# **Exhibit4(a)(2)**

# **MASTERSERVICES AGREEMENT**

 

 

This Master Services Agreement (“Agreement”) is madebetween Progen Pharmaceuticals Limited ABN 82 010 975 612 which has a place of business 16 BensonStreet, Toowong, Queensland 4066, Australia**(hereinafter “Sponsor”), and Quintiles EastAsia Pte Ltd aSingaproe corporation having its principal place of business at 89 Science ParkDrive, Lobby B, #03-08 The Rutherford, Science Park One, Singapore 118261 (hereinafter “Quintiles”). When signedby both parties, this Agreement will set forth the terms and conditions underwhich Quintiles agrees to provide certain services to Sponsor as set forthherein.

 

**Recitals:**

 

A.            Sponsoris in the business of developing, manufacturing and/or distributingpharmaceutical products, medical devices, biotechnology and/or pharmaceuticalproducts and has made significant, up-front investments in technologies relatedto those products and building on important inventions.  Quintiles is in the business of providingclinical trial services, research, and other services for the pharmaceutical,medical device and biotechnology industries and has made significant, up-frontinvestments in technologies related to those industries, building on importantinventions and web-based technologies.

 

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

 

**Agreement:**

 

1.0                                 **Scopeof the Agreement; Work Orders; Nature of Services.**

 

(a)                                  Scope of Agreement. As a “master” form of contract, this Agreement allows the parties tocontract for multiple projects through the issuance of multiple Work Orders (asdiscussed in Section 1(b) below), without having to re-negotiate the basicterms and conditions contained herein. This Agreement covers the provision of services by Quintiles and Quintiles’corporate affiliates (see Section 18) and, accordingly, this Agreementrepresents a vehicle by which Sponsor can efficiently contract with Quintilesand 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 formacceptable to the parties (each such writing, a “Work Order”).  A sample Work Order is attached hereto asExhibit 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 thisAgreement, in addition to the specific details set forth in the Work Order.  To the extent any terms or provisions of aWork Order conflict with the terms and provisions of this

 

*CONFIDENTIAL*

 

 

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Agreement, the terms andprovisions of this Agreement shall control, except to the extent that theapplicable Work Order expressly and specifically states an intent to supersedethe Agreement on a specific matter. All Work Orders and other exhibits heretoshall 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 andanalysis, data processing, data management, regulatory, clerical, projectmanagement, central laboratory services, preclinical services, pharmaceuticalsciences services, medical device services, and other research and developmentservices requested by Sponsor and agreed to by Quintiles as set forth in therelevant Work Order (collectively, the “Services”).

 

2.0                             **Paymentof Fees and Expenses****.****** Sponsor will pay Quintiles for fees, expensesand pass-through costs in accordance with the budget and payment schedulecontained in each Work Order.  Based on theestimated cash flow of the Project, Sponsor agrees that a prepayment may beneeded for Quintiles to maintain cash neutrality over the term of the Projecttaking into account the payment terms agreed to between the parties.For Projectsover multiple calendar years, the budget will include an annualizationpercentage.  Unless otherwise agreed in a particular Work Order,the following shall apply: (a) Quintiles will invoice Sponsor for it fees inaccordance with the payment schedule, and monthly for its expenses andpass-through costs at cost to Quintiles with no mark-up, incurred in performingthe Services; and, (b) with the exception of any prepayment or advances andinvestigator invoices, which aredue and payable upon receipt, all other invoice payments shall be made toQuintiles within thirty (30) days of receipt. In the event that taxes or duties, of whatevernature, are required to be made or withheld on payments made pursuant to thisAgreement or an applicable Work Order by any state, federal, provincial orforeign government, including, but not limited to, Value Added Tax, Sponsorshall promptly pay said taxes and duties to the appropriate taxing authoritywithout any deduction to any amount owed to Quintiles.  Sponsor shall secure and deliver to Quintilesany official receipt for any such taxes paid. Alternatively, Quintiles mayinvoice Sponsor for the taxes accompanied by the official invoice showing thatsuch 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 requirementsof this provision shall not apply to any employment-related taxes, duties, orwithholding and shall only apply to taxes applicable to the Services. Expenses andpass-through costs will be supported by a summary sheet. If any portion of an invoice is disputed, thenSponsor shall pay the undisputed amounts as set forth in the preceding sentenceand the parties shall use good faith efforts to reconcile the disputed amountas soon as practicable.  Sponsor shallpay Quintiles interest in an amount equal to four percent (4%) above the baseinterest rate established by Hambros Bank Limited per month of all undisputedamounts owing hereunder and not paid when due (or the maximum lesser amountpermitted by applicable law.

