Exhibit
4(a)(2)


MASTER
SERVICES AGREEMENT


 


 


This Master Services Agreement (“Agreement”) is made
between Progen Pharmaceuticals Limited ABN 82 010 975 612 which has a place of business 16 Benson
Street, Toowong, Queensland 4066, Australia  (hereinafter “Sponsor”), and Quintiles East
Asia Pte Ltd a
Singaproe corporation having its principal place of business at 89 Science Park
Drive, Lobby B, #03-08 The Rutherford, Science Park One, Singapore 118261 (hereinafter “Quintiles”). When signed
by both parties, this Agreement will set forth the terms and conditions under
which Quintiles agrees to provide certain services to Sponsor as set forth
herein.


 


Recitals:


 


A.            Sponsor
is in the business of developing, manufacturing and/or distributing
pharmaceutical products, medical devices, biotechnology and/or pharmaceutical
products and has made significant, up-front investments in technologies related
to those products and building on important inventions.  Quintiles is in the business of providing
clinical trial services, research, and other services for the pharmaceutical,
medical device and biotechnology industries and has made significant, up-front
investments in technologies related to those industries, building on important
inventions and web-based technologies.


 


B.            Sponsor
and Quintiles desire to enter into this Agreement to provide the terms and
conditions upon which Sponsor may engage Quintiles from time-to-time to provide
services for individual studies or projects by executing individual Work Orders
(as defined below) specifying the details of the services and the related terms
and conditions.


 


Agreement:


 


1.0                                 Scope
of the Agreement; Work Orders; Nature of Services.


 


(a)                                  Scope of Agreement. 
As a “master” form of contract, this Agreement allows the parties to
contract for multiple projects through the issuance of multiple Work Orders (as
discussed in Section 1(b) below), without having to re-negotiate the basic
terms and conditions contained herein. 
This Agreement covers the provision of services by Quintiles and Quintiles’
corporate affiliates (see Section 18) and, accordingly, this Agreement
represents a vehicle by which Sponsor can efficiently contract with Quintiles
and its corporate affiliates for a broad range of services.


 


(b)                                 Work Orders. 
The specific details of each project under this Agreement (each “Project”)
shall be separately negotiated and specified in writing on terms and in a form
acceptable to the parties (each such writing, a “Work Order”).  A sample Work Order is attached hereto as
Exhibit A.  Each Work Order will include,
as appropriate, the scope of work, time line, and budget and payment schedule.
Each Work Order shall be subject to all of the terms and conditions of this
Agreement, in addition to the specific details set forth in the Work Order.  To the extent any terms or provisions of a
Work Order conflict with the terms and provisions of this


 


CONFIDENTIAL


 


 


1

















 


Agreement, the terms and
provisions of this Agreement shall control, except to the extent that the
applicable Work Order expressly and specifically states an intent to supersede
the Agreement on a specific matter. All Work Orders and other exhibits hereto
shall be deemed to be incorporated herein by reference.


 


(c)                                  Nature of Services. 
The services covered by this Agreement may include strategic planning,
expert consultation, clinical trial services, statistical programming and
analysis, data processing, data management, regulatory, clerical, project
management, central laboratory services, preclinical services, pharmaceutical
sciences services, medical device services, and other research and development
services requested by Sponsor and agreed to by Quintiles as set forth in the
relevant Work Order (collectively, the “Services”).


 


2.0                             Payment
of Fees and Expenses.   Sponsor will pay Quintiles for fees, expenses
and pass-through costs in accordance with the budget and payment schedule
contained in each Work Order.  Based on the
estimated cash flow of the Project, Sponsor agrees that a prepayment may be
needed for Quintiles to maintain cash neutrality over the term of the Project
taking into account the payment terms agreed to between the parties.  For Projects
over multiple calendar years, the budget will include an annualization
percentage.  Unless otherwise agreed in a particular Work Order,
the following shall apply: (a) Quintiles will invoice Sponsor for it fees in
accordance with the payment schedule, and monthly for its expenses and
pass-through costs at cost to Quintiles with no mark-up, incurred in performing
the Services; and, (b) with the exception of any prepayment or advances and
investigator invoices, which are
due and payable upon receipt, all other invoice payments shall be made to
Quintiles within thirty (30) days of receipt. In the event that taxes or duties, of whatever
nature, are required to be made or withheld on payments made pursuant to this
Agreement or an applicable Work Order by any state, federal, provincial or
foreign government, including, but not limited to, Value Added Tax, Sponsor
shall promptly pay said taxes and duties to the appropriate taxing authority
without any deduction to any amount owed to Quintiles.  Sponsor shall secure and deliver to Quintiles
any official receipt for any such taxes paid. Alternatively, Quintiles may
invoice Sponsor for the taxes accompanied by the official invoice showing that
such taxes have been charged, without a mark-up, as a pass-through expense,
collect the taxes from Sponsor, and pay the taxes due on the Services.  For the avoidance of doubt, the requirements
of this provision shall not apply to any employment-related taxes, duties, or
withholding and shall only apply to taxes applicable to the Services. Expenses and
pass-through costs will be supported by a summary sheet. If any portion of an invoice is disputed, then
Sponsor shall pay the undisputed amounts as set forth in the preceding sentence
and the parties shall use good faith efforts to reconcile the disputed amount
as soon as practicable.  Sponsor shall
pay Quintiles interest in an amount equal to four percent (4%) above the base
interest rate established by Hambros Bank Limited per month of all undisputed
amounts owing hereunder and not paid when due (or the maximum lesser amount
permitted by applicable law.


