Contract
Exhibit 4.70
Certain portions of this Exhibit have been omitted pursuant to a
request for “Confidential Treatment” under
Rule 24b-2 of the Securities and Exchange Commission. Such
portions have been redacted and bracketed in the request and
appear as [*] in the text of this Exhibit. The omitted
confidential information has been filed with the Securities and
Exchange Commission.
AMENDMENT
to the Clinical Trial Agreement between
Amarin Neuroscience Limited
and
University of Rochester
WHEREAS, University of Rochester (“University”) and
Amarin Neuroscience Limited (“Sponsor”) are currently
under contract whereby University has undertaken certain
activities related to a clinical trial research study entitled:
“A Multi-Center, Double-Blind, Randomized, Parallel Group,
Placebo-Controlled Trial of Ethyl-EPA
(Miraxiontm)
in subjects with Mild to Moderate Huntington’s Disease
(TREND-HD)”, and
WHEREAS, University and Sponsor have agreed to enter into
Protocol Amendment Number 2, to extend the open-label protocol
treatment period and procedures for an additional six months;
therefore
THIS AMENDMENT does hereby amend the Clinical Trial Agreement
(hereinafter, the “Agreement”) between Sponsor and
University, dated March 18, 2005 as follows:
| 1. | The parties agree that protocol number AN01.01.0011, attached to the Agreement as Exhibit A, amended in accordance with Protocol Amendment Number 2, attached hereto as Exhibit A-1; and the Budget for the Study, attached to the Agreement as Exhibit C, is fully and completely replaced by the amended budget attached hereto as Exhibit C-1. | |
| 2. | The Scope of Work for the Study, attached to the Agreement as Exhibit B, shall remain unchanged and shall apply to all activities specified in protocol number AN01.01.001, as amended herein. |
Except as provided herein, all terms and conditions of the
Agreement, as heretofore amended, remain unchanged.
| AMARIN NEUROSCIENCE LIMITED | UNIVERSITY OF ROCHESTER | |||||
| BY: |
|
BY: |
|
|||
|
Name: Title: |
X. Xxxxxxx CEO |
Xxxxxx X. Xxxxxxxx Xx. Research Administrator Office of Research & Project Administration |
||||
|
DATE:
|
8/12/06 | DATE: | 11/28/06 | |||
EXHIBIT
A-l
Protocol Amendment Number 2
AMENDMENT
2
VERSION: November 27, 2006
[*]
Summary
of Changes to Protocol ANA01.01.0011
Amendment
#2 November 17, 2006
[*]
University
of Rochester
Clinical Trials Coordination Center
Budget for Miraxion
Sponsor: Amaria
Clinical Trials Coordination Center
Budget for Miraxion
Sponsor: Amaria
Exhibit C-1
[*]
University
of Rochester
Clinical Trials Coordination Center
Budget for Miraxion
Sponsor: Amarin
Clinical Trials Coordination Center
Budget for Miraxion
Sponsor: Amarin
Exhibit C-1a
Payment Schedule for Miraxion (TREND HD) Study —
Exclusive of Site Payments
|
Total Due from Amarin
|
$[*] | |||
|
Less: Site Payments (and UR
indirects on payments)
|
−$[*] | |||
|
Total CTCC / HSG Operating Costs
|
$[*] |
|
Months |
||||||||||||||||||||
|
Actual / |
Between |
|||||||||||||||||||
|
Milestone:
|
Percent Due | Amount Due | Projected Date | Balance Remaining | Payments | |||||||||||||||
|
Execution of Contract
|
[*]% | $ | [*] | 3/30/2005 | Paid | $[*] | 0 | |||||||||||||
|
First Patient Dosed
|
[*]% | $ | [*] | 11/29/2005 | Paid | $[*] | 8 | |||||||||||||
|
Enrollment 25% Complete
|
[*]% | $ | [*] | 3/14/2006 | Paid | $[*] | 4 | |||||||||||||
|
Enrollment 75% Complete
|
[*]% | $ | [*] | 7/18/2006 | Paid | $[*] | 4 | |||||||||||||
|
Data Transfer to
Amarin —
All Subjects 6 Mo. Complete |
[*]% | $ | [*] | 1/31/2007 | $[*] | 6 | ||||||||||||||
|
Last Subject Enrolled enters OLE
|
[*]% | $ | [*] | 7/15/2007 | $[*] | 6 | ||||||||||||||
|
Final Data Base to Amarin
|
[*]% | $ | [*] | 3/31/2008 | $[*] | 9 | ||||||||||||||
|
Final Study Results Available
|
[*]% | $ | [*] | 5/31/2008 | $[*] | 2 | ||||||||||||||
|
Totals
|
100% | $ | [*] | |||||||||||||||||
