o
|
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR 12(g)
|
OF
THE SECURITIES EXCHANGE ACT OF 1934
|
|
OR
|
|
þ
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d)
|
OF
THE SECURITIES EXCHANGE ACT OF 1934
|
|
FOR
THE FISCAL YEAR ENDED DECEMBER 31, 2007
|
|
OR
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d)
|
OF
THE SECURITIES EXCHANGE ACT OF 1934
|
|
FOR
THE TRANSITION PERIOD FROM TO
|
|
OR
|
|
o
|
SHELL
COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d)
|
OF
THE SECURITIES EXCHANGE ACT OF 1934
|
|
DATE
OF EVENT REQUIRING THIS SHELL COMPANY
REPORT
|
Title of Each Class
|
Name of Each Exchange on Which
Registered
|
|
None
|
None
|
INTRODUCTION
|
3 | |
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
4 | |
PART I
|
||
Item
1
|
Identity
of Directors, Senior Management and Advisers
|
5
|
Item
2
|
Offer
Statistics and Expected Timetable
|
5
|
Item
3
|
Key
Information
|
5
|
Item
4
|
Information
on the Company
|
20
|
Item
4A
|
Unresolved
Staff Comments
|
29
|
Item
5
|
Operating
and Financial Review and Prospects
|
29
|
Item
6
|
Directors,
Senior Management and Employees
|
36
|
Item
7
|
Major
Shareholders and Related Party Transactions
|
44
|
Item
8
|
Financial
Information
|
46
|
Item
9
|
The
Offer and Listing
|
48
|
Item
10
|
Additional
Information
|
49
|
Item
11
|
Quantitative
and Qualitative Disclosures About Market Risk
|
68
|
Item
12
|
Description
of Securities Other than Equity Securities
|
69
|
PART II
|
||
Item
13
|
Defaults,
Dividend Arrearages and Delinquencies
|
69
|
Item
14
|
Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
69
|
Item15
|
Controls
and Procedures
|
69
|
Item
16
|
[Reserved]
|
70
|
Item
16A
|
Audit
Committee Financial Expert
|
70
|
Item
16B
|
Code
of Ethics
|
70
|
Item
16C
|
Principal
Accountant Fees and Services
|
70
|
Item
16D
|
Exemptions
from the Listing Standards for Audit Committees
|
71
|
Item
16E
|
Purchases
of Equity Securities by the Issuer and Affiliated
Purchasers
|
71
|
PART III
|
||
Item
17
|
Financial
Statements
|
71
|
Item
18
|
Financial
Statements
|
71
|
Item
19
|
Exhibits
|
71
|
SIGNATURES
|
77
|
2006
|
2007
|
|||||||
(In
U.S. $, thousands
except per share data and number of shares information) |
||||||||
Statement
of Operations Data — IFRS
Net
sales revenues
|
500 | — | ||||||
Total
loss from operations
|
(28,068 | ) | (40,733 | ) | ||||
Net
loss
|
(26,751 | ) | (38,197 | ) | ||||
Net
loss per Ordinary Share (basic – post share split**)
|
(3.25 | ) | (3.90 | ) | ||||
Net
loss per Ordinary Share (basic – pre share split**)
|
(0.33 | ) | (0.39 | ) | ||||
Net
loss per Ordinary Share (diluted – post share split**)
|
(3.25 | ) | (3.90 | ) | ||||
Net
loss per Ordinary Share (diluted – pre share split**)
|
(0.33 | ) | (0.39 | ) | ||||
Consolidated
balance sheet data -
amounts
in accordance with IFRS
Working
capital assets
|
28,710 | 6,316 | ||||||
Total
assets
|
49,559 | 42,254 | ||||||
Long
term
obligations
|
(110 | ) | (2,693 | ) | ||||
Capital
stock (ordinary shares)
|
7,990 | 12,942 | ||||||
Total
shareholders’ equity
|
38,568 | 24,149 | ||||||
Number
of ordinary shares in issue (thousands – post share
split**)
|
9,068 | 13,906 | ||||||
Number
of ordinary shares in issue (thousands – pre share
split**)
|
90,684 | 139,057 | ||||||
Denomination
of each ordinary share (post share split**)
|
£0.50 | £0.50 | ||||||
Denomination
of each ordinary share (pre share split**)
|
£0.05 | £0.05 |
Years
Ended December 31
|
||||||||||||
2003
|
2004*
as
restated
|
2005*
as
restated
|
||||||||||
(In
U.S. $, thousands except per share
data and number of shares information) |
||||||||||||
Statement
of Operations Data — U.K.
GAAP
Net
sales
revenues
|
7,365 | 1,017 | 500 | |||||||||
Total
loss from
operations
|
(38,821 | ) | (11,875 | ) | (20,748 | ) | ||||||
Loss
from continuing
operations
|
(6,200 | ) | (10,608 | ) | (20,748 | ) | ||||||
Net
(loss)/income
|
(19,224 | ) | 3,229 | (20,547 | ) | |||||||
Loss
from continuing operations per Ordinary Share (basic – post share
split**)
|
(3.63 | ) | (4.71 | ) | (4.45 | ) | ||||||
Loss
from continuing operations per Ordinary Share (basic – pre share
split**)
|
(0.36 | ) | (0.47 | ) | (0.45 | ) | ||||||
Net
(loss)/income per Ordinary Share (basic – post share
split**)
|
(11.25 | ) | 1.43 | (4.41 | ) | |||||||
Net
(loss)/income per Ordinary Share (basic – pre share
split**)
|
(1.13 | ) | 0.14 | (0.44 | ) | |||||||
Net
(loss)/income per Ordinary Share (diluted – post share
split**)
|
(11.25 | ) | 1.43 | (4.41 | ) | |||||||
Net
(loss)/income per Ordinary Share (diluted – pre share
split**)
|
(1.13 | ) | 0.14 | (0.44 | ) | |||||||
Consolidated
balance sheet data -
amounts
in accordance with U.K. GAAP
Working
capital
(liabilities)/assets
|
(39,128 | ) | 8,651 | 28,673 | ||||||||
Total
assets
|
47,377 | 23,721 | 46,760 | |||||||||
Long
term
obligations
|
— | (2,687 | ) | (180 | ) | |||||||
Capital
stock (ordinary
shares)
|
29,088 | 3,206 | 6,778 | |||||||||
Total
shareholders’
(deficit)/equity
|
(6,348 | ) | 16,693 | 38,580 | ||||||||
Number
of ordinary shares in issue (thousands – post share
split**)
|
1,794 | 3,763 | 7,755 | |||||||||
Number
of ordinary shares in issue (thousands – pre share
split**)
|
17,940 | 37,632 | 77,549 | |||||||||
Denomination
of each ordinary share (post share
split**)
|
£10.00 | £0.50 | £0.50 | |||||||||
Denomination
of each ordinary share (pre share
split**)
|
£1.00 | £0.05 | £0.05 |
*
|
As
restated for the non-cash compensation expense due to the adoption of U.K.
GAAP, Financial Reporting Standard 20 “Share-based
payments”.
|
**
|
On
January 18, 2008, our Ordinary Shares were consolidated on a one-for-ten
basis whereby ten Ordinary Shares of 5p each became one Ordinary Share of
50p. Post-split shares and share information above has been adjusted to
reflect this share consolidation.
|
Fiscal
Period
|
Average
Noon
Buying
Rate
|
(U.S. Dollars/pound
sterling)
|
|
12 months
ended December 31,
2003
|
1.6450
|
12 months
ended December 31,
2004
|
1.8356
|
12 months
ended December 31,
2005
|
1.8204
|
12 months
ended December 31,
2006
|
1.8434
|
12 months
ended December 31,
2007
|
2.0073
|
Month
|
High
Noon Buying Rate
|
Low
Noon Buying Rate
|
(U.S. Dollars/pound
sterling)
|
(U.S. Dollars/pound
sterling)
|
|
November
2007
|
2.1104
|
2.0478
|
December
2007
|
2.0658
|
1.9774
|
January
2008
|
1.9895
|
1.9515
|
February
2008
|
1.9923
|
1.9405
|
March
2008
|
2.0311
|
1.9823
|
April 2008 |
1.9994
|
1.9627
|
·
|
increasing
our vulnerability to general adverse economic and industry
conditions;
|
·
|
limiting
our ability to obtain additional financing in the future for working
capital, capital expenditures, acquisitions or other business
purposes;
|
·
|
limiting
our flexibility to plan for, or react to, changes in our business and the
industry in which we compete;
|
·
|
placing
us at a possible disadvantage to competitors with fewer debt obligations
and competitors that have better access to capital resources;
and
|
·
|
requiring
us to dedicate a substantial portion of our cash flow from operations to
payments on our indebtedness, thereby reducing the availability of our
cash flow to fund working capital expenditures, research and development
efforts and other general corporate
purposes.
|
•
|
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices for use in clinical
trials;
|
•
|
slower
than expected rates of patient
recruitment;
|
•
|
the
inability to observe patients adequately after
treatment;
|
•
|
changes
in regulatory requirements for clinical
trials;
|
•
|
the
lack of effectiveness during clinical
trials;
|
•
|
unforeseen
safety issues;
|
•
|
delay,
suspension, or termination of a trial by the institutional review board
responsible for overseeing the study at a particular study
site; and
|
•
|
government
or regulatory delays or “clinical holds” requiring suspension or
termination of a trial.
|
•
|
acquire
patented or patentable products and
technologies;
|
•
|
obtain
and maintain patent protection for our current and acquired
products;
|
•
|
preserve
any trade secrets relating to our current and future
products; and
|
•
|
operate
without infringing the proprietary rights of third
parties.
|
·
|
the
announcement of new products or
technologies;
|
·
|
innovation
by us or our competitors;
|
·
|
developments
or disputes concerning any future patent or proprietary
rights;
|
·
|
actual
or potential medical results relating to our products or our competitors’
products;
|
·
|
interim
failures or setbacks in product
development;
|
·
|
regulatory
developments in the United States, the European Union or other
countries;
|
·
|
currency
exchange rate
fluctuations; and
|
·
|
period-to-period
variations in our results of
operations.
|
•
|
Under
English law, each shareholder present at a meeting has only one vote
unless a valid demand is made for a vote on a poll, in which each holder
gets one vote per share owned. Under U.S. law, each shareholder
typically is entitled to one vote per share at all meetings. Under English
law, it is only on a poll that the number of shares determines the number
of votes a holder may cast. You should be aware, however, that the voting
rights of ADSs are also governed by the provisions of a deposit agreement
with our depositary bank.
|
•
|
Under
English law, each shareholder generally has pre-emptive rights to
subscribe on a proportionate basis to any issuance of shares. Under
U.S. law, shareholders generally do not have pre-emptive rights
unless specifically granted in the certificate of incorporation or
otherwise.
|
•
|
Under
English law, certain matters require the approval of 75% of the
shareholders, including amendments to the memorandum and articles of
association. This may make it more difficult for us to complete corporate
transactions deemed advisable by our board of directors. Under
U.S. law, generally only majority shareholder approval is required to
amend the certificate of incorporation or to approve other significant
transactions. Under the rules of AIM and IEX, certain transactions require
the approval of 50% of the shareholders, including disposals resulting in
a fundamental change of business and reverse takeovers. In addition,
certain transactions with a party related to the Group for the purposes of
the AIM rules requires that the Group consult with its nominated adviser
as to whether the transaction is fair and reasonable as far as
shareholders are concerned.
|
•
|
Under
English law, shareholders may be required to disclose information
regarding their equity interests upon our request, and the failure to
provide the required information could result in the loss or restriction
of rights attaching to the shares, including prohibitions on the transfer
of the shares, as well as restrictions on dividends and other payments.
Comparable provisions generally do not exist under
U.S. law.
|
•
|
The
quorum requirements for a shareholders’ meeting is a minimum of two
persons present in person or by proxy. Under U.S. law, a majority of
the shares eligible to vote must generally be present (in person or by
proxy) at a shareholders’ meeting in order to constitute a quorum. The
minimum number of shares required for a quorum can be reduced pursuant to
a provision in a company’s certificate of incorporation or bylaws, but
typically not below one-third of the shares entitled to vote at the
meeting.
|
•
|
failing
to approve or challenging the prices charged for health care
products;
|
•
|
introducing
reimportation schemes from lower priced
jurisdictions;
|
•
|
limiting
both coverage and the amount of reimbursement for new therapeutic
products;
|
•
|
denying
or limiting coverage for products that are approved by the regulatory
agencies but are considered to be experimental or investigational by
third-party payers;
|
•
|
refusing
to provide coverage when an approved product is used in a way that has not
received regulatory marketing
approval; and
|
•
|
refusing
to provide coverage when an approved product is not appraised favorably by
the National Institute for Clinical Excellence in the U.K., or similar
agencies in other countries.
|
·
|
changes
to our manufacturing arrangements;
|
·
|
additions
or modifications to product
labeling;
|
·
|
the
recall or discontinuation of our
products; or
|
·
|
additional
record-keeping requirements.
|
•
|
any
additional patents will be issued for AMR101 or any other or future
products in any or all appropriate
jurisdictions;
|
•
|
any
patents that we or our licensees may obtain will not be successfully
challenged in the future;
|
•
|
our
technologies, processes or products will not infringe upon the patents of
third parties; or
|
•
|
the
scope of any patents will be sufficient to prevent third parties from
developing similar products.
|
Subsidiary
Name
|
Country
of Incorporation
or Registration |
Proportion
of
Ownership Interest
and
Voting Power Held |
|
Amarin
Neuroscience
Limited
|
Scotland
|
100%
|
|
Amarin
Pharmaceuticals Ireland
Limited
|
Ireland
|
100%
|
|
Amarin
Finance
Limited
|
Bermuda
|
100%
|
|
Ester
Neurosciences
Limited
|
Israel
|
100%
|
Location
|
Use
|
Ownership
|
Size
(sq. ft.)
|
||
Ely,
Cambridgeshire, England
Ground
Floor
|
Offices
|
Leased
and sub-let
|
7,135
|
||
First
Floor
|
Offices
|
Leased
and sub-let
|
2,800
|
||
Godmanchester,
Cambridgeshire,
England
|
Offices
|
Leased
and sub-let
|
7,000
|
||
London,
England
|
Offices
|
Leased
|
2,830
|
||
Oxford,
England
|
Offices
|
Leased
|
3,000
|
||
Dublin,
Ireland
|
Offices
|
Leased
|
3,251
|
•
|
intangible
assets and research and development
expenditure;
|
•
|
foreign
currency; and
|
•
|
revenue
recognition.
|
(i)
|
assets
and liabilities for each balance sheet presented are translated at the
closing rate at the date of that balance
sheet;
|
(ii)
|
income
and expenses for each income statement are translated at average exchange
rates (unless this average is not a reasonable approximation of the
cumulative effect of the rates prevailing on the transaction dates, in
which case income and expenses are translated at the rate on the dates of
the transactions); and
|
(iii)
|
all
resulting exchange differences are recognized as a separate component of
equity.
|
Payments Due by Period
in $000’s
|
|||||||||||||
Total
|
Less
than
1 Year
|
1-2
Years
|
2-3
Years
|
3-4
Years
|
4-5
Years
|
Thereafter
|
|||||||
Long-term
debt
|
2,750
|
—
|
—
|
2,750
|
—
|
—
|
—
|
||||||
Capital/finance
lease
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||
Operating
lease
|
4,529
|
1,278
|
1,145
|
755
|
572
|
283
|
496
|
||||||
Purchase
obligations
|
674
|
674
|
—
|
—
|
—
|
—
|
—
|
||||||
Other
long-term creditors
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||
Total
|
7,953
|
1,952
|
1,145
|
3,505
|
572
|
283
|
496
|
Estimated Payments Due
by Period in $000’s from 1 January 2008
|
|||||||||||||
Total
|
Less
than
1 Year
|
1-2
Years
|
2-3
Years
|
3-4
Years
|
4-5
Years
|
Thereafter
|
|||||||
Clinical
research
|
2,825
|
2,825
|
—
|
—
|
—
|
—
|
—
|
Name
|
Age
|
Position
|
||
Thomas
Lynch
|
51
|
Chairman
and Chief Executive Officer
|
||
Alan
Cooke
|
37
|
President,
Chief Operating Officer and Director*
|
||
Dr.
Declan Doogan
|
56
|
Head,
Research & Development and Director
|
||
John
Groom
|
69
|
Non-Executive
Director
|
||
Anthony
Russell-Roberts
|
62
|
Non-Executive
Director
|
||
Dr.
William Mason
|
56
|
Non-Executive
Director
|
||
Dr.
Simon Kukes
|
51
|
Non-Executive
Director
|
||
Dr.
Michael Walsh
|
56
|
Non-Executive
Director
|
||
Dr.
Prem Lachman
|
47
|
Non-Executive
Director
|
||
Dr.
John Climax
|
55
|
Non-Executive
Director
|
||
Prof.
William Hall
|
58
|
Non-Executive
Director
|
||
Tom
Maher
|
41
|
General
Counsel and Company Secretary
|
||
Conor
Dalton
|
43
|
Vice
President, Finance & Principal Accounting
Officer
|
Name
|
Salary
&
fees
|
Benefits
in
kind
|
Annual
bonus
|
2007
Total
|
||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Thomas
Lynch (Chairman and Chief Executive Officer)*
|
482 | — | 390 | 872 | ||||||||||||
Richard
Stewart (Former Chief Executive Officer)**
†
|
1,249 | 18 | 250 | 1,517 | ||||||||||||
Alan
Cooke (President & Chief Operating Officer)**
|
401 | 4 | 227 | 632 | ||||||||||||
Dr.
Declan Doogan (Head, Research & Development)**
|
140 | — | 105 | 245 | ||||||||||||
John
Groom
|
— | — | — | — | ||||||||||||
Anthony
Russell-Roberts
|
100 | — | — | 100 | ||||||||||||
Dr.
William Mason
|
80 | — | — | 80 | ||||||||||||
Dr.
Simon Kukes
|
50 | — | — | 50 | ||||||||||||
Dr.
Michael Walsh
|
50 | — | — | 50 | ||||||||||||
Dr.
Prem Lachman
|
50 | — | — | 50 | ||||||||||||
Dr.
John Climax
|
50 | — | — | 50 | ||||||||||||
Prof.
William Hall
|
42 | — | — | 42 | ||||||||||||
2,694 | 22 | 972 | 3,688 |
*
|
Fees
in respect of a Consultancy Agreement with Mr. Thomas Lynch. See
“Item 7B — Related Party Transactions. Included above is Mr.
Lynch’s bonus payment’s for 2006 and 2007.
|
**
|
In
addition to the above, Mr. Stewart, Mr. Cooke and Dr. Doogan had
pension contributions paid into their personal scheme or accrued by the
Group in 2007 of $60,000, $22,000 and $8,000 respectively. Mr. Stewart’s
payment, which is in excess of his normal entitlement under the Group’s
pension scheme arrangements, was approved by the Remuneration
Committee.
|
† | On December 19, 2007, Mr. Richard Stewart resigned as Chief Executive Officer and Executive Director of Amarin. Pursuant to the terms of a compromise agreement between Amarin and Mr. Stewart, Amarin agreed to pay Mr. Stewart £402,500 ($804,000) in respect of a termination payment and bonus, £10,673 ($21,000) in respect of 10 days accrued but untaken holiday entitlement, other expenses of £4,000 ($8,000) and £37,338 ($75,000) in respect of accrued pension entitlement up to the date of termination, December 19, 2007. These amounts are included in Mr. Stewart's emoluments above. |
•
|
Dr. William
Mason (Chairman) (appointed October 22,
2002);
|
•
|
Dr. Simon
Kukes (appointed March 20, 2006, resigned May 16,
2008); and
|
•
|
Mr. John
Groom (Financial Expert) (appointed October 24, 2003, resigned
May 16, 2008).
|
•
|
Mr. Anthony
Russell-Roberts (Chairman) (appointed July 19,
2002);
|
•
|
Dr. Michael
Walsh (appointed February 28, 2005, resigned May 16,
2008); and
|
•
|
Dr. Prem
Lachman (appointed March 20, 2006, resigned May 16,
2008).
|
Employment
Activity
|
Number
of
Employees
12/31/07
|
Number
of
Employees
12/31/06
|
|
Marketing
and Administration
|
17
|
12
|
|
Research
and Development
|
8
|
|
6
|
Total
|
25
|
18
|
Country
|
Number
of
Employees
12/31/07
|
Number
of
Employees
12/31/06
|
||||||
U.K
|
11 | 10 | ||||||
Ireland
|
14 | 8 | ||||||
Total
|
25 | 18 |
Director/Officer
|
Note
|
Options/Warrants
Outstanding
to
Acquire
Number
of
Ordinary
Shares
|
Date
of Grant
(dd/mm/yy)
|
Exercise
Price
per
Ordinary
Share
|
Ordinary
Shares
or
ADS
Equivalents
Beneficially
Owned
|
Percentage
of
Outstanding
Share
Capital*
|
J.
Groom
|
1
|
15,000
|
23/01/02
|
$17.65
|
417,778
|
—
|
1
|
15,000
|
06/11/02
|
$3.10
|
|||
1
|
25,000
|
21/07/04
|
$0.84
|
|||
7
|
55,099
|
21/12/05
|
$1.43
|
|||
1
|
20,000
|
11/01/06
|
$1.35
|
|||
1&17
|
20,000
|
08/12/06
|
$0.44
|
|||
T.
G.
Lynch
|
2
|
500,000
|
25/02/04
|
$1.90
|
10,729,060
|
7.7%
|
8
|
207,921
|
21/12/05
|
$1.43
|
|||
11
|
12,480
|
01/6/07
|
$0.72
|
|||
12
|
303,030
|
06/12/07
|
$0.48
|
|||
|
|
|
Director/Officer
|
Note
|
Options/Warrants
Outstanding
to
Acquire
Number
of
Ordinary
Shares
|
Date
of Grant
(dd/mm/yy
|
Exercise
Price
per
Ordinary
Share
|
Ordinary
Shares
or
ADS
Equivalents
Beneficially
Owned
|
Percentage
of
Outstanding
Share
Capital*
|
W. Mason |
1
|
15,000
|
06/11/02
|
$3.10
|
—
|
—
|
1&3
|
25,000
|
21/07/04
|
$0.84
|
|||
1&3
|
20,000
|
11/01/06
|
$1.35
|
|||
1&17
|
20,000
|
08/12/06
|
$0.44
|
|||
A.
Russell-Roberts
|
4
|
10,000
|
07/04/00
|
$3.00
|
2,350
|
—
|
4
|
10,000
|
19/02/01
|
$6.12
|
|||
1
|
15,000
|
23/01/02
|
$17.65
|
|||
1
|
15,000
|
06/11/02
|
$3.10
|
|||
1
|
25,000
|
21/07/04
|
$0.84
|
|||
1
|
20,000
|
11/01/06
|
$1.35
|
|||
1&17
|
20,000
|
08/12/06
|
$0.44
|
|||
S.
Kukes
|
7
|
519,802
|
21/12/05
|
$1.43
|
9,516,081
|
6.8%
|
1
|
20,000
|
11/01/06
|
$1.35
|
|||
1&17
|
20,000
|
08/12/06
|
$0.44
|
|||
13
|
33,278
|
01/6/07
|
$0.72
|
|||
14
|
454,545
|
06/12/07
|
$0.48
|
|||
M.
Walsh
|
7
|
38,119
|
21/12/05
|
$1.43
|
530,896
|
—
|
1
|
20,000
|
11/01/06
|
$1.35
|
|||
1&17
|
20,000
|
08/12/06
|
$0.44
|
|||
13
|
16,639
|
01/6/07
|
$0.72
|
|||
14
|
208,333
|
06/12/07
|
$0.48
|
|||
A.
Cooke
|
1
|
375,000
|
07/07/04
|
$0.85
|
270,211
|
—
|
6
|
200,000
|
10/06/05
|
$1.30
|
|||
7
|
15,594
|
21/12/05
|
$1.43
|
|||
1
|
200,000
|
16/01/06
|
$1.95
|
|||
1&17
|
675,000
|
08/12/06
|
$0.44
|
|||
P.
Lachman
|
1
|
20,000
|
11/01/06
|
$1.35
|
234,709
|
—
|
1&17
|
20,000
|
08/12/06
|
$0.44
|
|||
13
|
8,320
|
01/6/07
|
$0.72
|
|||
14
|
75,756
|
06/12/07
|
$0.48
|
|||
J.
Climax
|
9
|
226,980
|
21/12/05
|
$1.43
|
9,440,160
|
6.8%
|
1
|
20,000
|
27/01/06
|
$2.72
|
|||
1
|
20,000
|
20/03/06
|
$3.26
|
|||
1&17
|
20,000
|
08/12/06
|
$0.44
|
|||
15
|
33,278
|
01/6/07
|
$0.72
|
|||
16
|
1,363,636
|
06/12/07
|
$0.48
|
|||
W.
Hall
|
1&17
|
75,000
|
08/03/07
|
$0.44
|
—
|
—
|
T.
Maher
|
1
|
325,000
|
02/12/05
|
$1.16
|
19,802
|
—
|
7
|
6,931
|
21/12/05
|
$1.43
|
|||
1&17
|
350,000
|
08/12/06
|
$0.44
|
|||
1
|
150,000
|
02/08/07
|
$0.44
|
|||
1
|
150,000
|
28/08/07
|
$0.46
|
|||
D.
Doogan
|
1&17
|
650,000
|
09/04/07
|
$0.44
|
—
|
—
|
C.
Dalton
|
1
|
100,000
|
28/06/05
|
$1.09
|
—
|
—
|
1
|
50,000
|
12/01/06
|
$1.53
|
—
|
—
|
|
1&17
|
200,000
|
08/12/06
|
$0.44
|
—
|
—
|
(1)
|
These
options are exercisable as to one third on each of the first, second and
third anniversaries of the date of grant and remain exercisable for a
period ended on the tenth anniversary of the date of
grant.
|
(2)
|
The
Ordinary Shares are held in the form of ADSs by Amarin Investment Holding
Limited. The warrants issued to Amarin Investment Holding Limited are
exercisable for up to 500,000 Ordinary Shares, on or before
February 25, 2009. Amarin Investment Holding Limited is an entity
controlled by our Chairman and Chief Executive Officer,
Mr. Thomas Lynch.
|
(3)
|
These
options were issued to Vision Resources Limited, a company wholly owned by
Dr. Mason.
|
(4)
|
These
options are currently exercisable and remain exercisable until ten years
from the date of grant.
|
(5)
|
When
granted 100,000 of these options were to become exercisable at an exercise
price of $25.00 in tranches upon the price of our Ordinary Shares
achieving certain pre-determined levels. On February 9, 2000, our
remuneration committee approved the re-pricing of these 100,000 options to
an exercise price of US$5.00 per Ordinary Share, exercisable
immediately and the Group entered into an amendment agreement on the same
day amending the exercise price from $25.00 to $5.00 and removing the
performance criteria attached to such options. These options are currently
exercisable and remain exercisable until 1st April
2009.
|
(6)
|
These
options are exercisable as to 50% on the second anniversary of grant, as
to 75% of the third anniversary of grant and in full on the fourth
anniversary of grant.
|
(7)
|
These
warrants were granted to all investors in the December 2005 private
placement including directors and are exercisable at anytime after
180 days from the grant date. If our trading market price is equal to
or above $10.20, as adjusted for any stock splits, stock combinations,
stock dividends and other similar events, for each of any twenty
consecutive trading days, then the Group at any time thereafter shall have
the right, but not the obligation, on 20 days’ prior written notice
to the holder, to cancel any unexercised portion of this warrant for which
a notice of exercise has not yet been delivered prior to the cancellation
date.
|
(8)
|
These
warrants were granted to all investors in the December 2005 private
placement including directors and are exercisable at anytime after
180 days from the grant date. The warrants were issued to Amarin
Investment Holding Limited which is an entity controlled by our Chairman
and Chief Executive Officer, Mr. Thomas Lynch. If our trading market
price is equal to or above $10.20, as adjusted for any stock splits, stock
combinations, stock dividends and other similar events, for each of any
twenty consecutive trading days, then the Group at any time thereafter
shall have the right, but not the obligation, on 20 days’ prior
written notice to the holder, to cancel any unexercised portion of this
warrant for which a notice of exercise has not yet been delivered prior to
the cancellation date.
|
(9)
|
The
Ordinary Shares are held in the form of ADSs by Sunninghill Limited. The
warrants granted to all investors in the December 2005 private placement
including directors are exercisable at any time after 180 days from
the grant date. These warrants were issued to Sunninghill Limited which is
an entity controlled by one of our non-executive directors Dr. John
Climax.
|
(10)
|
These
options were granted to Laxdale employees as replacement Laxdale options
due to the acquisition of Laxdale by Amarin. These options vested
immediately on granting and expire on 31 March
2009.
|
(11)
|
These
warrants were granted to all investors in the June 2007 registered direct
offering including directors and are exercisable immediately from the
grant date. The warrants were issued to Amarin Investment Holding Limited
which is an entity controlled by our Chairman and Chief Executive Officer,
Mr. Thomas Lynch.
|
(12)
|
These
warrants were granted to all investors in the December 2007 registered
direct offering including directors and are exercisable immediately from
the grant date. The warrants were issued to Amarin Investment Holding
Limited which is an entity controlled by our Chairman and Chief Executive
Officer, Mr. Thomas Lynch.
|
(13)
|
These
warrants were granted to all investors in the June 2007 registered direct
offering including directors and are exercisable immediately from the
grant date.
|
(14)
|
These
warrants were granted to all investors in the December 2007 registered
direct offering including directors and are exercisable immediately from
the grant date.
|
(15)
|
These
warrants were granted to all investors in the June 2007 registered direct
offering including directors and are exercisable immediately from the
grant date. These warrants were issued to Sunninghill Limited
which is an entity controlled by one of our non-executive directors
Dr. John Climax.
|
(16)
|
These
warrants were granted to all investors in the December 2007 registered
direct offering including directors and are exercisable immediately from
the grant date. These warrants were issued to Sunninghill Limited which is
an entity controlled by one of our non-executive directors Dr. John
Climax.
|
(17)
|
The
exercise price of all options granted between December 8, 2006 and April
11, 2007 were amended to $0.44 – see note 28 to the F-section in this
annual report for further details of the options
amendment.
|
*
|
This
information is based on 139,057,370 Ordinary Shares outstanding as of
December 31, 2007.
|
Name of
Owner(1)
|
Number
of
Ordinary Shares
or
ADS Equivalents
Beneficially Owned
Capital
|
Percentage
of
Outstanding
Share (2) |
|
Amarin
Investment Holding
Limited(3)
|
11,752,491
|
6.9%
|
|
Sunninghill
Limited(5)
|
11,124,054
|
6.5%
|
|
Simon
G.
Kukes(4)
|
10,563,706
|
6.2%
|
|
Medica
Funds(6)
|
10,077,969
|
5.9%
|
(1)
|
Unless
otherwise noted, the persons referred to above have sole investment
power.
|
(2)
|
This
information is based on 139,057,370 Ordinary Shares outstanding,
20,838,235 warrants granted over Ordinary Shares and 10,804,850 share
options granted over Ordinary Shares as of December 31,
2007.
|
(3)
|
Includes
warrants to purchase 500,000 Ordinary Shares, which warrants are
exercisable on or before February 25, 2009 and warrants to purchase
523,431 Ordinary Shares, which are currently exercisable. Amarin
Investment Holding Limited is an entity controlled by our Chairman and
Chief Executive Officer, Mr. Thomas Lynch.
|
(4)
|
Includes
warrants to purchase 1,007,625 Ordinary Shares, which are currently
exercisable and options to purchase 40,000 Ordinary Shares of which 13,333
are currently exercisable.
|
(5)
|
Includes
warrants to purchase 1,623,894 Ordinary Shares, which are currently
exercisable and share options to purchase 60,000 Ordinary Shares of which
20,000 are currently exercisable. Sunninghill Limited is an entity
controlled by one of our non-executive directors, Dr. John
Climax.
|
(6)
|
This
information is based on the following
holdings:
|
Name of
Fund
|
Ordinary
Shares
|
Medica
II Investments International
LP
|
4,091,635
|
Medica
Investments Israel
LP
|
2,916,808
|
Medica
II Investments Israel
LP
|
1,524,010
|
Medica
II Investments PF Israel
LP
|
785,386
|
Medica
II Management
LP
|
413,666
|
Medica
II Baxter
LP
|
346,464
|
Name of
Owner(1)
|
2007
|
2006
|
Amarin
Investment Holding Limited
|
7.7
|
11.0
|
Simon
G. Kukes
|
6.8
|
8.3
|
Medica
Funds
|
7.2
|
—
|
Sunninghill
Limited
|
6.8
|
7.0
|
Southpoint
|
—
|
9.9
|
*
|
Share
price information for 2008 has been adjusted for the one-for-ten stock
consolidation which became effective on January 18,
2007
|
•
|
he
or any other person receives a security or indemnity in respect of money
lent or obligations incurred by him or any other person at the request of
or for the benefit of us or any of our
subsidiaries;
|
•
|
a
security is given to a third party in respect of a debt or obligation of
us or any of our subsidiaries which he has himself guaranteed or secured
in whole or in part;
|
•
|
a
contract or arrangement concerning an offer or invitation for our shares,
debentures or other securities or those of any of our subsidiaries, if he
subscribes as a holder of securities or if he underwrites or
sub-underwrites in the offer;
|
•
|
a
contract or arrangement in which he is interested by virtue of his
interest in our shares, debentures or other securities or by reason of any
interest in or through us;
|
•
|
a
contract or arrangement concerning any other company (not being a company
in which he owns 1% or more) in which he is interested directly or
indirectly whether as an officer, shareholder, creditor or
otherwise;
|
•
|
a
proposal concerning the adoption, modification or operation of a pension
fund or retirement, death or disability benefits scheme for both our
directors and employees and those of any of our subsidiaries which does
not give him, as a director, any privilege or advantage not accorded to
the employees to whom the scheme or fund
relates;
|
•
|
an
arrangement for the benefit of our employees or those of any of our
subsidiaries which does not give him any privilege or advantage not
generally available to the employees to whom the arrangement
relates; and
|
•
|
insurance
which we propose to maintain or purchase for the benefit of directors or
for the benefit of persons including
directors.
|
•
|
the
chairman of the meeting;
|
•
|
at
least two shareholders entitled to vote at the
meeting;
|
•
|
any
shareholder or shareholders representing in the aggregate not less than
one-tenth of the total voting rights of all shareholders entitled to vote
at the meeting; or
|
•
|
any
shareholder or shareholders holding shares conferring a right to vote at
the meeting on which there have been paid up sums in the aggregate equal
to not less than one-tenth of the total sum paid up on all the shares
conferring that right.
|
•
|
the
election of directors;
|
•
|
the
approval of financial statements;
|
•
|
the
declaration of final dividends;
|
•
|
the
appointment of auditors;
|
•
|
the
increase of authorized share
capital; or
|
•
|
the
grant of authority to issue shares.
|
●
|
80 of
the 5 pence Preference Shares be consolidated and divided into 8
Preference Shares with a nominal value of 50 pence each;
and
|
●
|
the
Preference Shares with a nominal value of 50 pence each to be issued and
allotted to subscribers shall be known as "Series A Preference Shares" and
shall be issued with the rights, and subject to the restrictions and
limitations, set out in forms 128(1) and 128(4) filed with Companies House
in the U.K. in May 2008.
|
•
|
Clinical
Supply Agreement between Laxdale Limited (“Laxdale”) and Nisshin Flour
Milling Co., Limited (“Nisshin”) dated October 27, 1999 relating to
the supply of ethyl-eicosapentaenoate (ethyl-EPA) by Nisshin to Laxdale
whereby Nisshin is obliged to supply all Laxdale’s requirements of
ethyl-EPA to Laxdale for clinical supply to be used in clinical
trials.
|
•
|
Asset
Purchase Agreement dated February 11, 2004 between Valeant
Pharmaceuticals International, (“Valeant”) and Amarin Corporation plc and
Amendment No.1 thereto dated February 25, 2004, which together
provide for the sale to Valeant of Amarin Pharmaceuticals, Inc. (a former
subsidiary), and our rights to Permax, Zelapar and the primary care
portfolio at a purchase price of $38 million paid at closing and
$8 million in contingent milestone
payments.
|
•
|
Settlement
Agreement dated February 25, 2004 between Amarin Corporation plc,
Elan Corporation plc (“Elan”) and certain affiliates thereof, providing
for the restructuring of all of Amarin Corporation plc’s outstanding
obligations to Elan. In connection with the Settlement Agreement, Amarin
Corporation plc issued loan notes in the aggregate principal amount of
$5 million, bearing interest at 8% per annum with a maturity
date of February 25, 2009. Also in connection with the Settlement
Agreement, Amarin Corporation plc issued a warrant exercisable for 500,000
Ordinary Shares.
|
•
|
Settlement
Agreement dated September 27, 2004 between Amarin Corporation plc,
Amarin Pharmaceuticals Company Limited (a former subsidiary) and Valeant
in respect of the full and final settlement of a contractual dispute as
between Valeant and Amarin Corporation plc arising out of the purchase by
Valeant of Amarin Pharmaceuticals Inc. Pursuant to this Settlement
Agreement, we agreed to forgo part of the contingent milestones payable by
Valeant to Amarin Corporation plc due under the Asset Purchase Agreement
for the Amarin Pharmaceuticals Inc. transaction, namely the entire
$5.0 million contingent milestone payable upon FDA approval of
Zelapar and $1.0 million of the $3.0 million contingent
milestone previously due when the remaining safety studies were
successfully completed. Also, Valeant has agreed that Amarin Corporation
plc is no longer required to purchase $414,000 of further inventory from
wholesalers and that the remaining $2.0 million contingent milestone
previously due when the remaining Zelapar safety studies were successfully
completed would be paid on November 30, 2004 without any such
contingency.
|
•
|
Form
of Subscription Agreement dated October 7, 2004 between Amarin
Corporation plc and the Purchasers named therein. Amarin Corporation plc
entered into 14 separate Subscription Agreements on October 7, 2004
all substantially similar in form and content to this form of Subscription
Agreement pursuant to which we issued an aggregate of 13,474,945 Ordinary
Shares to such Purchasers including management. The purchase price was
$0.947 per share for Purchasers other than management based on the
average closing price of our American Depository Shares (“ADSs”) on the
Nasdaq SmallCap Market for the ten trading days ended October 6, 2004
and the purchase price was $1.04 per share for management investors
based on the average closing price of our ADSs on the Nasdaq SmallCap
Market for the five trading days ended October 6,
2004.
|
•
|
Form
of Registration Rights Agreement dated October 7, 2004 between Amarin
Corporation plc and the Purchasers named therein. Amarin Corporation plc
entered into 14 separate Registration Rights Agreements on October 7,
2004 all substantially similar in form and content to this form of
Registration Rights Agreement. Pursuant to such Registration Rights
Agreements, Amarin Corporation plc agreed to use commercially reasonable
efforts to file a registration statement with respect to the securities
purchased pursuant to the Subscription Agreements dated October 7, 2004
and to use commercially reasonable efforts to cause the registration
statement to be declared effective and to remain effective for a period
ending with the first to occur of (i) the sale of all securities
covered by the registration statement and (ii) March 30,
2006.
|
•
|
Share
Purchase Agreement dated October 8, 2004 between Amarin Corporation
plc, Vida Capital Partners Limited and the Vendors named therein relating
to the entire issued share capital of Laxdale. The purchase price for the
acquisition of Laxdale comprised an initial consideration of 3,500,000
ADSs representing 3,500,000 Ordinary Shares and certain success based
milestone payments payable on a pro rata basis to the shareholders of
Laxdale.
|
•
|
Clinical
Trial Agreement dated March 18, 2005 between Amarin Neuroscience
Limited and the University of Rochester. Pursuant to this
agreement the University is obliged to carry out or to facilitate the
carrying out of a clinical trial research study set forth in a research
protocol on AMR101 in patients with Huntington’s
disease.
|
•
|
Form
of Securities Purchase Agreement dated May, 2005 between Amarin
Corporation plc and the Purchasers named therein. Amarin Corporation plc
entered into 34 separate Securities Purchase Agreements in May, 2005
all substantially similar in form and content to this Securities Purchase
Agreement pursuant to which we issued an aggregate of 13,677,110 ordinary
shares to such Purchasers, including management. The purchase price was
$1.30 per ordinary share.
|
•
|
Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited
and Amarin Neuroscience Limited. Pursuant to this agreement, Amarin
Neuroscience Limited appointed Icon Clinical Research Limited as its
clinical research organization for the European arm of the Phase III
clinical trials relating to the use of AMR101 in Huntington’s
disease.
|
•
|
Employment
Agreement dated May 12, 2004 and amended September 1, 2005 with
Alan Cooke.
|
•
|
Clinical
Supply Extension Agreement dated December 13, 2005 between Amarin
Pharmaceuticals Ireland Limited and Amarin Neuroscience Limited and
Nisshin Flour Milling Co.
|
•
|
Form
of Securities Purchase Agreement dated December 16, 2005 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 44 separate Securities Purchase Agreements on
December 16, 2005 all substantially similar in form and content to
this Securities Purchase Agreement pursuant to which we issued an
aggregate of 26,100,098 ordinary shares to such Purchasers, including
management. The purchase price was $1.01 per ordinary
share.
|
•
|
Form
of Securities Purchase Agreement dated January 23, 2006 between
Amarin Corporation plc and the Purchasers named therein. The Company
entered into 2 separate Securities Purchase Agreements on
January 23, 2006 both substantially similar in form and content to
this Securities Purchase Agreement pursuant to which we issued an
aggregate of 840,000 ordinary shares to such Purchasers. The purchase
price was $2.50 per ordinary
share.
|
•
|
Assignment
Agreement dated May 17, 2006 between Amarin Pharmaceuticals Ireland
Limited and Dr Anthony Clarke. Pursuant to this agreement, Amarin
Pharmaceuticals Ireland Limited acquired the global rights to a novel oral
formulation of Apomorphine for the treatment of “off” episodes in patients
with advanced Parkinson’s disease.
|
•
|
Amendment
(Change Order Number 2), dated June 8, 2006 to Services Agreement dated
June 16, 2005 between Icon Clinical Research Limited and Amarin
Neuroscience Limited. Pursuant to this agreement, Icon Clinical
Research Limited revised the European Project Spceifications and related
costs.
|
•
|
Lease
Agreement dated July 4, 2006 between Amarin Neuroscience Limited and
Magdalen Development Company Limited and Prudential Development Management
Limited. Pursuant to this agreement, Amarin Neuroscience Limited took a
lease of a premises at the South West Wing First Floor Office Suite, The
Magdalen Centre North, The Oxford Science Park, Oxford,
England.
|
•
|
Form
of Securities Purchase Agreement dated October 18, 2006 between
Amarin Corporation plc and the Purchasers named therein. The Company
entered into 32 separate Securities Purchase Agreements on
October 18, 2006 all substantially similar in form and content to
this Securities Purchase Agreement pursuant to which we issued an
aggregate of 8,965,600 ordinary shares to such Purchasers. The purchase
price was $2.09 per ordinary share.
|
•
|
Master
Services Agreement dated November 15, 2006 between Amarin
Pharmaceuticals Ireland Limited and Icon Clinical Research (U.K.) Limited.
