedule, transfer
of Sponsor obligations, Contact Information, Budget Estimate for Services, Pass-Through
Budget, and Payment Schedule.
	 
	 	n.	 	Time and Materials: A form of pricing whereby Sponsor pays the hourly
rates for Services actually performed according to the current PRA Price Schedule for
Time and Materials Services, which rates shall not be increased during the term of this
Agreement.

	2.0	 	Services

PRA, itself or through one of its Affiliates or subcontractors (if applicable), shall perform the
Services as specified in this Agreement and any associated Task Order(s), in accordance with the
terms and conditions of this Agreement. PRA shall use reasonable efforts to perform the Services
described in any Task Order issued hereunder and to meet all obligations and deadlines described in
such Task Orders. PRA’s inability to meet an obligation and/or established deadline for reasons
not within the control of PRA, any PRA Affiliate or subcontractor shall not constitute a breach of
this Agreement. All Services shall be mutually agreed upon by the parties and authorized in
writing through the execution of a Task Order. PRA shall not begin work on any Services without an
executed Task Order authorizing the Services.

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	2.1	 	Task Orders

PRA will provide Services as specified in one or more Task Orders, which will be prepared in a
format substantially similar to the Form of Task Order, attached hereto as Appendix A. Each Task
Order shall include detailed information with respect to a specific project, including Project
Specifications, Project Schedule, Budget Estimate for Services, Pass-Through Budget, Payment
Schedule, Designation of Key Personnel and transfer of Sponsor Obligations, if required. Task
Orders shall become effective when signed by an authorized representative of both parties.

	 	a.	 	Project Specifications. The Task Order shall provide Project
Specifications, which shall include without limitation, a description of the study
protocol, investigator sites, subjects, case report forms (CRFs), reports and Services
to be provided by PRA. Sponsor acknowledges that the Project Specifications in each
Task Order consist of descriptions, assumptions and assignment of responsibilities
provided to PRA by Sponsor and/or agreed to by Sponsor, that PRA has relied upon this
information in preparing the timelines and budgets outlined in the Task Order, and that
the accuracy and completeness of the Project Specifications are the responsibility of
Sponsor.
	 
	 	b.	 	Transfer of Sponsor Obligations. A Task Order may require PRA to
perform certain responsibilities of the Sponsor with respect to studies performed under
the Federal Food, Drug and Cosmetic Act, as amended (“FDCA”) and 21 C.F.R. Part 312,
Subpart D, and that such responsibilities will be transferred to PRA. Any such
transfer of obligations under the Task Order shall be specified in the associated Task
Order. Sponsor retains responsibility for any and all such responsibilities not
transferred to PRA under the Task Order.
	 
	 	c.	 	Project Schedule.

	 	i.	 	The Task Order shall include major project milestones and target dates
for completion of each Milestone. The parties mutually agree that the timelines in
the Project Schedule are reasonable based upon the Project Specifications. PRA
agrees to use all reasonable efforts to meet target dates for major milestones and
completion of the project as outlined in the Project Schedule. Sponsor agrees to
make all reasonable efforts to respond fully and promptly to PRA’s requests for
information, approvals and other actions, which are reasonably necessary for PRA’s
completion of the Services as outlined in the Project Schedule. Sponsor
acknowledges that any failure to respond to such requests from PRA, which results
in delay or contributes in any material way to the failure of PRA to meet the
timelines specified within the Project Schedule, may result in changes to the Task
Order that are reasonably related to the delay, with a corresponding impact on the
Project Schedule and Budget Estimate for Services which shall be documented in
accordance with Section 2.2 below.
	 
	 	ii.	 	Project Plans and Deadlines: The parties acknowledge that PRA
will prepare a Project Plan which will outline each step of the Services and
allocate a specific amount of time for each step. Continuity of Services may
depend on approval or delivery of information by Sponsor, and Sponsor acknowledges
that some steps in

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	 	 	 	the plan will not proceed unless and until PRA receives the approval or information.
Conversely, other steps in the plan will proceed in the absence of Sponsor’s
approval in the interest of meeting the Project Schedule. Should Sponsor fail to
make a decision, transmit approval or submit information which results in a delay,
Sponsor will be responsible for any additional costs associated with such delays.
Such delays shall not be construed as breaches of this Agreement or any associated
Task Order by PRA. Sponsor agrees that any rework required by PRA which is
attributable to Sponsor’s failure to make a decision, transmit approval or
information, shall be done at Sponsor’s expense.

	 	d.	 	Budget Estimate for Services. Each Task Order shall include a Budget
Estimate for the Services to be performed by PRA and shall include, without limitation,
the costs related to the Services to be provided. PRA agrees not to exceed the total
cost outlined in the Budget Estimate for Services without the prior approval of
Sponsor, unless specifically authorized by Change Notification Form and/or Amendment,
as set out in Section 2.2 below. Sponsor acknowledges that the Budget Estimate for
Services presented in each Task Order is an estimate based upon the Project
Specifications and Project Schedule. Any changes to the Project Specifications,
including without limitation, a request by Sponsor for compression of the timelines or
extensions of the timelines for any reason, may result in changes to the Task Order,
including the Budget Estimate for Services, Pass-Through Budget and/or Project
Schedule, which shall be documented in accordance with Section 2.2 below.
	 
	 	e.	 	Pass-Through Budget. Each Task Order shall include a Pass-Through
Budget, which shall contain an estimate of anticipated pass-through expenses to be
incurred on Sponsor’s behalf in connection with performance of the Services. Sponsor
acknowledges that the Pass-Through Budget contains an estimate based on the Project
Specifications, the Project Schedule, and information supplied by third party
suppliers, and that such costs cannot be predicted with complete certainty at the
outset of a Study. Sponsor agrees to reimburse all of PRA’s actual direct costs for
pass-through expenses incurred in performance of the Services, in accordance with
Section 3.3 below. Amounts included in the Pass Through Budget for any Task Order will
not include social security or other taxes or other amounts which may be due and
payable by PRA to local governmental authorities as a consequence of making payments to
investigators, since these costs cannot be predicted at the outset of a Study. Sponsor
will be notified of all such taxes when assessed, and will be responsible for all such
amounts payable in the same manner as the investigator fees. PRA agrees to notify in
writing Sponsor of any increases or decreases in the Pass-Through Budget upon receipt
of such information from third party suppliers or other sources, as the case may be,
and that such information will be included in an Amendment to the applicable Task
Order.
	 
	 	f.	 	Payment Schedule. Each Task Order shall contain a Payment Schedule,
which will specify the manner and timing of all payments for Services and pass-through
expenses described in the Task Order. Any changes to the Project Specifications, and
corresponding changes to the Budget Estimate for Services or Pass-Through Budget, will
be reflected in a corresponding change in the Payment Schedule.

