o |
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE
ACT OF 1934
|
x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 FOR THE FISCAL YEAR ENDED DECEMBER 31,
2008
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 FOR THE TRANSITION PERIOD FROM
TO
|
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
|
Page | |
INTRODUCTION
|
1
|
CAUTIONARY
NOTE REGARDING FORWARD−LOOKING STATEMENTS
|
2
|
Item
1
|
Identity
of Directors, Senior Management and Advisers
|
3
|
Item
2
|
Offer
Statistics and Expected Timetable
|
3
|
Item
3
|
Key
Information
|
3
|
Item
4
|
Information
on the Company
|
20
|
Item
4A
|
Unresolved
Staff Comments
|
30
|
Item
5
|
Operating
and Financial Review and Prospects
|
30
|
Item
6
|
Directors,
Senior Management and Employees
|
44
|
Item
7
|
Major
Shareholders and Related Party Transactions
|
54
|
Item
8
|
Financial
Information
|
57
|
Item
9
|
The
Offer and Listing
|
60
|
Item
10
|
Additional
Information
|
62
|
Item
11
|
Quantitative
and Qualitative Disclosures About Market Risk
|
82
|
Item
12
|
Description
of Securities Other than Equity Securities
|
82
|
Item
13
|
Defaults,
Dividend Arrearages and Delinquencies
|
82
|
Item
14
|
Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
82
|
Item
15
|
Controls
and Procedures
|
83
|
Item 15T | Controls and Procedures | 83 |
Item
16
|
[Reserved]
|
84
|
Item
16A
|
Audit
Committee Financial Expert
|
84
|
Item
16B
|
Code
of Ethics
|
84
|
Item
16C
|
Principal
Accountant Fees and Services
|
84
|
Item
16D
|
Exemptions
from the Listing Standards for Audit Committees
|
84
|
Item
16E
|
Purchases
of Equity Securities by the Issuer and Affiliated
Purchasers
|
84
|
Item
16F
|
Change
in Registrants Certified Accountant
|
85
|
Item
16G
|
Corporate
Governance
|
85
|
Item
17
|
Financial
Statements
|
85
|
Item
18
|
Financial
Statements
|
85
|
Item
19
|
Exhibits
|
85
|
SIGNATURES | 93 | |
|
·
|
Nanocrystal®,
which during the fiscal year covered by this report was registered in Elan
Corporation plc or its affiliates, which we may refer to in this annual
report as “Elan”.
|
|
·
|
Permax®,
which during the fiscal year covered by this report was registered in Eli
Lilly and Company or its affiliates, which we may refer to in this annual
report as “Lilly”.
|
|
·
|
The
success of our research and development
activities;
|
|
·
|
Decisions
by regulatory authorities regarding whether and when to approve our drug
applications, as well as their decisions regarding labeling and other
matters that could affect the commercial potential of our
products;
|
|
·
|
The
speed with which regulatory authorizations, pricing approvals and product
launches may be achieved;
|
|
·
|
The
success with which developed products may be
commercialized;
|
|
·
|
Competitive
developments affecting our products under
development;
|
|
·
|
The
effect of possible domestic and foreign legislation or regulatory action
affecting, among other things, pharmaceutical pricing and reimbursement,
including under Medicaid and Medicare in the United States, and
involuntary approval of prescription medicines for over-the-counter
use;
|
|
·
|
Claims
and concerns that may arise regarding the safety or efficacy of our
product candidates;
|
|
·
|
Governmental
laws and regulations affecting our operations, including those affecting
taxation;
|
|
·
|
Our
ability to maintain sufficient cash and other liquid resources to meet
operating requirements and debt service
requirements;
|
|
·
|
General
changes in International Financial Reporting Standards (“IFRS”) as adopted
by the European Union (“E.U.”) and as issued by the International
Accounting Standards Board
(“IASB”);
|
|
·
|
Patent
positions can be highly uncertain and patent disputes are not unusual. An
adverse result in a patent dispute can hamper commercialization of
products or negatively impact sales of future products or result in
injunctive relief and payment of financial
remedies;
|
|
·
|
Uncertainties
of the U.S. Food and Drug Administration (“FDA”) approval process and the
regulatory approval processes in other countries, including, without
limitation, delays in approval of new
products;
|
|
·
|
Difficulties
in product development. Pharmaceutical product development is highly
uncertain. Products that appear promising in development may fail to reach
market for numerous reasons. They may be found to be ineffective or to
have harmful side effects in clinical or pre-clinical testing, they may
fail to receive the necessary regulatory approvals, they may turn out not
to be economically feasible because of manufacturing costs or other
factors or they may be precluded from commercialization by the proprietary
rights of others;
|
|
·
|
Growth
in costs and expenses; and
|
|
·
|
The
impact of acquisitions, divestitures and other unusual
items.
