WORK AUTHORISATION Reference: WA002 (PBT2-204)

Exhibit 4.28

Prana Biotechnology Limited

WORK AUTHORISATION
Reference: WA002 (PBT2-204)

This Work Authorisation is between Prana Biotechnology Limited of Xxxxx 0, 000 Xxxxx Xxxxxx, Xxxxxxxxx, XXX 0000, Xxxxxxxxx (hereinafter “Customer”) and INCResearch Australia Pty Limited ACN 080 425 387 & ABN 67 080 425 387, 000 Xxxxxx Xxxxxx, Xxxx Xxxxxxxx 0000 XX (hereinafter “INC”) and relates to the Master Services Agreement dated 28th September 2011, (the “Master Agreement”). Pursuant to the Master Agreement, INC has agreed to provide certain services in accordance with written work authorisations, such as this one, entered into from time-to-time describing such services.

Study Title: Randomised, Double-blind, Placebo-controlled, Xxxxxxxx-xxxxx, Xxxxx 0 Study to Evaluate the Effect of One Dose of PBT2 (250mg daily) for 52 Weeks on Aβ Deposition in the Brains of Patients with Mild Alzheimer’s Disease Compared to Placebo and to Evaluate the Safety and Tolerability of PBT2 (250mg daily) for 52 Weeks in Patients with Mild Alzheimer’s Disease

The parties hereby agree as follows:

1. Work Authorisation. This document constitutes a “Work Authorisation” under the Master Agreement and this Work Authorisation 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 Authorisation (the “Services”) and the related payment terms and obligations are set forth in the following attachments, which are incorporated herein by reference:

SCOPE OF WORK	ATTACHMENT 1
PROJECT BUDGET & SCHEDULE OF PAYMENT	ATTACHMENT 2

3. Term. The term of this Work Authorisation shall commence on the 28th September 2011 and shall continue until 31st December 2013, unless this Work Authorisation is terminated in accordance with the Master Agreement or extended by written agreement.

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

5. Currency Exchange. All amounts are stated in Australian Dollars (AUD). This will also be the prime currency for invoicing and payment on this project.

ACKNOWLEDGED, ACCEPTED AND AGREED TO:

Prana Biotechnology Limited			INCResearch Australia Limited
By:			By:
Name:	Xxxxxx Xxxxx		Name:	Xxxxx Xxxxxxx
Title:	Chief Operating Officer		Title:	General Manager
Date:	2 April 2012		Date:	18 April 2012

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Attachment 1:

SCOPE OF WORK

1.	ASSUMPTIONS-SERVICES
1.1	General Assumptions

GENERAL
Phase		II
Number of Study Sites + Location		3 sites in Melbourne
Number of Subjects Screened		Not Specified
Number of Subjects Randomised		40
Local Study Sponsor - Australia		Prana
SOPs to be Used		INC
CLINICAL
Site Identification		Sites have been identified by Prana
Investigator Meeting (length, location)		1 day meeting in Melbourne
Monitoring Frequency or Total No.		13 one-day visits per site
Visits/Site
Paper or eCRF		Paper
No. CRF pages/Subject		80 pages
% SDV		100
Monitor Location		Melbourne
Project Manager		Prana
SAFETY REPORTING and MEDICAL MONITORING
No. (%) of SAEs Expected		Assume 1
SAEs Initially Reported to...		INC
SAE Reporting to Local Regulatory Authority		INC
Medical Monitor		Prana (INC as back up)
BIOMETRICS
CRF Design		INC
Medical Coding of Adverse Events		MedDra
Medical Coding Medications		WHO Drug
Data Entry		Double DE
Number of Datasets		25
No. of Check Programs per panel		7
Expected Query rate		7 queries per 100 pages
Laboratory data		Central labs: Safety data (electronic) Local labs: None
Exports		2 (draft and final)
Frequency of Reporting		Monthly Data Management Metrics
DSMC requirements		3 (10%, 40%, 70%)
Statistics tasks		Input to Protocol, Randomisation, Statistical Analysis Plan, Statistical Analyses, DSMB, Statistical Text for CSR

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1.2 Timelines Assumptions

Timelines		Start		End
Start-up		1-Oct-11		10-Oct-11
Recruitment		11-Oct-11		10-Jun-12
Treatment		11-Jun-12		10-Jul-13
Follow-up		11-Jul-13		10-Aug-13
Study Conduct		11-Oct-11		10-Jul-13
Close-out		10-Aug-13		10-Oct-13
Total Duration		1-Oct-11		10-Oct-13

In the event that any of these tasks cannot be completed by the End dates above, INC will notify the Customer immediately, providing:

reasons for the delay;

revised End dates;

any impact on costs; and

where any delay is caused by INC due to factors within their control, the Customer requires INC to show how any lost time can be made up.

The Customer acknowledges that, subject to clause 33, INC and the Customer will meet to agree any additional costs for any delays that INC can establish to, the Customer’s reasonable satisfaction are outside of the control of INC.

1.3 Detailed Transfer of Responsibilities

ACTIVITY		Customer/ Third Party		INC
Study Start-up Activities
Study Sponsorship – Australia		ü
Protocol Development		ü
Approval and Authorisation of Final Protocol		ü
Patient Information Sheet & Consent Template Development		ü
Creation of Study Manual/Monitoring Guidelines				ü
List Trial on Public Register e.g. ANZCTR, Xxxxxxxxxxxxxx.xxx		ü
Conduct Internal Team Kick-Off Meeting				ü
Investigator/Site Identification		ü
Approval of Final Investigator’s/Sites		ü
Finalise Clinical Trial Agreements		ü
Creation and Collection of Essential Documents				ü
Conduct Pre-study/Site Qualification Visits		NA		NA
Complete Ethics Submissions and Follow-up		ü
Respond to Issues Raised by the Ethics Committee		ü
Regulatory Submissions (CTN)		ü
Import/Export Permit Handling		ü
Investigator’s Meeting
Attend Investigator’s Meeting		ü		ü
Present at Investigator’s Meeting		ü		ü
Organise Investigator’s Meeting		ü

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ACTIVITY		Customer/ Third Party		INC
Investigational Product (IP)
IP Packaging and Labelling		ü
IP Storage		ü
IP Distribution		ü
IP Accountability				ü
IP Destruction		ü
Site Visits
Site Initiation Visits				ü
Monitoring Visits				ü
Unblinded Monitoring Visits		NA		NA
Close-out Visits				ü
Completion of Visit Reports				ü
Site Management
Site Management				ü
Project Management
Project Management (Local)		ü
Project Tool Development		ü
Create Master Study Files		ü
Maintenance of Master Study Files During Study		ü
Create Investigator In-house and Site Study Files		ü
Maintain In-house Investigator Study Files During Study		ü
Manage and Make Payments to Investigators/Sites		ü
Produce/Distribute Newsletters		ü
Archiving of Study Files Post-study		ü
Safety Reporting & Medical Monitoring
Initial Receipt and Handling of SAEs				ü
Medical Review of SAEs & Narrative Creation				ü
Reporting to Local Regulatory Authority				ü
Follow-up of SAEs				ü
Creation and Distribution of Investigator Notification Letters				ü
Six-monthly SUSAR Line Listings				ü
Annual Update of IB or Annual Safety Report (EU		ü
Medical Monitoring		ü		ü (back up)
Biometrics
Data Mgt – CRF Design and Development		ü		ü
Data Mgt – CRF Approval		ü
Data Mgt – Database Design and Build				ü
Data Mgt – Database Consistency Check Programming				ü
Data Mgt – Data Validation Manual/Data Management Plan				ü
Data Mgt – Data Entry				ü
Data Mgt – Medical Coding				ü
Data Mgt – Quality Control				ü
Data Mgt – Generation of Data Queries				ü
Data Mgt – Delivery of Clean Verified CRFs to Customer				ü
Statistics – Sample Size Determination		ü