 


3.0                                 Term. 
This Agreement shall commence on the date it has been signed by all
parties and shall continue for a period of five (5) years from the date of
execution, or until terminated by either party in accordance with Section 17
below.  The Agreement will automatically


 


2

















 


renew each year
thereafter for a period of one year, unless either party notifies the other
party in writing at least 30 days prior to the renewal date that it does not
want to renew the Agreement.


 


4.0                                 Change
Orders. 
Any change in the details of a Work Order or the assumptions upon which
the Work Order is based (including, but not limited to, changes in an agreed
starting date for a Project or suspension of the Project by Sponsor) may
require changes in the budget and/or time lines, and shall require a written
amendment to the Work Order (a “Change Order”). 
Each Change Order shall detail the requested changes to the applicable
task, responsibility, duty, budget, time line or other matter.  The Change Order will become effective upon
the execution of the Change Order by both parties, and Quintiles will be given
a reasonable period of time within which to implement the changes.  Both parties agree to act in good faith and
promptly when considering a Change Order requested by the other party.  Without limiting the foregoing, Sponsor
agrees that it will not unreasonably withhold approval of a Change Order, even
if it involves a fixed price contract, if the proposed changes in budgets or
time lines result from, among other appropriate reasons, forces outside the
reasonable control of Quintiles or changes in the assumptions upon which the
initial budget or time lines were based, including, but not limited to, the
assumptions set forth in the budget or timelines.  Quintiles reserves the right to postpone
effecting material changes in the Project’s scope until such time as the
parties agree to and execute the corresponding Change Order.   For any Change Order that affects the scope
of the regulatory obligations that have been transferred to Quintiles,
Quintiles and Sponsor shall execute a corresponding amendment to the Transfer
of Obligations Form.  Sponsor shall file
such amendment where appropriate, or as required by law or regulation.


 


5.0                                 Confidentiality. 
It is understood that during the course of this Agreement, Quintiles and
its employees may be exposed to data and information that are confidential and
proprietary to Sponsor.  All such data
and information (hereinafter “Sponsor Confidential Information”) written or
verbal, tangible or intangible, made available, disclosed, or otherwise made
known to Quintiles and its employees as a result of Services under this
Agreement shall be considered confidential and shall be considered the sole
property of Sponsor.  All information
regarding Quintiles’ operations, methods, and pricing and all Quintiles’
Property (as defined in Section 6.0 below), disclosed by Quintiles to Sponsor
in connection with this Agreement is proprietary, confidential information
belonging to Quintiles (the “Quintiles Confidential Information”, and together
with the Sponsor Confidential Information, the “Confidential Information”).  The Confidential Information shall be used by
the receiving party and its employees only for purposes of performing the
receiving party’s obligations hereunder. 
Each party agrees that it will not reveal, publish or otherwise disclose
the Confidential Information of the other party to any third party without the
prior written consent of the disclosing party. 
Each party agrees that it will not disclose the terms of this Agreement
or any Work Order to any third party without the written consent of the other
party, which shall not unreasonably be withheld.  These obligations of
confidentiality and nondisclosure shall remain in effect for a period of ten
(10) years after the completion or termination of the applicable Work Order.


 


3

















 


The foregoing obligations shall not apply to
Confidential Information to the extent that it: (a) is or becomes generally
available to the public other than as a result of a disclosure by the receiving
party;  (b) becomes available to the
receiving party on a non-confidential basis from a source which is not prohibited
from disclosing such information;  (c)
was developed independently of any disclosure by the disclosing party or was
known to the receiving party prior to its receipt from the disclosing party, as
shown by contemporaneous written evidence; or, (d) is required by law or
regulation  to be disclosed.


 


6.0                                 Ownership
and Inventions.  All data and information generated or
derived by Quintiles as the result of services performed by Quintiles under
this Agreement shall be and remain the exclusive property of Sponsor.  Any inventions that may evolve from the data
and information described above or as the result of services performed by
Quintiles under this Agreement shall belong to Sponsor and Quintiles agrees to
assign its rights in all such inventions and/or related patents to Sponsor.
Quintiles acknowledges that Sponsor possesses certain inventions, processes,
know-how, trade secrets, improvements, other intellectual properties and other
assets, including but not limited to analytical methods, procedures and
techniques, procedure manuals, personnel data, financial
information, computer technical expertise and software, which have been
independently developed by Sponsor and which relate to its business or
operations (collectively “Sponsor’ Property”). 
Quintiles and Progen agree that any Sponsors’ Property or improvements
thereto which are used, improved, modified or developed by Sponsor under or
during the term of this Agreement are the sole and exclusive property of
Sponsor.  Notwithstanding the foregoing,
Sponsor acknowledges that Quintiles possesses certain inventions, processes,
know-how, trade secrets, improvements, other intellectual properties and other
assets, including but not limited to analytical methods, procedures and
techniques, procedure manuals, personnel data, financial
information, computer technical expertise and software, which have been
independently developed by Quintiles and which relate to its business or
operations (collectively “Quintiles’ Property”).  Sponsor and Quintiles agree that any
Quintiles’ Property or improvements thereto which are used, improved, modified
or developed by Quintiles under or during the term of this Agreement are the
sole and exclusive property of Quintiles.


