exhibit_4-27.htm










Exhibit 4.27


 





 


WORK ORDER


INC Research Project # 1002213


Protocol # PBT2-203


 


This Work Order (hereinafter “Work Order”) is between Prana Biotechnology Limited (hereinafter “Sponsor”) with principal offices located at Level 2, 369 Royal Parade, Parkville VIC 3052 Australia and INCResearch Australia Pty Limited, together with its parent company, subsidiaries and legal affiliates (hereinafter “INC Research”) with offices located at 124 Lipson Street, Port Adelaide SA 5015 Australia and relates to the Master Services Agreement effectively dated 22nd September 2011 which expressly incorporates this Work Order hereto by reference into the Master Services Agreement. Pursuant to the Master Services Agreement, INC Research has agreed to perform certain services in accordance with written work orders, such as this one, entered into from time to time describing such services.


 


This document constitutes a Work Order under the Master Services Agreement and this Work Order and the Services contemplated herein are subject to the terms and provisions of the Master Services Agreement.



	  	  
	
1.

	
SERVICES: INC Research will render such services (hereinafter “Services”) as may be necessary to complete in a professional manner the project described below:


	  	  
	  	
Protocol # PBT2-203: 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.


	  	  
	  	
INC Research will perform the Services as specified in Attachment A to this Work Order.


	  	  
	
2.

	
PROJECT SCHEDULE: The major project milestones and target dates are described in Attachment B to this Work Order. Both parties agree that the Project Schedule is a reasonable schedule for the Services to be performed and will put forth all reasonable efforts to comply with these dates.


	  	  
	
3.

	
COMPENSATION AND EXPENSES: Sponsor shall pay the fees for INC Research’s Services in accordance with the Project Budget and Payment Schedule provided in Attachment C of this Work Order. INC Research shall invoice Sponsor for taxes or duties actually incurred by INC Research which are imposed upon INC Research by any governmental agency, including, but not limited to Value Added Tax, Stamp Tax, and/or General Sales Tax, as a result of this Agreement with the exception of taxes based on INC Research’s income.







 



	
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4.

	
NOTICES AND PAYMENTS: All communications, notices and payments required under this Work Order shall be mailed by first class mail, postage prepaid, or by overnight carriers, to the respective parties at the addresses set forth below, or to such other addresses as the parties may from time to time specify in writing.







 



	  	  	  
	  	
If to Sponsor:

	  
	  	  	
Carolyn Stone


	  	  	
Clinical Program Manager


	  	  	
Prana Biotechnology Limited


	  	  	
Level 2


	  	  	
369 Royal Parade


	  	  	
Parkville VIC 3052 Australia


	  	  	
cstone@pranabio.com


	  	  	  
	  	  	
Cc: Caroline Herd


	  	  	
cherd@pranabio.com


	  	  	  
	  	
If to INC Research:

	  





 



	  	
For Communications:

	
Contracts Management


	  	  	
INCResearch Australia Pty Limited


	  	  	
124 Lipson Street


	  	  	
Port Adelaide SA 5015 Australia


	  	  	
Phone: +61 (0) 8 7202 1500


	  	  	
Facsimile: +61 (0) 8 7202 1599


	  	  	  
	  	
For Payments (Via Wire):

	  
	  	  	  
	  	
Beneficiary Bank:

	
HSBC Bank Australia Ltd


	  	
Beneficiary Bank Address:

	
Ground Floor, 55 Grenfell Street


	  	  	
Adelaide SA 5000, Australia


	  	
Account Name:

	
INCResearch Australia Pty Limited


	  	
BSB (Routing Number):

	 
	  	
Account Number:

	 
	  	
Swift:

	 





 



	
5.

	
TRANSFER OF OBLIGATIONS: Sponsor assigns the responsibilities pertaining to the Study to INC Research as indicated in Attachment A, Services,







 



	
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IN WITNESS WHEREOF, the undersigned have caused this Work Order to be executed by a duly authorized individual on behalf of each requisite party effective as of the day and year last written below. In the event that the parties execute this Work Order by exchange of electronically signed copies or facsimile signed copies, the parties agree that, upon being signed by both parties, this Work Order shall become effective and binding and that facsimile copies and/or electronic signatures will constitute evidence of the existence of this Work Order with the expectation that original documents may later be exchanged in good faith. Thereafter, the parties agree that in connection with request for information that either party may need from the other related to the Services provided hereunder, both parties expressly permit communication via facsimile to the extent allowed by applicable laws and regulations to be disseminated in that manner.


