EX-4.26 6 exhibit_4-26.htm EXHIBIT 4.26 exhibit_4-26.htm


Exhibit 4.26
 
(INC RESEARCH LOGO)
 
WORK ORDER
INC Research Project # 1000504
Protocol # PBT2-203
 
This Work Order (hereinafter “Work Order”) is between Prana Biotechnology Limited (hereinafter “Sponsor”) with principal offices located at Level 2, 369 Royal Parade, Parkville VIC 3052 Australia and INCResearch Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with offices located at 124 Lipson Street, Port Adelaide SA 5015 Australia and relates to the Master Services Agreement effectively dated 22nd 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.
 
This document constitutes a Work Order under the Master Services Agreement and this Work Order and the Services contemplated herein are subject to the terms and provisions of the Master Services Agreement.
 
1.
SERVICES: INC Research will render such services (hereinafter “Services”) as may be necessary to complete in a professional manner the project described below:
   
 
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 (#PBT2-203)
   
 
INC Research will perform the Services as specified in Attachment A to this Work Order.
   
2.
PROJECT SCHEDULE: The major project milestones and target dates are described in Attachment B to this Work Order. Both parties agree that the Project Schedule is a reasonable schedule for the Services to be performed and will put forth all reasonable efforts to comply with these dates.
   
3.
COMPENSATION AND EXPENSES: Sponsor shall pay the fees for INC Research’s Services in accordance with the Project Budget and Payment Schedule provided in Attachment C of this Work Order. INC Research shall invoice Sponsor for taxes or duties actually incurred by INC Research which are imposed upon INC Research by any governmental agency, including, but not limited to Value Added Tax, Stamp Tax, and/or General Sales Tax, as a result of this Agreement with the exception of taxes based on INC Research’s income.
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
4.
NOTICES AND PAYMENTS: All communications, notices and payments required under this Work Order shall be mailed by first class mail, postage prepaid, or by overnight carriers, to the respective parties at the addresses set forth below, or to such other addresses as the parties may from time to time specify in writing.
 
 
If to Sponsor:
 
   
Caroline Herd
Chief Development Consultant
Prana Biotechnology Limited
Level 2
369 Royal Parade
Parkville VIC 3052 Australia
Phone: +61 (0) 3 9349 4906
Facsimile: +61 (0) 3 9348 0377
 
If to INC Research:
 
     
 
For Communications:
Contracts Management
INCResearch Australia Pty Limited
124 Lipson Street
Port Adelaide SA 5015 Australia
Phone: +61 (0) 8 8447 3500
Facsimile: +61 (0) 8 8447 3511
 
For Payments (Via Wire):
 
     
 
Beneficiary Bank:
Bank of South Australia (A Division of
St George Bank Limited)
 
Account Name:
INCResearch Australia Pty Limited
 
BSB (Routing Number):
 
 
Account Number:
 
 
Swift:
 
 
5.
TRANSFER OF OBLIGATIONS: Sponsor assigns the responsibilities pertaining to the Study to INC Research as indicated in Attachment A, Services.
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
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:
      -s- dianne angus 
   
Name:
Dianne Angus
   
Title:
Chief Operating Officer
   
Date:
6th August 2012
 
INCResearch Australia Pty Limited
 
By:
      -s- garth tierney
   
Name:
Garth Tierney
   
Title:
Regional General Manager, Australia and South East Asia
   
Date:
14th August 2012.
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
ATTACHMENT A
Services
 
DETAILED ASSUMPTIONS
     
GENERAL
   
DRUG NAME
 
PBT2
INDICATION
 
Huntington Disease
PHASE
 
2a
SITES
   
NUMBER OF COUNTRIES
 
1 - Australia
NUMBER OF SITES
 
5
NUMBER OF APPLICABLE LANGUAGES
 
1 - English
CASE REPORT FORM (CRF)
   
PAPER OR ELECTRONIC CRF
 
eCRF
NUMBER OF PAGES PER ENROLLED PATIENT
 
70
TOTAL PAGES
 
2,100
INVESTIGATOR MEETING
   
NUMBER OF MEETING(S)
 
1 - Melbourne
DURATION OF MEETING(S)
 
1.5 days
 
NUMBER OF SITE ATTENDEES
 
3 attendees per site (15 total site attendees)
 
NUMBER OF CUSTOMER ATTENDEES
 
5
 
NUMBER OF INC RESEARCH ATTENDEES
 
2 CRAs + 1 PM
SITE MONITORING
   
NUMBER OF CRAs
 
3 - based in Sydney, Melbourne and Perth
NUMBER OF INITIATION VISITS
 
5
NUMBER OF MONITORING VISITS
 
25 one-day visits - 5 visits/site
NUMBER OF CLOSEOUT VISITS
 
5
PHARMACOVIGILANCE (SAFETY)
   
NUMBER OF SERIOUS ADVERSE EVENTS (SAEs)
 
