WORK ORDER INC Research Project # 1000504 Protocol # PBT2-203
Exhibit 4.26
WORK ORDER
INC Research Project # 1000504
Protocol # PBT2-203
This Work Order (hereinafter “Work Order”) is between Prana Biotechnology Limited (hereinafter “Sponsor”) with principal offices located at 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 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.
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1.
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SERVICES: INC Research will render such services (hereinafter “Services”) as may be necessary to complete in a professional manner the project described below:
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A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability, and Efficacy of PBT2 in Patients with Early to Mid-stage Huntington Disease (#PBT2-203)
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INC Research will perform the Services as specified in Attachment A to this Work Order.
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2.
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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.
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3.
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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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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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4.
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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.
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If to Sponsor:
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Xxxxxxxx Xxxx
Chief Development Consultant
Prana Biotechnology Limited Xxxxx 0 000 Xxxxx Xxxxxx
Xxxxxxxxx XXX 0000 Xxxxxxxxx
Phone: x00 (0) 0 0000 0000
Facsimile: x00 (0) 0 0000 0000
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If to INC Research:
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For Communications:
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Contracts Management
INCResearch Australia Pty Limited
000 Xxxxxx Xxxxxx Xxxx Xxxxxxxx XX 0000 Xxxxxxxxx
Phone: x00 (0) 0 0000 0000
Facsimile: x00 (0) 0 0000 0000
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For Payments (Via Wire):
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Beneficiary Bank:
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Bank of South Australia (A Division of
St Xxxxxx Bank Limited) |
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Account Name:
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INCResearch Australia Pty Limited
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BSB (Routing Number):
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Account Number:
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Swift:
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5.
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TRANSFER OF OBLIGATIONS: Sponsor assigns the responsibilities pertaining to the Study to INC Research as indicated in Attachment A, Services.
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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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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
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By:
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Name:
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Xxxxxx Xxxxx |
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Title:
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Chief Operating Officer
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Date:
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6th August 2012
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INCResearch Australia Pty Limited
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By:
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Name:
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Xxxxx Xxxxxxx
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Title:
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Regional General Manager, Australia and South East Asia
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Date:
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14th August 2012.
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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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ATTACHMENT A
Services
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DETAILED ASSUMPTIONS
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GENERAL
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DRUG NAME
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PBT2
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INDICATION
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Huntington Disease
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XXXXX
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0x
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XXXXX
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XXXXXX XX XXXXXXXXX
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0 - Xxxxxxxxx
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NUMBER OF SITES
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5
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NUMBER OF APPLICABLE LANGUAGES
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1 - English
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CASE REPORT FORM (CRF)
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PAPER OR ELECTRONIC CRF
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eCRF
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NUMBER OF PAGES PER ENROLLED PATIENT
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70
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TOTAL PAGES
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2,100
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INVESTIGATOR MEETING
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NUMBER OF MEETING(S)
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1 - Melbourne
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DURATION OF MEETING(S)
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1.5 days
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•
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NUMBER OF SITE ATTENDEES
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3 attendees per site (15 total site attendees)
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•
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NUMBER OF CUSTOMER ATTENDEES
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5
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•
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NUMBER OF INC RESEARCH ATTENDEES
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2 CRAs + 1 PM
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SITE MONITORING
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NUMBER OF CRAs
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3 - based in Sydney, Melbourne and Perth
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NUMBER OF INITIATION VISITS
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5
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NUMBER OF MONITORING VISITS
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25 one-day visits - 5 visits/site
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NUMBER OF CLOSEOUT VISITS
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5
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PHARMACOVIGILANCE (SAFETY)
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NUMBER OF SERIOUS ADVERSE EVENTS (SAEs)
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Assume 1
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NUMBER OF REPORTABLE SAEs
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Assume 1
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NUMBER OF SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS
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1
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NUMBER OF SAEs REPORTING TO LOCAL REGULATORY AUTHORITY
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1
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PROJECT MANAGEMENT
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NUMBER OF CUSTOMER TELECONFERENCES
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21
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•
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FREQUENCY OF TELECONFERENCES
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Monthly
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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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DETAILED ASSUMPTIONS
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•
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DURATION OF TELECONFERENCES
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1 hour
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•
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TELECONFERENCE ATTENDEES
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Project Manager
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ACTIVITY
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Prana
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INCResearch
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Study Start-up Activities
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Study Sponsorship - Australia
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ü
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Protocol Development