 


7.0                                 Records and Materials.  At the completion of the Services by Quintiles or upon
termination of this Agreement, all materials, information and all other data
owned by Sponsor, regardless of the method of storage or retrieval, shall be
delivered to Sponsor in such form as is then currently in the possession of
Quintiles, subject to the payment obligations set forth in Section 2
herein.   Alternatively, at Sponsor’s
written request, such materials and data may be retained by Quintiles for
Sponsor for  an agreed-upon time period, or
disposed of pursuant to the written directions of Sponsor.  Sponsor shall pay the costs associated with
any of the above options and shall pay a to-be-determined fee for storage by
Quintiles of records and materials after completion or termination of the
Services.  Quintiles, however, reserves
the right to retain, at its own cost and subject to the confidentiality
provisions herein, copies of all materials that may be needed  to satisfy regulatory requirements or to resolve disputes
regarding the Services.  Nothing in this
Agreement shall be construed to transfer from Sponsor to Quintiles any FDA or


 


4

















 


regulatory record-keeping
requirements unless such transfer is specifically provided for in the
applicable Transfer of Obligations Form.


 


8.0                                 Independent
Contractor Relationship.  For the
purposes of this Agreement, the parties hereto are independent contractors and
nothing contained in this Agreement shall be construed to place them in the
relationship of partners, principal and agent, employer/employee or joint
venturers.  Neither party shall have the
power or right to bind or obligate the other party, and neither party shall
hold itself out as having such authority. 
If, however, Sponsor desires to conduct clinical trials in one or more
countries that require a local sponsor or representative, and Sponsor requests
that Quintiles or its affiliates serve as its agent for that purpose, then
Quintiles may serve as Sponsor’s agent for the purpose of fulfilling local
sponsor or representative duties. 
[Sponsor shall pay Quintiles for such local representative services at
Quintiles’ standard daily rates, unless otherwise specified in the Work Order.


 


Certain countries require
that the local representative must indemnify sites for harm caused by the Study
Drug or otherwise assume primary responsibility for harm caused by the Study
Drug.  Those countries are currently
Singapore, Australia, Indonesia, Korea, Taiwan, China (depending on local
regulatory requirements) and Mexico (if IMSS sites are used). If Sponsor
requests that Quintiles serve as its local representative in those countries,
the parties must negotiate and enter into a Local Representative Agreement,
either as part of the applicable Work Order or as a stand alone agreement . In
addition, if Sponsor is not based in the European Union (“EU”) and services
will be performed in the EU, Sponsor may request that Quintiles serve as its
Legal Representative in the EU, and, if Quintiles agrees, the parties will
negotiate and enter into a separate agreement specifying the terms of such
legal representation.


 


9.0                                 a)  Regulatory
Compliance. Quintiles agrees that its Services will be
conducted in compliance with all applicable laws, rules and regulations, and
with the standard of care customary in the contract research organization
industry.  If the Services will be conducted under an FDA Investigational New Drug
Application (“IND”) or Investigational Device Exemption (“IDE”), then regarding
the FDA’s electronic records and signatures regulation, 21 CFR Part 11 (“Part
11”), Quintiles represents that it has a compliance plan in place as to its
applicable database applications and electronic records systems and it is
working diligently to implement its plan. Quintiles, however, is not
responsible for the compliance or non-compliance of applications or systems
used by third parties (including, but not limited to, investigative sites or
third party laboratories), or any Part 11 audits or assessments thereof, unless
such applications or systems are owned by Quintiles.  Quintiles’ standard operating procedures
will be used in performance of the Services, unless otherwise specifically
stated in the Scope of Work. Quintiles certifies that it has not been debarred
under the Generic Drug Enforcement Act and that it will not knowingly employ
any person or entity that has been so debarred to perform any Services under
this Agreement.  Sponsor represents and
certifies that it will not require Quintiles to perform any assignments or
tasks in a manner that would violate any applicable law or regulation.  Sponsor further represents that it will
cooperate with Quintiles in taking any actions that Quintiles reasonably
believes are necessary to comply with the regulatory obligations that have been
transferred to Quintiles.


 


5

















 


                                                b)  Inspections and Audits. Each
party acknowledges that the other party may respond independently to any
regulatory correspondence or inquiry in which such party or its affiliates is
named.  Each party, however, shall notify
the other party promptly of any FDA or other governmental or regulatory
inspection or inquiry concerning any study or Project of Sponsor in which
Quintiles is providing Services. During any such inspection or inquiry, the
parties agree to make reasonable efforts to disclose only the information
required to be disclosed.  During the
term of this Agreement, Quintiles will permit Sponsor’s representatives (unless
such representatives are competitors of Quintiles) to examine  or audit  the work
performed hereunder and the facilities at which the work is conducted upon
reasonable advance notice during regular business hours to determine that the
Project assignment is being conducted in accordance with the agreed task and
that the facilities are adequate. Sponsor agrees that it shall not disclose to
any third party any information ascertained by Sponsor in connection with any
such audit or examination, except to the extent required by law or
regulation.  Sponsor shall reimburse
Quintiles for its time and expenses (including reasonable attorney fees and the
costs of responding to findings) associated with any inspection, audit or
investigation relating to the Services (“Inspection”) instigated by Sponsor or
by a governmental authority, unless such Inspection finds that Quintiles
breached this Agreement or any applicable law or regulation.


