Change Order for Additional Biostatistics & Medical Writing Work
Ex.
4.81
|
Aramin
694/005 & 006
|
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
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Change
Order for Additional Biostatistics & Medical Writing Work
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DATED
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the
28th
May 2008
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BETWEEN
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Amarin
Neuroscience Limited of Magdalen Centre North, Oxford Science Park, Oxford
OX4 4GA UK ('Amarin')
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|
AND
|
ICON
Clinical Research Limited of South County Business Park, Leopardstown,
Dublin 18 ('ICON')
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|
|
WHEREAS:
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|
A.
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The
parties entered into an Agreement for Services on 30th
June 2005, concerning Study known as Protocol AN01.01.0012 &
AN01.01.0011 - A Multi-centre, double-blind, randomized, parallel group,
placebo-controlled trial of ethyl-epa (Ethyl-Icosapent) in patients with
Huntington's Disease (the "Agreement"). This Agreement was further amended
by various Change Order for both the US and
EU.
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|
B.
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The
parties have agreed to certain changes to the services to be provided and
the associated cost as set out
herein.
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IT
IS AGREED BY THE PARTIES AS FOLLOWS:
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1.
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The
parties agree to amend the Agreement to reflect changes set out in the
Appendix 1 which is attached hereto and incorporated
hereby.
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2
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The
activities and associated costs in this Change Order relate to both
protocols AN01.01.0011 (694/006) and AN01.01.0012
(694/005).
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3.
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Save
as otherwise provided in this Change Order, all the terms and conditions
of the Agreement dated the 30th
June 2005 and subsequent change orders shall remain in full force and
effect.
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4.
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The
value for completion of these activities shall be £91,818 in direct fees.
Additional tasks, including the CSR addendum for the AN01.01.0012 study,
of which an estimate is included in this cost, and any additional work on
patient narratives for both studies and any additional biostatistics work
requested will be charged on a time and materials basis as per the hourly
rates in Appendix 1. All costs will be invoiced upon completion of the
work.
|
|
Aramin
694/005 & 006
|
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
IN WITNESS WHEREOF, the
parties hereto have executed this Change Order by their duly authorised
representatives on the date(s) written below.
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Amarin
Neuroscience Limited
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ICON
Clinical Research Limited
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|
NAME___________________
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Xx.
Xxxxx Xxxxxxx
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TITLE
___________________
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TITLE: VP
Commercial Affairs
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DATE____________________
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DATE_________________
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SIGNED_________________
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SIGNED______________
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-2-
|
Aramin
694/005 & 006
|
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
Appendix
I
Section
1. Change Order Specifications
|
Item
|
Amarin
694005/694006
|
CO
Value (£)
|
Comments
/timelines
|
|
Date:
|
May-07
|
||
|
694005
extension phase efficacy analysis
|
|||
|
Management
|
3hrslwk
|
£615
|
2
weeks
|
|
SAP
|
10
hours
|
£1,026
|
SAP
Includes all time from Jan08 to 01May08 (synergy
applied)
|
|
TFLs
|
5
Unique Tables
|
£2,165
|
Unique
TFLs absorbs dataset programming and validation cost (visit excel
spreadsheet, last dose updates, revisit of LOCF for assessment dates,
etc.)