|
Item
3
|
Key
Information
|
2008
|
2007
as restated(1)
|
2006
|
||||||||||
(In
U.S. $, thousands except per share
data
and number of shares information)
|
||||||||||||
Statement
of Operation Data — IFRS
|
||||||||||||
Net
sales revenues
|
— | — | 500 | |||||||||
Total
loss from operations
|
(28,180 | ) | (40,733 | ) | (28,068 | ) | ||||||
Net
loss
|
(20,021 | ) | (37,800 | ) | (26,751 | ) | ||||||
Net
loss per Ordinary Share – basic*
|
(0.91 | ) | (3.86 | ) | (3.25 | ) | ||||||
Net
loss per Ordinary Share – diluted*
|
(0.91 | ) | (3.86 | ) | (3.25 | ) | ||||||
Consolidated
balance sheet data — amounts in accordance with IFRS
|
||||||||||||
Working
capital assets
|
10,069 | 11,072 | 28,710 | |||||||||
Total
assets
|
36,657 | 42,254 | 49,559 | |||||||||
Long
term obligations
|
(651 | ) | (4,801 | ) | (110 | ) | ||||||
Capital
stock (ordinary shares)
|
25,928 | 12,942 | 7,990 | |||||||||
Total
shareholders’ equity
|
28,898 | 26,797 | 38,568 | |||||||||
Number
of ordinary share in issue (thousands)*
|
27,047 | 13,906 | 9,068 | |||||||||
Denomination
of each ordinary share*
|
£0.50 | £0.50 | £0.50 |
(1)
|
see
our annual report on Form 20-F/A filed with the SEC on September 24, 2008
for information on our restatement.
|
*
|
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. Shares and share information above have been adjusted to
reflect this share consolidation.
|
Years
Ended December
|
||||||||
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
|
1,017 | 500 | ||||||
Total
loss from operations
|
(11,875 | ) | (20,478 | ) | ||||
Loss
from continuing operations
|
(10,608 | ) | (20,478 | ) | ||||
Net
income/(loss)
|
3,229 | (20,547 | ) | |||||
Loss
from continuing operations per Ordinary Share*
|
(4.71 | ) | (4.45 | ) | ||||
Net
income/(loss) per Ordinary Share – basic*
|
1.43 | (4.41 | ) | |||||
Net
income/(loss) per Ordinary Share – diluted*
|
1.43 | (4.41 | ) | |||||
Consolidated
balance sheet data — amounts in accordance with U.K. GAAP
|
||||||||
Working
capital assets
|
8,651 | 28,673 | ||||||
Total
assets
|
23,721 | 46,760 |
Long
term obligations
|
(2,687 | ) | (180 | ) | ||||
Capital
stock (ordinary shares)
|
3,206 | 6,778 | ||||||
Total
shareholders’ equity
|
16,693 | 38,580 | ||||||
Number
of ordinary shares in issue (thousands)*
|
3,763 | 7,755 | ||||||
Denominations
of each ordinary share*
|
£0.50 | £0.50 |
*
|
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. Shares and share information above has been adjusted to
reflect this share consolidation.
|
**
|
As
restated for the non-cash compensation expense due to the adoption of U.K.
GAAP, Financial Reporting Standard 20 “Share-based
payments”.
|
|
Exchange
Rates
|
Fiscal
Period
|
Average
Noon
Buying
Rate
(U.S.
Dollars/
pound
sterling)
|
|
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
|
|
12
months ended December 31, 2008
|
1.8546
|
Month
|
High
Noon
Buying
Rate
(U.S.
Dollars/
pound
sterling)
|
Low
Noon
Buying
Rate
(U.S.