Pursuant to this agreement, Icon Clinical Research (U.K.) Limited agreed
to provide due diligence services to Amarin Pharmaceuticals Ireland
Limited with respect to potential licensing opportunities on an ongoing
basis.
|
•
|
Amendment
dated December 8, 2006 to Clinical Trial Agreement dated March 18, 2005
between Amarin Neuroscience Limited and the University of
Rochester.
|
•
|
Agreement
dated January 18, 2007 between Neurostat Pharmaceuticals Inc.
(“Neurostat”), Amarin Pharmaceuticals Ireland Limited, Amarin Corporation
plc and Mr. Tim Lynch whereby the Company agreed to pay Neurostat a
finder’s fee relating to a potential licensing transaction and similar
payments comprising upfront and contingent milestones totaling $565,000
and warrants to purchase 175,000 ordinary shares with an exercise price of
$1.79 per ordinary share.
|
•
|
Lease
Agreement dated January 22, 2007 between Amarin Corporation plc, Amarin
Pharmaceuticals Ireland Limited and Mr. David Colgan, Mr. Philip
Monaghan, Mr. Finian McDonnell and Mr. Patrick Ryan. Pursuant to
this agreement, Amarin Pharmaceuticals Ireland Limited took a lease of a
premises at The First Floor, Block 3, The Oval, Shelbourne Road,
Dublin 4.
|
•
|
Amendment
(Change Order Number 4), dated February 15, 2007 to Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited
and Amarin Neuroscience Limited. Pursuant to this agreement, Icon Clinical
Research Limited agreed to conduct for Amarin Neuroscience Limited a one
year E.U. open label follow-up study to the existing Phase III study in
Huntington’s Disease.
|
•
|
Employment
Agreement Amendment dated February 21, 2007 with Alan
Cooke.
|
•
|
Amendment
(Change Order Number 3), dated March 1, 2007 to Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited
and Amarin Neuroscience Limited. Pursuant to this agreement, Icon Clinical
Research Limited agreed to increase the patient numbers to
290 patients from 240 patients (pursuant to the original
services agreement dated June 16, 2005 between Icon Clinical Research
Limited and Amarin Neuroscience
Limited).
|
•
|
Development
and License Agreement dated March 6, 2007 between Amarin Pharmaceuticals
Ireland Limited and Elan Pharma International Limited. Pursuant
to this agreement, Amarin Pharmaceuticals Ireland Limited acquired global
rights to a novel nasal lorazepam formulation for the treatment of
emergency seizures in epilepsy
patients.
|
•
|
Consultancy
Agreement dated March 9, 2007 between Amarin Corporation plc and
Dalriada Limited. Under the Consultancy Agreement, Amarin Corporation plc
will pay Dalriada Limited a fee of £240,000 per annum for the
provision of the consultancy services. Dalriada Limited is owned by a
family trust, the beneficiaries of which include our Chairman and Chief
Executive Officer, Mr. Thomas Lynch, and members of his
family.
|
•
|
Form
of Securities Purchase Agreement dated June 1, 2007 between Amarin
Corporation plc and the Purchasers named therein. Amarin Corporation plc
entered into 11 separate Securities Purchase Agreements on June 1, 2007
all substantially similar in form and content to this Securities Purchase
Agreement pursuant to which we issued an aggregate of 6,156,406 ordinary
shares to such Purchasers, including management. The purchase price was
$0.60 per ordinary share.
|
•
|
Equity
Credit Agreement dated June 1, 2007 between Amarin Corporation plc and
Brittany Capital Management. Pursuant to this agreement, Amarin
has an option to draw up to $15,000,000 of funding at any time over a
three year period solely at Amarin Corporation plc’s
discretion.
|
•
|
Form
of Equity Securities Purchase Agreement dated December 4, 2007 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 19 separate Equity Securities Purchase
Agreements on December 4, 2007 all substantially similar in form and
content to this Equity Securities Purchase Agreement pursuant to which we
issued an aggregate of 16,290,900 ordinary shares to such Purchasers,
including management. The purchase price was $0.33 per ordinary
share.
|
•
|
Form
of Debt Securities Purchase Agreement dated December 4, 2007 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 2 separate Debt Securities Purchase
Agreements on December 4, 2007 both substantially similar in form and
content to this Debt Securities Purchase Agreement pursuant to which we
issued an aggregate of $2,750,000 of 3 year convertible loan notes to such
Purchasers including management. The conversion price to convert the loan
notes into ordinary shares of Amarin Corporation plc is $0.48 per ordinary
share.
|
•
|
Stock
Purchase Agreement dated December 5, 2007 between Amarin Corporation plc,
the selling shareholders of Ester Neurosciences Limited (“Ester”), Ester,
and Medica II Management L.P. pursuant to which Amarin Corporation plc
acquired the entire issued share capital of Ester. Pursuant to
this agreement, Amarin Corporation plc paid initial consideration of
$15,000,000, of which $5,000,000 was paid in cash and $10,000,000 was paid
through the issuance of shares of Amarin Corporation
plc. Additional contingent payments, valued at an aggregate of
$17,000,000 are payable in the event that certain development-based
milestones are successfully
completed.
|
•
|
Letter
Agreement dated December 6, 2007 between Amarin Corporation plc and the
Seller’s Representatives of the selling shareholders of Ester pursuant to
which the definition of “Closing Date Average Buyer Stock Price” in the
Stock Purchase Agreement dated December 5, 2007 described above was
amended.
|
•
|
Senior
Indenture dated December 6, 2007 between Amarin Corporation plc and
Wilmington Trust Company. Under this Indenture, Amarin
Corporation plc may issue one or more series of senior debt securities
from time to time.
|
•
|
First
Supplemental Senior Indenture dated December 6, 2007 between Amarin
Corporation plc and Wilmington Trust Company. Under this
Supplemental Indenture, together with the senior debt indenture dated
December 6, 2007 described above, Amarin Corporation plc issued its 8%
Convertible Debentures due 2010.
|
•
|
Compromise
Agreement dated December 19, 2007 between Amarin Corporation plc and
Richard Stewart.
|
•
|
Collaboration
Agreement dated January 8, 2008 between Amarin Pharmaceuticals Ireland
Limited and ProSeed Capital Holdings (“ProSeed”). Pursuant to this
agreement, 975,000 ordinary shares in Amarin Corporation plc were issued
in the form of ADSs to ProSeed in respect of fees due for investment
banking advice provided to Amarin Corporation plc and Amarin
Pharmaceuticals Ireland Limited on the acquisition of
Ester.
|
•
|
Amendment
No. 1 to Stock Purchase Agreement dated April 7, 2008 between Amarin
Corporation plc and Medica II Management L.P. pursuant to which the
definition of “Milestone II Time Limit Date” in the Stock Purchase
Agreement dated December 5, 2007 described above was
amended.
|
•
|
Employment
Agreement dated April 28, 2008 with Dr Declan
Doogan.
|
•
|
Form
of Equity Securities Purchase Agreement dated May 13, 2008 between Amarin
Corporation plc and the Purchasers named therein. Amarin Corporation plc
entered into 9 separate Equity Securities Purchase Agreements
on May 13, 2008 all substantially similar in form and content to this
Securities Purchase Agreement pursuant to which we issued an aggregate
of 12,173,914 Ordinary Shares and 8 Preference Shares to such
Purchasers. The purchase price was $2.30 per Ordinary
Share.
|
•
|
an
individual citizen or resident of the
US;
|
•
|
a
corporation organized under the laws of the U.S. or any state thereof
or the District of
Columbia; or
|
•
|
otherwise
subject to U.S. federal income tax on a net income basis in respect
of the Ordinary Shares or ADSs.
|
•
|
upon
current U.K. tax law and Revenue and Customs practice and which may be
subject to change, perhaps with retroactive
effect; and
|
•
|
in
part upon representations of Citibank, N.A., as depositary, and assumes
that each obligation provided for in or otherwise contemplated by the
deposit agreement between us and Citibank and any related agreement will
be performed in accordance with its respective
terms.
|
•
|
you
are resident or, in the case of an individual, ordinarily resident in the
U.K. for U.K. tax purposes;
|
•
|
your
holding of ADSs or shares is effectively connected with a permanent
establishment in the U.K. through which you carry on business activities
or, in the case of an individual who performs independent personal
services, with a fixed base situated
therein; or
|
•
|
you
are a corporation which, alone or together with one or more associated
corporations, controls, directly or indirectly, 10% or more of our issued
voting share capital.
|
•
|
to,
or to a nominee or agent for, a person whose business is or includes the
provision of clearance
services; or
|
•
|
to,
or to a nominee or agent for, a person whose business is or includes
issuing depositary receipts.
|
·
|
an
individual who is a citizen or resident of the
U.S.;
|
·
|
a
corporation (or other entity treated as a corporation for U.S. federal
income tax purposes) created or organized in the U.S. or under the laws of
the U.S. or of any state thereof or the District of
Columbia;
|
·
|
an
estate, the income of which is includible in gross income for U.S. federal
income tax purposes regardless of its source;
or
|
·
|
a
trust (i) if a court within the U.S. is able to exercise primary
supervision over the administration of the trust and one or more U.S.
persons have the authority to control all substantial decisions of the
trust or (ii) if it made a valid election to be treated as a U.S.
person.
|
·
|
the
excess distribution or gain would be allocated ratably over the U.S.
Holder’s holding period, including the holding period that the U.S. Holder
owned the Debentures or Warrants;
|
·
|
the
amount allocated to the current taxable year and any taxable year prior to
the first taxable year in which we are a PFIC would be taxed as ordinary
income; and
|
·
|
the
amount allocated to each of the prior taxable years would be subject to
tax at the highest rate of tax in effect for the taxpayer for that year,
and an interest charge for the deemed deferral benefit would be imposed
with respect to the resulting tax attributable to each such prior taxable
year.
|
·
|
the
foreign exchange is regulated or supervised by a governmental authority of
the country in which the exchange is
located;
|
·
|
the
foreign exchange has trading volume, listing, financial disclosure, and
other requirements designed to prevent fraudulent and manipulative acts
and practices, remove impediments to, and perfect the mechanism of, a free
and open market, and to protect
investors;
|
·
|
the
laws of the country in which the exchange is located and the rules of the
exchange ensure that these requirements are actually enforced;
and
|
·
|
the
rules of the exchange effectively promote active trading of listed
stocks.
|
•
|
foreign
exchange rates — generating translation and transaction gains and
losses; and
|
•
|
interest
rate risks related to financial and other
liabilities.
|
2007
|
2006
|
||
($’000)
|
|
($’000)
|
|
Audit
fees
|
516
|
357
|
|
Audit-related
fees
|
153
|
150
|
|
Tax
fees
|
43
|
18
|
|
All
other fees
|
88
|
105
|
|
Total
|
800
|
630
|
1.1
|
Memorandum
of Association of the Group(16)
|
1.2
|
Articles
of Association of the Group(17)
|
2.1
|
Form
of Deposit Agreement, dated as of March 29, 1993, among the
Group,Citibank, N.A., as Depositary, and all holders from time to time of
American Depositary Receipts issued thereunder(1)
|
2.2
|
Amendment
No. 1 to Deposit Agreement, dated as of October 8, 1998, among
the Group, Citibank, N.A., as Depositary, and all holders from time to
time of the American Depositary Receipts issued
thereunder(2)
|
2.3
|
Amendment
No. 2 to Deposit Agreement, dated as of September 25,2002 among
the Group, Citibank N.A., as depositary, and all holders from time to time
of the American Depositary Receipts issued
thereunder(3)
|
2.4
|
Form
of Ordinary Share certificate(10)
|
2.5
|
Form
of American Depositary Receipt evidencing ADSs (included in
Exhibit 2.3)(3)
|
2.6
|
Registration
Rights Agreement, dated as of October 21, 1998, by and among Ethical
Holdings plc and Monksland Holdings B.V.(10)
|
2.7
|
Amendment
No. 1 to Registration Rights Agreement and Waiver, dated
January 27, 2003, by and among the Group, Elan International
Services, Ltd. and Monksland Holdings B.V.(10)
|
2.8
|
Second
Subscription Agreement, dated as of November 1999, among Ethical Holdings
PLC, Monksland Holdings B.V. and Elan Corporation
PLC(4)
|
2.9
|
Purchase
Agreement, dated as of June 16, 2000, by and among the Group and the
Purchasers named therein(4)
|
2.10
|
Registration
Rights Agreement, dated as of November 24, 2000, by and between the
Group and Laxdale Limited(5)
|
2.11
|
Form
of Subscription Agreement, dated as of January 27, 2003 by and among
the Group and the Purchasers named therein(10) (The Group entered into
twenty separate Subscription Agreements on January 27, 2003 all
substantially similar in form and content to this form of Subscription
Agreement.).
|
2.12
|
Form
of Registration Rights Agreement, dated as of January 27, 2003
between the Group and the Purchasers named therein (10) (The Group entered
into twenty separate Registration Rights Agreements on January 27,
2003 all substantially similar in form and content to this form of
Registration Rights Agreement.).
|
2.13
|
Securities
Purchase Agreement dated as of December 16, 2005 by and among the
Group and the purchasers named therein(16)
|
4.1
|
Amended
and Restated Asset Purchase Agreement dated September 29, 1999
between Elan Pharmaceuticals Inc. and the
Group(10)
|
4.36
|
Amendment
Agreement No. 1, dated August 4, 2003, to Amended and Restated
Asset Purchase Agreement among Elan International Services, Ltd., Elan
Pharmaceuticals, Inc. and theGroup(11)(12)
|
4.37
|
Warrant
dated February 25, 2004 issued by the Group in favor of the Warrant
Holders named therein(12)
|
4.38
|
Amendment
Agreement dated December 23, 2003, between Elan Corporation plc, Elan
Pharma International Limited, Elan Pharmaceuticals, Inc., Monksland
Holdings BV and the Group(11)(12)
|
4.39
|
Bridging
Loan Agreement dated December 23, 2003 between the Group and Elan
Pharmaceuticals, Inc.(11)(12)
|
4.40
|
Agreement
dated December 23, 2003 between the Group and Elan Pharma
International Limited, amending the Amended and Restated Option Agreement
dated August 4, 2003(11)(12)
|
4.41
|
Form
of Subscription Agreement, dated as of October 7, 2004 by and among
the Group and the Purchasers named therein(13) (The Group entered into 14
separate Subscription Agreements on October 7, 2004 all substantially
similar in form and content to this form of Subscription
Agreement.)
|
4.42
|
Form
of Registration Rights Agreement, dated as of October 7, 2004 between
the Group and the Purchasers named therein(13) (The Group entered into 14
separate Registration Rights Agreements on October 7, 2004 all
substantially similar in form and content to this form of Registration
Rights Agreement.)
|
4.43
|
Share
Purchase Agreement dated October 8, 2004 between the Group,Vida
Capital Partners Limited and theVendors named therein relating to the
entire issued share capital of Laxdale Limited(13)
|
4.44
|
Escrow
Agreement dated October 8, 2004 among the Group, Belsay Limited and
Simcocks Trust Limited as escrow agent(13)
|
4.45
|
Loan
Note Redemption Agreement dated October 14, 2004 between
Amarin Investment Holding Limited and the Group(13)
|
4.46
|
Settlement
agreement dated 27 September 2004 between the Group and Valeant
Pharmaceuticals International(14)†
|
4.47
|
Exclusive
License Agreement dated October 8, 2004 between Laxdale and Scarista
Limited pursuant to which Scarista has the exclusive right to use certain
of Laxdale’s intellectual property(14)†
|
4.48
|
Clinical
Supply Agreement between Laxdale and Nisshin Flour Milling Co.,Limited
dated 27th October 1999(14)†
|
4.49
|
Clinical
Trial Agreement dated March 18, 2005 between Amarin Neuroscience
Limited and the University of Rochester. Pursuant to this agreement the
University is obliged to carry out or to facilitate the carrying out of a
clinical trial research study set forth in a research protocol on AMR 101
in patients with Huntington’s disease(14)†
|
4.50
|
Loan
Note Redemption Agreement dated May, 2005 between Amarin
Investment Holding Limited and the Group.(14)
|
4.51
|
Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited
and Amarin Neuroscience Limited.(15)
|
4.52
|
Employment
Agreement with Alan Cooke, dated May 12, 2004 and amended
September 1, 2005.(16)
|
4.53
|
Clinical
Supply Extension Agreement dated December 13, 2005 to Agreement
between Amarin Pharmaceuticals Ireland Limited and Amarin Neuroscience
Limited and Nisshin Flour Milling Co.†(17)
|
4.54
|
Securities
Purchase Agreement dated May 20, 2005 between the Company and the
purchasers named therein. The Company entered into 34 separate
Securities Purchase Agreements on May 18, 2005 and in total issued
13,677,110 ordinary shares to management, institutional and accredited
investors. The purchase price was $1.30 per ordinary
share.(17)
|
4.55
|
Securities
Purchase Agreement dated January 23, 2006 between the Company and the
purchasers named therein. The Company entered into 2 separate
Securities Purchase Agreements on January 23, 2006 and in total
issued 840,000 ordinary shares to accredited investors. The purchase price
was $2.50 per ordinary
share.(17)
|
4.56
|
Assignment
Agreement dated May 17, 2006 between Amarin Pharmaceuticals Ireland
Limited and Dr Anthony Clarke, pursuant to which, Amarin
Pharmaceuticals Ireland Limited acquired the global rights to a novel oral
formulation of Apomorphine for the treatment of “off” episodes in patients
with advanced Parkinson’s disease.(17)
|
4.57 | Amendment (Change Order Numer 2), dated June 8, 2006 to Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited.* |
4.58
|
Lease
Agreement dated July 4, 2006 between Amarin Neuroscience Limited and
Magdalen Development Company Limited and Prudential Development Management
Limited. Pursuant to this agreement, Amarin Neuroscience Limited took a
lease of a premises at the South West Wing First Floor Office Suite, The
Magdalen Centre North, The Oxford Science Park, Oxford,
England.(17)
|
4.59
|
Securities
Purchase Agreement dated October 18, 2006 between the Company and the
purchasers named therein. The Company entered into 32 separate
Securities Purchase Agreements on October 18, 2006 and in total
issued 8,965,600 ordinary shares to institutional and accredited
investors. The purchase price was $2.09 per ordinary
share(17)
|
4.60
|
Master
Services
Agreement
dated November 15, 2006 between Amarin Pharmaceuticals Ireland
Limited and Icon Clinical Research (U.K.) Limited. Pursuant to this
agreement, Icon Clinical Research (U.K.) Limited agreed to provide due
diligence services to Amarin Pharmaceuticals Ireland Limited on ongoing
licensing opportunities on an ongoing basis.(17)
|
4.61
|
Amendment
dated December 8, 2006 to Clinical Trial Agreement dated
March 18, 2005 between Amarin Neuroscience Limited and the University
of Rochester.†(17)
|
4.62 | Agreement dated January 18, 2007 between Neurostat Pharmaceuticals Inc. ("Neurostat"), Amarin Pharmaceuticals Ireland Limited, Amarin Corporation plc and Mr. Tim Lynch whereby the Company agreed to pay Neurostat a finder's fee relating to a potential licensing transaction and similar payments comprising upfront and contingent milestones totaling $565,000 and warrants to purchase 175,000 ordinary shares with an exercise price of $1.79 per ordinary share.* |
4.63
|
Lease
Agreement dated January 22, 2007 between the Company, Amarin
Pharmaceuticals Ireland Limited and Mr. David Colgan, Mr. Philip
Monaghan, Mr. Finian McDonnell and Mr. Patrick Ryan. Pursuant to
this agreement, Amarin Pharmaceuticals Ireland Limited took a lease of a
premises at The First Floor, Block 3, The Oval, Shelbourne Road,
Dublin 4, Ireland.(17)
|
4.64
|
Amendment
(Change Order Number 4), dated February 15, 2007 to Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited
and Amarin Neuroscience Limited. (17)
|
4.65
|
Employment
Agreement Amendment with Alan Cooke, dated February 21,
2007.(17)
|
4.66
|
Amendment
(Change Order Number 3), dated March 1, 2007 to Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited and
Amarin Neuroscience Limited.(17)
|
4.67
|
Development
and License Agreement dated March 6, 2007 between Amarin Pharmaceuticals
Ireland Limited and Elan Pharma International Limited. Pursuant
to this agreement, Amarin Pharmaceuticals Ireland Limited acquired global
rights to a novel nasal lorazepam formulation for the treatment of
emergency seizures in epilepsy patients.*
†
|
4.68
|
Consultancy
Agreement dated March 9, 2007 between Amarin Corporation plc and
Dalriada Limited. Under the Consultancy Agreement, Amarin Corporation plc
will pay Dalriada Limited a fee of £240,000 per annum for the
provision of the consultancy services. Dalriada Limited is owned by a
family trust, the beneficiaries of which include our Chairman and Chief
Executive Officer, Mr. Thomas Lynch, and members of his
family.*
|
4.69
|
Form
of Securities Purchase Agreement dated June 1, 2007 between Amarin
Corporation plc and the Purchasers named therein. Amarin Corporation plc
entered into 11 separate Securities Purchase Agreements on June 1, 2007
all substantially similar in form and content to this Securities Purchase
Agreement pursuant to which we issued an aggregate of 6,156,406 ordinary
shares to such Purchasers, including management. The purchase price was
$0.60 per ordinary share.*
|
4.70
|
Equity
Credit Agreement dated June 1, 2007 between Amarin Corporation plc and
Brittany Capital Management. Pursuant to this agreement, Amarin
has an option to draw up to $15,000,000 of funding at any time over a
three year period solely at Amarin Corporation plc’s
discretion.(18)
|
4.71
|
Form
of Equity Securities Purchase Agreement dated December 4, 2007 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 19 separate Equity Securities Purchase
Agreements on December 4, 2007 all substantially similar in form and
content to this Equity Securities Purchase Agreement pursuant to which we
issued an aggregate of 16,290,900 ordinary shares to such Purchasers,
including management. The purchase price was $0.33 per ordinary
share.(19)
|
4.72
|
Form
of Debt Securities Purchase Agreement dated December 4, 2007 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 2 separate Debt Securities Purchase
Agreements on December 4, 2007 both substantially similar in form and
content to this Debt Securities Purchase Agreement pursuant to which we
issued an aggregate of $2,750,000 of 3 year convertible loan notes to such
Purchasers including management. The conversion price to convert the loan
notes into ordinary shares of Amarin Corporation plc is $0.48 per ordinary
share.(19)
|
4.73
|
Stock
Purchase Agreement dated December 5, 2007 between Amarin Corporation plc,
the selling shareholders of Ester Neurosciences Limited (“Ester”), Ester,
and Medica II Management L.P. pursuant to which Amarin Corporation plc
acquired the entire issued share capital of Ester. Pursuant to
this agreement, Amarin Corporation plc paid initial consideration of
$15,000,000, of which $5,000,000 was paid in cash and $10,000,000 was paid
through the issuance of shares of Amarin Corporation
plc. Additional contingent payments, valued at an aggregate of
$17,000,000 are payable in the event that certain development-based
milestones are successfully completed.(21)
|
4.74
|
Letter
Agreement dated December 6, 2007 between Amarin Corporation plc and the
Seller’s Representatives of the selling shareholders of Ester pursuant to
which the definition of “Closing Date Average Buyer Stock Price” in the
Stock Purchase Agreement dated December 5, 2007 described above was
amended.(22)
|
4.75
|
Senior
Indenture dated December 6, 2007 between Amarin Corporation plc and
Wilmington Trust Company. Under this Indenture, Amarin
Corporation plc may issue one or more series of senior debt securities
from time to time.(19)
|
4.76
|
First
Supplemental Senior Indenture dated December 6, 2007 between Amarin
Corporation plc and Wilmington Trust Company. Under this
Supplemental Indenture, together with the senior debt indenture dated
December 6, 2007 described above, Amarin Corporation plc issued its 8%
Convertible Debentures due 2010.(19)
|
4.77
|
Compromise
Agreement dated December 19, 2007 between Amarin Corporation plc and
Richard Stewart.(20)
|
4.78
|
Collaboration
Agreement dated January 8, 2008 between Amarin Pharmaceuticals Ireland
Limited and ProSeed Capital Holdings (“ProSeed”). Pursuant to this
agreement, 975,000 ordinary shares in Amarin Corporation plc were issued
in the form of ADSs to ProSeed in respect of fees due for investment
banking advice provided to Amarin Corporation plc and Amarin
Pharmaceuticals Ireland Limited on the acquisition of Ester.*
†
|
4.79
|
Amendment
No. 1 to Stock Purchase Agreement dated April 7, 2008 between Amarin
Corporation plc and Medica II Management L.P. pursuant to which the
definition of “Milestone II Time Limit Date” in the Stock Purchase
Agreement dated December 5, 2007 described above was
amended.*
|
4.80
|
Employment
Agreement dated April 28, 2008 with Dr Declan Doogan.*
|
4.81
|
Form
of Equity Securities Purchase Agreement dated May 13, 2008 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 9 separate Equity Securities Purchase
Agreements on May 13, 2008 all substantially similar in form and
content to this Securities Purchase Agreement pursuant to which we issued
an aggregate of 12,173,914 Ordinary Shares and 8 Preference Shares to
such Purchasers. The purchase price was $2.30 per Ordinary
Share.*
†
|
8.1
|
Subsidiaries
of the Group*
|
11.1
|
Code
of Ethics(17)
|
12.1
|
Certification
of Thomas G. Lynch required by Rl 15d-14(a) of the Securities Exchange Act
of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002*
|
12.2
|
Certification
of Alan Cooke required by Rule 15d-14(a) of the Securities Exchange
Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002*
|
13.1
|
Certification
of Thomas G. Lynch required by Section 1350 of Chapter 63 of
Title 18 of the United States Code, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002*
|
13.2
|
Certification
of Alan Cooke required by Section 1350 of Chapter 63 of
Title 18 of the United States Code, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002*
|
14.1
|
Consent
of PricewaterhouseCoopers *
|
*
|
Filed
herewith
|
†
|
Confidential
treatment requested (the confidential portions of such exhibits have been
omitted and filed separately with the Securities and Exchange
Commission)
|
(1)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F-1, File No. 33-58160, filed with the
Securities and Exchange Commission on February 11,
1993.
|
(2)
|
Incorporated
herein by reference to Exhibit (a)(i) to the Group’s Registration
Statement on Post-Effective Amendment No. 1 to Form F-6, File
No. 333-5946, filed with the Securities and Exchange Commission on
October 8, 1998.
|
(3)
|
Incorporated
herein by reference to Exhibit (a)(ii) to the Group’s Registration
Statement on Post-Effective Amendment No. 2 to Form F-6, File
No. 333-5946, filed with the Securities and Exchange Commission on
September 26, 2002.
|
(4)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 1999, filed with the
Securities and Exchange Commission on June 30,
2000.
|
(5)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F-3, File No. 333-13200, filed with the
Securities and Exchange Commission on February 22,
2001.
|
(6)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2000, filed with the
Securities and Exchange Commission on July 2,
2001.
|
(7)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2001, filed with the
Securities and Exchange Commission on May 9, 2002.
|
(8)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Pre-Effective Amendment No. 2 to Form F-3, File
No. 333-13200, filed with the Securities and Exchange Commission on
November 19, 2001.
|
(9)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form S-8, File No. 333-101775, filed with the
Securities and Exchange Commission on December 11,
2002.
|
(10)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2002, filed with the
Securities and Exchange Commission on April 24,
2003.
|
(11)
|
These
agreements are no longer in effect as a result of superseding agreements
entered into by the Group.
|
(12)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2003, filed with the
Securities and Exchange Commission on March 31,
2004.
|
(13)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F-3, File No. 333-121431, filed with the
Securities and Exchange Commission on December 20,
2004.
|
(14)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2004, filed with the
Securities and Exchange Commission on April 1,
2005.
|
(15)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F-3, File No. 333-
131479
, filed with the Securities and
Exchange Commission on February 2, 2006.
|
(16)
|
Incorporated
by reference herein to certain exhibits in the Group’s Annual Report on
Form 20-F for the year ended December 31, 2005, filed with the
Securities and Exchange Commission on March 30, 2006 as amended on
Form 20-F/A filed October 13, 2006.
