CHANGE ORDER N°3 to Work Order # 800089 (PBT2-204)
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 Xxxxx Xxxxxx, Xxxxxxxxx, XXX 0000, Xxxxxxxxx and INC Research Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with offices located at 000 Xxxxxx Xxxxxx, Xxxx Xxxxxxxx XX 0000, Xxxxxxxxx.
RECITALS
WHEREAS, Sponsor and INC Research have entered into Work Order # 800089 hereinafter “Agreement”) to perform Services for Xxxxxxxx XXX0-000 for study entitled: Randomised, Double-blind, Placebo-controlled, Xxxxxxxx-xxxxx, Xxxxx 0 Study to Evaluate the Effect of One Dose of PBT2 (250mg daily) for 52 Weeks on 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 $22,829.60
|
|
INC Research Australia Pty Limited – 800089
|
INC Research, LLC – CONFIDENTIAL
|
|
Prana PBT2-204, Change Order #3 version 1
|
Page 2 of 3
SIGNATURE
COUNTERPARTS. This Change Order may be signed in counterparts and said counterparts shall be treated as though signed as one document. The parties acknowledge legal validity of facsimile, portable document format or other commercially acceptable electronic exchange of copies of the documents, which are essential for Change Order execution. A party which uses a facsimile, portable document format or other commercially acceptable electronic exchange copy of an authorized person’s signature in the documents guaranties its authenticity.
IN WITNESS WHEREOF, the undersigned have caused this Change Order to be executed by a duly authorized individual on behalf of each requisite party effective as of the day and year last written below.
|
Prana Biotechnology Limited
|
INC Research Australia Pty Limited
|
||
 |
|||
|
Signature By:
|
Signature By:
|
||
|
XXXXXX XXXXX
|
|||
|
Name (print)
|
Name (print)
|
||
|
Chief Operating Officer
|
|||
|
Title
|
Title
|
||
|
14 March 2014
|
|||
|
Date
|
Date
|
|
INC Research Australia Pty Limited – 800089
|
INC Research, LLC – CONFIDENTIAL
|
|
Prana PBT2-204, Change Order #3 version 1
|
Page 3 of 3
Revised Total Budget
|
Service/Item
|
Comments
|
Unit Cost
|
WO & CO#1
Number of Units |
CO#2 Number
of Units |
CO#3 Number
of Units |
WO & CO#1
Item Cost
|
CO#2
Item Cost |
CO#3
Item Cost |
AUD$
|
||||||||||
|
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, Xxxxxxxxxx.xxx
|
310
|
0.00
|
0.00
|
0
|
0
|
0
|
||||||||||||
|
Investigator/Site Identification
|
Identify up to sites to select xxxxx 0
|
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 XXXXX 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 Xxxxx 0, 000 Xxxxx Xxxxxx, Xxxxxxxxx, XXX 0000, Xxxxxxxxx and INC Research Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with offices located at 000 Xxxx Xxxx Xxxxxxxxx, XX 0000, Xxxxxxxxx.
RECITALS
WHEREAS, Sponsor and INC Research have entered into Work Order # 800089 hereinafter “Agreement”) to perform Services for Xxxxxxxx XXX0-000 for study entitled: Randomised, Double-blind, Placebo-controlled, Xxxxxxxx-xxxxx, Xxxxx 0 Study to Evaluate the Effect of One Dose of PBT2 (250mg daily) for 52 Weeks on Aβ Deposition in the Brains of Patients with Mild Alzheimer’s Disease Compared to Placebo and to Evaluate the Safety and Tolerability of PBT2 (250mg 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
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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:
|
XXXXXXXX XXXXXXX |
Signature By:
|
Xxxxx Xxxxxx | ||
|
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
|
1
|