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ü
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Approval and Authorisation of Final Protocol
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ü
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Patient Information Sheet & Consent Template Development
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ü
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Creation of Study Manual/Monitoring Guidelines
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ü
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List Trial on Public Register e.g. ANZCTR, Xxxxxxxxxxxxxx.xxx
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ü
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Conduct Internal Team Kick-Off Meeting
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ü
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Investigator/Site Identification
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ü
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Approval of Final Investigator’s/Sites
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ü
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Finalise Clinical Trial Agreements
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ü
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Creation and Collection of Essential Documents
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ü
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Conduct Pre-study/Site Qualification Visits
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ü
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Complete Ethics Submissions and Follow-up
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ü
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Respond to Issues Raised by the Ethics Committee
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ü
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Regulatory Submissions
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ü
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Import/Export Permit Handling
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ü
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Customer Project Team Meetings
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Attend Project Team Meeting
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ü
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ü
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Organise Project Team Meeting
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ü
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Investigator’s Meeting
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Attend Investigator’s Meeting
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ü
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ü
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Present at Investigator’s Meeting
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ü
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Organise Investigator’s Meeting
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ü
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Investigational Product (IP)
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IP Packaging and Labelling
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ü
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IP Storage
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ü
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IP Distribution
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ü
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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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ACTIVITY
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Prana
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INCResearch
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IP Accountability
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ü
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IP Destruction
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ü
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Site Visits
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Site Initiation Visits
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ü
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Monitoring Visits
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ü
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Close-out Visits
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ü
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Completion of Visit Reports
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ü
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Site Management
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Site Management
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ü
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Project Management
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Project Management (Local)
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ü
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Project Tool Development
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ü
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Create Master Study Files
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ü
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Maintenance of Master Study Files During Study
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ü
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Create Investigator In-house and Site Study Files
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ü
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Maintain In-house Investigator Study Files During Study
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ü
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Manage and Make Payments to Investigators/Sites
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ü
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Archiving of Study Files Post-study
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ü
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Safety Reporting & Medical Monitoring
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Handling of SAEs (notification)
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ü
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Medical Review of SAEs & Narrative Creation
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ü
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Reporting to Local Regulatory Authority
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ü
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Follow-up of SAEs
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ü
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Creation and Distribution of Investigator Notification Letters
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ü
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Medical Monitoring
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ü
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Safety Management Plan (review)
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ü
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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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ATTACHMENT B
Project Schedule
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Project Timeline/Activities
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Project Milestones
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Duration
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Start Date
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End Date
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Pre-Study Period
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3 Months
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1-Mar-12
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31-May-12
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Enrolment Period
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8 Months
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1-Jun-12
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31-Dec-12
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Treatment Period
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8 Months
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1-Jan-13
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30-Sep-13
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Close-out Period
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2 Months
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1-Oct-13
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30-Nov-13
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Total Study Duration
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21 Months
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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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ATTACHMENT C
Project Budget and Payment Schedule
Goods and Services Tax (GST)
In Australia all goods and services are subject to GST of 10%. Unless otherwise specified, fees are expressed as exclusive of Goods and Services Tax (GST). Where fees are GST exclusive and INC Research is liable to pay GST in respect of any Services provided pursuant to this Agreement, INC Research may add the GST amount to invoices provide to Sponsor for the Services. Provided that the relevant invoice complies with the requirements of a tax invoice to enable Sponsor to claim a credit or refund of GST, Sponsor shall pay the GST amount at the same time and in the same manner as other amounts invoiced under this Agreement.