 


10.0                           Relationship
with Investigators.  If Quintiles
will be obligated to contract with investigators or investigative sites
(collectively, “Investigators”) then Quintiles will use its local CTA forms (“Local
CTAs”) that have developed for use in specific countries based on local
requirements with the benefit of local legal advice, which have been prepared
in local language and English language where applicable, unless an
industry-standard form is required in the country in question or a
site-specific form is required by a site that has been selected. If no Local
CTAs or industry-standard form exists for the country at issue, the Quintiles
Global CTA will be used. Any applicable Local CTAs, industry-standard forms,
site-specific forms, and the Global CTA will be provided for inspection by the
Sponsor and a copy of the fully executed version shall be provided to the
Sponsor for its legal records to fulfill its obligations herein.  Quintiles’ proposals, budgets and timelines
are based on the use of the CTA forms specified above, and use of other forms
may require changes to budgets and timelines and require increased costs for
local legal review and translations. If an Investigator insists upon any
material changes to any provisions that directly affect Sponsor
(confidentiality, intellectual property, publication, protocol compliance and
inspections), then Quintiles shall submit the proposed change to Sponsor, and
Sponsor shall review, comment on and/or approve such proposed changes within
five (5) working days.  If the forms
specified above, or any changes approved by Sponsor, differ from the terms of
this Agreement or an applicable Work Order (including, but not limited to, provisions
allowing an Investigator to publish results or data that Quintiles is
prohibited from revealing), then Quintiles shall have no liability for any such
provisions or changes.  Unless otherwise
stated in the attached Budget, [the time incurred by Quintiles in negotiating
CTA changes proposed by sites shall be billed at Quintiles’ Standard Rates.


 


6

















 


Quintiles  reserves the right to contract with certain
Investigators who a) may be employees of a Quintiles Affiliate;  or, b) may employ or utilize the services of
clinical research coordinators or similar personnel who may be employed or
provided by Quintiles or its Affiliates. Quintiles’ affiliations with such
Investigators will be identified to Sponsor and payments made to such
Investigators will be invoiced and paid as stated in the Investigator budget as
approved by Sponsor.  The parties
acknowledge and agree that, except as to employees of Quintiles or its
Affiliates, Investigators shall not be considered the employees, agents, or
subcontractors of Quintiles.  All
Investigators, however, shall exercise their own independent medical
judgment.  Quintiles’ responsibilities
with respect to Investigators shall be limited to those responsibilities
specifically set forth in this Agreement or the applicable Work Order.


 


                                                If Quintiles will be paying Investigators
on behalf of Sponsor, the parties will agree in the applicable Work Orders as
to a schedule of amounts to be paid to Investigators.  Sponsor acknowledges and agrees Quintiles
will only pay Investigators from advances or pre-payments received from Sponsor
for Investigators’ services, and that Quintiles will not make payments to
Investigators prior to receipt of sufficient funds from Sponsor.  Sponsor acknowledges and agrees that
Quintiles will not be responsible for delays in a study or Project to the
extent that such delays are caused by Sponsor’s failure to make adequate
pre-payment for Investigators’ services. 
Sponsor further acknowledges and agrees that payments for Investigators’
services are pass-through payments to third parties and are separate from
payments for Quintiles’ Services. 
Sponsor agrees that it will not withhold Investigator payments except to
the extent that it has reasonable questions about the services performed by a
particular Investigator.


 


11.0                           Third Party Indemnifications and
Agreements.  If any investigative sites or any other third
parties, including, but not limited to, Data Safety Monitoring Boards,
independent laboratories, Advisory Boards, or End Point Adjudication Committees
(collectively, “Third Parties”), request an indemnification for loss or damage
caused by the sponsor’s Project , then Sponsor shall provide such
indemnification directly to the Third Party. 
If Sponsor requests Quintiles’ assistance in negotiating the terms of
such indemnities, Quintiles shall provide such negotiation services at its
standard daily rates, unless otherwise agreed in the Work Order.  Quintiles shall not sign such
indemnifications on Sponsor’s behalf unless Sponsor has expressly authorized
Quintiles to act as its agent for such purpose or has given Quintiles a written
power of attorney to sign such indemnifications.


 


If Sponsor requests that Quintiles enter into
agreements to retain Third Parties to perform services regarding the Project,
such Third Parties shall be independent contractors and shall not be considered
the employees, agents, or subcontractors of Quintiles or Sponsor.  Sponsor shall pay Quintiles for its
reasonable time and expenses in negotiating and administering any such Third
Party Agreements.


 


12.0                           Conflict
of Agreements.  Quintiles represents to Sponsor that it is
not a party to any agreement which would prevent it from fulfilling its
obligations under this Agreement and that during the term of this Agreement,
Quintiles agrees that it will not enter into any agreement to provide services
which would in any way prevent it from providing the


 


7

















 


Services contemplated
under this Agreement.  Sponsor agrees
that it will not enter into an agreement with a third party that would alter or
affect the regulatory obligations delegated to Quintiles in any study or
Project without the written consent of Quintiles, which will not be
unreasonably withheld.