 

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

 

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renew each yearthereafter for a period of one year, unless either party notifies the otherparty in writing at least 30 days prior to the renewal date that it does notwant to renew the Agreement.

 

4.0                                 **ChangeOrders****.** Any change in the details of a Work Order or the assumptions upon whichthe Work Order is based (including, but not limited to, changes in an agreedstarting date for a Project or suspension of the Project by Sponsor) mayrequire changes in the budget and/or time lines, and shall require a writtenamendment to the Work Order (a “Change Order”). Each Change Order shall detail the requested changes to the applicabletask, responsibility, duty, budget, time line or other matter.  The Change Order will become effective uponthe execution of the Change Order by both parties, and Quintiles will be givena reasonable period of time within which to implement the changes.  Both parties agree to act in good faith andpromptly when considering a Change Order requested by the other party.  Without limiting the foregoing, Sponsoragrees that it will not unreasonably withhold approval of a Change Order, evenif it involves a fixed price contract, if the proposed changes in budgets ortime lines result from, among other appropriate reasons, forces outside thereasonable control of Quintiles or changes in the assumptions upon which theinitial budget or time lines were based, including, but not limited to, theassumptions set forth in the budget or timelines.  Quintiles reserves the right to postponeeffecting material changes in the Project’s scope until such time as theparties agree to and execute the corresponding Change Order.   For any Change Order that affects the scopeof the regulatory obligations that have been transferred to Quintiles,Quintiles and Sponsor shall execute a corresponding amendment to the Transferof Obligations Form.  Sponsor shall filesuch amendment where appropriate, or as required by law or regulation.

 

5.0                                 **Confidentiality**. It is understood that during the course of this Agreement, Quintiles andits employees may be exposed to data and information that are confidential andproprietary to Sponsor.  All such dataand information (hereinafter “Sponsor Confidential Information”) written orverbal, tangible or intangible, made available, disclosed, or otherwise madeknown to Quintiles and its employees as a result of Services under thisAgreement shall be considered confidential and shall be considered the soleproperty of Sponsor.  All informationregarding Quintiles’ operations, methods, and pricing and all Quintiles’Property (as defined in Section 6.0 below), disclosed by Quintiles to Sponsorin connection with this Agreement is proprietary, confidential informationbelonging to Quintiles (the “Quintiles Confidential Information”, and togetherwith the Sponsor Confidential Information, the “Confidential Information”).  The Confidential Information shall be used bythe receiving party and its employees only for purposes of performing thereceiving party’s obligations hereunder. Each party agrees that it will not reveal, publish or otherwise disclosethe Confidential Information of the other party to any third party without theprior written consent of the disclosing party. Each party agrees that it will not disclose the terms of this Agreementor any Work Order to any third party without the written consent of the otherparty, which shall not unreasonably be withheld.** **These obligations ofconfidentiality and nondisclosure shall remain in effect for a period of ten(10) years after the completion or termination of the applicable Work Order.

 

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

 

6.0                                 **Ownershipand Inventions****. **All data and information generated orderived by Quintiles as the result of services performed by Quintiles underthis Agreement shall be and remain the exclusive property of Sponsor.  Any inventions that may evolve from the dataand information described above or as the result of services performed byQuintiles under this Agreement shall belong to Sponsor and Quintiles agrees toassign 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 otherassets, including but not limited to analytical methods, procedures andtechniques, procedure manuals, personnel data**,**financialinformation, computer technical expertise and software, which have beenindependently developed by Sponsor and which relate to its business oroperations (collectively “Sponsor’ Property”). Quintiles and Progen agree that any Sponsors’ Property or improvementsthereto which are used, improved, modified or developed by Sponsor under orduring the term of this Agreement are the sole and exclusive property ofSponsor.  Notwithstanding the foregoing,Sponsor acknowledges that Quintiles possesses certain inventions, processes,know-how, trade secrets, improvements, other intellectual properties and otherassets, including but not limited to analytical methods, procedures andtechniques, procedure manuals, personnel data**,**financialinformation, computer technical expertise and software, which have beenindependently developed by Quintiles and which relate to its business oroperations (collectively “Quintiles’ Property”).  Sponsor and Quintiles agree that anyQuintiles’ Property or improvements thereto which are used, improved, modifiedor developed by Quintiles under or during the term of this Agreement are thesole and exclusive property of Quintiles.