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	 	g.	 	Contact Information and Designation of Key Personnel. Each Task Order
shall identify the Authorized Sponsor Representative(s) appointed by Sponsor and the
PRA Project Manager, and other Key Personnel as the parties may agree are to be
included. The Authorized Sponsor Representatives(s) are subject to change by Sponsor
at any time upon prior written notice to PRA.

	2.2	 	Amendments

Any changes to a Task Order, including but not limited to changes to the Project Specifications,
Project Schedule, Budget Estimate for Services or Pass-Through Budget, shall be mutually agreed
upon by the parties and documented first in a Change Notification Form (“CNF”), in a form
substantially similar to that attached hereto as Appendix D, and finally in an Amendment to the
Task Order in a form substantially similar to that attached hereto as Appendix B. The CNF shall
include detailed information on the changes to the Project Specifications and any associated
changes to the Project Schedule, Budget Estimate for Services, Pass-Through Budget and Payment
Schedule. Sponsor acknowledges that PRA will not perform any out of scope work described in a CNF
until it is approved in writing by both parties. PRA agrees to prepare Amendments promptly upon
receipt of approved CNFs and Sponsor agrees to promptly review and authorize such Amendments.

	 	a.	 	Unanticipated Changes. Sponsor acknowledges that some changes in costs
associated with clinical research resulting from, for example, modifications to the
study protocol, changes in amounts charged by third party suppliers or poor subject
enrollment due to changes in clinical practices, cannot be reasonably anticipated in
advance. Upon identification by either party of changes to the project assumptions or
other unanticipated changes to the Project Specifications, the parties agree to
negotiate in good faith an Amendment to accommodate increases or decreases to the
Project Budget, Project Schedule or Payment Schedule that are reasonably associated
with any such adjustments. Amendments shall be documented in accordance with the terms
of this Section 2.2. Such unanticipated changes may include, but are not limited to,
any of the following:

	 	i.	 	delays in receiving from Sponsor technical information or Sponsor’s
acceptance of documents submitted by PRA in the performance of its duties under
this Agreement or any Task Order, or any other delay on the part of Sponsor;
	 
	 	ii.	 	delay in receipt of regulatory approval from a regulatory agency,
Institutional Review Board or Ethics Committee;
	 
	 	iii.	 	delay in performance by a subcontractor not selected by PRA;
	 
	 	iv.	 	delay in shipment of study drug and/or clinical supplies;
	 
	 	v.	 	delay due to changes in standard of care imposed by law, regulation or
changes in medical practice affecting participating sites;
	 
	 	vi.	 	by reason of force majeure as defined herein;

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	 	vii.	 	Sponsor requested changes to the Services or protocol;
	 
	 	viii.	 	delays due to questions received by either party from regulatory
agencies or ethics committees regarding submission materials that relate to
characteristics of the study drug or protocol design;
	 
	 	ix.	 	delays due to any changes in applicable law or regulatory environment;
or
	 
	 	x.	 	for any other reason agreed upon in writing by Sponsor.

	 	b.	 	Delays in Finalizing Changes to Project Specifications. Sponsor
acknowledges that material changes in the scope of the Services may require a
considerable effort for the parties to analyze, re-write and agree upon revised Project
Specifications and an associated Amendment. In the event that Sponsor requests a
change to the Project Specifications and authorizes PRA to continue work before the
revised Project Specifications and Amendment are approved, PRA will conduct all such
out-of-scope work on a Time and Materials basis until such time as an Amendment is
executed by the parties. Upon such execution, PRA agrees to apply all such Time and
Materials fees related to the revised Project Specifications to the revised Project
Budget.

	2.3	 	Project Staffing

In performing the Services, PRA shall assign personnel who are adequately trained, qualified and
experienced to conduct the work as specified in a Task Order. Sponsor shall have the right to make
reasonable requests for replacement of assigned personnel for cause, such as unsatisfactory
performance or interpersonal conflicts. PRA agrees to promptly respond to any such request and
make reasonable efforts to correct the situation in order to improve performance, or to provide a
replacement, at its own expense, within a mutually agreeable timeframe.

	 	a.	 	Key Personnel. PRA will assign a PRA Project Manager and other
employees whose participation in a project is required for the duration of the project,
who shall serve as Key Personnel. Key Personnel may include, without limitation, Lead
Clinical Research Associates, Lead Data Managers, Medical Monitors and Lead
Biostatistician. PRA agrees to provide thirty (30) days notice to Sponsor, whenever
practical, of any changes to the Key Personnel, but will make reasonable efforts to not
change Key Personnel unless requested by Sponsor. PRA will provide project-specific
training to replacement Key Personnel at its own expense.
	 
	 	b.	 	Project Team. PRA will assign non-Core Team project personnel at its
sole discretion, from one or more of its offices located worldwide, as needed to
perform the Services in accordance with the Task Order.
	 
	 	c.	 	Use of Contract Employees. PRA may, at its own discretion, assign some
elements of the Services to contract employees. PRA agrees that any contract employees
used to perform the Services will be adequately qualified, experienced and trained as
required to perform the Services in the same manner as PRA qualifies and trains its own
employees. PRA shall remain responsible for satisfactory performance of all Services
performed by contract employees.

