Exhibit 10.9
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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

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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

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      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.

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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.

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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.

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  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,

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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.

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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.

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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.

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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.

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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

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