 

7.0**                                ****Records and Materials. **At the completion of the Services by Quintiles or upontermination of this Agreement, all materials, information and all other dataowned by Sponsor, regardless of the method of storage or retrieval, shall bedelivered to Sponsor in such form as is then currently in the possession ofQuintiles, subject to the payment obligations set forth in Section 2herein.   Alternatively, at Sponsor’swritten request, such materials and data may be retained by Quintiles forSponsor for****an agreed-upon time period, ordisposed of pursuant to the written directions of Sponsor.  Sponsor shall pay the costs associated withany of the above options and shall pay a to-be-determined fee for storage byQuintiles of records and materials after completion or termination of theServices.  Quintiles, however, reservesthe right to retain, at its own cost and subject to the confidentialityprovisions herein, copies of all materials that may be needed****to satisfy regulatory requirements or to resolve disputesregarding the Services.  Nothing in thisAgreement shall be construed to transfer from Sponsor to Quintiles any FDA or

 

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regulatory record-keepingrequirements unless such transfer is specifically provided for in theapplicable Transfer of Obligations Form.

 

8.0                                 **IndependentContractor Relationship**.  For thepurposes of this Agreement, the parties hereto are independent contractors andnothing contained in this Agreement shall be construed to place them in therelationship of partners, principal and agent, employer/employee or jointventurers.  Neither party shall have thepower or right to bind or obligate the other party, and neither party shallhold itself out as having such authority. If, however, Sponsor desires to conduct clinical trials in one or morecountries that require a local sponsor or representative, and Sponsor requeststhat Quintiles or its affiliates serve as its agent for that purpose, thenQuintiles may serve as Sponsor’s agent for the purpose of fulfilling localsponsor or representative duties. [Sponsor shall pay Quintiles for such local representative services atQuintiles’ standard daily rates, unless otherwise specified in the Work Order.

 

Certain countries requirethat the local representative must indemnify sites for harm caused by the StudyDrug or otherwise assume primary responsibility for harm caused by the StudyDrug.  Those countries are currentlySingapore, Australia, Indonesia, Korea, Taiwan, China (depending on localregulatory requirements) and Mexico (if IMSS sites are used). If Sponsorrequests 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 . Inaddition, if Sponsor is not based in the European Union (“EU”) and serviceswill be performed in the EU, Sponsor may request that Quintiles serve as itsLegal Representative in the EU, and, if Quintiles agrees, the parties willnegotiate and enter into a separate agreement specifying the terms of suchlegal representation.

 

9.0                                 **a)**  **RegulatoryCompliance**. Quintiles agrees that its Services will beconducted in compliance with all applicable laws, rules and regulations, andwith the standard of care customary in the contract research organizationindustry.  If the Services will be conducted under an FDA Investigational New DrugApplication (“IND”) or Investigational Device Exemption (“IDE”), then regardingthe FDA’s electronic records and signatures regulation, 21 CFR Part 11 (“Part11”), Quintiles represents that it has a compliance plan in place as to itsapplicable database applications and electronic records systems and it isworking diligently to implement its plan. Quintiles, however, is notresponsible for the compliance or non-compliance of applications or systemsused by third parties (including, but not limited to, investigative sites orthird party laboratories), or any Part 11 audits or assessments thereof, unlesssuch applications or systems are owned by Quintiles.  Quintiles’ standard operating procedureswill be used in performance of the Services, unless otherwise specificallystated in the Scope of Work. Quintiles certifies that it has not been debarredunder the Generic Drug Enforcement Act and that it will not knowingly employany person or entity that has been so debarred to perform any Services underthis Agreement.  Sponsor represents andcertifies that it will not require Quintiles to perform any assignments ortasks in a manner that would violate any applicable law or regulation.  Sponsor further represents that it willcooperate with Quintiles in taking any actions that Quintiles reasonablybelieves are necessary to comply with the regulatory obligations that have beentransferred to Quintiles.