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	2.4	 	Use of Sub-Contractors

PRA may use sub-contractors to conduct some elements of a Task Order, including without limitation,
clinical laboratories, patient recruitment services, interactive voice recognition (IVR) systems
and other services. PRA agrees to notify Sponsor in advance of its use of sub-contractors. In the
event that Sponsor objects, for reasonable cause, to any such PRA sub-contractors, PRA agrees to
make reasonable efforts to replace the sub-contractor within a mutually agreeable timeframe.

	 	a.	 	Sponsor-Selected Sub-Contractors. In the event that Sponsor contracts
directly with a sub-contractor or requires PRA to use a specific sub-contractor, PRA is
not responsible for any performance of this sub-contractor, and Sponsor agrees to
manage the performance of the sub-contractor and be responsible for any delays or
changes to the Project Schedule or Project Budget that result from the performance of
the sub-contractor. PRA agrees to notify Sponsor promptly of any performance issues
arising out of the use of any such sub-contractors. If Sponsor engages a
sub-contractor, but requires that PRA manage or oversee the performance of the
sub-contractor, then Sponsor shall supply PRA with a copy of the relevant contract with
the sub-contractor.
	 
	 	b.	 	PRA-Selected Sub-Contractors. For sub-contractors selected and
contracted directly by PRA, PRA is responsible for the performance and agrees to manage
the performance of the subcontractor.

	2.5	 	Applicable Standard Operating Procedures

The parties agree that PRA will provide the operational systems, processes and standard operating
procedures to be used in performance of the Services unless specified otherwise in the Project
Specifications.

	2.6	 	Sponsor-Provided Systems

In the event that Sponsor requires PRA to use Sponsor’s information systems and associated
processes, Sponsor is responsible for all costs associated with installation and operation of the
systems, including costs for hardware and software licenses, and for training of PRA personnel
assigned to the project in the use of Sponsor system(s).

	3.0	 	Payment

The parties acknowledge that the fees and other reimbursements that PRA will receive for performing
the Services hereunder will be outlined in each Task Order, will constitute full and complete
consideration for those Services, and are subject to the following terms and conditions. PRA
agrees that its fees will not exceed the Budget Estimate for Services and the pass through items
charged will not exceed the amounts included in the Pass-Through Budget in a Task Order or
associated Amendment without the prior approval of Sponsor.

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	3.1	 	Payment Schedule

Sponsor agrees to pay for Services and pass-through expenses in accordance with the payment
schedule outlined in each Task Order or associated Amendment.

	3.2	 	Invoices

	 	a.	 	Invoices for Services and pass-through expenses shall be submitted in
accordance with the Payment Schedule associated with the relevant Task Order and shall
be prepared monthly, or as frequently as necessary, in the format shown in Appendix C,
attached hereto. Any final payments specified in the Task Order will be invoiced upon
completion of the project and delivery to Sponsor of any final study databases, reports
or other deliverables as specified in the Project Specifications. If a final payment
is specified in a Task Order, it will be due within thirty (30) days of Sponsor’s
receipt of invoice unless Sponsor notifies PRA in writing of any deficiencies in the
Services. PRA shall correct any such deficiencies within thirty (30) days of notice
and resubmit the final invoice to Sponsor immediately upon final shipment of the
corrected project deliverable(s).
	 
	 	b.	 	All invoices under this Agreement shall be forwarded to the Sponsor
representative designated in the relevant Task Order.
	 
	 	c.	 	All payments under this Agreement shall be remitted to the PRA affiliate named
in the Task Order, to the address and manner set forth in the Payment Schedule of the
applicable Task Order.

	3.3	 	Pass-Through Expenses

	 	a.	 	Pass-Through Expenses. In order to provide funding for pass- through
expenses, Sponsor agrees to make an advance payment to PRA of ten percent (10%) of the
Pass-Through Budget related to all pass-through expenses immediately upon execution of
a Task Order. PRA will submit to Sponsor monthly invoices for amounts incurred during
the relevant billing period. The advance payment will be retained by PRA until the
completion of the Services, at which time a reconciliation of expenses will be done to
ensure that Sponsor pays for only those expenses actually incurred. The 10% advance
payment will then be applied to the final invoice, if unpaid, and any remaining advance
payment will be refunded to Sponsor within thirty (30) days from the date of the final
reconciliation.
	 
	 	b.	 	Sponsor shall reimburse all travel expenses in accordance with PRA’s applicable
Travel and Expense Policy, as shown on monthly invoices. Copies of travel related
receipts will not be provided unless specifically requested by Sponsor, and Sponsor
agrees to pay a reasonable administrative service fee for any such requested copies.

	3.4	 	Investigator Grants and Reconciliation.

In order to provide for timely payments to investigators, Sponsor agrees to make an advance payment
to PRA of ten percent (10%) of the amounts required for investigator grants

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immediately upon execution of a Task Order. PRA will submit to Sponsor quarterly invoices in
advance for estimated amounts to be paid to investigators to be incurred in the upcoming quarter to
ensure that adequate funds are available to pay such expenses. Sponsor acknowledges that PRA will
not make payments to investigators without sufficient funds available. The advance payment will be
retained by PRA until the completion of the Services, at which time a reconciliation of expenses
will be done to ensure that Sponsor pays for only those expenses actually incurred. The 10% advance
payment will then be applied to the final invoice, if unpaid, and any remaining advance payment
will be refunded to Sponsor within thirty (30) days from the date of the final reconciliation.

	3.5	 	Payment Terms

Sponsor agrees to pay for all Services, pass-through expenses and other correctly invoiced items
within thirty (30) days of receipt of invoice. All payments shall be made in the currency noted in
the Payment Schedule of the Task Order. All fees for Services and pass-through expenses are
exclusive of VAT (including non-refundable VAT), local taxes, charges or remittance fees, which
Sponsor agrees to pay when applicable. PRA reserves the right to charge interest against any
unpaid overdue balance a the rate of one percent (1.0%) per month, except against amounts
reasonably withheld by Sponsor due to PRA’s failure to provide Services in accordance with the
applicable Task Order.