Assume 1
NUMBER OF REPORTABLE SAEs
 
Assume 1
NUMBER OF SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS
 
1
NUMBER OF SAEs REPORTING TO LOCAL REGULATORY AUTHORITY
 
1
PROJECT MANAGEMENT
   
NUMBER OF CUSTOMER TELECONFERENCES
 
21
 
FREQUENCY OF TELECONFERENCES
 
Monthly

INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
DETAILED ASSUMPTIONS
 
DURATION OF TELECONFERENCES
 
1 hour
 
TELECONFERENCE ATTENDEES
 
Project Manager
 
ACTIVITY
 
Prana
 
INCResearch
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, Clinicaltrials.gov
 
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
 
ü
   
Complete Ethics Submissions and Follow-up
 
ü
   
Respond to Issues Raised by the Ethics Committee
 
ü
   
Regulatory Submissions
 
ü
   
Import/Export Permit Handling
 
ü
   
Customer Project Team Meetings
       
Attend Project Team Meeting
 
ü
 
ü
Organise Project Team Meeting
 
ü
   
Investigator’s Meeting
       
Attend Investigator’s Meeting
 
ü
 
ü
Present at Investigator’s Meeting
 
ü
   
Organise Investigator’s Meeting
 
ü
   
Investigational Product (IP)
 
 
   
IP Packaging and Labelling
 
ü
   
IP Storage
 
ü
   
IP Distribution
 
ü
   
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
ACTIVITY
 
Prana
 
INCResearch
IP Accountability
     
ü
IP Destruction
 
ü
   
Site Visits
       
Site Initiation Visits
     
ü
Monitoring Visits
     
ü
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
   
Archiving of Study Files Post-study
 
ü
   
Safety Reporting & Medical Monitoring
       
Handling of SAEs (notification)
     
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
   
Medical Monitoring
 
ü
   
Safety Management Plan (review)
     
ü
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
ATTACHMENT B
Project Schedule
 
Project Timeline/Activities
Project Milestones
 
Duration
 
Start Date
 
End Date
Pre-Study Period
 
3 Months
 
1-Mar-12
 
31-May-12
Enrolment Period
 
8 Months
 
1-Jun-12
 
31-Dec-12
Treatment Period
 
8 Months
 
1-Jan-13
 
30-Sep-13
Close-out Period
 
2 Months
 
1-Oct-13
 
30-Nov-13
Total Study Duration
 
21 Months
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
ATTACHMENT C
Project Budget and Payment Schedule
 
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 Research is liable to pay GST in respect of any Services provided pursuant to this Agreement, INC Research may add the GST amount to invoices provide to Sponsor for the Services. Provided that the relevant invoice complies with the requirements of a tax invoice to enable Sponsor to claim a credit or refund of GST, Sponsor 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 Sponsor GST will not be applicable.
 
Project Costs and Payment Schedule
 
The project budget has been provided in AUD. This will also be the prime currency for invoicing and payment on this project.
 
All clinical services will be invoiced on a unit basis as per the proposed direct cost estimate budget.
 
Upon execution of this Work Order, Sponsor shall make a payment of $58,338.40 (20% of the total direct costs). Thereafter, INC Research will invoice Sponsor on a monthly basis for actual units completed and reconciled at the end of the study.
 
If services requirement exceeding those specified in the cost estimate are required then written approval will be obtained from the Sponsor before conducting the additional services.
 
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 Research may increase fees beyond the period stated.
 
Indirect costs will be invoiced separately on a monthly basis.
 
INC Research shall provide Sponsor with itemized invoicing of all expenses and fees. Undisputed invoices are payable within 30 days of date of Sponsor’s receipt of invoice as per MSA clause 12.
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
DIRECT COSTS
 
Service/Item
 
Comments
 
Responsibility
 
Unit
 
Unit Cost (AUD)
 
Number
of Units
 
Item Cost
 
AUD$
Study Start Up Activities
                           
Study Training/Internal Kick Off Meeting
 
Familiarisation, Protocol, IB
 
CRA
 
per CRA
 
1123
 
3.00
 
3,370
   
Study Training/Internal Kick Off Meeting
 
Familiarisation, Protocol, IB
 
PM
 
per PM
 
1290
 
1.00
 
1,290
   
Essential Document Collection
 
Creation, Collection and Tracking
 
CRA
 
per site
 
1123
 
5.00
 
5,616
   
Study Files
 
Set-up of Study Master Files and Investigator Site Files
 
PA
 
per study
 
749
 
1.00
 
749
   
CRA Administration (March 2012 - May 2012)
 
