Document:

exhibit_4-28.htm

 

Exhibit 4.28

 

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

 

  

  

  

 

 

	
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):

	
105-018

	 	
Account Number:

	
082 159 540

	 	
Swift:

	
SGBLAU2S

	
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

 

  

  

  

 

 

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:

	DIANNE ANGUS	 
	  	  	 
	
Title:

	Chief Operating Officer	 
	  	  	 
	
Date:

	6th August 2012	 
	  	  	 
	
INCResearch Australia Pty Limited

	 
	  	  	 
	
By:

		 
	  	  	 
	
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

	 

 

  

  

  

 

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

 

  

  

  

 

 

	
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

 

  

  

  

 

 

	 	
 

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

 

  

  

  

 

 

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

 

  

  

  

 

 

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

 

  

  

  

 

 

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 month

	
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

   

  

  

  

     

     

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

 

  

  

  

 

 

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).

 

○    $100,000 threshold if contract value is less than $3,000,000; or 

○    $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

 

 

 

 

 

 

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 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

  

 

 

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

	
$3778  

	
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

 

	INC Research Australia Pty Limited - 1000504

Prana Change Order #1, v2, l0th 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

	 	 	  

INC Research, LLC - CONFIDENTIAL

 

	INCResearch Australia Pty Limited - 1000504

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

 

  

Page 5 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$

	

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 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

  

 

 

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:	 
	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 8exhibit_4-30.htm

Exhibit 4.30

 

	 
	Page 1 of 6
	  
	

 

CHANGE ORDER N°1 to Work Order #1002213

 

This Change Order number 1 to Work Order #1002213 (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 offices located at 124 Lipson Street, Port Adelaide SA 5015, Australia.

 

RECITALS

 

WHEREAS, Sponsor and INC Research have entered into Work Order #102213 (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 28th March 2013 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:

	  	  
	
●

	
Addition of Project Meetings, Teleconferences and Face to Face meetings with Sponsor.

	
●

	
Addition of Client Database Review.

	
●

	
Additional Statistical Analysis Plan (SAP) includes Text and Table and Listing Shells.

	
●

	
Removal of Identifying Protocol Deviations and Analysis populations.

	
●

	
Additional Analysis Datasets, Specification, Programming and Quality Control.

	
●

	
Reduction in Production of Tables & Listings (Lost or redundant programming due to closure of HSG involvement).

	
●

	
Removal of Statistical Analysis

	
●

	
Removal of Input to Final report

	
●

	
Removal of Unit based Data Management Costs for Program consistency checks and raising manual data queries.

	
●

	
Removal of Clinical Study Report (CSR).

	
●

	
Removal of Quality Assurance (QA) Site Audits.

 

INC Research, LLC – CONFIDENTIAL

	  
	
INCResearch Australia Pty Limited - 1002213

	
Prana (PBT2-203) Change Order #1, v4, 4th March 2014

 

  

  

  

 

Page 2 of 6

 

TW3.05C

Version 04

INC Research, LLC Change Order Form

 

The parties hereby agree the total cost associated with this Change Order is AUD $53,809.00

 

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

	
28th March 2013

	
$173,754.00

	
$2,310.00

	
$176,064.00

	
Change Order # 1

	
Upon Execution

	
$53,809.00

	
$0.00

	
$53,809.00

	
Total Contract Value

	  	
$227,563.00

	
2,310.00

	
$229,873.00

 

SIGNATURE

 

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. In the event that the parties execute this Change Order by exchange of electronically signed copies or facsimile signed copies, the parties agree that, upon being signed by both parties, this Change Order shall become effective and binding and that facsimile copies and/or electronic signatures will constitute evidence of the existence of this Change Order with the expectation that original documents may later be exchanged in good faith.

	  	  	  
	
Prana Biotechnology Limited

	  	
INCResearch Australia Pty Limited

	

	  	  
	
Signature By:

	  	
Signature By:

	  	  	  
	
DIANNE ANGUS

	  	  
	
Name (print)

	  	
Name (print)

	  	  	  
	
Chief Operating Officer

	  	  
	
Title

	  	
Title

	  	  	  
	
11 March 2014

	  	  
	
Date

	  	
Date

 

INC Research, LLC – CONFIDENTIAL

	  	  	 
	
INCResearch Australia Pty Limited - 1002213

	  	 
	
Prana (PBT2-203) Change Order #1, v4, 4th March 2014

	
2

	 

 

  

  

  

 

	  
	

 

Page 3 of 6

 

Revised Direct Costs

	  	 	  	 	  	  	  	  	  	  	  	  
	
Service/Item

	 	
Comments

	 	
Responsibility

	
Unit

	
Unit

Cost

(AUD)

	
Original

Number

of Units

	
CO#1

Number

of Units

	
Original

Item

Cost

	
CO#1

Item

Cost

	
AUD$

	
Data Management

& Statistics

	 	  	 	  	  	  	  	  	  	  	  
	
Project familiarization

	 	
Arrange test data extract from database, assess data structure and data quality. Receive final transfer from HSC.