	3.6	 	Project Delays

	 	a.	 	In the event that Sponsor requests temporary cessation of work due to clinical
holds imposed by regulatory authorities or any other reason, Sponsor acknowledges that
certain activities, such as site maintenance and database maintenance, may continue
during the delay and agrees to pay the expenses associated with this maintenance. In
addition, Sponsor shall have the option to request that PRA hold the Key Personnel, for
up to sixty (60) days, so that they remain available to re-initiate work immediately
upon notice by Sponsor. Sponsor agrees to pay to PRA a monthly fee equal to the
standard hourly rate for each of the Key Personnel held by Sponsor In the event of a
project delay where Sponsor does not agree to hold the Key Personnel, PRA may re-assign
the staff to other projects.
	 
	 	b.	 	The parties agree to cooperate with one another in fulfilling their respective
obligations under this Agreement and each Task Order issued hereunder. The parties
acknowledge that, in certain instances, timely and complete performance depends upon
cooperation between PRA and Sponsor. Therefore, in the event PRA does not meet a
Milestone which is attributable to:

	 	i.	 	Any event or circumstance described in Section 2.2 a.; or
	 
	 	ii.	 	Sponsor’s failure to cooperate with PRA in the performance of Services
undertaken by PRA within the timelines and budget provided for in the affected Task
Order; or

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	 	iii.	 	Sponsor’s failure to perform its obligations under this Agreement, or
any affected Task Order,
	 
	 	 	 	then PRA will not be accountable for such delay and the parties agree to make
appropriate modifications to the Project Specifications, Project Schedule, Budget
Estimate for Services and/or Pass-Through Budgets attached to the affected Task
Order, pursuant to Section 2.2.

	3.7	 	Accounting Records

PRA will maintain true and complete financial records relating to the Services performed under this
Agreement, including pass-through expenses and labor hours applied in connection with any Task
Order(s). Sponsor shall have the right to audit, at any reasonable time during normal business
hours and upon at least ten (10) business days prior written notice to PRA, on a confidential
basis, such records for the purpose of verifying the amounts charged under this Agreement. If any
such audit reveals that the amounts charged to Sponsor for any Task Order exceed 110% of the actual
amount owed for such Task Order, then PRA shall reimburse Sponsor for the documented costs of the
audit. In addition, within fifteen (15) days of the end of each calendar quarter during the term
of this Agreement, PRA shall deliver a notice to Sponsor setting forth, with respect to each open
Task Order, the approximate percentage of the Services completed.

	3.8	 	Exchange Rate Fluctuation

The value of the Budget Estimate for Services assumes exchange rates as detailed herein.
Immediately prior to execution of a Task Order, the exchange rates will be updated to reflect those
in effect at that time (the “Task Order Exchange Rates”). PRA reserves the right to modify the
Task Order Exchange Rates semi-annually beginning six months after execution of the Task Order.
The modified Task Order Exchange Rates will be derived from the average exchange rates for the
30-day period prior to each semi-annual anniversary date (the “Modified Task Order Exchange
Rates”). Further, PRA reserves the right to monitor the variance between (a) the exchange rates in
effect for each six month period and (b) the actual exchange rates in effect at the invoice dates
during each six month period. If the variance is greater than five percent (5%), PRA may quantify
the variance denominated in the contract currency and issue a credit memorandum or invoice. The
Modified Task Order Exchange Rates will be determined by using the Oanda.com FXHistory tool. All
other exchange rates will be taken from the Oanda.com midpoint closing rate.

	4.0	 	Term and Termination
	 
	4.1	 	Term

Unless earlier terminated according to Section 4.2, 4.3 or 4.4 below, this Agreement shall remain
in effect from the date first written above, until completion of all Services described herein.

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	4.2	 	Termination without Cause

This Agreement or any Task Order issued hereunder may be terminated by Sponsor for any reason upon
thirty (30) days’ written notice to PRA. Should Sponsor terminate this Agreement or a Task Order
without cause, the termination process and associated fees shall be as follows:

	 	a.	 	Sponsor and PRA shall meet within fifteen (15) days of PRA’s receipt of such
termination notice to develop a plan for (a) closing down administration of this
Agreement or (b) closing down the Study which is the subject of the terminated Task
Order, which shall include transferring any remaining tasks or other responsibilities
to Sponsor or its designee.
	 
	 	b.	 	Upon early termination of a Task Order, Sponsor will pay to PRA all sums due
and owing for Services and pass-through expenses incurred in the performance of the
terminated Task Order, and in the course of winding down or closing out a Task Order;
provided that PRA shall immediately cease work and cease incurring expenses upon
receipt of notice of termination from the Sponsor.

	4.3	 	Termination for Default By PRA

Failure of PRA to comply with any of the material terms or conditions of this Agreement shall
entitle Sponsor to give written notice of default via certified/return receipt mail or overnight
courier to ensure receipt by PRA. If PRA does not cure the default within thirty (30) days of
receipt of notice, this Agreement may be terminated by Sponsor, which will not be obligated to pay
the early termination fees pursuant to Section 4.2 above. Provided, however, that Sponsor agrees
to pay PRA for all Services rendered and pass-through expenses incurred pursuant to this Agreement
or any terminated Task Order through the date of notice of termination (excluding any wind down
expenses); provided, however, that such payment shall in no way limit Sponsor’s rights under this
Agreement to recover damages resulting from PRA’s default. Sponsor further agrees to pay for
Services and pass-through expenses necessary to conduct an orderly winding down of the
administration of this Agreement, or any terminated Task Order, which amount shall not exceed the
remaining unpaid balance of the Budget Estimate for Services of the Task Order, unless special
circumstances warrant otherwise. As soon as practicable following receipt of notice of
termination under this Section 4.3, PRA will submit an itemized accounting of costs incurred, costs
anticipated, and payments received in order to determine a balance to be paid by either party to
the other. Such balance will be paid within thirty (30) days of completion of work.