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ACTIVITY		Customer/ Third Party		INC
Statistics – Input to Protocol		ü
Statistics – Generation of Randomisation Schedule and Provision of Randomisation Envelopes.				ü
Statistics – Statistical Analysis Plan				ü
Statistics – Produce Tables, Figures and Listings				ü
Statistics – Interim Analysis				ü
Statistics – Analysis and Reporting				ü
Medical Writing
Provision of Top Line Data/results 4 weeks post database lock				ü
Provision of draft Clinical Study Report 7 weeks post database lock				ü
Provision of final Clinical Study Report 10 weeks post database lock				ü

Service & Expense Assumptions are as per agreed Proposal and Cost Estimate, version 5, dated 15th September 2011.

Study Start up and Document Management

●	Study training/kick-off/familiarisation is included to train the project team on the following:-
	●	Protocol
	●	Investigators’ Brochure
	●	Therapeutic Area Training (by INC’s Chief Medical Officer whose time is a value add service not charged to our Customers)
	●	SOPs
	●	CRF
	●	Monitoring Guidelines

An internal INC kick-off meeting will be held via teleconference at the beginning of the project for all members of the INC study team.

●	Customer kick-off meeting: The Customer will provide training for the CRA(s)/study team on the following;
●	Study protocol
●	Investigational product
●	CTMS (if applicable)
●	Relevant client procedures or plans
	(Amount of time to be discussed and agreed between INC and the Customer).
●	A Study Manual/Monitoring Manual will be produced for this study. This may include explanations of the following, but will vary depending on the Customer’s and the study requirements; applicable SOPs, communication procedures, initiation and monitoring visit procedures and reporting, source document verification (SDV) guidelines, protocol violation procedures, AE and SAE recording, concomitant medication recording, screen failures, withdrawals and early termination visits, investigational product (IP) handling, query resolution.

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●	Clinical Trial Notification (CTN) Handling – Prana will complete all forms and arrange submission of the regulatory applications to the relevant health authorities Therapeutic Goods Administration.
●	Ethics committee submissions includes Pl/consent customisation, completion of application, coordination of copies, coordination of any follow up required. Prana will be responsible for this task.
●	A 1.5 day Investigator’s meeting is scheduled in 2011, which will be organised by Prana. This will include a session for training the INC team.
●	Limited time has been allocated for the preparation of presentations. This will be a shared responsibility between the Customer and INC. Additional time may be required depending on the nature of the presentations that INC is required to develop.
Study Conduct and Monitoring
●	Study initiation visits include visit preparation, time on site, report completion after visits, follow-up correspondence with sites, post visit document handling and issue resolution.
●	Monitoring Visits
	It has been calculated that 39 monitoring days onsite will be required. This calculation is based on 40 patients, 100% SDV and an 80 page CRF. This assumes that it is possible to monitor an average of 85 CRF pages/day. It has been assumed that monitoring visits includes visit preparation, time on site, report completion after visits, follow-up correspondence with sites, post visit document handling and issue resolution.
●	Due to the varying rates of enrolment across sites, the INC Project Manager will have the discretion to reallocate monitoring visits across and between all sites as required. The number of monitoring visits will be assessed on an ongoing basis to determine if more or less monitoring visits are required. This will be discussed and agreed with the Customer on an ongoing basis.
●	Close-out visits includes visit preparation, time on site, report completion after visits, follow-up correspondence with sites, post visit document handling and issue resolution.
●	CRA site management includes: ongoing communications with study sites, regular contacts with site between visits, communications with the Project Manager and the Customer, issue resolution between visits, management of study files and liaison with data management.
Project Management
●	Project Management will be handled by Prana.
●	Teleconferences - It has been assumed that there will be monthly teleconferences for the project team for the period (October 2011 – October 2013).

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Safety Reporting and Medical Monitoring (Optional Service)

●	SAE reporting process (To be confirmed).
	SAEs will be reported directly to INC. INC will then conduct a medical review of the SAE and provide a final report to Prana. INC will be responsible for reporting the SAE to the local regulatory authorities.
●	For the purposes of this proposal, it has been assumed there will be a total of 1 SAE during the course of the trial which is reportable event. There will be 1 SAE Follow up. This provides a unit cost, in the case that there are more SAEs/reportable events and/or follow-ups these will be billed to Prana.
●	The INC Safety Officer will be responsible for the development of a study specific SAE Flow Chart. This will involve liaison with Prana’s Safety Officer or Department.
●	Safety administration – includes familiarisation, set-up, correspondence, tracking, customer liaison, filing, study completion and archiving and has been estimated from October 2011 – July 2013.
●	Investigator notification letters – Includes preparation and oversight
●	The Medical Monitor will be provided by Prana. If required INC can provide a Medical Monitor on a retainer for an additional monthly fee, this will include professional advice in relation to inclusion/exclusion criteria, therapeutic area and review and narrative creation of SAEs.

Data Management

CRF Design

INC will design the CRF using the final protocol and its associated schedules and employing INC’s set of standard pages combined with any example CRF pages provided by the client. Modules of the CRF will be drafted and once agreed will be replicated according to the study visit schedule to form the complete book. When the complete book is assembled navigation prompts will be added to form the final CRF.

The CRFs will be printed as 3 part NCR to provide for original, data management and site copies.

Database Design and Build

A database will be designed employing an annotated CRF which will detail on a blank CRF all database fields, code lists and database structures. This will be presented to the client in PDF format for approval prior to commencement of database build. The design of the database will be to INC internal database standards or CDISC (conversion to be costed).

INC will perform all necessary programming tasks, including developing and testing the database modules, data entry screens and code lists. The database will be maintained until conclusion and archive of the study.

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Data Validation Manual (DVM)

INC will prepare a Data Validation Manual. This will include detailed descriptions in the following categories, as applicable for the project:

●	CRF tracking and filing guidelines
●	Data entry guidelines
●	Pre-review guidelines
●	List of electronic edit checks to be performed
●	List of self-evident corrections and abbreviations
●	Electronic data integration plan
●	Local safety laboratory data handling procedures
●	Medical coding guidelines
●	Serious adverse event reconciliation guidelines
●	Quality control plan
●	Query reconciliation plan

The Data Validation Manual will be forwarded to the Customer for authorization prior to the commencement of data processing for the study.