 


Prana Biotechnology Limited



	  	  	 
	
By:

		 
	
Name:  

	
Dianne Angus

	 
	
Title:

	
C.O.O.

	 
	
Date:

	
27-3-2013

	 





 


INCResearch Australia Pty Limited


 



	
By:

		 
	
Name:  

	
Garth Tierney

	 
	
Title:

	
Regional General Manager, Australia and South East Asia

	 
	
Date

	
28/3/2013

	 





 



	
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IN WITNESS WHEREOF, the undersigned have caused this Work Order to be executed by a duly authorized individual on behalf of each requisite party effective as of the day and year last written below. In the event that the parties execute this Work Order by exchange of electronically signed copies or facsimile signed copies, the parties agree that, upon being signed by both parties, this Work Order shall become effective and binding and that facsimile copies and/or electronic signatures will constitute evidence of the existence of this Work Order with the expectation that original documents may later be exchanged in good faith. Thereafter, the parties agree that in connection with request for information that either party may need from the other related to the Services provided hereunder, both parties expressly permit communication via facsimile to the extent allowed by applicable laws and regulations to be disseminated in that manner.


 


Prana Biotechnology Limited



	  	  	 
	
By:

		 
	
Name:  

	
Dianne Angus

	 
	
Title:

	
C.O.O.

	 
	
Date:

	
27-3-2013

	 





 


INCResearch Australia Pty Limited


 



	
By:

	  	 
	
Name:  

	
Garth Tierney

	 
	
Title:

	
Regional General Manager, Australia and South East Asia

	 
	
Date:

	  	 





 



	
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ATTACHMENT A


Services



	  	  
	
Project Specifications


	
GENERAL

	  
	
Drug Name

	
PBT2


	
Indication

	
Huntington Disease


	
Phase

	
II


	
PROJECT MANAGEMENT


	
Number of Sponsor


Teleconferences

	
12 x 1 hour Teleconference monthly


Up to 4 Face to Face meetings if needed


	
STATISTICAL ANALYSIS/MEDICAL WRITING


	
Number of Statistical Analyses

	
19


	
Number of Unique


Tables/Listings/Figures for Final


Analysis

	
14 Unique Tables / 38 Listings / 36 Figures


	
Number Replicate Tables for


Final Analysis

	
20 Replicate Tables


	
Import of Biomarker, PK, ECG


and Imaging data

	
2 transfers for each data type


	
Final Deliverable

	
Final Analysis Sets and Clinical Study Report


	  	  
	
AUDIT SERVICES


	
Number of Countries

	
2 (USA & Australia)


	
Number of Audits

	
2 X GCP Audit & 1 X Vendor Audit


	
Travel Expense

	
The travel cost and travel time will depend upon the


location of sites and external service provider selected.







 



	
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ACTIVITY

	
Prana

	
INC


Research


	
1.

	
Pre-Trial Regulatory Filing/Country Level

	  	  
	
1.1

	
Compile relevant regulatory documents

	
X

	  
	
1.2

	
Obtain regulatory approval

	
X

	  
	
1.3

	
Answer regulatory queries

	
X

	  
	
1.4

	
Manage interactions with regulatory authorities

	
X

	  
	
2.

	
Study Documents Preparation/Study Docs

	  	  
	
2.1

	
Design Study

	
X

	  
	
3.

	
Protocol Versions

	  	  
	
3.1

	
Write protocol

	
X

	  
	
3.2

	
QC approved protocol

	
X

	  
	
3.3

	
Print final protocol copies in English

	
X

	  
	
3.4

	
Final protocol translations and certification

	
X

	  
	
3.5

	
Printing of translation of protocol

	
X

	  
	
4.

	
Study Guide Versions

	  	  
	
4.1

	
Prepare study procedures manual

	
X

	  
	
4.2

	
Print study procedures manual

	
X

	  
	
5.

	
Investigator Brochure & Study Aids

	  	  
	
5.1

	
Prepare Clinical Investigator Brochure

	
X

	  
	
5.2

	
Print Clinical Investigator Brochure

	
X

	  
	
5.3

	
Prepare study aids

	
X

	  
	
5.4

	
Print study aids

	
X

	  
	
6.

	
Informed Consent Form

	  	  
	
6.1

	
Write template Participant Information Sheet (PIS) and Informed Consent Form (CF)

	
X

	  
	
6.2

	
Review site specific PIS and ICF

	
X

	  
	
6.3

	
Translations of PIS and ICF

	
X

	  
	
7.