	4.4	 	Termination for Default by Sponsor

Failure of Sponsor to comply with any of the material terms or conditions of this Agreement or to
fail to respond to PRA’s inquiries or requests for information shall entitle PRA to give written
notice of default via certified/return receipt mail or overnight courier to ensure receipt by
Sponsor. If Sponsor does not cure the default within sixty (60) days of receipt of notice or for
such reasonable amount of time thereafter, if the default is not susceptible of cure within sixty
(60) days,, this Agreement may be terminated by PRA, and Sponsor shall pay to PRA all amounts due
and owing for Services performed, pass-through expenses incurred, costs associated

Page 11 of 21

 

with winding up activities and the early termination fee, described in Section 4.2 above, as well
as any late fees which may be due, pursuant to Section 3.4 above.

	4.5	 	Survival

Expiration or termination of this Agreement will not relieve the parties of any obligation accruing
prior to such expiration or termination. In addition, Sections 4.0, 7.1, 7.2, 8.0, 9.0, 11.0,
13.0, 14.0, 16.0, 17.0, 18.0, 19.0 and 22.0 will survive expiration or termination of this
Agreement indefinitely, or for the period of time noted in the specific clause.

	5.0	 	Representations and Warranties
	 
	5.1	 	Acknowledgments

Sponsor acknowledges that the results of the Services to be provided hereunder are inherently
uncertain and that, accordingly, there can be no assurance, representation or warranty by PRA that
the drug, compound, device or other material which is the subject of research covered by this
Agreement or any Task Order issued hereunder can, either during the term of this Agreement or
thereafter, be successfully developed or, if so developed, will receive the required approval by
the United States Food and Drug Administration (FDA) or other regulatory authority. Sponsor
acknowledges that PRA makes no warranties regarding the Services to be performed hereunder other
than those expressly set forth herein.

	5.2	 	Representations and Warranties of Sponsor

	 	a.	 	Sponsor represents and warrants that it has the right, title and interest in
the drug, compound, device or other material which is the subject of research covered
by this Agreement or any Task Order and that it has the legal right, authority and
power to enter into this Agreement, and to perform any clinical trial which is the
subject of a Task Order issued hereunder.
	 
	 	b.	 	In all instances in which a Task Order includes Services which require PRA to
act as Sponsor’s representative in any jurisdiction before any regulatory or
governmental agency, for the purposes of, inter alia, seeking approval for conducting a
trial, importation of study drug into a particular country, or for any other reason,
Sponsor warrants that it shall supply to PRA all information necessary to support
applications or submissions so made to such regulatory or governmental agencies.
Sponsor further warrants that all information supplied to PRA for whatever purpose
will, to the best of its knowledge, be complete, accurate, true and correct, and
entirely free from defect, and that Sponsor shall provide assistance to PRA of whatever
nature PRA deems necessary, during the course of such representation.
	 
	 	c.	 	If Sponsor requires PRA to use MedDRA to code, analyze or report data for a
Study, Sponsor represents and warrants that it has a current and valid license
agreement with the Maintenance and Support Services Organization (“MSSO”) to use
MedDRA. Furthermore, if PRA is required to use WHO Drug, WHO Herbal or WHO ART for
coding of data, Sponsor warrants and represents that it has a current and valid license
agreement with The Uppsala Monitoring Centre for the dictionaries which PRA will

Page 12 of 21

 

	 	 	 	be required to use. If Sponsor does not currently have such licenses, it hereby
represents that such licenses will be in place prior to PRA’s delivery of data which is
coded using these dictionaries. PRA is in no occasion liable to Sponsor for wrongful use
of data coded using these dictionaries as a result of lack of licenses of Sponsor, and
Sponsor will hold PRA harmless in these occasions.
	 
	 	d.	 	Sponsor further warrants and represents that for any software application,
computer system or program that is required to be used by PRA in the performance of
Services, it shall have acquired and will maintain current and valid licenses which are
necessary for the legitimate use of such applications or programs, and that PRA’s use
of such applications or programs will not subject PRA to any liability for improper
use.

	5.3	 	Representations and Warranties of PRA

	 	a.	 	PRA warrants that it will render the Services in accordance with high
professional standards and that the Services will be completed in conformance with the
terms of this Agreement and any Task Order issued hereunder.
	 
	 	b.	 	PRA warrants that the personnel assigned to perform Services rendered under
this Agreement shall be capable professionally and that it has sufficient personnel and
resources to perform the Services in a timely fashion.
	 
	 	c.	 	PRA further warrants that it will perform the Services in compliance with all
applicable laws and regulations and that it will make available to Sponsor or to the
responsible regulatory authority relevant records, programs, and data as may be
reasonably requested by Sponsor for purposes related to filing and prosecution of
Sponsor’s related new drug applications.
	 
	 	d.	 	The warranties contained in this Section are in lieu of all other warranties
expressed or implied.

	6.0	 	Debarment Certification

	 	a.	 	PRA hereby certifies that it has not been debarred under Section 306 of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §335a(a) or (b). In the event that PRA
becomes debarred, PRA agrees to notify Sponsor immediately.
	 
	 	b.	 	PRA hereby certifies that it has not and will not use in any capacity the
services of any individual, corporation, partnership, or association which has been
debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C §335a
(a) or (b). In the event that PRA becomes aware of or receives notice of the debarment
of any individual, corporation, partnership, or association providing services to PRA,
which relate to the Services being provided under this Agreement, PRA agrees to notify
Sponsor immediately.