 

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                                                **b)****Inspections and Audits.**Eachparty acknowledges that the other party may respond independently to anyregulatory correspondence or inquiry in which such party or its affiliates isnamed.  Each party, however, shall notifythe other party promptly of any FDA or other governmental or regulatoryinspection or inquiry concerning any study or Project of Sponsor in whichQuintiles is providing Services. During any such inspection or inquiry, theparties agree to make reasonable efforts to disclose only the informationrequired to be disclosed.  During theterm of this Agreement, Quintiles will permit Sponsor’s representatives (unlesssuch representatives are competitors of Quintiles) to examine****or audit****the workperformed hereunder and the facilities at which the work is conducted uponreasonable advance notice during regular business hours to determine that theProject assignment is being conducted in accordance with the agreed task andthat the facilities are adequate. Sponsor agrees that it shall not disclose toany third party any information ascertained by Sponsor in connection with anysuch audit or examination, except to the extent required by law orregulation.  Sponsor shall reimburseQuintiles for its time and expenses (including reasonable attorney fees and thecosts of responding to findings) associated with any inspection, audit orinvestigation relating to the Services (“Inspection”) instigated by Sponsor orby a governmental authority, unless such Inspection finds that Quintilesbreached this Agreement or any applicable law or regulation.

 

**10.0****                          ****Relationshipwith Investigators****.**  If Quintileswill be obligated to contract with investigators or investigative sites(collectively, “Investigators”) then Quintiles will use its local CTA forms (“LocalCTAs”) that have developed for use in specific countries based on localrequirements with the benefit of local legal advice, which have been preparedin local language and English language where applicable, unless anindustry-standard form is required in the country in question or asite-specific form is required by a site that has been selected. If no LocalCTAs or industry-standard form exists for the country at issue, the QuintilesGlobal CTA will be used. Any applicable Local CTAs, industry-standard forms,site-specific forms, and the Global CTA will be provided for inspection by theSponsor and a copy of the fully executed version shall be provided to theSponsor for its legal records to fulfill its obligations herein.  Quintiles’ proposals, budgets and timelinesare based on the use of the CTA forms specified above, and use of other formsmay require changes to budgets and timelines and require increased costs forlocal legal review and translations. If an Investigator insists upon anymaterial changes to any provisions that directly affect Sponsor(confidentiality, intellectual property, publication, protocol compliance andinspections), then Quintiles shall submit the proposed change to Sponsor, andSponsor shall review, comment on and/or approve such proposed changes withinfive (5) working days.  If the formsspecified above, or any changes approved by Sponsor, differ from the terms ofthis Agreement or an applicable Work Order (including, but not limited to, provisionsallowing an Investigator to publish results or data that Quintiles isprohibited from revealing), then Quintiles shall have no liability for any suchprovisions or changes.  Unless otherwisestated in the attached Budget, [the time incurred by Quintiles in negotiatingCTA changes proposed by sites shall be billed at Quintiles’ Standard Rates.

 

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Quintiles  reserves the right to contract with certainInvestigators who a) may be employees of a Quintiles Affiliate;  or, b) may employ or utilize the services ofclinical research coordinators or similar personnel who may be employed orprovided by Quintiles or its Affiliates. Quintiles’ affiliations with suchInvestigators will be identified to Sponsor and payments made to suchInvestigators will be invoiced and paid as stated in the Investigator budget asapproved by Sponsor.  The partiesacknowledge and agree that, except as to employees of Quintiles or itsAffiliates, Investigators shall not be considered the employees, agents, orsubcontractors of Quintiles.  AllInvestigators, however, shall exercise their own independent medicaljudgment.  Quintiles’ responsibilitieswith respect to Investigators shall be limited to those responsibilitiesspecifically set forth in this Agreement or the applicable Work Order.

 

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

 

11.0                           **Third Party Indemnifications andAgreements**.  If any investigative sites or any other thirdparties, 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 damagecaused by the sponsor’s Project , then Sponsor shall provide suchindemnification directly to the Third Party. If Sponsor requests Quintiles’ assistance in negotiating the terms ofsuch indemnities, Quintiles shall provide such negotiation services at itsstandard daily rates, unless otherwise agreed in the Work Order.  Quintiles shall not sign suchindemnifications on Sponsor’s behalf unless Sponsor has expressly authorizedQuintiles to act as its agent for such purpose or has given Quintiles a writtenpower of attorney to sign such indemnifications.