Dollars/
pound
sterling)
|
||
April
2009
|
1.4990
|
1.4607
|
||
May
2009
|
1.6160
|
1.4881
|
||
June
2009
|
1.6547
|
1.5976
|
||
July
2009
|
1.6713
|
1.6027
|
||
August
2009
|
1.6977
|
1.6212
|
||
September
2009
|
1.6695
|
1.5910
|
·
|
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 or preclinical
studies;
|
·
|
the
lack of effectiveness during clinical
trials;
|
·
|
unforeseen
safety issues emerge in clinical or preclinical
studies;
|
·
|
delay,
suspension, or termination of a trial by the institutional review board
responsible for overseeing the study at a particular study
site;
|
·
|
unanticipated
changes to the requirements imposed by regulatory authorities
on the extent, nature or timing of studies to be conducted on quality,
safety and efficacy; 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 or market exclusivity 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 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 preemptive rights to subscribe
on a proportionate basis to any issuance of shares. Under U.S.
law, shareholders generally do not have preemptive 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
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 requirement 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
Pharma Inc
|
United
States
|
100%
|
|
Amarin
Finance Limited
|
Bermuda
|
100%
|
|
Ester
Neurosciences Limited
|
Israel
|
100%
|
Item
5
|
Operating
and Financial Review and Prospects
|
|
·
|
intangible
assets and research and development
expenditure;
|
|
·
|
foreign
currency;
|
|
·
|
revenue
recognition;
|
|
·
|
impairment
of intangible assets; and
|
|
·
|
derivative
financial liabilities.
|
(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. |
|
·
|
The
amount and timing of projected future cash
flows;
|
|
·
|
The
selected discount and tax rate;
|
|
·
|
The
outcome of R&D activities (compound efficacy, results of clinical
trials, etc.);
|
|
·
|
The
amount and timing of projected costs to develop EN101 into commercially
viable products;
|
|
·
|
The
probability of obtaining regulatory
approval;
|
|
·
|
Long-term
sales forecasts; and
|
|
·
|
Sales
erosion rates after the end of patent protection and timing of the entry
of generic competition.
|
|
·
|
Negative
outcome from research and development activities with
EN101;
|
|
·
|
Failure
to obtain regulatory approval;
|
|
·
·
|
Failure
to secure a development and marketing partner;
Failure to maintain a license from the licensor;
and
|
|
·
|
Lower
than anticipated future sales for
EN101.
|
Discount
rate
|
15%
|
Probability
of success
|
15
to 30%
|
Peak
penetration rate
|
49%
|
Population
Growth rate
|
0.4%
to 0.6%
|
Prevalence
|
14/100,000
|
Payment
Due By Period in $000’s
|
||||||||||||||||||||||||||||
Total
|
Less
than
1
Year
|
1-2
Years
|
2-3
Years
|
3-4
Years
|
4-5
Years
|
Thereafter
|
||||||||||||||||||||||
Capital/finance
lease obligations
|
36 | 12 | 24 | — | — | — | — | |||||||||||||||||||||
Operating
lease obligations
|
2,467 | 929 | 628 | 486 | 161 | 137 | 126 | |||||||||||||||||||||
Clinical
research obligations
|
1,485 | 1,485 | — | — | — | — | — | |||||||||||||||||||||
Purchase
obligations
|
864 | 864 | — | — | — | — | — | |||||||||||||||||||||
Total
|
4,852 | 3,290 | 652 | 486 | 161 | 137 | 126 |
Name
|
Age
|
Position
|
Thomas
Lynch
|
52
|
Chairman
and Chief Executive Officer
|
Anthony
Russell-Roberts
|
63
|
Non-Executive
Director
|
Dr.
William Mason
|
57
|
Non-Executive
Director
|
Dr.
John Climax
|
56
|
Non-Executive
Director
|
Dr.
James I. Healy
|
44
|
Non-Executive
Director
|
Dr.
Carl L. Gordon
|
44
|
Non-Executive
Director
|
Dr.
Eric Aguiar
|
47
|
Non-Executive
Director
|
Dr.
Srinivas Akkaraju
|
41
|
Non-Executive
Director
|
Dr.
Lars Ekman
|
59
|
Non-Executive
Director
|
Alan
Cooke*
|
38
|
President
and Chief Operating Officer
|
Dr.
Declan Doogan
|
56
|
Head,
Research & Development
|
Tom
Maher
|
42
|
General
Counsel and Company Secretary
|
Conor
Dalton
|
44
|
Vice
President, Finance & Principal Accounting
Officer
|
*
|
Mr.
Cooke also acts as Chief Financial
Officer
|
Name
|
Salary
&
fees $000 |
Benefits
in kind $000 |
Annual
bonus $000 |
2008
Total $000 |
||||||||||||
Thomas
Lynch (Chairman and Chief Executive Officer)*
|
516 | — | 100 | 616 | ||||||||||||
Dr.