|
(17) | Incorporated by reference herein to certain exhibits in the Group's Annual Report on Form 20-F for the year ended December 31, 2006, filed with the Securities and Exchange Commission on March 5, 2007. |
(18) | Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on June 1, 2007. |
(19) | Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on December 17, 2007. |
(20) | Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on December 19, 2007. |
(21) | Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on January 28, 2008. |
(22) | Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on February 1, 2008. |
|
By: /s/ THOMAS
G. LYNCH
|
Total
|
Total
|
|||||||||||
Note
|
2007
|
2006
|
||||||||||
$’000
|
$’000
|
|||||||||||
Revenue
|
4 | — | 500 | |||||||||
Gross
profit
|
— | 500 | ||||||||||
Research
and development
expenses
|
6 | (12,108 | ) | (15,106 | ) | |||||||
Selling,
general and administrative
expenses
|
6 | (19,841 | ) | (13,462 | ) | |||||||
Impairment
of intangible
assets
|
5, 6 | (8,784 | ) | — | ||||||||
Total
operating
expenses
|
(40,733 | ) | (28,568 | ) | ||||||||
Operating
loss
|
(40,733 | ) | (28,068 | ) | ||||||||
Finance
income
|
9 | 1,882 | 3,344 | |||||||||
Finance
costs
|
10 | (183 | ) | (2,826 | ) | |||||||
Loss
before
taxation
|
(39,034 | ) | (27,550 | ) | ||||||||
Tax
credit
|
12 | 837 | 799 | |||||||||
Loss
attributable to equity holders of the
parent
|
(38,197 | ) | (26,751 | ) | ||||||||
U.S. Cents
|
U.S. Cents
|
|||||||||||
Basic loss per ordinary
share*
|
14 | (3.90 | ) | (3.25 | ) | |||||||
Diluted loss per
ordinary
share*
|
14 | (3.90 | ) | (3.25 | ) |
Group
|
Company
|
|||||||||||||||||||
Note
|
2007
|
2006
|
2007
|
2006
|
||||||||||||||||
$’000
|
$’000
|
$’000
|
$’000
|
|||||||||||||||||
Non-current
assets
Property,
plant and equipment
|
16
|
595 | 314 | 19 | 25 | |||||||||||||||
Intangible
assets
|
15
|
19,916 | 9,636 | 19,916 | 3,765 | |||||||||||||||
Investments
in subsidiaries
|
17
|
— | — | 60,136 | 22,715 | |||||||||||||||
Available
for sale investments
|
20
|
15 | 18 | 15 | 18 | |||||||||||||||
Total
non-current assets
|
20,526 | 9,968 | 80,086 | 26,523 | ||||||||||||||||
Current
assets
Inventory
|
18
|
— | — | — | — | |||||||||||||||
Current
tax recoverable
|
19 | 1,704 | 1,617 | — | — | |||||||||||||||
Other
current assets
|
19 | 1,721 | 1,172 | 1,059 | 770 | |||||||||||||||
Cash
and cash equivalents
|
18,303 | 36,802 | 17,298 | 34,719 | ||||||||||||||||
Total
current assets
|
21,728 | 39,591 | 18,357 | 35,489 | ||||||||||||||||
Total
assets
|
42,254 | 49,559 | 98,443 | 62,012 | ||||||||||||||||
Non-current
liabilities
Borrowings
|
21 | 2,051 | — | 2,051 | — | |||||||||||||||
Provisions
|
24 | 606 | 110 | 606 | 110 | |||||||||||||||
Other
liabilities
|
23 | 36 | — | — | — | |||||||||||||||
Total
non-current liabilities
|
2,693 | 110 | 2,657 | 110 | ||||||||||||||||
Current
liabilities
|
||||||||||||||||||||
Trade
payables
|
3,462 | 2,096 | 841 | 396 | ||||||||||||||||
Accrued
expenses and other liabilities
|
22 | 6,733 | 8,625 | 3,430 | 1,814 | |||||||||||||||
Provisions
|
24 | 5,217 | 160 | 5,217 | 160 | |||||||||||||||
Total
current
liabilities
|
15,412 | 10,881 | 9,488 | 2,370 | ||||||||||||||||
Total
liabilities
|
18,105 | 10,991 | 12,145 | 2,480 | ||||||||||||||||
Equity
Capital
and reserves attributable to equity holders of the Company
Share
capital
|
26
|
12,942 | 7,990 | 12,942 | 7,990 | |||||||||||||||
Share
premium
|
147,171 | 139,313 | 147,171 | 136,587 | ||||||||||||||||
Share
based payment reserve
|
28 | 10,175 | 4,824 | 10,175 | 4,824 | |||||||||||||||
Warrant
reserve
|
13,328 | 10,009 | 13,328 | 10,009 | ||||||||||||||||
Equity
component of 8% convertible debt
|
145 | — | 145 | — | ||||||||||||||||
Capital
redemption
reserve
|
27,633 | 27,633 | 27,633 | 27,633 | ||||||||||||||||
Treasury
shares
|
(217 | ) | (217 | ) | — | — | ||||||||||||||
Foreign
currency translation reserve
|
(1,836 | ) | (1,261 | ) | 832 | 683 | ||||||||||||||
Retained
earnings
|
(185,192 | ) | (149,723 | ) | (125,928 | ) | (128,194 | ) | ||||||||||||
Total
shareholders’
equity
|
24,149 | 38,568 | 86,298 | 59,532 | ||||||||||||||||
Total
shareholders’ equity and liabilities
|
42,254 | 49,559 | 98,443 | 62,012 |
Share
capital
|
Share
premium
|
Share
based payment reserve
|
Warrant
reserve
|
Equity
component of 8% convertible debt
|
Capital
redemption reserve
|
Treasury
shares
|
Foreign
currency translation reserve
|
Retained
earnings
|
Total
|
|||||||||||||||||||||||||||||||
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||||||||||||||||||
At
January 1, 2006
|
6,778 | 113,239 | 2,623 | 9,620 | — | 27,633 | (217 | ) | 697 | (122,972 | ) | 37,401 | ||||||||||||||||||||||||||||
Share
issuances
|
1,212 | 25,212 | — | — | — | — | — | — | — | 26,424 | ||||||||||||||||||||||||||||||
Share
issuance costs
|
— | (2,450 | ) | — | — | — | — | — | — | — | (2,450 | ) | ||||||||||||||||||||||||||||
Share
based compensation
|
— | — | 2,201 | — | — | — | — | — | — | 2,201 | ||||||||||||||||||||||||||||||
Fair
value of future investment right
|
— | 3,701 | — | — | — | — | — | — | — | 3,701 | ||||||||||||||||||||||||||||||
Warrant
issue/exercise
|
— | (389 | ) | — | 389 | — | — | — | — | — | — | |||||||||||||||||||||||||||||
Recognized income and
expense:
|
||||||||||||||||||||||||||||||||||||||||
Foreign
currency translation adjustment
|
— | — | — | — | — | — | — | (1,958 | ) | — | (1,958 | ) | ||||||||||||||||||||||||||||
Net
loss recognized directly in equity
|
— | — | — | — | — | — | — | (1,958 | ) | — | (1,958 | ) | ||||||||||||||||||||||||||||
Loss
for the year
|
— | — | — | — | — | — | — | — | (26,751 | ) | (26,751 | ) | ||||||||||||||||||||||||||||
Total
recognized income and expense
|
— | — | — | — | — | — | — | (1,958 | ) | (26,751 | ) | (28,709 | ) | |||||||||||||||||||||||||||
At
December 31, 2006 and
January
1, 2007
|
7,990 | 139,313 | 4,824 | 10,009 | — | 27,633 | (217 | ) | (1,261 | ) | (149,723 | ) | 38,568 | |||||||||||||||||||||||||||
Share
issuances
|
4,952 | 14,032 | — | — | — | — | — | — | — | 18,984 | ||||||||||||||||||||||||||||||
Share
issuance costs
|
— | (948 | ) | — | — | — | — | — | — | — | (948 | ) | ||||||||||||||||||||||||||||
Share
based compensation
|
— | — | 5,351 | — | — | — | — | — | — | 5,351 | ||||||||||||||||||||||||||||||
Warrant
issue/exercise
|
— | (2,498 | ) | — | 3,319 | — | — | — | — | — | 821 | |||||||||||||||||||||||||||||
Strike
off of subsidiary
|
— | (2,728 | ) | — | — | — | — | — | — | 2,728 | — | |||||||||||||||||||||||||||||
Fair
value of equity on 8%
convertible
debt
|
— | — | — | — | 145 | — | — | — | — | 145 | ||||||||||||||||||||||||||||||
Recognized income and
expense:
|
||||||||||||||||||||||||||||||||||||||||
Foreign
currency translation
adjustment
|
— | — | — | — | — | — | — | (575 | ) | — | (575 | ) | ||||||||||||||||||||||||||||
Net
loss recognized directly in equity
|
— | — | — | — | — | — | — | (575 | ) | — | (575 | ) | ||||||||||||||||||||||||||||
Loss
for the year
|
— | — | — | — | — | — | — | — | (38,197 | ) | (38,197 | ) | ||||||||||||||||||||||||||||
Total
recognized income and expense
|
(575 | ) | (38,197 | ) | (38,772 | ) | ||||||||||||||||||||||||||||||||||
At
December 31, 2007
|
12,942 | 147,171 | 10,175 | 13,328 | 145 | 27,633 | (217 | ) | (1,836 | ) | (185,192 | ) | 24,149 |
Share
capital
|
Share
premium |
Share
based payment
reserve |
Warrant
reserve |
Equity
component
of
8% convertible debt |
Capital
redemption reserve
|
Foreign
currency translation reserve |
Retained
earnings |
Total
|
|||||||||||||||||||||
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||||||||
At
January 1, 2006
|
6,778 | 110,513 | 2,623 | 9,620 | — | 27,633 | (235 | ) | (120,842 | ) | 36,090 | ||||||||||||||||||
Share
issuances
|
1,212 | 25,212 | — | — | — | — | — | — | 26,424 | ||||||||||||||||||||
Share
issuance costs
|
— | (2,450) | — | — | — | — | — | — | (2,450 | ) | |||||||||||||||||||
Share
based ompensation
|
— | — | 2,201 | — | — | — | — | — | 2,201 | ||||||||||||||||||||
Fair
value of future investment right
|
— | 3,701 | — | — | — | — | — | — | 3,701 | ||||||||||||||||||||
Warrant
issue/exercise
|
— | (389) | — | 389 | — | — | — | — | — | ||||||||||||||||||||
Recognized income and
expense:
|
|||||||||||||||||||||||||||||
Foreign
currency translation adjustment
|
— | — | — | — | — | — | 918 | — | 918 | ||||||||||||||||||||
Net
loss recognized directly in equity
|
— | — | — | — | — | — | 918 | — | 918 | ||||||||||||||||||||
Loss
for the year
|
— | — | — | — | — | — | — | (7,352 | ) | (7,352 | ) | ||||||||||||||||||
Total
recognized income and expense
|
— | — | — | — | — | — | 918 | (7,352 | ) | (6,434 | ) | ||||||||||||||||||
At
December 31, 2006 and
January
1, 2007
|
7,990 | 136,587 | 4,824 | 10,009 | — | 27,633 | 683 | (128,194 | ) | 59,532 | |||||||||||||||||||
Share
issuances
|
4,952 | 14,032 | — | — | — | — | — | — | 18,984 | ||||||||||||||||||||
Share
issuance costs
|
— | (950) | — | — | — | — | — | — | (950 | ) | |||||||||||||||||||
Share
based compensation
|
— | — | 5,351 | — | — | — | — | — | 5,351 | ||||||||||||||||||||
Warrant
issue/exercise
|
— | (2,498) | — | 3,319 | — | — | — | — | 821 | ||||||||||||||||||||
Adjustment
on asset acquisition
|
— | — | — | — | — | — | — | (371 | ) | (371 | ) | ||||||||||||||||||
Fair
value of equity on 8%
convertible
debt
|
— | — | — | — | 145 | — | — | — | 145 | ||||||||||||||||||||
Recognized income and
expense:
|
|||||||||||||||||||||||||||||
Foreign
currency translation
djustment
|
— | — | — | — | — | — | 149 | — | 149 | ||||||||||||||||||||
Net
loss recognized directly in equity
|
— | — | — | — | — | — | 149 | — | 149 | ||||||||||||||||||||
Profit
for the year
|
— | — | — | — | — | — | — | 2,637 | 2,637 | ||||||||||||||||||||
Total
recognized income and expense
|
— | — | — | — | — | — | 149 | 2,637 | 2,786 | ||||||||||||||||||||
At
December 31, 2007
|
12,942 | 147,171 | 10,175 | 13,328 | 145 | 27,633 | 832 | (125,928 | ) | 86,298 |
Group
|
Company
|
|||||||||||||||||||
Note
|
2007
|
2006
|
2007
|
2006
|
||||||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||||||
Cash flows from
operating
activities
|
||||||||||||||||||||
(Loss)/Profit
after tax
|
(38,197 | ) | (26,751 | ) | 2,637 | (7,352 | ) | |||||||||||||
Adjustments:
Depreciation
of property, plant and equipment
|
16
|
217 | 121 | 20 | 31 | |||||||||||||||
Amortization
of intangible assets
|
15
|
169 | 674 | 58 | 232 | |||||||||||||||
Impairment
of investment in subsidiary
|
17
|
— | — | 4,593 | — | |||||||||||||||
Impairment
of intangible assets
|
15
|
8,784 | — | 3,707 | — | |||||||||||||||
Impairment
of property, plant and equipment
|
— | 235 | — | 151 | ||||||||||||||||
Impairment
of available for sale investment
|
20
|
3 | — | 3 | — | |||||||||||||||
Share
based compensation
|
28,
17
|
5,001 | 2,201 | (640 | ) | 2,201 | ||||||||||||||
Share
based compensation - warrants
|
28
|
275 | — | 275 | — | |||||||||||||||
Effect
of exchange rate changes on assets/liabilities and other
items*
|
(560 | ) | (2,020 | ) | (858 | ) | 1,867 | |||||||||||||
Interest
received
|
9
|
(1,252 | ) | (1,344 | ) | (1,197 | ) | (1,299 | ) | |||||||||||
Interest
expense
|
10
|
176 | — | 176 | — | |||||||||||||||
Interest
paid on finance leases
|
4 | (2 | ) | — | — | |||||||||||||||
(Increase)/decrease
in other current assets
|
(250 | ) | 282 | 10 | (75 | ) | ||||||||||||||
(Decrease)/increase
in current liabilities
|
(1,359 | ) | 2,690 | 1,238 | (2,408 | ) | ||||||||||||||
(Decrease)
in other liabilities
|
— | (49 | ) | — | — | |||||||||||||||
Gain
on strike off of subsidiaries
|
17
|
— | — | (14,085 | ) | — | ||||||||||||||
Increase/(decrease)
in provisions
|
797 | 104 | 797 | (35 | ) | |||||||||||||||
R&D
tax credit
|
12
|
(837 | ) | (799 | ) | — | — | |||||||||||||
Cash
expended on operating activities
|
(27,029 | ) | (24,658 | ) | (3,266 | ) | (6,687 | ) | ||||||||||||
Tax
refund
|
750 | 505 | — | — | ||||||||||||||||
Net
cash outflow from operating activities
|
(26,279 | ) | (24,153 | ) | (3,266 | ) | (6,687 | ) | ||||||||||||
Cash
flows from investing activities
Purchase
intangible assets
|
(5,810 | ) | — | (5,810 | ) | — | ||||||||||||||
Interest
received
|
9
|
1,252 | 1,344 | 1,197 | 1,299 | |||||||||||||||
Investment
in subsidiaries
|
17
|
— | — | (22,288 | ) | (19,524 | ) | |||||||||||||
Purchases
of property, plant and equipment
|
(415 | ) | (245 | ) | (14 | ) | (13 | ) | ||||||||||||
Net
cash (outflow)/inflow from investing activities
|
(4,973 | ) | 1,099 | (26,915 | ) | (18,238 | ) | |||||||||||||
Cash
flows from financing activities
Proceeds
from issue of share capital
|
26
|
9,685 | 26,424 | 9,685 | 26,424 | |||||||||||||||
Proceeds
on the issue of convertible debentures
|
21
|
2,750 | — | 2,750 | — | |||||||||||||||
Expenses
on issue of share capital
|
(285 | ) | (2,450 | ) | (285 | ) | (2,450 | ) | ||||||||||||
Expenses
on issue of convertible debentures
|
(20 | ) | — | (20 | ) | — | ||||||||||||||
Repayment
of finance lease
|
(7 | ) | (25 | ) | — | — | ||||||||||||||
Net
cash inflow from financing activities
|
12,123 | 23,949 | 12,130 | 23,974 | ||||||||||||||||
Net
(decrease)/increase in cash and cash equivalents
|
(19,129 | ) | 895 | (18,051 | ) | (951 | ) | |||||||||||||
Cash
and cash equivalents at the beginning of the year
|
36,802 | 33,907 | 34,719 | 33,691 | ||||||||||||||||
Exchange
rate gains on cash and cash equivalents
|
630 | 2,000 | 630 | 1,979 | ||||||||||||||||
Cash
and cash equivalents at end of year
|
18,303 | 36,802 | 17,298 | 34,719 |
*
|
Included
in the 2006 comparative figure is an amount of $2,818,000 reflecting the
loss arising from the movement in the fair value between January 1, 2006
and the date of settlement, March 15, 2006 of the Future Investment Right
negotiated as part of the May 2005
financing.
|
·
|
IFRS
2 “Vesting conditions and cancellations - Amendment to IFRS 2 Share-based
Payment”, (effective for accounting periods beginning on or after January
1, 2009).
The
amendment addresses two matters. It clarifies that vesting
conditions are service conditions and performance conditions only.
Other features of a share-based payment are not vesting conditions.
It also specifies that all cancellations, whether by the entity or
by other parties, should receive the same accounting treatment. The
Group will apply this revised standard from the effective date and is
currently assessing the impact on the Group’s financial
statements;
|
·
|
IAS
23, (Amendment), “Borrowing Costs” (effective for accounting periods
beginning on or after January 1, 2009). The amendment to the standard
requires an entity to capitalize borrowing costs directly attributable to
the acquisition, construction or production of a qualifying asset (one
that takes a substantial period of time to get ready for use or sale) as
part of the cost of that asset. The option of immediately expensing those
borrowing costs will be removed. The Group will apply IAS 23 (Amended)
from January 1, 2009 but is currently not applicable to the Group as there
are no qualifying assets;
|
·
|
IAS
32 and IAS 1 (Amendment) “Puttable financial instruments and obligations
arising on liquidation”, (effective for annual periods beginning on or
after 1 January 2009). The amendments require some puttable financial
instruments and some financial instruments that impose on the entity an
obligation to deliver to another party a pro rata share of net assets of
the entity only on liquidation to be classified as
equity;
|
·
|
IFRS
8, “Operating Segments” (effective for accounting periods beginning on or
after January 1, 2009). This standard will replace IAS 14 “Segment
Reporting”, and will require additional disclosures relating to operating
segments than those currently
required;
|
·
|
IFRS
3 (Revised), “Business combinations”, (effective for accounting periods
beginning on or after 1 July 2009). The standard continues to
apply the acquisition method to business combinations, with some
significant changes. These changes include a requirement that
all payments to purchase a business are to be recorded at fair value at
the acquisition date, with some contingent payments subsequently
re-measured through income. Goodwill may be calculated based on
the parent’s share of net assets or it may include goodwill related to
minority interest. All transactions costs will be
expensed;
|
·
|
IAS
27 (Revised), ‘Consolidated and separate financial statements’, (effective
for annual periods beginning on or after 1 July 2009). IAS 27
(revised) requires the effect of all transactions with non-controlling
interests to be recorded in equity if there is no change in
control. They will no longer result in goodwill or gains and
losses. The standard also specifies the accounting when control
is lost. Any remaining interest in the entity is re-measured to
fair value and a gain or loss is recognized in profit or
loss.
|
(i)
|
assets
and liabilities for each balance sheet presented are translated at the
closing rate at the date of that balance
sheet;
|
(ii)
|
income
and expenses for each income statement are translated at average exchange
rates (unless this average is not a reasonable approximation of the
cumulative effect of the rates prevailing on the transaction dates, in
which case income and expenses are translated at the rate on the dates of
the transactions); and
|
(iii)
|
all
resulting exchange differences are recognized as a separate component of
equity.
|
Plant
and equipment
|
5-10
years
|
Short
leasehold
|
5-10
years
|
Fixtures
and
fittings
|
5
years
|
Computer
equipment
|
3
years
|
.
|
Initial
consideration of approximately $15 million on closing comprising
$5.191 million in cash and $10 million in Amarin shares (subject to a
maximum of 25 million Ordinary
Shares).
|
.
|
$5
million, payable, at Amarin’s option in either, (i) Amarin shares at the
volume weighted average closing price for the 10-day trading period ending
the day before the Acquisition Agreement is signed (“First Share Amount”),
subject to the adjustment described below or (ii) cash, upon achievement
of Milestone Ia – Monarsen Phase II in MG study meeting its study
objectives: Efficacy – having a QMG score of one or more of the three
doses being superior to Mestinon as compared to the baseline by at least
10%; Safety – no major adverse drug related side effects. If
the weighted average closing price for the 10-day trading period
commencing immediately after the date of announcement of the achievement
of Milestone Ia (“Milestone Ia Price”) exceeds twice the Closing Price by
any amount (“First Excess”), the First Share Amount will be reduced by a
percentage calculated by dividing 2/3rds of the First Excess by the
Milestone Ia Price provided that if the Milestone Ia Price exceeds $50 per
Amarin Share ($5 per Amarin Share pre one-for-ten share consolidation
which became effective on January 18, 2008), such excess shall be
disregarded and the Milestone Ia Price shall be deemed to be $50 per
Amarin Share ($5 per Amarin Share pre one-for-ten share consolidation
which became effective on January 18, 2008). If the Milestone
Ia Price is less than the Closing Price no adjustment will be made to the
First Share Amount.
|
.
|
$6
million in cash on the achievement of Milestone II – successful completion
of the US Phase III clinical trial program (to include successful
completion of long term studies) enabling NDA filing for Monarsen for MG
in the US. If Milestone Ia is successfully achieved, a time
limit date is triggered for Milestone II being the date which falls two
years following the achievement of Milestone Ib (“Time Limit
Date”). If on the Time Limit Date, Milestone II has not yet
been achieved (other than by reason of failure to meet primary endpoints
in any Phase III Clinical Study or a delay in completing the U.S. Phase
III Clinical Study caused by certain Monarsen-related factors), Amarin
will pay the Sellers $3 million in cash with the
remaining
$3 million being payable whenever Milestone II is achieved. In
addition, if the Milestone Ib Price is greater than or equal to $10 ($1
pre one-for-ten share consolidation which became effective on January 18,
2008), no Time Limit Date will
apply.
|
$’000
|
|
Fair
value of Amarin common stock issued
|
9,000
|
Fair
value of cash paid
|
5,191
|
Fair
value of Amarin common stock to be issued under Milestone
Ia
|
4,756
|
Direct
acquisition costs
|
1,340
|
Total
preliminary purchase price
|
20,287
|
Ester
|
Adjustments
|
Acquisition
accounting
|
||||||||||
$'000
|
$'000
|
$'000
|
||||||||||
Intangible
assets
|
- | 19,916 | 19,916 | |||||||||
Property,
plant and equipment
|
7 | - | 7 | |||||||||
Net
current assets
|
364 | - | 364 | |||||||||
Net
assets acquired
|
371 | 19,916 | 20,287 | |||||||||
Consideration
|
||||||||||||
No.
of Shares ('000)
|
$ |
$'000
|
||||||||||
Fair
value of Amarin common stock issued
|
25,000 | 0.36 | 9,000 | |||||||||
Cash
payment
|
5,191 | |||||||||||
Fair
value of Amarin common stock to be issued under Milestone
Ia
|
4,756 | |||||||||||
Direct
acquisition costs
|
1,340 | |||||||||||
Cost
of investment
|
20,287 |
2007
|
2006
|
|||||||||||||||||||||||
UK
& Ireland
|
Rest
of world
|
Total
|
UK
& Ireland
|
Rest
of world
|
Total
|
|||||||||||||||||||
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||||||
Revenue
|
— | — | — | 500 | — | 500 | ||||||||||||||||||
Operating
expenses
|
(40,571 | ) | (162 | ) | (40,733 | ) | (28,568 | ) | — | (28,568 | ) | |||||||||||||
Operating
loss
|
(40,571 | ) | (162 | ) | (40,733 | ) | (28,068 | ) | — | (28,068 | ) | |||||||||||||
Finance
income
|
1,882 | — | 1,882 | 3,344 | — | 3,344 | ||||||||||||||||||
Finance
costs
|
(183 | ) | — | (183 | ) | (2,826 | ) | — | (2,826 | ) | ||||||||||||||
Loss
before taxation
|
(38,872 | ) | (162 | ) | (39,034 | ) | (27,550 | ) | — | (27,550 | ) | |||||||||||||
Tax
credit
|
837 | — | 837 | 799 | — | 799 | ||||||||||||||||||
Loss
for the year
|
(38,035 | ) | (162 | ) | (38,197 | ) | (26,751 | ) | — | (26,751 | ) | |||||||||||||
Other
segment items:
|
||||||||||||||||||||||||
Impairment
of intangible assets
|
(8,784 | ) | — | (8,784 | ) | — | — | — | ||||||||||||||||
Impairment
of property, plant and equipment
|
— | — | — | (235 | ) | — | (235 | ) |
2007
|
2006
|
|||||||||||||||||||||||
UK
& Ireland
|
Rest
of world
|
Total
|
UK
& Ireland
|
Rest
of world
|
Total
|
|||||||||||||||||||
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||||||
Segment
assets
|
41,996 | 258 | 42,254 | 49,559 | — | 49,559 | ||||||||||||||||||
Segment
liabilities
|
(17,876 | ) | (49 | ) | (17,925 | ) | (10,838 | ) | — | (10,838 | ) | |||||||||||||
Unallocated
liabilities:Income tax liabilities
|
(180 | ) | — | (180 | ) | (153 | ) | — | (153 | ) | ||||||||||||||
Net
assets
|
23,940 | 209 | 24,149 | 38,568 | — | 38,568 | ||||||||||||||||||
Other
segment items:
|
||||||||||||||||||||||||
Capital
expenditure on property, plant and equipment
|
444 | — | 444 | 245 | — | 245 | ||||||||||||||||||
Capital
expenditure on intangible assets
|
20,287 | — | 20,287 | — | — | — | ||||||||||||||||||
Depreciation
|
217 | — | 217 | 121 | — | 121 |
2007
|
2006
|
|
$’000
|
$’000
|
|
Impairment
of intangible assets
|
8,784
|
—
|
Redundancy
|
—
|
277
|
Property
|
—
|
19
|
Impairment
of property, plant and equipment
|
—
|
235
|
Total
|
8,784
|
531
|
Note
|
2007
|
2006
|
||||||||||
$’000 | $’000 | |||||||||||
Selling,
general and administrative expenses
|
||||||||||||
Administrative
and general expenses*
|
9,794 | 6,306 | ||||||||||
Employee
benefit expenses
|
4,736 | 3,535 | ||||||||||
Depreciation
of property, plant and equipment
|
217 | 121 | ||||||||||
Operating
lease expenses
|
1,260 | 820 | ||||||||||
Amortization
of intangible assets
|
169 | 674 | ||||||||||
Restructuring
costs
|
5
|
— | 531 | |||||||||
Share
based compensation
|
28
|
3,665 | 1,475 | |||||||||
|
19,841 | 13,462 | ||||||||||
Impairment of intangible assets |
5
|
8,784 | — | |||||||||
Total
selling, general and administrative expenses
|
28,625 | 13,462 | ||||||||||
Research
and development expenses
|
||||||||||||
General
research and development expenses
|
8,563 | 12,831 | ||||||||||
Employee
benefit expenses
|
2,209 | 1,549 | ||||||||||
Share
based compensation
|
28
|
1,336 | 726 | |||||||||
Total
research and development expenses
|
12,108 | 15,106 | ||||||||||
Total
operating expenses
|
40,733 | 28,568 |
2007
|
2006
|
|
$’000
|
$’000
|
|
Aggregate
emoluments
|
3,688
|
2,097
|
Group
pension contributions to money purchase schemes
|
90
|
294
|
3,778
|
2,391
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Aggregate
emoluments*
|
1,517
|
815
|
Group
pension contributions to money purchase
schemes
|
60
|
169
|
1,577
|
984
|
2007
Number
|
2006
Number
|
|
Marketing
and
administration
|
17
|
12
|
Research
and
development
|
8
|
6
|
25
|
18
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Staff
costs (for the above persons):
|
||
Wages
and
salaries
|
6,075
|
4,228
|
Social
security
costs
|
566
|
453
|
Other
pension
costs
|
304
|
403
|
6,945
|
5,084
|
2007
Number
|
2006
Number
|
|
Marketing
and administration
|
2
|
3
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Staff
costs (for the above persons):
|
||
Wages
and salaries
|
677
|
1,032
|
Social
security costs
|
121
|
87
|
Other
pension costs
|
68
|
181
|
866
|
1,300
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Interest
income on short term bank
deposits
|
1,252
|
1,344
|
Foreign
exchange
gains
|
630
|
2,000
|
1,882
|
3,344
|
2007
|
2006
|
|
$’000
|
$’000
|
|
On
future investment right
|
—
|
2,818
|
On
finance leases
|
4
|
2
|
On
8% convertible debentures
|
176
|
—
|
Impairment
on available for sale investments
|
3
|
6
|
183
|
2,826
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Loss
before taxation is stated after charging/(crediting):
|
||
Depreciation/amortization
charge for the period:
|
||
Intangible
assets
|
169
|
674
|
Owned
property, plant and
equipment
|
207
|
111
|
Property,
plant and equipment held under finance
leases
|
10
|
10
|
Auditors
remuneration:
|
||
Auditor’s
remuneration for audit of Company and consolidated statutory
accounts*
|
444
|
408
|
Auditor’s
remuneration for audit of subsidiaries’ statutory
accounts*
|
72
|
69
|
Auditor’s
service for Sarbanes
Oxley
|
101
|
|
Other
advisory
services
|
52
|
4
|
Taxation
Compliance
services
|
43
|
19
|
Taxation
Advisory
services
|
88
|
85
|
Operating
lease
charges:
|
||
Plant
and
machinery
|
10
|
21
|
Other
operating lease
charges
|
1,250
|
799
|
Foreign
exchange
difference
|
(630)
|
(2,000)
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Tax
on loss before taxation:
|
||
United
Kingdom corporation tax at 30%:
|
||
current
year
|
(837)
|
(799)
|
|
|
|
Total
current tax
credit
|
(837)
|
(799)
|
|
|
|
Total
tax
credit
|
(837)
|
(799)
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Loss
before
taxation
|
(39,034)
|
(27,550
)
|
Loss
on ordinary activities multiplied by standard rate of corporate tax in the
U.K. of 30%
|
(11,710)
|
(8,265)
|
Overseas
tax and adjustments in respect of foreign tax
rates
|
521
|
238
|
Unrecognized
accelerated capital allowances and other timing
differences
|
4,516
|
7,320
|
Research
and development tax credit relief (rate
differences)
|
734
|
1,079
|
Expenses
not deductible for tax
purposes
|
5,102
|
1,171
|
Total
tax
credit
|
(837)
|
(799)
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Accelerated
capital allowances
|
(19,409)
|
(19,380)
|
Short
term timing differences
|
(3,446)
|
(1,143)
|
Losses
|
(32,499)
|
(26,772)
|
(55,354)
|
(47,295)
|
2007
|
2006
|
|||||||
$’000 | $’000 | |||||||
Loss
for the financial year attributable to ordinary
shareholders
|
(38,197 | ) | (26,751 | ) |
U.S. cents
|
U.S. cents
|
|||||||
Basic
loss per ordinary
share
|
(3.90 | ) | (3.25 | ) | ||||
Diluted
loss per ordinary
share
|
(3.90 | ) | (3.25 | ) |
Number
|
Number
|
|||||||
Weighted
average number of ordinary shares in issue
|
9,783,595 | 8,233,705 | ||||||
Dilutive
impact of convertible debentures
|
— | — | ||||||
Dilutive
impact of share options and warrants outstanding
|
— | — | ||||||
Diluted
average number of ordinary shares in issue
|
9,783,595 | 8,233,705 |
IPR&D
|
||||
$’000 | ||||
Group
Cost
At
January 1,
2006
|
12,753 | |||
Foreign
currency
adjustment
|
1,343 | |||
At
December 31, 2006 and at January 1,
2007
|
14,096 | |||
Acquisitions
|
19,916 | |||
Impairments
|
(14,096 | ) | ||
At
December 31,
2007
|
19,916 | |||
Amortization
At
January 1,
2006
|
3,361 | |||
Charge
for the
year
|
674 | |||
Foreign
currency
adjustment
|
425 | |||
At
December 31, 2006 and at January 1,
2007
|
4,460 | |||
Charge
for the
year
|
169 | |||
Eliminated
on
impairments
|
(4,629 | ) | ||
At
December 31,
2007
|
— | |||
Net
book value at December 31,
2007
|
19,916 | |||
Net
book value at December 31,
2006
|
9,636 | |||
Net
book value at January 1,
2006
|
9,392 |
IPR&D
|
||||
$’000 | ||||
Cost
At
January 1,
2006
|
5,895 | |||
Foreign
currency
adjustment
|
1,343 | |||
At
December 31, 2006 and at January 1,
2007
|
7,238 | |||
Acquisitions
|
19,916 | |||
Impairments
|
(7,238 | ) | ||
At
December 31,
2007
|
19,916 | |||
Amortization
At
January 1,
2006
|
2,816 | |||
Charge
for the
year
|
232 | |||
Foreign
currency
adjustment
|
425 | |||
At
December 31, 2006 and at January 1,
2007
|
3,473 | |||
Charge
for the
year
|
58 | |||
Eliminated
on
impairments
|
(3,531 | ) | ||
At
December 31,
2007
|
— | |||
Net
book value at December 31,
2007
|
19,916 | |||
Net
book value at December 31,
2006
|
3,765 | |||
Net
book value at January 1,
2006
|
3,079 |
Cost
|
Short
leasehold
|
Plant
and
equipment
|
Fixtures
and fittings
|
Computer
equipment
|
Total
|
|||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | ||||||||||||||||
At
January 1,
2006
|
409 | 37 | 192 | 341 | 979 | |||||||||||||||
Additions
|
102 | 11 | 21 | 111 | 245 | |||||||||||||||
Impairments
|
(408 | ) | — | (95 | ) | — | (503 | ) | ||||||||||||
Disposals
|
— | (33 | ) | (90 | ) | — | (123 | ) | ||||||||||||
Foreign
exchange
adjustments
|
6 | 1 | 1 | 24 | 32 | |||||||||||||||
At
December 31, 2006 and at 1 January 2007
|
109 | 16 | 29 | 476 | 630 | |||||||||||||||
Additions
|
152 | 76 | 8 | 232 | 468 | |||||||||||||||
Disposals
|
— | — | — | — | — | |||||||||||||||
Foreign
exchange
adjustments
|
3 | 3 | 5 | 19 | 30 | |||||||||||||||
At
December 31,
2007
|
264 | 95 | 42 | 727 | 1,128 | |||||||||||||||
Accumulated
depreciation
|
||||||||||||||||||||
At
January 1,
2006
|
165 | 8 | 111 | 235 | 519 | |||||||||||||||
Charge
for the
year
|
17 | 13 | 21 | 70 | 121 | |||||||||||||||
Eliminated
on
disposals
|
— | (18 | ) | (38 | ) | — | (56 | ) | ||||||||||||
Eliminated
on
impairments
|
(178 | ) | — | (90 | ) | — | (268 | ) | ||||||||||||
At
December 31, 2006 and January 1, 2007
|
4 | 3 | 4 | 305 | 316 | |||||||||||||||
Charge
for the
year
|
40 | 17 | 12 | 148 | 217 | |||||||||||||||
Eliminated
on
disposals
|
— | — | — | — | — | |||||||||||||||
At
December 31,
2007
|
44 | 20 | 16 | 453 | 533 | |||||||||||||||
Net
book value At December 31, 2007
|
220 | 75 | 26 | 274 | 595 | |||||||||||||||
At
December 31,
2006
|
105 | 13 | 25 | 171 | 314 | |||||||||||||||
At
January 1,
2006
|
244 | 29 | 81 | 106 | 460 |
$’000 | ||||
At
January 1,
2006
|
33 | |||
Disposals
|
(33 | ) | ||
At
December 31, 2006 and January 1,
2007
|
— | |||
Additions
|
53 | |||
At
December 31,
2007
|
53 | |||
Accumulated
depreciation
At
January 1,
2006
|
8 | |||
Charge
for the
year
|
10 | |||
Disposals
|
(18 | ) | ||
At
December 31, 2006 and January 1,
2007
|
— | |||
Charge
for the
year
|
10 | |||
Disposals
|
— | |||
At
December 31,
2007
|
10 | |||
Net
book value At December 31,
2007
|
43 | |||
At
December 31,
2006
|
— |
Cost
|
Short
leasehold
|
Fixtures
and fittings
|
Computer
equipment
|
Total
|
||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
At
January 1, 2006
|
293 | 95 | 246 | 634 | ||||||||||||
Additions
|
— | — | 13 | 13 | ||||||||||||
Impairments
|
(293 | ) | (95 | ) | — | (388 | ) | |||||||||
At
December 31, 2006 and at January 1, 2007
|
— | — | 259 | 259 | ||||||||||||
Additions
|
— | 8 | 6 | 14 | ||||||||||||
At
December 31, 2007
|
— | 8 | 265 | 273 | ||||||||||||
Accumulated
depreciation
At
January 1, 2006
|
140 | 85 | 215 | 440 | ||||||||||||
Charge
for the year
|
7 | 5 | 19 | 31 | ||||||||||||
Eliminated
on impairments
|
(147 | ) | (90 | ) | — | (237 | ) | |||||||||
At
December 31, 2006 and at January 1, 2007
|
— | — | 234 | 234 | ||||||||||||
Charge
for the year
|
— | 1 | 19 | 20 | ||||||||||||
At
December 31,
2007
|
— | 1 | 253 | 254 | ||||||||||||
Net
book value
At
December 31, 2007
|
— | 7 | 12 | 19 | ||||||||||||
At
December 31, 2006
|
— | — | 25 | 25 |
|
||||
Cost
At
January 1, 2006
|
$'000
3,191 |
|||
Inter
company movements during the year
|
19,524 | |||
At
December 31, 2006 and January 1, 2007
|
22,715 | |||
Gain
on strike off of Amarin Pharmaceuticals Company Limited
|
15,745 | |||
Loss
on strike off of Ethical Pharmaceuticals (U.K.)
