CHANGE ORDER N°1 to Work Order #1002213
Exhibit 4.30
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CHANGE ORDER N°1 to Work Order #1002213
This Change Order number 1 to Work Order #1002213 (hereinafter “Change Order”) is made and entered into as of the date of last signature (hereinafter “Effective Date”) by and between Prana Biotechnology Limited (hereinafter “Sponsor”) with an office located at Xxxxx 0, 000 Xxxxx Xxxxxx, Xxxxxxxxx XXX 0000 Xxxxxxxxx and INCResearch Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with offices located at 000 Xxxxxx Xxxxxx, Xxxx Xxxxxxxx XX 0000, Xxxxxxxxx.
RECITALS
WHEREAS, Sponsor and INC Research have entered into Work Order #102213 (hereinafter “Agreement”) to perform Services for Xxxxxxxx # XXX0-000, for study entitled: A randomized, double-blind, placebo controlled study to assess the safety and tolerability and efficacy of PBT2 in patients with early to mid-stage Huntington disease (hereinafter “Study”), which was signed by Sponsor and INC Research on 28th March 2013 and
WHEREAS, during the course of the performance of the Study, Sponsor and INC Research have identified changes in assumptions; and
WHEREAS, Sponsor desires to retain additional services from INC Research and INC Research desires to supply such services to Sponsor under the terms and conditions set forth herein; and
WHEREAS, Sponsor and INC Research agree that all other terms and conditions of the Agreement shall remain in full force and effect, unless specifically agreed otherwise in this Change Order; and
WHEREAS, Sponsor and INC Research agree that the services and costs covered by this Change Order are additional to the services and costs covered by the Agreement;
NOW THEREFORE, subject to the terms, conditions and covenants hereinafter set forth, INC Research and Sponsor agree as follows:
SECTION I: CHANGES IN SCOPE
This section contains an overview of the changes in assumptions, timelines, and revision in Scope of services. In summary, this Change Order mainly reflects the following changes:
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Addition of Project Meetings, Teleconferences and Face to Face meetings with Sponsor.
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Addition of Client Database Review.
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Additional Statistical Analysis Plan (SAP) includes Text and Table and Listing Shells.
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Removal of Identifying Protocol Deviations and Analysis populations.
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Additional Analysis Datasets, Specification, Programming and Quality Control.
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Reduction in Production of Tables & Listings (Lost or redundant programming due to closure of HSG involvement).
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Removal of Statistical Analysis
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Removal of Input to Final report
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Removal of Unit based Data Management Costs for Program consistency checks and raising manual data queries.
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Removal of Clinical Study Report (CSR).
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Removal of Quality Assurance (QA) Site Audits.
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1002213
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Prana (PBT2-203) Change Order #1, v4, 4th March 2014
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Page 2 of 6
TW3.05C
Version 04
INC Research, LLC Change Order Form
The parties hereby agree the total cost associated with this Change Order is AUD $53,809.00
SECTION II: COSTS OVERVIEW
The additional deliverables and tasks performed by INC Research are specified in Attachment A. This Attachment includes an overview of the total prices of deliverables in the original agreement and previous change orders, and an overview of the additional total prices of the new deliverables and services. The total amount of all contracted deliverables (original agreement including all change orders) is shown in Attachment A.
A summary of both direct and indirect costs related to the original agreement and all changes in scope as occurred is provided in the table below:
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Effective Date
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Direct Costs
AUD$
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Indirect Costs
AUD$
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Grand Total
AUD$
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Original Contract
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28th March 2013
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$173,754.00
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$2,310.00
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$176,064.00
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Xxxxxx Xxxxx # 0
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Xxxx Xxxxxxxxx
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$53,809.00
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$0.00
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$53,809.00
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Total Contract Value
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$227,563.00
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2,310.00
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$229,873.00
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SIGNATURE
IN WITNESS WHEREOF, the undersigned have caused this Change Order to be executed by a duly authorized individual on behalf of each requisite party effective as of the day and year last written below. In the event that the parties execute this Change Order by exchange of electronically signed copies or facsimile signed copies, the parties agree that, upon being signed by both parties, this Change Order shall become effective and binding and that facsimile copies and/or electronic signatures will constitute evidence of the existence of this Change Order with the expectation that original documents may later be exchanged in good faith.