Consistency Check Programming

After the Data Validation Manual has been authorized INC will develop the consistency check programs. Programs will check for problems with structural integrity, missing data, the logical consistency of data and the reasonability of data against set upper and lower ranges. In addition, listings will arrange data in convenient order so that cross checks of adverse events and other study data can be conducted as a back up to the CRA’s manual review.

Approximately 140 electronic CRF consistency checks as agreed with the Customer will be programmed. In addition 35 structural checks and manual listings will be programmed as required.

For appropriate checks (specified in the Data Validation Manual), output will be produced in the form of data query forms ready for review by the Clinical Data Associate. For others the output will be in the form of discrepancy listings which will be reviewed in full by the Clinical Data Associate.

All programming will be fully QC’d and validated using data entered into a test database prior to the programs being applied to the production databases.

Data Entry

Prior to data entry the completed CRF pages will be pre-coded (as defined in the data validation guidelines) by INC to allow efficient and timely entry of the data. The data will then be entered into the project database using validated data entry guidelines. The data entry will be via the entry and verification technique. This will involve entry by two independent data entry clerks.

Electronic Data

Electronic data for the study will be identified. For this project safety data is expected.

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During the database setup process a data transfer specification will be prepared for each electronic source of data. This will describe the agreed format of the data to be transferred, the frequency, the data structure and whether partial or cumulative transfers are expected. The transfer plan will be signed off by INC and the third party supplier. INC will seek one test transfer of data from the supplier and confirm that the data is being transferred in the agreed format prior to production transfers being received.

Upon receipt of electronic data INC will check the file for structural integrity and cross check it with relevant CRF data. Any discrepancies found will be queried for resolution with the supplier and/or the investigator.

Query Management

Upon successful entry of the data consistency checks will be run regularly across the database. We will review the data for completeness, logical consistency and reasonability of numeric values. We will also perform a manual review of key safety data – particularly adverse events and medications. Any discrepancies found will assessed and where necessary data queries issued. All queries will be provided to clinical operations for resolution with the study site.

All queries will be uniquely numbered and tracked electronically. On receipt of resolved queries, the Clinical Data Associate will update the query log, then, edit the database and CRF as appropriate.

Computer generated query resolution is an ongoing process that begins when the first CRF is received and processed, and continues through to study completion.

Medical Coding

Medical coding of adverse events will be conducted employing the MedDRA 14.0 coding dictionary. Coding of medications will be conducted using the WHO drug dictionary Q2, 2010.

Auto-encoders will be created for the study to code all unique adverse event terms and medications. This means that common terms are coded directly from the dictionary and repetitive terms only need to be coded once. Coding commences with the clarification of any unclear adverse event or medication terms. This may involve the use of data queries. When all terms are clear the medical coder will undertake the medical coding utilizing the auto-encoder. After events and medications are coded listings of coded items are submitted for medical review and any miscoding updated. Clients may also be involved in this review process according to their preference.

Quality Control

Patient’s data will be checked according to the QC plan which will be fully detailed in the Data Validation Manual. For this study it is proposed that 100% of CRF pages be compared to the database for 10% of the patients. In addition a 100% QC of all critically defined data will be conducted as patients become frozen awaiting lock.

Database Lock

At the end of data processing, when all queries have been resolved and SAE reconciliation completed the database will be frozen. Before the database lock a final error rate will be calculated. If above 0.1% then an additional 10% of data will be QC’d and the error rate recalculated. If the error rate is still above 0.1 then 100% of the data is QC’d. When the QC has been satisfactorily completed and authorization has been received from the Customer, the database will be locked.

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Statistics

A randomization schedule will be generated programmatically and provided as a master list to authorized personnel. Individual subjects’ blind break envelopes will be provided to the PI.

A draft Statistical Analysis Plan (SAP) will be prepared in accordance with SOPs and will include specifications for all tables, listings and figures to be produced. This will also detail how the study population will be defined for the study and how key efficacy and safety data will be analysed.

The Customer will review the draft SAP and any feedback/review will be incorporated into the final analysis plan, which will be approved by the Customer prior to the statistical analysis.

After the SAP is finalized the analysis datasets will be defined and programmed.

After database lock a review of the data and protocol violations will be conducted and patients allocated to the study populations applicable for the study.

The study blind will be broken and we will perform the SAS programming and QC processes and produce the agreed tables, listings and figures.

The statistician will analyse the data using the methods agreed in the SAP; determine the statistical results for the study, and provide text for inclusion in the study report.

A maximum of 35 tables (15 unique and 20 repeat formatted tables), 35 associated listings, 0 figures and 10 analysis endpoints are budgeted using SAS V9.2.

A Data Safety Monitoring Committee will meet after approximately 10%, 40% and 70% of total study treatment has occurred. It is anticipated that listings as described in the SAP for the final analysis will be able to be produced for these meetings. However extra programmed listings can be provided (as required) according to the unit cost of listings in the study budget.

At the end of the study INC will prepare a final statistical package including:

●	Final Statistical Analysis Plan
●	Tables, figure, and listings, in an industry-common electronic format, such as SAS, Adobe PDF or Microsoft Word, that will be mutually agreed upon prior to the transfer.
●	A summary and list of protocol deviations and other anomalies known to INC staff.

INC will provide the transfer on CD-R media

Medical Writing (Optional Service)

● The final Clinical Study Report (CSR) for this study will be to International Conference on Harmonisation (ICH) format taking into account any relevant guidelines. The expected length of the report is 30-40 pages of prepared text plus tables and listings as appendices.

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●	We assume one review cycle (i.e., an initial draft report is prepared for client review and following receipt of Customer comments a final report can be issued).
●	We assume that the final report is delivered to the customer in an electronic format.
●	Prana may wish to include an optional of 8 hours QA review. A quality control check is automatically incorporated.
●	Additional services (e.g., full electronic compilation) can be provided at additional cost

It is only possible to provide estimates for Medical Writing services at this stage. We will discuss specific requirements with Prana so that we can that we can tailor our services to meet the Prana’s needs. Due to the nature of Medical Writing the time required to complete a project depends on a number of factors including the CSR template to be used, the length of a document, the complexity of the study, the nature of the study results and the amount of supporting literature provided by the Customer.

The CSR can be developed using a client-provided CSR template if requested by the client but the use of INC’s CSR template has been costed in this proposal.

Expense Assumptions

INC will always obtain the best possible prices to minimise expenditure. Expenses are invoiced separately on a pass through basis and relevant receipt copies are always included, except for general expenses, as outlined below. All amounts specified are in Australian dollars.

Customer Project Team Meeting

●	INC assumes that the Customer Project Kick-off meeting will be held in Melbourne, and therefore, there will be no travel expenses.
Investigator’s Meeting Expenses
●	An Australian investigator meeting will be held in Melbourne.
Travel Related Expenses (Airfares/Accommodation/Taxis)
●	As all monitoring will be regionalised there are no travel related expenses for site visits.
Site Visit Expenses (Parking/Meals/Tolls/Incidentals)
●	An allowance of $50 per day has been estimated for site visits.