Where the services are directly contracted by an overseas Sponsor GST will not be applicable.
Project Costs and Payment Schedule
The project budget has been provided in AUD. This will also be the prime currency for invoicing and payment on this project.
All clinical services will be invoiced on a unit basis as per the proposed direct cost estimate budget.
Upon execution of this Work Order, Sponsor shall make a payment of $58,338.40 (20% of the total direct costs). Thereafter, INC Research will invoice Sponsor on a monthly basis for actual units completed and reconciled at the end of the study.
If services requirement exceeding those specified in the cost estimate are required then written approval will be obtained from the Sponsor before conducting the additional services.
All professional services have been adjusted to take into account standard fee reviews that would occur over the period of the trial. If the timelines extend beyond the period estimated then INC Research may increase fees beyond the period stated.
Indirect costs will be invoiced separately on a monthly basis.
INC Research shall provide Sponsor with itemized invoicing of all expenses and fees. Undisputed invoices are payable within 30 days of date of Sponsor’s receipt of invoice as per MSA clause 12.
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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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DIRECT COSTS
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Service/Item
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Comments
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Responsibility
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Unit
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Unit Cost (AUD)
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Number
of Units |
Item Cost
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AUD$
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|||||||
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Study Start Up Activities
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||||||||||||||
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Study Training/Internal Kick Off Meeting
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Familiarisation, Protocol, IB
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CRA
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per CRA
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1123
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3.00
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3,370
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Study Training/Internal Kick Off Meeting
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Familiarisation, Protocol, IB
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PM
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per PM
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1290
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1.00
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1,290
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Essential Document Collection
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Creation, Collection and Tracking
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CRA
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per site
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1123
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5.00
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5,616
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Study Files
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Set-up of Study Master Files and Investigator Site Files
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PA
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per study
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749
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1.00
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749
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CRA Administration (March 2012 - May 2012)
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Communications - Customer, Site, Project Manager
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CRA
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per month
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3019
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3.00
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9,056
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Subtotal
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$20,080
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Customer Project Team Meetings
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||||||||||||||
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Customer Kick-off Meeting
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Teleconference
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PM
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per PM
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322
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1.00
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322
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Sponsor Teleconference Participation
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21 x 1 hour Telecon
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PM
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per telecon
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165
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21.00
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3,456
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||||||||
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Subtotal
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$3,778
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|||||||||||||
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Investigator’s/Monitor’s meeting
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||||||||||||||
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Travel Time
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4 hours Return
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PM
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per PM
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645
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1.00
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645
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Travel Time
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8 hours Return
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CRA
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per CRA
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1123
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1.00
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1,123
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||||||||
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Attendance
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Assume 1.5 day Meeting, 1 PM
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PM
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per PM
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1934
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1.00
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1,934
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||||||||
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Attendance
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Assume 1.5 day Meeting, 2 CRAs
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CRA
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per CRA
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1685
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2.00
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3,370
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||||||||
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Subtotal
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$7,072
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|||||||||||||
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Site Visits
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||||||||||||||
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Study Initiation
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Includes Preparation, Travel, Time On-site, Reporting and Follow-up
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CRA
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per visit
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1404
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5.00
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7,020
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Monitoring Visits (1 Day Visits)
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Including Preparation, Travel, 1 day On-site, Reporting and Follow-up 5 Visits/Site
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CRA
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per visit
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1579
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25.00