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Prana Biotechnology Limited
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INCResearch Australia Pty Limited
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Signature By:
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Signature By:
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XXXXXX XXXXX
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Name (print)
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Name (print)
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Chief Operating Officer
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Title
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Title
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11 March 2014
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Date
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Date
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1002213
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Prana (PBT2-203) Change Order #1, v4, 4th March 2014
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2
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Page 3 of 6
Revised Direct Costs
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Service/Item
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Comments
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Responsibility
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Unit
|
Unit
Cost
(AUD)
|
Original
Number
of Units
|
CO#1
Number
of Units
|
Original
Item
Cost
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CO#1
Item
Cost
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AUD$
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Data Management
& Statistics
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Project familiarization
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Arrange test data extract from database, assess data structure and data quality. Receive final transfer from HSC.
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Clinical
Programmer
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1hr
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108
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16.00
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0.00
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1,728
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0
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|||
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Project Meetings
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Teleconference and face to face meetings with Prana, CTCC and key opinion leaders
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Statistician
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10hr/week
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2120
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0.00
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26.00
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0
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55,120
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HSG Meeting (USA)
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Three days of meetings plus travel time. (Jan Steyn or Xxxxxxx Xxxxxx Xxxxxxxx and Xxxxx Xxxxxxx). Travel & accommodation arranged by Prana
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40hrs per
person
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8000
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2.00
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0.00
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16,000
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0
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Database design
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Review annotated CRF and database specification documentations
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Clinical
Programmer
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0.5hr/dat
aset
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30
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25.00
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0.00
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750
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0
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Data Validation Manual
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Review DVM text/data management plan specifying edit checks
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CDA
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40hrs
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104
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16.00
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0.00
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1,664
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0
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Xxxxxx XX, XX, XXX and immunology data
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Electronic transfer of Biomarker, PK, ECG and MRI data (Data transfer plans, test transfers & final transfer)
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DBA
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1 study
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1122
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4.00
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0.00
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4,488
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0
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1002213
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Prana (PBT2-203) Change Order #1, v4, 4th March 2014
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Page 4 of 6
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TW3.05C
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Version 04
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INC Research, LLC Change Order Form
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Service/Item
|
Comments
|
Responsibility
|
Unit
|
Unit
Cost
(AUD)
|
Original
Number
of Units
|
CO#1
Number
of Units
|
Original
Item
Cost
|
CO#1
Item
Cost
|
AUD$
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||||
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Client Database Review
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Database Report prepared by Xxxxx Xxxxxxxx
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DM Systems
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40hrs
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7400
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0.00
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1.00
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0
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7,400
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Statistical Analysis Plan (SAP)
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Includes text and table and listing shells
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Statistician
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1 SAP
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9426
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1.00
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0.00
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9,426
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0
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Statistical Analysis Plan (SAP)
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Additional text and table and listing shells
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Statistician
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1 SAP
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13936
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0.00
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1.00
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0
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13,936
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Statistical Analysis Plan (SAP)
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SAP Amendment 1 (24 hours)
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Statistician
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1 SAP
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5088
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0.00
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1.00
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0
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5,088
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Identify Protocol Deviations and define Analysis populations
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Unblinding, Protocol deviations and Definition of populations
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Statistician
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1 study
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1600
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1.00
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-1.00
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1,600
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-1,600
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Analysis Datasets
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Specification, Programming & QC
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SAS
Programmer
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1 study
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21294
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1.00
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0.00
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21,294
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0
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Data Cleaning Issues
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Resolving data issues in CTCC data sets
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SAS
Programmer
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per hour
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169
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0.00
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400.00
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0
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67,600
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Production of Tables & Listings
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14 Unique tables. Cost per extra $1014
20 Repeat tables. Cost per extra $338 36 Figures. Cost per extra $592 38 Listings. Cost per extra $422 |
SAS
Programmer
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1 study
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52221
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1.00
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0.00
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52,221
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0
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Production of Tables & Listings (Lost or redundant programming due to closure of HSG involvement)
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Primary programming lost: 20 analyses programs lost @ $212, 19 unique tables lost @$507, 68 tables requiring modification @ $126.75, 51 Listings requring minor modification @ $84.50.