	 	
Clinical

Programmer

	
1hr

	
108

	
16.00

	
0.00

	
1,728

	
0

	  
	
Project Meetings

	 	
Teleconference and face to face meetings with Prana, CTCC and key opinion leaders

	 	
Statistician

	
10hr/week

	
2120

	
0.00

	
26.00

	
0

	
55,120

	  
	
HSG Meeting (USA)

	 	
Three days of meetings plus travel time. (Jan Steyn or Melanie Bailey Tippetts and Peter Fursdon). Travel & accommodation arranged by Prana

	 	  	
40hrs per

person

	
8000

	
2.00

	
0.00

	
16,000

	
0

	  
	
Database design

	 	
Review annotated CRF and database specification documentations

	 	
Clinical

Programmer

	
0.5hr/dat

aset

	
30

	
25.00

	
0.00

	
750

	
0

	  
	
Data Validation Manual

	 	
Review DVM text/data management plan specifying edit checks

	 	
CDA

	
40hrs

	
104

	
16.00

	
0.00

	
1,664

	
0

	  
	
Import BM, PK, ECG and immunology data

	 	
Electronic transfer of Biomarker, PK, ECG and MRI data (Data transfer plans, test transfers & final transfer)

	 	
DBA

	
1 study

	
1122

	
4.00

	
0.00

	
4,488

	
0

	  

 

INC Research, LLC – CONFIDENTIAL

	  	 	 
	
INCResearch Australia Pty Limited - 1002213

	 	 
	
Prana (PBT2-203) Change Order #1, v4, 4th March 2014

	3	 

 

  

  

  

 

Page 4 of 6

	  
	
TW3.05C

	
Version 04

	
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

	
CO#1

Item

Cost

	
AUD$

	  	
Client Database Review

	  	  	
Database Report prepared by Karen Reynolds

	 	
DM Systems

	
40hrs

	
7400

	
0.00

	
1.00

	
0

	
7,400

	  
	  	
Statistical Analysis Plan (SAP)

	  	  	
Includes text and table and listing shells

	 	
Statistician

	
1 SAP

	
9426

	
1.00

	
0.00

	
9,426

	
0

	  
	  	
Statistical Analysis Plan (SAP)

	  	  	
Additional text and table and listing shells

	 	
Statistician

	
1 SAP

	
13936

	
0.00

	
1.00

	
0

	
13,936

	  
	  	
Statistical Analysis Plan (SAP)

	  	  	
SAP Amendment 1 (24 hours)

	 	
Statistician

	
1 SAP

	
5088

	
0.00

	
1.00

	
0

	
5,088

	  
	  	
Identify Protocol Deviations and define Analysis populations

	  	  	
Unblinding, Protocol deviations and Definition of populations

	 	
Statistician

	
1 study

	
1600

	
1.00

	
-1.00

	
1,600

	
-1,600

	  
	  	
Analysis Datasets

	  	  	
Specification, Programming & QC

	 	
SAS

Programmer

	
1 study

	
21294

	
1.00

	
0.00

	
21,294

	
0

	  
	  	
Data Cleaning Issues

	  	  	
Resolving data issues in CTCC data sets

	 	
SAS

Programmer

	
per hour

	
169

	
0.00

	
400.00

	
0

	
67,600

	  
	  	
Production of Tables & Listings

	  	  	
14 Unique tables. Cost per extra $1014 

20 Repeat tables. Cost per extra $338

36 Figures. Cost per extra $592 

38 Listings. Cost per extra $422

	 	
SAS

Programmer

	
1 study

	
52221

	
1.00

	
0.00

	
52,221

	
0

	  
	  	
Production of Tables & Listings (Lost or redundant programming due to closure of HSG involvement)

	  	  	
Primary programming lost: 20 analyses programs lost @ $212, 19 unique tables lost @$507, 68 tables requiring modification @ $126.75, 51 Listings requring minor modification @ $84.50.