|
|
16
Replicate Tables
|
£1,728
|
||
|
3
Unique Listings
|
£648
|
||
|
4
Repeat Listings
|
£324
|
||
|
Total
|
£6,506
|
||
|
694005
extension phase safety analysis
|
|||
|
Management
|
3hrs/wk
|
£615
|
2
weeks
|
|
SAP
|
10
hours
|
£1,026
|
SAP
includes all time from Jan08 to 01 May08 (synergy
applied)
|
|
TFLs
|
8
Unique Tables
|
£
3,464
|
|
|
11
Replicate Tables
|
£1,188
|
||
|
1
Unique Listing
|
£216
|
||
|
22
Replicate Listings
|
£1,782
|
||
|
Total
|
£8,291
|
||
|
694006
extension phase efficacy analysis
|
|||
|
Management
|
3
hrslwk
|
£615
|
2
weeks
|
|
SAP
|
10
hours
|
£1,026
|
SAP
includes all time from Jan08 to 01May08 (synergy
applied)
|
|
TFLs
- 1
parameter
|
5
Unique Tables
|
£2,165
|
|
|
22
Replicate Tables
|
£2,376
|
||
|
6
Repeat Listings
|
£486
|
||
|
Total
|
£6,668
|
||
|
694006
extension phase safety analysis
|
|||
|
Management
|
3hrs/wk
|
£615
|
2
weeks
|
-3-
|
Aramin
694/005 & 006
|
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
|
SAP
|
10
hours
|
£1,026
|
SAP
Includes all time from Jan08 to 01 May08 (synergy
applied)
|
|
TFLs
|
9
Unique Tables
|
£3,897
|
|
|
17
Replicate Tables
|
£1,836
|
||
|
3
Unique Listings
|
£648
|
||
|
23
Replicate Listings
|
£1,863
|
||
|
Total
|
£9,885
|
||
|
694006
main phase rerun safety
|
|||
|
Management
|
3
hrs/wk
|
£308
|
|
|
Dry
Run
|
1
dry run
|
£5,103
|
|
|
Total
|
£5,411
|
||
|
694006
main phase rerun efficacy
|
|||
|
Management
|
3
hrs/wk
|
£308
|
|
|
Dry
Run
|
1
dry run
|
£5,103
|
|
|
Total
|
£5,411
|
||
|
STATS TOTAL
|
£ 42,172
|
Medical
Writing
Clinical
Study Report:
The costs
for the Clinical Study Report (CSR) for the AN01.01.0011 study are based on the
following assumptions, with any deviations from these assumptions requiring a
further recost:
|
·
|
Amarin
want the existing CSR for the double-blind phase (dated 01 June 2007) to
be updated to include the OLE study methods and results, a brief summary
of the EFA laboratory data (maximum one days work), and a revision of the
double-blind data. It has been assumed that any changes to the
double-blind data will not change the message of the existing CSR dated 01
June 2007.
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·
|
The
cost includes the provision of a mock report including shell results
tables for client review.
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·
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Two
sets of consolidated client comments after the provision of Draft 1. Any
additional revisions will be charged on a timesheet
basis.
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·
|
ICON
has provided a separate unit cost for narrative writing and updates as
required.
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·
|
ICON
Medical Writing will not be compiling the
appendices.
|
The costs
for this are £25,844
The costs
for the open-label extension CSR addendum for the AN.01.01.0012 study will be
charged on a timesheet basis using the hourly rates in section 3 below. It is
estimated that the cost will be £23,802, which includes revisions based on two
sets of consolidated client comments, but excludes an estimate for narratives
(for which unit costs are presented below).
-4-
|
Aramin
694/005 & 006
|
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
|
|
Patient
Narratives:
|
Various
different complexities of work will need to be done to the patient narratives
for both studies. These will be charges on a unit basis as detailed
below:
|
·
|
A
new narrative written from scratch -* £204.05 per
narrative
|
|
·
|
An
existing narrative QC'd against listings and SAE reports/CIOMS, and
updated à
£153.04
|
|
·
|
An
existing narrative QC'd against listings only, and updated à
£102.02
|
(Exchange
rate used = €1 =£0.6988, as per contract)
-5-
|
Aramin
694/005 & 006
|
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
Section
2. Summary of Costs
|
Biostatistics
|
||
|
AN01.01.0011
|
||
|
Extension
Phase Efficacy Analysis
|
£
|
6,668
|
|
Extension
Phase Safety Analysis
|
£
|
9,885
|
|
Main
Phase Rerun Safety
|
£
|
5,411
|
|
Main
Phase Rerun Efficacy
|
£
|
5,411
|
|
AN01.01.0012
|
||
|
Extension
Phase Efficacy Analysis
|
£
|
6,506
|
|
Extension
Phase Safety Analysis
|
£
|
8,291
|
|
Total
Biostatistics
|
£
|
42,172
|
|
Medical
Writing
|
||
|
AN01.01.0011
CSR
|
£
|
25,844
|
|
AN.01.01.0012
Open-Label Extension CSR addendum
|
£
|
23,802
|
|
Patient
Narratives
|
Unit
Costs
|
|
|
Total
Medical Writing
|
£
|
49,646
|
|
TOTAL
|
£
|
91,818
|
Section
3. Hourly Rates to be used for any additional Work Requested by
Amarin
The
following hourly rates will be applied for any additional work required by
Amarin.
|
|
Biostatistics
|
|
·
|
Senior
Statistician à
£102.58
|
|
|
Medical
|
|
·
|
Medical
Writing - à
£127.62
|
|
·
|
QA
à
£111.72
|