 

If Sponsor requests that Quintiles enter intoagreements to retain Third Parties to perform services regarding the Project,such Third Parties shall be independent contractors and shall not be consideredthe employees, agents, or subcontractors of Quintiles or Sponsor.  Sponsor shall pay Quintiles for itsreasonable time and expenses in negotiating and administering any such ThirdParty Agreements.

 

12.0                           **Conflictof Agreements**.  Quintiles represents to Sponsor that it isnot a party to any agreement which would prevent it from fulfilling itsobligations under this Agreement and that during the term of this Agreement,Quintiles agrees that it will not enter into any agreement to provide serviceswhich would in any way prevent it from providing the

 

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Services contemplatedunder this Agreement.  Sponsor agreesthat it will not enter into an agreement with a third party that would alter oraffect the regulatory obligations delegated to Quintiles in any study orProject without the written consent of Quintiles, which will not beunreasonably withheld.

 

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

 

14.0                           **Limitationof Liability**.

 

a)             NeitherQuintiles, 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 anytype of indirect or consequential damages in connection with this Agreement orany Work Order or the Services performed by Quintiles.

** **

**                                               **b)            Inno event shall the collective, aggregate liability (including withoutlimitation, contract, negligence and tort liability) of Quintiles or itsaffiliates, directors, officers, employees, subcontractors or agents under thisAgreement exceed the amount of fees actually received by Quintiles from Sponsorunder the applicable Work Order.

 

c)             Nothingherein is intended to exclude or limit any liability for willful misconduct orany liability for death or personal injury caused by negligence.

 

15.0                           **Indemnification**.

 

a)             Sponsor shall indemnify, defend and hold harmlessQuintiles and its affiliates, and its and their directors, officers, employeesand agents (each, a “Quintiles Indemnified Party”), from and against any andall losses, damages, liabilities, reasonable attorney fees, court costs, andexpenses (collectively “Quintiles Losses”), joint or several, resulting orarising from any third-party claims, actions, proceedings, investigations orlitigation relating to or arising from or in connection with this Agreement,any Work Order, or the Services contemplated herein (including, withoutlimitation, any Quintiles Losses arising from or in connection with any study,test, device, product or potential product to which this Agreement or any WorkOrder relates), except to the extent such Quintiles Losses are determined tohave resulted from the negligence or intentional misconduct of the QuintilesIndemnified Party seeking indemnity hereunder.

 

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

 

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

 

16.0                           **IndemnificationProcedure**.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 shallfully cooperate with the indemnifying party and its legal representatives in the investigation of any matter thesubject of indemnification.   Under nocircumstances shall an indemnified party settle or otherwise compromise anyclaim, liability, or action covered by this Indemnification provision withoutthe indemnified party’s prior written consent, which consent will not beunreasonably withheld.

 

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

 

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

 

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and close-out of affectedProjects, including the fulfillment of any regulatory requirements.  In addition, if the termination is by Sponsorwithout cause, or by Quintiles for cause, and the total fees for the Project aregreater than one million U.S. dollars in value, then Sponsor shall pay toQuintiles an amount equal to ten percent (10%) of the budget for the remainderof Services that have not yet been performed and are scheduled to be performedwithin the twelve (12) months following termination, to cover Quintiles’ costsassociated with early termination.

 

18.0                           **Relationshipwith Affiliates**.  Sponsor agrees that Quintilesmay use the services of its corporate affiliates as subcontractors to fulfill Quintiles’ obligations under thisAgreement or any Work Order.  Quintiles shall remain responsible for allServices performed by its affiliates, and its affiliates shall be subjectto all of the terms, conditions andrights applicable to Quintiles under this Agreement or any Work Order.Any affiliate of Quintiles or Sponsor may enter into a Work Order under thisAgreement, and the terms, conditions and rights in this Agreement shall beincorporated into the Work Order and be binding on such affiliate.  The term “affiliate” shall mean all entitiescontrolling, controlled by or under common control with Quintiles.  The term “control” shall mean the ability tovote fifty percent (50%) or more of the voting securities of any entity orotherwise having the ability to influence and direct the polices and directionof an entity.