	 	
SAS

Programmer

	
1 study

	
29152

	
0.00

	
-1.00

	
0

	
-29,152

	  

 

	
INC Research, LLC – CONFIDENTIAL

	  	 	 
	
INCResearch Australia Pty Limited - 1002213

	 	 
	
Prana (PBT2-203) Change Order #1, v4, 4th March 2014 

	4 	 

  

  

  

 

Page 5 of 6

	
TW3.05C

	
Version 04

	
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

	
CO#1 Item 

Cost

	
AUD$

	  
	  	
Statistical Analysis

	  	  	
Analysis endpoints. Cost per extra $424

	 	
Statistician

	
1 analysis endpoint

	
424

	
19.00

	
-19.00

	
8,056

	
-8,056

	  	  
	  	
Input to Final report

	  	  	
Text for inclusion in study report

	 	
Statistician

	
1 Study

	
5088

	
1.00

	
-1.00

	
5,088

	
-5,088

	  	  
	  	
Unit based Data Management Costs

	  	  	
Program consistency check

	 	
Clinical Programmer

	
1 check

	
60

	
1.00

	
-1.00

	
60

	
-60

	  	  
	  	
Unit based Data Management Costs

	  	  	
Raise manual data query

	 	
CDA

	
1 query

	
52

	
1.00

	
-1.00

	
52

	
-52

	  	  
	  	  	  	  	  	 	  	  	  	  	
Subtotal

	
122,427

	
105,136

	
$227,563

	  
	  	
Medical Writing

	  	  	  	 	  	  	  	  	  	  	  	  	  
	  	
Clinical Study Report (CSR)

	  	  	 	 	
Medical Writer

	
per CSR

	
25418

	
1.00

	
-1.00

	
25,418

	
-25,418

	  	  
	  	  	  	  	  	 	  	  	  	  	
Subtotal

	
25,418

	
-25,418

	
$0

	  
	  	
Quality Assurance - Site Audits

	  	  	  	 	  	  	  	  	  	  	  	  	  
	  	
Quality Assurance Site Audits

	  	  	
GCP Audits preparation time

	 	
QAA

	
Site Audit

	
1314

	
2.00

	
-2.00

	
2,628

	
-2,628

	  	  
	  	  	  	  	
GCP Audits on-site

	 	
QAA

	
Site Audit

	
2628

	
2.00

	
-2.00

	
5,255

	
-5,255

	  	  
	  	  	  	  	
GCP Audits report preparation

	 	
QAA

	
Site Audit

	
1971

	
2.00

	
-2.00

	
3,941

	
-3,941

	  	  
	  	  	  	  	
GCP Audits travel time

	 	
QAA

	
Site Audit

	
1570

	
2.00

	
-2.00

	
3,140

	
-3,140

	  	  
	  	  	  	  	
Review of Audit reports

	 	
QAA

	
Site Audit

	
443

	
2.00

	
-2.00

	
886

	
-886

	  	  
	  	
QA Audit of Vendor(s)

	  	  	 	 	
QAA

	
Audit

	
10059

	
1.00

	
-1.00

	
10,059

	
-10,059

	  	  
	  	  	  	  	  	 	  	  	  	  	
Subtotal

	
25,909

	
-25,909

	
$0

	  
	  	  	  	  	  	 	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	 	  	  	  	  	
TOTAL

	
173,754

	
53,809

	
$227,563

	  

	
INC Research, LLC – CONFIDENTIAL

 

	
INCResearch Australia Pty Limited - 1002213

	 	 
	
Prana (PBT2-203) Change Order #1, v4, 4th March 2014

	5	 

 

  

  

  

 

Page 6 of 6

	  
	
TW3.05C

	
Version 04

	
INC Research, LLC Change Order Form

	  
	
Pass-Through Costs – NIL changes

	  	
Expense/Item

	  	
Comments

	
Unit Cost (AUD)

	
Original

Number

of Units

	
CO#1

Number of Units

	
Original

Item Cost

AUD$

	
CO#1

Item

Cost

AUD$

	
AUD$

	  	
Site Visits

	  	  	  	  	  	  	  	  
	  	
Travel Costs

(flights/accommodation/taxis)

	  	  	
$1,155/visit

	
2

	
0

	
2,310

	
0

	  
	  	  	  	  	  	  	
Subtotal

	
2,310

	
0

	
$2,310

	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	
TOTAL

	
2,310

	
0

	
$2,310

	
INC Research, LLC - CONFIDENTIAL

 

	
INCResearch Australia Pty Limited - 1002213

	 	 
	
Prana (PBT2-203) Change Order #1, v4, 4th March 2014

	6

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00237-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00237-of-00352.parquet"}]]