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General Expenses/Other

●	Costs related to couriers, and teleconference call will be passed though at cost.
●	A general expense has been calculated to include photocopying (excluding ethics submission copying), stationery (files), express post costs, standard postage and communications (excluding teleconferences). This will be billed at a set rate for the duration of the study.
●	CRF printing – this has been estimated at $2,500, assuming this will be on 3 part no-carbon required (NCR) paper.

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Attachment 2:

PROJECT BUDGET & PAYMENT SCHEDULE

1.  PAYMENT SCHEDULE AND INVOICING

Goods and Services Tax (GST)

In Australia all goods and services are subject to GST of 10%. Unless otherwise specified, fees are expressed as exclusive of Goods and Services Tax (GST). Where fees are GST exclusive and INC is liable to pay GST in respect of any Services provided pursuant to this Agreement, INC may add the GST amount to invoices provided to Customer for the Services. Provided that the relevant invoice complies with the requirements of a tax invoice to enable Customer to claim a credit or refund of GST, Customer shall pay the GST amount at the same time and in the same manner as other amounts invoiced under this Agreement.

Where the services are directly contracted by an overseas Customer GST will not be applicable.

All Clinical Services will be on a unit basis comprising of fixed units (e.g. File Management, Site Management and Management/Supervision) which will be invoiced monthly at the fixed cost as per the Cost Sheet and variable units (e.g. Site Visits), which will be invoiced according to actual number of units incurred each month.

Data Management/Statistics and Medical Writing will be invoiced on a milestone basis.

A percentage of the contract value will be payable upfront upon execution of the Work Authorisation.

If services requirements exceeding those specified in the cost estimate are required then written approval will be obtained from the Customer before conducting the additional services.

INC will invoice the Customer for Data Management/Statistics/Medical Writing according to the following schedule:

	●	Execution of agreement	20%
	●	Database Complete	20%
	●	100% data entered	20%
	●	Data base Lock	20%
	●	1st Draft Study Report	10%
	●	Final Study Report	10%

INC will invoice the Customer for provision of services on a monthly basis. This will include any service units incurred during the previous month.

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All Professional Services have been adjusted to take into account standard fee reviews that would occur over the period of the trial. If the timelines extend beyond the period estimated then INC may increase fees beyond the period stated and any additional costs will be prior approved in writing by the Customer.

Disbursements will be invoiced separately on a monthly basis and will include copies of receipts where relevant.

Payment will be due within 30 days of date of invoices.

Invoices will be submitted to the following E mail address:

Email:	xxxxx@xxxxxxxx.xxx
Cc:	Xxxxxxxx@xxxxxxx.xxx.xx and xxxxxx@xxxxxxxx.xxx

Attention:    Xxxxx Xxxx

Payment will be made by electronic transfer as follows:

Bank Name: Bank of South Australia (A Division of St Xxxxxx Bank Limited)

Swift Code:

BSB (Routing Number):

Account Number:

Account Name: INCResearch Australia Pty Limited

2.  CONTACTS & COMMUNICATION

The key Customer contact person for project related issues, contract and financial issues is Pene Amor. The key contact for INC for project related matters is Xxxxxxx Xxxxxx. The key contact for contract related matters is Xxxxx Xxxxxxx.

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4.1  Budget- Services

Service/Item		Comments		Responsibility		Unit		Unit Cost		Number of Units		Item Cost		AUD$
Study Start Up Activities
Study Training/ Internal Kick Off Meeting		Familiarisation, Protocol. IB, CRF, procedures etc.		CRA		per CRA		1080		1.00		1,080		‘
Essential document collection		Creation, Collection and tracking		CRA		per site		1350		3.00		4,050
Study Manual/Monitoring Manual Development				Med Writer / PM		per manual		3100		1		3,100
Study Files		Set up of study master files and Investigator site files		PA		per study		720		1.00		720
File Management		per month		PA		per month		283		24.00		6,787
												Subtotal		$15,737
Customer Project Team Meetings
Teleconference participation		25 x 1 hour Telecon, 1 CRAs		CRA		per telecon		138		25.00		3.450
												Subtotal		$3,450
Investigator’s/Monitor’s Meeting
Preparation of Presentations		Trident & Customer shared responsibility		CRA		per meeting		1620		1.00		1.620
Attendance		assume 1 day meeting, 1 CRA		CRA		per CRA		1080		1.00		1,080
												Subtotal		$2,700
Site Visits
Study Initiation		Incl. prep, travel, on-site, reporting & follow-up		CRA		per visit		1620		3.00		4,860
Monitoring Visits (1 Day visits)		Incl. prep, travel, 1 day on-site, reporting & follow-up 13 visits/site		CRA		per visit		1932		39.00		75,348
Closeout visits		Incl. prep, travel, on-site, reporting & follow-up		CRA		per visit		2070		3.00		6,210
												Subtotal		$86,418
Site Management
Site Management (October 2011 - July 2013)		per month		CRA		per month		1780		22.00		39,164
Site Management (August 2013 - September 2013)		per month		CRA		per month		828		2.00		1,656
Management/Supervision		per month		Management		per month		340		24.00		8,160
												Subtotal		$48,980
Safety Monitoring
Safety Administration		Incl. set up, maintenance and completion activities		Safety Officer				3979		1.00		3,979
Initial Receipt and handling SAEs		All events - assume 1 SAE		Safety Officer		per SAE		330		1.00		330
Medical Review of SAEs and Narrative creation		Optional - as required		Medical Monitor		per SAE		838		0,00		0
Reporting to local Authorities		Assume 1 Reportable events		Safety Officer		per SAE		660		1.00		660
Follow up of SAEs		Assume 2 hours/Follow-up/SAE, 1 Follow-ups		Safety Officer		per follow-up		330		1.00		330
Investigator Notification Letters		preparation and oversight		Safety Officer		per letter		165		1.00		165
Med Monitor Retainer (June 12 - Oct 13)				Medical Monitor		per month		419		16.00		6,704
												Subtotal		$12,167