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39,478
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Closeout Visits
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Includes Preparation, Travel, Time On-site, Reporting and Follow-up
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CRA
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per visit
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1752
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5.00
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8,761
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Subtotal
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$55,258
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|||||||||||||
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Site Management
|
||||||||||||||
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Site Management (June 2012 • September 2013)
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per Month
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CRA
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per month
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3086
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16.00
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49,383
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||||||||
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Site Management (October 2013 • November 2013)
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per Month
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CRA
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per month
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1460
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2.00
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2,920
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||||||||
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Subtotal
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$52,303
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|||||||||||||
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Project Management
|
||||||||||||||
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Local Coordination/Supervision (March 2012 • May 2012)
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per Month
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PM
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per month
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5158
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3.00
|
15,475
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||||||||
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Local Coordination/Supervision (June 2012 • September 2013)
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per Month
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PM
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per month
|
3296
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16.00
|
52,743
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||||||||
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Local Coordination/Supervision (October 2013 - November 2013)
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per Month
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PM
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per month
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3353
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2.00
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6,706
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||||||||
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Project Assistance (March 2012 • November 2013)
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per Month
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PA
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per rronth
|
2054
|
21.00
|
43,144
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||||||||
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Subtotal
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$118,068
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|||||||||||||
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Safety Monitoring
|
||||||||||||||
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Safety Administration
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Includes Set-up, Maintenance and Completion Activities
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Safety Officer
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per study
|
4597
|
1.00
|
4,597
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||||||||
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Handling of SAEs (Notifications)
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All Events - Assume 1 SAE
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Safety Officer
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per SAE
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330
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1.00
|
330
|
||||||||
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Medical Review of SAEs and Narrative Creation
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All Events - Assume 1 SAE
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Medical Monitor
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per SAE
|
851
|
1.00
|
851
|
||||||||
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Reporting to Local Authorities
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Assume 1 Reportable Event
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Safety Officer
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per SAE
|
659
|
1.00
|
659
|
||||||||
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Safety Management Plan (review)
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Safety Officer
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per study
|
659
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1.00
|
659
|
|||||||||
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Teleconference
|
Assume 1 hour teleconference
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Safety Officer
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per telecon
|
165
|
1.00
|
165
|
||||||||
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Subtotal
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$7,261
|
|||||||||||||
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TOTAL
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$263,821
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INCResearch Australia Pty Limited
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Prana Work Order 1000504 v4 3rd August 2012
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INDIRECT COSTS
|
Expense/Item
|
Comments
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Unit Cost
|
Number
of Units
|
Item Cost
AUD$
|
AUD$
|
|||||
|
Investigator’s/Monitor’s Meeting Attendance
|
||||||||||
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Travel/Attendance Costs
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Airfares, accommodation & meals provided by Client, $500 - taxis, currency exchange, meals in transit, phone
|
$500/person
|
2
|
1,000
|
||||||
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Subtotal
|
$1,000
|
|||||||||
|
Site Visits
|
||||||||||
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Other Site visit Costs
|
Parking/tolls/meals and incidentals for site visits
|
$50/day
|
35
|
1,750
|
||||||
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Subtotal
|
$1,750
|
|||||||||
|
General Expenses
|
||||||||||
|
Couriers, Express Post, Teleconferences
|
$7,000
|
1
|
7,000 |
|
||||||
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Copying (Excluding ethics submissions), postage, telecommunications (excluding teleconferences), stationery (files)
|
$70/site/month, 5 sites for 21 months
|
$350/month
|
21
|
7,350
|
||||||
|
Subtotal
|
$14,350
|
|||||||||
|
TOTAL
|
$17,100
|
|
INCResearch Australia Pty Limited
|
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Prana Work Order 1000504 v4 3rd August 2012
|
Change Orders/Changes in Scope
INC Research’s participation in this study is based upon the parameters outlined in Attachment A – Services and Attachment B – Project Schedule. Unless otherwise specified in this Work Order, all study Services will be performed under the INC Research Standard Operating Procedures (SOPs). If the scope of the study varies from these study parameters, a Contract Modification (CM) may be necessary. A CM may be due to, but is not limited to, the following project specific situations that change the study parameters (i.e., timeline1, number of subjects or sites) or the scope of work (i.e., additional services; tasks for current services; or costs for current services are modified). These changes in scope may modify the time or costs (direct or indirect) required to complete the study. Requests to engage additional contractors or to incur additional costs with existing contractors engaged by INC Research are considered changes in scope. Accordingly, negotiating efforts to secure confidentiality agreements and service agreements with newly engaged contractors are also considered changes in scope.