Limited
|
(1,660 | ) | ||
Loss
on impairment of investment in subsidiary
|
(4,593 | ) | ||
IFRS
2 re-charges to subsidiaries during the period
|
5,641 | |||
Other
inter company movements during the year
|
22,288 | |||
At
December 31, 2007
|
60,136 |
Proportion
of nominal
|
||||||||||
value
of issued share
|
||||||||||
Country
of
|
capital held by the
|
|||||||||
incorporation
|
||||||||||
Name of Undertaking
|
or registration
|
Description of shares held
|
Group
|
Company
|
||||||
%
|
%
|
|||||||||
Amarin
Neuroscience
Limited
|
Scotland
|
4,000,000
£1 ordinary shares
|
100
|
100
|
||||||
Amarin
Pharmaceuticals Ireland Limited
|
Ireland
|
100
€1 ordinary shares
|
100
|
100
|
||||||
Amarin
Finance
Limited
|
Bermuda
|
11,991
$1 ordinary shares
|
100
|
100
|
||||||
Ester
Neurosciences
Limited
|
Israel
|
1,320,264
NIS 0.01 ordinary shares
|
100
|
|
100
|
|||||
440,526
NIS 0.01 “A” redeemable convertible preference shares
|
100
|
100
|
||||||||
1,121,145
NIS 0.01 “B” redeemable convertible preference shares
|
100
|
100
|
Group
|
Company
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Raw
materials and
consumables
|
982 | 414 | — | — | ||||||||||||
Provision
|
(982 | ) | (414 | ) | — | — | ||||||||||
Net
realizable
value
|
— | — | — | — |
Group
|
Company
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Corporation
tax receivable
|
1,704 | 1,617 | — | — | ||||||||||||
Other
current assets
|
||||||||||||||||
Other
debtors
|
840 | 456 | 625 | 271 | ||||||||||||
Prepayments
and accrued income
|
881 | 716 | 434 | 499 | ||||||||||||
1,721 | 1,172 | 1,059 | 770 |
$’000
|
|
At
January 1, 2006
|
24
|
Impairments
recorded in the income statement
|
(6)
|
At
December 31, 2006
|
18
|
Impairments
recorded in the income statement
|
(3)
|
At
December 31, 2007
|
15
|
2007
|
2006
|
|
$’000
|
$’000
|
|
Gross
proceeds of convertible debentures issued
|
2,750
|
—
|
Liability
component at the date of issue
|
(2,055)
|
—
|
Equity
and warrants component
|
695
|
|
Attributable
to:
|
||
Fair
value of warrants
component
|
550
|
—
|
Fair
value of equity
component
|
145
|
—
|
Liability
component at the date of
issue
|
695
|
—
|
Group
|
Company
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Trade
creditors
|
3,462 | 2,096 | 841 | 396 | ||||||||||||
Current
liabilities
|
||||||||||||||||
Obligations
under finance leases
|
10 | — | — | — | ||||||||||||
Corporation
tax payable
|
— | 94 | — | 94 | ||||||||||||
Other
taxation and social security payable
|
180 | 153 | 60 | 45 | ||||||||||||
Other
creditors
|
206 | 162 | 86 | 129 | ||||||||||||
Accruals
and deferred income
|
6,337 | 8,216 | 3,284 | 1,546 | ||||||||||||
6,733 | 8,625 | 3,430 | 1,814 |
Group
|
Company
|
|||||||||||||||||
2007 | 2006 | 2006 | 2007 | |||||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||||
Obligations
under finance
leases
|
36 | — | — | — |
Group
|
Company
|
|||
2007
|
2006
|
2007
|
2006
|
|
$’000
|
$’000
|
$’000
|
$’000
|
|
Not
later than one year
|
13
|
—
|
—
|
—
|
Later
than one year and not later than five years
|
40
|
—
|
—
|
—
|
Less:
future finance charges on finance leases
|
(7)
|
—
|
—
|
—
|
46
|
—
|
—
|
—
|
|
Less:
current maturities
|
(10)
|
—
|
—
|
—
|
Long-term
maturity
|
36
|
—
|
—
|
—
|
Ester
milestone
|
Onerous
lease
|
National
insurance
|
Total
|
|||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
At
January 1,
2006
|
— | 220 | 15 | 235 | ||||||||||||
Charged
to the income
statement
|
— | — | 218 | 218 | ||||||||||||
Released
to the income
statement
|
— | (69 | ) | (114 | ) | (183 | ) | |||||||||
At
December 31,
2006
|
— | 151 | 119 | 270 | ||||||||||||
Capitalized
to intangible
assets
|
4,756 | — | — | 4,756 | ||||||||||||
Charged
to the income
statement
|
— | 957 | — | 957 | ||||||||||||
Released
to the income statementts
|
— | (41 | ) | (119 | ) | (160 | ) | |||||||||
At
December 31,
2007
|
4,756 | 1,067 | — | 5,823 |
At
December 31 2007
|
Less
than
|
Between
1
|
Between
2
|
Over
5
|
1 year
|
and 2 years
|
and 5 years
|
years
|
|
$’000
|
$’000
|
$’000
|
$’000
|
|
Borrowings
|
220
|
220
|
2,970
|
—
|
Trade
and other payables
|
10,187
|
—
|
—
|
—
|
Finance
Leases
|
13
|
13
|
27
|
—
|
At
December 31 2006
|
Less
than
|
Between
1
|
Between
2
|
Over
5
|
1 year
|
and 2 years
|
and 5 years
|
years
|
|
$’000
|
$’000
|
$’000
|
$’000
|
|
Borrowings
|
—
|
—
|
—
|
—
|
Trade
and other payables
|
10,627
|
—
|
—
|
—
|
|
|
|||
Company
|
||||
At
December 31 2007
|
Less
than
|
Between
1
|
Between
2
|
Over
5
|
1 year
|
and 2 years
|
and 5 years
|
years
|
|
$’000
|
$’000
|
$’000
|
$’000
|
|
Borrowings
|
220
|
220
|
2,970
|
—
|
Trade
and other payables
|
4,271
|
—
|
—
|
—
|
|
||||
At
December 31 2006
|
Less
than
|
Between
1
|
Between
2
|
Over
5
|
1 year
|
and 2 years
|
and 5 years
|
years
|
|
$’000
|
$’000
|
$’000
|
$’000
|
|
Borrowings
|
—
|
—
|
—
|
—
|
Trade
and other payables
|
2,115
|
—
|
—
|
—
|
2007
|
2006
|
|||||||||||||||||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
No
Interest
|
Total
|
Floating
Rate
|
Fixed
Rate
|
No
Interest
|
Total
|
|||||||||||||||||||||||||
$000 | $000 | $000 | $000 | $000 | $000 | $000 | $000 | |||||||||||||||||||||||||
Sterling
|
— | 46 | 5,144 | 5,190 | — | — | 6,795 | 6,795 | ||||||||||||||||||||||||
Euro
|
— | — | 2,290 | 2,290 | — | — | 1,300 | 1,300 | ||||||||||||||||||||||||
U.S. Dollar
|
— | 2,750 | 2,704 | 5,454 | — | — | 2,532 | 2,532 | ||||||||||||||||||||||||
NIS
|
— | — | 49 | 49 | — | — | — | — | ||||||||||||||||||||||||
Total
|
— | 2,796 | 10,187 | 12,983 | — | — | 10,627 | 10,627 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
No
Interest
|
Total
|
Floating
Rate
|
Fixed
Rate
|
No
Interest
|
Total
|
|||||||||||||||||||||||||
$000 | $000 | $000 | $000 | $000 | $000 | $000 | $000 | |||||||||||||||||||||||||
Sterling
|
— | — | 1,972 | 1,972 | — | — | 1,833 | 1,833 | ||||||||||||||||||||||||
Euro
|
— | — | 813 | 813 | — | — | 130 | 130 | ||||||||||||||||||||||||
U.S. Dollar
|
— | 2,750 | 1,486 | 4,236 | — | — | 152 | 152 | ||||||||||||||||||||||||
Total
|
— | 2,750 | 4,271 | 7,021 | — | — | 2,115 | 2,115 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
No
Interest
|
Total
|
Floating
Rate
|
Fixed
Rate
|
No
Interest
|
Total
|
|||||||||||||||||||||||||
$000 | $000 | $000 | $000 | $000 | $000 | $000 | $000 | |||||||||||||||||||||||||
Sterling
|
9,046 | — | 343 | 9,389 | 23,773 | — | 288 | 24,061 | ||||||||||||||||||||||||
Euro
|
606 | — | 46 | 652 | 5,102 | — | 50 | 5,152 | ||||||||||||||||||||||||
U.S. Dollar
|
8,666 | — | 79 | 8,745 | 7,945 | — | 115 | 8,060 | ||||||||||||||||||||||||
NIS
|
— | — | 57 | 57 | — | — | — | — | ||||||||||||||||||||||||
Total
|
18,318 | — | 525 | 18,843 | 36,820 | — | 453 | 37,273 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
No
Interest
|
Total
|
Floating
Rate
|
Fixed
Rate
|
No
Interest
|
Total
|
|||||||||||||||||||||||||
$000 | $000 | $000 | $000 | $000 | $000 | $000 | $000 | |||||||||||||||||||||||||
Sterling
|
8,950 | — | 176 | 9,126 | 22,635 | — | 133 | 22,768 | ||||||||||||||||||||||||
Euro
|
173 | — | 1 | 174 | 4,638 | — | 14 | 4,652 | ||||||||||||||||||||||||
U.S. Dollar
|
8,189 | — | 79 | 8,268 | 7,464 | — | 115 | 7,579 | ||||||||||||||||||||||||
Total
|
17,312 | — | 256 | 17,568 | 34,737 | — | 262 | 34,999 |
Financial Assets
|
Financial Liabilities
|
|||||||
$’000 | $’000 | |||||||
Sterling
|
9,389 | 5,190 | ||||||
Euro
|
652 | 2,290 | ||||||
NIS
|
57 | 49 | ||||||
10,098 | 7,529 |
Financial Assets
|
Financial Liabilities
|
|||||||
$’000 | $’000 | |||||||
Sterling
|
24,061 | 6,795 | ||||||
Euro
|
5,152 | 1,300 | ||||||
NIS
|
— | — | ||||||
29,213 | 8,095 |
Financial Assets
|
Financial Liabilities
|
|||||||
$’000 | $’000 | |||||||
Sterling
|
9,126 | 1,972 | ||||||
Euro
|
174 | 813 | ||||||
9,300 | 2,785 |
Financial Assets
|
Financial Liabilities
|
|||||||
$’000 | $’000 | |||||||
Sterling
|
22,768 | 1,833 | ||||||
Euro
|
4,652 | 130 | ||||||
27,420 | 1,963 |
Impact
on Profit or Loss
of the
Group
|
||||||||
2007 | * | 2006 | * | |||||
$’000 | $’000 | |||||||
Sterling
|
420 | 1727 | ||||||
Euro
|
164 | 385 | ||||||
NIS
|
1 | — | ||||||
Impact
on Profit or Loss
of
the Company
|
||||||||
2007 | * | 2006 | * | |||||
$’000 | $’000 | |||||||
Sterling
|
715 | 2,094 | ||||||
Euro
|
64 | 452 |
2007
|
2006
|
|||||||
$’000 | $’000 | |||||||
Authorized
1,559,144,066
ordinary shares of £0.05 each (1,559,144,066 ordinary shares of £0.05 each
for December 31, 2006)
|
125,319 | 125,319 | ||||||
440,855,934
preference shares of £0.05 (December 31, 2006:
440,855,434)
|
40,566 | 40,566 | ||||||
165,885 | 165,885 | |||||||
Allotted,
called up and fully paid
|
||||||||
139,057,370
ordinary shares of £0.05 each (December 31, 2006:
90,684,230)
|
12,942 | 7,990 |
●
|
80 of
the 5 pence Preference Shares be consolidated and divided into 8
Preference Shares with a nominal value of 50 pence each;
and
|
●
|
the
Preference Shares with a nominal value of 50 pence each to be issued and
allotted to subscribers shall be known as "Series A Preference Shares" and
shall be issued with the rights, and subject to the restrictions and
limitations, set out in forms 128(1) and 128(4) filed with Companies House
in the U.K. in May 2008.
|
Number
of share
options
outstanding
over
£0.05 Ordinary
Shares*
|
Note
|
Date
Option
Granted
|
Exercise
price per
Ordinary Share*
|
Number
of share
options
repriced
at
US$5.00 per
Ordinary Share
|
Number
of share
options
repriced
at
US$0.44 per
Ordinary Share
|
|||||||||||||||
US$
|
(Note 1)
|
(Note 20)
|
||||||||||||||||||
100,000 |
1
|
23 November
1998
|
25.00 | 100,000 | — | |||||||||||||||
250,000 | 2 |
23 November
1998
|
5.00 | — | — | |||||||||||||||
5,000 | 3 |
2 March
1999
|
7.22 | — | — | |||||||||||||||
5,500 | 4 |
7 September
1999
|
3.00 | — | — | |||||||||||||||
37,500 | 4 |
1 April
2000
|
3.00 | — | — | |||||||||||||||
10,000 | 3 |
7 April
2000
|
3.00 | — | — | |||||||||||||||
5,000 | 4 |
23 May
2000
|
3.00 | — | — | |||||||||||||||
3,293 | 4 |
26 September
2000
|
3.00 | — | — | |||||||||||||||
10,000 | 3 |
19 February
2001
|
6.13 | — | — | |||||||||||||||
45,000 | 6 |
4 June
2001
|
8.65 | — | — | |||||||||||||||
15,000 | 6 |
2 July
2001
|
10.00 | — | — | |||||||||||||||
6,000 | 6 |
27 July
2001
|
12.88 | — | — | |||||||||||||||
186,500 | 6,7 |
23 January
2002
|
17.65 | — | — | |||||||||||||||
80,000 | 8 |
18 February
2002
|
13.26 | — | — | |||||||||||||||
20,000 | 7 |
1 May
2002
|
19.70 | — | — | |||||||||||||||
15,000 | 7 |
1 May
2002
|
21.30 | — | — | |||||||||||||||
5,000 | 7 |
19 July
2002
|
8.81 | — | — | |||||||||||||||
15,000 | 7 |
5 September
2002
|
3.33 | — | — | |||||||||||||||
60,000 | 7 |
6 November
2002
|
3.46 | — | — | |||||||||||||||
221,667 | 9 |
6 November
2002
|
3.10 | — | — | |||||||||||||||
105,933 | 10 |
24 February
2003
|
3.17 | — | — | |||||||||||||||
40,000 | 6 |
29 April
2003
|
2.82 | — | — | |||||||||||||||
10,000 | 7 |
2 July
2003
|
3.37 | — | — | |||||||||||||||
70,000 | 6 |
21 November
2003
|
2.38 | — | — | |||||||||||||||
375,000 | 6 |
7 July
2004
|
0.85 | — | — | |||||||||||||||
170,000 | 11 |
21 July
2004
|
0.84 | — | — | |||||||||||||||
210,000 | 12 |
8 October
2004
|
1.25 | — | — | |||||||||||||||
19,125 | 13 |
8 October
2004
|
1.25 | — | — | |||||||||||||||
20,000 | 6 |
29 November
2004
|
2.40 | — | — | |||||||||||||||
100,000 | 14 |
28 February
2005
|
3.04 | — | — | |||||||||||||||
100,000 | 14 |
28 February
2005
|
3.04 | — | — | |||||||||||||||
350,000 | 15 |
28 February
2005
|
3.04 | — | — | |||||||||||||||
10,000 | 6 |
28 March
2005
|
2.43 | — | — | |||||||||||||||
150,000 | 21 |
10 June
2005
|
1.30 | — | — | |||||||||||||||
200,000 | 16 |
10 June
2005
|
1.30 | — | — | |||||||||||||||
200,000 | 17 |
28 June
2005
|
1.09 | — | — | |||||||||||||||
160,000 | 6 |
28 June
2005
|
1.09 | — | — |
Number
of share
options
outstanding
over
£0.05 Ordinary
Shares*
|
Note
|
Date
Option
Granted
|
Exercise
price per
Ordinary Share*
|
Number
of share
options
repriced
at US$5.00 per Ordinary Share |
Number
of share
options
repriced
at US$0.44 per Ordinary Share |
|||||||||||||||
(Note 1)
|
(Note 20)
|
|||||||||||||||||||
20,000 | 6 |
13 July
2005
|
1.37 | — | — | |||||||||||||||
20,000 | 6 |
1 September
2005
|
1.44 | — | — | |||||||||||||||
10,000 | 6 |
9 September
2005
|
1.42 | — | — | |||||||||||||||
20,000 | 6 |
20 September
2005
|
1.49 | — | — | |||||||||||||||
100,000 | 6 |
27 September
2005
|
1.50 | — | — | |||||||||||||||
10,000 | 18 |
28 October
2005
|
1.38 | — | — | |||||||||||||||
325,000 | 19 |
2 December
2005
|
1.16 | — | — | |||||||||||||||
10,000 | 6 |
12 December
2005
|
1.18 | — | — | |||||||||||||||
120,000 | 6 |
11 January
2006
|
1.35 | — | — | |||||||||||||||
431,000 | 6 |
12 January
2006
|
1.53 | — | — | |||||||||||||||
100,000 | 21 |
16 January
2006
|
1.95 | — | — | |||||||||||||||
200,000 | 6 |
16 January
2006
|
1.95 | — | — | |||||||||||||||
80,000 | 6 |
27 January
2006
|
2.72 | — | — | |||||||||||||||
100,000 | 6 |
3 February
2006
|
3.46 | — | — | |||||||||||||||
20,000 | 6 |
20 March
2006
|
3.26 | — | — | |||||||||||||||
30,000 | 5 |
7 April
2006
|
2.86 | — | — | |||||||||||||||
40,000 | 6 |
5 May
2006
|
2.95 | — | — | |||||||||||||||
20,000 | 6 |
6 June
2006
|
2.38 | — | — | |||||||||||||||
10,000 | 6 |
10 July
2006
|
2.40 | — | — | |||||||||||||||
10,000 | 6 |
28 July
2006
|
2.45 | — | — | |||||||||||||||
10,000 | 6 |
20 September
2006
|
2.65 | — | — | |||||||||||||||
10,000 | 6 |
25 October
2006
|
2.23 | — | — | |||||||||||||||
2,721,666 | 6,20 |
8 December
2006
|
2.30 | — | 2,721,666 | |||||||||||||||
266,666 | 20,21 |
8 December
2006
|
2.30 | — | 266,666 | |||||||||||||||
20,000 | 6,20 |
8 January
2007
|
2.27 | — | 20,000 | |||||||||||||||
20,000 | 6,20 |
12
February 2007
|
1.87 | — | 20,000 | |||||||||||||||
20,000 | 6,20 |
19
February 2007
|
1.83 | — | 20,000 | |||||||||||||||
20,000 | 6,20 |
21
February 2007
|
1.87 | — | 20,000 | |||||||||||||||
175,000 | 6,20 |
23
February 2007
|
1.80 | — | 175,000 | |||||||||||||||
75,000 | 6,20 |
8
March 2007
|
1.82 | — | 75,000 | |||||||||||||||
75,000 | 6,20 |
15
March 2007
|
2.49 | — | 75,000 | |||||||||||||||
600,000 | 6,20 |
2
April 2007
|
2.30 | — | 600,000 | |||||||||||||||
650,000 | 6,20 |
9
April 2007
|
2.49 | — | 650,000 | |||||||||||||||
350,000 | 6,20 |
11
April 2007
|
3.00 | — | 350,000 | |||||||||||||||
50,000 | 6 |
4
June 2007
|
0.60 | — | — | |||||||||||||||
450,000 | 6 |
2
August 2007
|
0.44 | — | — | |||||||||||||||
150,000 | 6 |
28
August 2007
|
0.46 | — | — | |||||||||||||||
30,000 | 6 |
11
September 2007
|
0.52 | — | — | |||||||||||||||
50,000 | 6 |
12
September 2007
|
0.54 | — | — | |||||||||||||||
10,804,850 | 100,000 | 4,993,332 |
*
|
On
June 21, 2004, each of the issued ordinary shares of £1 each was
sub-divided and converted into one ordinary share of £0.05 and one
deferred share of £0.95. Additionally, each authorized but unissued share
of £1 each was sub-divided into 20 ordinary shares of £0.05
each.
|
|
1.
|
When
granted these options were to become exercisable in tranches upon the
Group’s share price achieving certain pre-determined levels. On February
9, 2000, the Group’s remuneration committee approved the re-pricing of
these 100,000 options to an exercise price of US$0.50 per share
(US$5.00 per share following the conversion of the nominal value
of
|
|
ordinary
shares from 10p to £1 in 2002; the 2004 conversion discussed above has no
effect on the exercise price), and the Group entered into an amendment
agreement on the same day amending the exercise price and also removing
the performance criteria attached to such options. These options are
currently exercisable and remain exercisable until November 23,
2008.
|
|
2.
|
Of
these options 80% became exercisable immediately and 20% after six months
from date of grant and are exercisable until ten years from date of
grant.
|
|
3.
|
These
options are exercisable now and remain exercisable until November 30,
2008.
|
|
4.
|
These
options were granted to a former employee of Amarin Corporation plc, are
now exercisable and expire on November 30,
2008.
|
|
5.
|
These
options were granted to a former employee of Amarin Corporation plc. These
options became exercisable on the date of grant and expire on May 31,
2009.
|
|
6.
|
These
options become exercisable in tranches of 33% over three years on the
first, second and third anniversary of the date of grant and expire
10 years from the date of the
grant.
|
|
7.
|
These
options become exercisable in tranches of 33% over three years on the
first, second and third anniversary of the date employment commences. The
options expire 10 years from the date of the
grant.
|
|
8.
|
These
options became exercisable in October 2005 and expire on March 31,
2009.
|
|
9.
|
These
options become exercisable in tranches of 33% over three years on the
first, second and third anniversary of the date of grant and expire
10 years from the date of the grant. Of these options 26,667 were
immediately vested in October 2005 and expiry dated March 31,
2009.
|
|
10.
|
These
options become exercisable in tranches of 33% over three years on the
first, second and third anniversary of the date of grant and expire
10 years from the date of the grant. Of these options 65,933 were
immediately vested in October 2005 and expiry dated March 31,
2009.
|
|
11.
|
These
options become exercisable in tranches of 33% over three years on the
first, second and third anniversary of the date of grant and expire
10 years from the date of the grant. Of these options 125,000 were
immediately vested in October 2005 and expiry dated March 31,
2009.
|
|
12.
|
Of
these options, 40,000 were issued to a consultant and 170,000 were issued
to employees of Amarin Neuroscience Limited (formerly Laxdale
Limited) on the date of acquisition by the Group and become exercisable in
tranches of 33% over three years on the first, second and third
anniversary of the date of grant and expire 10 years from the date of
the grant. Of these options, 5,125 were immediately vested in June 2005
with expiry dated January 31, 2007.
|
|
13.
|
These
options were issued to employees of Amarin Neuroscience Limited (formerly
Laxdale Limited) on the date of acquisition by the Group in consideration
of the cancellation of a comparable number of stock options (in value
terms) previously held by these employees in Amarin Neuroscience Limited.
All these options are fully vested.
|
|
14.
|
These
options became exercisable on the date of grant and expire 10 years
from the date of the grant.
|
|
15.
|
These
options become exercisable, subject to performance criteria, in tranches
of 33% over three years on the first, second and third anniversary of the
date of grant and expire 10 years from the date of the
grant.
|
|
16.
|
These
options become exercisable in tranches of 50% on the second anniversary,
25% on the third anniversary and 25% on the fourth anniversary of the date
of grant and expire 10 years from the date of the
grant.
|
|
17.
|
These
options became exercisable on the date of grant and expire 4 years
from the date of grant.
|
|
18.
|
These
options became exercisable on the date of grant and expire 5 years
from the date of grant.
|
|
19.
|
These
options were granted prior to commencement of employment and become
exercisable in tranches of 33% over three years on the first, second and
third anniversary of the date of grant and expire 10 years from the
date of the grant.
|
20.
|
Following
the significant decline in the Company's stock price as a result of the
disappointing outcome of the two Phase III studies of AMR 101 conducted by
the Company in Huntington’s Disease, the Remuneration Committee (the
“Committee”) reviewed the effect of that decline on certain awards of
stock options previously made to Directors, employees and the Board's
Scientific Advisor under the Company's 2002 Stock Option Plan and has
determined that, in order to incentivise Directors, employees and the
Board's Scientific Advisor in relation to future performance and to
re-align their interests with those of the Company's shareholders, the
option exercise price stated in all Award Agreements relating to stock
options granted in the period from December 8, 2006 to April 11, 2007
should be amended so that it will be equal to the sale price of the
Company's American Depositary Receipts at market close on NASDAQ on the
last trading day preceding a meeting of the Committee to be convened as
soon as practicable following the AGM. The Committee was conscious that
shareholders may potentially be sensitive to the making of such amendments
to the Award Agreements and considers it appropriate that the shareholders
approve the Committee’s action in making such amendments. At
the Annual General Meeting held on July 19, 2007, a resolution to the
above affect was approved by the shareholders. On August 2, 2007 the
Remuneration Committee approved the amendment. The new strike price for
these stock options was set at
$0.44.
|
21.
|
On
December 19, 2007 (“Termination Date”), Rick Stewart, Amarin’s Chief
Executive Officer resigned. Mr Stewart’s vested options became exercisable
for a period of 12 months following the Termination Date in accordance
with the terms of the 2002 Stock Option Plan and upon the expiration of
such 12 month period, Mr. Stewart’s vested options shall cease to be
exercisable and shall expire. Mr Stewart’s options which had not vested as
at the Termination Date expired and accordingly are no longer exercisable
after the Termination Date and accordingly, expired on the Termination
Date.
|
Number of warrants
outstanding |
Note
|
Date warrant granted
|
Exercise
price per
ordinary share
|
Share
price at date
of issue |
Fair
value per warrant
at date of issue |
313,234
|
1
|
27 January
2003
|
US$3.48
|
US$2.84
|
US$2.13
|
500,000
|
2
|
25 February
2004
|
US$1.90
|
US$1.68
|
US$1.28
|
8,463,246
|
3
|
21 December
2005
|
US$1.43
|
US$1.19
|
US$0.91
|
294,000
|
4
|
26 January
2006
|
US$3.06
|
US$2.72
|
US$2.10
|
175,000
|
5
|
27
April 2007
|
US$1.79
|
US$1.82
|
US$1.49
|
615,643
|
6
|
1
June 2007
|
US$0.72
|
US$0.60
|
US$0.49
|
30,000
|
7
|
21
June 2007
|
US$0.60
|
US$0.54
|
US$0.37
|
10,000
|
8
|
29
November 2007
|
US$0.34
|
US$0.36
|
US$0.30
|
10,437,112
|
9
|
4
December 2007
|
US$0.48
|
US$0.36
|
US$0.24
|
20,838,235
|
(1)
|
During
January 2003, 313,234 warrants were issued to Security Research Associates
Inc. and may be exercised between 27 January 2004 and 26 January
2008.
|
(2)
|
In
February 2004, all debt obligations due to Elan were settled by a cash
payment of $17,195,000 (part of which represented the cost of acquiring
Zelapar that was concurrently sold to Valeant) and the issuance of a loan
note for $5,000,000 and 500,000 warrants granted to Elan at a price of
$1.90 and exercisable from 25 February 2004 to 25 February 2009.
During September 2004, Elan sold its remaining interests in Amarin to
Amarin Investment Holding Limited, an entity controlled by Amarin’s
Chairman and Chief Executive Officer, Mr. Thomas Lynch. These interests
included Elan’s equity interest, the $5,000,000 loan note and the 500,000
warrants.
|
(3)
|
During
December 2005, 9,135,034 warrants were issued to those investors at a rate
of approximately 35% of shares acquired. These warrants were granted at a
price of $1.43 and are exercisable from 19 June 2006 to
21 December 2010. If our trading market price is equal to or above
$4.76, as adjusted for any stock splits, stock combinations, stock
dividends and other similar events, for each of any twenty consecutive
trading days, then the Group at any time thereafter shall have the right,
but not the obligation, on 20 days’ prior written notice to the
holder, to cancel any unexercised portion of this warrant for which a
notice of exercise has not yet been delivered prior to the cancellation
date.
|
(4)
|
During
January 2006, via the private placement referred to in note 26,
240,000 warrants were issued to those investors at a rate of approximately
35% of shares acquired. These warrants were granted at a price of $3.06
and are exercisable from 25 July 2006 to 26 January 2011. If our
trading market price is equal to or above $10.20, as adjusted for any
stock splits, stock combinations, stock dividends and other similar
events, for each of any twenty consecutive trading days, then the Group at
any time thereafter shall have the right, but not the obligation, on
20 days’ prior written notice to the holder, to cancel any
unexercised portion of this warrant for which a notice of exercise has not
yet been delivered prior to the cancellation date.
|
(5)
|
In
April 2007, 175,000 warrants were issued in consideration for termination
and release of certain contractual obligations and a license of certain
intellectual property rights pursuant to an agreement between NeuroStat,
Amarin Pharmaceuticals Ireland Limited, Amarin Corporation plc and Tim
Lynch. These warrants were granted at a price of $1.79 and are exercisable
from April 27, 2007 to January 17, 2014. The fair value of these warrants
were expensed to the income statement in accordance with IFRS
2.
|
(6)
|
During
June 2007, via the registered direct offering referred to in note 26,
615,643 warrants were issued to those investors at a rate of approximately
10% of shares acquired. These warrants were granted at a price
of $0.72 and are exercisable from June 1, 2007 to May 31, 2012. If our
trading market price is equal to or above $1.80, as adjusted for any stock
splits, stock combinations, stock dividends and other similar events, for
each of any twenty consecutive trading days, then the Group at any time
thereafter shall have the right, but not the obligation, on 20 days’
prior written notice to the holder, to cancel any unexercised portion of
this warrant for which a notice of exercise has not yet been delivered
prior to the cancellation date.
|
(7)
|
During
June 2007, 30,000 warrants were issued in consideration for advisory
services performed by ProSeed pursuant to an advisory services agreement
between ProSeed and Amarin Corporation plc. These warrants were
granted at a price of $0.60 and are exercisable from June 21, 2007 to June
20, 2010. The fair value of these warrants were expensed to the income
statement in accordance with IFRS 2. If our trading market price is equal
to or above $1.80, as adjusted for any stock splits, stock combinations,
stock dividends and other similar events, for each of any twenty
consecutive trading days, then the Group at any time thereafter shall have
the right, but not the obligation, on 20 days’ prior written notice
to the holder, to cancel any unexercised portion of this warrant for which
a notice of exercise has not yet been delivered prior to the cancellation
date.
|
(8)
|
During
November 2007, 10,000 warrants were issued in consideration for consulting
services performed by Strategic Pharmaceuticals Solutions, Inc., pursuant
to the Consulting Agreement, dated as of July 31, 2007, by and among
Amarin Pharmaceuticals Ireland Limited, a wholly owned subsidiary of the
Company, and the Strategic Pharmaceuticals Solutions, Inc. The fair value
of these warrants were expensed to the income statement in accordance with
IFRS 2. These warrants were granted at a price of $0.34 and are
exercisable from November 29, 2007 to November 28,
2012.
|
(9)
|
During
December 2007, via the registered direct offering referred to in note 26,
8,145,446 warrants were issued to those equity investors at a rate of
approximately 50% of shares acquired and 2,291,666 warrants were issued to
those convertible debt investors at a rate of approximately 40% of debt
acquired. These warrants were granted at a price of $0.48 and
are exercisable from December 4, 2007 to December 3, 2012. If our trading
market price is equal to or above $0.915, as adjusted for any stock
splits, stock combinations, stock dividends and other similar events, for
each of any twenty consecutive trading days, then the Group at any time
thereafter shall have the right, but not the obligation, on 20 days’
prior written notice to the holder, to cancel any unexercised portion of
this warrant for which a notice of exercise has not yet been delivered
prior to the cancellation date. Per the warrant agreement, if at any
time prior to December 6, 2009, the Company issues Ordinary Shares,
securities convertible into ADSs or Ordinary Shares, warrants to purchase
ADSs or Ordinary Shares or options to purchase any of the foregoing to a
third party (other than any Exempt Issuance) at a price that is less than,
or converts at a price that is less than, $3.66 (such lesser price, the
“Down-round Price”), then the Exercise Price shall be adjusted to equal
130% of the Down-round Price.
On
May 14, 2008, we announced a private placement of Ordinary Shares for up
to $60.0 million. The first tranche from new investors of $28.0 million
closed on May 19, 2008
(see note 33 for further details).
These warrants have therefore been re-priced to $2.99 per share from their
original grant price of $4.80 per share
(
post share
consolidation effective January 18,
2008).
|
2007
Options
|
2007
Weighted
average
exercise
price
|
2006
Options
|
2006
Weighted
average
exercise
price *
|
|
$
|
$
|
|||
Outstanding
at
January 1,
|
8,964,975
|
1.99
|
4,821,952
|
3.55
|
Granted
|
2,735,000
|
0.45
|
4,907,666
|
0.88
|
Exercised
|
(6,666)
|
1.25
|
(694,643)
|
1.49
|
Lapsed
|
(888,459
)
|
0.93
|
(70,000
)
|
8.79
|
Outstanding
at
December 31,
|
10,804,850
|
1.69
|
8,964,975
|
1.99
|
Exercisable
at
December 31,
|
5,113,073
|
2.75
|
2,677,308
|
4.28
|
2007
options |
2007
Weighted
average
exercise
price |
2006
options |
2006
Weighted
average
exercise
price *
|
|||||||||||||
$
|
$
|
|||||||||||||||
Outstanding
at December 31,
Options
granted at market
price
|
9,759,390 | 1.11 | 7,919,515 | 1.32 | ||||||||||||
Options
granted at a discount to the market
price
|
697,793 | 8.01 | 697,793 | 8.01 | ||||||||||||
Options
granted at a premium to the market
price
|
347,667 | 5.25 | 347,667 | 5.25 | ||||||||||||
Exercisable
at December 31,
Options
granted at market
price
|
4,067,613 | 1.64 | 1,631,848 | 2.47 | ||||||||||||
Options
granted at a discount to the market
price
|
697,793 | 8.01 | 697,793 | 8.01 | ||||||||||||
Options
granted at a premium to the market
price
|
347,667 | 5.25 | 347,667 | 5.25 |
Year
ended
December
31
2007
|
Year
ended
December
31
2006
|
|
Risk
free interest rate
(percentage)
|
4.58
|
4.47
|
Volatility
(percentage)
|
100%
|
98%
|
Expected
forfeiture rate
(percentage)
|
5%
|
5%
|
Dividend
yield
|
—
|
—
|
Expected
option
life
|
4
|
4
|
Forced
exercise rate
(percentage)
|
10%
|
10%
|
Minimum
gain for voluntary exercise rate
(percentage)
|
33%
|
33%
|
Voluntary
early exercise at a minimum gain rate
(percentage)
|
50%
|
50%
|
2007
Land and buildings
|
2006
Land and buildings
|
|||||||||||||||
Group
|
Company
|
Group
|
Company
|
|||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Not
later than one
year
|
1,278 | 715 | 1,235 | 687 | ||||||||||||
Later
than one year and not later than five years
|
2,755 | 1,714 | 3,637 | 2,096 | ||||||||||||
Later
then five
years
|
496 | 496 | 741 | 741 | ||||||||||||
4,529 | 2,925 | 5,613 | 3,524 |
2007
Land and buildings
|
2006
Land and buildings
|
|||||||||||||||
Group
|
Company
|
Group
|
Company
|
|||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Not
later than one
year
|
265 | 265 | 260 | 260 | ||||||||||||
Later
than one year and not later than five years
|
562 | 562 | 812 | 812 | ||||||||||||
Later
then five
years
|
— | — | — | — | ||||||||||||
827 | 827 | 1,072 | 1,072 |
·
|
$5
million, payable, at Amarin’s option, in cash or shares upon achievement
of Milestone Ia – Monarsen Phase II in MG study meeting its study
objectives: Efficacy – having a QMG score of one or more of the three
doses being superior to Mestinon as compared to the baseline by at least
10%; Safety – no major adverse drug related side effects. The fair value
of this milestone payment is included in accrued expenses and other
liabilities as it is probable that this milestone will be
achieved.
|
·
|
$6
million payable, at Amarin’s option, in cash or shares upon successful
completion of Monarsen Phase II MG study program with adequate efficacy
and safety data that fully supports the commencement of a Phase III
program in the U.S.
|
·
|
$6
million payable, in cash, upon successful completion of the U.S. Phase III
clinical trial program (to include successful completion of long term
studies) enabling NDA filing for Monarsen for MG in the U.S, Milestone
II.
|
2007
US$’000
|
2006
US$’000
|
|
Short-term
employee benefits
|
4,569
|
3,361
|
Post-employment
benefits
|
—
|
—
|
Share-based
compensation
|
2,300
|
1,045
|
Total
|
6,869
|
4,406
|
·
|
Amarin
Corporation plc: US$ (no change)
|
·
|
Amarin
Neuroscience Limited: Stg£ (previously US$ under U.K.
GAAP)
|
·
|
Amarin
Pharmaceuticals Ireland Limited: € (previously US$ under U.K.
GAAP)
|
·
|
A
contract that will or may be settled in the entity’s own equity
instruments and is:
|
·
|
A
non-derivative for which the entity is or may be obliged to deliver a
variable number of the entity’s own equity instruments;
or
|
·
|
A
derivative that will or may be settled other than by the exchange of a
fixed amount of cash or another financial asset for a fixed number of the
entity’s own equity instruments.
|
·
|
There
is little or no upfront investment
|
·
|
The
value of the right moves in relation to the movement in the underlying
share price of the Company subject to a
cap
|
·
|
It
is settled at a future date; under IFRS, expiry at maturity date is a form
of settlement.
|
Amarin 694/005 | ||
Protocol AN01.01.0012 |
Change Order
no. 2, 8th June 2006
|
DATED
|
the
8th day of June 2006.
|
BETWEEN
|
Amarin
Neuroscience Limited of King’s Park House, Laurelhill Business Park,
Stirling, UK FK7 9PQ (‘Amarin’)
|
AND
|
ICON
Clinical Research Limited of South County Business Park, Leopardstown,
Dublin 18 (‘ICON’)
|
A.
|
The
parties entered into an Agreement for Services on 30th June 2005,
concerning Study known as Protocol AN01.01.0012A Multi-centre,
double-blind, randomized, parallel group, placebo-controlled trial of
ethylepa (Ethyl-Icosapent) in patients with Huntington’s
Disease. This is a Europe only
study.
|
B.
|
The
main changes to the project specifications are to the study timelines, the
site and patient distribution and the CRF page numbers. The
revised specifications are detailed in Appendix 1
attached.
|
|
1.
|
The
parties agree to amend the Agreement to reflect changes set out in the
‘European Revised Project Specifications and Cost Document’ which is
attached hereto and incorporated
hereby.
|
|
2.
|
Save
as otherwise provided in this Change Order, all the terms and conditions
of the Agreement dated the 30th June 2005 shall remain in full force and
effect.
|
|
3.
|
The
value of this Change Order shall be £382,057 in direct fees and £1,385,655
in pass through costs. The direct fees shall be paid in an
initial fee of 10% at signature of this agreement and monthly fees
thereafter as outlined below:
|
Change Order Direct Fee Value: | £382,057 |
Initial
Payment 10% on siqnature of Change Order (June 06)
|
£38,205
|
Monthly
Payments x 12 months (June’06 to May’07)
|
£28,654.33
|
Amarin 694/005 | ||
Protocol AN01.01.0012 |
Change Order
no. 2, 8th June 2006
|
Amarin
Neuroscience Limited
|
ICON
Clinical Research Limited
|
King’s
Park House
|
South
County Business Park
|
Laurelhill
Business Park
|
Leopardstown
|
UKFK7
9PQ
|
Dublin
18
|
United
Kingdom
|
Ireland
|
30 June 2006 | 29 September 2006 | |
DATE
|
DATE
|
|
/s/ Anthony Clarke | /s/ Sean Leech | |
SIGNED
|
SIGNED
|
|
A. CLARKE | SEAN LEECH | |
NAME
|
NAME
|
|
V.P.
CLINICAL DEVELOPMENT
|
EXEC. VP COMMERCIAL AND ORGANISATIONAL DEVELOPMENT | |
TITLE
|
TITLE
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
1. Introduction
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
2. Revised
Clinical project Specifications
|
·
|
A
delay of 2.5 months to study
set-up.
|
·
|
The
inclusion of the 1-month follow-up period (i.e. patients will be in the
study for 6 months plus 1 month
follow-up)
|
·
|
The
inclusion of an additional 2 weeks period (It was planned to screen the
first patient in December 2005; in the project meeting in November it was
decided that the last patient in date would be June 2006, in total 6.5
months).
|
·
|
Last
patient in date means date last patient randomised to
medication
|
·
|
Last
patient out date is 1 month/35 days after last patient off
treatment.
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Country
|
Number
of
screened
sites
|
Number
of
initiated
sites
|
Number
of
randomized
patients
|
Germany
|
14
|
12
|
96
|
Netherlands
|
|||
UK
|
24
|
18
|
144
|
Spain
|
|||
TOTAL
|
38
|
30
|
240
|
Country
|
Number
of
screened
sites
|
Number
of
initiated
sites
|
Number
of
randomized
patients
|
Austria
|
2
|
2
|
24
|
Germany
|
9
|
9
|
80
|
Italy
|
4
|
4
|
30
|
Netherlands
|
1
|
0
|
0
|
Portugal
|
3
|
2
|
8
|
Spain
|
5
|
4
|
28
|
Switerland
|
1
|
0
|
0
|
UK
|
12
|
9
|
70
|
TOTAL
|
37
|
30
|
240
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
·
|
ICON
will write the Austrian Protocol Amendment required for EC and regulatory
submissions.
|
·
|
ICON
will organise for the translation of medication instructions through a
third party vendor.
|
·
|
ICON
will organise for the translation of the study protocol into Spanish
through a third party vendor.
|
·
|
ICON
will organise for the translation of regulatory documentation through a
third party vendor.
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
3. Revised
Biometrics Project Specifications
|
Data
Management
|
Contract
|
CO#1
|
Comments
|
US
Study and Synergies:
|
-
|
-
|
Both
the costs for the US study and the synergies (for managing both studies in
parallel) have been removed.
|
Timelines
(EU study):
|
21
|
28
|
The
original contract specifications were based on 21 months (from 1 Apr 05 to
1 Jan 07). The date for database lock has been moved so the
timelines have been extended by 5 months thus increasing the costs for the
following activities: Project Management, teleconferences and
the review of monthly central laboratory and ECG transfers. The
date for Database lock is estimated to be 4-6 weeks post Last Patient Last
Visit (LPLV) date. ICON will make all possible efforts to
achieve Database Lock as early as possible.
|
Status
Reports (EU study):
|
21
|
76
|
The
original contract specifications were based on monthly status reports over
21 months. From April 2006 status reports will be provided on a
weekly basis, thus the number of reports has increased to
76.
|
Face-to-face
Meetings (EU study):
|
2
|
6
|
The
original contract specifications were based on attendance at two
face-to-face meetings. Four additional meetings have been
included (including travel costs) as the Data Management group has already
attended two meetings to date and it is expected that there will be
quarterly meetings on an ongoing basis.
|
Pages
(EU Study):
|
13,680
|
21,816
|
The
original contract specifications were based on 13,680 (24 drop-outs x 30
pages plus 216 completers x 60 pages) pages. The number of CRF
pages has now increased to 21,816 pages (24 drop-outs x 45 pages plus 216
completers x 96 pages), thus increasing the costs for data and query
processing (10%).
|
CRF
Design (EU study):
|
60
|
96
|
The
original contract was based on 30 unique/30 replicate CRF
pages. This has now increased to 30 unique/66 replicate pages
thus increasing the costs for CRF
design.
