Document:

exhibit_4-32.htm

Exhibit 4.32

  

 

CHANGE ORDER N°3 to Work Order # 800089 (PBT2-204)

 

This Change Order number 3 to Work Order # 800089 (PBT2-204) (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 INC Research 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 # 800089 hereinafter “Agreement”) to perform Services for Protocol PBT2-204 for study entitled: Randomised, Double-blind, Placebo-controlled, Parallel-group, Phase 2 Study to Evaluate the Effect of One Dose of PBT2 (250mg daily) for 52 Weeks on Aß 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 (hereinafter “Study”), which was signed by Sponsor and INC Research on 18th April 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 and previous Change Orders;

 

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:

 

Services

	  	
●

	
Additional Cost for work related to Case Report Form (CRF) design guidelines

	  	
●

	
Edits and revisions for CRF version 2

	  	
●

	
Database and edit check programming in support of CRF version 2

	  	
●

	
Data Entry for 3,640 questionnaires

	  	
●

	
Additional queries and pages cleaned/monitored

	  	
●

	
Quality Check (QC) of additional Safety Lab programming

	  	
●

	
Programming of two biomarker labs.

	
 INC Research Australia Pty Limited – 800089

	
INC Research, LLC – CONFIDENTIAL

	
 Prana PBT2-204, Change Order #3 version 1

	  

 

  

Page 1 of 3

  

 

	  	
●

	
Statistical Analysis Plan updates to include expansion of analysis, editing, additional text, additional tables and listing shells.

	  	
●

	
Additional analysis datasets to support increased analysis.

	  	
●

	
Addition of 22 Unique tables

	  	
●

	
Addition of 70 Repeat tables

	  	
●

	
Addition of 40 Listings

	  	
●

	
Addition of 190 analysis endpoints

 

The parties hereby agree the total cost associated with this Change Order is AUD $193,000.00

 

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

	
18th April 2012

	
$353,588.00

	
$10,000.00

	
$363,588.00

	
Change Order # 1

	
19th July 2012

	
$30,398.00

	
$2,990.00

	
$33,388.00

	
Change Order # 2

	
29th July 2013

	
$322,360.00

	
$8,420.00

	
$330,780.00

	
Change Order #3

	
Upon Execution

	
$193,291.00

	
$0.00

	
$193,291.00

	
Total Contract Value

	  	
$899,637.00

	
$21,410.00

	
$921,047.00

 

SECTION III: REVISED PAYMENT TERMS

 

INC will invoice the Sponsor for Data Management, Statistics and Medical Writing Direct costs according to the following schedule:

	  	  	  	  	  
	  	
●

	
Execution of Agreement

	
-

	
Invoiced AUD $36,827.00 from original WO

	  	
●

	
Database Complete

	
-

	
Invoiced AUD $36,827.00 from original WO

 

New contract total for Data Management, Statistics and Medical Writing Direct costs = AUD $530,246.00, less total already invoiced = AUD $73,654.00. New total to be invoiced = AUD $456,592.00

	  	  	  	  	  
	  	
●

	
50% Data Entered

	
-

	
25% of new total = AUD $114,148.00

	  	
●

	
100% Data Entered

	
-

	
25% of new total = AUD $114,148.00

	  	
●

	
Database Lock

	
-

	
25% of new total = AUD $114,148.00

	  	
●

	
1st Draft 1st Study Report

	
-

	
15% of new total = AUD $68,488.80

	  	
●

	
1st Draft 2nd Study Report

	
-

	
5% of new total = AUD $22,829.60

	  	
●

	
Final Study Report

	
-

	
5% of new total = AUD $22,829.60

	
 INC Research Australia Pty Limited – 800089

	
INC Research, LLC – CONFIDENTIAL

	
 Prana PBT2-204, Change Order #3 version 1

	  

 

  

Page 2 of 3

  

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

	  	
INC Research Australia Pty Limited

	  
	  	  	  	  
	

	  	  	  
	
Signature By:

	  	
Signature By:

	  
	
DIANNE ANGUS

	  	  	  
	
Name (print)

	  	
Name (print)

	  
	
Chief Operating Officer

	  	  	  
	
Title

	  	
Title

	  
	
14 March 2014

	  	  	  
	
Date

	  	
Date

	  

	
 INC Research Australia Pty Limited – 800089

	
INC Research, LLC – CONFIDENTIAL

	
 Prana PBT2-204, Change Order #3 version 1

	  

 

  

Page 3 of 3

  

 

Revised Total Budget

	 	

Service/Item

	 	

Comments

	 	

Unit Cost

	 	

WO & CO#1

Number

of Units

	 	

CO#2 Number

of Units

	 	

CO#3 Number 

of Units

	 	

WO & CO#1

Item Cost

	 	

CO#2

Item Cost

	 	

CO#3 

Item Cost

	 	

AUD$

	 	

Study Start Up Activities

	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	 	

Study Training/ Internal Kick Off Meeting

	 	

Familiarization, Protocol, IB, CRF, procedures etc.

	 	

1080

	 	

1.00

	 	

0.00

	 	

0.00

	 	

1,080

	 	

0

	 	

0

	 	  
	 	

Study Training/ Internal Kick Off Meeting

	 	

Familiarization, Protocol, IB, CRF, procedures etc.

	 	

620

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Study Sponsorship

	 	

Contract/insurance review, Indemnification

	 	

5000

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Study Manual/Monitoring Manual Development

	 	

To be confirmed by client if required

	 	

3100

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

List Trial on Public Register

	 	

e.g.. ACTR, Clintrials.gov

	 	

310

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Investigator/Site Identification

	 	

Identify up to sites to select final 5

	 	

540

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Clinical Trial Agreements

	 	

Negotiation / coordination with site

	 	

930

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Study Training

	 	

Familiarization etc

	 	

540

	 	

1.00

	 	

0.00

	 	

0.00

	 	

540

	 	

0

	 	

0

	 	  
	 	

Study Training on Protocol Amendment

	 	

Familiarization etc

	 	

270

	 	

0.00

	 	

2.00

	 	

0.00

	 	

0

	 	

540

	 	

0

	 	  
	 	

Study Training on Protocol Amendment

	 	

Familiarization etc

	 	

310

	 	

0.00

	 	

1.00

	 	

0.00

	 	

0

	 	

310

	 	

0

	 	  
	 	

Essential document collection

	 	

Creation, Collection and tracking

	 	

1350

	 	

5.00

	 	

4.00

	 	

0.00

	 	

6,750

	 	

5,400

	 	

0

	 	  
	 	

Ethics submissions - Australia

	 	

Per site includes application, customize IC/PI document, copying/collation, follow up with ethics questions

	 	

1890

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Ethics submissions - New Zealand

	 	

Per site includes application, customize IC/PI document, copying/collation, follow up with ethics questions

	 	

2160

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Regulatory Submissions - Australia

	 	

Creation of CTN form and TGA liaison

	 	

270

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Regulatory Submissions - New Zealand 

	 	

Creation of SCOTT form and MedSafe liaison

	 	

810

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Regulatory Submissions Follow-up - New Zealand

	 	

6-monthly status reports and close out final report

	 	

851

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Study Manual/Monitoring Manual Development  

	 	 	 	

3100

	 	

1.00

	 	

0.00

	 	

0.00

	 	

3,100

	 	

0

	 	

0

	 	  
	 	

Study Files

	 	

Set up of study master files and Investigator site files

	 	

720

	 	

1.00

	 	

1.00

	 	

0.00

	 	

720

	 	

720

	 	

0

	 	  
	 	

File Management

	 	

per month

	 	

283

	 	

24.00

	 	

0.00

	 	

0.00

	 	

6,787

	 	

0

	 	

0

	 	  
	 	

CRA Administration

	 	

Communications - Customer, site, project Manager

	 	

2903

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Import/Export Permit Handling

	 	

TGA/AQIS liaison, application, distribution

	 	

620

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Senior Management overview

	 	

Study status, issue resolution, client liaison

	 	

0

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

File Management - 2 new sites

	 	

per month from August 2012

	 	

283

	 	

14.00

	 	

0.00

	 	

0.00

	 	

3,959

	 	

0

	 	

0

	 	  
	 	

File Management - 4 Sites

	 	

per month from October 2013

	 	

377

	 	

0.00

	 	

14.00

	 	

0.00

	 	

0

	 	

5,279

	 	

0

	 	  
	 	  	 	  	 	  	 	  	 	  	 	
Subtotal

	 	

22,937

	 	

12,249

	 	

0

	 	

$35,186

	 	

Customer Project Team Meetings

	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	 	

Travel time

	 	

0 hours return

	 	

0

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Travel time

	 	

0 hours return

	 	

0

	 	

1.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Attendance

	 	

Location

	 	

0

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Attendance

	 	

Location

	 	

0

	 	

1.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Customer Kick-off Meeting

	 	

Teleconference

	 	

0

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Customer Kick-off Meeting

	 	

Teleconference

	 	

0

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Coordination of meeting

	 	  	 	

90

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Teleconference participation

	 	

25 x 1 hour Telecon, 1 CRAs

	 	

138

	 	

25.00

	 	

0.00

	 	

0.00

	 	