Once a CM is identified, INC Research will log the out-of-scope activities in a Change Order Log and obtain written acknowledgement from the Sponsor confirming the scope of the possible CM. Once the out-of-scope services reach an estimated 3% of direct project costs (or $10,000, whichever is reached first), a Change Notification Form (CNF) will be submitted to the Sponsor for verification of the project change and to determine if INC Research should wait to begin out-of-scope trial activities or continue while good faith negotiations move towards an executed Change Order (CO).
A CO shall be completed once the following threshold amount is reached (which is based on the original contract value of the study).
|
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
|
|
Prana Work Order 1000504 v4 3rd August 2012
|
CHANGE ORDER N°1 to Work Order #1000504
This Change Order number 1 to Work Order #1000504 (hereinafter “Change Order”) is made and entered into as of the date of last signature (hereinafter “Effective Date”) by and between Prana Biotechnology Limited (hereinafter “Sponsor”) with an office located at 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 principal offices located at 000 Xxxxxx Xxxxxx, Xxxx Xxxxxxxx XX 0000, Xxxxxxxxx.
RECITALS
WHEREAS, Sponsor and INC Research have entered into Work Order #1000504 (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 14th August 2012, and
WHEREAS, during the course of the performance of the Study, Sponsor and INC Research have identified changes in assumptions; and
WHEREAS, Sponsor desires to retain additional services from INC Research and INC Research desires to supply such services to Sponsor under the terms and conditions set forth herein; and
WHEREAS, Sponsor and INC Research agree that all other terms and conditions of the Agreement shall remain in full force and effect, unless specifically agreed otherwise in this Change Order; and
WHEREAS, Sponsor and INC Research agree that the services and costs covered by this Change Order are additional to the services and costs covered by the Agreement;
NOW THEREFORE, subject to the terms, conditions and covenants hereinafter set forth, INC Research and Sponsor agree as follows:
SECTION I: CHANGES IN SCOPE
This section contains an overview of the changes in assumptions, timelines, and revision in Scope of services. In summary, this Change Order mainly reflects the following changes:
Direct Costs
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●
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Addition of seven (7) x One Day Monitoring Visits, to be invoiced only if required.
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●
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Addition of eight (8) x Two Day Monitoring Visits, to be invoiced only if required.
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●
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Addition of one (1) x Four Day Monitoring Visit.
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●
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Addition of nine (9) x Serious Adverse Events (SAE) Notifications, to be invoiced only if required.
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●
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Addition of four (4) x Reporting to Local Authorities of SAEs, to be invoiced only if required.
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●
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Addition of 6 Monthly Suspected Unexpected Serious Adverse Reaction (SUSAR) Line Listings time for Safety Officer, to be invoiced only if required.
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1000504
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Prana Change Order #1, v2, 10th April 2013
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Page 1 of 8
INC Research, LLC Change Order Form
Indirect Costs
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●
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Addition of twenty-seven (27) x Other Site Visit Costs.
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The parties hereby agree the total cost associated with this Change Order is AUD $48,505.00.
SECTION II: COSTS OVERVIEW
The additional deliverables and tasks performed by INC Research are specified in Attachment A. This Attachment includes an overview of the total prices of deliverables in the original agreement and previous change orders, and an overview of the additional total prices of the new deliverables and services. The total amount of all contracted deliverables (original agreement including all change orders) is shown in Attachment A.