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Service/Item		Comments		Responsibility		Unit		Unit Cost		Number of Units		Item Cost		AUD$
Data Management & Statistics
CRF Design		25 unique pages. 80 pages of CRF and 11 pages of questionnaire. 91 Total pages.   One print run.		Data Operations Assoc Manager		1 study		14520		1.00		14,520
Database design and build				DBA/CDA		1 Data set		463		25.00		11,563
Database / Consistency Check programming				DBA/CDA		1 Check		53		208.25		11,114
Data Validation Manual / Data Management Plan				CDA		1 DVM/DMP		3400		1.00		3.400
Data entry		Double Data Entry 40 patients × 80 CRF pages plus 40 × 11 questionaires=3640 total pages. Cost per extra page=5.87		DE		1 page		6		3640.00		21,385
Medical Coding		MedDRA - AE, WHO - Drug		DBA/CDA		1 Coded term		6		800.00		5,036
Data Cleaning / Monitoring		3200 CRF pages. Cost per extra page=$5.10                  224 Queries. Cost per extra query=$42.50		CDA		1 study		29617		1.00		29,617
Quality Control		10% of all patients, 100% of all critical data   (15% critical / 85% non critical)		CDA		1 page		3		811.40		2,391
Import laboratory data		1 central lab		DBA/CDA		1  study		3680		1.00		3,680
Data exports		Assume 2 exports		DBA		1  export		360		2.00		720
Database maintenance		Study Duration = 18 months		DBA		1  month		0		18.00		4,320
DM & Statistics - Project Management		Client meetings & corresp, DM metrics. 1hrs/month x 18 months		DM		1 month		120		18.00		1,530
Input to protocol		Text and sample size calcualtion / power		Statistician		1 hour		200		4,00		800
Generation of Randomisation schedule		1 Schedule.     40 Envelopes. Cost per		Statistician		1		1175		1.00		1,175
Statistical Analysis Plan		Includes text and table and Isting shells		Statistician		1 Statistical		5840		1.00		5,840
Identify Protocol Deviations and define Analysis		Unblinding, Protocol deviations and		Statistician		1 study		1600		1.00		1,600
Analysis Datasets		Specification, Programming   & QC		SAS Programmer		1 study		4800		1.00		4,800
Production of Tables & Listings		15 Unique tables.   Cost per extra $720 20 Repeat tables. Cost per extra $240 0 Figures. Cost per extra S420 35 Listings. Cost per extra S300		SAS Programmer		1 study		26100		1.00		26,100
Statistical Analysis		10 analysis endpoints. Cost per extra $400		Statistician		1 analysis endpoint		400		10.00		4,000
Provision of data to DSMB		Assumes interim running and QC of  6 TFLs in row ‘Programming Tables and listings.		Statistician		1  meeting		960		3.00		2,880
Input to Final report		Text for inclusion in study report.		Statistician		1  hour		2400		1.00		2,400
												Subtotal		$158,869
Medical Writing (Optional)
Clinical study report (CSR)				Medical Writer		per CSR		22497		1.00		22,497
QA review of CSR		Optional for Client		Medical Writer		per CSR		2769		1.00		2,769
												Subtotal		$25,266
												TOTAL		$353,588

WA002 PBT2-204 (800089) V4, 2nd April 2012

Page 16 of 17

Prana Biotechnology Limited

4.2  Budget- Expenses

Expense/Item		Comments		Unit Cost		Number of Units		Item Cost AUD$		AUD$
Site Visits
Other Site visit Costs		Parking/tolls/meals and incidentals for site visits		$50/day		45.00		2,250
								Subtotal		$2,250
General Expenses
General Expenses - Couriers, Postage, Telecommunications, Copying, stationery (files)		$70/site/month, 3 sites for 25 months		$210/month		25		5,250
CRF Printing				$2,500		1		2,500
								Subtotal		$7,750
								TOTAL		$10,000

WA002 PBT2-204 (800089) V4, 2nd April 2012

Page 17 of 17

27 June 2012

1st Amendment to Work Order # 800089 (PBT2-204)

This 1st Amendment to Work Order (hereinafter “Work Order”) is between Prana Biotechnology Limited (hereinafter “Sponsor”) with principal offices located at Xxxxx 0, 000 Xxxxx Xxxxxx, Xxxxxxxxx, XXX 0000, Xxxxxxxxx and INCResearch Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with offices located at 000 Xxxxxx Xxxxxx, Xxxx Xxxxxxxx XX 0000 Xxxxxxxxx and relates to the Master Services Agreement effectively dated 28th September 2011 which expressly incorporates this Work Order hereto by reference into the Master Services Agreement. Pursuant to the Master Services Agreement, INC Research has agreed to perform certain services in accordance with written work orders, such as this one, entered into from time to time describing such services.

Study Title: Randomised, Double-blind, Placebo-controlled, Xxxxxxxx-xxxxx, Xxxxx 0 Study to Evaluate the Effect of One Dose of PBT2 (250mg daily) for 52 weeks on Ab Deposition in the Brains of Patients with Mild Alzheimer’s Disease Compared to Placebo and to Evaluate the Safety and Tolerability of PBT2 (250mg daily) for 52 weeks in Patients with Mild Alzheimer’s Disease

The parties hereby agree as follows:

Amendment Summary:

Agreement		Details
Original Agreement		WA002
Date of Original Agreement		Version 4, doted 2nd April 2012
Amendment number		Amendment #1
Version & Date of Amendment		Version 2, doted 27th June 2012
Project ID (INC internal code)		800089
Client		Prono Biotechnology Limited
Client Project Code		PBT2-204
Description of Amendment			●	Additional 2 sites – RMH and Geelong Private
			●	1 additional CRA
			●	Reduction in 1 day Monitoring visits
			●	Addition of 2 day Monitoring visits
			●	Deletion of Medical Monitor retainer
			●	Site Management adjustment

Prana 800089 (PBT2-204) version 2, 27th June 2012 

Page 1 of 6

Costs Implication for Amendment		Direct Costs (Services)
			●	Study Training for additional 1 CRA @  $540/CRA = $540.00
			●	Additional 2 Sites Essential Document Collection @ $1350/site = $2,700.00
			●	Additional 14 months File Management  for 2 new sites @ $283/month = $3,959.00
			●	16 x 1 hour Teleconference participation  for additional 1 CRA @ $138/telecom = $2,208.00
			●	2 additional Study Initiation Visits @ $1620/visit = $3,240.00
			●	Reduction of 19 x 1 day monitoring visits @ $1932/visit = -$36,708.00
			●	15 x 2 day monitoring visits @ $3174/visit = $47,610.00
			●	2 additional Close out Visits @ $2070/visit = $4,140.00
			●	Addition of 2 months of Site Management for 1 site @ $593.50/month = $1,187.00
			●	Addition of 6 months of Site Management for 2 sites @ $1187/month = $7,121.00
			●	Reduction in 8 months of Site Management of 3 sites @ $1780/month = -$14,240.00
			●	12 months Site Management for 2 new sites @ $1187/month = $14,242.00
			●	2 months Site Management for 2 new sites @ $552/month = $1,104.00
			●	Deletion of Medical Monitor retainer =  -$6,704.00
				-    Total Cost $30,398.00
		Indirect Costs (Expenses)
			●	15 days of additional Other Site Visit costs @ $50/day = $750.00
			●	Additional General Expenses for 2 new sites for 16 months @ $140/month = $2,240.00
				-    Total Cost = $2,990.00
Total Cost Implication for Amendment		$33,388.00

Prana 800089 (PBT2-204) version 2, 27th June 2012 

Page 2 of 6

Budget Summary:

Work Order		Services		Expenses		Total Contract
Original Work Order		$353,588.00		$10,000.00		$363,588.00
Amendment #1		$30,398.00		$2,990.00		$33,388.00
Revised Contract Value		$383,986.00		$12,990.00		$396,976.00