	
Participant Diaries


Pre-Study Preparation and Recruitment/Study

	  	  
	
7.1

	
Design and finalise diary cards or equivalent

	
X

	  





 



	
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7.2

	
Translate diary cards

	
X

	  
	
7.3

	
Print diary cards

	
X

	  
	
7.4

	
Site/Sponsor Trial Master File organisation

	
X

	  
	
7.5

	
Prepare study site files

	
X

	  
	
7.6

	
Print study site files

	
X

	  
	
8.

	
Evaluation Visits

	  	  
	
8.1

	
Identify trial sites

	
X

	  
	
8.2

	
Select Site investigators

	
X

	  
	
8.3

	
Evaluate trial site

	
X

	  
	
8.4

	
Prepare and finalise confidentiality agreement for investigators

	
X

	  
	
8.5

	
Pre-study visits

	
X

	  
	
9.

	
Negotiation Visits

	  	  
	
9.1

	
Prepare, negotiate and execute site contractual agreement and budget.

	
X

	  
	
10.

	
Ethics

	  	  
	
10.1

	
Preparation/Co-ordination of IEC/IRB submission

	
X

	  
	
10.2

	
Investigator/Patient indemnity agreement

	
X

	  
	
10.3

	
Obtain Local IEC/IRB approval

	
X

	  
	
10.4

	
Pay Ethics Committee

	
X

	  
	
11.

	
Investigator Meetings

	  	  
	
11.1

	
Planning/ Administration of Investigator Meetings

	
X

	  
	
11.2

	
Prepare Investigator Meetings Binders/ materials

	
X

	  
	
11.3

	
Attendance/Input at Investigator Meetings

	
X

	  
	
11.4

	
Train Investigator and Site Personnel

	
X

	  
	
12.

	
CRO Training/Trainings

	  	  
	
12.1

	
Administration and responsibility for monitor training (SOP, protocol, IMP)

	
X

	  
	
12.2

	
Attendance/input for monitor training

	
X

	  
	
13.

	
Project Management

	  	  
	
13.1

	
Administer and track site payments

	
X

	  
	
13.2

	
Collect pre-study documents e.g. 1572s, CVs, IEC/IRB approvals

	
X

	  
	
13.3

	
Development & maintenance of project databases

	
X

	  





 



	
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13.4

	
Preparation of status reports

	
X

	  
	
13.5

	
PM Meetings & telephone contacts with Prana

	  	
X


	
13.6

	
Establishment & maintenance of project files -statistical & CSR only

	  	
X


	
13.7

	
Periodic budget & contract review

	
X

	
X


	
14.

	
Safety/ Pharmacovigilance

	  	  
	
14.1

	
24/7 Medical Monitor Hotline

	
X

	  
	
14.2

	
Generate data for Annual Safety Report (if applicable)

	
X

	  
	
15.

	
Central Laboratory

	  	  
	
15.1

	
Identification of Central Laboratories

	
X

	  
	
15.2

	
Pre-Qualification Audit of Central Laboratories

	
X

	  
	
15.3

	
Selection of Central Laboratories

	
X

	  
	
15.4

	
Payment of Central Laboratories

	
X

	  
	
15.5

	
Management of Central Laboratories

	
X

	  
	
15.6

	
Organise Project Teleconferences

	
X

	  
	
15.7

	
Provide status reports

	
X

	  
	
15.8

	
Review of clinical laboratory data

	
X

	  
	
15.9

	
Lab Data transfer to study database

	
X

	  
	
16.

	
Audits

	  	  
	
16.1

	
Conduct of GCP audit

	  	
X


	
16.2

	
QA site audits (as per audit plan)

	  	
X


	
16.3

	
Final QA audit of report, database, sites (if required) and systems

	  	
X


	
17.

	
Site Initiation Visits/Initiation Days

	  	  
	
17.1

	
Conduct site initiation visits & provide written reports

	
X

	  
	
18.

	
Site Monitoring/Monitor Days

	  	  
	
18.1

	
Monitor sites regularly (per GCP)

	
X

	  
	
18.2

	
Source data verification (SDV) of CRFs

	
X

	  
	
18.3

	
Provide written monitoring reports

	
X

	  
	
18.4

	
Review Monitoring Visit Reports

	
X

	  
	
18.5

	
Perform Drug/Accountability at Site

	
X

	  
	
19.