Page 13 of 21

 

	7.0	 	Inspections
	 
	7.1	 	Inspection by Sponsor

PRA agrees to permit representatives of Sponsor who are not competitors of PRA to examine, at any
reasonable time during normal business hours and subject to at least ten (10) business days prior
written notice to PRA, (i) the facilities where the Services are being conducted; (ii) related
study documentation; and (iii) any other relevant information necessary for Sponsor to confirm that
the Services are being conducted in conformance with applicable standard operating procedures, the
specific Task Orders, this Agreement and in compliance with applicable laws and regulations. PRA
shall provide copies of any materials reasonably requested by Sponsor during such inspection.

	7.2	 	Inspection by Regulatory Authorities

PRA agrees to permit regulatory authorities to examine, (i) the facilities where the Services are
being conducted; (ii) study documentation; and (iii) any other relevant information, including
information that may be designated by one or both of the parties as confidential, reasonably
necessary for regulatory authorities to confirm that the Services are being conducted in compliance
with applicable laws and regulations. Each party shall immediately notify the other if any
regulatory authority schedules, or without scheduling, begins such an inspection, and PRA shall
permit Sponsor to participate in any meetings with such regulatory authorities.

	8.0	 	Disposition of Computer Files and Study Materials

PRA will take reasonable and customary precautions, including periodic backup of computer files, to
prevent the loss or alteration of Sponsor’s study data, documentation, and correspondence, but PRA
cannot guarantee against any such loss or alteration. Upon termination of this Agreement, PRA will
dispose of Sponsor computer-stored files and study materials according to PRA’s internal standard
operating procedures; provided that none of the foregoing items shall be disposed of without giving
Sponsor at least thirty (30) days prior written notice. Sponsor may communicate any special
request for the disposition of materials in writing to PRA. Sponsor shall bear all costs incurred
by PRA in complying with any such written instructions furnished by Sponsor. PRA will provide a
written estimate to Sponsor, and Sponsor will provide written approval, of all such costs prior to
any action by PRA.

	9.0	 	Ownership and Confidentiality
	 
	9.1	 	Ownership of Data and Intellectual Property

All data (including without limitation, written, printed, graphic, video and audio material, and
information contained in any computer database or computer readable form) generated by PRA in the
course of conducting the Services (the “Data”) and related to the Services shall be the property of
Sponsor. Any copyrightable work created in connection with performance of the Services and
contained in the Data shall be considered work made for hire, whether published or unpublished, and
all rights therein shall be the property of Sponsor as employer, author and owner of copyright in
such work.

Page 14 of 21

 

PRA understands and agrees that the underlying rights to the intellectual property and materials
that are the subject of each Task Order, including, without limitation, all intellectual property
rights in Sponsor’s drug candidates or products, are owned solely by Sponsor. Neither PRA, its
Affiliates nor any of their respective subcontractors shall acquire any rights of any kind
whatsoever with respect to Sponsor’s drug candidates or products or proprietary information as a
result of conducting Services hereunder. All rights to any know-how, trade secrets, developments,
discoveries, inventions or improvements (whether or not patentable) conceived or reduced to
practice in the performance of work conducted under this Agreement by PRA’s or its Affiliates’
employees, or independent contractors, either solely or jointly with employees, agents, consultants
or other representatives of Sponsor (the “Intellectual Property”), will be owned solely by Sponsor,
and PRA shall promptly notify Sponsor in writing of any such information. PRA, its Affiliates and
their respective employees and subcontractors shall sign and deliver to Sponsor all writings and do
all such things as may be necessary or appropriate to vest in Sponsor all right, title and interest
in and to such Intellectual Property. PRA will promptly disclose to Sponsor any such Intellectual
Property arising under this Agreement. Sponsor may, in its sole discretion, file and prosecute in
its own name and at its own expense, patent applications on any patentable inventions within the
Intellectual Property. Upon the request of Sponsor, and at the sole expense of Sponsor, PRA will
assist Sponsor in the preparation, filing and prosecution of such patent applications and will
execute and deliver any and all instruments necessary to effectuate the ownership of such patent
applications and to enable Sponsor to file and prosecute such patent applications in any country.

Notwithstanding the foregoing, Sponsor acknowledges that PRA possesses or may in the future possess
analytical methods, computer technical expertise and software, which have been independently
developed by PRA and which will remain the sole and exclusive property of PRA, except to the extent
that improvements or modifications include, incorporate or are based upon Sponsor’s information or
are specifically incorporated into the deliverables of the Services. Sponsor may use this
information of PRA free of charge for interpretation purposes or regulatory authorities’ purposes
or for any purposes that is appropriate within the scope of this Agreement. Any improvement on
information of Sponsor shall remain de sole property of Sponsor.

	9.2	 	Sponsor Confidential Information

	 	a.	 	Sponsor may provide confidential information to PRA during the course of this
Agreement. All information provided by Sponsor or data collected by PRA for Sponsor
during the performance of the Services is deemed to be the confidential information of
Sponsor when designated “Confidential” and is hereinafter referred to as “Sponsor
Information”. PRA shall not disclose Sponsor Information to any person other than its
employees, agents, and independent contractors involved in the Services or use any such
information for any purpose other than the performance of Services without the prior
written consent of Sponsor.
	 
	 	b.	 	PRA shall ensure that it and its Affiliates’ employees, agents, and independent
contractors involved in the Services shall comply with the terms substantively similar
to the confidentiality provisions of this Agreement. PRA shall disclose only the
Sponsor Information to those of its employees, agents, and independent contractors who
reasonably need to know the Sponsor Information.