3,450

	 	

0

	 	

0

	 	  
	 	

Teleconference participation

	 	

16 x monthly hour Telecon, 1 CRA

	 	

138

	 	

16.00

	 	

0.00

	 	

0.00

	 	

2,208

	 	

0

	 	

0

	 	  
	 	

Teleconference participation

	 	

24 x fortnightly 1 hour Telecon, 2 CRAs

	 	

276

	 	

0.00

	 	

24.00

	 	

0.00

	 	

0

	 	

6,624

	 	

0

	 	  
	 	

Teleconference participation

	 	

24 x fortnightly 1 hour Telecon, 1 PM

	 	

155

	 	

0.00

	 	

24.00

	 	

0.00

	 	

0

	 	

3,720

	 	

0

	 	  
	 	  	 	  	 	  	 	  	 	  	 	

Subtotal

	 	

5,658

	 	

10,344

	 	

0

	 	

$16,002

	 	

Investigator’s/Monitor’s Meeting

	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	 	

Preparation of presentations

	 	

Trident & Customer shared responsibility

	 	

1620

	 	

1.00

	 	

0.00

	 	

0.00

	 	

1,620

	 	

0

	 	

0

	 	  

 

	Prana Biotechnology Limited	 	 
	Protocol #: PBT2-204 	INC Research, LLC – CONFIDENTIAL	1
	INCR Project Code: 800089	 	 

 

  

  

  

 

Revised Total Budget

	 	

Travel time

	 	

0 hours return

	 	

0

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Travel time

	 	

0 hours return

	 	

0

	 	

1.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Attendance

	 	

assume 1 day meeting, 0 PM

	 	

1240

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Attendance

	 	

assume 1 day meeting, 1 CRA

	 	

1080

	 	

1.00

	 	

0.00

	 	

0.00

	 	

1,080

	 	

0

	 	

0

	 	  
	 	

Coordination of meeting

	 	

Mlg coordination, travel, dinner, binders, etc

	 	

155

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Coordination of meeting

	 	

Mlg coordination, travel, dinner, binders, etc

	 	
90

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	  	 	  	 	  	 	  	 	  	 	

Subtotal

	 	

2,700

	 	

0

	 	

0

	 	

$2,700

	 	

Site Visits

	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	 	

Additional Travel time for each round of site visits

	 	

0 hours return

	 	

0

	 	

0.00

	 	  	 	  	 	
 

	 	  	 	  	 	  
	 	

Pre-Study Visits

	 	

Incl. prep, travel, on-site, reporting & follow-up

	 	

1215

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Study Initiation

	 	

Incl. prep, travel, on-site, reporting & follow-up

	 	

1620

	 	

5.00

	 	

0.00

	 	

0.00

	 	

8,100

	 	

0

	 	

0

	 	  
	 	

Study Initiation

	 	

Incl. prep, travel, on-site, reporting & follow-up

	 	

1080

	 	

0.00

	 	

2.00

	 	

0.00

	 	

0

	 	

2,160

	 	

0

	 	  
	 	

Monitoring Visits (1 Day visits)

	 	

Incl. prep, travel, 1 day on-site, reporting & follow-up 4 visits/site

	 	

1932

	 	

20.00

	 	

24.00

	 	

0.00

	 	

38,640

	 	

46,368

	 	

0

	 	  
	 	

Monitoring Visits (2 Day visits)

	 	

Incl. prep, travel, 2 days on-site, reporting & follow-up 3 visits/site

	 	

3174

	 	

15.00

	 	

10.00

	 	

0.00

	 	

47,610

	 	

31,740

	 	

0

	 	  
	 	

Monitoring Visits (3 Day visits)

	 	

Incl. prep, travel, 3 days on-site, reporting & follow-up 0 visits/site

	 	

4666

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Follow-up Monitoring Visits

	 	

Incl. prep, travel, on-site, reporting & follow-up 0 visits/site

	 	

146

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Unblinded Monitoring Visits

	 	

Incl. prep, travel, on-site, reporting & follow-up 0 visits/site

	 	

848

	 	

0.00

	 	  	 	

0.00

	 	

0

	 	

0

	 	

0

	 	  
	 	

Closeout visits

	 	

Incl. prep, travel, on-site, reporting & follow-up

	 	

2070

	 	

5.00

	 	

0.00

	 	

0.00

	 	

10,350

	 	

0

	 	

0

	 	  
	 	

Closeout visits

	 	

Incl. prep, travel, on-site, reporting & follow-up

	 	

1656

	 	

0.00

	 	

4.00

	 	

0.00

	 	

0

	 	

6,624

	 	

0

	 	  
	 	

Site Audit attendance

	 	

Incl. prep, travel, 1 day on-site, reporting & follow-up 0 visits

	 	

1845

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	  	 	  	 	  	 	  	 	  	 	

Subtotal

	 	

104,700

	 	

86,392

	 	

0

	 	

$191,592

	 	

Site Management:

	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	 	

Site Management (October 2011 - Nov 2011)

	 	

1 site

	 	

593

	 	

2.00

	 	

0.00

	 	

0.00

	 	

1,187

	 	

0

	 	

0

	 	  
	 	

Site Management (Dec 2011 - May 2012)

	 	

2 sites

	 	

1187

	 	

6.00

	 	

0.00

	 	

0.00

	 	

7,121

	 	

0

	 	

0

	 	  
	 	

Site Management (June 2012 - July 2013)

	 	

3 sites

	 	

1780

	 	

14.00

	 	

0.00

	 	

0.00

	 	

24,923

	 	

0

	 	

0

	 	  
	 	

Site Management (August 2012 - July 2013)

	 	

per month - 2 new sites

	 	

1187

	 	

12.00

	 	

0.00

	 	

0.00

	 	

14,242

	 	

0

	 	

0

	 	  
	 	

Site Management (August 2013 - September 2013)

	 	

3 sites

	 	

828

	 	

2.00

	 	

0.00

	 	

0.00

	 	

1,656

	 	

0

	 	

0

	 	  
	 	

Site Management (August 2013 - September 2013)

	 	

per month - 2 new sites

	 	

552

	 	

2.00

	 	

0.00

	 	

0.00

	 	

1,104

	 	

0

	 	

0

	 	  
	 	

Site Management (October 2013 - November 2014)

	 	

per month - 4 Sites

	 	

2208

	 	

0.00

	 	

14.00

	 	

0.00

	 	

0

	 	

30,912

	 	

0

	 	  
	 	

Management/Supervision

	 	

per month

	 	

340

	 	

24.00

	 	

14.00

	 	

0.00

	 	

8,160

	 	

4,760

	 	

0

	 	  
	 	  	 	  	 	  	 	  	 	  	 	

Subtotal

	 	

58,392

	 	

35,672

	 	

0

	 	

$94,064

	 	

Project Management

	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	 	

Local coordination/supervision (June 2011 - August 2011)

	 	

per month

	 	

3100

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

Local coordination/supervision (August 2011 - May ***) Biotechnology Limited

	 	

per month

	 	

1580

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  
	 	

File Management

	 	

per month

	 	

471

	 	

0.00

	 	  	 	  	 	

0

	 	  	 	  	 	  

 

	Prana Biotechnology Limited	 	 
	Protocol #: PBT2-204 	INC Research, LLC – CONFIDENTIAL	2
	INCR Project Code: 800089	 	 

 

  

  

  

 

Revised Total Budget

	 	

Administer Site Payments

	 	 	

per site

	 	 	

3448

	 	 	

0.00

	 	 	  	 	 	  	 	 	

0

	 	 	  	 	 	  	 	 	  	 
	 	

Teleconference participation with client/PM

	 	 	

0 x 1 hour Sponsor Telecon, and 0 x 1 hour 

Team Tetecon

	 	 	

158

	 	 	

0.00

	 	 	  	 	 	  	 	 	

0

	 	 	  	 	 	  	 	 	  	 
	 	

Project Status Reporting

	 	 	

per month

	 	 	

163

	 	 	

0.00

	 	 	  	 	 	  	 	 	

0

	 	 	  	 	 	  	 	 	  	 
	 	

Project Assistance (June 2011 - July 2013)

	 	 	

per month

	 	 	

378

	 	 	

0.00

	 	 	  	 	 	  	 	 	

0

	 	 	  	 	 	  	 	 	  	 
	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	

Subtotal

	 	 	  	 	 	  	 	 	

$0

	 
	 	

Safety Monitoring

	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 
	 	

Familiarization and Set up

	 	 	  	 	 	

1280

	 	 	

1.00

	 	 	  	 	 	  	 	 	

1,280

	 	 	  	 	 	  	 	 	  	 
	 	

 

Study Completion

	 	 	

 

Archiving, collation and client correspondence

	 	 	

 

501

	 	 	

 

1.00

	 	 	  	 	 	  	 	 	

 

501

	 	 	  	 	 	  	 	 	  	 
	 	

 

Study administration (first 6 months)

	 	 	

 

Correspondence, tracking, client liaison, filing

	 	 	

 

160

	 	 	

 

6.00

	 	 	  	 	 	  	 	 	

 

960

	 	 	  	 	 	  	 	 	  	 
	 	

 