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
4. Revised
Pass-through Costs
|
Activity
|
Description
|
Travel
Costs
|
Cost
estimates for site visits have been increased from an average of £210 to
£300 due to the revised site allocation. It is estimated that
there will be an additional 26 visits conducted.
|
Translations
|
Translation
costs for the following have been included in the
budget:
|
Translation
of patient cards into 7 languages.
|
|
Translation
of medication instructions into 7 languages.
|
|
Translation
of the study protocol into Spanish.
|
|
Translation
of the study synopsis into 3 additional languages.
|
|
Translation
of the informed consent form into 4 additional
languages.
|
|
Translation
of additional EC documentation for 6 additional
submissions.
|
|
Translation
of regulatory documents from three languages into
English.
|
|
Translation
of investigator contracts.
|
|
Regulatory
Agency Fees
|
Regulatory
fees for 3 clinical trial submissions have been included in the revised
pass-through budget.
|
Ethics
Committee Fees
|
EC
fees for one less EC submission have been deduced from the revised
pass-through budget.
|
Investigator
Fees
|
Cost
estimates for investigators fees including hospital overheads and pharmacy
fees have been included in the revised past-through
budget.
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
5. Revised
Cost Estimates (Clinical)5. Revised Cost Estimates
(Clinical)
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Support
Services
|
Units
|
Number
of
Units |
Price
per
unit* |
Revised
Cost
(STG£) |
Contract
(STG£) |
Change
Order (STG£)
|
Local
Ethics Committee Submissions
|
Sites
|
27
|
552
|
14,905
|
16,562
|
-1,657
|
Central
Ethics Committee Submission
|
Sites
|
6
|
828
|
4,968
|
3,312
|
1,656
|
Regulatory
Submission
|
Submission
|
3
|
3,005
|
9,015
|
0
|
9,015
|
ICOTrack
Set-up
|
System
Set-
|
1
|
2,795
|
2,795
|
2,795
|
0
|
ICOTrackMaintenance
|
Months
|
26
|
177
|
4,612
|
4,612
|
0
|
SUPPORT
SERVICES SUB-TOTAL
|
£36,295
|
£27,281
|
£9,013
|
ICON
CLINICAL RESEARCH
|
£1,488,541
|
£1,106,484
|
£382,057
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Estimated
pass-through costs
|
Units
|
Number
of
Units
|
Price
per unit
|
Revised
Cost (STG£)
|
Contract
(STG£)
|
Change
Order
(STGE)
|
Travel
|
||||||
Site
Visit Adjustment
|
Visits
|
333
|
300
|
99,900
|
69,810
|
30,090
|
Additional
Site visits
|
Visit
|
26
|
300
|
7,800
|
0
|
7,800
|
Team
Meetings
|
Meetings
|
7
|
629
|
4,402
|
4,402
|
0
|
Sponsor
Meetings
|
Meetings
|
7
|
1,118
|
7,827
|
7,827
|
0
|
Investigator
Fees
|
||||||
Investigator
Fees
|
Patient
|
240
|
4,900
|
1,176,000
|
0
|
1,176,000
|
Pharmacy
Fees
|
site
|
30
|
340
|
10,200
|
0
|
10,200
|
Hospital
Overheads
|
10%
per
|
240
|
490
|
117,600
|
0
|
117,600
|
Investigator
Meetings
|
||||||
Travel
|
Attendees
|
69
|
1,747
|
120,543
|
120,543
|
0
|
Administrative
Fee - 10%
|
12,054
|
12,054
|
0
|
|||
Translations
|
||||||
Protocol
synopsis (1,000 words)
|
Language
|
6
|
391
|
2,348
|
1,174
|
1,174
|
Protocol
|
Language
|
1
|
3,000
|
3,000
|
0
|
3,000
|
Informed
consent document
|
Language
|
7
|
783
|
5,479
|
2,348
|
3,131
|
EC
documents
|
Submission
|
33
|
433
|
14,297
|
11,265
|
3,033
|
Medication
Instructions
|
Language
|
7
|
120
|
840
|
0
|
840
|
Regulatory
documents
|
Submission
|
3
|
866
|
2,598
|
0
|
2,598
|
Patient
Cards
|
Language
|
7
|
53
|
371
|
0
|
371
|
Investigator
Contracts
|
Site
|
23
|
800
|
18,400
|
0
|
18,400
|
Other
|
||||||
Teleconferencing
(3 lines)
|
Meetings
|
65
|
84
|
5,451
|
5,451
|
0
|
Ethics
Committee Fees
|
Sites
|
33
|
559
|
18,448
|
19,007
|
-559
|
Regulatory
Fees
|
Submission
|
3
|
800
|
2,400
|
0
|
2,400
|
Courier
|
per
site/month
|
120
|
71
|
33,258
|
24,710
|
8,548
|
Mobile
phones
|
per
CRA per
|
25
|
42
|
3,675
|
2,646
|
1,029
|
£1,666,891
|
£281,237
|
£1,385,655
|
||||
CLINICAL
RESEARCH TOTAL
|
£1,488,541
|
£1,106,484
|
£382,057
|
|||
ESTIMATED
PASS THROUGH COSTS
|
£1,666,891
|
£281,237
|
£1,385,655
|
|||
OVERALL
TOTAL
|
£3,155,432
|
£1,387,720
|
£1,763,512
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Revised
cost Estimates (Biometrics)
|
Data
Management
|
Contract
Costs
|
Removal
of US
Study
Costs and
Synergies
|
EU
Study Cost
(No
Synergy)
|
New
Costs
(CO#1)
|
Change
in
Specifications
|
Cost
Reduction
|
1.
Project Management
|
£30,677
|
£17,367
|
£13,310
|
£29,951
|
£16,641
|
-£726
|
Planning
|
£9,409
|
£6,914
|
£2,495
|
£3,327
|
£832
|
-£6,082
|
Communications
|
£9,409
|
£6,914
|
£2,495
|
£3,327
|
£832
|
-£6,082
|
Set-up
of Status Reports
|
£992
|
£22
|
£969
|
£969
|
£0
|
-£22
|
Ongoing
Status Reports
|
£1,884
|
£637
|
£1,248
|
£4,515
|
£3,267
|
£2,631
|
2.
Meetings
|
||||||
Teleconference
with Sponsor
|
£7,651
|
£3,612
|
£4,039
|
£5,385
|
£1,346
|
-£2,265
|
Kick-off
Meeting
|
£3,328
|
£75
|
£3,253
|
£3,253
|
£0
|
-£75
|
Face-to-face
Meetings
|
£3,948
|
£1,997
|
£1,952
|
£16,263
|
£14,312
|
£12,315
|
3.
Project Set-up
|
||||||
Data
Management Plan
|
£4,225
|
£1,492
|
£2,733
|
£2,733
|
£0
|
-£1,492
|
Study
Specific Procedures
|
£5,147
|
£1,104
|
£4,042
|
£4,042
|
£0
|
-£1,104
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Data
Management
|
Contract
Costs
|
Removal
of US
Study Costs and Synergies |
EU
Study Cost
(No
Synergy)
|
New
Costs
(CO#1)
|
Change
in
Specifications
|
Cost
Reduction
|
Edit
Check Document
|
£6,659
|
£1,906
|
£4,753
|
£4,753
|
£0
|
-£1,906
|
Data
Management Report
|
£3,026
|
£649
|
£2,376
|
£2,376
|
£0
|
-£649
|
Database
Setup
|
£14,839
|
£1,628
|
£13,211
|
£13,211
|
£0
|
-£1,628
|
Edit
Programming
|
£28,107
|
£8,046
|
£20,061
|
£20,061
|
£0
|
-£8,046
|
Data
Listings - Programming
|
£3,026
|
£649
|
£2,376
|
£2,376
|
£0
|
-£649
|
Central
Laboratory - Programming
|
£4,886
|
£1,678
|
£3,208
|
£3,208
|
£0
|
-£1,678
|
ECG
- Programming
|
£6,491
|
£3,282
|
£3,208
|
£3,208
|
£0
|
-£3,282
|
4.
Review External Data
|
||||||
Central
Laboratory - Data
Reconciliation
|
£11,745
|
£7,067
|
£4,679
|
£6,238
|
£1,560
|
-£5,507
|
ECG
- data Reconciliation
|
£5,873
|
£3,533
|
£2,339
|
£3,119
|
£780
|
-£2,754
|
5.
Data Processing
|
||||||
CRF
Scanning
|
£20,269
|
£11,264
|
£9,005
|
£13,772
|
£4,766
|
-£6,498
|
Data
Entry
|
£58,239
|
£32,685
|
£25,555
|
£40,753
|
£15,198
|
-£17,486
|
Obvious
Corrections
|
£42,736
|
£23,984
|
£18,752
|
£29,905
|
£11,153
|
-£12,831
|
Data
Listings - Review
|
£5,001
|
£2,807
|
£2,194
|
£3,499
|
£1,305
|
-£1,502
|
Validation
|
£60,777
|
£34,109
|
£26,668
|
£42,529
|
£15,861
|
-£18,248
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Data
Management
|
Contract
Costs
|
Removal of US
Study Costs and Synergies |
EU
Study Cost
(No
Synergy)
|
New
Costs
(CO#1)
|
Change
in
Specifications
|
Cost
Reduction
|
6.
Coding
|
||||||
Data
Coding (60% autoencode)
|
£9,228
|
£5,179
|
£4,049
|
£4,049
|
£0
|
-£5,179
|
7.
Query Processing
|
||||||
Query
Resolution
|
£28,864
|
£16,199
|
£12,665
|
£20,198
|
£7,532
|
-£8,666
|
8.
Data Transfers to Sponsor
|
||||||
Test
Transfer
|
£2,449
|
£1,176
|
£1,274
|
£1,274
|
£0
|
-£1,176
|
Final
Database Transfer
|
£12,625
|
£5,981
|
£6,644
|
£6,644
|
£0
|
-£5,981
|
9.
Closeout Activities
|
||||||
CRF
Quality Control Reviews (SQRT n+1) Enrolled Patients
|
£1,483
|
£791
|
£692
|
£692
|
£0
|
-£791
|
Critical
Item Reviews 100% Enrolled Patients
|
£12,796
|
£8,411
|
£4,384
|
£4,384
|
£0
|
-£8,411
|
Closeout
& Archive
|
£4,893
|
£2,648
|
£2,246
|
£2,246
|
£0
|
-£2,648
|
10.
SAE Reconciliation
|
||||||
SAE
Reconciliation
|
£5,741
|
£3,313
|
£2,428
|
£2,428
|
£0
|
-£3,313
|
DATA
MANAGEMENT*
|
£426,423
|
£217,119
|
£209,304
|
£304,688
|
£95,384
|
-£121,734
|
CFR
DESIGN
|
£16,393
|
£3,279
|
£13,114
|
£15,906
|
£2,791
|
-£487
|
BIOSTATISTICS
|
£163,451
|
-
|
-
|
£163,451
|
-
|
-
|
PASS-THROUGH
COSTS
|
£50,742
|
£26,972
|
£23,770
|
£34,019
|
£10,249
|
£16,723
|
Amarin Neuroscience |
CONFIDENTIAL
|
Change Order
No. 2
|
||
|
Version 4, 7th
of June 2006
|
Overall
costs
|
Revised
Cost
(STG£) |
Contract
Costs
(STG£) |
Change
Order
(STG£) |
CLINICAL
RESEARCH TOTAL
|
1,488,541
|
1,106,484
|
382,057
|
ESTIMATED
PASS THROUGH COSTS
|
1,666,891
|
281,237
|
1,385,655
|
OVERALL
CLINICAL TOTAL
|
£3,155,432
|
£1,387,720
|
£1,763,512
|
DATA
MANAGEMENT
|
304,688
|
426,423
|
-121,734
|
CRF
DESIGN
|
15,906
|
16,393
|
-487
|
BIOSTATISTICS
|
163,451
|
163,451
|
0
|
DM
and BIOSTAT PASS-THROUGH Costs
|
34,019
|
50,742
|
-16,723
|
OVERALL
DM and BIOSTAT TOTAL
|
£518,064
|
£657,009
|
-£138,944
|
OVERALL
TOTAL
|
£3,673,496
|
£2,044,729
|
£1,624,568
|
Amarin 694/005 |
|
|
||
Protocol AN01.01.0012 |
Change Order No.
2
Version 4, 7th
of June 2006
|
|||
|
Payment
Schedule
|
Summary
of Costs (CO#2)
|
Change
Order Direct Fee Value: £382,057
|
|
Initial
Payment 10% on signature of Change Order (June 06)
|
£38,205
|
Monthly
Payments x 12 months (June ’06 to May ’07)
£28,654.33
per month
|
£343,852
|
Change
Order Direct Fee Value: -£122,221
|
|
Initial
Payment 10% on signature of Change Order (June 06)
|
-£12,222
|
Monthly
Payments x 12 months (June ’06 to May ’07) -
£1,018.51
per month
|
£109,999
|
SUMMARY: Change
Order 2 Payment Schedule
|
|
Change
Order Direct Fee Value: Clinical
|
£382,057
|
Change
Order Direct Fee Value: Data Management
|
-£122,221
|
£259,836
|
Summary
of Costs (CO#2)
|
10%
upon signature
|
£25,984
|
Monthly
Payments x 12 months (June ’06 to May ’07)
|
|
£19,487.70
per month
|
£233,852
|
£259,836
|
REVISED
ICON EU PAYMENT SCHEDULED (CHANGE ORDER #2)U PAYMENT SCHEDULED (CHANGE
ORDER #2)
|
|
Milestone
Payments
|
|
Task
Completed
|
Contract
Value
|
Contract
Signed
|
342,550
|
All
sites initiated
|
192,684
|
50%
of patients enrolled
|
192,684
|
Initial
Payment 10% on signature of C/O#2
|
25,984
|
100%
of patients enrolled
|
192,684
|
Mid-point
of treatment phase
|
192,684
|
All
patients completed and data at DM
|
192,684
|
All
sites closed
|
38,537
|
Final
Tables & Listings
|
25,691
|
Total
Milestones payments
|
£1,396,185
|
|||
Monthly
Payments contract
|
April
’05 - June ‘07
|
22
|
15,570
|
342,550
|
Monthly
Payments change order #2*
|
Jun
’06 - May ‘07
|
12
|
19,488
|
233,852
|
Total
Monthly payments
|
£576,403
|
Total
payments
|
£1,972,587
|
Amarin 694/005 |
|
|
||
Protocol AN01.01.0012 |
Change Order No.
2
Version 4, 7th
of June 2006
|
|||
|
Payment
Schedule
|
Amarin
Neuroscience Limited
|
ICON
Clinical Research Limited
|
King’s
Park House
|
South
County Business Park
|
Laurelhill
Business Park
|
Leopardstown
|
UKFK7
9PQ
|
Dublin
18
|
United
Kingdom
|
Ireland
|
16 October 2006 | 29 September 2006 | |
DATE
|
DATE
|
|
/s/ Anthony Clarke | /s/ Sean Leech | |
SIGNED
|
SIGNED
|
|
A. CLARKE | SEAN LEECH | |
NAME
|
NAME
|
|
VP CLINICAL DEVELOPMENT
|
EXEC. VP COMMERCIAL AND ORGANISATIONAL DEVELOPMENT | |
TITLE
|
TITLE
|
(1)
|
NEUROSTAT PHARMACEUTICALS
INC
. a company organised under the laws of the state of Delaware,
with a principal place of business at 1422 NW First Street, Bend, OR
97701, United States of America (
NeuroStat
);
and
|
(2)
|
AMARIN PHARMACEUTICALS IRELAND
LIMITED
a company incorporated in Ireland under registration number
408912, with a registered office is at 50 Pembroke Road, Ballsbridge,
Dublin 4, Republic of Ireland (
Amarin Pharma
);
and
|
(3)
|
AMARIN CORPORATION PLC
a
company registered in England with registered number 02353920 and a
registered office at 110 Cannon Street, London EC4N 6AR, United Kingdom
(
Amarin Corp
);
and
|
(4)
|
TIM LYNCH
of 1422 NW
First Street, Bend, OR 97701, United States of America (
Mr
Lynch
).
|
(A)
|
Amarin
Pharma is a neuroscience company focused on the research, development and
commercialisation of novel drugs for the treatment of central nervous
system disorders. Amarin Pharma is a wholly-owned subsidiary of
Amarin Corp.
|
(B)
|
NeuroStat
and Amarin Corp entered into an Mutual Confidentiality Agreement dated 2
November 2006 (the
Confidentiality
Agreement
). NeuroStat has valuable, confidential
information relating to various forms of Lorazepam (as defined below)
including a compound known as nano-Lorazepam under development by Elan
Corporation plc of Treasury Building, Lower Grand Canal Street, Dublin 2,
Republic of Ireland and its Affiliates (as defined below) (together
referred to as
Elan
; and specifically
including Elan Pharma International Limited, a limited liability company
incorporated under the laws of
Ireland).
|
(C)
|
Under
the Confidentiality Agreement, due to the sensitivity of the Confidential
Information held by NeuroStat, Amarin Corp agreed, among other things, not
to pursue the license or development of a Lorazepam product with Elan or
any of its affiliates. NeuroStat and Amarin Corp have agreed to
terminate the Confidentiality Agreement on the following terms and
conditions.
|
1.1
|
In
this Agreement and in the Schedules to this Agreement the following words
and phrases shall have the following meanings unless the context requires
otherwise:
|
|
(a)
|
with
respect to any legal entity, the direct or indirect ownership or
possession of (i) the power to direct or cause the direction of the
management and policies of a company or entity whether by contract or
otherwise; (ii) at least 50% (in the aggregate) of the voting power of all
outstanding shares entitled to vote at a general election of directors of
a company or entity; or (iii) at least 50% of the assets of a company or
entity;
|
|
(b)
|
with
respect to any material, item of information, or intellectual property
right, the possession, whether by ownership or licence, of the right to
grant a licence or sub-licence with respect thereto, without breaching any
prior written obligation to any Third
Party,
|
1.2
|
In
this Agreement:
|
|
(a)
|
unless
the context otherwise requires, all references to a particular clause or
schedule shall be a reference to that clause or schedule in or to this
Agreement as it may be amended from time to time pursuant to this
Agreement;
|
|
(b)
|
the
headings are inserted for convenience only and shall be ignored in
construing this Agreement;
|
|
(c)
|
unless
the contrary intention appears, words importing the masculine gender shall
include the feminine and vice versa and words in the singular include the
plural and vice versa;
|
|
(d)
|
any
reference to persons includes natural persons, firms, partnerships,
limited liability partnerships, companies, corporations, unincorporated
associations, local authorities, governments, states, foundations and
trusts (in each case whether or not having separate legal personality) and
any agency of any of the above;
|
|
(e)
|
any
phrase introduced by the terms “including”, “include”, “in particular” or
any similar expression shall be construed as illustrative and shall not
limit the sense of the words preceding those
terms;
|
|
(f)
|
any
reference to a statute, statutory provision or subordinate legislation
(legislation) (except where the context otherwise requires) (i) shall be
deemed to include any bye-laws, licences, statutory instruments, rules,
regulations, orders, notices, directions, consents or permissions made
under that legislation and (ii) shall be construed as referring to any
legislation which replaces, re-enacts, amends or consolidates such
legislation (with or without modification) at any time;
and
|
|
(g)
|
any
reference to a Party includes a reference to their respective
successors-in-title and permitted
assignees.
|
2.1
|
Subject
to the terms and conditions of this Agreement, NeuroStat and Amarin Corp
hereby agree to terminate the Confidentiality Agreement and release each
other from further compliance with the Confidentiality Agreement with
effect from the Commencement Date.
|
2.2
|
Subject
to Amarin Corp’s satisfaction of its obligations under this Agreement,
NeuroStat hereby releases, waives and discharges Amarin Corp and its
Affiliates, successors, directors, agents, servants, officers,
shareholders, employees and representatives of and from all claims, debts,
demands, rights and causes of action, arising out of the transactions,
events and occurrences, or any other claims NeuroStat presently may have
against Amarin Corp, relating to the Confidentiality
Agreement.
|
2.3
|
Amarin
Corp hereby releases, waives and forever discharges NeuroStat and its
Affiliates, successors, directors, agents, servants, officers,
shareholders, employees and representatives of and from all claims, debts,
demands, rights and causes of action, arising out of the transactions,
events and occurrences, or any other claims Amarin Corp presently may have
against NeuroStat, relating to the Confidentiality
Agreement.
|
3.1
|
NeuroStat
shall, forthwith following the Commencement Date and free of charge to
Amarin Pharma, disclose and supply to Amarin Pharma any and all Licensed
Know How to the extent not already disclosed to Amarin Corp or Amarin
Pharma. To avoid any doubt, NeuroStat has no obligation to
disclose any information with respect to which it or Tim Lynch has any
obligation of confidentiality or non-use to
Elan.
|
3.2
|
Mr
Lynch shall enter into a consultancy agreement on mutually acceptable
terms pursuant to which, during a period of six months following the
Commencement Date, Mr
Lynch
shall render such assistance as Amarin Pharma may request in negotiations
with Elan relating to the in-licensing of rights to Products and in
initiating development of Products. Mr Lynch shall be
remunerated on a daily rate basis and the rate payable shall be
US$2,000. NeuroStat hereby irrevocably consents to such an
arrangement.
|
4.1
|
In
consideration of the terms and conditions of this Agreement, including the
license of the Licensed Know How pursuant to Clause 6 and the release and
termination pursuant to Clause 2, and conditional upon Amarin Pharma or an
Affiliate of Amarin Pharma entering into an Elan Lorazepam Agreement (as
defined below):
|
|
(a)
|
In
exchange for the property rights set forth above, Amarin Corp shall issue
to NeuroStat, within 10 days of Amarin Pharma or an Affiliate of Amarin
Pharma entering into an Elan Lorazepam Agreement, immediately exercisable
warrants to purchase 175,000 ordinary shares of Amarin Corp of five pence
par value at the exercise price per share set forth below in the form of
ADSs, exercisable no later than the seventh anniversary of the
Commencement Date on 10 days’ written notice to Amarin Corp (the
Warrants
). The
Warrants and the underlying ADSs shall be issued to NeuroStat pursuant to
a prospectus supplement to Amarin Corp’s shelf registration statement
filed with the Securities Exchange Commission which became effective on 2
August 2006.
|
|
NeuroStat
may exercise the Warrants in respect of amounts of not less than 25,000
ordinary shares on each occasion of
exercise.
|
|
The
exercise price of the Warrants shall be the NASDAQ closing price on the
Business Day before the date upon which Amarin Pharma or an Affiliate of
Amarin Pharma enters into Elan Lorazepam
Agreement.
|
|
(b)
|
Amarin
Pharma shall make the following payments to
NeuroStat:
|
|
(i)
|
a
non-refundable, non-creditable sum of US$165,000 within 10 days after the
date upon which Amarin Pharma or any Affiliate of Amarin Pharma executes a
legally-binding agreement with Elan (or any one of the companies that is
defined as being part of Elan) pursuant to which Amarin Pharma or any
Affiliate of Amarin Pharma obtains any right with respect to or in
connection with any Product, including any license, any option, any
covenant not to sue, any supply commitment, any right to distribute,
and/or any other right with respect to or in connection with any Product
(each, an
Elan Lorazepam
Agreement
; Elan Lorazepam Agreements exclude, however,
any confidential disclosure or similar agreement in both cases pursuant to
which Amarin Pharma or any Affiliate of Amarin Pharma obtains solely the
right to use confidential information relating to Lorazepam or Products in
order to evaluate whether to enter into an Elan Lorazepam Agreement but
does not receive any other rights with
respect
|
|
(ii)
|
non-refundable,
non-creditable milestone payments within 10 days after the relevant
milestone event as follows:
|
|
(A)
|
US$200,000
on the first administration to a human subject of a Product covered by an
Elan Lorazepam Agreement (defined in Clause 4.1(b)(i));
and
|
|
(B)
|
US$200,000
on the first administration to a human subject of a Product covered by an
Elan Lorazepam Agreement (defined in Clause 4.1(b)(i)) in the first
clinical study that is designed to assess the efficacy of such a Product,
however such clinical trial is denominated (with respect to phase of
trial) and whether or not such first clinical study is in a limited
patient group. Clinical studies in any patient population (or
patient populations) are considered “designed to assess the efficacy of
such a Product” for this purpose.
|
4.2
|
Within
five days from the Commencement Date or, if later, receipt by Amarin
Pharma of the relevant copy invoices, Amarin Pharma shall reimburse
NeuroStat’s and Mr Lynch’s reasonable and documented attorneys’ fees and
expenses in connection with the negotiation and documentation of this
Agreement and to the extent such fees and expenses do not exceed in total
US$15,000.
|
5.1
|
NeuroStat
and Mr Lynch hereby jointly undertake that neither shall, and each of
NeuroStat and Mr Lynch shall procure that none of NeuroStat’s Affiliates
shall, whether alone or in conjunction with an Affiliate or Third
Party:
|
|
(a)
|
Prior
to the expiration or termination of this Agreement, enter into or continue
any discussions or negotiations relating to the grant by Elan of any
rights in any Product to NeuroStat, any Affiliate of NeuroStat or Mr Lynch
or any entity Controlled by Mr Lynch;
or
|
|
(b)
|
Prior
to the expiration or termination of this Agreement, research, develop,
use, keep, make, have made, import, offer for sale, sell or otherwise
dispose of Products anywhere in the world or grant or receive any licence
to do any of the foregoing.
|
6.1
|
Subject
to the terms and conditions of this Agreement, NeuroStat hereby grants to
Amarin Pharma and its Affiliates an exclusive, worldwide right and license
to use the Licensed Know-How to (a) seek to enter into an Elan Lorazepam
Agreement, and (b) to research, develop, use, make, have made, import,
offer for sale, sell and otherwise dispose of Products with respect to
which Amarin Pharma or an Amarin Pharma Affiliate has obtained rights
pursuant to an Elan Lorazepam Agreement. Such license to Amarin
Pharma and its Affiliates shall include the right to grant sub-licenses
within the scope of
|
7.1
|
All
payments due to NeuroStat under this Agreement shall be made in US dollars
and by electronic bank transfer to an account specified by
NeuroStat.
|
7.2
|
Without
prejudice to NeuroStat’s right to receive payment on the due date, where
NeuroStat does not receive payment of any sums due to it pursuant to this
Clause 4 within the time specified, interest shall accrue on the sum due
and owing to NeuroStat at the rate equivalent to an annual rate the
greater of (i) 1% over the then current base rate of National Westminster
Bank plc, for the United Kingdom, calculated on a daily basis, and (ii)
10% and such interest shall run from the date on which payment is due to
the date on which payment is made by Amarin Pharma, which the Parties
acknowledge to be a substantial remedy for failure to pay the sums due
within the time specified. If Amarin is late in tendering any
payment that it is otherwise permitted to tender in warrants or equity
(e.g., if it does not tender payment in warrants or equity within the
10-day period for payment after achievement of the event triggering
payment under Clause 4.1), then NeuroStat shall be entitled by written
notice to Amarin to require the payment to be made by wire transfer of
immediately available funds instead;
provided
that if Amarin
timely notified NeuroStat in writing of the payment-triggering event for
the particular payment as required under Clause 4.1 by a notice that is in
accordance with Clause 14, then Amarin will have 3 business days from
receiving NeuroStat's written notice that payment is due to make the
payment of warrants, equity or
cash.
|
7.3
|
All
payments to NeuroStat under this Agreement are expressed to be exclusive
of goods, sales, valued added or any similar such tax (Value Added Tax)
howsoever arising, and Amarin Corp or Amarin Pharma (as the case may be)
shall pay to NeuroStat in addition to those payments or if earlier on
receipt of a tax invoice or invoices from NeuroStat, all Value Added Tax
for which NeuroStat is liable to account to any competent authority in
relation to any supply made or deemed to be made for Value Added Tax
purposes pursuant to this
Agreement.
|
7.4
|
NeuroStat
shall be entitled to request to audit and shall be given access to
appropriate records to confirm the timing payments are due hereunder (and
in the case of payments made in warrants or equity the appropriate
calculation of the number of warrants or shares in accordance with this
Agreement).
|
8.1
|
Each
Party represents and warrants to the other Parties
that:
|
|
(a)
|
it
has legal power, authority and right to enter into this Agreement and to
perform its respective obligations
hereunder;
|
|
(b)
|
it
is not at the Commencement Date a party to any agreement, arrangement or
understanding with any Third Party which conflicts with this
Agreement;
|
|
(c)
|
this
Agreement has been duly authorised, executed, and delivered by that Party
and is a valid, binding, and legally enforceable obligation of that Party;
and
|
|
(d)
|
no
consent, approval, authorisation, or order of any court or governmental
agency or body is required for the consummation of the transactions
contemplated by this Agreement.
|
8.2
|
NeuroStat
gives no warranty of any nature as to the completeness, accuracy or
otherwise of the Licensed Know How and accepts no liability howsoever
arising from Amarin Pharma’s use of the Licensed Know
How.
|
8.3
|
Subject
to Clause 8.4, neither Party shall be liable to the other or any of the
other Party’s Affiliates or any sub-licensees for any of the following
types of loss, damage, cost or expense arising (whether in contract, tort,
negligence, breach of statutory duty or otherwise) under or in relation to
this Agreement or the subject-matter of this
Agreement:
|
|
(a)
|
any
loss of profits, business, contracts, anticipated savings, goodwill, or
revenue; or
|
|
(b)
|
any
indirect or consequential loss or damage whatsoever, even if that party
was advised in advance of the possibility of such loss or damage;
or
|
|
(c)
|
any
punitive, exemplary or similar
damages.
|
8.4
|
Nothing
in Clause 8.2 shall prohibit or hinder the exercise of another Party’s
rights in respect of any liability for fraud or fraudulent
misrepresentation, notwithstanding that any loss or damage that Party may
be seeking to recover is of the type referred to in Clause
8.2.
|
8.5
|
The
rights, powers and remedies provided in this Agreement are (except as
expressly provided) cumulative and not exclusive of any rights, powers and
remedies provided by law, or
otherwise.
|
9.1
|
A
confidential relationship with respect to such Confidential Information
shall be established as of the Commencement Date between the
Parties.
|
9.2
|
Each
Party to whom Confidential Information is disclosed (a
Recipient
) by another
Party (a
Disclosing
Party
) shall use all necessary care to prevent disclosure or
release of Confidential Information of a Disclosing Party to any third
party, except with the Disclosing Party’s prior written
consent. Each Recipient shall limit dissemination of
Confidential Information of a Disclosing Party to those officers and
employees of Recipient who reasonably require access to Confidential
Information of a Disclosing Party for the purposes of this
Agreement and who have been made aware that Confidential Information is
confidential, are bound by written obligations of confidentiality to the
Recipient to treat information such as the Confidential Information of a
Disclosing Party in the strictest
confidence.
|
9.3
|
Each
Recipient shall only use the Confidential Information of a Disclosing
Party for the purposes of this Agreement including in the case
of Amarin Pharma as permitted by Clause
6.
|
9.4
|
Recipient
undertakes to maintain in confidence the fact that discussions are or will
be taking place, the nature of the discussions envisaged by this Agreement
and the fact that the parties have entered into this
Agreement.
|
9.5
|
All
Confidential Information given or transmitted under the terms of this
Agreement will be subject to the terms of this Agreement, except for
Confidential Information that a Recipient can
establish:
|
|
(a)
|
came
lawfully into Recipient’s possession prior to the date of
disclosure;
|
|
(b)
|
is
or becomes public knowledge through no fault or omission of
Recipient;
|
|
(c)
|
is
required to be disclosed by law, in which case Recipient shall give the
Disclosing Party as much advance notice of the proposed disclosure as is
practical (including a copy of any written request or order), and shall
cooperate with the Disclosing Party in any effort to limit or restrict
such disclosure, via a protective order or
otherwise;
|
|
(d)
|
is
furnished or made known to the Recipient by a third party otherwise than
in breach of any obligation of confidentiality to the Disclosing Party;
or
|
|
(e)
|
is
independently developed by the Recipient or one of its Affiliates, without
access to the Confidential Information disclosed by the Disclosing
Party.
|
9.6
|
The
terms of this Agreement and negotiations leading to the execution of this
Agreement shall be considered to be Confidential Information of both
parties.
|
9.7
|
The
obligations of confidence referred to in this Clause 9 shall furthermore
not extend to any Confidential Information
which:
|
|
(a)
|
being
Licensed Know How, Amarin Pharma considers reasonably considers should be
disclosed to sub-licensees, agents, consultants, Affiliates and/or other
Third Parties for the research and development, manufacturing and/or
marketing of Products (or for such Third Parties to determine their
interest in performing such activities) on the condition that such Third
Parties agree to be bound by confidentiality obligations no less onerous
than those contained in this Agreement;
and
|
|
(b)
|
Amarin
Pharma reasonably wishes to disclose to consultants, agents or other Third
Parties solely to the extent required in connection with the purposes of
this Agreement or in connection with due diligence or similar
investigations by such Third Parties, and disclosure to potential Third
Party investors in confidential financing documents or for the purposes of
such financing (and, for the avoidance of doubt to potential sub-licensees
or other strategic partners) on the condition that such Third Parties
agree to be bound by confidentiality obligations no less onerous than
those contained in this Agreement.
|
9.8
|
It
is acknowledged for the avoidance of doubt that Confidential Information
disclosed pursuant to the Confidentiality Agreement shall be considered to
have been disclosed pursuant to, and subject to the provision of, this
Agreement.
|
9.9
|
The
Parties recognise and agree that remedies at law for breach of the
provisions of this Clause 9 are likely to be inadequate and that the
disclosing Party shall, in addition to any other rights it may have, be
entitled to seek injunctive relief.
|
9.10
|
The
obligations of each Party under this Clause 9 shall survive until five
years after the expiry or termination for whatever reason of this
Agreement.
|
10.1
|
This
Agreement shall come into effect on the Commencement Date and, subject to
earlier termination in accordance with this Clause 10, will expire on the
first anniversary of the Commencement Date provided that in the event that
Amarin Pharma or an Affiliate of Amarin Pharma enters into an agreement
with Elan for the development of Products prior to the first anniversary
of the Commencement Date and prior to earlier termination under this
Clause 10, Amarin Pharma shall on written notice be entitled to extend the
term of this Agreement until the second anniversary of the date on which
such agreement with Elan enters
effect.
|
10.2
|
Each
of NeuroStat and Amarin Pharma shall have the right to terminate this
Agreement effective at any time on or after 1 June 2007 on 30 days’
written notice to Amarin Pharma and NeuroStat
respectively. This right to terminate can only take effect
if
|
10.3
|
Amarin
Pharma on the one hand or NeuroStat on the other hand (the
Terminating Party
) shall
have the right to terminate this Agreement in its entirety forthwith upon
giving written notice of termination to NeuroStat and Mr Lynch on the one
hand or Amarin Corp and Amarin Pharma on the other hand (the
Defaulting Party
), upon
the occurrence of any of the following events at any time during this
Agreement:
|
|
(a)
|
the
Defaulting Party commits a material breach of an obligation set out in
this Agreement which is not capable of remedy;
or
|
|
(b)
|
the
Defaulting Party commits a material breach of an obligation set out in
this Agreement which is capable of remedy but has not been remedied within
30 days of the receipt by it of a notice identifying the breach and
requiring its remedy.
|
11.1
|
In
the event of expiry of this Agreement or termination of this Agreement
pursuant to Clause 10.2 and 10.3: (a) subject to Clause 11.2, all rights
and licences granted to Amarin under this Agreement shall terminate; and
(b) each Party shall return all data, files, records and other materials
in its possession or control containing or comprising the other Party’s
Confidential Information to which such first Party does not retain rights
hereunder (except one copy of which may be retained by the returning
Party’s legal department solely for archival
purposes).
|
11.2
|
Following
the expiry of this Agreement after the extended term set out in the
proviso to Clause 10.1 (but not otherwise), the exclusive license granted
pursuant to Clause 6.1 shall -- subject to Amarin and its Affiliates'
continued compliance with this Agreement, including payment obligations,
and in particular (but without limitation) the next sentence -- become
irrevocable, perpetual, fully paid-up and royalty-free (subject to the
next sentence), but shall otherwise continue in full force and
effect. Notwithstanding the foregoing, if all
consideration provided to be payable or potentially payable under Clause 4
have not as of the time of such expiration been paid, then the obligations
to provide the remaining-unpaid consideration shall survive and in this
sense the license shall remain royalty-bearing until all such
consideration has been paid.
|
11.3
|
Following
the expiry or termination of this Agreement, Amarin Corp, Amarin Pharma
and the Affiliates of each of them shall not pursue the license or
development of a Lorazepam Product with Elan (or any of the companies
defined as being part of Elan), and shall not enter into any Elan
Lorazepam Agreement, unless Amarin Pharma or an Affiliate has previously
entered into an Elan Lorazepam Agreement prior to the expiry or
termination of this Agreement. Without limiting or implying any
exception to the foregoing, if Amarin Pharma, Amarin Corp, or the
Affiliate of either of them enters into any Elan Lorazepam Agreement or
develops a Lorazepam Product with or under license with (or other right
from) Elan (or any of the companies defined as being part of
Elan)
|
11.4
|
Termination
or expiry of this Agreement for whatever reason shall not affect the
accrued rights of the Parties arising in any way out of this Agreement as
at the date of termination or expiry and in particular but without
limitation the right to recover damages and interest, and the provisions
of Clauses 9, 10 and 11 shall remain in full force and
effect. NeuroStat’s and Mr. Lynch’s rights under Clause 4 shall
be considered accrued rights as of the Effective Date for this purpose,
however, the payments under Clause 4 shall not actually be due until the
times provided for in Clause 4 (i.e., each payment remains contingent on
achievement of the corresponding Milestone or other event specified in
Clause 4, but such contingency need not be achieved prior to the
expiration or termination of this
Agreement).
|
12.
|
Waiver
|
12.1
|
No
Party shall be deemed to have waived any of its rights or remedies
conferred by this Agreement unless the waiver is made in writing and
signed by a duly authorised representative of that Party. In
particular, no delay or failure of any Party in exercising or enforcing
any of its rights or remedies conferred by this Agreement shall operate as
a waiver of those rights or remedies or so as to preclude or impair the
exercise or enforcement of those rights or remedies nor shall any partial
exercise or enforcement of any right or remedy by any Party preclude or
impair any other exercise or enforcement of that right or remedy by that
Party.
|
13.1
|
This
Agreement constitutes the entire agreement and understanding between the
Parties and supersedes all prior oral or written understandings,
arrangements, representations or agreements between them relating to the
subject matter of this Agreement (including the Confidentiality
Agreement).
|
13.2
|
No
variation, amendments, modification or supplement to this Agreement shall
be valid unless made in writing in the English language and signed by a
duly authorised representative of each
Party.
|
14.1
|
Any
notice to be given pursuant to this Agreement shall be in writing in the
English language and shall be delivered by hand, sent by registered or
recorded delivery airmail post or sent by facsimile confirmed by
registered or recorded delivery post to the address or facsimile number of
the recipient set out at the start of this Agreement or such other address
or facsimile number as a Party may from time to time designate by written
notice to the other Party.
|
14.2
|
Any
notice given pursuant to this Clause 14 shall be deemed to have been
received:
|
|
(a)
|
in
the case of delivery by hand, when delivered;
or
|
|
(b)
|
in
the case of sending by post:
|
|
(i)
|
where
posted in the country of the addressee, on the third Business Day
following the day of posting; and
|
|
(ii)
|
where
posted in any other country, on the seventh Business Day following the day
of posting; or
|
|
(c)
|
in
the case of facsimile, on acknowledgement by the recipient facsimile
receiving equipment on a Business Day if the acknowledgement occurs before
1700 hours local time of the recipient and in any other case on the
following Business Day.
|
14.3
|
All
notices to NeuroStat and all notices to Mr. Lynch must also be faxed to +1
415 268 7522, attention Laura Spiegelman, and +1 650 494 0792, attention
Chip Lion to be considered effectively given under this
agreement. For the avoidance of doubt, the absence of Ms.