Page 15 of 21

 

	 	c.	 	PRA shall exercise due care to prevent the unauthorized disclosure and use of
Sponsor Information associated with the Services.
	 
	 	d.	 	This confidentiality and nondisclosure provision shall not apply to information
that PRA can demonstrate by competent evidence:

	 	i.	 	Information which was known by PRA before initiation of the Services or
which is independently discovered, after the initiation of the Services, without
the aid, application or use of the confidential information, as evidenced by
written records;
	 
	 	ii.	 	Information which is in the public domain at the initiation of the
Services or subsequently becomes publicly available through no fault or action of
PRA; or
	 
	 	iii.	 	Information which is disclosed to PRA on a non-confidential basis by a
third party authorized to disclose it.

	 	e.	 	In no event shall either party be prohibited from disclosing Information to the
extent required by law to be disclosed, provided that PRA provides Sponsor with written
notice thereof, prior to disclosure, to the extent reasonably practicable, and, at
Sponsor’s request and expense, cooperates with Sponsor’s efforts to obtain a protective
order or other confidential treatment of the information required to be disclosed.
	 
	 	f.	 	In addition to any other remedies it may have at law or in equity, Sponsor
shall be entitled in the event of any breach or threatened breach of this Section to
obtain injunctive relief without the need to show actual damages or to post any bond.

	9.3	 	PRA Confidential Information

Sponsor acknowledges that all business processes, contract terms, prices, procedures, policies,
methodologies, systems, computer programs, software, applications, databases, proposals and other
documentation generally used by PRA and not developed solely for Sponsor are the exclusive and
confidential property of PRA (hereinafter “PRA Information”) or the third parties from whom PRA has
secured the right to use. Sponsor agrees that all PRA Information, along with any improvement,
alteration or enhancement made thereto during the course of the Services shall be the confidential
property of PRA, and shall be subject to the same degree of protection as is required of PRA to
protect the confidential information of Sponsor.

	9.4	 	Survival

The restrictions of confidentiality and nondisclosure shall survive the performance and/or
termination of this Agreement for a period of seven (7) years.

	10.0	 	Publicity

Sponsor may use, refer to and disseminate reprints of scientific, medical and other published
articles which disclose the name of PRA consistent with applicable international copyright laws,

Page 16 of 21

 

provided such use does not constitute an endorsement of any commercial product or service by PRA.
Neither party shall disclose publicly or utilize in any advertising or promotional materials or
media the existence of this Agreement or its association with the other, or use of the other
party’s name or the name of any of the other party’s Affiliates, divisions, subsidiaries, products
or investigations without the prior written permission of the other party, provided however, that
PRA may use the name of Sponsor in its list of customers; And provided, further, that either party
may make such public disclosures as it determines, based on advice of counsel, are reasonably
necessary to comply with laws or regulations.

	11.0	 	Indemnification
	 
	11.1	 	Sponsor’s Agreement

	 	a.	 	Subject to Section 11.1(c), Sponsor will hold harmless, defend and indemnify
PRA, its Affiliates, and their officers, directors, agents, employees, independent
(sub)contractors, and clinical investigators approved by Sponsor (each an “Indemnitee”)
against any claim, suit, action, proceeding, arbitration or investigation, pending or
threatened by a third party (each a “Claim”) against them based on, relating to or in
connection with the Services and other work conducted under this Agreement, including
but not limited to court costs, legal fees, awards or settlements. Claims made against
PRA in its capacity as Sponsor’s representative in any country are specifically
included, including those made if PRA is engaged to act as Sponsor’s legal
representative within the meaning of the Article 19 of Directive 2001/20/EC. PRA
shall promptly notify Sponsor upon receipt of notice of any Claim (provided that the
failure to give such notice shall not relieve Sponsor of its obligations under this
Section except to the extent, if at all, it is prejudiced thereby) and shall permit
Sponsor’s attorneys and personnel, at Sponsor’s discretion and cost, to handle and
control the defense of such claims and suits. In the event that representation of PRA
and Sponsor by the same counsel is a conflict of interest for such counsel, PRA may
select its own independent counsel, at Sponsor’s expense, without relieving Sponsor of
its obligations under this Section.
	 
	 	b.	 	Under no circumstances, however, shall Sponsor accept liability, settle or
otherwise compromise any Claims without the prior written consent of PRA, which shall
not be unreasonably withheld or be required for any settlement or compromise if Sponsor
does not admit any liability or wrongdoing on the part of PRA. PRA will agree to fully
cooperate and aid in such defense.
	 
	 	c.	 	Sponsor does not agree to indemnify, defend, or hold harmless PRA against any
Claim to the extent that such Claim arose as a result of PRA’s negligence,
recklessness, intentional misconduct or material breach of a warranty. Under such
circumstances PRA will repay to Sponsor any defense costs incurred by Sponsor on its
behalf.

Page 17 of 21

 

	11.2	 	PRA’s Agreement

	 	a.	 	PRA shall indemnify, defend and hold harmless Sponsor and its employees,
officers, and directors against any and all losses, costs, expenses and damages,
including but not limited to reasonable attorney’s fees, based on a personal injury
allegedly resulting from PRA’s negligence or reckless or intentional misconduct, or
failure to perform its obligations and responsibilities under this Agreement. Sponsor
shall promptly notify PRA upon receipt of notice of any claim for which it intends to
seek indemnification hereunder, provided that the failure to give such notice shall not
relieve PRA of its obligations under this Section except to the extent, if at all, it
is prejudiced thereby. Sponsor shall permit PRA’s attorneys and personnel, at PRA’s
discretion and cost, to handle and control the defense of such claims and suits. In
the event that representation of Sponsor and PRA by the same counsel is a conflict of
interest for such counsel, Sponsor may select its own independent counsel, at PRA’s
expense, without relieving PRA of its obligations under this Section.
	 
	 	b.	 	Under no circumstances, however, shall PRA accept liability, settle or
otherwise compromise any claims subject to indemnification under this Section without
prior written consent of Sponsor. Sponsor agrees to fully cooperate and aid in such
defense.
	 
	 	c.	 	PRA does not agree, and shall have no obligation to indemnify, defend or hold
harmless Sponsor against any claim to the extent that such claim arose as a result of
Sponsor’s negligence, recklessness, intentional misconduct or material breach of a
warranty. Under such circumstances Sponsor will repay to PRA any defense costs
incurred by PRA on its behalf.