Study administration (XXXX - XXXX)

	 	 	

 

Correspondence, tracking, client liaison, filing

	 	 	

 

83

	 	 	

 

15.00

	 	 	  	 	 	  	 	 	

 

1,238

	 	 	  	 	 	  	 	 	  	 
	 	

Safety Administration

	 	 	

Incl. set up, maintenance and completion

activities

	 	 	

3979

	 	 	

1.00

	 	 	

0.00

	 	 	

0.00

	 	 	

3,979

	 	 	

0

	 	 	

0

	 	 	  	 
	 	

Safety Administration

	 	 	

Study Extension

	 	 	

83

	 	 	

0.00

	 	 	

14.00

	 	 	

0.00

	 	 	

0

	 	 	

1,155

	 	 	

0

	 	 	  	 
	 	

Initial Receipt and handling SAEs

	 	 	

All events- assume 1 SAE

	 	 	

330

	 	 	

1.00

	 	 	

10.00

	 	 	

0.00

	 	 	

330

	 	 	

3,300

	 	 	

0

	 	 	  	 
	 	

Medical Review of SAEs and Narrative creation

	 	 	

Optional - as required

	 	 	

838

	 	 	

0.00

	 	 	

10.00

	 	 	

0.00

	 	 	

0

	 	 	

8,380

	 	 	

0

	 	 	  	 
	 	

Reporting to local Authorities

	 	 	

Assume 1 Reportable events

	 	 	

860

	 	 	

1.00

	 	 	

10.00

	 	 	

0.00

	 	 	

660

	 	 	

6,600

	 	 	

0

	 	 	  	 
	 	

 

Follow up of SAEs

	 	 	

 

Assume 2 hours/Follow-up/SAE. 1 Follow-ups

	 	 	

 

330

	 	 	

 

1.00

	 	 	

 

10.00

	 	 	

 

0.00

	 	 	

 

330

	 	 	

 

3,300

	 	 	

 

0

	 	 	  	 
	 	

Investigator Notification Letters

	 	 	

preparation and oversight

	 	 	

165

	 	 	

1.00

	 	 	

10.00

	 	 	

0.00

	 	 	

165

	 	 	

1,650

	 	 	

0

	 	 	  	 
	 	

Medical Monitor

	 	 	

only if required

	 	 	

419

	 	 	

0.00

	 	 	  	 	 	  	 	 	

0

	 	 	  	 	 	  	 	 	  	 
	 	

Set Up DSMB Charter

	 	 	  	 	 	

1257

	 	 	

0.00

	 	 	  	 	 	  	 	 	

0

	 	 	  	 	 	  	 	 	  	 
	 	

Attend DSMB meetings (via teleconference)

	 	 	

assume 1 hr meetings x 2 meetings

	 	 	

168

	 	 	

0.00

	 	 	  	 	 	  	 	 	

0

	 	 	  	 	 	  	 	 	  	 
	 	

Prepare Minutes/Reports from DSMB meetings

	 	 	  	 	 	

670

	 	 	

0.00

	 	 	  	 	 	  	 	 	

0

	 	 	  	 	 	  	 	 	  	 
	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	

Subtotal

	 	 	

5,464

	 	 	

24,385

	 	 	

0

	 	 	

$29,848

	 
	 	

Data Management & Statistics

	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 
	 	

CRF Design

	 	 	

25 unique pages. 80 pages of CRF and 11

pages of questionnaire 91 Total pages. One 

print run.

	 	 	

14520

	 	 	

1.00

	 	 	

0.00

	 	 	

0.00

	 	 	

14,520

	 	 	

0

	 	 	

0

	 	 	  	 
	 	

CRF Design

	 	 	

CRF design guidelines

	 	 	

85

	 	 	

0.00

	 	 	

0.00

	 	 	

16.00

	 	 	

0

	 	 	

0

	 	 	

1,360

	 	 	  	 
	 	

CRF Design

	 	 	

Edits and revisions for version 2

	 	 	

120

	 	 	

000

	 	 	

0.00

	 	 	

16.00

	 	 	

0

	 	 	

0

	 	 	

1,920

	 	 	  	 
	 	

CRF Design (extension)

	 	 	

80 pages of CRF (70 on average entered ) 

One print run.

	 	 	

2834

	 	 	

0.00

	 	 	

1.00

	 	 	

0.00

	 	 	

0

	 	 	

2,834

	 	 	

0

	 	 	  	 
	 	

Database design and build

	 	 	  	 	 	

463

	 	 	

25.00

	 	 	

0.00

	 	 	

0.00

	 	 	

11,563

	 	 	

0

	 	 	

0

	 	 	  	 
	 	

Database design and build (extension)

	 	 	  	 	 	

57

	 	 	

0.00

	 	 	

25.00

	 	 	

0.00

	 	 	

0

	 	 	

1,429

	 	 	

0

	 	 	  	 
	 	

Database / Consistency Check programming

	 	 	  	 	 	

53

	 	 	

208.25

	 	 	

0.00

	 	 	

0.00

	 	 	

11,114

	 	 	

0

	 	 	

0

	 	 	  	 
	 	

Database / Consistency Check programming

	 	 	

Database and edit check programming in

support of version 2

	 	 	

120

	 	 	

0.00

	 	 	

0.00

	 	 	

24.00

	 	 	

0

	 	 	

0

	 	 	

2,880

	 	 	  	 
	 	

Database / Consistency Check programming

extension)

	 	 	  	 	 	

33

	 	 	

0.00

	 	 	

202.00

	 	 	

0.00

	 	 	

0

	 	 	

6,676

	 	 	

0

	 	 	  	 
	 	

 

Data Validation Manual / Data Management Plan

	 	 	  	 	 	

3400

	 	 	

1.00

	 	 	

0.00

	 	 	

0.00

	 	 	

3,400

	 	 	

0

	 	 	

0

	 	 	  	 
	 	

Data Validation Manual / Data Management Plan (extension)

	 	 	  	 	 	

1664

	 	 	

0.00

	 	 	

1.00

	 	 	

0.00

	 	 	

0

	 	 	

1,664

	 	 	

0

	 	 	  	 
	 	

Data entry

	 	 	

 

Double Data Entry 40 patients x 80 CRF pages 

plus 40 x 11 questionnaires=3640 tolal pages. 

Cost per extra page=5.87

	 	 	

6

	 	 	

3640.00

	 	 	

0.00

	 	 	

294.00

	 	 	

21,385

	 	 	

0

	 	 	

1,727

	 	 	  	 

 

	Prana Biotechnology Limited	 	 
	Protocol #: PBT2-204 	INC Research, LLC – CONFIDENTIAL	3
	INCR Project Code: 800089	 	 

 

  

  

  

	 	
Revised Total Budget

	 	
Data entry (extension)

	 	
Double Data Entry 33 patients x 70 entered CRF pages 2310 total pages. Cost per extra page=36.26

	
6

	
0.00

	
2310.00

	
0.00

	
0

	
14,453

	
0

	  
	 	Medical Coding   	 	MedDRA-AE, WHO - Drug  	6	800.00	0.00	0.00	5,036	0	0	  
	 	Medical Coding (extension) 	 	MedDRA-AE, WHO - Drug  	7	0.00	660.00	0.00	0	4,600	0	 
	 	
Data Cleaning / Monitoring

	 	
3200 CRF pages. Cost per extra page=$5.10 224 Queries. Cost per extra query=$42.50

	
29617

	
1.00

	
0.00

	
0.00

	
29,617

	
0

	
0

	  
	 	
Data Cleaning / Monitoring

	 	
Additional pages cleaned/monitored

	
5.10

	
0.00

	
0.00

	
734.00

	
0

	
0

	
3,743

	  
	 	
Data Cleaning / Monitoring

	 	
Additional queries raised

	
42.50

	
0.00

	
0.00

	
646.00

	
0

	
0

	
27,455

	  
	 	
Data Cleaning / Monitoring (Extension)

	 	
2310 CRF pages. Cost per extra page=$7.00 162 Queries. Cost per extra query=$52.00

	
26270

	
0.00

	
1.00

	
0.00

	
0

	
26,270

	
0

	  
	 	
Quality Control

	 	
10% of all patients, 100% of all critical data (15% critical /85% non critical)

	
2.95

	
811.40

	
0.00

	
0.00

	
2,391

	
0

	
0

	  
	 	
Quality Control

	 	
Additional Safety Lab QC programming

	
120

	
0.00

	
0.00

	
4.00

	
0

	
0

	
480

	 
	 	
Quality Control

	 	
Additional Safety Lab QC (pages)

	
2.81

	
0.00

	

0.00

	
91.00

	
0

	
0

	
256

	 
	 	
Quality Control (extension)

	 	
10% of all patients, 100% of all critical data (15% critical / 85% non critical)

	
3.34

	
0.00

	
543.00

	
0.00

	
0

	
1,813

	
0

	  
	 	
Import laboratory data

	 	
1 central lab

	
3680

	
1.00

	
0.00

	
0.00

	
3,680

	
0

	
0

	  
	 	
Import laboratory data

	 	
2 biomarker labs -programming

	
120

	
0.00

	
0.00

	
6.00

	
0

	
0

	
720

	  
	 	