William Mason~
|
117 | — | — | 117 | ||||||||||||
Anthony
Russell-Roberts~
|
93 | — | — | 93 | ||||||||||||
Dr.
John Climax~
|
46 | — | — | 46 | ||||||||||||
Dr.
James I. Healy**
|
29 | — | — | 29 | ||||||||||||
Dr.
Carl L. Gordon**
|
29 | — | — | 29 | ||||||||||||
Dr.
Eric Aguiar**~
|
— | — | — | — | ||||||||||||
Dr.
Srinivas Akkaraju**~
|
— | — | — | — | ||||||||||||
Dr.
Lars Ekman***
|
8 | — | — | 8 | ||||||||||||
Alan
Cooke (Chief Financial Officer) †
|
207 | 2 | 50 | 259 | ||||||||||||
Dr.
Declan Doogan (Head, Research & Development) †
|
137 | 1 | 34 | 172 | ||||||||||||
John
Groom†
|
— | — | — | — | ||||||||||||
Dr.
Simon Kukes†
|
17 | — | — | 17 | ||||||||||||
Dr.
Michael Walsh†
|
17 | — | — | 17 | ||||||||||||
Dr.
Prem Lachman†
|
17 | — | — | 17 | ||||||||||||
Prof.
William Hall†
|
17 | — | — | 17 | ||||||||||||
1,250 | 3 | 225 | 1,437 |
*
|
Fees
in respect of a Consultancy Agreement with Mr. Thomas Lynch. See “Item 7B
— Related Party Transactions". In addition, Mr. Lynch had pension
contributions paid into his personal pension scheme or accrued by the
Group of $27,000.
|
**
|
Appointed
as directors May 16, 2008.
|
***
|
Appointed
as director November 3, 2008.
|
†
|
Resigned
as directors May 16, 2008. In addition to the above Mr. Cooke and Dr.
Doogan had pension contributions paid into their personal scheme or
accrued by the Group up to May 16, 2008 of $12,000 and $8,000
respectively.
|
~
|
On
June 1, 2009 and May 15, 2009, Drs Aguiar and Akkaraju resigned from their
positions as non-executive directors respectively. On October 16, 2009,
Mr. Anthony Russell-Roberts and Drs. John Climax and William Mason
resigned from their positions as non-executive
directors.
|
|
·
|
Dr.
William Mason (Chairman) (appointed October 22, 2002; resigned October 16,
2009);
|
|
·
|
Mr. Anthony Russell-Roberts (appointed May 16; resigned October 16, 2009); |
|
·
|
Dr.
Srinivas Akkaraju (appointed May 16, 2008; resigned May 15, 2009);
and
|
|
·
|
Dr.
Eric Aguiar (appointed May 16, 2008; resigned June 1,
2009).
|
|
·
|
Mr.
Anthony Russell-Roberts (Chairman) (appointed July 19, 2002; resigned
October 16, 2009);
|
|
·
|
Dr.
William Mason (appointed May 16, 2008; resigned October 16,
2009);
|
|
·
|
Dr.
James I. Healy (appointed May 16, 2008);
and
|
|
·
|
Dr.
Carl Gordon (appointed May 16,
2008).
|
Number
of
Employees
|
Number
of
Employees
|
Number
of
Employees
|
||||||||||
Employment Activity
|
12/31/08
|
12/31/07
|
12/31/06
|
|||||||||
Marketing
and Administration
|
17 | 17 | 12 | |||||||||
Research
and Development
|
10 | 8 | 6 | |||||||||
Total
|
27 | 25 | 18 |
Number
of
Employees
|
Number
of
Employees
|
Number
of
Employees
|
||||||||||
Country
|
12/31/08
|
12/31/07
|
12/31/06
|
|||||||||
U.K.
|
11 | 11 | 10 | |||||||||
Ireland
|
12 | 14 | 8 | |||||||||
U.S.
|
4 | — | — | |||||||||
Total
|
27 | 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*
|
||||||||||||||||||
T.G.
Lynch
|
2 | 50,000 |
25/02/04
|
$19.00 | 1,072,906 | 4.0 | % | |||||||||||||||||
7 | 20,792 |
21/12/05
|
$14.30 | |||||||||||||||||||||
9 | 1,248 |
01/06/07
|
$7.20 | |||||||||||||||||||||
10 | 30,303 |
06/12/07
|
$2.99 | |||||||||||||||||||||
W.