 

19.0                           **Cooperation;Sponsor or Quintiles Delays; Disclosure of Hazards****.** Sponsor shall forward to Quintiles in atimely manner all documents, materials and information in Sponsor’s possessionor control necessary for Quintiles to conduct the Services.  Quintiles agreesand acknowledges that time is of the essence and shall use commerciallyreasonable efforts to perform its’ obligations in the conduct of the Serviceswithin the timeframe(s) set forth under the applicable Work Order , includingbut not limited to the Scope of Work and any other Attachments(s)  and anyamendments thereto agreed to by the parties in writing. Quintiles shallnot 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 providedocuments, materials or information or to otherwise cooperate with Quintiles inorder for Quintiles to timely and properly perform its obligations, and anysuch failure by Sponsor shall automatically extend any timelines affected by atime period reasonably commensurate to take into account such failure, unlessSponsor agrees in writing to pay any additional costs  that would be required to meet the originaltimeline.  If Sponsor delays a projectfrom its agreed starting date or suspends performance of the project theneither: a) Sponsor will pay the standard daily rate of the Quintiles’ personnelassigned to the project, based on the percentage of their time allocated to theproject, for the period of the delay, in order to keep the current teammembers; or, b) Quintiles may re-allocate the personnel at its discretion, andSponsor will pay the costs of re-training new personnel. In addition, Sponsorwill pay all non-cancelable costs and expenses incurred by Quintiles due to thedelay and will adjust all timelines to reflect additional time required due tothe delay. In order for Quintiles to comply with the Health and Safety at WorkAct 1974 and any applicable regulation made pursuant thereto it is a conditionof Quintiles providing the contract Services that Sponsor shall provideQuintiles with all information available to it regarding known or potentialhazards associated with the use of any substances supplied to Quintiles bySponsor, and

 

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Sponsor shall comply withall current legislation and regulations concerning the shipment of substancesby the land, sea or air.

 

20.0                           **ForceMajeure**.  In the event either party shall be delayed orhindered in or prevented from the performance of any act required hereunder byreasons of strike, lockouts, labor troubles, inability to procure materials orservices, failure of power or restrictive government or judicial orders, ordecrees, riots, insurrection, war, Acts of God, inclement weather or otherreason 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 suchdelay.

 

21.0                           **Noticesand Deliveries**.  Any notice required orpermitted to be given hereunder by either party hereunder shall be in writingand shall be deemed given on the date received if delivered personally or by areputable overnight delivery service, or three (3) days after the date postmarkedif sent by registered or certified mail, return receipt requested, postageprepaid 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 ordocuments to Quintiles, or requests that Quintiles deliver, ship, or mailmaterials or documents to Sponsor or to third parties, then the expense andrisk of loss for such deliveries, shipments, or mailings shall be borne bySponsor.  Quintiles disclaims anyliability for the actions or omissions of third-party delivery services orcarriers. All information transmitted by Quintiles pursuant to this

 

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

 

22.0   **                 ****Insurance**. During the term of this Agreement tocover its obligations hereunder, each party shall maintain insurance coveragewith a reputable insurance company as follows: i) Clinical Trials and/orProduct Liability insurance for Sponsor of not less than US$5,000,000 perannum; ii)  Professional Indemnityinsurance 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 statutorylevel, whichever is greater. All insurance amounts may be obtained by full,individual primary policy amount; a primary amount of less than minimumrequirement enhanced by a blanket excess umbrella policy; or a combination ofeither. Each party shall provide the other party with a certificate ofinsurance upon request. The insured party will ensure that the other party’sinterest is noted on the policy or policies.

 

23.0                       **Foreign Currency Exchange**. The currency to be used for invoice and payment shall be the currencystated in the Budget or Table attached to the applicable Work Order (the “ContractedCurrency”). If Quintiles incurs pass-through costs in a currency other than theContracted Currency, then Sponsor shall reimburse Quintiles for Quintiles’actual costs in the Contracted Currency based on the Oanda foreign currencyexchange rate (Oanda.com) for the applicable currencies on the last businessday of the month in which such pass-through costs are submitted. ** **If acurrency referenced within the Budget is replaced by the Euro or otherwiseceases to become legal tender, the applicable replacement currency will besubstituted for such currency for purposes of this provision at an establishedconversion rate.