Import laboratory data

	 	
2 biomarker labs -data review

	
85

	
0.00

	
0.00

	
6.00

	
0

	
0

	
510

	  
	 	
Import laboratory data (extension)

	 	
1 central lab. Import and review

	
3182

	
0.00

	
1.00

	
0.00

	
0

	
3,182

	
0

	  
	 	
Data exports

	 	
Assume 2 exports

	
360

	
200

	
0.00

	
0.00

	
720

	
0

	
0

	  
	 	
Data exports (extension)

	 	
Assume 2 exports

	
327

	
0.00

	
2.00

	
0.00

	
0

	
054

	
0

	  
	 	
Database maintenance

	 	
Study Duration = 18 months

	
240

	
18.00

	
0.00

	
0.00

	
4,320

	
0

	
0

	  
	 	
Database maintenance (extension)

	 	
Study Duration = 18 months

	
218

	
0.00

	
18.00

	
0.00

	
0

	
3,924

	
0

	  
	 	
DM & Statisties - Project Management

	 	
Client meetings & corresp, DM metrics 1hrs/month x 18 months

	
120

	
16.00

	
0.00

	
0.00

	
1,530

	
0

	
0

	  
	 	
DM & Statisties - Project Management (extension)

	 	
Client meetings & corresp, DM metrics 1hrs/month x 18 months

	
104

	
0.00

	
18.00

	
0.00

	
0

	
1,872

	
0

	  
	 	
Input to protocol

	 	
Text and sample size calculation / power

	
200

	
4.00

	
0.00

	
0.00

	
800

	
0

	
0

	  
	 	
Generation of Randomisation schedule

	 	
envelope $12.50

	
1175

	
1.00

	
0.00

	
0.00

	
1,175

	
0

	
0

	  
	 	
Statistical Analysis Plan

	 	
Includes text and table and listing shells.

	
5840

	
1.00

	
0.00

	
0.00

	
5,840

	
0

	
0

	  
	 	
Statistical Analysis Plan

	 	
 

Additional hours to cover expansion of analysis. Includes discussion, editing, additional text additional tables and listing shells.

	
200

	
0.00

	
0.00

	
116.00

	
0

	
0

	
23,200

	  
	 	
Statistical Analysis Plan

	 	
 

Adaption of SAP for extension and combined analysis. Includes text plus table & listing shells

	
6072

	
0.00

	
1.00

	
0.00

	
0

	
6,072

	
0

	  
	 	
populations

	 	
populations

	
1600

	
1.00

	
0.00

	
0.00

	
1,600

	
0

	
0

	  
	 	
(extension)Analysis populations

	 	
populations

	
1600

	
0.00

	
1.00

	
0.00

	
0

	
1,600

	
0

	  
	 	
Analysis Datasets

	 	
Specification, Programming & QC

	
4800

	
1.00

	
0.00

	
0.00

	
4,800

	
0

	
0

	  
	 	
Analysis Datasets

	 	
Additional analysis datasets to support increased analysis

	
600

	
0.00

	
0.00

	
14.00

	
0

	
0

	
8,400

	  
	 	
Analysis Datasets (extension)

	 	
Specification, Programming & QC

	
3936

	
0.00

	
1.00

	
0.00

	
0

	
3,936

	
0

	  
	 	
Production of Tables & 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

	
26100

	
1.00

	
0.00

	
0.00

	
26,100

	
0

	
0

	  

 

	Prana Biotechnology Limited	 	 
	Protocol #: PBT2-204 	INC Research, LLC – CONFIDENTIAL	4
	INCR Project Code: 800089	 	 

 

  

  

  

 

Revised Total Budget

	 	
Production of Tables & Listings

	 	
22 Unique tables. Cost per extra $720

70 Repeat tables. Cost per extra $240

0 Figures. Cost per extra $420

40 Listings. Cost per extra $300

	 	
44640

	
0.00

	
0.00

	
1.00

	
0

	
0

	
44,640

	  
	 	
Production of Tables & Listings (extension)

	 	
2 Unique tables. Cost per extra $720

68 Repeat tables. Cost per extra $240

0 Figures. Cost per extra $420

35 Listings. Cost per extra $300

	 	
38622

	
0.00

	
1.00

	
0.00

	
0

	
38,622

	
0

	  
	 	
Statistical Analysis

	 	
10 analysis endpoints. Cost per extra $400

	 	
400

	
10.00

	
0.00

	
190.00

	
4,000

	
0

	
76,000

	  
	 	
Statistical Analysis (extension)

	 	
10 analysis endpoints. Cost per extra $424

	 	
424

	
0.00

	
10.00

	
0.00

	
0

	
4,240

	
0

	  
	 	
Provision of data to DSMB

	 	
Assumes Interim running and QC of 6 TFLs in now Programming Tables and listings.

	 	
960

	
3.00

	
0.00

	
0.00

	
2,880

	
0

	
0

	  
	 	
Provision of data to DSMB (extension)

	 	
Assumes provision of excel spreadsheets and graphed laboratory values

	 	
1312

	
0.00

	
3.00

	
0.00

	
0

	
3,936

	
0

	  
	 	
Input to Final report

	 	
Text for Inclusion in study report.

	 	
2400

	
1.00

	
0.00

	
0.00

	
2,400

	
0

	
0

	  
	 	
Input to Final report (extension)

	 	
Text for Inclusion in study report.

	 	
2544

	
0.00

	
1.00

	
0.00

	
0

	
2,544

	
0

	  
	 	  	 	  	 	  	  	  	
Subtotal

	
158,869

	
130,321

	
193,291

	
$482,482  

	 	
Medical Writing (Optional)

	 	  	 	  	  	  	  	  	  	  	  
	 	
Clinical study report (CSR)

	 	  	 	
22497

	
1.00

	
1.00

	
0.00

	
22,497

	
22,497

	
0

	  
	 	
QA review of CSR

	 	
Optional for Client

	 	
2769

	
1.00

	
0.00

	
0.00

	
2,769

	
0

	
0

	  
	 	  	 	  	 	  	  	  	
Subtotal

	
25,266

	
22,497

	
0

	
$47,763  

	 	  	 	  	 	  	  	  	  	  	  	  	  
	 	  	 	  	 	  	  	  	
TOTAL

	
383,986

	
322,360

	
193,291

	
$899,637  

 

Prana Biotechnology Limited

Protocol #: PBT2-204

	
INCR Project Code: 800089

	
INC Research, LLC – CONFIDENTIAL

	
5

 

  

  

  

 

Revised Total Budget

 

	 	

Expense/Item

	 	 	

Comments

	 	 	

Unit Cost

	 	 	

WO & CO#1 

Number 

of Units

	 	 	

CO#2 

Number 

of Units

	 	 	

WO & CO#1

Item Cost 

AUD$

	 	 	

CO#2 

Item Cost 

AUD$

	 	 	

CO#3 

Item Cost 

AUD$

	 	 	

AUD$

	 
	 	

Site Visits

	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 
	 	

Other Site visit Costs

	 	 	

Parking/tolls/meals and 

incidentals for site visits

	 	 	

$50/day

	 	 	

60.00

	 	 	

50.00

	 	 	

3,000

	 	 	

2,500

	 	 	

0

	 	 	  	 
	 	  	 	 	  	 	 	  	 	 	  	 	 	

Subtotal

	 	 	

3,000

	 	 	

2,500

	 	 	

0

	 	 	

$5,500

	 
	 	

General Expenses

	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 
	 	

 

General Expenses - Couriers, Postage, 

Telecommunications, Copying, stationery (files)

	 	 	

$70/site/month, 3 sites for 25 

months

	 	 	

S210/month

	 	 	

25

	 	 	

0.00

	 	 	

5,250

	 	 	

0

	 	 	

0

	 	 	  	 
	 	

 

General Expenses - Couriers, Postage,

Telecommunications, Copying, stationery (files)

	 	 	

$70/site/month, 2 new sites for 16 months

	 	 	

$140/month

	 	 	

16

	 	 	

0.00

	 	 	

2,240

	 	 	

0

	 	 	

0

	 	 	  	 
	 	

 

General Expenses - Couriers, Postage,

Telecommunications, Copying, stationery (files)

	 	 	

$70/site/month, 4 sites for 14 

months

	 	 	

$280/month

	 	 	

0

	 	 	

14.00

	 	 	

0

	 	 	

3,920

	 	 	

0

	 	 	  	 
	 	

 

CRF Printing

	 	 	  	 	 	

$2,500

	 	 	

1

	 	 	

1.00

	 	 	

2,500

	 	 	

2,000

	 	 	

0

	 	 	  	 
	 	  	 	 	  	 	 	  	 	 	  	 	 	

Subtotal

	 	 	

9,990

	 	 	

5,920

	 	 	

0

	 	 	

$15,910

	 
	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 	 	  	 
	 	  	 	 	  	 	 	  	 	 	  	 	 	

TOTAL

	 	 	

12,990

	 	 	

8,420

	 	 	

0

	 	 	

$21,410

	 

 

	
Prana Biotechnology Limited 

Protocol #: PBT2-204 

INCR Project Code: 800089

	INC Research, LLC – CONFIDENTIAL	1

 

  

  

  

 

 

CHANGE ORDER N°4 to Work Order # 800089 (PBT2-204)

 

This Change Order number 4 to Work Order # 800089 (PBT2-204) (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 INC Research Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with offices located at 159 Port Road Hindmarsh, SA 5007, Australia.