 


13.0                           Publication. 
Project results may not be published or referred to, in whole or in
part, by Quintiles or its affiliates without the prior expressed written
consent of Sponsor.  Neither party will
use the other party’s name in connection with any publication or promotion
without the other party’s prior, written consent.


 


14.0                           Limitation
of Liability.


 


a)             Neither
Quintiles, nor its affiliates,  directors,
officers, employees, subcontractors or agents shall have any liability
(including without limitation, contract, negligence and tort liability)  for any loss of profits, opportunities or goodwill or any
type of indirect or consequential damages in connection with this Agreement or
any Work Order or the Services performed by Quintiles.


 


                                                b)            In
no event shall the collective, aggregate liability (including without
limitation, contract, negligence and tort liability) of Quintiles or its
affiliates, directors, officers, employees, subcontractors or agents under this
Agreement exceed the amount of fees actually received by Quintiles from Sponsor
under the applicable Work Order.


 


c)             Nothing
herein is intended to exclude or limit any liability for willful misconduct or
any liability for death or personal injury caused by negligence.


 


15.0                           Indemnification.


 


a)             Sponsor shall indemnify, defend and hold harmless
Quintiles and its affiliates, and its and their directors, officers, employees
and agents (each, a “Quintiles Indemnified Party”), from and against any and
all losses, damages, liabilities, reasonable attorney fees, court costs, and
expenses (collectively “Quintiles Losses”), joint or several, resulting or
arising from any third-party claims, actions, proceedings, investigations or
litigation relating to or arising from or in connection with this Agreement,
any Work Order, or the Services contemplated herein (including, without
limitation, any Quintiles Losses arising from or in connection with any study,
test, device, product or potential product to which this Agreement or any Work
Order relates), except to the extent such Quintiles Losses are determined to
have resulted from the negligence or intentional misconduct of the Quintiles
Indemnified Party seeking indemnity hereunder.


 


b)            Quintiles shall indemnify, defend and hold harmless
Sponsor and its affiliates, and its and their directors, officers, employees
and agents, from and against any and all losses, damages, liabilities,
reasonable attorney fees, court costs, and expenses (collectively “Sponsor
Losses”), joint or several, resulting or arising from any third-party claims,
actions, proceedings, investigations or litigation relating to or arising from
or in connection with this Agreement or the Services contemplated herein
(including, without limitation, any Sponsor Losses arising from or in
connection with any study, test, device, product or potential product to which
this Agreement relates), to the extent such Sponsor


 


8

















 


Losses are determined to
have resulted from the negligence or intentional misconduct of Quintiles.


 


16.0                           Indemnification
Procedure.
Each person or entity seeking indemnification under sections 15.0 a) or b)
shall promptly notify the indemnifying party 
of any such claim or lawsuit (including provision of  a copy thereof) served upon it and shall
fully cooperate with the indemnifying party 
and its legal representatives in the investigation of any matter the
subject of indemnification.   Under no
circumstances shall an indemnified party settle or otherwise compromise any
claim, liability, or action covered by this Indemnification provision without
the indemnified party’s prior written consent, which consent will not be
unreasonably withheld.


 


17.0                           Termination. 
Sponsor or Quintiles may terminate this Agreement or any Work Order
without cause at any time during the term of the Agreement on sixty (60) day’s
prior written notice to Quintiles or Sponsor, as appropriate.  Either party may terminate this Agreement or
any Work Order for material breach upon thirty (30) days’ written notice
specifying the nature of the breach, if such breach has not been substantially
cured within the thirty (30) day period. 
During the 30-day cure period for termination due to breach, each party
will continue to perform its obligations under the Agreement.  If the termination notice is not due to a
breach, or if the cure period has expired without a substantial cure of the
breach, then the parties shall promptly meet to prepare a close-out schedule,
and Quintiles shall cease performing all work not necessary for the orderly
close-out of the Services or required by laws or regulations.   If Quintiles determines, in its sole
discretion, that its continued performance of the Services contemplated by one
or more Work Orders would constitute a potential or actual violation of
regulatory or scientific standards of integrity, then Quintiles may terminate
the applicable Work Order(s) by giving written notice stating the effective
date (which may be less than thirty days from the notice date) of such
termination.  Either party may terminate
this Agreement or any Work Orders immediately upon provision of written notice
if the other party becomes insolvent or files for bankruptcy.  Any written termination notice shall identify
the specific Work Order or Work Orders that are being terminated.


 


                                                If this Agreement or any Work Order is
terminated, Sponsor shall pay Quintiles for all Services performed in
accordance with this Agreement and any applicable Work Order and reimburse
Quintiles for all costs and expenses incurred in performing those Services,
including all non-cancelable costs incurred prior to termination but paid after
the termination date. Sponsor shall pay for all the work actually performed in
accordance with this Agreement and the applicable Work Order, even if the
parties’ original payment schedule spreads-out payments for certain services or
defers payments for certain services until the end of the Study.  If payments are unit or milestone based, and
the Agreement or a Work Order is terminated after costs have been incurred
toward achieving portions of one or more incomplete units or milestones,
Sponsor will pay Quintiles’ standard fees for actual work performed toward
those incomplete units or milestones up to the date of termination, in addition
to paying for completed units or milestones.  
Sponsor shall pay for all actual costs, including time spent by
Quintiles personnel (which shall be billed at Quintiles’ standard daily rates
in effect as of the date of the termination notice), incurred to complete
activities associated with the termination


 


9

















 


and close-out of affected
Projects, including the fulfillment of any regulatory requirements.  In addition, if the termination is by Sponsor
without cause, or by Quintiles for cause, and the total fees for the Project are
greater than one million U.S. dollars in value, then Sponsor shall pay to
Quintiles an amount equal to ten percent (10%) of the budget for the remainder
of Services that have not yet been performed and are scheduled to be performed
within the twelve (12) months following termination, to cover Quintiles’ costs
associated with early termination.