Spiegelman or Mr. Lion from these fax numbers, law firm or locations will
not adversely affect whether or not the required copy notice has been
given.
|
15.1
|
Neither
Party may assign its rights or delegate its obligations under this
Agreement, whether by operation of law or otherwise, in whole or in part
without the prior written consent of the other Party, which consent shall
not be unreasonably withheld or delayed, except that Amarin Corp and
Amarin Pharma shall always have the right, without such consent: (a) to
perform any or all of their obligations and exercise any or all of their
rights under this Agreement through any of their Affiliates or
sub-licensees; and (b) assign any or all of their rights and delegate any
or all of its obligations hereunder to any of their Affiliates or to any
successor in interest (whether by merger, acquisition, asset purchase or
otherwise) to all or substantially all of the business to which this
Agreement relates (which shall include any sub-licensee under any rights
granted to Amarin Pharma or an Affiliate pursuant to an agreement with
Elan for the development of
Products),
|
15.2
|
Any
permitted successor of a Party or any permitted assignee of all of a
Party’s rights under this Agreement that has also assumed all of such
Party’s obligations hereunder in writing shall, upon any such succession
or assignment and assumption, be deemed to be a party to this Agreement as
though named herein in substitution for the assigning Party, whereupon the
assigning Party shall cease to be a party to this Agreement and shall
cease to have any rights or obligations under this
Agreement.
|
15.3
|
All
validly assigned rights of a Party shall inure to the benefit of and be
enforceable by, and all validly delegated obligations of such Party shall
be binding on and be enforceable against, the permitted successors and
assigns of such Party. Any attempted assignment or delegation
in violation of this Clause 15 shall be
void.
|
16.1
|
No
Party shall be liable to another Party for failure or delay of any of its
obligations under this Agreement, for the time and to the extent such
failure or delay is caused by riots, civil commotions, wars, hostilities
between nations, embargoes, acts of God, storms, fires, accidents, labour
disputes or strikes, sabotage, explosions or other similar or different
contingencies which affect its performance or are beyond its reasonable
control. If the performance of any obligation under this Agreement is
delayed owing to force majeure for any continuous period of more than six
months, the Parties shall consult with respect to an equitable solution,
including the possible termination of this
Agreement.
|
17.1
|
If
the whole or any part of this Agreement is or becomes or is declared
illegal, invalid or unenforceable in any jurisdiction for any reason
(including both by reason of the provisions of any legislation and also by
reason of any court or competent authority which either has jurisdiction
over this Agreement or has jurisdiction over any of the
Parties):
|
|
(a)
|
in
the case of the illegality, invalidity or un-enforceability of the whole
of this Agreement it shall terminate only in relation to the jurisdiction
in question; or
|
|
(b)
|
in
the case of the illegality, invalidity or un-enforceability of part of
this Agreement that part shall be severed from this Agreement in the
jurisdiction in question and that illegality, invalidity or
un-enforceability shall not in any way whatsoever prejudice or affect the
remaining parts of this Agreement which shall continue in full force and
effect.
|
17.2
|
If
in the reasonable opinion of any Party any severance under this Clause 17
materially affects the commercial basis of this Agreement, the Parties
shall discuss, in good faith, ways to eliminate the material
effect.
|
18.1
|
None
of the provisions of this Agreement shall be deemed to constitute a
partnership between the Parties and neither Party shall have any authority
to bind the other in any way except as provided in this
Agreement.
|
19.1
|
Except
as provided in Clause 19.2, neither Party shall, without the prior written
consent of the other Party:
|
|
(a)
|
release
any information about this Agreement, or any information or results of
work undertaken by either Party pursuant to this Agreement;
or
|
|
(b)
|
use
in advertising, publicly or otherwise, any trade-name, personal name,
trade mark, trade device, service mark, symbol, or any abbreviation,
contraction or simulation thereof, owned by the other Party;
or
|
|
(c)
|
represent,
either directly or indirectly, that any product or service of the other
Party is a product or service of the representing Party or that it is made
in accordance with or utilises the information or documents of the other
Party.
|
19.2
|
The
restrictions in Clause 19.1 shall not apply to the
following:
|
|
(a)
|
use
as required by any applicable law or governmental regulation;
or
|
|
(b)
|
any
disclosures as a Party determines, based on the advice of counsel, are
required to comply with law or applicable rule or regulation of any
nationally recognised securities exchange (such exchange to include the
London Stock Exchange, Euronext and NASDAQ), provided the same is
accurate.
|
20.1
|
Save
as provided in Clause 4.2, each Party shall bear its own legal costs,
legal fees and other expenses incurred in the preparation and execution of
this Agreement.
|
20.2
|
This
Agreement may be entered into by the parties in any number of
counterparts. Each counterpart shall, when executed and
delivered, be regarded as an original, and all the counterparts shall
together constitute one and the same instrument. This Agreement
shall not take effect until it has been executed by all the
parties. This Agreement may be validly exchanged and delivered
by fax.
|
21.1
|
It
is hereby agreed that this Agreement is not intended by the Parties to
create rights or benefits in favour of any person not party to this
Agreement or make any rights or benefits enforceable by or on behalf of
such third parties and for the avoidance of doubt all laws providing to
the contrary in any country including the provisions of the Contracts
(Rights of Third Parties) Act 1999 in the United Kingdom are hereby
excluded to the fullest extent
permitted.
|
22.1
|
This
Agreement shall be governed by the laws of the State of New York,
USA.
|
22.2
|
Any
question, difference or dispute which may arise concerning the
construction meaning or effect of this Agreement or concerning the rights
and liabilities of the parties hereunder shall be subject to the exclusive
jurisdiction of the federal and state courts in New York, New
York.
|
23.
|
Attorneys’
Fees
|
23.1
|
In
the event that any suit or action is instituted to enforce any of the
terms of this Agreement, the prevailing party in such dispute shall be
entitled to all fees, costs and expenses of enforcing any right of such
prevailing party under or with respect to this Agreement (including
reasonable attorneys’ fees), in addition to any other relief to which such
party is entitled.
|
ELAN
PHARMA INTERNATIONAL LIMITED
AND
AMARIN
PHARMACEUTICALS IRELAND LIMITED
|
||
|
||
DEVELOPMENT
AND LICENSE AGREEMENT
|
1.
|
Definitions
and Interpretation
|
2
|
2.
|
The
License
|
13
|
3.
|
Intellectual
Property
|
15
|
4.
|
Non-Competition
|
21
|
5.
|
Development
of the Product Intermediate
|
23
|
6.
|
Project
Team and Project Management
|
24
|
7.
|
Regulatory
Matters
|
25
|
8.
|
Clinical
Develpmt, Registration, Marketing and the Promotion of the
Product
|
27
|
9.
|
Commercial
Manufacture
|
30
|
10.
|
Financial
Provisions
|
31
|
11.
|
Payments,
Reports and Audits
|
35
|
12.
|
Duration
and Termination
|
37
|
13.
|
Consequences
of Termination
|
39
|
14.
|
Warranties,
Indemnification and Liability
|
41
|
15.
|
Confidentiality
|
44
|
16.
|
Miscellaneous
Provisions
|
46
|
Schedule
1
|
Elan
Patents
|
51
|
Schedule
2
|
R&D
Program
|
52
|
Schedule
3
|
Technological
Competitors of Elan
|
54
|
Schedule
4
|
Manufacturing
Costs
|
55
|
Schedule
5
|
Amarin
Stage I Activities
|
56
|
(1)
|
ELAN
PHARMA INTERNATIONAL LIMITED
,
a limited
liability company incorporated under the laws of Ireland, having its
registered office at Monksland, Athlone, Co. Westmeath, Ireland (“
Elan
”);
and
|
(2)
|
AMARIN PHARMACEUTICALS IRELAND
LIMTED
, a limited liability company incorporated under the laws of
Ireland, having its principal place of business at First Floor, Block 3,
the Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland (“
Amarin
”).
|
(A)
|
Elan
possesses certain proprietary small particle technology as well as
proprietary know-how and confidential information used or useful in the
manufacture and use of products containing
nanoparticles.
|
(B)
|
Amarin
has certain expertise relating to the Compound (as defined
below).
|
(C)
|
Amarin
wishes to enter into this Agreement to obtain the right to utilize the
Elan Intellectual Property (as defined below) to import, use, offer for
sale and sell the Product in the Field in the Territory, and to have Elan
develop the Product Intermediate for Amarin, in accordance with the terms
and conditions set out below.
|
1.
|
DEFINITIONS AND
INTERPRETATION
|
1.1.
|
Definitions
. In
this Agreement:
|
(i)
|
trade,
cash or quantity discounts, allowances, adjustments and
rejections;
|
(ii)
|
rebates,
recalls (other than where the Product is replaced without charge) and
returns;
|
(iii)
|
price
reductions or rebates imposed by Governmental
Authorities;
|
(iv)
|
sales,
excise, turnover, inventory, value-added and similar taxes assessed on the
royalty-bearing sale of such Product, but not including any taxes on
income paid by or assessed against Amarin or a permitted
sub-licensee;
|
(v)
|
transportation,
importation, shipping, insurance and other handling expenses directly
chargeable to the royalty-bearing sale of the Product, but only to the
extent that such expenses are separately delineated in the applicable
invoices; and
|
(vi)
|
credits,
chargebacks, prime vendor rebates, reimbursements and similar payments
granted to drug wholesalers or their customers in cases where there are
not direct shipments to such customers by Amarin or its permitted
sublicense.
|
(a)
|
for
(i) the launch year and (ii) if no Statement is due to be produced prior
to ninety (90) days of the estimated first commercial sale in such
country, the Notional NSP shall be estimated in good faith;
and
|
(b)
|
in
each subsequent year, Notional NSP shall be calculated by reference to the
average NSP in that country as evidenced by the last four Statements (or
such lesser number of Statements as have actually been produced in
relation to that country);
|
(a)
|
to
secure the grant of any patent application within such
class;
|
(b)
|
to
file and prosecute patent applications on patentable inventions and
discoveries relating to that class;
|
(c)
|
to
defend all such applications against third party oppositions;
and
|
(d)
|
to
maintain in force any issued letters patent relating to the
same
|
(vii)
|
trade,
cash or quantity discounts, allowances, adjustments and
rejections;
|
(viii)
|
rebates,
recalls (other than where the Product is replaced without charge) and
returns;
|
(ix)
|
price
reductions or rebates imposed by Governmental
Authorities;
|
(x)
|
sales,
excise, turnover, inventory, value-added and similar taxes assessed on the
royalty-bearing sale of such Product, but not including any taxes on
income paid by or assessed against Amarin or a permitted
sub-licensee;
|
(xi)
|
transportation,
importation, shipping, insurance and other handling expenses directly
chargeable to the royalty-bearing sale of the Product, but only to the
extent that such expenses are separately delineated in the applicable
invoices; and
|
(xii)
|
(xiii)
|
credits,
chargebacks, prime vendor rebates, reimbursements and similar payments
granted to drug wholesalers or their customers in cases where there are
not direct shipments to such customers by Amarin or its permitted
sublicense.
|
1.2.
|
Further
Definitions
. In addition, the following definitions have
the meanings in the Clauses corresponding thereto, as set forth
below:
|
Definition
|
Clause
|
“Acquiring/Successor
Entity”
|
15.15
|
“Confidential
Information”
|
15.1
|
“Combination
Formulation”
|
2.4
|
“Disclosing
Party”
|
15.12
|
“Due
Date”
|
11.9
|
“Elan
License”
|
2.1
|
“Expanded
Formulation”
|
2.4.1
|
“Infringement
Claim”
|
3.4.1
|
“Initial
Term”
|
12.1
|
“License
Milestone Payments”
|
10.1
|
“Notice”
|
16.11.1
|
“Project
Team”
|
6.1
|
“Relevant
Marks”
|
3.7.4
|
“Statement”
|
11.1
|
“Third
Party Site”
|
9.6
|
“Trademark
Owner”
|
3.7.4
|
“Trademark
User”
|
3.7.4
|
1.3.
|
Interpretation
. In
this Agreement:
|
1.3.1
|
the
singular includes the plural and vice versa, and unless the context or
subject otherwise requires, references to words in one gender include
references to the other genders;
|
1.3.2
|
unless
the context otherwise requires, reference to a recital, article,
paragraph, provision, clause or schedule is to a recital, article,
paragraph, provision, clause or schedule of or to this
Agreement;
|
1.3.3
|
the
headings in this Agreement are inserted for convenience only and do not
affect its construction; and
|
1.3.4
|
the
expressions “include”, “includes”, “including”, “in particular” and
similar expressions shall be construed without
limitation.
|
2.
|
THE
LICENSE
|
2.1.
|
Elan License to
Amarin
. Subject to the terms of this Agreement, Elan
hereby grants to Amarin for the Term an exclusive license (the “
Elan License
”) to the
Elan Intellectual Property to import, export, use (other than for
formulation development activities), offer for sale and sell the Product
in the Field in the Territory. For the avoidance of doubt,
nothing in this license grant permits Amarin to make or have made Product
Intermediate or to carry out, directly or indirectly (other than through
Elan which retains these rights), any formulation development activities
with regard to the Compound using the Elan Intellectual
Property.
|
2.2.
|
Elan
acknowledges that Amarin may contract with a third party (who is not a
Technological Competitor) to further carry out any activities required to
fill the Product Intermediate into a Device. Elan agrees to
provide such third party with a royalty-free, non-exclusive license to any
Elan Intellectual Property limited to the extent necessary for the third
party to conduct such activities, subject to the formulation development
restrictions set out in Clause 2.1.
|
2.3.
|
Sub-licensing
. Amarin
shall be entitled, subject to [*] to grant sub-licenses in respect of the
Elan Intellectual Property to import, export, have imported, have
exported, use (other than formulation development activities), offer for
sale and sell the Product in the Field in one or more countries of the
Territory. Any grant of sub-license shall also be subject to
the following conditions:
|
2.3.1
|
Amarin
shall grant one sub-license only per country except as required by
law;
|
2.3.2
|
Amarin
shall not grant a sub-license to a Technological Competitor, nor in
circumstances which cause a material adverse tax consequence to Elan which
is not fully compensated for by
Amarin;
|
2.3.3
|
Amarin
shall remain responsible for all payments due to Elan under this
Agreement;
|
2.3.4
|
Any
sub-license granted shall be in the same terms as the terms of this
Agreement insofar as they are applicable, mutatis mutandis, but excluding
the right to grant a sub-license; provided that the sub-licence need not
contain obligations with respect to diligence in marketing and promotion
efforts, provided further that nothing herein shall prejudice Amarin’s
obligations in respect thereof (including in that part of the territory
sub-licensed);
|
2.3.5
|
Amarin
shall use reasonable efforts to obtain for Elan the same rights of audit
and inspection vis-à-vis a sub-licensee as Elan has vis-à-vis Amarin
pursuant to this Agreement; provided, however, if Amarin does not obtain
such rights for Elan with respect to a sub-licensee, Amarin shall obtain
such rights for itself with respect to such sub-licensee and shall
promptly exercise such rights upon written request of
Elan.
|
2.3.6
|
Amarin
shall be liable to Elan for all acts and omissions of any sub-licensee as
though such acts and omissions were by
Amarin.
|
2.3.7
|
Amarin
shall undertake to protect the confidentiality of Elan’s formulation,
engineering and manufacturing processes for the Product Intermediate and
the Product in its dealings with permitted sub-licensees and shall not
disclose any information from the CMC Section to any third party,
including a permitted sub-licensee, without the prior written consent of
Elan.
|
2.4.
|
Option
. In
the event that, within 3 (three) years of the commencement of the R&D
Program, it is determined by the parties that the Product is not feasible,
then Amarin shall have an option, which shall become effective on the date
that the parties agree that the Product is not feasible and shall expire
sixty (60) days thereafter if the option is not exercised in writing by
Amarin before that time, to expand the Elan License to include (i) a
Buccal Formulation or a Sublingual Formulation of the Compound in
combination with the Elan Technology or, alternatively,
(ii) one of any of a nasal formulation or a Buccal Formulation
or a Sublingual Formulation of the Other Compound, by written notice to
Elan. Upon exercise of such
option:
|
2.4.1
|
Amarin
shall promptly articulate the precise option it wishes to exercise, namely
the exact compound and the route of delivery that is to be developed
(“
Expanded
Formulation
”);
|
2.4.2
|
this
Agreement shall expand and apply as necessary (including but not limited
to the expansion of the terms “Compound”, “Product Intermediate” and
“Product” throughout this Agreement) to include the exact compound and the
exact route of delivery of the Expanded
Formulation;
|
2.4.3
|
subject
to the provisions of Clause 10.1, the provisions of this Agreement
regarding milestones and royalties shall additionally apply to such
Expanded Formulation;
|
2.4.4
|
a
new Expanded Formulation R&D Program will be determined by the parties
through good faith negotiations within 90 days from the date that Amarin
notifies Elan that it intends to exercise the option granted under this
Clause 2.4;
|
2.4.5
|
pricing
for development services and for commercial supply of such Expanded
Formulation will be determined by the parties through good faith
negotiations;
|
2.4.6
|
such
other changes as shall be agreed by the parties in good
faith. For the avoidance of doubt, the parties acknowledge and
agree that Elan shall not be required under any circumstances to fund any
further aspect of the R&D Program unless it so agrees;
and
|
2.4.7
|
the
parties shall be released from of any further obligation to pursue the
development and marketing of a Product Intermediate or Product for nasal
use containing the Compound.
|
2.5.
|
Secondary
Territory
. Prior to marketing the Product in any country
of the Secondary Territory, Amarin shall notify Elan of its intention to
do so, and thereafter Elan may if it considers it necessary to protect its
Confidential Information, remove such country from the Territory and the
Secondary Territory.
|
3.
|
INTELLECTUAL
PROPERTY
|
3.1.
|
Ownership of
Intellectual Property
.
|
3.1.1
|
Elan
shall remain the owner of the Elan Intellectual
Property.
|
3.1.2
|
Amarin
shall remain the owner of the Amarin Intellectual
Property.
|
3.1.3
|
Elan
and Amarin shall jointly own the [*] and each party shall have an
undivided interest in such [*] and may exercise its interests in such [*]
(including, subject to Clause 2.1, the right to grant licences) without
accounting to the other party except as otherwise specifically provided
for herein. To the extent either party or its Affiliates would
be deemed to be the sole owner of such [*] under the intellectual property
laws of any jurisdiction, such party hereby irrevocably assigns, and shall
cause such Affiliate to assign, to the other party an equal undivided
interest in such [*].
|
3.1.4
|
Elan
owns Elan Compound Data.
|
3.1.5
|
Amarin
owns Amarin Compound Data.
|
3.1.6
|
Amarin
grants Elan the right to use Amarin Compound Data to Prosecute Elan
Patents or Elan Improvements and/or
[*].
|
3.2.
|
Patent Prosecution and
Maintenance
.
|
3.2.1
|
Elan,
at its sole discretion and expense, may Prosecute the Elan Intellectual
Property in the Territory. Elan and Amarin shall discuss any
filing strategy in the Territory for any proposed patent applications (s)
relating to the Product, the Product Intermediate and/or [*]. Elan shall
inform Amarin of any patent applications relating to the Product, the
Product Intermediate and/or [*] filed in the Territory. Elan
shall have the first right to Prosecute Product Patents and
[*]. Elan shall keep Amarin reasonably informed regarding the
prosecution of Product Patents and [*]. Amarin shall treat such
information as Confidential Information. Where Elan chooses not
to Prosecute any Product Patents or [*] Patent Rights, Elan shall provide
written notice to this effect to Amarin. Upon receipt of such
notice, Amarin shall have the right at its sole expense to Prosecute the
Product Patents or [*] referred to in this
notice.
|
3.2.2
|
Amarin,
at its sole discretion and expense, may Prosecute the Amarin Intellectual
Property in the Territory.
|
3.2.3
|
Elan
shall promptly notify Amarin of any developments that fall within the
Amarin Intellectual Property. Amarin shall promptly notify Elan
of any developments that fall within the Elan Intellectual
Property.
|
3.2.4
|
Each
party shall provide the other with reasonable support in the Prosecution
of the Elan Intellectual Property and the Amarin Intellectual Property in
respect of any inventions that were developed under this Agreement and
shall provide all information and/or data in its possession that is
necessary to support any relevant patent application in the
Territory.
|
3.2.5
|
Amarin
and Elan shall discuss the filing strategy for any proposed patent
application(s) in the Territory and shall co-ordinate the filing of such
patent application(s) between the two parties in order to protect the
intellectual property rights of both parties in the
Territory.
|
3.3.
|
Enforcement
.
|
3.3.1
|
Elan
and Amarin shall promptly inform each other in writing of any actual or
alleged unauthorized use of the Elan Intellectual Property or the Amarin
Intellectual Property by a third party of which it becomes aware and
provide the other party with any available evidence of such unauthorized
use.
|
3.3.2
|
Elan
shall have the right to enforce for Elan’s own benefit (including by
agreement or by litigation) Elan Intellectual Property at its own
instigation and expense. Amarin shall reasonably cooperate with
Elan to enforce such rights, provided that Amarin is indemnified for any
out-of-pocket expenses incurred in providing such
cooperation. Amarin shall be kept advised at all times of such
suit or proceedings brought by
Elan.
|
3.3.3
|
In
the event that Elan does not wish to enforce its rights in respect of
Product Patents within sixty (60) days of notification under Clause 3.3.1,
then insofar as the alleged infringement occurred after the Effective
Date, Amarin may instead at its own instigation and expense enforce for
its own benefit (including by agreement or by litigation) such Product
Patents, subject to the following
provisions:
|
3.3.3.1
|
Elan
shall reasonably cooperate with Amarin to enforce such rights, provided
that Elan is indemnified for out-of-pocket expenses incurred in providing
such cooperation;
|
3.3.3.2
|
Such
proceedings shall be conducted at Amarin’s
expense;
|
3.3.3.3
|
Elan
shall be kept advised at all times of such suit or proceedings brought by
Amarin;
|
3.3.3.4
|
Elan
shall have the right to review and comment on settlement agreement
proposals and any pleadings or other documents to be filed with the court
in any such litigation and shall do so promptly. Amarin shall
consider such comments and take them into account as is necessary and
reasonable;
|
3.3.3.5
|
Without prejudice to
Clause
12.6.1.1
,
prior to
knowingly making any statements, that would render any Product Patents
unenforceable, invalid or unpatentable, Amarin shall notify Elan of such
statement and discuss reasonable alternatives with Elan (except as
prohibited by applicable law); however in no circumstances shall Amarin
make any such statement without the prior written consent of Elan, except
to the extent required by applicable law;
and
|
3.3.3.6
|
Under
no circumstances shall Amarin, without Elan’s prior written consent,
purport to grant, or otherwise suggest or offer the grant of, any license
to Product Patents as a part of any settlement proposal
.
|
3.3.4
|
Amarin
shall have the right to enforce for Amarin’s own benefit (including by
agreement or through litigation) Amarin Intellectual Property at its own
instigation and expense. Elan shall reasonably cooperate with
Amarin to enforce such rights, provided that Elan is indemnified for
out-of-pocket expenses incurred in providing such
cooperation. Elan shall be kept advised at all times of such
suit or proceedings brought by
Amarin.
|
3.4.
|
Defense of and
Liability for Infringement
Claims
.
|
3.4.1
|
Each
of the parties shall promptly notify the other party in writing of any
Claim made or brought against either of them alleging infringement or
other unauthorised use of the proprietary rights of a third party arising
from the manufacture, importation, use, offer for sale, sale or other
commercialization of the Product or Product Intermediate in the Territory
(“
Infringement
Claim
”).
|
3.4.2
|
Notwithstanding
any term or provision to the contrary contained in this Agreement, Amarin
shall indemnify and hold harmless Elan against all Infringement Claims
arising from the use or sale of Product or Product Intermediate by Amarin,
its Affiliates, permitted sub-licensees, distributors or other Amarin
subcontractors except to the extent such claims arise from a breach by
Elan of its representations and warranties set forth in Clause 14.1 herein
or except as provided in Clause 3.4.3. Amarin shall indemnify
and hold harmless Elan against all Infringement Claims arising from but
not limited to:
|
3.4.2.1
|
the
handling or storage of the Product Intermediate or Product by or on behalf
of Amarin, its Affiliates, permitted sub-licensees, distributors or other
Amarin subcontractors;
|
3.4.2.2
|
the
further processing of the Product Intermediate by or on behalf of Amarin,
its Affiliates, permitted sub-licensees, distributors or other Amarin
subcontractors;
|
3.4.2.3
|
the
handling or use of any Device in relation to the Product by or on behalf
of Amarin, its Affiliates, permitted sub-licensees, distributors or other
Amarin subcontractors, including any use of a Device to administer the
Product; or
|
3.4.2.4
|
the
method by which the Product is administered to any patient as directed by
or on behalf of Amarin, its Affiliates, permitted sub-licensees,
distributors or other Amarin
subcontractors.
|
3.4.3
|
Elan
will provide reasonable assistance to Amarin in its defence of
Infringement Claims. In respect of those Infringement Claims
related to the Elan Patents, Elan Know-How or the Elan Improvements, the
Infringement Claim Fees and/or Third Party Royalties arising from the use
or sale of Product or Product Intermediate by Amarin, its Affiliates,
permitted sub-licensees, distributors or other Amarin subcontractors shall
be apportioned as follows subject to the terms and conditions as set forth
in Clause 3.5 herein:
|
3.4.3.1
|
Elan
shall be responsible for [*] of Infringement Claim Fees arising from any
Infringement Claims related to Elan Patents, Elan Know-How or Elan
Improvements and/or Third Party Royalties payable up to [*] of
the royalties otherwise payable to Elan under this
Agreement;
|
3.4.3.2
|
Amarin
shall be responsible for any excess Infringement Claim Fees and/or Third
Party Royalties over and above the amount as set forth in Clause
3.4.3.1;
|
3.4.3.3
|
Amarin
will be entitled to recover Infringement Claim Fees and/or Third Party
Royalties due by Elan as set forth in Clause 3.4.3.1 as a credit against
up to [*] of the royalties otherwise payable to Elan under this Agreement
in a calendar quarter, subject to Clause 3.5
below;
|
3.4.3.4
|
Any
deficit remaining in Amarin’s recovery of amounts due by Elan to Amarin
under Clause 3.4.3.1 may be carried over to subsequent calendar quarters
until exhausted. Such carry-over shall remain subject to the
limit of up to [*] of the royalties otherwise payable to Elan under this
Agreement in such calendar quarter (subject to Clause
3.5).
|
3.4.4
|
In
its defence of Infringement Claims, Amarin
shall:
|
3.4.4.1
|
keep
Elan informed with respect to any developments in such proceedings that
are reasonably likely to have a material adverse effect on sales of the
Product;
|
3.4.4.2
|
provide
Elan with the right to review and comment, as practical, on any pleadings
or other documents to be filed with the court in any such litigation
(including at the option of Elan through separately appointed counsel);
and
|
3.4.4.3
|
except
to the extent required by applicable law, not make any reference to Elan
Intellectual Property in any proceedings, without the prior written
consent of Elan, such consent not to be unreasonably withheld, conditioned
or delayed.
|
3.4.5
|
Save
as specifically provided otherwise in this Clause 3.4, the provisions of
Clause 14.6 shall apply as regards the conduct of any Infringement
Claim.
|
3.5.
|
For
the avoidance of doubt, Elan's maximum aggregate liability for all Third
Party Royalties and all Infringement Claim Fees under Clause 3.4.3.1 in
any calendar quarter shall be limited to up to [*] of the royalties
otherwise payable to Elan under Clause 10.4 in that calendar quarter,
provided that
any
sums paid by Amarin to Elan pursuant to Clauses 9 and 10 or
under the Manufacturing Agreement for the supply of Product Intermediate
shall not be treated as royalty payments for the purposes of this Clause
3.5.
|
3.6.
|
With
reference to the provisions of this Clause 3, Elan and Amarin shall
consult as regards any actions Elan or Amarin proposes to take in order to
mitigate any loss or liability in respect of any Infringement Claim, such
as for example Amarin ceasing to sell the Product, the parties agreeing to
modify the Product, or either or both of the parties entering into a
licensing or settlement negotiation with the third party. In
the event that the parties
|
3.7.
|
Trademarks
.
|
3.7.1
|
Amarin
shall market the Product in the Territory under the Amarin
Trademark.
|
3.7.2
|
Amarin
shall prominently display the Elan Trademark on the packaging of the
Product and on all promotional materials in relation to the Product to
acknowledge that the Elan Technology has been applied in developing and
manufacturing the Product.
|
3.7.3
|
For
this purpose:
|
3.7.3.1
|
Amarin
grants to Elan and its Affiliates for the Term a royalty free, worldwide,
non-exclusive license to the Amarin Trademark and, if different,
trademarks showing Amarin’s corporate logo, solely for the purpose of
Elan’s promotion of its activities in relation to this Agreement and of
the Elan Technology in relation to this Agreement;
and
|
3.7.3.2
|
Elan
grants to Amarin for the Term a paid-up, worldwide, non-exclusive license
to the Elan Trademark, solely for the purpose of fulfilling Amarin’s
obligations in relation to this Agreement, and for the purpose of Amarin’s
promotion of its activities in relation to this
Agreement.
|
3.7.4
|
The
following provisions shall apply to the use by one party (“
Trademark User
”) of the
trademark(s) (“
Relevant
Marks
”) of the other (“
Trademark
Owner
”):
|
3.7.4.1
|
Trademark
User shall ensure that each reference to and use of the Relevant Marks by
Trademark User is in a manner from time to time approved by Trademark
Owner and accompanied by an acknowledgement, in a form approved by
Trademark Owner, that the same is a trademark (or registered trademark) of
Trademark Owner.
|
3.7.4.2
|
Trademark
User shall not use the Relevant Mark in any way which might materially
prejudice its distinctiveness or validity or the goodwill of Trademark
Owner therein.
|
3.7.4.3
|
Trademark
User shall not use in the Territory any trademarks or trade names so
resembling the Relevant Marks or any of them as to be likely to cause
confusion or deception.
|
3.7.4.4
|
Trademark
Owner shall, at its sole discretion and expense, file and prosecute
applications to register and maintain registrations of Relevant Marks in
the Territory.
|
3.7.4.5
|
Trademark
Owner will be entitled to conduct all enforcement proceedings relating to
the Relevant Marks and shall at its sole discretion decide what action, if
any, to take in respect of any infringement or alleged infringement of the
Relevant Marks or passing-off or any other claim or counter-claim brought
or threatened in respect of the use or registration of the Relevant
Marks. Any such proceedings shall be conducted at Trademark
Owner’s expense and for its own
benefit.
|
4.
|
NON-COMPETITION
|
4.1.
|
Product and Product
Intermediate
. During the Term, Amarin shall not, and
shall procure that its Affiliates do not, either directly or
indirectly:
|
4.1.1
|
market,
sell or distribute the Product or Product Intermediate in a country
outside the EEA (other than in those countries outside the EEA which are
part of the Territory), or sell the Product to any person who it believes
or ought reasonably to know intends to sell the Product in such a country;
or
|
4.1.2
|
actively
sell the Product or Product Intermediate into a territory in the EEA
reserved on an exclusive basis to Elan or a territory allocated by Elan on
an exclusive basis to its other licensees and/or
distributors. For this purpose, the parties acknowledge that
each territory which is not exclusively allocated by Elan to other
licensees and/or distributors and in respect of which this Agreement has
been terminated is reserved to
Elan.
|
4.2.
|
Competing Products
(Amarin)
. Amarin shall not, and shall procure that its
Affiliates do not market or sell:
|
4.2.1
|
any
nasal formulation containing the Compound (but not including the Other
Compound in any circumstances as formulations of Other Compound are
regulated by Clause 4.2.2) as its sole active ingredient, other
than the Product: (i) in the EEA for a period of five years beginning on
the date of the first In Market sale of the Product in the EEA, or (ii)
elsewhere in the Territory during the Initial
Term;
|
4.2.2
|
any
formulation containing the Compound as its sole active ingredient for use
in buccal or sublingual administration or any formulation containing the
Other Compound as its sole active ingredient for use in nasal, buccal or
sublingual administration, as from the Effective Date until the soonest
of:
|
(a)
|
the
end of the Initial Term; or
|
(b)
|
where
Amarin exercises its option under Clause 2.4, the restriction imposed by
this Clause 4.2 shall immediately terminate in relation to any option
formulation that Amarin does not chose to be the Expanded Formulation;
or
|
(c)
|
service
of notice by Amarin on Elan that it wishes to terminate its option rights
under Clause 2.4 prior to the expiry of the time period referred to in
Clause 2.4; or
|
(d)
|
expiry
of the period referred to in Clause 2.4 without the exercise of an option
in respect of an Expanded
Formulation.
|
4.3.
|
Competing Products
(Elan)
. Elan shall not, and shall procure that its
Affiliates do not, use or license the Elan Technology to market or
sell:
|
4.3.1
|
any
nasal formulation containing the Compound (not including the Other
Compound in any circumstances as formulations of Other Compound are
regulated by Clause 4.3.2) as its sole active ingredient, other than the
Product in circumstances and in countries where Elan is entitled under
this Agreement to market Product: (i) in the EEA for a period of five
years beginning on the date of the first In Market sale of the Product in
the EEA or (ii) elsewhere in the Territory during the Initial
Term;
|
4.3.2
|
any
formulation containing the Compound as its sole active ingredient for use
in buccal or sublingual administration or any formulation containing the
Other Compound as its sole active ingredient for use in nasal, buccal, or
sublingual administration as from the Effective Date until the
soonest of:
|
(a)
|
the
end of the Initial Term; or
|
(b)
|
where
Amarin exercises its option under Clause 2.4, the restriction imposed by
this Clause 4.3 shall immediately terminate in relation to any option
formulation that Amarin does not chose to be the Expanded Formulation;
or
|
(c)
|
service
of notice by Amarin on Elan that it wishes to terminate its option to
expand the license under Clause 2.4 prior to the expiry of the time period
referred to in Clause 2.4; or
|
(d)
|
expiry
of the period referred to in Clause 2.4 without the exercise of
an option having been made under Clause 2.4 in respect of an
Extended Formulation.
|
4.4
|
Competing Combination
Products
. Clauses
4.2
and
4.3
shall apply mutatis mutandis to
such formulations in which the Compound is an active ingredient but not
the sole active ingredient (“
Combination
Formulation
”), provided that such Combination Formulation does not
require human clinical trials comparing the efficacy of such Combination
Formulation to both the Compound and the other active ingredient
individually.
|
5.
|
DEVELOPMENT OF THE
PRODUCT INTERMEDIATE
|
5.1.
|
Development
. Elan
shall use commercially reasonable efforts to develop the Product
Intermediate in accordance with the R&D
Program:
|
5.1.1
|
in
particular, Elan agrees that it
shall:
|
5.1.1.1
|
be
responsible for obtaining and maintaining the necessary licenses and
permits for the development, manufacturing, testing and storage of the
Product Intermediate by Elan as may be required under the R&D
Program.
|
5.1.1.2
|
provide
Product Intermediate as agreed in the R&D Program and shall
manufacture such Product Intermediate in accordance with prevailing cGLP,
cGCP and cGMP and, in all material respects, in accordance with all
applicable Governmental Authority
|
5.2.
|
Compound
Supply
. Elan shall supply Compound for its activities
under the R&D Program up until the completion of the initial animal
pharmacokinetic. Thereafter, Amarin shall re-imburse Elan for
any Compound purchased by Elan for use in the R&D
Program.
|
5.3.
|
Other Materials, Third
Party Costs and Services
. Following the completion of
the initial animal pharmacokinetic study, Amarin shall reimburse Elan for
all materials (including but not limited to the Compound as set out in
Clause 5.2), other out-of-pocket expenses, third party costs and
development services provided by Elan under the R&D Program in
accordance with Clause 10.3.
|
5.4.
|
Changes and Additional
Work
. Any changes to the R&D Program shall be agreed
in advance with Elan, and Amarin shall bear the cost of any resulting
additional work. The Parties also agreed that additional work
will be conducted under additional workplans, which if agreed and
undertaken, will be appended and controlled by the terms of this
Agreement.
|
6.
|
PROJECT TEAM AND
PROJECT MANAGEMENT
|
6.1.
|
Establishment
. Within
sixty (60) days of the Effective Date, the parties will establish a
project team (“
Project
Team
”), which shall consist of development personnel from each
party who are appropriately skilled and knowledgeable in relation to the
R&D Program and who are deemed necessary to accomplish the work of the
R&D Program.
|
6.2.
|
Conduct
. Unless
otherwise agreed by the parties:
|
6.2.1
|
the
Project Team shall meet at least once each calendar quarter, such meetings
to continue until the time of launch or such later time as may be agreed,
alternatively at the offices of Elan and
Amarin;
|
6.2.2
|
meetings
shall be chaired by an Elan
representative;
|
6.2.3
|
each
party shall be responsible for its own costs in respect of travel and
accommodation expenses in attending meetings of the Project
Team;
|
6.2.4
|
at
and between meetings of the Project Team, each party shall keep the other
fully and regularly informed as to its progress with its respective tasks
and obligations under the R&D
Program;
|
6.2.5
|
the
Project Team shall also monitor the progress of the R&D Program
against the timeframe set for it and shall report on delays in the conduct
of the R&D Program which would materially affect Elan’s ability to
successfully complete the R&D Program within the timeframe set out for
it and recommend whether corrective action is required under the
provisions of Clause 6.3.