Details of Amendment 1

Assumption - General Services

GENERAL
Phase	II
Number of Study Sites + Location	5 sites in Melbourne
Number of Subjects Screened	Not Specified
Number of Subjects Randomised	40
Local Study Sponsor – Australia	Prana
SOPs to be Used	INC
CLINICAL
Site Identification	Sites have been identified by Prana
Investigator Meeting (length, location)	1 day meeting in Melbourne
Monitoring Frequency or Total No. Visits/Site	4 x 1 day visits and 3 x 2 day visit per site
Paper or eCRF	Paper
No. CRF pages/Subject	80 pages
% SDV	100
Monitor Location	Melbourne x 2
Project Manager	Prana
SAFETY REPORTING and MEDICAL MONITORING
No. (%) of SAEs Expected	Assume 1
SAEs Initially Reported to...	INC
SAE Reporting to Local Regulatory Authority	INC
Medical Monitor	Prana (INC as back up)
BIOMETRICS
CRF Design	INC
Medical Coding of Adverse Events	MedDra
Medical Coding Medications	WHO Drug
Data Entry	Double DE
Number of Datasets	25
No. of Check Programs per panel	7

Prana 800089 (PBT2-204) version 2, 27th June 2012 

Page 3 of 6

Expected Query rate	7 queries per 100 pages
Laboratory data	Central labs: Safety data (electronic) Local labs: None
Exports	2 (draft and final)
Frequency of Reporting	Monthly Data Management Metrics
DSMC requirements	3 (10%, 40%, 70%)
Statistics tasks	Input to Protocol, Randomisation, Statistical Analysis Plan, Statistical Analyses, DSMB, Statistical Text for CSR

Amendment 1 to Budget Services

Service/Item		Comments		Responsibility		Unit		Unit Cost		Number of Units		Item Cost		AUD$
Study Start Up Activities
Study Training/ Internal Kick Off Meeting		Familiarisation, Protocol, IB, CRF, procedures etc.		CRA		per CRA		1080		1.00		1,080
Study Training		Familiarisation etc.		CRA		per CRA		540		1.00		540
Essential document collection		Creation, Collection and tracking		CRA		per site		1350		5.00		6,750
Study Manual/Monitoring Manual Development				Med Writer / PM		per manual		3100		1		3,100
Study Files		Set up of study master files and Investigator site files		PA		per study		720		1.00		720
File Management		per month		PA		per month		283		24.00		6,787
File Management - 2 new sites		per month from August 2012		PA		per month		283		14.00		3,959
												Subtotal		$22.937
Customer Project Team Meetings
Teleconference participation		25 x 1 hour Telecon, 1 CRAs		CRA		per telecon		138		25.00		3,450
Teleconference participation		16 x monthly hour Telecon, 1 CRA		CRA		per telecon		138		16.00		2,208
												Subtotal		$5,658
Investigator’s Monitor’s Meeting
Preparation of Presentations		Trident & Customer shared responsibility		CRA		per meeting		1620		1.00		1,620
Attendance		assume 1 day meeting, 1 CRA		CRA		per CRA		1080		1.00		1,080
												Subtotal		$2,700
Site Visits
Study Initiation		Incl. prep, travel, on-site, reporting & follow-up		CRA		per visit		1620		5.00		8,100
Monitoring Visits (1 Day visits)		Incl. prep, travel, 1 day on-site, reporting & follow-up 4 visits/site		CRA		per visit		1932		20.00		38,640
Monitoring Visits (2 Day visits)		Incl. prep, travel, 2 day’s on-site, reporting & follow-up 3 visits/site		CRA		per visit		3174		15.00		47,610
Closeout visits		Incl. prep, travel, on-site, reporting & follow-up		CRA		Per visit		2070		5.00		10,350
												Subtotal		$104,700
Site Management
Site Management (October 2011 - Nov 2011)		1 site		CRA		per month		593		2.00		1,187
Site Management (Dec 2011 - May 2012)		2 sites		CRA		per month		1187		6.00		7,121
Site Management (June 2012 - July 2013)		3 sites		CRA		per month		1780		14.00		24,923
Site Management (August 2012 - July 2013)		per month - 2 new sites		CRA		per month		1187		12.00		14,242
Site Management (August 2013 - September 2013)		3 sites		CRA		per month		828		2.00		1,656
Site Management (August 2013 - September 2013)		per month - 2 new sites		CRA		per month		552		2.00		1,104
Management/Supervision		per month		Management		per month		340		24.00		8,160
												Subtotal		$58,392
Safety Monitoring
Safety Administration		Incl. set up, maintenance and completion activities		Safety Officer				3979		1.00		3,979
Initial Receipt and handling SAEs		All events - assume 1 SAE		Safety Officer		per SAE		330		1.00		330
Medical Review of SAEs and Narrative creation		Optional - as required		Medical Monitor		per SAE		838		0.00		0
Reporting to local Authorities		Assume 1 Reportable events		Safety Officer		per SAE		660		1.00		660
Follow up of SAEs		Assume 2 hours/Follow-up/SAE, 1 Follow ups		Safety Officer		per follow-up		330		1.00		330
Investigator Notification Letters		preparation and oversight		Safety Officer		per letter		165		1.00		165
												Subtotal		$5,464

Prana 800089 (PBT2-204) version 2, 27th June 2012

Page 4 of 6

Service/Item		Comments		Responsibility		Unit		Unit Cost		Number of Units		Item Cost		AUD$
Data Management & Statistics
CRF Design		25 unique pages. 80 pages of CRF and 11 pages of questionnaire. 91 Total pages.   One print run.		Data Operations Assoc Manager		1 study		14520		1.00		14,520
Database design and build				DBA/CDA		1 Data set		463		25.00		11,563
Database / Consistency Check programming				OBA/CDA		1 Check		53		208.25		11,114
Data Validation Manual / Data Management Plan				CDA		1 DVM/DMP		3400		1.00		3,400
Data entry		Double Data Entry 40 patients x 80 CRF pages plus 40 x 11 questionaires=3640 total pages. Cost per extra page=5.87		DE		1 page		6		3640.00		21,385
Medical Coding		MedDRA - AE, WHO - Drug		DBA/CDA		1 Coded term		6		800.00		5,036
Data Cleaning / Monitoring		3200 CRF pages. Cost per extra page=$5.10         224 Queries. Cost per extra query=$42.50		CDA		1 study		29617		1.00		29,617
Quality Control		10% of all patients, 100% of all critical data (15% critical / 85% non critical)		CDA		1 page		3		811.40		2,391
Impart laboratory data		1 central lab.		DBA/CDA		1 study		3680		1.00		3,680
Data exports		Assume 2 exports		DBA		1 export		360		2.00		720
Database maintenance		Study Duration = 18 months		DBA		1 month		0		18.00		4,320
DM & Statistics - Project Management		Client meetings & corresp, DM metrics. 1hrs/month x 18 months		DM		1 month		120		18.00		1,530
Input to protocol		Text and sample size calcualtion / power		Statistician		1 hour		200		4.00		800
Generation of Randomisation schedule		1 Schedule.   40 Envelopes. Cost per		Statistician		1		1175		1.00		1,175
Statistical Analysis Plan		Includes text and table and Isting shells		Statistician		1 Statistical		5840		1.00		5,840
Identify Protocol Deviations and define Analysis		Unblinding. Protocol deviations and		Statistician		1 study		1600		1.00		1,600
Analysis Datasets		Specification, Programming  & QC		SAS Programmer		1 study		4800		1.00		4,800
Production of Tables 4 Listings		15 Unique tables. Cost per extra $720 20 Repeat tables. Cost per extra $240 0 Figures. Cost per extra $420 35 Listings, Cost per extra $300		SAS Programmer		1 study		26100		1.00		26,100
Statistical Analysis		10 analysis endpoints. Cost per extra $400		Statistician		1 analysis endpoint		400		10.00		4,000
Provision of data to DSMB		Assumes interim running and QC of 6 TFLs in row Programming Tables and listings.		Statistician		1 meeting		960		3.00		2,880
Input to Final report		Text for inclusion in study report.		Statistician		1 hour		2400		1.00		2,400
												Subtotal		$158,869
Medical Writing (Optional)
Clinical study report (CSR)				Medical Writer		per CSR		22497		1.00		22,497
QA review of CSR		Optional for Client		Medical Writer		per CSR		2769		1.00		2,769
												Subtotal		$25,266
												TOTAL		$383,986