	
Site Close-Out

	  	  
	
19.1

	
Perform final drug accountability

	
X

	  
	
19.2

	
Disposal of unused supplies

	
X

	  





 



	
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19.3

	
Conduct site close-out visit & provide written reports

	
X

	  
	
20.

	
Site management/Site Months

	  	  
	
20.1

	
Telephone sites as required

	
X

	  
	
20.2

	
Shipment and tracking of completed CRFs to Data Management (if applicable)

	
X

	  
	
20.3

	
Provide status reports

	
X

	  
	
21.

	
IMP Packaging and Distribution/Completed Pts

	  	  
	
21.1

	
Supply IMP to Clinical Trial Supply ESP

	
X

	  
	
21.2

	
Source and supply of ancillary clinical trial supplies

	
X

	  
	
21.3

	
Shipment and co-ordination of IMP to sites

	
X

	  
	
21.4

	
Drug tracking: Sponsor → Sites → Destruction

	
X

	  
	
22.

	
Case Report Form

	  	  
	
22.1

	
Select EDC Vendor

	
X

	  
	
22.2

	
Design of eCRF

	
X

	  
	
22.3

	
QC approval of eCRF

	
X

	  
	
22.4

	
QA approved eCRF

	
X

	  
	
22.5

	
Print eCRFs in English (If applicable)

	
X

	  
	
22.6

	
Translation of eCRFs

	
X

	  
	
22.7

	
Prepare eCRF Instruction Manual

	
X

	  
	
23.

	
Date Clean-Up/eCRF Pages

	  	  
	
23.1

	
Issue CRF Queries

	
X

	  
	
25.

	
Data Management

	  	  
	
25.1

	
Data entry

	
X

	  
	
25.2

	
Medical coding (MedDRA & WHO)

	
X

	  
	
25.3

	
Data Validation: CRF pre-entry review

	
X

	  
	
25.4

	
Data Validation: Running validation programs

	
X

	  
	
25.5

	
Data Validation: Query resolution, handling, editing

	
X

	  
	
25.6

	
Data QC/Report

	
X

	  
	
25.7

	
Reconciliation of SAEs

	
X

	  
	
25.8

	
Transfer Laboratory Data

	
X

	
X


	
25.9

	
Database lock

	
X

	  
	
26.

	
Statistics

	  	  





 



	
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26.1

	
Statistical input into study design

	
X

	  
	
26.2

	
Prepare and finalise Statistical Analysis Plan

	  	
X


	
26.3

	
Perform statistical analysis

	  	
X


	
26.4

	
Prepare statistical text for inclusion in the Clinical study report

	  	
X


	
26.5

	
QA checks of statistical text

	  	
X


	
27.

	
Clinical Study Report

	  	  
	
27.1

	
Approval of Style Manual for Clinical Study Report

	
X

	  
	
27.2

	
Prepare ICH format Clinical Study Report

	  	
X


	
27.4

	
Validation of any data conversion

	  	
X


	
27.5

	
Validation of data transfer

	  	
X


	
27.6

	
Review of CSR drafts (x2)

	
X

	
X


	
27.7

	
Provide final copy of ICH format Clinical Study Report (Word & PDF), including all appendices

	  	
X


	
27.8

	
QC of Clinical Study report

	  	
X


	
28.

	
Archiving

	  	  
	
28.1

	
Assistance with archiving of Investigator Study file if required.

	  	
X


	
28.2

	
Database – final archiving

	
X

	  





 



	
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ATTACHMENT B


Project Schedule


 



	
Timelines


	
Start Date

	
End Date


	
1st January 2013

	
1st January 2014


	
Total - 12 Months







 



	
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ATTACHMENT C


Project Budget and Payment Schedule


 



	
Total Cost Summary (AUD)


	
Direct Costs

	
$ 173,754.00


	
Pass-Through Costs

	
$ 2,310.00


	
TOTAL PROJECT COST

	
$ 176,064.00







 


Goods and Services Tax (GST)


 


In Australia all goods and services are subject to GST of 10%. Unless otherwise specified, fees are expressed as exclusive of Goods and Services Tax (GST). Where fees are GST exclusive and INC Research is liable to pay GST in respect of any Services provided pursuant to this Agreement, INC Research may add the GST amount to invoices provide to Sponsor for the Services. Provided that the relevant invoice complies with the requirements of a tax invoice to enable Sponsor to claim a credit or refund of GST, Sponsor shall pay the GST amount at the same time and in the same manner as other amounts invoiced under this Agreement.