A summary of both direct and indirect costs related to the original agreement and all changes in scope as occurred is provided in the table below:
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Effective Date
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Direct Costs
AUD$
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Indirect Costs
AUD$
|
Grand Total
AUD$
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|||||
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Original Contract
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14th August 2012
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$263,821.00
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$17,100.00
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$280,921.00
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||||
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Xxxxxx Xxxxx # 0
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Xxxx Xxxxxxxxx
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$47,155.00
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$1,350.00
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$48,505.00
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||||
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Total Contract Value
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$310,976.00
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$18,450.00
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$329,426.00
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1000504
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Prana Change Order #1, v2, 10th April 2013
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Page 2 of 8
Revised Direct Costs
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Service/Item
|
Comments
|
Responsibility
|
Unit
|
Unit
Cost
(AUD)
|
Original
Number
of Units
|
CO#1
Number
of Units
|
Original
Item
Cost
(AUD$)
|
CO#1
Item
Cost
(AUD$)
|
TOTAL
COST
AUD$
|
|||||||||
|
Study Start Up Activities
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||||||||||||||||||
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Study Training/Internal Kick Off Meeting
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Familiarisation, Protocol, IB
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CRA
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per CRA
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1123
|
3
|
0
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3,370
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0
|
||||||||||
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Study Training/Internal Kick Off Meeting
|
Familiarisation, Protocol, IB
|
PM
|
per PM
|
1290
|
1
|
0
|
1,290
|
0
|
||||||||||
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Essential Document Collection
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Creation, Collection and Tracking
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CRA
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per site
|
1123
|
5
|
0
|
5,616
|
0
|
||||||||||
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Study Files
|
Set-up of Study Master Files and Investigator Site Files
|
PA
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per study
|
749
|
1
|
0
|
749
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0
|
||||||||||
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CRA Administration (March 2012-May 2012)
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Communications - Customer, Site, Project Manager
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CRA
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per month
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3019
|
3
|
0
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9,056
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0
|
||||||||||
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Subtotal
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20,080
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0
|
$20,080
|
|||||||||||||||
|
Customer Project Team Meetings
|
||||||||||||||||||
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Customer Kick-off Meeting
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Teleconference
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PM
|
per PM
|
322
|
1
|
0
|
322
|
0
|
||||||||||
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Sponsor Teleconference Participation
|
21 x 1 hour Telecon
|
PM
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per telecon
|
165
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21
|
0
|
3,456
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0
|
||||||||||
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Subtotal
|
3,778
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0
|
$3,778
|
|||||||||||||||
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Investigator’s/Monitor’s meeting
|
||||||||||||||||||
|
Travel Time
|
4 hours Return
|
PM
|
per PM
|
645
|
1
|
0
|
645
|
0
|
||||||||||
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Travel Time
|
8 hours Return
|
CRA
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per CRA
|
1123
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1
|
0
|
1,123
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0
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1000504
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Prana Change Order #1, v2, 10th April 2013
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Page 3 of 8
INC Research, LLC Change Order Form
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Service/Item
|
Comments
|
Responsibility
|
Unit
|
Unit
Cost
(AUD)
|
Original
Number
of Units
|
CO#1
Number
of Units
|
Original
Item
Cost
(AUD$)
|
CO#1
Item
Cost
(AUD$)
|