Communications - Customer, Site, Project Manager
 
CRA
 
per month
 
3019
 
3.00
 
9,056
   
                       
Subtotal
 
$20,080
Customer Project Team Meetings
                           
Customer Kick-off Meeting
 
Teleconference
 
PM
 
per PM
 
322
 
1.00
 
322
   
Sponsor Teleconference Participation
 
21 x 1 hour Telecon
 
PM
 
per telecon
 
165
 
21.00
 
3,456
   
                       
Subtotal
 
$3,778
Investigator’s/Monitor’s meeting
                           
Travel Time
 
4 hours Return
 
PM
 
per PM
 
645
 
1.00
 
645
   
Travel Time
 
8 hours Return
 
CRA
 
per CRA
 
1123
 
1.00
 
1,123
   
Attendance
 
Assume 1.5 day Meeting, 1 PM
 
PM
 
per PM
 
1934
 
1.00
 
1,934
   
Attendance
 
Assume 1.5 day Meeting, 2 CRAs
 
CRA
 
per CRA
 
1685
 
2.00
 
3,370
   
                       
Subtotal
 
$7,072
Site Visits
                           
Study Initiation
 
Includes Preparation, Travel, Time On-site, Reporting and Follow-up
 
CRA
 
per visit
 
1404
 
5.00
 
7,020
   
Monitoring Visits (1 Day Visits)
 
Including Preparation, Travel, 1 day On­-site, Reporting and Follow-up 5 Visits/Site
 
CRA
 
per visit
 
1579
 
25.00
 
39,478
   
Closeout Visits
 
Includes Preparation, Travel, Time On-site, Reporting and Follow-up
 
CRA
 
per visit
 
1752
 
5.00
 
8,761
   
                       
Subtotal
 
$55,258
Site Management
                           
Site Management (June 2012 • September 2013)
 
per Month
 
CRA
 
per month
 
3086
 
16.00
 
49,383
   
Site Management (October 2013 • November 2013)
 
per Month
 
CRA
 
per month
 
1460
 
2.00
 
2,920
   
                       
Subtotal
 
$52,303
Project Management
                           
Local Coordination/Supervision (March 2012 • May 2012)
 
per Month
 
PM
 
per month
 
5158
 
3.00
 
15,475
   
Local Coordination/Supervision (June 2012 • September 2013)
 
per Month
 
PM
 
per month
 
3296
 
16.00
 
52,743
   
Local Coordination/Supervision (October 2013 - November 2013)
 
per Month
 
PM
 
per month
 
3353
 
2.00
 
6,706
   
Project Assistance (March 2012 • November 2013)
 
per Month
 
PA
 
per rronth
 
2054
 
21.00
 
43,144
   
                       
Subtotal
 
$118,068
Safety Monitoring
                           
Safety Administration
 
Includes Set-up, Maintenance and Completion Activities
 
Safety Officer
 
per study
 
4597
 
1.00
 
4,597
   
Handling of SAEs (Notifications)
 
All Events - Assume 1 SAE
 
Safety Officer
 
per SAE
 
330
 
1.00
 
330
   
Medical Review of SAEs and Narrative Creation
 
All Events - Assume 1 SAE
 
Medical Monitor
 
per SAE
 
851
 
1.00
 
851
   
Reporting to Local Authorities
 
Assume 1 Reportable Event
 
Safety Officer
 
per SAE
 
659
 
1.00
 
659
   
Safety Management Plan (review)
     
Safety Officer
 
per study
 
659
 
1.00
 
659
   
Teleconference
 
Assume 1 hour teleconference
 
Safety Officer
 
per telecon
 
165
 
1.00
 
165
   
                       
Subtotal
 
$7,261
                             
                       
TOTAL
 
$263,821
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
INDIRECT COSTS
 
Expense/Item
 
Comments
 
Unit Cost
 
Number
of Units
 
Item Cost
AUD$
 
AUD$
                     
Investigator’s/Monitor’s Meeting Attendance
                   
Travel/Attendance Costs
 
Airfares, accommodation & meals provided by Client, $500 - taxis, currency exchange, meals in transit, phone
 
$500/person
 
2
 
1,000
   
               
Subtotal
 
$1,000
Site Visits
                   
Other Site visit Costs
 
Parking/tolls/meals and incidentals for site visits
 
$50/day
 
35
 
1,750
   
               
Subtotal
 
$1,750
General Expenses
                   
Couriers, Express Post, Teleconferences
     
$7,000
 
1
  7,000  
 
Copying (Excluding ethics submissions), postage, telecommunications (excluding teleconferences), stationery (files)
 