 


Where the services are directly contracted by an overseas Sponsor GST will not be applicable.


 


Project Costs and Payment Schedule


 


INC Research’s study budget includes inflation for annual wage/earnings increases at a rate of three percent (3%). If a subsequent change in scope necessitates a revision to the study timeline, any inflationary adjustment will be delineated in applicable invoices as a separate line item rather than embedded in the affected unit price.


 


All services will be invoiced on a unit basis as per the proposed direct cost estimate budget.


 


Upon execution of this Work Order, Sponsor shall make a payment of AUD $34,302.00 (20% of the total direct costs). Thereafter, INC Research will invoice Sponsor on a monthly basis for actual units completed and reconciled at the end of the study.


 


If services requirement exceeding those specified in the cost estimate are required then written approval will be obtained from the Sponsor before conducting the additional services.



	  	  	  
	
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Indirect costs will be invoiced separately on a monthly basis.


 


As some of the study pass-through expenses may be incurred in a currency other than AUD, pass-through expenses will be invoiced to Sponsor in AUD based upon actual invoices, and subject to the exchange rate published in oanda.com at the spot rate on the day the expense is invoiced by INC Research.


 


INC Research shall provide Sponsor with itemized invoicing of all expenses and fees. Undisputed invoices are payable within 30 days of date of Sponsor’s receipt of invoice as per MSA clause 12.



	  	  	  
	
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Direct Costs


 



	
Service/Item

	 	
Comments

	 	
Responsibility

	 	
Unit

	 	
Unit 

Cost 

(AUD)

	 	
Number 

of Units

	 	
Item

Cost

	 	
ALD$


	
Data Management & Statistics

	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	
Project familiarization

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

	 	
Clinical Programmer

	 	
1hr

	 	
108

	 	
16.00

	 	
1,728

	 	  
	
HSG Meeting (USA)

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

	 	  	 	
40hrs per person

	 	
8000

	 	
2.00

	 	
16,000

	 	  
	
Database design

	 	
Review annotated CRF and database specification documentations

	 	
Clinical Programmer

	 	
0.5hr/dataset

	 	
30

	 	
25.00

	 	
750

	 	  
	
Data Validation Manual

	 	
Review DVM text/data management plan specifying edit checks

	 	
CDA

	 	
40hrs

	 	
104

	 	
16.00

	 	
1,664

	 	  
	
Import BM, PK, ECG and immunology data

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

	 	
DBA

	 	
1 lab source

	 	
1122

	 	
4.00

	 	
4,488

	 	  
	
Statistical Analysis Plan (SAP)

	 	
Includes text and table and listing shells

	 	
Statistician

	 	
1 SAP

	 	
9426

	 	
1.00

	 	
9,426

	 	  
	
Identify Protocol Deviations and define Analysis populations

	 	
Unblinding, Protocol deviations and Definition of populations

	 	
Statistician

	 	
I study

	 	
1600

	 	
1.00

	 	
1,600

	 	  
	
Analysis Datasets

	 	
Specification, Programming & QC

	 	
SAS Programmer

	 	
1 study

	 	
21294

	 	
1.00

	 	
21,294

	 	  





 



	
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Service/Item

	 	
Comments

	 	
Responsibility

	 	
Unit

	 	
Unit 

Cost 

(AUD)

	 	
Number 

of Units

	 	
Item


Cost

	 	
AUD$


	
Production of Tables & Listings

	 	
14 Unique tables. Cost per extra $1014 20 Repeat tables. Cost per extra $338 36 Figures, Cost per extra $592 38 Listings. Cost per extra $422

	 	
SAS Programmer

	 	
1 study

	 	
52221

	 	
1.00

	 	
52,221

	 	  
	
Statistical Analysis

	 	
19 analysis endpoints. Cost per extra $424

	 	
Statistician

	 	
1 analysis endpoint

	 	
424

	 	
19.00

	 	
8,056

	 	  
	
Input to Final report

	 	
Text for inclusion in study report

	 	
Statistician

	 	
1 Study

	 	
5088

	 	
1.00

	 	
5,088

	 	  
	
Unit based Data Management Costs

	 	
Program consistency check

	 	
Clinical Programmer

	 	
1 check

	 	
60

	 	
1.00

	 	
60

	 	  
	
Unit based Data Management Costs

	 	
Raise manual data query

	 	
CDA

	 	
1 query

	 	
52

	 	
1.00

	 	
52

	 	  
	  	 	  	 	  	 	  	 	  	 	  	 	