|
6.3.
|
Co-operation
. Elan
and Amarin shall undertake their respective obligations under the R&D
Program on a collaborative basis. Accordingly, the parties
shall co-operate in good faith particularly with respect to unknown
problems or contingencies and shall perform their respective obligations
in a commercially reasonable, diligent and workmanlike
manner.
|
6.4.
|
The
parties hereby confirm that the parties first and primary objective (under
the R&D Program and under this Agreement generally) is to generate an
NDA and to secure an NDA Approval for the Product in the United
States. While it is the parties desire and expectation that
where possible the body of data generated by them for NDA filing and NDA
Approval may also be used to support other regulatory filings and
approvals, the parties’ initial focus and efforts during the development
program will be intended to generate an NDA and secure NDA
Approval.
|
7.
|
REGULATORY
MATTERS
|
7.1.
|
Elan
. Elan
shall own, and shall be responsible for, filing for and
maintaining:
|
7.1.1
|
regulatory
approvals in respect of the Elan
Technology;
|
7.1.2
|
the
DMF and any equivalent; and
|
7.1.3
|
all
necessary manufacturing approvals for the manufacture of the Product
Intermediate.
|
7.2.
|
Amarin
. Except
as provided in Clause
7.1
, Amarin
shall own and shall be responsible for filing for and maintaining the
Amarin Compound Data and all necessary Regulatory Approvals, including any
necessary export or import licenses in relation to the Compound (where
applicable), Product Intermediate and/or the Product. For the
avoidance of doubt, all of the data, filings and other information
provided by Elan to Amarin or any such Affiliate to support Amarin
regulatory filings shall be treated as Confidential Information belonging
to Elan and its Affiliates in accordance with the provisions of Clause
15.
|
7.3.
|
Disclosure
. Without
prejudice to any other right of Elan under this Agreement, Amarin shall
pursue a strategy of minimum disclosure of information relating to the
manufacturing process of the Product. The parties shall discuss
the implementation of this strategy in good faith on a case by case
basis.
|
7.4.
|
Review
. Elan
shall be given a reasonable opportunity to review and comment upon all
regulatory submissions prior to their
submission.
|
7.5.
|
Co-operation
. Elan
and Amarin will provide all reasonable co-operation with respect to the
other’s regulatory filings.
|
7.6.
|
Keep
Advised
. Amarin shall keep Elan promptly and fully
advised of all Amarin’s regulatory activities in respect of the Product
and the Compound. Without prejudice to the generality of the
foregoing, Amarin shall:
|
7.6.1
|
notify
Elan upon the date of submission of any Regulatory Application in the
Territory;
|
7.6.2
|
notify
Elan upon the date of issue of a Regulatory Approval or related regulatory
action letters; and
|
7.6.3
|
submit
to Elan a quarterly report, for every calendar quarter prior to the
marketing of the Product within 14 days of the end of the relevant quarter
fully outlining the regulatory status of the Product throughout the
Territory.
|
7.7.
|
Right of Reference to
DMF
. Elan will authorise Amarin to reference Elan’s DMF
with the Governmental Authorities to the extent necessary to enable Amarin
to file Regulatory Applications and to maintain Regulatory Approvals in
connection with the Product. In the event that a Governmental
Authority raises any queries in relation to Elan’s DMF which can only be
resolved by Elan (and not by Amarin), Elan shall use commercially
reasonable efforts to resolve any such queries with said Governmental
Authority in an expeditious manner.
|
7.8.
|
Retention of
Samples
. Unless the parties agree otherwise, Elan will
maintain raw material, clinical supply and analytical samples in storage
for a time period based upon Elan’s sample retention policy, or such
longer period of time as Amarin may reasonably request. Elan agrees to
maintain Product Intermediate batch production and control records and
associated test results until the marketing application is approved by the
FDA or until Amarin notifies FDA of discontinuation of the
IND.
|
7.9.
|
Access
. Upon
Elan’s prior written notice, Amarin shall permit Elan to have access to
the Regulatory Applications and Regulatory Approvals and to take
photocopies of same, as required by Elan to fulfil reporting requirements
or as otherwise may reasonably be required by Elan in connection with this
Agreement.
|
7.10.
|
Governmental
Inspection
. Each party shall notify the other as soon as
possible of any notification received by that party from a Governmental
Authority to conduct an inspection of its manufacturing or other
facilities specific to the development, manufacturing, packaging, storage
or handling of the Compound, Product Intermediate and/or the
Product. Copies of all correspondence with the Governmental
Authority solely related to the Compound, Product Intermediate or the
Product and material to that party’s activities under this Agreement will
be provided to that other party.
|
7.11.
|
Right to
Inspect
. Each party shall make that portion of its
facility where the Compound, Product Intermediate or the Product is
manufactured, tested or stored, including all record and reference
samples, available for inspection upon reasonable notice and not more than
once per annum:
|
7.11.1
|
by
the other party’s duly qualified employee or, with the consent of the
party being inspected, by the other party’s duly qualified agent or
contractor; or
|
7.11.2
|
by
the relevant Governmental
Authority.
|
8.
|
CLINICAL DEVELOPMENT,
REGISTRATION, MARKETING AND THE PROMOTION OF THE
PRODUCT
|
8.1.
|
Diligent
Efforts
. Amarin shall be responsible for (at its own
cost) and shall use commercially reasonable efforts to (i) conduct all
stage I activities set out in Schedule 5; (ii) conduct any further
development activities and any further clinical trials with respect to the
Product Intermediate, the Product or any relevant Device to commercialize
Product in the Primary Territory and (iii) register, market and promote
the Product in the Primary
Territory:
|
8.1.1
|
in
particular in respect of the Primary Territory, Amarin agrees that it, its
Affiliates and permitted sub-licensees
shall:
|
8.1.1.1
|
conduct
in an expeditious manner all necessary pre-clinical and clinical studies
in respect of the Product Intermediate, the Product and any Device that
may be used to administer the Product or Product Intermediate and to
conduct such activities in accordance with prevailing cGLP, cGCP and cGMP
and, in all material respects, in accordance with all applicable
Governmental Authority standards and
guidelines;
|
8.1.1.2
|
obtain
Regulatory Approvals for the Product and all necessary governmental
approvals that may need to be obtained for the Device in order to market
the Product in the Primary
Territory;
|
8.1.1.3
|
promote
the Product as the flagship brand under Amarin’s prevailing trademark(s)
for use in an outpatient setting in repetitive epileptic seizures and for
any other indications in a country for which the Product is approved for
use in that country and to otherwise use the same level of effort as used
by Amarin with other similar products of similar sales
potential;
|
8.1.1.4
|
market
and promote the Product with a view to achieving maximum market impact and
concentration throughout the Primary Territory and at least the same level
of effort as with other similar products of similar sales potential which
it markets; and in the event that Amarin elects to market the Product in
any part of the Secondary Territory, the same obligation shall apply to
such territory; and
|
8.1.1.5
|
comply
with all applicable rules and regulations, in all material
respects, in regard to the storage, handling, development and
commercialization of Product and Product Intermediate and otherwise
conduct all storage, handling, development and commercialization
activities relating to the Product and Product Intermediate with due care
in accordance with normal standards in the pharmaceutical
industry.
|
8.2.
|
Promotional
Campaign
. Amarin
shall:
|
8.2.1
|
control
and be responsible for the content and format of each promotional campaign
to be submitted to the relevant Governmental Authority, but shall inform
Elan thereof and, upon reasonable request by Elan, provide to Elan a copy
of such submissions;
|
8.2.2
|
within
ninety (90) days after the filing of the first Regulatory Application in
the Territory, if requested in writing by Elan, outline to Elan the
structure of the promotional activities to be carried out by Amarin for
the period up to the first launch of the Product and for a period of 1
year thereafter; and
|
8.2.3
|
both
prior to and subsequent to the launch of the Product, communicate with
Elan regarding its objectives for and performance of the Product in the
Territory.
|
8.3.
|
Packaging and
Labels
. Amarin shall submit to Elan for Elan’s
information copies of all trade packaging and labels and other printed
materials which Amarin proposes at any time to use in relation to the sale
of the Product. For the avoidance of doubt, nothing in this
Clause
8.3
affects any other
obligation of Amarin, and Amarin shall indemnify and hold harmless Elan
against all Claims which may arise relating to the activities described in
this Clause
8
.
|
8.4.
|
Changes
. Amarin
shall be entitled to change such trade packaging and labels and other
printed materials only as often as is commercially reasonable and in
compliance with applicable laws and regulations. Such changes
shall be at Amarin’s sole expense and for the avoidance of doubt shall not
constitute allowable deductions from Net
Sales.
|
8.5.
|
Required
Markings
. All trade packaging and marketing materials
shall:
|
8.5.1
|
to
the extent permitted by law, include due acknowledgement that the Product
Intermediate is developed and manufactured by Elan;
and
|
8.5.2
|
have
marked representative patent number(s) including that of the formulation
patent in respect of the Elan Patents on all Product, or otherwise
reasonably communicate to the trade the existence of any Elan Patents for
the countries within the Territory in such a manner as to ensure
compliance with, and enforceability under, applicable
laws.
|
8.6.
|
Launch
. Amarin
shall effect the first full scale national commercial launch of the
Product:
|
8.6.1
|
in
the United States within 180 days of the Regulatory Approval in the United
States, provided that Amarin shall have received the agreed quantities of
Launch Stocks ordered pursuant to firm purchase orders under this
Agreement at least 60 days in advance of the launch date;
and
|
8.6.2
|
in
each of the other countries of the Territory, within 270 days after the
relevant Regulatory Approval.
|
8.7.
|
Reporting
. Following
first Regulatory Approval of the Product, the parties shall meet as often
as reasonably requested by the other (not more than once per calendar
quarter). At such meetings, Amarin shall report on the ongoing
sales performance of the Product in each country of the Territory,
including marketing approaches, promotional and educational campaigns,
performance against competitors, its ongoing objectives for the Product
and its plans for promotion of the Product for the next quarterly
period. Such meetings may be held by telephone. If
held in person, each party shall be responsible for its own costs in
respect of travel and accommodation expenses in attending such
meetings.
|
9.
|
COMMERCIAL
MANUFACTURE
|
9.1.
|
Elan
shall maintain the exclusive right and obligation to manufacture or have
manufactured and to supply or have supplied Amarin’s entire requirement of
commercial supplies of Product Intermediate in the Field in the Territory,
subject to Clause 9.6 and 9.7. Elan shall be entitled to
subcontract or delegate these obligations (subject to Amarin’s prior
written consent which shall not be unreasonably withheld, conditioned or
delayed), but shall remain liable to Amarin for all acts or omissions of
any Affiliate or subcontractor under the Manufacturing Agreement as though
such acts or omissions were by
Elan.
|
9.2.
|
Elan
shall be responsible for the cost and sourcing of the Compound for the
commercial supply of Product Intermediate referred to in Clause
9.1.
|
9.3.
|
The
Product Intermediate supplied shall be manufactured in accordance with
cGMP and all applicable laws and regulations. The manner in
which Amarin shall notify Elan of any failure by Elan to supply Product
Intermediate to Amarin that conforms to such requirements and the methods
by which Elan may rectify such problems and other consequences for failing
to provide Product Intermediate in accordance with these requirements
shall be negotiated in good faith and set out in the Manufacturing
Agreement.
|
9.4.
|
The
price of Product Intermediate manufactured by Elan under the Manufacturing
Agreement shall be equivalent to [*] of Notional NSP (the “
Supply Price
”) and upon
delivery Elan will render to Amarin an invoice for Product Intermediate
supplied EXW Elan’s Facility packaged and labelled in a form to be agreed
between the parties.
|
9.5.
|
For
the avoidance of doubt the parties agree that if for whatever reason the
Product Intermediate supplied by Elan to Amarin, which meets agreed
Product Intermediate specifications and applicable law and regulatory
requirements, is not sold by Amarin, payment for such Product Intermediate
shall nonetheless be effected and the price of the Product
Intermediate shall be the Supply
Price.
|
9.6.
|
In
the event that either party is of the opinion that [*] of Manufacturing
Cost for one unit of Product Intermediate would exceed the Supply Price,
then it shall promptly notify the other in writing. In such event the
parties shall meet within thirty (30) days of such notification to
discuss,
inter
alia
, the manner in which Manufacturing Cost is calculated by Elan
and also Amarin’s commercialisation plans. Thereafter, the parties
shall re-negotiate in good faith (i) the Supply Price or,
alternatively, (ii) whether Elan shall use commercially reasonable efforts
to locate a third party site (“
Third Party Site
”) of
Elan’s choosing (but subject to Amarin’s prior written consent which shall
not be unreasonably withheld, conditioned or delayed) to supply
the Product Intermediate and to arrange for a technology transfer between
Elan and that third party at Elan’s cost. The parties further
agree that during the course of such good faith discussions and during any
period prior to the time at which the Third Party Site is ready to
commence manufacture of the Product Intermediate, Elan shall
continue to supply Product Intermediate to Amarin at a price of not less
than [*] of Manufacturing Cost.
|
9.7.
|
In
the event that the parties cannot agree on a Supply Price or on the
technology transfer as provided in Clause 9.6, then Elan shall continue to
supply the Product Intermediate to Amarin but at a price not less than [*]
of Manufacturing Cost.
|
9.8.
|
Forecasting
and ordering provisions will be agreed in good faith, taking into account
the practical requirements involved in manufacturing the Product
Intermediate including,
inter alia,
the fact
that the Compound is a controlled
substance;
|
9.9.
|
Amarin
will be responsible for the purchase of (and shall own) any capital
equipment specifically required for the manufacture of the Product
Intermediate which is unique and/or dedicated to the manufacture of
Product Intermediate. Elan will be responsible for all other
capital equipment used in
manufacture;
|
9.10.
|
In
circumstances where the gross sales of the Product exceed US$50,000,000,
Elan shall establish a second site of manufacture. In such
circumstance, Amarin shall bear its own and all third-party costs related
to any regulatory filing fees and any regulatory maintenance fees or any
license fees related to the registration of such second site, to the
extent related to the manufacture of Product
Intermediate.
|
10.
|
FINANCIAL
PROVISIONS
|
10.1.
|
Milestone
Payments
. In consideration of the grant of the Elan
License, Amarin shall pay to Elan the following non-refundable
amounts:
|
10.1.1
|
A
milestone of [*] upon the earlier of: (i) the commencement of
Stage 1 of the R&D Program or (ii) the commencement of the second
animal pharmacokinetic study that may be conducted on Product
Intermediate;
|
10.1.2
|
a
milestone payment of [*] upon the commencement of the first Phase III
Study of the Product;
|
10.1.3
|
a
milestone payment of [*] upon the filing of the first Regulatory
Application in the United States or in any other country in the Primary
Territory;
|
10.1.4
|
a
milestone payment of [*] upon Regulatory Approval in the United
States;
|
10.1.5
|
a
milestone payment of [*] upon first Regulatory Approval in any country
other than the United States in the Primary
Territory.
|
10.2.
|
Not Subject to Future
Performance Obligations
. The License Milestone Payments
shall not be subject to future performance obligations of Elan to Amarin
and shall not be applicable against future services provided by Elan to
Amarin.
|
10.3.
|
Development
Fees
. Following the completion of the initial animal
pharmacokinetic study that is conducted on the Product or Product
Intermediate in accordance with the R&D Program, Amarin shall
reimburse Elan for all materials (including the Compound), other
reasonable out-of-pocket expenses and third party costs incurred by Elan
during the R&D Program. Amarin shall also reimburse Elan for all
services provided by Elan after the completion of the initial animal
pharmacokinetic study that is conducted on the Product or Product
Intermediate during the R&D Program at Elan’s prevailing full time
equivalent rate (“FTE”), currently
US$250/hour.
|
10.4.
|
Royalties
. In
consideration of the grant of the Elan License, Amarin shall pay to Elan
non-refundable royalties as
follows:
|
10.4.1
|
If
Amarin or an Amarin Affiliate sells the Product In Market in any country
in the Territory, then subject to Clause 10.5, a non-refundable royalty,
calculated by reference to the table set out below, being the sum of the
royalties payable to Elan within the bands of Net Sales generated by
Amarin or an Amarin Affiliate in the Territory at the corresponding
royalty percentage below:
|
Annual
Worldwide Net Sales Bands
|
Applicable
Royalty Rate
|
First[*]
of Worldwide Net Sales
|
[*]
of Net Sales generated by Amarin or an Amarin Affiliate in the
Territory
|
Increments
above [*] of Worldwide Net Sales
|
[*]
of Net Sales generated by Amarin or an Amarin Affiliate in the
Territory.
|
10.4.2
|
If
Amarin enters into a Sub-License Agreement or other agreement whereby a
third party is granted rights to sell the Product in the United States,
then subject to Clause 10.5, a non-refundable royalty calculated by
reference to the table set out below, being the sum of royalties payable
to Elan with the bands of Net Sales generated by the third party
sub-licensee at the corresponding royalty percentage
below:
|
Annual
Worldwide Net Sales Bands
|
Applicable
Royalty Rate
|
First
[*] of Worldwide Net Sales
|
[*]
of Net Sales generated in the US.
|
Increments
above [*] of Worldwide Net Sales
|
[*]
of Net Sales generated in the US.
|
10.4.3
|
If
Amarin enters into a Sub-License Agreement or other agreement whereby a
third party is granted rights to sell the Product outside the United
States, then subject to Clause
10.5:
|
10.4.3.1
|
a
non-refundable royalty of [*] of the Ex-US Net Revenues;
and
|
10.4.3.2
|
the
Manufacturing Royalty, which shall be payable by Amarin to Elan for the
commercial manufacture and supply of the Product Intermediate by Elan to
Amarin for Product that is sold by a third party outside the United
States.
|
10.5.
|
Generic
Competition
. In the event of Generic Competition in a
given country, the parties agree that Elan shall at all times continue to
receive the Manufacturing Royalty for all Product Intermediate supplied by
or on behalf of Elan pursuant to this Agreement and the Manufacturing
Agreement but that the remaining royalties due to Elan pursuant to Clause
10.4 shall be [*] as from the date of commencement of such Generic
Competition in that country.
|
10.6.
|
Bundling
. In
the event that Amarin, an Amarin Affiliate, permitted sub-licensee and a
third party distributor or any permitted sub-licensee shall
sell the Product together with other products of Amarin, an Amarin
Affiliate, a permitted sub-licensee and third party distributor to third
parties (by the method commonly known in the pharmaceutical industry as
“bundling”) and the price attributable to the Product is less than the
average price of “arms length” sales to similar customers for the
reporting period in which sales occur (such sales to be excluded from the
calculation of the average price of “arms length” sales), Net Sales for
any such sales shall be the average price of “arms length” sales by Amarin
or sub permitted sub-licensee to similar customers in the country where
such bundling occurs during the reporting period in which such sales
occur.
|
10.7.
|
Method of calculation
of fees
. The parties acknowledge and agree that the
methods for calculating the royalties and fees under this Agreement are
for the purposes of the convenience of the parties, are freely chosen and
not coerced.
|
11.
|
PAYMENTS, REPORTS AND
AUDITS
|
11.1.
|
Records
. Amarin
shall keep true and accurate records of gross sales of the Product, the
items deducted from the gross amount in calculating the Net Sales, the Net
Sales and the royalties payable to Elan under Clause
10.4
. Amarin shall deliver
to Elan a written statement (the “
Statement
”) thereof
within 45 days following the end of each calendar quarter, (or any part
thereof in the first or last calendar quarter of this Agreement) for such
calendar quarter. The Statement shall outline on a
country-by-country basis, the calculation of the Net Sales from gross
revenues during that calendar quarter, the applicable percentage rate, and
a computation of the sums due to Elan. The parties’ financial
officers shall agree upon the precise format of the
Statement.
|
11.2.
|
Foreign
Currency
. Payments due on Net Sales of the Product based
on sales amounts in a currency other than US$ shall first be calculated in
the foreign currency and then converted to US$ on the basis of the
exchange rate in effect for the purchase of US$ with such foreign currency
quoted in the Wall Street Journal (or comparable publication if not quoted
in the Wall Street Journal) on the last day of the relevant calendar
quarter.
|
11.3.
|
VAT
. All
payments to Elan are exclusive of any applicable value added or any other
sales tax, for which Amarin will be additionally liable if
applicable.
|
11.4.
|
Taxes
. If
Amarin is required by law to pay or withhold any income or other taxes on
behalf of Elan with respect to any monies payable to Elan under this
Agreement:
|
11.4.1
|
Amarin
shall deduct them from the amount of such monies
due;
|
11.4.2
|
any
such tax required to be paid or withheld shall be an expense of and borne
solely by Elan;
|
11.4.3
|
Amarin
shall promptly provide Elan with a certificate or other documentary
evidence to enable Elan to support a claim for a refund or a foreign tax
credit.
|
11.5.
|
Withholding
Notice
. In the event that Amarin is required by law to withhold any
income or other taxes on behalf of Elan from any payment to Elan under the
terms of this Agreement, Amarin shall use commercially reasonable efforts
to notify Elan at least thirty (30) days in advance of making any such
payment.
|
11.6.
|
Double Tax
Co-operation
. Elan and Amarin agree to co-operate in all
respects necessary to take advantage of any double taxation agreements or
similar agreements as may, from time to time, be available in order to
enable Amarin to make such payments to Elan without any deduction or
withholding.
|
11.7.
|
Timing
. Payments
to Elan shall be made as follows:
|
11.7.1
|
each
of the License Milestone Payments shall be paid within 45 days of the
achievement of the relevant event to which they
relate;
|
11.7.2
|
payment
for all Product supplied shall be made within 30 days of receipt of the
relevant invoice; and
|
11.7.3
|
payment
of royalties shall be made upon provision of the
Statement.
|
11.8.
|
Manner of
Payment
. All payments due hereunder shall be made in US$
to the designated bank account of Elan in accordance with such timely
written instructions as Elan shall from time to time
provide.
|
11.9.
|
Interest
. Without
prejudice to Elan’s other remedies hereunder, Amarin shall pay interest to
Elan on sums not paid to Elan on the date on which payment should have
been made pursuant to the applicable provisions of this Agreement (“
Due Date
”) over the
period from the Due Date until the date of actual payment (both before and
after judgement) at the Prime Rate publicly announced by Morgan Guaranty
Trust Company of New York at its principal office on the Due Date (or next
to occur business day, if such date is not a business day) plus [*], such
interest to payable on demand from time to time and compounded
monthly. Interest shall be payable both before and after
judgment.
|
11.10.
|
Audit
. For
the 180 day period following the close of each calendar year of the
Agreement, Elan and Amarin will, in the event that the other party
reasonably requests such access, provide each other’s independent
certified accountants (reasonably acceptable to the other party) with
access, during regular business hours and subject to the confidentiality
provisions as contained in this Agreement, to such party’s books and
records relating to the Product, solely for the purpose of verifying the
accuracy and reasonable composition of the calculations under this
Agreement for the calendar year then
ended.
|
11.11.
|
Correction of
Discrepancies
. In the event of a discovery of a
discrepancy, a correcting payment shall be made forthwith by Amarin to
Elan or Elan to Amarin, as the case may be, together with interest at the
rate specified in Clause
11.9
. If the discrepancy
exceeds 5% of the amount due or charged by a party for any period and
provided that the amount of the discrepancy exceeds US$5,000, then
additionally the cost of such accountants shall be borne by the audited
party.
|
12.
|
DURATION AND
TERMINATION
|
12.1.
|
Initial
Term
. This Agreement shall be deemed to have come into
force on the Effective Date and, subject to the rights of termination
outlined in this Clause
12
and the
provisions of applicable laws, will expire on a country by country
basis:-
|
12.1.1
|
on
the 15th anniversary of the date of the first In Market sale of the
Product in the country concerned;
or
|
12.1.2
|
in
any country upon expiry of the last Valid Patent
Claim –
|
12.2.
|
Continuation
. At
the end of the Initial Term, the Agreement shall continue automatically
for rolling 3 year periods thereafter, unless the Agreement has been
terminated by either of the parties by serving 2 years’ written notice on
the other party immediately prior to the end of the Initial Term or any
such additional 3 year period.
|
12.3.
|
Breach /
Insolvency
. In addition to the rights of termination
provided for elsewhere in this Agreement, either party will be entitled
forthwith to terminate this Agreement by written notice to the other party
if:
|
12.3.1
|
that
other party commits a material breach of any of the provisions of this
Agreement or the Manufacturing Agreement, and fails to cure the same
within 60 days after receipt of a written notice from another party hereto
giving full particulars of the breach and requiring it to be remedied;
provided, that if the breaching party has proposed a course of action to
cure the breach and is acting in good faith to cure same but has not cured
the breach by the 60th day, such period shall be extended by such period
as is reasonably necessary to permit the breach to be cured, provided that
such period shall not be extended by more than 90 days, unless otherwise
agreed in writing by the parties;
|
12.3.2
|
that
other party goes into liquidation under the laws of any applicable
jurisdiction (except for the purposes of amalgamation or reconstruction
and in such manner that the company resulting therefrom effectively agrees
to be bound by or assume the obligations imposed on that other party under
this Agreement);
|
12.3.3
|
a
receiver, administrator, examiner, trustee or similar officer is appointed
over all or substantially all of assets of that other party under the laws
of any applicable jurisdiction; or
|
12.3.4
|
any
proceedings are filed or commenced by that other party under bankruptcy,
insolvency or debtor relief laws, or anything analogous to any of the
foregoing under the laws of any applicable jurisdiction occurs in relation
to that other party.
|
12.4.
|
Free Termination by
Amarin
. Amarin may terminate this Agreement upon thirty
(30) days’ written notice to Elan:
|
12.4.1
|
at
any time up to the initiation of a Phase III Study of the Product;
or
|
12.4.2
|
at
any time following the failure of a Phase III Study;
or
|
12.4.3
|
at
any time after the fifth anniversary of the first In Market sale of the
Product; or
|
12.4.4
|
if
Elan is in breach of Clause 4.3, provided that if such breach results
solely from the acquisition of Elan by a third party, Amarin shall not
terminate this Agreement if the acquirer completes the divestiture of the
competing products or the Product Intermediate within six (6)
months. Save with respect to the provision in the previous
sentence, this Clause shall not prejudice any other remedy Amarin may have
in respect of such breach.
|
12.5.
|
Other Termination by
Amarin
. Amarin may terminate this Agreement on a
country-by-country basis at any time upon thirty (30) days’ written notice
to Elan where:
|
12.5.1
|
the
sale of the Product becomes prohibited by a Governmental Authority in that
country; or
|
12.5.2
|
despite
having used commercially reasonable efforts, Amarin is unable to obtain
Regulatory Approval for the Product in such country so as to permit a
reasonable commercial return for
Amarin.
|
12.6.
|
Additional Elan
Termination Rights
. In further addition to the rights
and termination provided for elsewhere in this Agreement, Elan shall be
entitled to terminate this Agreement upon thirty (30) days written notice
to Amarin:
|
12.6.1
|
in
its entirety in the event that:
|
12.6.1.1
|
Amarin,
its Affiliates or a permitted sub-licensee knowingly challenges the
validity and/or ownership of any of the Elan Patents and/or the scope of
any claims therein in a formal proceeding, mediation or binding
arbitration; or
|
12.6.1.2
|
Amarin
is in breach of Clause
4.2
,
provided that if such breach results solely from the acquisition of Amarin
by a third party, Elan shall not terminate this Agreement if the acquiror
completes the divestiture of the competing product(s) or the Product
(without prejudice to any right of Elan to withhold consent to such
divestiture) within six (6) months. Save with respect to the
proviso in the previous sentence, this Clause shall not prejudice any
other remedy Elan may have in respect of such
breach.
|
12.6.2
|
for
any country or countries of the Territory in the event
that Amarin fails
to file a Regulatory Application:
|
12.6.2.1
|
in
the United States within [*] after the completion of first human
pharmacokenetics study that enables entry into efficacy studies (“
PK
Date
”);
|
12.6.2.2
|
in
an EU Major Market (through either a local or EU procedure which would
result in the immediate approval of the Product in a EU Major Market) [*]
from the PK Date; or
|
12.6.2.3
|
in
Japan [*] from the PK Date.
|
13.
|
CONSEQUENCES OF
TERMINATION
|
13.1.
|
13.2.
|
Specific
Consequences
. Upon termination of the Agreement, or upon
termination of a license for a particular country under Clause
12.6
, the following shall be the
consequences relating to the Territory or the particular country, as
applicable:
|
13.2.1
|
any
sums that were due from Amarin to Elan under the provisions of this
Agreement prior to its termination or expiry shall be paid in full within
30 days of termination of this Agreement and Elan shall not be liable to
repay to Amarin any amount of money paid or payable by Amarin to Elan up
to the date of the termination of this
Agreement;
|
13.2.2
|
the
provisions of this Agreement regarding with respect to confidentiality and
non-use of Confidential Information shall remain in effect for a further
period of 7 (seven) years.
|
13.2.3
|
Clauses
1, 3.1, 3.4, 3.5, 3.6, 11, 13 (in accordance with its terms), 14.1 through
14.10, 14.11 (in accordance with its terms), and 16 shall survive
termination;
|
13.2.4
|
any
sub-license granted under Clause
2.3
shall automatically terminate,
although Elan agrees that it will negotiate in good faith with
sub-licensees to renew such sub-license agreements after the date of such
termination provided that Elan is satisfied that renewing said agreements
will produce a reasonable economic return for Elan and the sub-licensee is
not a Technological Competitor. In the event that such
negotiations do not result in the renewal of the relevant license rights,
the sub-licensee shall be provided with a certain period of time in which
to deplete stock and to return or destroy all Elan Confidential
Information in its possession;
|
13.2.5
|
where
Elan terminates under Clause 12.3, 12.6 or where Amarin terminates this
License on a country-by-country basis or for reasons other than a breach
of this Agreement by Elan, [Elan shall be entitled to research, develop
and commercialise the Product for its own benefit in the Territory or in
the relevant country or countries of the Territory] in accordance with the
provisions of Clause
13.3
;
|
13.2.6
|
where
Elan terminates under Clause 12.3, 12.6 or where Amarin terminates this
License on a country-by-country basis or for reasons other than a breach
of this Agreement by Elan, [*];
|
13.2.7
|
for
the avoidance of doubt, the parties further agree that the termination of
this Agreement for any reason shall not relieve the parties of any
obligation accruing prior thereto and shall be without prejudice to the
rights and remedies of either party with respect to any antecedent breach
of the provisions of this
Agreement.
|
13.2.8
|
If
following the date of termination of this Agreement Amarin is required to
indemnify Elan under the provisions of
[*].
|
13.3.
|
Ancillary
Rights. [*]
|
14.
|
WARRANTIES,
INDEMNIFICATION AND
LIABILITY
|
14.1.
|
Elan
Warranties
. Elan represents and warrants to Amarin as of
the Effective Date, as follows:
|
14.1.1
|
Elan
owns, beneficially or otherwise, the Elan Patents has the right to enter
into this Agreement and grant the Elan
License.
|
14.1.2
|
There
are no agreements between Elan and any third party that conflict with this
Agreement.
|
14.1.3
|
Except
for the oppositions in the European Patent Office of EP-B-499299 and
EP-1185371, Elan has not been notified of and, to the best of Elan’s
knowledge, information and belief with no special search (i) there are no
infringement proceedings, actions, suits or complaints pending against nor
any outstanding injunctions, judgments, orders, decrees, rulings or other
charges against Elan or any Affiliate of Elan in connection with the Elan
Patents or the Elan Know How in the Territory that may affect the making,
using, or selling of the Product, (ii) there are no claims or litigation
brought or threatened by any third party alleging that the Elan Patents
are invalid or unenforceable, in whole or in part and (iii) Elan or any
Affiliate has not received notice from a third party indicating that the
use of the Elan Patents or Elan Know-How infringes any third party patent
rights which would adversely affect the commercialization of the Product
in the Territory.
|
14.1.4
|
Elan
has not been notified and to the best of its knowledge without any special
search no allegation has been made that the application of the Elan
Technology ot the Product Intermediate infringes the patent rights of any
third party.
|
14.2.
|
Amarin
Warranties
. Amarin represents and warrants to Elan as of
the Effective Date, as follows:
|
14.2.1
|
Amarin
has the right to enter into this
Agreement.
|
14.2.2
|
There
are no agreements between Amarin and any third party that conflict with
this Agreement.
|
14.2.3
|
As
of the Effective Date of this Agreement, there is no Amarin Intellectual
Property in existence.
|
14.2.4
|
Amarin
has not been notified and has no actual knowledge that application of the
Elan Technology to the Product Intermediate infringes the patent rights of
any third party.
|
14.3.
|
Mutual
Indemnification
. Each of the parties (“Indemnifying
Party”) shall indemnify and hold harmless the other party (“Indemnified
Party”) against all Claims insofar as they arise out of any breach by the
Indemnifying Party of any of its obligations or warranties under this
Agreement or from the Indemnifying Party’s fraud or wilful misconduct.
|
14.4.
|
14.5.
|
Indemnification
(Medical Claims)
. Except to the relative extent that
Elan is obliged to indemnify Amarin under this Agreement, Amarin shall
indemnify Elan against all any Claims made or brought against Elan seeking
damages for personal injury (including death) and/or for the cost of
medical treatment, caused by or attributed to the Product Intermediate or
Product.
|
14.5.1
|
the
use, sale, promotion, distribution, storage of Product or Product
Intermediate in the Territory;
|
14.5.2
|
the
application and use of any Device with the Product or Product
Intermediate
|
14.5.3
|
the
storage of and any further processing, packaging or other activities
performed by, or on behalf of Amarin, its Affiliates, its permitted
sub-licensees or its permitted subcontractors of the Product
Intermediate;
|
14.5.4
|
any
clinical trial programs conducted by, on behalf of, or at the request of
Amarin, its Affiliates, its permitted sub-licensees or permitted third
party subcontractors with respect to the development of the Product and
Product Intermediate and in respect of all regulatory activities conducted
in connection with the Product or Product
Intermediate.
|
14.6.
|
Conduct of
Claims
. The party seeking an indemnity
shall:
|
14.6.1
|
fully
and promptly notify the other party of any claim or proceedings, or
threatened claim or proceedings;
|
14.6.2
|
permit
the indemnifying party to take full control of such claim or proceedings,
with counsel of the indemnifying party’s choice, provided that the
indemnifying party shall reasonably and regularly consult with the
indemnified party in relation to the progress and status of such claim or
proceedings;
|
14.6.3
|
co-operate
in the investigation and defense of such claim or proceedings;
and
|
14.6.4
|
take
all reasonable steps to mitigate any loss or liability in respect of any
such claim or proceedings.
|
14.7.
|
Exclusion of Implied
Warranties
. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, AMARIN ACKNOWLEDGES THAT THE ELAN LICENSE IS GRANTED AND THE
PRODUCT INTERMEDIATE SUPPLIED ON AN “AS IS” BASIS, WITHOUT REPRESENTATION
OR WARRANTY WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF
THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED TO
THE FULLEST EXTENT PERMITTED BY APPLICABLE
LAWS.
|
14.8.
|
Exclusion of
Consequential Loss
. WITHOUT PREJUDICE TO THE OBLIGATION
OF EITHER PARTY TO INDEMNIFY THE OTHER IN RESPECT OF CLAIMS BY A THIRD
PARTY, NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN
AND AMARIN SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY
REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON
LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY INDIRECT,
CONSEQUENTIAL, SPECIAL, INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR
LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE)
AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR
EMPLOYEES OR AGENTS OR OTHERWISE.
|
14.9.
|
Extension of
Indemnification
. Where this Agreement provides for the
indemnification of a party to this Agreement or for the limitation of a
party’s liability, such indemnification and/or limitation (as the case may
be) shall also apply for the benefit of such party’s Affiliates and the
employees, officers, directors and agents of any of them, acting in such
capacity.
|
14.10.
|
Inherent
Risk
. It is hereby acknowledged that there are inherent
uncertainties involved in the development and registration of
pharmaceutical products and such uncertainties form part of the business
risk involved in undertaking the form of commercial collaboration outlined
in this Agreement. Accordingly, Amarin shall have no liability
to Elan as a result of the failure of the Product to obtain Regulatory
Approval in one or more countries in the Territory provided that Amarin
has satisfied its diligence efforts under Clause 8.1 to conduct
pre-clinical and clinical studies in respect of the Product Intermediate
and Product and Elan will have no liability to Amarin as a
result of any failure or delay of the Product Intermediate to achieve the
Product Intermediate Specifications or one or more of the milestones set
out in the R&D Program and/or to obtain the Regulatory Approval in one
or more of the countries of the Territory provided that Elan uses
commercially reasonable efforts under Clause 5.1 to develop the Product
Intermediate in accordance with the R&D
Program.
|
14.11.
|
Insurance
. Amarin
shall maintain clinical trial insurance and comprehensive general
liability insurance including product liability insurance on the Product,
the Product Intermediate and Compound in such prudent amount as the
parties may agree for the duration of this Agreement and for such period
thereafter as necessary to cover the insured
risks.
|
15.
|
CONFIDENTIALITY
|
15.1.
|
Confidential
Information
: The parties agree that it will be
necessary, from time to time, to disclose to each other confidential and
proprietary materials and information, including without limitation,
inventions, trade secrets, specifications, designs, data, know-how and
other proprietary information relating to the Product, processes, services
and business of the disclosing
party.
|
15.2.
|
Exclusion
. Confidential
Information shall be deemed not to
include:
|
15.2.1
|
information
which is in the public domain;
|
15.2.2
|
information
which is made public through no breach of this
Agreement;
|
15.2.3
|
information
which is independently developed by a party, as evidenced by such party’s
records; or
|
15.2.4
|
information
that becomes available to a receiving party on a non-confidential basis,
whether directly or indirectly, from a source other than the other party
hereto, which source did not acquire this information on a confidential
basis.
|
15.3.
|
Use of Confidential
Information
. Any Confidential Information disclosed by
the disclosing party shall be used by the receiving party exclusively for
the purposes of fulfilling the receiving party’s obligations under this
Agreement and for no other purpose.
|
15.4.
|
Non-Disclosure
. Except
as otherwise specifically provided in this Agreement, each party shall
disclose Confidential Information of the other party only to those
employees, representatives and agents requiring knowledge thereof in
connection with fulfilling the party’s obligations under this Agreement,
and not to any other third party.
|
15.5.
|
Obligation to
Inform
. Each party further agrees to inform all such
employees, representatives and agents of the terms and provisions of this
Agreement relating to Confidential Information and to obtain their
agreement hereto as a condition of receiving Confidential
Information.
|
15.6.