 


18.0                           Relationship
with Affiliates.  Sponsor agrees that Quintiles
may use the services of its corporate affiliates as subcontractors to fulfill Quintiles’ obligations under this
Agreement or any Work Order.  Quintiles shall remain responsible for all
Services performed by its affiliates, and its affiliates shall be subject
to all of the terms, conditions and
rights applicable to Quintiles under this Agreement or any Work Order.
Any affiliate of Quintiles or Sponsor may enter into a Work Order under this
Agreement, and the terms, conditions and rights in this Agreement shall be
incorporated into the Work Order and be binding on such affiliate.  The term “affiliate” shall mean all entities
controlling, controlled by or under common control with Quintiles.  The term “control” shall mean the ability to
vote fifty percent (50%) or more of the voting securities of any entity or
otherwise having the ability to influence and direct the polices and direction
of an entity.


 


19.0                           Cooperation;
Sponsor or Quintiles Delays; Disclosure of Hazards. Sponsor shall forward to Quintiles in a
timely manner all documents, materials and information in Sponsor’s possession
or control necessary for Quintiles to conduct the Services.  Quintiles agrees
and acknowledges that time is of the essence and shall use commercially
reasonable efforts to perform its’ obligations in the conduct of the Services
within the timeframe(s) set forth under the applicable Work Order , including
but not limited to the Scope of Work and 
any other Attachments(s)  and any
amendments thereto agreed to by the parties in writing. Quintiles shall
not be liable to Sponsor nor be deemed to have breached this Agreement for errors,
delays or other consequences arising from Sponsor’s failure to timely provide
documents, materials or information or to otherwise cooperate with Quintiles in
order for Quintiles to timely and properly perform its obligations, and any
such failure by Sponsor shall automatically extend any timelines affected by a
time period reasonably commensurate to take into account such failure, unless
Sponsor agrees in writing to pay any additional costs  that would be required to meet the original
timeline.  If Sponsor delays a project
from its agreed starting date or suspends performance of the project then
either: a) Sponsor will pay the standard daily rate of the Quintiles’ personnel
assigned to the project, based on the percentage of their time allocated to the
project, for the period of the delay, in order to keep the current team
members; or, b) Quintiles may re-allocate the personnel at its discretion, and
Sponsor will pay the costs of re-training new personnel. In addition, Sponsor
will pay all non-cancelable costs and expenses incurred by Quintiles due to the
delay and will adjust all timelines to reflect additional time required due to
the delay. In order for Quintiles to comply with the Health and Safety at Work
Act 1974 and any applicable regulation made pursuant thereto it is a condition
of Quintiles providing the contract Services that Sponsor shall provide
Quintiles with all information available to it regarding known or potential
hazards associated with the use of any substances supplied to Quintiles by
Sponsor, and


 


10

















 


Sponsor shall comply with
all current legislation and regulations concerning the shipment of substances
by the land, sea or air.


 


20.0                           Force
Majeure.  In the event either party shall be delayed or
hindered in or prevented from the performance of any act required hereunder by
reasons of strike, lockouts, labor troubles, inability to procure materials or
services, failure of power or restrictive government or judicial orders, or
decrees, riots, insurrection, war, Acts of God, inclement weather or other
reason or cause beyond that party’s control, then performance of such act
(except for the payment of money owed) shall be excused for the period of such
delay.


 


21.0                           Notices
and Deliveries.  Any notice required or
permitted to be given hereunder by either party hereunder shall be in writing
and shall be deemed given on the date received if delivered personally or by a
reputable overnight delivery service, or three (3) days after the date postmarked
if sent by registered or certified mail, return receipt requested, postage
prepaid to the following addresses:


 


	
  If to Quintiles:

  	
   

  	
  If to Sponsor:

  
	
  Quintiles East Asia Pte Ltd

  89 Science Park Drive

  Lobby B #03-08

  The Rutherford, Science Park One

  Singapore 118261

  	
   

  	
  Liz Wilson

  Director of Clinical Operations

  Progen Pharmaceuticals Ltd

  16 Benson Street (PO Box 2403)

  Toowong, QLD 4066 Australia

  
	
  Attention: Anand Tharmaratnam

  	
   

  	
   

  
	
  Head
  of Clinical

  	
   

  	
   

  
	
  Development,
  Asia Pacific

  	
   

  	
   

  



 


 


With a copy to:


 


	
  If to Quintiles:

  Quintiles Transnational Legal

  Department

  P.O. Box 13979

  Research Triangle Park, North

  Carolina, U.S.A.