TOTAL
COST
AUD$
|
|||||||||
|
Attendance
|
Assume 1.5 day Meeting, 1 PM
|
PM
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per PM
|
1934
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1
|
0
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1,934
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0
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||||||||||
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Attendance
|
Assume 1.5 day Meeting, 2 CRAs
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CRA
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per CRA
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1685
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2
|
0
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3,370
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0
|
||||||||||
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Subtotal
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7,072
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0
|
$7,072
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|||||||||||||||
|
Site Visits
|
||||||||||||||||||
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Study Initiation
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Includes Preparation, Travel, Time On-site, Reporting and Follow-up
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CRA
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per visit
|
1404
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5
|
0
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7,020
|
0
|
||||||||||
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Monitoring Visits (1 Day Visits)
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Including Preparation, Travel, 1 day On-site, Reporting and Follow-up - only if required
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CRA
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per visit
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1579
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25
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7
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39,478
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11,054
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||||||||||
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Monitoring Visits (2 Day Visits)
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Including Preparation, Travel, 2 days On-site, Reporting and Follow-up - only if required
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CRA
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per visit
|
3015
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0
|
8
|
0
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24,117
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||||||||||
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Monitoring Visits (4 Day Visits)
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Including Preparation, Travel, 4 days On-site, Reporting and Follow-up
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CRA
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per visit
|
5886
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0
|
1
|
0
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5,886
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||||||||||
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Closeout Visits
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Includes Preparation, Travel, Time On-site, Reporting and Follow-up
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CRA
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per visit
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1752
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5
|
0
|
8,761
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0
|
||||||||||
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Subtotal
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55,258
|
41,057
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$96,315
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|||||||||||||||
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Site Management
|
||||||||||||||||||
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Site Management (June 2012 - September 2013)
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per Month
|
CRA
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per month
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3086
|
16
|
0
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49,383
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0
|
||||||||||
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Site Management (October 2013 - November 2013)
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per Month
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CRA
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per month
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1460
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2
|
0
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2,920
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0
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||||||||||
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Subtotal
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52,303
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0
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$52,303
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INC Research, LLC – CONFIDENTIAL
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INCResearch Australia Pty Limited - 1000504
|
|
Prana Change Order #1, v2, 10th April 2013
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Page 4 of 8
INC Research, LLC Change Order Form