$70/site/month, 5 sites for 21 months
 
$350/month
 
21
 
7,350
   
               
Subtotal
 
$14,350
                     
               
TOTAL
 
$17,100
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC RESEARCH LOGO)
 
Change Orders/Changes in Scope
 
INC Research’s participation in this study is based upon the parameters outlined in Attachment A  Services and Attachment B – Project Schedule. Unless otherwise specified in this Work Order, all study Services will be performed under the INC Research Standard Operating Procedures (SOPs). If the scope of the study varies from these study parameters, a Contract Modification (CM) may be necessary. A CM may be due to, but is not limited to, the following project specific situations that change the study parameters (i.e., timeline1, number of subjects or sites) or the scope of work (i.e., additional services; tasks for current services; or costs for current services are modified). These changes in scope may modify the time or costs (direct or indirect) required to complete the study. Requests to engage additional contractors or to incur additional costs with existing contractors engaged by INC Research are considered changes in scope. Accordingly, negotiating efforts to secure confidentiality agreements and service agreements with newly engaged contractors are also considered changes in scope.
 
Once a CM is identified, INC Research will log the out-of-scope activities in a Change Order Log and obtain written acknowledgement from the Sponsor confirming the scope of the possible CM. Once the out-of-scope services reach an estimated 3% of direct project costs (or $10,000, whichever is reached first), a Change Notification Form (CNF) will be submitted to the Sponsor for verification of the project change and to determine if INC Research should wait to begin out-of-scope trial activities or continue while good faith negotiations move towards an executed Change Order (CO).
 
A CO shall be completed once the following threshold amount is reached (which is based on the original contract value of the study).
 
 
o
$100,000 threshold if contract value is less than $3,000,000; or
 
o
$300,000 threshold if contract value is over $3,000,000.
 
If out of scope activities do not reach the threshold amount for longer than 180 days since the first CNF or particular CO was initiated, then a CO shall be issued once the time threshold is reached.
 
If out of scope activities do not reach the value or time thresholds prior to end of study, then a CO shall be issued and signed by Sponsor prior to release of the final project deliverable.
 

1 An increase in the study timeline may increase the inflation calculation. Change orders will only address an increase in costs due to inflation for uncompleted activities if the study timeline is pushed into a new calendar year
 
INCResearch Australia Pty Limited
Prana Work Order 1000504 v4 3rd August 2012
 
 
 

 
 
(INC LOGO)
 
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 Level 2, 369 Royal Parade, Parkville VIC 3052, Australia and INCResearch Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with principal offices located at 124 Lipson Street, Port Adelaide SA 5015, Australia.
 
RECITALS
 
WHEREAS, Sponsor and INC Research have entered into Work Order #1000504 (hereinafter “Agreement”) to perform Services for Protocol # PBT2-203 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 I: 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 - 1000504
Prana Change Order #1, v2, 10th April 2013
 
 
Page 1 of 8

 
 
(INC LOGO)
 
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
Change Order # 1
 
Upon Execution
 
$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 - 1000504
Prana Change Order #1, v2, 10th April 2013
 
 
Page 2 of 8

 
 
(INC LOGO)
 
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 LOGO)
 
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 - 1000504
Prana Change Order #1, v2, 10th April 2013
 
 
Page 4 of 8

 
 
(INC LOGO)
 
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$
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
   
 
INC Research, LLC  CONFIDENTIAL
 
INCResearch Australia Pty Limited - 1000504
Prana Change Order #1, v2, 10th April 2013
 
 
Page 5 of 8

 
 
(INC LOGO)
 
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
                           
Travel/Attendance Costs
 
Airfares, accommodation & 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
   
 
INC Research, LLC  CONFIDENTIAL
 
INCResearch Australia Pty Limited - 1000504
Prana Change Order #1, v2, 10th April 2013
 
 
Page 6 of 8

 
 
(INC LOGO)
 
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
 
INC Research, LLC  CONFIDENTIAL
 
INCResearch Australia Pty Limited - 1000504
Prana Change Order #1, v2, 10th April 2013
 
 
Page 7 of 8

 
 
(INC LOGO)
 
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
                          -s- dianne angus                             -s- garth tierney
Signature By:
 
Signature By:
DIANNE ANGUS
 
Garth Tierney
Name (print)
 
Name (print)
C.O.O
 
Executive Vice President, Asia/Pacific
Title
 
Title
16 / April / 2013
 
24/04/2013
Date
 
Date
 
INC Research, LLC  CONFIDENTIAL
 
INCResearch Australia Pty Limited - 1000504
Prana Change Order #1, v2, 10th April 2013
 
Page 8 of 8