 

RECITALS

 

WHEREAS, Sponsor and INC Research have entered into Work Order # 800089 hereinafter “Agreement”) to perform Services for Protocol PBT2-204 for study entitled: Randomised, Double-blind, Placebo-controlled, Parallel-group, Phase 2 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 dally) for 52 Weeks in Patients with Mild Alzheimer’s Disease (hereinafter “Study”), which was signed by Sponsor and INC Research on 18th April 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 and previous Change Orders;

 

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:

 

Services

●     Case Report Form (CRF) version#2 update

●     Database update and testing due to CRF version# 2 update

●     Edit Checks update and testing due to CRF version#2 update

 

The parties hereby agree the total cost associated with this Change Order is AUD $1,440

	
 INC Research Australia Pty Limited – 800089

	
INC Research, LLC – CONFIDENTIAL

	
 Prana PBT2-204, Change Order #4 version 1

	  

 

  

Page 1 of 3

  

 

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:

 

	 	***	***	***	***
	

Original Contract

	

18th April 2012

	

$353,588.00

	

$10,000.00

	

$363,588.00

	

Change Order #1

	

19th July 2012

	

$30,398.00

	

$2,990.00

	

$33,388.00

	

Change Order # 2

	

29th July 2013

	

$322,360.00

	

$8,420.00

	

$330,780.00

	

Change Order #3

	

18 March 2014

	

$193,291.00

	

$0.00

	

$193,291.00

	

Change Order #4

	

Upon Execution

	

$1,440.00

	

$0,00

	

$1,440.00

	

Total Contract Value

	  	

$901,077.00

	

$21,410.00

	

$922,487.00

 

SECTION III: REVISED PAYMENT TERMS

 

INC will Invoice the Sponsor for Data Management, Statistics and Medical Writing Direct costs according to the following schedule:

	 	 	 	 
	●	Execution of Agreement	-	Invoiced AUD $36,827.00 from original WO
	●	Database Complete	-	Invoiced AUD $36,827.00 from original WO

 

New contract total for Data Management, Statistics and Medical Writing Direct costs = AUD $531,686.00, less total already invoiced = AUD $73,654.00. New total to be invoiced = AUD $458,032.00

	 	 	 	 
	●	50% Data Entered	-	25% of new total = AUD $114,508.00
	●	100% Data Entered	-	25% of new total = AUD $114,508.00
	●	Database lock	-	25% of new total = AUD $114,508.00
	●	1st Draft 1st Study Report	-	15% of new total = AUD $68,704.80
	●	1st Draft 2nd Study Report	-	5% of new total = AUD $22,901.60
	●	Final Study Report	-	5% of new total = AUD $22,901.60

	
 INC Research Australia Pty Limited – 800089

	
INC Research, LLC – CONFIDENTIAL

	
 Prana PBT2-204, Change Order #4 version 1

	  

 

  

Page 2 of 3

  

 

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

	 	
INC Research Australia Pty Limited

	 
		 		 
	
Signature By:

 

	GEOFFREY KEMPLER	 	
Signature By:

	David Fuller	 
	
Name (print)

	 	 	
Name (print)

	
Senior Vice President 

Clinical Development

	 
	
Title

 

	CEO	 	Title	11th July 2014	 
	
Date

 

	1st July 2014	 	
Date

	 	 

	
 INC Research Australia Pty Limited – 800089

	
INC Research, LLC – CONFIDENTIAL

	
 Prana PBT2-204, Change Order #4 version 1

	  

 

  

Page 3 of 3

  

 

Revised Total Budget

 

	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	Study Start Up/***	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
Study Training/ Internal Kick Off Meeting

	 	
***Protocol, IB, CRF, procedures etc.

	 	
1080

	 	1.00	 	0.00	 	0.00	 	 	 	1,080	 	
0

	 	
0

	 	 	 	 
	
Study Training

	 	
*** etc

	 	
840

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
540

	 	
0

	 	
0

	 	  	 	  
	
Study Training on Protocol Amendment

	 	
*** etc

	 	
270

	 	
 0.00

	 	
2.00

	 	
0.00

	 	  	 	
0

	 	
540

	 	
0

	 	  	 	  
	
Study Trainig on Protocol Amendment

	 	
*** etc

	 	
310

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
310

	 	
0

	 	  	 	  
	
Essential document collection

	 	
Creuton, Collection and tracloting

	 	
1350

	 	
6.00

	 	
400

	 	
0.00

	 	  	 	
6,750

	 	
5,400

	 	
0

	 	  	 	  
	
Study Manual/Monitoring Manual Development

	 	  	 	
3100

	 	
1:00

	 	
0.00

	 	
0.00

	 	  	 	
3,100

	 	
0

	 	
0

	 	  	 	  
	
Study Files

	 	
Set up of study master files and Investigator *he files

	 	
720

	 	
1.00

	 	
1.00

	 	
0.00

	 	  	 	
720

	 	
720

	 	
0

	 	  	 	  
	
File Management

	 	
per month

	 	
283

	 	
24.00

	 	
0.00

	 	
0.00

	 	  	 	
6,787

	 	
0

	 	
0

	 	  	 	  
	
File Management - 2 new sites

	 	
per month from August 2012

	 	
283

	 	
14.00

	 	
0.00

	 	
0.00

	 	  	 	
3,959

	 	
0

	 	
0

	 	  	 	  
	
File Management - 4 sites

	 	
per month from October 2013

	 	
377

	 	
0.00

	 	
14.00

	 	
0.00

	 	  	 	
0

	 	
6,279

	 	
0

	 	  	 	  
	  	 	  	 	  	 	  	 	  	 	Subtotal  	 	  	 	
22,837

	 	
12,249

	 	
0

	 	  	 	
***

	
***

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
Teleconference  participation

	 	
25 x 1 hour Telecon, 1 CRAs

	 	
138

	 	
26.00

	 	
0.00

	 	
0.00

	 	  	 	
3,450

	 	
0

	 	
0

	 	  	 	  
	
Teleconference  participation

	 	
16 x monthly hour Telecon, 1 CRA

	 	
138

	 	
16.00

	 	
0.00

	 	
0.00

	 	  	 	
2,208

	 	
0

	 	
0

	 	  	 	  
	
Teleconference participation

	 	
24 x *** 1 hour Telecon, 2 CRAs.

	 	
276

	 	
0.00

	 	
24.00

	 	
0.00

	 	  	 	
0

	 	
6,624

	 	
0

	 	  	 	  
	
Teleconference participation

	 	
24 x *** 1 hour Telecon, 1 PM

	 	
155

	 	
0.00

	 	
24.00

	 	
0.00

	 	  	 	
0

	 	
3,720

	 	
0

	 	  	 	  
	  	 	  	 	  	 	  	 	  	 	Subtotal	 	  	 	5,654  	 	
10,344

	 	  	 	  	 	
$16,002

	***	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Preparation of Presentations	 	
Trident & Customer shared responsibilty

	 	
1620

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
1,820

	 	
0

	 	
0

	 	  	 	  
	
Attendance

	 	
*** 1 day meeting, 1. CRA

	 	
1080

	 	
1.00

	 	
0,00

	 	
0.00

	 	  	 	
1,080

	 	
0

	 	
0

	 	  	 	  
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 2,760	 	 0	 	0 	 	 	 	 $2,700
	
Site Visits

	 	  	 	  	 	  	 	  	 	  	 	  	 	
 

	 	
 

	 	  	 	  	 	
 

	
Sutdy Initiation

	 	
Incl. prop, travel, on-site, reporting & follow-up

	 	
1620

	 	
5.00

	 	
0.00

	 	
0.00

	 	  	 	
8,100

	 	
0

	 	
0

	 	  	 	  
	
Study Initiation

	 	
Incl. prop, travel, on-site, reporting & follow-up

	 	
1080

	 	
0.00

	 	
2.00

	 	
0.00

	 	  	 	
0

	 	
2,160

	 	
0

	 	  	 	  
	
Monitoring Visits  (1 Day visits)

	 	
Incl. prop, travel, 1 day on-site, reporting & follow-up 4 visits/site

	 	
1932

	 	
20.00

	 	
24.00

	 	
0.00

	 	  	 	
38,640

	 	
46,366

	 	
0

	 	  	 	  
	
Monitoring visits (2 Day visits)

	 	
Incl. prop, travel, 2 day’s on-site, reporting & follow-up 3 visits/site

	 	
3174

	 	
15.00

	 	
10.00

	 	
0.00

	 	  	 	
47,610

	 	
31,740

	 	
0

	 	  	 	  
	
Closeout visits

	 	
Incl. prop, travel, on-site, reporting & follow-up

	 	
2070

	 	
5.00

	 	
0.00

	 	
0.00

	 	  	 	
10,350

	 	
0

	 	
0

	 	  	 	  
	