  27709-3979

  Attention: Head of Legal Department

  	
   

  	
  Progen Legal Department

  Progen Pharmaceuticals Ltd

  16 Benson St (PO Box 2403)

  Toowong, QLD 4066 Australia

  



 


 


If Sponsor delivers, ships, or mails materials or
documents to Quintiles, or requests that Quintiles deliver, ship, or mail
materials or documents to Sponsor or to third parties, then the expense and
risk of loss for such deliveries, shipments, or mailings shall be borne by
Sponsor.  Quintiles disclaims any
liability for the actions or omissions of third-party delivery services or
carriers. All information transmitted by Quintiles pursuant to this


 


11
















 


Agreement will be sent by the standard transmission
method selected by Quintiles (telephone, facsimile, mail, personal delivery or
email).  Sponsor hereby consents and
authorizes Quintiles to send facsimiles relating to the Services, or relating
to potential future services, to any office of Sponsor or Sponsor’s affiliates.


 


22.0                     Insurance. During the term of this Agreement to
cover its obligations hereunder, each party shall maintain insurance coverage
with a reputable insurance company as follows: i) Clinical Trials and/or
Product Liability insurance for Sponsor of not less than US$5,000,000 per
annum; ii)  Professional Indemnity
insurance for Quintiles of not less than US$5,000,000 per annum; and, iii)  Liability to third parties with a limit of
$1,000,000 per claim or series of related claims, or at the minimum statutory
level, whichever is greater. All insurance amounts may be obtained by full,
individual primary policy amount; a primary amount of less than minimum
requirement enhanced by a blanket excess umbrella policy; or a combination of
either. Each party shall provide the other party with a certificate of
insurance upon request. The insured party will ensure that the other party’s
interest is noted on the policy or policies.


 


23.0                       Foreign Currency Exchange. 
The currency to be used for invoice and payment shall be the currency
stated in the Budget or Table attached to the applicable Work Order (the “Contracted
Currency”). If Quintiles incurs pass-through costs in a currency other than the
Contracted Currency, then Sponsor shall reimburse Quintiles for Quintiles’
actual costs in the Contracted Currency based on the Oanda foreign currency
exchange rate (Oanda.com) for the applicable currencies on the last business
day of the month in which such pass-through costs are submitted.  If a
currency referenced within the Budget is replaced by the Euro or otherwise
ceases to become legal tender, the applicable replacement currency will be
substituted for such currency for purposes of this provision at an established
conversion rate.


 


If this Agreement involves the performance of Services
by Quintiles or its affiliates in any country that uses a currency other than
the Contracted Currency, then the Budget for those Services will be based on
the local rates in the currency used by Quintiles for pricing that country, but
converted to and reflected in the Contracted Currency.  Sponsor acknowledges that, due to
fluctuations in currency exchange rates, Quintiles’ actual fees may be greater
or lesser than the budgeted or estimated amounts contained in this
Agreement.  If the fees for Services in
currencies other than the Contracted Currency exceed $500,000 and the
conversion rate between the local currencies and the Contracted Currency has
fluctuated more than 2%, plus or minus, since the Budget was prepared,
Quintiles may calculate a foreign currency exchange adjustment based upon the
following:


 


a)             In
the case of Fee for Service budgets, fees will be converted on each invoice
based on the Oanda foreign currency exchange spot rate (Oanda.com) from the
last Friday of the preceding month in which services were performed; or,


 


b)            For
all other budget types including fixed fee, milestone or unit priced budgets,
the adjustment will be calculated every 12 months after the contract execution
date (or in the final invoice if the agreement is for less than 12 months). The
foreign currency adjustment will be calculated by comparing the foreign
currency exchange rate stated in


 


12

















 


the Budget or Table attached to the Agreement to the
Oanda (Oanda.com) average rate over the preceding 12 months. Any resulting
decrease in costs will be credited to Sponsor and any resulting increase in
costs will be invoiced to Sponsor.


24.0                           Data Protection.  Quintiles and Sponsor agree to comply with all
applicable privacy laws and regulations. 
If the services will involve the collection or processing of personal
data (as defined by applicable data protection legislation) within the European
Economic Area (“EEA”), then Sponsor shall serve as the controller of such data,
as defined by the European Union (“EU”) Data Protection Directive (the “Directive”),
and Quintiles shall act only under the instructions of the Sponsor in regard to
personal data.  If Sponsor is not based
in the EEA, Sponsor must appoint an EEA company to act as its local
representative for data protection purposes in order to comply with the
Directive, and if Sponsor requests that a Quintiles Affiliate in the EEA serve
as its local representative, and Quintiles agrees, then the parties shall
negotiate and enter into a separate agreement specifying such representative
duties. If Quintiles determines that it is required, the parties shall enter
into a Data Transfer Agreement between the parties containing the Standard
Contractual Clauses set forth by the EU Commission Decision of 15 June 2001
(Decision 2001/497/EC) before Quintiles will assume any such representative
duties.


25.0                           Binding Agreement and  Assignment.
This Agreement shall be binding upon and inure to the benefit of Sponsor and
Quintiles and their respective successors and permitted assigns.  Except as stated above in Section 18, neither
party may assign any of its rights or obligations under this Agreement to any
party without the express, written consent of the other party.