** **

If this Agreement involves the performance of Servicesby Quintiles or its affiliates in any country that uses a currency other thanthe Contracted Currency, then the Budget for those Services will be based onthe local rates in the currency used by Quintiles for pricing that country, butconverted to and reflected in the Contracted Currency.  Sponsor acknowledges that, due tofluctuations in currency exchange rates, Quintiles’ actual fees may be greateror lesser than the budgeted or estimated amounts contained in thisAgreement.  If the fees for Services incurrencies other than the Contracted Currency exceed $500,000 and theconversion rate between the local currencies and the Contracted Currency hasfluctuated more than 2%, plus or minus, since the Budget was prepared,Quintiles may calculate a foreign currency exchange adjustment based upon thefollowing:

 

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

 

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

 

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

24.0                           **Data Protection. **Quintiles and Sponsor agree to comply with allapplicable privacy laws and regulations. If the services will involve the collection or processing of personaldata (as defined by applicable data protection legislation) within the EuropeanEconomic 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 topersonal data.  If Sponsor is not basedin the EEA, Sponsor must appoint an EEA company to act as its localrepresentative for data protection purposes in order to comply with theDirective, and if Sponsor requests that a Quintiles Affiliate in the EEA serveas its local representative, and Quintiles agrees, then the parties shallnegotiate and enter into a separate agreement specifying such representativeduties. If Quintiles determines that it is required, the parties shall enterinto a Data Transfer Agreement between the parties containing the StandardContractual Clauses set forth by the EU Commission Decision of 15 June 2001(Decision 2001/497/EC) before Quintiles will assume any such representativeduties.

25.0                           **Binding Agreement and****Assignment****.**This Agreement shall be binding upon and inure to the benefit of Sponsor andQuintiles and their respective successors and permitted assigns.  Except as stated above in Section 18, neitherparty may assign any of its rights or obligations under this Agreement to anyparty without the express, written consent of the other party.

 

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

 

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

 

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

 

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in English by onearbitrator mutually acceptable to the parties selected in accordance with ICCRules.

 

29.0                                 **Entire Agreement, Headings andModification**.This Agreement, together with the applicable Work Orders, contains the entireunderstandings of the parties with respect to the subject matter herein, andsupersedes all previous agreements (oral and written), negotiations anddiscussions. The descriptive headings of the sections of this Agreement areinserted for convenience only and shall not control or affect the meaning orconstruction of any provision hereof. Any modifications to the provisions herein must be in writing and signedby the parties.

 

 

IN WITNESS WHEREOF, thisAgreement has been executed by the parties hereto through their duly authorizedofficers 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: |   |   |
|                              |             |                                 |  |  |  |  |  |  |  |  |  |  |

 

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|   |   |   | By:                                |        |   |
|--------|--------|--------|------------------------------------|-------------|--------|
|   |   |   |                               | (signature) |
|   |   |   |                               |        |   |
|   |   |   | Print Name:                        |        |
|   |   |   | T. Justus Homburg                  |        |
|   |   |   |                               |        |   |
|   |   |   | Title: CEO & Managing Director |        |
|   |   |   |                               |        |   |
|   |   |   | Date:                              |        |   |
|        |        |        |                                    |             |        |  |  |

 

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*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, Quintileshas 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.             WorkOrder.  This document constitutes a “WorkOrder” under the Master Agreement and this Work Order and the servicescontemplated herein are subject to the terms and provisions of the MasterAgreement.

 

2.             Servicesand 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 followingattachments, 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 onthe date of execution and shall continue until the services described in Attachment1 are completed, unless this Work Order is terminated in accordance withthe Master Agreement.  If the MasterAgreement is terminated or expires, but this Work Order is not terminated orcompleted, then the terms of the Master Agreement shall continue to apply tothis Work Order until the Work Order is either terminated or completed.

 

4.             Subcontractors.   Any subcontractors or consultants (otherthan Quintiles’ affiliates) that will be used by Quintiles in performing theServices are listed below:

 

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

 

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

 

6.             CurrencyExchange.

 

7.             Inflationand Cost Adjustment.

 

 

*ACKNOWLEDGED,ACCEPTED AND AGREED TO:*

 
| [Quintiles] |   | [Sponsor] |
|-------------|--------|-----------|
|        |   |      |   |   |
| By:         |   |      | By: |   |
|        |   |      |   |   |
| Title:      |   |      | Title: |   |
|        |   |      |   |   |
| Date:       |   |      | Date: |   |
|             |        |           |  |  |  |  |

 

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