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Service/Item
|
Comments
|
Responsibility
|
Unit
|
Unit
Cost
(AUD)
|
Original
Number
of Units
|
CO#1
Number
of Units
|
Original
Item
Cost
(AUD$)
|
CO#1
Item
Cost
(AUD$)
|
TOTAL
COST
AUD$
|
|||||||||
|
Project Management
|
||||||||||||||||||
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Local Coordination/Supervision (March 2012 - May 2012)
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per Month
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PM
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per month
|
5158
|
3
|
0
|
15,475
|
0
|
||||||||||
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Local Coordination/Supervision (June 2012 - September 2013)
|
per Month
|
PM
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per month
|
3296
|
16
|
0
|
52,743
|
0
|
||||||||||
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Local Coordination/Supervision (October 2013 - November 2013)
|
per Month
|
PM
|
per month
|
3353
|
2
|
0
|
6,706
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0
|
||||||||||
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Project Assistance (March 2012-November 2013)
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per Month
|
PA
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per month
|
2054
|
21
|
0
|
43,144
|
0
|
||||||||||
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Subtotal
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118,068
|
0
|
$118,068
|
|||||||||||||||
|
Safety Monitoring
|
||||||||||||||||||
|
Safety Administration
|
Includes Set-up, Maintenance and Completion Activities
|
Safety Officer
|
per study
|
4597
|
1
|
0
|
4,597
|
0
|
||||||||||
|
Handling of SAEs (Notifications)
|
All Events - Assume 10
|
Safety Officer
|
per SAE
|
330
|
1
|
9
|
330
|
2,967
|
||||||||||
|
Medical Review of SAEs and Narrative Creation
|
All Events - Assume 1 SAE
|
Medical Monitor
|
per SAE
|
851
|
1
|
0
|
851
|
0
|
||||||||||
|
Reporting to Local Authorities
|
All Events - Assume 5
|
Safety Officer
|
per SAE
|
659
|
1
|
4
|
659
|
2,637
|
||||||||||
|
6-Monthly SUSAR Line Listing
|
Preparation, distribute and tracking
|
Safety Officer
|
per study
|
494
|
0
|
1
|
0
|
494
|
||||||||||
|
Safety Management Plan (review)
|
Safety Officer
|
per study
|
659
|
1
|
0
|
659
|
0
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INC Research, LLC – CONFIDENTIAL
|
INCResearch Australia Pty Limited - 1000504
|
|
Prana Change Order #1, v2, 10th April 2013
|
Page 5 of 8
INC Research, LLC Change Order Form
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Service/Item
|
Comments
|
Responsibility
|
Unit
|
Unit
Cost
(AUD)
|
Original
Number
of Units
|
CO#1
Number
of Units
|
Original
Item
Cost
(AUD$)
|
CO#1
Item
Cost
(AUD$)
|
TOTAL
COST
AUD$
|
|||||||||
|
Teleconference
|
Assume 1 hour teleconference
|
Safety Officer
|
per telecon
|
165
|
1
|
0
|
165
|
0
|
||||||||||
|
Subtotal
|
7,261
|
6,098
|
$13,360
|
|||||||||||||||
|
TOTAL
|
263,821
|
47,155
|
$310,976
|
Revised Indirect Costs
|
Expense/Item
|
Comments
|
Unit Cost
|
Original
Number
of Units
|
CO#1
Number
of Units
|
Original
Item
Cost
AUD$
|
CO#1
Item
Cost
AUD$
|
TOTAL
COST
AUD$
|
|||||||
|
Investigator’s/Monitor’s Meeting Attendance
|
||||||||||||||
|
Travel/Attendance Costs
|
Airfares, accommodation & meals provided by Client, $500 - taxis, currency exchange, meals in transit, phone
|
$500/person
|
2
|
0
|
1,000
|
0
|
||||||||
|
Subtotal
|
1,000
|
0
|
$1,000
|
|||||||||||
|
Site Visits
|
||||||||||||||
|
Other Site visit Costs
|
Parking/tolls/meals and incidentals for site visits
|
$50/day
|
35
|
27
|
1,750
|
1,350
|
||||||||
|
Subtotal
|
1,750
|
1,350
|
$3,100
|
|||||||||||
|
General Expenses
|
||||||||||||||
|
Couriers, Express Post, Teleconferences
|
$7,000
|
1
|
0
|
7,000
|
0
|
INC Research, LLC – CONFIDENTIAL
|
INCResearch Australia Pty Limited - 1000504
|
|
Prana Change Order #1, v2, 10th April 2013
|
Page 6 of 8
INC Research, LLC Change Order Form
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Copying (Excluding ethics submissions), postage, telecommunications (excluding teleconferences), stationery (files)
|
$70/site/month, 5 sites for 21 months
|
$350/month
|
21
|
0
|
7,350
|
0
|
||||||||
|
Subtotal
|
14,350
|
0
|
$14,350
|
|||||||||||
|
TOTAL
|
17,100
|
1,350
|
$18,450
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INC Research, LLC – CONFIDENTIAL
|
INCResearch Australia Pty Limited - 1000504
|
|
Prana Change Order #1, v2, 10th April 2013
|
Page 7 of 8
SIGNATURE
COUNTERPARTS. This Change Order may be signed in counterparts and said counterparts shall be treated as though signed as one document. The parties acknowledge legal validity of facsimile, portable document format or other commercially acceptable electronic exchange of copies of the documents, which are essential for Change Order execution. A party which uses a facsimile, portable document format or other commercially acceptable electronic exchange copy of an authorized person’s signature in the documents guaranties its authenticity.
IN WITNESS WHEREOF, the undersigned have caused this Change Order to be executed by a duly authorized individual on behalf of each requisite party effective as of the day and year last written below.
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Prana Biotechnology Limited
|
INCResearch Australia Pty Limited
|
|
 |
 |
|
|
Signature By:
|
Signature By:
|
|
|
XXXXXX XXXXX
|
Xxxxx Xxxxxxx
|
|
|
Name (print)
|
Name (print)
|
|
|
C.O.O
|
Executive Vice President, Asia/Pacific
|
|
|
Title
|
Title
|
|
|
16 / April / 2013
|
24/04/2013
|
|
|
Date
|
Date
|
INC Research, LLC – CONFIDENTIAL
|
INCResearch Australia Pty Limited - 1000504
|
|
Prana Change Order #1, v2, 10th April 2013
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Page 8 of 8