Closeout visits

	 	
Incl. prep, travel, on-site, reporting & follow-up

	 	
1656

	 	
0.00

	 	
4.00

	 	
0.00

	 	  	 	
0

	 	
6,824

	 	
0

	 	  	 	  
	  	 	  	 	  	 	  	 	  	 	  Subtotal	 	  	 	
164,700

	 	
***

	 	
0

	 	  	 	
$101,502

	Site Management 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
Site Management (October 2011 -Nov 2011)

	 	
1 site

	 	
593

	 	
2.00

	 	
0.00

	 	
0.00

	 	  	 	
1,187

	 	
0

	 	
0

	 	  	 	  
	
Site Management (Dec 2011 - May 2012)

	 	
2 sites

	 	
1187

	 	
6.00

	 	
0.00

	 	
0.00

	 	  	 	
7,121

	 	
0

	 	
0

	 	  	 	  
	
Site Management (June 2012- July 2013)

	 	
3 sites

	 	
1780

	 	
14.00

	 	
0.00

	 	
0.00

	 	  	 	
24,923

	 	
0

	 	
0

	 	  	 	  
	
Site Management August 2012 - July 2013)

	 	
per month - 2 new sites

	 	
1187

	 	
12.00

	 	
0.00

	 	
0.00

	 	  	 	
14,242

	 	
0

	 	
0

	 	  	 	  
	
Site Management (August 2013 - September 2013)

	 	
3 sites

	 	
828

	 	
2.00

	 	
0.00

	 	
0.00

	 	  	 	
1,858

	 	
0

	 	
0

	 	  	 	  
	
Site Management (August 2013 - September 2013)

	 	
per month - 2 now sites

	 	
552

	 	
2.00

	 	
0.00

	 	
0.00

	 	  	 	
1,104

	 	
0

	 	
0

	 	  	 	  
	
Site Management (October 2013 - November 2014)

	 	
per month - 4sites

	 	
2208

	 	
0.00

	 	
14,00

	 	
0.00

	 	  	 	
0

	 	
30,912

	 	
0

	 	  	 	  
	
Management/Supervision

	 	
per month

	 	
340

	 	
24.00

	 	
14.00

	 	
0.00

	 	  	 	
8,160

	 	
4,760

	 	
0

	 	  	 	  
	  	 	  	 	  	 	  	 	  	 	
Subtotal  

	 	  	 	
***

	 	
35,672

	 	
0

	 	  	 	***
	***	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	
*** and Set up 

	 	  	 	
1280

	 	
1.00

	 	  	 	  	 	  	 	
1,280

	 	  	 	  	 	  	 	  
	
Study Completion

	 	
*** and client correspondance

	 	
501

	 	
1.00

	 	  	 	  	 	  	 	
501

	 	  	 	  	 	  	 	  
	
Study administration (first 8 months)

	 	
Correspondence,  tracking, client, vision, filing

	 	
160

	 	
6.00

	 	  	 	  	 	  	 	
960

	 	  	 	  	 	  	 	  
	
Prana Biotectnology Limited. *** (XXXX - XXXX)

	 	
Correspondence,  tracking, client vision, filling

	 	
83

	 	
15.00

	 	  	 	  	 	  	 	
1,238

	 	  	 	  	 	  	 	  

 

	INCR Project Code: 800089	INC Research, LLC - CONFIDENTIAL	1

 

 

 

 

 

Revised Total Budget

 

	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	
Safety Administration

	 	
Incl. set up, maintenance and completion activities

	 	
3979

	 	1.00	 	0.00	 	
0.00

	 	 	 	
3,979

	 	
0

	 	
0

	 	 	 	 
	
Safaty Administration 

	 	
Study Extension

	 	
83

	 	0.00	 	14.00	 	
0.00

	 	 	 	
0

	 	
1,155

	 	
0

	 	 	 	 
	
Initial Receipt and handing SAEs

	 	
All events - assume 1 SAE

	 	
330

	 	
1.00

	 	
10.00

	 	
0.00

	 	  	 	
330

	 	
3,300

	 	
0

	 	  	 	  
	
Medical Review of SAEs and Narrative creation

	 	
Optional as required

	 	
838

	 	
0.00

	 	
10.00

	 	
0.00

	 	  	 	
0

	 	
8,380

	 	
0

	 	  	 	  
	
Reporting to local Authorities

	 	
Assume 1 Reportable events

	 	
680

	 	
1.00

	 	
10.00

	 	
0.00

	 	  	 	
560

	 	
6,600

	 	
0

	 	  	 	  
	
Follow up of SAEs

	 	
Assume 2 hours/Follow-up/SAE, 1 Follow ups.

	 	
330

	 	
1.00

	 	
10.00

	 	
0.00

	 	  	 	
330

	 	
3,300

	 	
0

	 	  	 	  
	
Investigator Notification Latters

	 	
properstion and oversight

	 	
185

	 	
1.00

	 	
10.00

	 	
0.00

	 	  	 	
165

	 	
1,650 

	 	
0

	 	  	 	 
	 	 	 	 	 	 	 	 	 	 	Subtotal	 	 	 	
5,464

	 	24,385	 	
0

	 	 	 	
***

	
***

	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	
CRF Design

	 	
25 unique pages. 60 pages of CRF and 11 pages of questionsite 91 Total pages One print run.

	 	
14,520

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
14,520

	 	
0

	 	
0

	 	  	 	  
	
CRF Design

	 	
CRF design guidelines

	 	
85

	 	
0.00

	 	
0.00

	 	
18.00

	 	  	 	
0

	 	
0

	 	
1,360

	 	  	 	  
	
CRF Design

	 	
Edits and revisions for version 2

	 	
120

	 	
0.00

	 	
0.00

	 	
18.00

	 	  	 	
0

	 	
0

	 	
1,820

	 	  	 	  
	
CRF design update to version 2.0

	 	
Update to version 2

	 	
120

	 	  	 	  	 	  	 	
4.00

	 	  	 	  	 	  	 	
480

	 	  
	
CRF Design (extension)

	 	
80 pages of CRF (70 on average entered ). One print run.

	 	
2834

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
2,834

	 	
0

	 	  	 	  
	
Datebase design and build

	 	  	 	
463

	 	
25.00

	 	
0.00

	 	
0.00

	 	  	 	
11,563

	 	
0

	 	
0

	 	  	 	  
	
Database design and build (extension)

	 	  	 	
57

	 	
0.00

	 	
25.00

	 	
0.00

	 	  	 	
0

	 	
1,428

	 	
0

	 	  	 	  
	
Database update and testing per V2 of the CRFs       

	 	
Update to version 2

	 	
120

	 	  	 	  	 	  	 	
4.00

	 	  	 	  	 	  	 	
480

	 	  
	
Edit Checks updete. end testing per V2 of the CRFs

	 	
Update to version 3

	 	
120

	 	  	 	  	 	  	 	
4.00

	 	  	 	  	 	  	 	
480

	 	  
	
Database/ Consistance Check programning

	 	  	 	
53

	 	
208.25

	 	
0.00

	 	
0.00

	 	  	 	
11,114

	 	
0

	 	
0

	 	  	 	  
	
Database /Consistancy Check programming

	 	
Datebase and edit check programaning in support of version 2

	 	
120

	 	
0.00

	 	
0.00

	 	
24.00

	 	  	 	
0

	 	
0

	 	
2,880

	 	  	 	  
	
Database / Consistancy Check programming (extension)

	 	  	 	
33

	 	
0.00

	 	
202.00

	 	
0.00

	 	  	 	
0

	 	
6,676

	 	
0

	 	  	 	  
	
Data Validation Manual / Date Management Plan

	 	  	 	
3400

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
3,400

	 	
0

	 	
0

	 	  	 	  
	
Date Validation Manual/ Date Management

	 	  	 	
1664

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
1,664

	 	
0 

	 	  	 	  
	
Data entry

	 	
Double Data Entry 40 patterns x 80 CRF pages plus 40 x 11 questionaires 3640 total pages. Cost per extra pages=5.87

	 	
6

	 	
3640.00

	 	
0.00

	 	
294.00

	 	  	 	
21,385

	 	
0

	 	
1,727

	 	  	 	  
	
Data entry (extension)

	 	
Double Data Entry 33 patients X TO entered CRF pages 231D total pages. Coat oar extra pages=$6.28

	 	
6

	 	
0.00

	 	
2310.00

	 	
0.00

	 	  	 	
0

	 	
14,453

	 	
0

	 	  	 	  
	
Medical Coding

	 	
MedDRA - AE. WHO - Drug

	 	
6

	 	
800.00

	 	
0.00

	 	
0.00

	 	  	 	
5,036

	 	
0

	 	
0

	 	  	 	  
	
Medical Coding (extension)

	 	
MedDRA - AE. WHO - Drug

	 	
7

	 	
0.00

	 	
680.00

	 	
0.00

	 	  	 	
0

	 	
4,600

	 	
0

	 	  	 	  
	
Data Clearing /Monitoring

	 	
3200. CRF pages. Cost per. extra pages=$5.10                    224 Queries. Cost per extra quaery=$42.50

	 	
29617

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
29.617

	 	
0

	 	
0

	 	  	 	  
	