Subtotal

	 	
$122,427


	
Medical Writing

	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	
Clinical Study Report (CSR)

	 	  	 	
Medical Writer

	 	
per CSR

	 	
25418

	 	
1.00

	 	
25,418

	 	  
	  	 	  	 	  	 	  	 	  	 	  	 	
Subtotal

	 	
$25,418


	
Quality Assurance -Site Audits

	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	
Quality Assurance Site Audits

	 	
GCP Audits preparation time

	 	
QAA

	 	
Site Audit

	 	
1314

	 	
2.00

	 	
2,628

	 	  
	  	 	
GCP Audits on-site

	 	
QAA

	 	
Site Audit

	 	
2628

	 	
2.00

	 	
5,255

	 	  
	  	 	
GCP Audits report preparation

	 	
QAA

	 	
Site Audit

	 	
1971

	 	
2.00

	 	
3,941

	 	  
	  	 	
GCP Audits travel time

	 	
QAA

	 	
Site Audit

	 	
1570

	 	
2.00

	 	
3,140

	 	  
	  	 	
Review of Audit reports

	 	
QAA

	 	
Site Audit

	 	
443

	 	
2.00

	 	
886

	 	  
	
QA Audit of Vendor(s)

	 	  	 	
QAA

	 	
Audit

	 	
10059

	 	
1.00

	 	
10,059

	 	  
	  	 	  	 	  	 	  	 	  	 	  	 	
Subtotal

	 	
$25,909


	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  
	  	 	  	 	  	 	  	 	  	 	  	 	
TOTAL

	 	
$173,754







 



	
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Pass-Through Costs


 



	
Expense/Item

	 	
Comments

	 	
Unit Cost 

(AUD)

	 	
Number 

of Units

	 	
Item 

Cost 

AUD$

	 	
AUD$


	
Site Visits

	 	  	 	  	 	  	 	  	 	  
	
Travel Costs (flights/accommodation/taxis)

	 	  	 	
$l,155/visit

	 	
2

	 	
2,310

	 	  
	  	 	  	 	  	 	  	 	
Subtotal

	 	
$2,310


	  	 	  	 	  	 	  	 	  	 	  
	  	 	  	 	  	 	  	 	
TOTAL

	 	
$2,310







 



	
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Change Orders/Changes in Scope


 


INC Research's participation in this study is based upon the parameters outlined in Attachment A - Services and Attachment B - Project Schedule. Unless otherwise specified in this Work Order, all study Services will be performed under the INC Research Standard Operating Procedures (SOPs). If the scope of the study varies from these study parameters, a Contract Modification (CM) may be necessary. A CM may be due to, but is not limited to, the following project specific situations that change the study parameters (i.e., timeline , number of subjects or sites) or the scope of work (i.e., additional services; tasks for current services; or costs for current services are modified). These changes in scope may modify the time or costs (direct or indirect) required to complete the study. Requests to engage additional contractors or to incur additional costs with existing contractors engaged by INC Research are considered changes in scope. Accordingly, negotiating efforts to secure confidentiality agreements and service agreements with newly engaged contractors are also considered changes in scope.


 


Once a CM is identified, INC Research will log the out-of-scope activities in a Change Order Log and obtain written acknowledgement from the Sponsor confirming the scope of the possible CM. Once the out-of-scope services reach an estimated 3% of direct project costs (or $10,000, whichever is reached first), a Change Notification Form (CNF) will be submitted to the Sponsor for verification of the project change and to determine if INC Research should wait to begin out-of-scope trial activities or continue while good faith negotiations move towards an executed Change Order (CO).


 


A CO shall be completed once the following threshold amount is reached (which is based on the original contract value of the study).


 


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


o    $300,000 threshold if contract value is over $3,000,000.


 


If out of scope activities do not reach the threshold amount for longer than 180 days since the first CNF or particular CO was initiated, then a CO shall be issued once the time threshold is reached.


 


If out of scope activities do not reach the value or time thresholds prior to end of study, then a CO shall be issued and signed by Sponsor prior to release of the final project deliverable.


 








1 An increase in the study timeline may increase the inflation calculation. Change orders will only address an increase in costs due to inflation for uncompleted activities if the study timeline is pushed into a new calendar year


 



	
INCResearch Australia Pty Limited - 1002213

	  	  
	
Prana Biotechnology Limited Work Order, Version 3, 30th January 2013

	  	
 







 


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