 


26.0                           Choice of Law, Waiver and
Enforceability.
This Agreement shall be construed, governed, interpreted, and applied in
accordance with the laws of Singapore. The failure to enforce any right or
provision herein shall not constitute a waiver of that right or provision.  Any waiver of a breach of a provision shall
not constitute a waiver of any subsequent breach of that provision.  If any provisions herein are found to be
unenforceable on the grounds that they are overly broad or in conflict with
applicable laws, it is the intent of the parties that such provisions be
replaced, reformed or narrowed so that their original business purpose can be
accomplished to the extent permitted by law, and that the remaining provisions
shall not in any way be affected or impaired thereby.


 


27.0                           Survival. 
The rights and obligations of Sponsor and Quintiles, which by intent or
meaning have validity beyond such termination (including, but not limited to,
rights with respect to inventions, confidentiality, discoveries and
improvements, indemnification and liability limitations) shall survive the
termination of this Agreement or any Work Order.


 


28.0                           Arbitration. Any controversy or claim arising out of
or relating to this Agreement or the breach thereof shall be settled by
arbitration administered by the International Chamber of Commerce (“ICC”) under
its International Rules of Arbitration, and judgment on the award rendered by
the arbitrator shall be binding and may be entered in any court having
jurisdiction thereof.  Such arbitration
shall be filed and conducted at the office of the ICC closest to the Quintiles
office having responsibility for the Project, and shall be conducted 


 


13

















 


in English by one
arbitrator mutually acceptable to the parties selected in accordance with ICC
Rules.


 


29.0                                 Entire Agreement, Headings and
Modification.
This Agreement, together with the applicable Work Orders, contains the entire
understandings of the parties with respect to the subject matter herein, and
supersedes all previous agreements (oral and written), negotiations and
discussions. The descriptive headings of the sections of this Agreement are
inserted for convenience only and shall not control or affect the meaning or
construction of any provision hereof. 
Any modifications to the provisions herein must be in writing and signed
by the parties.


 


 


IN WITNESS WHEREOF, this
Agreement has been executed by the parties hereto through their duly authorized
officers on the date(s) set forth below.


 


 


 


ACKNOWLEDGED,
ACCEPTED AND AGREED TO:


 


	
  Quintiles East Asia Pte
  Ltd

  	
   

  	
  Progen Pharmaceuticals
  Limited

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
  (signature)

  	
   

  	
   

  	
  (signature)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Print Name:

  	
   

  	
   

  	
  Print Name:

  	
   

  
	
   

  	
   

  	
   

  	
  James Garner

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Vice President of Clinical & Medical Affairs

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  (signature)

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Print Name:

  	
   

  
	
   

  	
   

  	
   

  	
  Linton Burns

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  	
  CFO & Company Secretary

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
													



 


14

















 


 


	
   

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  (signature)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Print Name:

  	
   

  
	
   

  	
   

  	
   

  	
  T. Justus Homburg

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Title: CEO & Managing Director

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
								



 


15

















 


EXHIBIT A


SAMPLE WORK ORDER


 


WORK ORDER


 


This Work Order (“Work Order”) is between                         
(“Sponsor”) and                                          
(“Quintiles”) and relates to the Master Services Agreement dated                            
(the “Master Agreement”), which is incorporated by reference herein.  Pursuant to the Master Agreement, Quintiles
has agreed to perform certain services in accordance with written work orders,
such as this one, entered into from time-to-time.


 


The parties hereby agree as follows:


 


1.             Work
Order.  This document constitutes a “Work
Order” under the Master Agreement and this Work Order and the services
contemplated herein are subject to the terms and provisions of the Master
Agreement.


 


2.             Services
and Payment of Fees and Expenses.  
The specific services contemplated by this Work Order (the “Services”)
and the related payment terms and obligations are set forth on the following
attachments, which are incorporated herein by reference:


 


	
  SCOPE OF WORK

  	
  ATTACHMENT 1

  
	
  PROJECT BUDGET

  	
  ATTACHMENT 2

  
	
  TIMELINE

  	
  ATTACHMENT 3

  
	
  PAYMENT SCHEDULE

  	
  ATTACHMENT 4

  
	
  TRANSFER OF OBLIGATIONS

  	
   

  
	
  (if applicable)

  	
  ATTACHMENT 5

  
	
  LOCAL REPRESENTATIVE DUTIES

  	
   

  
	
  (if applicable)

  	
  ATTACHMENT 6

  



 


 


3.             Term.  The term of this Work Order shall commence on
the date of execution and shall continue until the services described in Attachment
1 are completed, unless this Work Order is terminated in accordance with
the Master Agreement.  If the Master
Agreement is terminated or expires, but this Work Order is not terminated or
completed, then the terms of the Master Agreement shall continue to apply to
this Work Order until the Work Order is either terminated or completed.


 


4.             Subcontractors.   Any subcontractors or consultants (other
than Quintiles’ affiliates) that will be used by Quintiles in performing the
Services are listed below:


 


[Insert names  of  any subcontractors or consultants, other than Quintiles’ affiliates,
that will be used]


 


16

















 


5.             Amendments.  No modification, amendment, or waiver of this
Work Order shall be effective unless in writing and duly executed and delivered
by each party to the other.


 


6.             Currency
Exchange.


 


7.             Inflation
and Cost Adjustment.


 


 


ACKNOWLEDGED,
ACCEPTED AND AGREED TO:


 


	
  [Quintiles]

  	
   

  	
  [Sponsor]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  
							



 


17