	11.3	 	Limits of Liability

In no event shall PRA be liable to Sponsor for any indirect, incidental, special, or consequential
damages or lost profits arising out of or related to its provision of Services to Sponsor, even if
PRA has been advised of the possibility of such damages, except to the extent that such damages
result from the negligence, recklessness or intentional misconduct of PRA, its employees,
independent contractors or agents.

	11.4	 	Insurance

Each party shall secure and maintain in full force and effect throughout the term of this Agreement
appropriate insurance coverage for its activities in relation to this Agreement in amounts
consistent with industry standards. If Sponsor engages PRA to be its legal representative within
the meaning of the Article 19 of Directive 2001/20/EC, Sponsor must maintain comprehensive
insurance coverage of no less than Ten Million Dollars ($10,000,000.00) or its equivalent in
another currency, or more, if required by PRA in the exercise of its reasonable discretion, which
coverage extends to PRA as an additional named insured.

Page 18 of 21

 

	12.0	 	Independent Contractor Relationship

PRA and Sponsor are independent contractors. Nothing in this Agreement shall be construed to
create the relationship of partners, joint venturers, or employer and employee between PRA and
Sponsor or PRA’s employees. Neither party, nor its employees, or independent contractors shall
have authority to act on behalf of or bind the other party in any manner whatsoever unless
otherwise authorized in this Agreement or a specific Task Order or in a separate writing signed by
both parties.

	13.0	 	Employees

Neither party, during the term of this Agreement and for twelve months thereafter, shall, without
the prior written consent of the other party, directly or indirectly solicit for employment or
contract, attempt to employ or contract with or assist any other entity in employing, contracting
with or soliciting for employment or contract any employee or executive who is at that time
employed/contracted by the other party and who had been employed/contracted of the other party in
connection with one or more Task Orders issued hereunder. Provided, however, that the foregoing
provision will not prevent either party from conduction solicitation via a general advertisement
for employment that is not specifically directed to any such employee or from employing any such
person who responds to such solicitation.

	14.0	 	Notices

Except as otherwise provided, all communications and notices required under this Agreement shall be
mailed by first class mail or sent via nationally recognized overnight courier to the addresses set
forth below, or to such other addresses as the parties from time to time specify in writing.

	 	 	 
	If to Sponsor:

	 	If to PRA:
	 
	 	 
	CytRx Corporation

	 	Pharmaceutical Research Associates, Inc.
	11726 San Vicente Blvd.

	 	4105 Lewis and Clark Drive
	Los Angeles, CA 90049

	 	Charlottesville, VA 22911
	Attn: Dr. Scott Wieland,
Vice President, Clinical
and Regulatory Affairs

	 	Attn: Bruce A. Teplitzky, Executive Vice
President, Business Development

	15.0	 	Force Majeure

If the performance of this Agreement by PRA or Sponsor is prevented, restricted, interfered with or
delayed (either totally or in part) by reason of any cause beyond the control of the parties
(including, but not limited to acts of God, explosion, disease, weather, war, insurrection,
terrorism, civil strike, riots or extensive power failure), the party so affected shall, upon
giving notice to the other party as soon as is practical, be excused from such performance to the
extent of such prevention, restriction, interference or delay, provided that the affected party
shall use reasonable efforts to avoid or remove such causes of non-performance and shall continue
performance whenever such causes are removed.

Page 19 of 21

 

	16.0	 	Governing Law

This Agreement shall be governed in all respects by the internal laws of the State of Delaware,
United States of America.

	17.0	 	Severability

If any of the provisions or a portion of any provision of this Agreement is held to be
unenforceable or invalid by a court of competent jurisdiction, the validity and enforceability of
the enforceable portion of any such provision and/or the remaining provisions shall not be affected
thereby.

	18.0	 	Assignment

Neither party may assign this Agreement without the prior written consent of the other party, which
consent will not be unreasonably withheld; provided, however, that Sponsor may assign this
Agreement without consent to a successor in interest to substantially all of the business of that
party to which the subject matter of this Agreement relates upon delivery to PRA of notice of such
assignment.

	19.0	 	Waiver

No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in
any one or more instances shall be deemed to be construed as a further or continuing waiver of such
term, provision or condition or of any other term, provision or condition of this Agreement.

	20.0	 	Entire Agreement

This Agreement, including all Attachments hereto contains the full understanding of the parties
with respect to the Services and supersedes all existing Agreements and all other oral, written or
other communications between the parties concerning the subject matter hereof. This Agreement will
not be modified in any way except in writing and signed by a duly authorized officer of Sponsor and
an authorized officer of PRA.

	21.0	 	Counterparts

This Agreement may be executed in several counterparts, each of which shall be deemed an original
but all of which shall constitute one and the same instrument.

	22.0	 	Arbitration

In the event a dispute relating to this Agreement or any Task Order arises between the parties, the
parties shall use all reasonable efforts to resolve the dispute through direct discussions for a
period of thirty (30) business days. The senior management of each party commits itself to respond
to any such dispute. Subsequent to such thirty-day period either party may, but shall not be
required to, resort to binding arbitration procedures. If arbitration is being conducted it shall
take place in Los Angeles, California under the rules of the American Arbitration Association.

Page 20 of 21

 

The undersigned have executed this Agreement as of the day and year noted below.

	 	 	 
	PHARMACEUTICAL RESEARCH ASSOCIATES, INC.
	 
	 	 
	 

Name

	 	 
	 
	 	 
	 

Title

	 	 
	 
	 	 
	 

Date

	 	 
	 
	 	 
	CYTRX CORPORATION
	 	 
	 
	 	 
	 

Name

	 	 
	 
	 	 
	 

Title

	 	 
	 
	 	 
	 

Date

	 	 

LIST OF ATTACHMENTS

Attachment A: Form of Task Order

Attachment B: Form of Amendment

Attachment C: Invoice Format

Attachment D: Change Notification Form

Page 21 of 21

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