Data Cleaning / Monitoring

	 	
Additional pages cleaned/montored

	 	
5.10

	 	
0.00

	 	
0.00

	 	
734.00

	 	  	 	
0

	 	
0

	 	
3,743

	 	  	 	  
	
Data Clearing / Monitoring

	 	
Additional queries raised

	 	
42.50

	 	
0.00

	 	
0.00

	 	
846.00

	 	  	 	
0

	 	
0

	 	
27,455

	 	  	 	  
	
Data Clearing Monitoring (Externsion)

	 	
2310 CRF pages. Cost per em page=$7.00                    182 Queries. Cost per extra query=$52.00

	 	
28270

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
26,270

	 	
0

	 	  	 	  
	
Quality Control

	 	
10% of all patiemts 100% of all critical data (15% critical / 85% non critical)

	 	
2.95

	 	
811,40

	 	
0.00

	 	
0.00

	 	  	 	
***

	 	
0

	 	
0

	 	  	 	  
	
Quality Control

	 	
Additional Safety Lab QC Programming

	 	
120

	 	
0.00

	 	
0.00

	 	
4.00

	 	  	 	
0

	 	
0

	 	
480

	 	  	 	  
	
Quality Control

	 	
Additional Safety Lab QC(pages)

	 	
2.81

	 	
0.00

	 	
0.00

	 	
91.00

	 	  	 	
0

	 	
0

	 	
256 

	 	  	 	  
	
Quality Control (extension)

	 	
10% of all patients, 100% of all critical data (15% critical / 85% non critical)

	 	
3.34

	 	
0.00

	 	
543,00

	 	
0.00

	 	  	 	
0

	 	
1,313

	 	
0

	 	  	 	  
	
Import laboratory data

	 	
1 central lab.

	 	
3680

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	 3,680	 	
0

	 	
0

	 	  	 	  
	

***

	 	
2 biomarker labs - programming

	 	
120

	 	
0.00

	 	
0.00

	 	
***

	 	  	 	0 	 	
0

	 	
720

	 	  	 	  
	
***

	 	
2 biomarker labs - data review 

	 	
85

	 	
0.00

	 	
0.00

	 	
***

	 	  	 	 0	 	
0

	 	
910

	 	  	 	  

 

	INCR Project Code: 800089	INC Research, LLC - CONFIDENTIAL	2

 

  

  

  

 

Revised Total Budget

 

	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	***	 	
***

	
Import laboratory data (extension)

	 	
1 central lab.       Import and review.

	 	3182	 	0.00	 	1.00	 	
0.00

	 	 	 	0	 	3,182	 	0 	 	 	 	 
	
Data exports

	 	
Assume 2 exports

	 	360	 	2.00	 	
0.00

	 	
0.00

	 	 	 	720	 	0	 	0	 	 	 	 
	
Data exports (extension)

	 	
Assume 2 exports

	 	327	 	0.00	 	2.00	 	0.00	 	 	 	0	 	854	 	
0

	 	 	 	 
	
Database maintenance

	 	
Study Duration = 18 months

	 	
240

	 	
18.00

	 	
0.00

	 	
0.00

	 	  	 	
4,320

	 	
0   

	 	
0

	 	  	 	  
	
Database maintenance (extension)

	 	
Study Duration = 18 months

	 	
218

	 	
0.00

	 	
18.00

	 	
0.00

	 	  	 	
0

	 	
3,934

	 	
0

	 	  	 	  
	
DM & Statistics - Project Management

	 	
Client meetings & corresp. DM metrics, 1hrs/month x 18 months

	 	
120

	 	
18.00

	 	
0.00

	 	
0.00

	 	  	 	
1,530

	 	
0

	 	
0

	 	  	 	  
	
DM & Statistics - Project Management

	 	
Client meetings & corresp. DM metrics, 1hrs/month x 18 months

	 	
104

	 	
0.00

	 	
18.00

	 	
0.00

	 	  	 	
0

	 	
1,872

	 	
0

	 	  	 	  
	
Input to protocol

	 	
Text and sample size calcualtion / power

	 	
200

	 	
4.00

	 	
0.00

	 	
0.00

	 	  	 	
800

	 	
0

	 	
0

	 	  	 	  
	
Generation of Randomisation schedule

	 	
extra envelope $12.50

	 	
1175

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
1,175

	 	
0

	 	
0

	 	  	 	  
	
Statistical Analysis Plan

	 	
Includes text and tables and listing shells

	 	
5840

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
5,840

	 	
0

	 	
0

	 	  	 	  
	
Statistical Analysis Plan

	 	
Additional hours to cover expansion of analysis. Includes discussion, editing, additional text additional tables and listing shells.

	 	
200

	 	
0.00

	 	
0.00

	 	
116.00

	 	  	 	
0

	 	
0

	 	
23,200

	 	  	 	  
	
Statistical Analysis Plan

	 	
Adaption of SAP for entension and comoined analysis. Includes text plus table & listing shells

	 	
6072

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
6,072

	 	
0

	 	  	 	  
	
Analysis populations

	 	
Definition of populations

	 	
1600

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
1,600

	 	
0

	 	
0

	 	  	 	  
	
(extension) Analysis populations

	 	
Populations

	 	
1600

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
1,600

	 	
0

	 	  	 	  
	
Analysis ***

	 	
Specification, Programming & QC

	 	
4800

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
4,800

	 	
0

	 	
0

	 	  	 	  
	
Analysis ***

	 	
Additional analysis *** to support increased analysis

	 	
600

	 	
0.00

	 	
0.00

	 	
14.00

	 	  	 	
0

	 	
0

	 	
8,400

	 	  	 	  
	
Analysis *** (extension)

	 	
Specification, Programming & QC

	 	
3936

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
3,936

	 	
0

	 	  	 	  
	
Production of Tables & 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

	 	
26100

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
26,100

	 	
0

	 	
0

	 	  	 	  
	
Production of Tables & Listings

	 	
22 Unique tables. Cost per extra $720 70 Report tables. Cost per extra $240 0 Figures. Cost per extra $420 

40 Listings. Cost per extra $300

	 	
44640

	 	
0.00

	 	
0.00

	 	
1.00

	 	  	 	
0

	 	
0

	 	
44,640

	 	  	 	  
	
Production of Tables & Listings (extension)

	 	
2 Uniques tables. Cost per extra $720 68 Repeat tables. Cost per extra $240 0 Figures. Cost per extra $420 

35 Listings. Cost per extra $300

	 	
38622

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
38,622

	 	
0

	 	  	 	  
	
Statistical Analysis

	 	
10 analysis endpoints. Cost per extra $400

	 	
400

	 	
10.00

	 	
0.00

	 	
190.00

	 	  	 	
4,000

	 	
0

	 	
76,000

	 	  	 	  
	
Statistical Analysis (extension)

	 	
10 analysis endpoints. Cost per extra $424

	 	
424

	 	
0.00

	 	
10.00

	 	
0.00

	 	  	 	
0

	 	
4,240

	 	
0

	 	  	 	  
	
Provision of *** to DSMB

	 	
Assumes interim running and QC of 6 TFLs In row Programming Tables and ***.

	 	
960

	 	
3.00

	 	
0.00

	 	
0.00

	 	  	 	
2,880

	 	
0

	 	
0

	 	  	 	  
	
Provision of *** to DSMB (extension)

	 	
Assumes provisional excel spredsheets and graphed laboratory values

	 	
1312

	 	
0.00

	 	
3.00

	 	
0.00

	 	  	 	
0

	 	
3,936

	 	
0

	 	  	 	  
	
Input to Final report

	 	
Text for inclusion in study report

	 	
2400

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
2,400

	 	
0

	 	
0

	 	  	 	  
	
Input to Final report (extension)

	 	
Text for inclusion in study report

	 	
2544

	 	
0.00

	 	
1.00

	 	
0.00

	 	  	 	
0

	 	
2,544

	 	
0

	 	  	 	  
	  	 	  	 	  	 	  	 	  	 	Subtotal	 	  	 	
158,369

	 	
130,321

	 	
193,291

	 	
***

	 	$483,822
	Medical/Writing/(Optional)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Clinical study report (CSR)  	 	  	 	
22497

	 	
1.00

	 	
1.00

	 	
0.00

	 	 	 	
22,497

	 	
22,497

	 	
0

	 	  	 	 
	
QA review of CSR

	 	
Optional for Client

	 	
2769

	 	
1.00

	 	
0.00

	 	
0.00

	 	  	 	
2,769

	 	
0

	 	
0

	 	  	 	 
	 	 	 	 	 	 	 	 	 	 	Subtotal	 	 	 	   25,288 	 	  22,497	 	0	 	 	 	$47,763
	  	 	  	 	  	 	  	 	  	 	 	 	  	 	 	 	 	 	 	 	  	 	 
	  	 	  	 	
 

	 	 	 	  TOTAL	 	  	 	***	 	***	 	183,231	 	 ***  	 	***

 

	
Prana Biotechnology Limited

Protocol #: PBT2-204

INCR Project Code: 800089

	
INC Research, LLC - CONFIDENTIAL

	
3

 

  

  

  

 