Amendment 1 to Budget Expenses

Expense/Item		Comments		Unit Cost		Number of Units		Item Cost AUD$		AUD$
Site Visits
Other Site visit Costs		Parking/tolls/meals and incidentals for site visits		$50/day		60.00		3,000
								Subtotal		$3,000
General Expenses
General Expenses - Couriers, Postage, Telecommunications, Copying, stationery (files)		$70/site/month, 3 sites for 25 months		$210/month		25		5,250
General Expenses - Couriers. Postage, Telecommunications, Copying, stationery (files)		$70/site/month, 2 new sites for 16 months		$140/month		16		2,240
CRF Printing				$2,500		1		2,500
								Subtotal		$9,990
								TOTAL		$12,990

Prana 800089 (PBT2-204) version 2, 27th June 2012

Page 5 of 6

IN WITNESS WHEREOF, the undersigned have caused this Work Order to be executed by a duly authorized individual on behalf of each requisite party effective as of the day and year last written below. In the event that the parties execute this Work Order by exchange of electronically signed copies or facsimile signed copies, the parties agree that, upon being signed by both parties, this Work Order shall become effective and binding and that facsimile copies and/or electronic signatures will constitute evidence of the existence of this Work Order with the expectation that original documents may later be exchanged in good faith. Thereafter, the parties agree that in connection with request for information that either party may need from the other related to the Services provided hereunder, both parties expressly permit communication via facsimile to the extent allowed by applicable laws and regulations to be disseminated in that manner.

Prana Biotechnology Limited
By:
Name:	Xxxxxx Xxxxx
Title:	Chief Operating Officer
Date:	13 July 2012

INCResearch Australia Pty Limited
By:
Name:	Xxxxx Xxxxxxx
Title:	Regional General Manager, Australia and South East Asia
Date:	19 July 2012

Prana 800089 (PBT2-204) version 2, 27th June 2012

Page 6 of 6

CHANGE ORDER N°1 to Work Order #1000504

This Change Order number 1 to Work Order #1000504 (hereinafter “Change Order”) is made and entered into as of the date of last signature (hereinafter “Effective Date”) by and between Prana Biotechnology Limited (hereinafter “Sponsor”) with an office located at Xxxxx 0, 000 Xxxxx Xxxxxx, Xxxxxxxxx XXX 0000, Xxxxxxxxx and INCResearch Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with principal offices located at 000 Xxxxxx Xxxxxx, Xxxx Xxxxxxxx XX 0000, Xxxxxxxxx.

RECITALS

WHEREAS, Sponsor and INC Research have entered into Work Order #1000504 (hereinafter “Agreement”) to perform Services for Xxxxxxxx # XXX0-000 for study entitled: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability, and Efficacy of PBT2 in Patients with Early to Mid-stage Huntington Disease (hereinafter “Study”), which was signed by Sponsor and INC Research on 14th August 2012, and

WHEREAS, during the course of the performance of the Study, Sponsor and INC Research have identified changes in assumptions; and

WHEREAS, Sponsor desires to retain additional services from INC Research and INC Research desires to supply such services to Sponsor under the terms and conditions set forth herein; and

WHEREAS, Sponsor and INC Research agree that all other terms and conditions of the Agreement shall remain in full force and effect, unless specifically agreed otherwise in this Change Order; and

WHEREAS, Sponsor and INC Research agree that the services and costs covered by this Change Order are additional to the services and costs covered by the Agreement;

NOW THEREFORE, subject to the terms, conditions and covenants hereinafter set forth, INC Research and Sponsor agree as follows:

SECTION l: CHANGES IN SCOPE

This section contains an overview of the changes in assumptions, timelines, and revision in Scope of services. In summary, this Change Order mainly reflects the following changes:

Direct Costs

●	Addition of seven (7) x One Day Monitoring Visits, to be invoiced only if required.
●	Addition of eight (8) x Two Day Monitoring Visits, to be invoiced only if required.
●	Addition of one (1) x Four Day Monitoring Visit.
●	Addition of nine (9) x Serious Adverse Events (SAE) Notifications, to be invoiced only if required.
●	Addition of four (4) x Reporting to Local Authorities of SAEs, to be invoiced only if required.
●	Addition of 6 Monthly Suspected Unexpected Serious Adverse Reaction (SUSAR) Line Listings time for Safety Officer, to be invoiced only if required.

INC Research, LLC – CONFIDENTIAL

INCResearch Australia Pty Limited - 0000000 

Xxxxx Xxxxxx Xxxxx #0, x0, x0xx April 2013 

Page 1 of 8

INC Research, LLC Change Order Form

Indirect Costs

●    Addition of twenty-seven (27) x Other Site Visit Costs.

The parties hereby agree the total cost associated with this Change Order is AUD $48,505.00.

SECTION II: COSTS OVERVIEW

The additional deliverables and tasks performed by INC Research are specified in Attachment A. This Attachment includes an overview of the total prices of deliverables in the original agreement and previous change orders, and an overview of the additional total prices of the new deliverables and services. The total amount of all contracted deliverables (original agreement including all change orders) is shown in Attachment A.

A summary of both direct and indirect costs related to the original agreement and all changes in scope as occurred is provided in the table below:

		Effective Date		Direct Costs AUD$		Indirect Costs AUD$		Grand Total AUD$
Original Contract		14th August 2012		$263,821.00		$17,100.00		$280,921.00
Xxxxxx Xxxxx # 0		Xxxx Xxxxxxxxx		$47,155.00		$1,350.00		$48,505.00
Total Contract Value				$310,976.00		$18,450.00		$329,426.00