|
Care
. Each
party shall exercise the same standard of care as it would itself exercise
in relation to its own confidential information (but in no event less than
a reasonable standard of care) to protect and preserve the proprietary and
confidential nature of the Confidential Information disclosed to it by the
other party.
|
15.7.
|
Return of
Information
. Upon termination or expiration of this
Agreement, each party shall promptly, upon request of the other party,
return all documents and any copies thereof containing Confidential
Information belonging to, or disclosed by, such other party, save that it
may retain one copy of the same solely for the purposes of ensuring
compliance with this Clause
15
.
|
15.8.
|
Attribution
. Any
breach of this Clause
15
by any
person informed by one of the parties is considered a breach by the party
itself.
|
15.9.
|
Acknowledgment
. The
parties agree that the obligations of this Clause
15
are necessary and reasonable in
order to protect the parties’ respective businesses. The
parties further agree that monetary damages may be inadequate to
compensate a party for any breach by the other party of its covenants and
agreements with respect to confidentiality, and that each party shall be
entitled to seek injunctive or other equitable relief against the
threatened or continued breach of those provisions, in addition to with
any other remedy which may be
available.
|
15.10.
|
Compound
Data
. For the purpose of demonstrating to third parties
the benefits of the Elan Technology, Elan shall be entitled, with the
prior written consent of Amarin, to disclose to third parties the
numerical values underlying the Amarin Compound Data provided that Elan
does not disclose Amarin’s name or the name of the
Compound.
|
15.11.
|
Announcements
. No
announcement or public statement concerning the existence, subject matter
or any term of this Agreement, or its performance, shall be made by or on
behalf of any party without the prior written approval of the other, such
approval not to be unreasonably withheld or delayed. Any such
statement by Amarin shall contain suitable reference to the fact that the
Product is developed using the Elan Technology, and that Elan is the owner
of such technology.
|
15.12.
|
Required
Disclosure
s
. A
party (the “
Disclosing
Party
”) will be entitled to make an announcement or public
statement concerning the existence, subject matter or any term of this
Agreement, or to disclose Confidential Information that the Disclosing
Party is required to make or disclose pursuant
to:
|
15.12.1
|
a
valid order of a court or Governmental Authority;
or
|
15.12.2
|
any
other requirement of law or any securities or stock
exchange;
|
15.13.
|
Disclosures to
Regulatory Authorities
. Notwithstanding Clause
15.12
, Amarin (and its distributors
and permitted sub-licensees) shall not be permitted to include Elan’s
Confidential Information in any Regulatory Application or other regulatory
filings, without Elan’s prior written consent. For the
avoidance of doubt, such consent shall not be taken to permit Amarin, its
distributors and/or permitted sub-licensees to claim ownership rights to
the information provided and/or to use the information for any purpose
other than the specific use and in such manner as that for which consent
was obtained.
|
15.14.
|
Other
Disclosures
. Each of the parties shall be entitled to
provide a redacted copy of this Agreement, to be agreed by the parties, to
any potential distributor or sub-licensees without the prior
written consent of the other party on the condition that such potential
sub-licensees agree to be bound by confidentiality obligations no less
onerous than those contained in this
Agreement.
|
15.15.
|
Technological
Competitors
. [*]
|
16.
|
MISCELLANEOUS
PROVISIONS
|
16.1.
|
Force
Majeure
. Neither party shall be liable for failure or
delay in the performance of any of its obligations under this Agreement if
such failure or delay results from Force Majeure, but any such failure or
delay shall be remedied by such party as soon as
practicable.
|
16.2.
|
Assignment
.
|
16.2.1
|
Each
party be entitled without the consent of the
other:
|
16.2.1.1
|
to
subcontract or delegate the whole or any part of its duties hereunder to
its Affiliate(s); and/or
|
16.2.1.2
|
to
assign this Agreement to its Affiliate, provided that such assignment has
no material adverse tax implications for the other
party.
|
16.2.2
|
Amarin
may assign this Agreement to any person to whom it would be permitted to
grant a sub-license under the Elan License, subject to any conditions
which would attach thereto. For the avoidance of doubt, Amarin
shall under no circumstances assign this Agreement to a Technological
Competitor.
|
16.2.3
|
Each
party shall be entitled to assign this Agreement to any acquiror of all or
substantially all of its assets related to this Agreement, regardless of
the form of such transaction provided that Amarin shall under no
circumstances assign this Agreement to a Technological Competitor and
shall make Elan whole for any tax consequence.
|
16.2.4
|
16.2.5
|
In
the event that an Affiliate of Amarin to whom this Agreement has been
assigned ceases to be an Affiliate of Amarin, this Agreement shall be
deemed automatically reassigned to Amarin (or such Affiliate as it may
specify, subject to the condition set out in Clause
16.2.1.2
).
|
16.2.6
|
Any
assignee shall assume the obligations of the assignor under this
Agreement.
|
16.2.7
|
16.2.8
|
Each
party is entering into this Agreement on its own behalf and not on behalf
of any other person or entity.
|
16.3.
|
Parties
Bound
. This Agreement shall be binding upon and run for
the benefit of the parties, their successors and permitted
assigns.
|
16.4.
|
Relationship of the
Parties
. In this Agreement, nothing shall be deemed to
constitute a partnership between the parties or make either party an agent
for the other, for any purpose
whatsoever.
|
16.5.
|
Entire
Agreement
. This Agreement constitutes the entire
agreement and understanding between the parties with respect to its
subject matter, and except as expressly provided, supersedes all prior
representations, writings, negotiations or understandings with respect to
that subject matter.
|
16.6.
|
Severability
. If
any provision in this Agreement is deemed to be, or becomes invalid,
illegal, void or unenforceable under applicable laws, such provision will
be deemed amended to conform to applicable laws so as to be valid and
enforceable, or if it cannot be so amended without materially altering the
intention of the parties, it will be deleted, but the validity, legality
and enforceability of the remaining provisions of this Agreement shall not
be impaired or affected in any way.
|
16.7.
|
Further
Assurance
. Each party shall do and execute, or arrange
for the doing and executing of, each necessary act, document and thing
reasonably within its power to implement this
Agreement.
|
16.8.
|
Counterparts
. This
Agreement may be executed in any number of counterparts, each of which
when so executed shall be deemed to be an original and all of which when
taken together shall constitute this
Agreement.
|
16.9.
|
Waivers
. A
failure to exercise or delay in exercising a right or remedy provided by
this Agreement or by law does not constitute a waiver of the right or
remedy or a waiver of other rights or remedies. No single or
partial exercise of a right or remedy provided by this Agreement or by law
prevents further exercise of the right or remedy or the exercise of
another right or remedy.
|
16.10.
|
Variations
. No
variation of this Agreement shall be effective unless it is made in
writing and signed by each of the
parties.
|
16.11.
|
Notices
.
|
16.11.1
|
A
notice under or in connection with this Agreement (a “
Notice
”):
|
16.11.1.1
|
shall
be in writing; and
|
16.11.1.2
|
may
be delivered personally or sent by first class post (and air mail if
overseas) or by fax to the party due to receive the Notice at its address
set out below:
|
16.11.2
|
The
address referred to in Clause
16.11.1.2
is:
|
Address:
|
Elan
Pharma International Limited
|
Monksland | |
|
Athlone
|
Co.
Westmeath
|
|
Ireland
|
|
Attention:
|
Vice
President & Legal Counsel
|
Fax:
|
+
353 9064 95402
|
Address:
|
Amarin
Pharmaceuticals Ireland Limited
|
First
Floor
|
|
Block
3
|
|
The
Oval
|
|
Shelbourne
Road
|
|
Ballsbridge
|
|
Dublin
4
|
|
Ireland
|
|
Fax:
|
+353
1 669 9028
|
Marked
for the attention of : General Counsel
|
16.11.3
|
Notice
is deemed given:
|
16.11.3.1
|
if
delivered personally, when the person delivering the notice obtains the
signature of a person at the address referred to in Clause
16.11.1.2
;
|
16.11.3.2
|
if
sent by post, except air mail, two Business Days after posting
it;
|
16.11.3.3
|
if
sent by air mail, six Business Days after posting
it;
|
16.11.3.4
|
if
sent by fax, when confirmation of its transmission has been recorded by
the sender's fax machine.
|
16.12.
|
Set-off
. Each
of the parties will be entitled but not obliged to set-off against any
amount of money payable to it by the other party under this Agreement, any
amount of money payable by it to the other party under this
Agreement.
|
16.13.
|
Disputes
. Any
disputes between the parties which cannot be amicably resolved shall first
be referred to the Chief Operations Officer of Elan Drug Technologies and
the Chief Executive Office of Amarin, who shall attempt to resolve the
matter in good faith.
|
16.14.
|
Governing Law and
Jurisdiction
: This Agreement shall be governed by and
construed in accordance with the laws of Ireland, without regard to its
conflict of laws rules, and shall be subject to the exclusive jurisdiction
of Irish Courts.
|
(b)
|
Such
indirect labour, factory, laboratory and other overhead costs properly
allocable. Overhead allocations shall include expenses of plant
maintenance and engineering, plant management, receiving and warehousing,
disposal and treatment of waste, building occupancy, quality control,
costs of services provided to manufacturing, insurance provided to
manufacturing, and depreciation/amortisation of applicable
capital.
|
·
|
[*
]
|
SIGNED
|
_________________________________
|
Duly
authorised for and on behalf of:
|
ELAN
PHARMA INTERNATIONAL LIMITED
|
SIGNED
|
_________________________________
|
Duly
authorised for and on behalf of:
|
AMARIN
PHARMACEUTICALS IRELAND LIMITED
|
(1)
|
Amarin
Corporation plc, a company incorporated under the laws of United Kingdom
having its registered office at 7 Curzon Street, London, W1J 5HG (the
"Company")
|
(2)
|
Dalriada
Limited, a Bermuda exempted company limited by shares and having its
registered office at Clarendon House, 2 Church Street, Hamilton HM 11,
Bermuda (the "Consultant").
|
A.
|
The
Consultant has certain skills and abilities and provides
consultancy/advisory/management consultancy services which the Company
wishes to avail of on a non-exclusive "as required"
basis.
|
B.
|
The
Consultant as an independent contractor is willing and hereby agrees to
provide services to the Company as set out
herein.
|
1
|
DEFINITIONS
AND INTERPRETATION
|
2
|
CONSULTANCY
SERVICES
|
3
|
DURATION
|
3.1
|
This
Agreement shall be deemed to have commenced on the Effective Date and
shall be for an initial period of 1 year from the Effective Date and shall
renew thereafter automatically for rolling periods of 1 year, unless at
any time the Agreement is terminated by either party in accordance with
clause 6.
|
4
|
CONSULTANT'S
OBLIGATIONS
|
4.1
|
For
the purpose of this Agreement and the provision of the Services, the
Consultant shall procure and make available to the Company the services,
skills and expertise of Mr. Thomas G. Lynch and any additional or
substitute persons as may be agreed between the parties hereto ("the
Consultant's Representative").
|
4.2
|
The
Consultant is retained on a non-exclusive "as required" basis to provide
the Services to the Company.
|
5
|
FEE
/ EXPENSES
|
5.1
|
The
Company will pay to the Consultant a fee of £240,000 per annum for the
provision of the Services, which will be paid to the Consultant quarterly
in arrears. This fee will be reviewed by the Company and the
Consultant on an annual basis in advance of renewal in accordance with
clause 3.1. The Company may also determine to pay the
Consultant performance-related payments from time to
time.
|
5.2
|
The
Company shall reimburse the Consultant in respect of all expenses
reasonably incurred in the proper performance of the Services, subject to
the Consultant providing such receipts or other evidence as the Company
may require.
|
6
|
TERMINATION
|
6.1
|
This
Agreement may be terminated by either party giving to the other not less
than three months prior notice in
writing.
|
6.2
|
Each
of the parties shall be entitled to forthwith terminate this Agreement if
the other party:
|
6.2.1
|
shall
be in breach of any of the terms of this Agreement;
or
|
6.2.2
|
goes
into liquidation, receivership or Court protection or enters into an
arrangement with its creditors.
|
7
|
USE
OF CONFIDENTIAL INFORMATION
|
7.1
|
The
Consultant acknowledges:
|
7.1.1
|
that
the Company possesses a valuable body of Confidential Information;
and
|
7.1.2
|
that
the Company will give the Consultant access to Confidential Information in
order to facilitate the proper provision of the
Services.
|
7.2
|
The
Consultant shall and shall procure that its servants or agents (including
the Consultant's Representative) shall keep secret and shall not at any
time either during the term of this Agreement, or after its termination
for whatever reason, use, communicate, reveal, or cause any unauthorised
disclosure to any person any of the Confidential
Information.
|
7.3
|
The
restrictions contained in this clause shall not apply to any disclosure
required in the ordinary and proper course of the provision of the
Services under this Agreement or as required by the order of a court of
competent jurisdiction or an appropriate regulatory authority or any
information which the Consultant can demonstrate was known to the
Consultant prior to the commencement of this Agreement or is in the public
domain otherwise than as a result of a breach of this
clause.
|
8
|
STATUS
AND INDEMNITY
|
8.1
|
It
is hereby declared that the Consultant's Representative is not and will
not become an employee of the Company and it is agreed that the Consultant
shall be responsible for all payments to the Consultant's Representative
for his services to the Consultant for the purposes of this Agreement and
will be responsible for, if applicable, the deduction of income tax
liabilities and pay related social insurance or similar contributions in
respect of any payments to the Consultant's Representative. The
Consultant hereby agrees to indemnify and hold harmless the Company
against any claims or demands that may be made by the relevant authorities
in respect of income tax, pay related social insurance, penalties or
interest relating to payments to the Consultant's Representative in
respect of his services to the Consultant for the purposes of this
Agreement.
|
8.2
|
It
is further declared that this Agreement shall not constitute or create a
partnership between the parties or between either
party.
|
8.3
|
It
is acknowledged by the Company that the Consultant will be free to
undertake activities and offer the same or other services (including the
services of the Consultant's Representative) at the same
time.
|
8.4
|
The
indemnity contained in this clause 8 shall remain in full force and effect
notwithstanding termination by either party in any manner
whatsoever.
|
9
|
INTELLECTUAL
PROPERTY RIGHTS
|
9.1
|
This
clause 9 applies to any Intellectual Property produced invented or
discovered by the Consultant, its servants or agents, including the
Consultant's Representative, whether alone or with any other person at any
time during the term of this Agreement which relates directly to the
business of the Group.
|
9.2
|
All
Intellectual Property to which this clause 9 applies shall to the fullest
extent permitted by law belong to, vest in and be the absolute and sole
property of the Company.
|
9.3
|
The
Consultant hereby undertakes In relation to any Intellectual Property to
which this clause 9 applies:
|
9.3.1
|
to
hold on trust for the benefit of the Company any such Intellectual
Property to the extent that the same may not be, and until the same is,
vested absolutely in the Company;
|
9.3.2
|
at
the expense of the Company, to execute all such documents, make such
applications, give such assistance and do such acts and things as may be
necessary or desirable to vest in and register or obtain letters patent in
the name of the Company and otherwise to protect and maintain such
Intellectual Property.
|
10
|
SEVERABILITY
|
11
|
BINDING
ON SUCCESSORS AND ASSIGNMENTS
|
11.1
|
This
Agreement shall enure for the benefit of and be binding upon the
respective parties hereto and their respective successors and
assigns.
|
11.2
|
Neither
party may assign or transfer this Agreement or any of the rights arising
hereunder without the prior written consent of the other
party.
|
12
|
VARIATION
|
13
|
WHOLE
AGREEMENT
|
14
|
WAIVER,
RELEASE AND REMEDIES
|
14.1
|
A
waiver by either party of any breach of any of the terms, provisions or
conditions of this Agreement shall not constitute a general waiver of such
term, provision or condition or to any subsequent act contrary
thereto.
|
14.2
|
Any
remedy or right conferred upon either party for breach of this Agreement
shall be in addition to and without prejudice to all other rights and
remedies available to it whether pursuant to this Agreement or otherwise
provided for by law.
|
15
|
NOTICES
|
16
|
GOVERNING
LAW AND JURISDICTION
|
Bank:
|
Wachovia
Bank, NY, USA
|
ABA
No:
|
026–005–092
|
For
the account of:
|
Lloyds
TSB plc
|
Swift
Code:
|
PNBPUS3NNYC
|
For
further credit to:
|
|
Lloyds
TSB,
|
|
Minster
Place
|
|
Ely,
Cambridge
|
|
CB7
4EN
|
|
U.K.
|
|
Account
Name:
|
Amarin
Corporation plc
|
Account
No:
|
11427458
|
Sort
Code:
|
30
– 93 – 05
|
Swift
Code:
|
LOYDGB21265
|
IBAN
No:
|
GB82
LOYD 3093 0511 4274 58
|
No. W-[ ] |
June 1,
2007
|
AMARIN
CORPORATION PLC
|
By:_____________________________
Name: Thomas
G. Lynch
Title: Chairman
|
Address: 7
Curzon Street
London, Greater LondonW1J 5HG
United Kingdom
Attention: Chief Financial Officer
Facsimile: 44 20 7499 9004
|
Name
of DTC Participant acting for undersigned:
|
|
DTC
Participant Account No.:
|
|
Account
No. for undersigned at DTC Participant (f/b/o
information):
|
|
Onward
Delivery Instructions of undersigned:
|
|
Contact
person at DTC Participant:
|
|
Daytime
telephone number of contact person at DTC Participant:
|
(Signature)
|
(Holder’s
Name)
|
(Authorized Signature)
|
(Title)
|
____________________________________
(Tax
ID Number)
|
____________________________________
(Telephone)
|
|
Name:_______________________________________
|
|
(Please
Print)
|
|
Address:____________________________________
____________________________________
|
|
(Please
Print)
|
Holder’s
Name:___________________________
|
Title:___________________________________
|
Holder’s
Address:_________________________
|
Holder’s
Telephone:_______________________
|
Facsimile:_______________________________
|
Assignee
Tax ID No.:_______________________
|
Assignee
Telephone: _______________________
|
Assignee
Facsimile: ________________________
|
Signature
Guaranteed:_______________________
|
(i)
|
provide
the Company with corporate contacts to access key
decision-makers and influencers within Covered
Parties;
|
(ii)
|
help
facilitate the business process;
|
(iii)
|
help
recruit internal champions within Covered Parties and present,
and follow-up with each key corporate
contact;
|
|
(iv)
|
participate
in face to face meetings and in conference call sessions with Covered
Parties;
|
(v)
|
assist
the Company where required throughout the negotiation in order to complete
successful agreements;
|
(vi)
|
involve
the Company in all aspect of the process including in major presentations,
conference calls and face to face meetings;
and
|
(vii)
|
provide
such other services as may be reasonably requested by the Company and
mutually agreed upon by ProSeed and the
Company.
|
|
1.1 Success
Fee -
|
Amount
of Consideration
|
Percentage
Payable to ProSeed
|
First
$[*]
|
[*]
|
Next
$[*]
|
[*]
|
Increments
above $[*]
|
[*]
|
A.
|
Is
known to the recipient thereof prior to receipt thereof from the other
party hereto, in a manner which did not result in the breach of any
confidentiality obligation between disclosing party and any other
party;
|
B.
|
Is
disclosed to said recipient after the date hereof by a third party who has
the right to make such disclosure;
|
C.
|
Is
or becomes a part of the public domain through no fault of the said
recipient; or
|
D.
|
Is
required to be disclosed by applicable law, regulation or court proceeding
in which case the recipient shall give the disclosing party as much
advance notice of the proposed disclosure as is practical (including a
copy of any written request or order), and shall cooperate with the
disclosing party in any effort to limit or restrict such disclosure, via a
protective order or otherwise.
|
The
Company
|
PROSEED
|
|
By:
/s/ Tom
Maher
|
By:
/s/
Benjamin
Van Oudenhove
|
|
Name:
Tom Maher
|
Name:
Benjamin Van Oudenhove
|
|
Title:
Company Secretary
|
Title:
Chairman
|
|
Date:
January 8,
2008
|
Date:
______________________
|
MEDICA
II MANAGEMENT L.P.
|
By:
/s/ Ehud
Geller
|
Name:
Title:
|
AMARIN
CORPORATION PLC
|
By:
/s/ Alan
Cooke
|
Name:
Title:
|
1.
|
Employer
|
2.
|
Employee
(the
“Executive”)
|
3.
|
Commencement
Date and Role Title
|
4.
|
Place
of Work
|
5.
|
Reporting
Line
|
6.
|
Working
hours
|
7.
|
Duties
|
8.
|
Remuneration
|
9.
|
Car
Allowance
|
10.
|
Deductions
from pay
|
·
|
Overpayment
of salary or bonus.
|
·
|
Sums
representing holiday taken in excess of
entitlement.
|
·
|
Overpayment
of expenses.
|
·
|
Motoring
fines incurred by you for a Company
vehicle.
|
·
|
Loans
made to you by the Company.
|
·
|
Personal
expenditure incurred on Company credit
cards.
|
·
|
Where
the Company has sustained loss in relation to monies of the Company caused
through your negligence, recklessness, dishonesty or through breach of the
Company rules the Company requires the employee to repay any proven
loss.
|
·
|
Where
you leave the Company the balance of any training assistance given under a
study loan agreement.
|
11.
|
Expenses
|
12.
|
Pension
|
13.
|
Insurance
Benefits
|
·
|
Permanent
Health Insurance (PHI)
|
·
|
Life
Assurance (4 x salary)
|
·
|
Private
Medical Insurance (PMI)
|
14.
|
Stock
Options
|
15.
|
Holidays
|
16.
|
Sickness
|
Length
of continuous employment on commencement of absence
|
Period
for which full pay is normally payable in a twelve month
period
|
Up
to 1 year
|
4
weeks
|
Over
1 year and up to 3 years
|
8
weeks
|
Over
3 years and up to 5 years
|
13
weeks
|
Over
5 years
|
26
weeks
|
17.
|
Confidential
Information and Company Documents
|
18.
|
Intellectual
Property Rights
|
a)
|
to
make, discover and conceive inventions, processes, techniques, designs,
improvements or developments relating to or capable of use or adaptation
for use in connection with the business or any Group Company (“an
Invention”)
|
b)
|
to
consider in what manner and by what new methods or devices the products,
services, processes, equipment or systems of the Company or any Group
Company with which the Executive is concerned or for which the Executive
is responsible, might be improved (“a
Development”);
|
c)
|
promptly
to give to the Company or any Group Company full details of any such
Invention or Development which the Executive may from time to time make or
discover in the course of their Employment;
and
|
d)
|
to
further the interests of the Company’s or any Group Company’s undertaking
with regard thereto
|
19.
|
Restrictions
during Employment
|
a)
|
be
directly or indirectly employed, engaged, concerned or interested in any
other business or undertaking; or
|
b)
|
engage
in any activity which the Board reasonably considers may be, or become
harmful to the interests of Company or any Group Company or which might
reasonably be considered to interfere with the performance of the
Executive’s duties under this
Agreement.
|
|
The
above Clause shall not apply:
|
a)
|
to
the Executive holding (directly or through nominees) of investments listed
on the London Stock Exchange or in respect of which dealing takes place in
the Unlisted Securities Market on the London Stock Exchange or any
recognised stock exchange as long as he does not hold more than 5% of the
issued shares or other securities of any class of any one Company;
or
|
b)
|
to
any act undertaken by the Executive after prior notification to the Board;
or
|
c)
|
to
any interest, notified in advance to the Board, for the Executive to serve
from time to time and continue to serve on the Boards of and hold any
other offices or positions in companies or organisations which will not
present any conflict of interest with Company or any Group Company and
provided that such activities do not materially detract from the
performance of the Executive’s
duties.
|
20.
|
Share
Dealings
|
21.
|
Notice
|
22.
|
Termination
of Employment
|
·
|
if
the Executive commits a criminal offence or is found guilty of serious
misconduct or wilful neglect whether during the performance of his duties
or otherwise which in the opinion of the Company renders the executive
unfit to continue his Employment with the Company or which would be likely
to adversely prejudice the reputation or interests of the Company or any
group company;
|
·
|
if
the Executive seriously or persistently breaches any provision in this
Agreement or is , in the opinion of the Board, incompetent in the
performance of his duties;
|
·
|
if
the Director is unable to perform his duties as result of illness or
injury for a period or periods aggregating at least 90 working days in any
period of 12 consecutive calendar
months;
|
·
|
if
the Executive becomes insolvent or bankrupt or enters into any composition
or arrangement with or for the benefit of his
creditors;
|
·
|
if
the Executive becomes of unsound
mind;
|
·
|
if
the Director becomes prohibited by law from being a
director.
|
23.
|
Restrictions
after Termination
|
24.
|
Resolving
Problems
|
25.
|
Reconstruction
and Amalgamations
|
26.
|
Health
and Safety
|
27.
|
Security
|
28.
|
Data
Protection
|
29.
|
Retirement
|
30.
|
Company
Property
|
31.
|
Variation
of Contract and handbook
|
32.
|
The
Agreement
|
·
|
Receipt
of two references in terms acceptable to the
Company.
|
·
|
You
being contractually free to join the Company on the day of
commencement.
|
·
|
That
you are not subject to any contractual term that would be breached by you
commencing work with us.
|
33.
|
Whole
Agreement
|
34.
|
Applicable
Law
|
SECTION
1.1.
|
Purchase and Sale of
Securities
.
|
If
to the Company:
|
Amarin
Corporation plc
7
Curzon Street
London
W1J 5HG
England
Facsimile: 44-20-7499-9004
Attn: Chief
Financial Officer
cc: General
Counsel
|
With
a copy (which shall not constitute notice) to:
|
Cahill
Gordon & Reindel
LLP
80
Pine Street
New
York, New York 10005-1702
Facsimile: 212-269-5420
Attn: Geoffrey
E. Liebmann
|
AMARIN
CORPORATION PLC
|
By:
Name:
Title:
|
Name
of
Purchaser: _________________________________________________________________________________
|
Signature of Authorized
Signatory of Purchaser
:
___________________________________________________________
|
Name
of Authorized Signatory:
_________________________________________________________________________
|
Title
of Authorized Signatory:
__________________________________________________________________________
|
Email
Address of Purchaser:
___________________________________________________________________________
|
Fax
Number of Purchaser:
_____________________________________________________________________________
|
Purchaser
|
Pro
Rata Percentage
|
First
Closing Committed Amount
|
First
Closing Ordinary Shares
|
Preference
Shares
|
Aggregate
First Closing Purchase Price
|
Total:
|
100.00%
|
$28,000,000.00
|
12,173,914
|
8
|
$28,000,002.20
|
|
Re:
|
Amarin Corporation
plc
|
·
|
Caduceus
Private Investments III, LP
|
·
|
Orbimed
Associates III, LP
|
·
|
Sofinnova
Venture Partners VII, L.P.
|
·
|
Panorama
Capital, L.P.
|
·
|
Thomas,
McNerney & Partners II, L.P.
|
·
|
TMP
Nominee II, LLC
|
·
|
TMP
Associates II, L.P.
|
·
|
Longitude
Venture Partners, L.P.
|
·
|
Fountain
Healthcare Partners Fund 1, L.P.
|
1.1.
|
CONSOLIDATION
OF PREFERENCE SHARES
|
1.2.
|
RIGHTS
ATTACHING TO SERIES A PREFERENCE
SHARES
|
|
(A)
|
Prior
to August 22, 2008, the written consent of the holders (the “
Series A Holders
”) of at
least two-thirds (2/3s) of the issued and outstanding Series A Preference
Shares (a “
Majority of
the Series A Holders
”) shall be required prior to any appointment
by the Company’s Board of Directors (the “
Board
”) or election by
the Company’s shareholders of a Director of the Company which would
increase the total number of Directors of the Company then in office to
more than 8.
|
|
(B)
|
From
and after August 22, 2008, the written consent of a Majority of the Series
A Holders shall be required prior to any appointment by the Board or
election by the Company’s shareholders of a Director of the Company which
would increase the total number of Directors of the Company then in office
to more than 9 (inclusive of the Director appointed pursuant to paragraph
1.2(b)(ii)(D) below).
|
|
(A)
|
Subject
to paragraph 1.2(b)(ii)(D) below, the Series A Holders shall be entitled
(x) to elect four (4) members (each such member and any additional
director elected by the Series A Holders under paragraph 1.2(b)(ii)(D)
below to be known as a “
Series A Director
”) to
the Board, (y) to remove from office any Series A Director, with or
without cause, and (z) to fill any vacancy caused by the resignation,
death, or removal of a Series A
Director.
|
|
(B)
|
Subject
to paragraph 1.2(b)(ii)(E) below, the election of each Series A Director
by the Series A Directors (including to fill any vacancy caused by the
resignation, death, or removal of a Series A Director) shall be by a vote,
in person or by written consent, of a Majority of the Series A
Holders.
|
|
(C)
|
Subject
to paragraph 1.2(b)(ii)(E) below, in each election of a Series A Director
(other than where such election takes place at a general meeting of the
Company) and all other matters referred to in this paragraph 1.2(b) upon
which the holders of Series A Preference Shares shall be entitled to vote,
each Series A Preference Share shall entitle the Series A Holder thereof
to the number of votes equal to the product of (i) 1,000 and (ii) the
quotient obtained by dividing the number of the Company’s Ordinary Shares
at the time owned by such Series A Holder, directly or through American
Depositary Shares, by the number of the Company’s Ordinary Shares at the
time so owned by all the Series A
Holders.
|
|
(D)
|
If
(x) on or before August 22, 2008, an individual who is mutually acceptable
(each such mutually acceptable individual, the “
Mutually Selected
Director
”) to the Directors of the Company who are not Series A
Directors, on the one hand, and a majority of the Series A Directors (a
“
Majority of the Series A
Directors
”), on the other hand, shall not
have
|
|
(E)
|
In
the case of any resolution proposed on a poll at a general meeting of the
Company to appoint any person as a Director of the Company who has
previously been appointed as a Series A Director (whether by written
notice, by the Board or otherwise) or any person nominated by a Majority
of the Series A Holders pursuant to Article 113, the holders of the Series
A Preference Shares shall be entitled to vote, and each Series A
Preference Share held by a Series A Holder shall entitle such Series A
Holder to cast in respect of such resolution such number of votes as is
equal to the product obtained by
multiplying
(i)
the product of the total number of the Company’s Ordinary Shares then
outstanding times five (5)
by
(ii) the
quotient obtained by dividing the number of the Ordinary Shares at the
time owned by such Series A Holder, directly or through American
Depositary Shares, by the number of the Company’s Ordinary Shares at the
time so owned by all the Series A Holders (for each Series A Holder, its
“
Number of Supermajority
Votes
”). In the case of any resolution proposed on a poll at a
general meeting of the Company to remove any Series A Director or to elect
any person(s) whose election would cause the total number of Series A
Directors following such general meeting to be less than four (4), the
holders of the Series A Preference Shares shall be entitled to vote, and
each Series A Preference Share held by a Series A Holder shall entitle
such Series A Holder to cast in respect of such resolution such number of
votes as is equal to its Number of Supermajority
Votes.
|
|
(A)
|
Each
Series A Holder shall have a right of first refusal to purchase up to such
Series A Holder’s pro rata share (as described below) of any offering by
the Company of Ordinary Shares or any other class or series of its capital
stock, or any other securities convertible into or exchangeable for
Ordinary Shares or any other class or series of capital stock (including
convertible stock, redeemable stock and debt with warrants, but excluding
any Exempt Securities (as defined below), any issuances pursuant to the
Company’s equity credit agreement with Brittany Capital Management Ltd.
dated as of 1 June 2007, provided such issuance shall have been approved
by the affirmative vote of at least a majority of all the members of the
Board plus one additional Director (the “
Supermajority
Directors
”), and any issuances pursuant to that certain Securities
Purchase Agreement, dated May 13, 2008, by and among the Company and the
purchasers named therein related to an additional financing), in each
case, on the same terms as the other investors participating in such
offering. Each Series A Holder’s pro rata share shall be equal
to the percentage of the Company’s outstanding Ordinary Shares that are
owned by such Series A Holder at the time of each such
offering.
|
|
(B)
|
The
Company shall provide written notice to each Series A Holder that the
Company is considering any proposed future financing subject to such
preemptive rights, providing a general outline of the proposed structure
and anticipated terms thereof, not less than 15 days prior to completion
thereof (the “
Completion
Date
”). The Company shall also provide written notice to
each such Series A Holder describing in reasonable detail the terms of any
such proposed future financing (the “
Detailed Notice
”) within
a reasonable period of time (but not less than ten (10) days prior to the
Completion Date). Unless a Series A Holder provides the Company
notice in writing within five (5) days of its receipt of the Detailed
Notice that it wishes to participate in such financing, such Series A
Holder’s right with respect to such proposed future financing shall be
deemed waived. Anything herein to the contrary notwithstanding,
if required to accumulate from its investors the funds necessary to
participate in any such financing, each Series A Holder who has delivered
timely notice of its intent to participate in such financing shall have up
to fifteen (15) Business Days from the date it sent such notice of its
intent to participate to fund its purchase even if any such period extends
beyond the Completion Date.
|
|
(C)
|
The
rights and obligations established pursuant to this paragraph 1.2(b)(v)
shall terminate if (x) a Special Rights Termination Event (as defined
below) shall have occurred, or (y) the Series A Holders (and/or their
Affiliates (as defined below)) cease to own in the aggregate at least 33%
of the number of Shares (as defined in the Purchase Agreement) purchased
by them in the First Closing (as defined in the Purchase Agreement) and
the Second Closing (as defined in the Purchase
Agreement).
|
|
(D)
|
For
purposes herein:
|
|
(x)
|
“
Exempt Securities
”
means (i) options
granted, and shares issued upon exercise thereof, to employees, Directors
or consultants under the Company’s stock option plans in amounts approved
by the Company’s Board of Directors upon the recommendation of its
remuneration committee (as appropriately adjusted for stock splits, stock
dividends, and the like), (ii) securities offered under a registration
statement on Form F-4 (or any applicable successor form), (iii) the
conversion or exercise of convertible debt or exercisable securities
outstanding on the date hereof as set forth on Schedule 2.27 of the
Disclosure Schedule to the Purchase Agreement, (iv) the issuance of
Ordinary Shares to pay milestones which may become payable in relation to
the acquisitions by the Company of Laxdale Limited and Ester Neurosciences
Ltd. as set forth on Schedule 2.26 of the Disclosure Schedule to the
Purchase Agreement, (v) the issuance of shares in connection with bank
financing or similar transactions that are primarily of a non-equity
financing nature and approved by the Board, and (vi) securities issued
pursuant to acquisitions or strategic transactions approved by the
Supermajority Directors.
|
|
(y)
|
“
Special Rights Termination
Event
” shall mean either (1) the failure of the Series A Holders to
timely exercise their option to fund the Second Closing Amount (as defined
in the Purchase Agreement) pursuant to Section 1.1(c) of the Purchase
Agreement, or (2) the timely exercise of such option by the Series A
Holders followed by the failure of the Second Closing to occur due to the
failure of the Series A Holders to satisfy any of the conditions provided
in Sections 5.3(a)-(c) of the Purchase
Agreement.
|
|
(A)
|
If
(x) the Second Closing occurs, and (y) at the Second Closing, any Series A
Holder funds less than such Series A Holder’s full Pro Rata Percentage (as
set forth opposite such Series A Holder’s name on Exhibit A to the
Purchase Agreement) of the Second Closing Amount, then each Series A
Preference Share held by such Series A Holder shall automatically convert
into one (1) Ordinary Share.
|
|
(B)
|
Each
Series A Preference Share held by all the Series A Holders shall
automatically convert into one Ordinary Share, and the rights and
obligations of the Series A Preference Shares shall terminate, if, at
any time after the Second Closing, (x) a Special Rights Termination Event
shall have occurred, or (y) the Series A Holders (and/or their
Affiliates)
|
|
cease
to own in the aggregate at least 33% of the number of Shares purchased by
them in the First Closing and the Second
Closing.
|
|
(C)
|
For
purposes herein, “
Affiliates
” shall mean
with respect to any Person, any other Person controlling, controlled by or
under direct or indirect common control with such Person (for the purposes
of this definition “
control
,” when used with
respect to any specified Person, shall mean the power to direct the
management and policies of such Person, directly or indirectly, whether
through ownership of voting securities, by contract or otherwise; and the
terms “
controlling
” and “
controlled
” shall have
meanings correlative to the
foregoing).
|
|
(A)
|
Any
amendment, alteration or repeal of any provision contained in this
paragraph 1.2(b);
|
|
(B)
|
Any
amendment, alteration or repeal of any provision contained in Articles 5
to 30 inclusive of the Company’s Articles of Association, in force as at
May 13, 2008, if such amendment, alteration or repeal of any such
provision would be adverse or inconsistent with the specific rights
attaching to the Series A Preference Shares as expressly set forth in this
paragraph 1.2(b) (the “
Specific Series A
Rights
”);
|
|
(C)
|
Any
issuance of any additional Series A Preference Shares;
or
|
|
(D)
|
Any
authorization, creation or designation, whether by reclassification or
otherwise, of any new class or series of capital stock or any other
securities convertible into equity securities of the Company which would
amend alter or repeal any of the Specific Series A Rights, or grant any
rights which are identical or superior to any of the Specific Series A
Rights.
|
Subsidiary
Name
|
Country
of Incorporation
or
Registration
|
Proportion of
Ownership Interest
and
Voting Power
Held
|
|
Amarin
Neuroscience
Limited
|
Scotland
|
100%
|
|
Amarin
Pharmaceuticals Ireland
Limited
|
Ireland
|
100%
|
|
Amarin
Finance
Limited
|
Bermuda
|
100%
|
|
Ester
Neurosciences
Limited
|
Israel
|
100%
|
1.
|
I
have reviewed this annual report on Form 20-F of Amarin Corporation
plc;
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the company
as of, and for, the periods presented in this
report;
|
4.
|
The
company’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the company and
have:
|
5.
|
The
company’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the
company’s auditors and the audit committee of the company’s board of
directors (or persons performing the equivalent
function):
|
1.
|
I
have reviewed this annual report on Form 20-F of Amarin Corporation
plc;
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the company
as of, and for, the periods presented in this
report;
|
4.
|
The
company’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the company and
have:
|
5.
|
The
company’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the
company’s auditors and the audit committee of the company’s board of
directors (or persons performing the equivalent
function):
|
1.
|
The
Report fully complies with the requirements of Section 13(a) or 15(d)
of the Securities Exchange Act of
1934; and
|
2.
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the
Company.
|
1.
|
The
Report fully complies with the requirements of Section 13(a) or 15(d)
of the Securities Exchange Act of
1934; and
|
2.
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the
Company.
|