	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	 	
***

	Site Visits	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Other Site visit Costs	 	Pariding/tolls/meals and incidentals for site visits	 	$50/day	 	60.00	 	50.00 	 	3,000	 	2,500	 	0	 	0	 	 	 	 
	 	 	 	 	 	 	 	 	
Subtotal

	 	
3,000

	 	***	 	0	 	0	 	
$5,500

	 	
$5,610

	General Expenses 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
General Expenses - Couriers, Postage, Telecommunications, Copying; stationary (files)

	 	$70/site/month, 3 sites for 25 months	 	$210/month	 	25	 	
0.00

	 	
5,250

	 	0	 	0	 	0	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
General Expenses - Couriers, Postage, Telecommunications, Copying, stationery (files)

	 	
$70/site/month, 2 new sites for 16 months

	 	
$140/month

	 	
16

	 	
0.00

	 	
2,240

	 	
0

	 	
0

	 	
0

	 	  	 	  
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
General Expenses - Couriers, Postage, Telecommunications, Copying, stationery (files)

	 	
$70/site/month, 4 sites for 14 months

	 	
$280/month

	 	
0

	 	14.00	 	0	 	
3,920

	 	
0

	 	0	 	 	 	 
	
CRF Printing

	 	 	 	
$2,500

	 	
1

	 	1.00	 	2,500	 	
2,000

	 	
0

	 	
0

	 	 	 	 
	 	 	 	 	 	 	 	 	
Subtotal

	 	
***

	 	
***

	 	0	 	0	 	$15,919	 	$16,228
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	
TOTAL

	 	12,990	 	5,420	 	0	 	0	 	$21,410	 	$21,833

 

	
Prana Biotechnology Limited

Protocol #: PBT2-204

INCR Project Code: 800089

	
INC Research, LLC - CONFIDENTIAL

	
1exhibit_4-35.htm

Exhibit 4.35

 

Amendment 1 to Agreement dated 19th Aug’13 signed by and between

Dr. Reddy’s Laboratories Limited

Bollaram Road, Miyapur,

Hyderabad 500 049

India

(Hereinafter referred to as “Dr. Reddy’s”)

and

Prana Biotechnology Ltd

Level 2,369 Royal Parade, Parkville Victoria, 3052

Australia

(Hereinafter referred to as “Prana”)

Dr. Reddy’s and Prana are collectively referred to as the “PARTIES”

	  

 

This amendment will include the following amended clauses in the above mentioned agreement and will be in effect from 26th September 2013.

 

1. Terms to varied.

 

The following project item (Sub-Project 1) in Appendix A (Project works and time table section) is set for amendment.

 

i. Bifurcation of Sub project 1 in Appendix A(project works and time table section)

 

	
Project item

(Sub-Project)

	  	  	
Responsible

Party

	  	  	
Milestone

Payment

	  	  	
Timeline

	
1-Completion of

Process Development

work (towards

filtration)

	  	  	
Dr.Reddy’s

	  	  	
USD 45,000

	  	  	
Commence April

1st 2013, “start

date”. Milestone

payment on

completion.

 

Is amended as follows

 

	
Project item

(Sub-Project)

	  	  	
Responsible

Party

	  	  	
Milestone

Payment

	  	  	
Timeline

	
1(a)- Completion of

Process Development

work (towards

filtration) till stage 4

(CDDQ-4)

	  	  	
Dr.Reddy’s

	  	  	
USD 36,000

	  	  	
Commence April

lst 2013, “start

date”. Milestone

payment on

completion.

	
1(b)- Completion of

Process Development

work (towards

filtration) from stage 4

(CDDQ-4) to stage 5

(CDDQ-5)

	  	  	
Dr.Reddy’s

	  	  	
USD 9,000

	  	  	
Commence April

lst 2013, “start

date”.Milestone

payment on

completion.

 

 

  

Page 1 of 2

  

The deliverables of sub project 1 (a) and 1(b) will be in line with the deliverables of Sub project 1, mentioned in the master service agreement dated 19th Aug 13.

 

All other terms and conditions of the original Agreement dated 19th Aug’13 remain unchanged.

 

In witness whereof, the parties hereto have signed this Agreement

	  	  	  
	
Signed for and on behalf of

	
Signed for and on behalf of

	
Dr. Reddy’s Laboratories Limited

	
Prana Biotechnology Ltd.

	  	  
		
	  	  
	
Signature

	
Signature

	
Name: Manoj Mehrotra

	
Name: Dianne Angus

	  	  	  
		  	
	
Witness Signature

	  	
Witness Signature

	
Witness Name: Animesh Kondiparthy

	
Witness Name: Elisabeth Gautier

 

 

  

Page 2 of 2

  

 

Amendment 2 to Agreement Commencement Date 5th April’13 signed

by and between

Dr. Reddy’s Laboratories Limited

Bollaram Road, Miyapur,

Hyderabad 500 049

India

(Hereinafter referred to as “Dr. Reddy’s”)

and

Prana Biotechnology Ltd

Level 2, 369 Royal Parade, Parkville Victoria, 3052

Australia

(Hereinafter referred to as “Prana”)

Dr. Reddy’s and Prana are collectively referred to as the “PARTIES”

	  	  	  
	  	  	  
	  	
This amendment will include the following amended clauses in the above mentioned agreement and will be in effect from 31st August 2013.

	  
	  	  	  
	  	
1. Terms to the amendment would remain as same as that of MSA Commencement Date 5th April’13

	  
	  	  	  
	  	
The following project item (Sub-Project) in Appendix A (Project works and time table section) is added with the following activities as additional section -8

	  
	  	  	  
	  	
Sub project-section -8 in Appendix A (project works and time table section) is added with the additional line items as described below

	  

 

  

Page 1 of 2

  

	 	 	 	 	 	 	 	 	 	 	 
	  	
Sr.

No.

	 	 	
Project item (Sub-Project) Appendix A

	  	
Responsible

Party

	  	
Milestone 

Payment in

USD on 

completion 

of line item

	 	
Expected /

Estimated

Timeline and

invoicing

	  	
8. EOP2, analytical & crystallization work package

	  	
a.

	 	
l

	
Analysis of IDT batches & sharing required set of data as per the revised Assay & RS methods

	  	
Dr. Reddy’s & Prana (sample to be provided by Prana

	  	
2,000

	 	  
	  	 	  	  	  	  	  	 	  
	  	
l

	
Comparing physical properties for all key API batches Batch Number 1457(2011 campaign), 1433(current campaign) are plant scale batches and DA1020702.1 is IDT batch. These batches will be analyzed & compared for physical properties e.g. PSD, DSC, XRPD and bulk density (if sufficient quantity is available)

 

	  	
Dr. Reddy’s & Prana (sample to be provided by Prana)

	  	
6,000

	 	
Sep’14

	  	
l

	
Expanding specifications of CDDQ-3 as a regulatory starting material & related analytical work.

	  	  	  	  	 	  

	  	  	  	  	
Specification development as per requirement of Regulatory starting material

	  	
Dr. Reddy’s & Prana

	  	
10,000

	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	
l

	
Part Compilation of data as part of CMC package for EOP2 meeting

Creating batch history for CDDQ-3,4,5i-impurity profiling, showing equivalency to the earlier material, method. Old batches may not be available, however impurity profile would be created for all the batches manufactured now onwards – Compiled data would be presented

	  	
Dr. Reddy’s & Prana

	  	
5,000

	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	
b.

	  	
CMC summary for EOP2:

	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  
	  	  	
l

	
Expanding specifications of CDDQ-3 as a regulatory starting material & related analytical work- Method development and validation for related substances by HPLC and assay by HPLC – Compiled data would be presented

	  	
Dr. Reddy’s & Prana

	  	
13,000

	  	
Sept’ 14

	  	  	  	  	  	  	  	  	  	  
	  	  	
l

	
Analytical support for crystallization development work including PSD analysis- Compiled data would be presented

	  	
Dr. Reddy’s & Prana

	  	
14,000

	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	
c.

	  	
l

	
Material Generation for Crystallization work

	  	
Dr. Reddy’s

	  	
5,500

	  	
Oct’14

	  	  	
l

	
Analysis for the support on Crystallization studies for the lab samples

	  	
Dr. Reddy’s

	  	
13,500

	  
	  	  	  	  	  	  	  	  	  	  	  
	  	
d.

	  	
l

	
Analysis of Optimized Samples and Report Finalization for Crystallization work

	  	
Dr. Reddy’s

	  	
8000

	  	
Nov’14

 

EOP2 means- End of phase 2 meeting, all other terms and conditions of the original Agreement commencement date 5th April’13 remain unchanged.

 

In witness whereof, the parties hereto have signed this Agreement

	  	  
	
Signed for and on behalf of

	
Signed for and on behalf of

	
Dr. Reddy’s Laboratories Limited

	
Prana Biotechnology Ltd.

	
    25th Sept 2014

	   2/9/14.
	
Signature

	
Signature

	
Name: Anurag Roy

	
Name: Dianne Angus

	   25th Sept 2014	
	 	 
	
Witness Signature

	
Witness Signature

	
Witness Name: Suresh Kumar Ramachandran

	
Witness Name: Elisabeth Gautier          2 Sept 2014

 

Page 2 of 2

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