INC Research, LLC – CONFIDENTIAL

INCResearch Australia Pty Limited - 0000000 

Xxxxx Xxxxxx Xxxxx #0, x0, x0xx April 2013 

Page 2 of 8

Revised Direct Costs

Service/Item		Comments		Responsibility		Unit		Unit Cost (AUD)		Original Number of Units		CO#1 Number of Units		Original Item Cost (AUD$)		CO#1 Item Cost (AUD$)		TOTAL COST AUD$
Study Start Up Activities
Study Training/Internal Kick Off Meeting		Familiarisation, Protocol, IB		CRA		per CRA		1123		3		0		3,370		0
Study Training/Internal Kick Off Meeting		Familiarisation, Protocol, IB		PM		per PM		1290		1		0		1,290		0
Essential Document Collection		Creation, Collection and Tracking		CRA		per site		1123		5		0		5,616		0
Study Files		Set-up of Study Master Files and Investigator Site Files		PA		per study		749		1		0		749		0
CRA Administration (March 2012 -May 2012)		Communications - Customer, Site, Project Manager		CRA		per month		3019		3		0		9,056		0
												Subtotal		20,080		0		$20,080
Customer Project Team Meetings
Customer Kick-off Meeting		Teleconference		PM		per PM		322		1		0		322		0
Sponsor Teleconference Participation		21 x 1 hour Telecon		PM		per telecon		165		21		0		3,456		0
												Subtotal		3,778		0		$3,778
Investigator’s/Monitor’s meeting
Travel Time		4 hours Return		PM		per PM		645		1		0		645		0
Travel Time		8 hours Return		CRA		per CRA		1123		1		0		1,123		0

INC Research, LLC – CONFIDENTIAL

INCResearch Australia Pty Limited - 1000504 

Prana Change Order #1, v2, 10th April 2013 

Page 3 of 8

INC Research, LLC Change Order Form

Service/Item		Comments		Responsibility		Unit		Unit Cost (AUD)		Original Number of Units		CO#1 Number of Units		Original Item Cost (AUD$)		CO#1 Item Cost (AUD$)		TOTAL COST AUD$
Attendance		Assume 1.5 day Meeting, 1 PM		PM		per PM		1934		1		0		1,934		0
Attendance		Assume 1.5 day Meeting, 2 CRAs		CRA		per CRA		1685		2		0		3,370		0
												Subtotal		7,072		0		$7,072
Site Visits
Study Initiation		Includes Preparation, Travel, Time On-site, Reporting and Follow-up		CRA		Per visit		1404		5		0		7,020		0
Monitoring Visits (1 Day Visits)		Including Preparation, Travel, 1 day On-site, Reporting and Follow-up - only if required		CRA		Per  visit		1579		25		7		39,478		11,054
Monitoring Visits (2 Day Visits)		Including Preparation, Travel, 2 days On-site, Reporting and Follow-up - only if required		CRA		Per visit		3015		0		8		0		24,117
Monitoring Visits (4 Day Visits)		Including Preparation, Travel, 4 days On-site, Reporting and Follow-up		CRA		per visit		5886		0		1		0		5,886
Closeout Visits		Includes Preparation, Travel, Time On-site, Reporting and Follow-up		CRA		per visit		1752		5		0		8,761		0
				-						-		Subtotal		55,258		41,057		$96,315
Site Management
Site Management (June 2012 -September 2013)		per Month		CRA		per month		3086		16		0		49,383		0
Site Management (October 2013 - November 2013)		per Month		CRA		Per month		1460		2		0		2,920		0
												Subtotal		52,303		0		$52,303

INC Research, LLC – CONFIDENTIAL

INCResearch Australia Pty Limited - 0000000

Xxxxx Xxxxxx Xxxxx #0, x0, x0xx April 2013

Page 4 of 8

INC Research, LLC Change Order Form

Service/Item		Comments		Responsibility		Unit		Unit Cost (AUD)		Original Number of Units		CO#1 Number of Units		Original Item Cost (AUD$)		CO#1 Item Cost (AUD$)		TOTAL COST AUDS
Project Management
Local Coordination/Supervision (March 2012 - May 2012)		per Month		PM		per month		5158		3		0		15,475		0
Local Coordination/Supervision (June 2012 - September 2013)		per Month		PM		per month		3296		16		0		52,743		0
Local Coordination/Supervision (October 2013 - November 2013)		per Month		PM		per month		3353		2		0		6,706		0
Project Assistance (March 2012 - November 2013)		per Month		PA		per month		2054		21		0		43,144		0
												Subtotal		118,068		0		$118,068
Safety Monitoring
Safety Administration		Includes Set-up, Maintenance and Completion Activities		Safety Officer		per study		4597		1		0		4,597		0
Handling of SAEs (Notifications)		All Events - Assume 10		Safety Officer		per SAE		330		1		9		330		2,967
Medical Review of SAEs and Narrative Creation		All Events - Assume 1 SAE		Medical Monitor		per SAE		851		1		0		851		0
Reporting to Local Authorities		All Events - Assume 5		Safety Officer		per SAE		659		1		4		659		2,637
6-Monthly SUSAR Line Listing		Preparation, distribute and tracking		Safety Officer		per study		494		0		1		0		494
Safety Management Plan (review)				Safety Officer		per study		659		1		0		659		0

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INC Research, LLC Change Order Form

Service/Item		Comments		Responsibility		Unit		Unit Cost (AUD)		Original Number of Units		CO#1 Number of Units		Original Item Cost (AUD$)		CO#1 Item Cost (AUD$)		TOTAL COST AUD$
Teleconference		Assume 1 hour teleconference		Safety Officer		per telecon		165		1		0		165		0
												Subtotal		7,261		6,098		$13,360
												TOTAL		263,821		47,155		$310,976

Revised Indirect Costs

Expense/Item		Comments		Unit Cost		Original Number of Units		CO#1 Number of Units		Original Item Cost AUD$		CO#1 Item Cost AUD$		TOTAL COST AUD$
Investigator’s/Monitor’s Meeting Attendance
		Airfares, accommodation &
Travel/Attendance Costs		meals provided by Client, $500 - taxis, currency exchange, meals in transit, phone		$500/person		2		0		1,000		0
								Subtotal		1,000		0		$1,000
Site Visits
Other Site visit Costs		Parking/tolls/meals and incidentals for site visits		$50/day		35		27		1,750		1,350
								Subtotal		1,750		1,350		$3,100
General Expenses
Couriers, Express Post, Teleconferences				$7,000		1		0		7,000		0

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INC Research, LLC Change Order Form

Copying (Excluding ethics submissions), postage, telecommunications (excluding teleconferences), stationery (files)		$70/site/month, 5 sites for 21 months		$350/month		21		0		7,350		0
								Subtotal		14,350		0		$14,350
								TOTAL		17,100		1,350		$18,450

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SIGNATURE

COUNTERPARTS. This Change Order may be signed in counterparts and said counterparts shall be treated as though signed as one document. The parties acknowledge legal validity of facsimile, portable document format or other commercially acceptable electronic exchange of copies of the documents, which are essential for Change Order execution. A party which uses a facsimile, portable document format or other commercially acceptable electronic exchange copy of an authorized person’s signature in the documents guaranties its authenticity.

IN WITNESS WHEREOF, the undersigned have caused this Change Order to be executed by a duly authorized individual on behalf of each requisite party effective as of the day and year last written below.

Prana Biotechnology Limited		INCResearch Australia Pty Limited
Signature By:		Signature By:
XXXXXX XXXXX		Xxxxx Xxxxxxx
Name (print)		Name (print)
C.O.O		Executive Vice President, Asia/Pacific
Title		Title
16/April/2013		24/04/2013
Date		Date

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