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SAS
Programmer
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1 study
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29152
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0.00
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-1.00
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0
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-29,152
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1002213
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Prana (PBT2-203) Change Order #1, v4, 4th March 2014
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Page 5 of 6
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TW3.05C
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Version 04
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INC Research, LLC Change Order Form
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Service/Item
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Comments
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Responsibility
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Unit
|
Unit
Cost
(AUD)
|
Original Number of Units
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CO#1 Number of Units
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Original Item
Cost |
CO#1 Item
Cost |
AUD$
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Statistical Analysis
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Analysis endpoints. Cost per extra $424
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Statistician
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1 analysis endpoint
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424
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19.00
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-19.00
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8,056
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-8,056
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Input to Final report
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Text for inclusion in study report
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Statistician
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1 Study
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5088
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1.00
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-1.00
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5,088
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-5,088
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Unit based Data Management Costs
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Program consistency check
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Clinical Programmer
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1 check
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60
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1.00
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-1.00
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60
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-60
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Unit based Data Management Costs
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Raise manual data query
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CDA
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1 query
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52
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1.00
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-1.00
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52
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-52
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Subtotal
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122,427
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105,136
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$227,563
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Medical Writing
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Clinical Study Report (CSR)
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Medical Writer
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per CSR
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25418
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1.00
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-1.00
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25,418
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-25,418
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Subtotal
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25,418
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-25,418
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$0
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|||||||||||
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Quality Assurance - Site Audits
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||||||||||||||
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Quality Assurance Site Audits
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GCP Audits preparation time
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QAA
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Site Audit
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1314
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2.00
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-2.00
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2,628
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-2,628
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GCP Audits on-site
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QAA
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Site Audit
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2628
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2.00
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-2.00
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5,255
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-5,255
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GCP Audits report preparation
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QAA
|
Site Audit
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1971
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2.00
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-2.00
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3,941
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-3,941
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GCP Audits travel time
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QAA
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Site Audit
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1570
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2.00
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-2.00
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3,140
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-3,140
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Review of Audit reports
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QAA
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Site Audit
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443
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2.00
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-2.00
|
000
|
-000
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|||||||
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QA Audit of Vendor(s)
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QAA
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Audit
|
10059
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1.00
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-1.00
|
10,059
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-10,059
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|||||||
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Subtotal
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25,909
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-25,909
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$0
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TOTAL
|
173,754
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53,809
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$227,563
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1002213
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Prana (PBT2-203) Change Order #1, v4, 4th March 2014
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5 |
Page 6 of 6
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TW3.05C
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Version 04
|
|
INC Research, LLC Change Order Form
|
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Pass-Through Costs – NIL changes
|
|
Expense/Item
|
Comments
|
Unit Cost (AUD)
|
Original
Number
of Units
|
CO#1
Number of Units
|
Original
Item Cost
AUD$
|
CO#1
Item
Cost
AUD$
|
AUD$
|
||
|
Site Visits
|
|||||||||
|
Travel Costs
(flights/accommodation/taxis)
|
$1,155/visit
|
2
|
0
|
2,310
|
0
|
||||
|
Subtotal
|
2,310
|
0
|
$2,310
|
||||||
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TOTAL
|
2,310
|
0
|
$2,310
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INC Research, LLC - CONFIDENTIAL
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INCResearch Australia Pty Limited - 1002213
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Prana (PBT2-203) Change Order #1, v4, 4th March 2014
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6 |