Mason
|
1 | 1,500 |
06/11/02
|
$31.00 | — | — | ||||||||||||||||||
1&3
|
2,500 |
21/07/04
|
$8.40 | |||||||||||||||||||||
1&3
|
2,000 |
11/01/06
|
$13.50 | |||||||||||||||||||||
1&13
|
2,000 |
08/12/06
|
$4.40 | |||||||||||||||||||||
A.
Russell-Roberts
|
4 | 1,000 |
07/04/00
|
$30.00 | 235 | — | ||||||||||||||||||
4 | 1,000 |
19/02/01
|
$61.20 | |||||||||||||||||||||
1 | 1,500 |
23/01/02
|
$176.50 | |||||||||||||||||||||
1 | 1,500 |
06/11/02
|
$31.00 | |||||||||||||||||||||
1 | 2,500 |
21/07/04
|
$8.40 | |||||||||||||||||||||
1 | 2,000 |
11/01/06
|
$13.50 | |||||||||||||||||||||
1&13
|
2,000 |
08/12/06
|
$4.40 | |||||||||||||||||||||
J.
Climax
|
7 | 22,698 |
21/12/05
|
$14.30 | 1,465,755 | 5.4 | % | |||||||||||||||||
1 | 2,000 |
27/01/06
|
$27.20 | |||||||||||||||||||||
1 | 2,000 |
20/03/06
|
$32.60 | |||||||||||||||||||||
1&13
|
2,000 |
08/12/06
|
$4.40 | |||||||||||||||||||||
11 | 3,327 |
01/06/07
|
$7.20 | |||||||||||||||||||||
12 | 136,363 |
06/12/07
|
$2.99 | |||||||||||||||||||||
J.
Healy
|
14 | — | — | — | 3,586,957 | 13.3 | % | |||||||||||||||||
C.
Gordon
|
15 | — | — | — | 3,260,870 | 12.1 | % | |||||||||||||||||
E.
Aguiar
|
16 | — | — | — | 2,173,913 | 8.0 | % | |||||||||||||||||
S.
Akkaraju
|
17 | — | — | — | 1,847,826 | 6.9 | % | |||||||||||||||||
A.
Cooke
|
1 | 37,500 |
07/07/04
|
$8.50 | 27,021 | — | ||||||||||||||||||
5 | 20,000 |
10/06/05
|
$13.00 | |||||||||||||||||||||
6 | 1,559 |
21/12/05
|
$14.30 | |||||||||||||||||||||
1 | 20,000 |
16/01/06
|
$19.50 | |||||||||||||||||||||
1&13
|
67,500 |
08/12/06
|
$4.40 | |||||||||||||||||||||
1 | 400,000 |
20/05/08
|
$2.60 | — | — | |||||||||||||||||||
D.
Doogan
|
1&13
|
65,000 |
09/04/07
|
$4.40 | — | — | ||||||||||||||||||
1 | 400,000 |
20/05/08
|
$2.60 | — | — | |||||||||||||||||||
T.
Maher
|
1 | 32,500 |
02/12/05
|
$11.60 | 1,980 | |||||||||||||||||||
6 | 693 |
21/12/05
|
$14.30 | |||||||||||||||||||||
1&13
|
35,000 |
08/12/06
|
$4.40 | |||||||||||||||||||||
1 | 15,000 |
02/08/07
|
$4.40 | |||||||||||||||||||||
1 | 15,000 |
28/08/07
|
$4.60 | |||||||||||||||||||||
1 | 280,000 |
20/05/08
|
$2.60 | — | — | |||||||||||||||||||
C.
Dalton
|
1 | 10,000 |
28/06/05
|
$10.90 | — | — | ||||||||||||||||||
1 | 5,000 |
12/01/06
|
$15.30 | — | — | |||||||||||||||||||
1&13
|
20,000 |
08/12/06
|
$4.40 | — | — | |||||||||||||||||||
1 | 50,000 |
20/05/08
|
$2.60 | — | — |
|
(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 50,000 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)
|
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.
|
|
(6)
|
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
$102, 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)
|
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 $102, 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)
|
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.
|
|
(9)
|
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.
|
|
(10)
|
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. There is a price adjustment clause in the
December 2007 warrant agreement which provides that 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 16, 2008, Amarin raised gross proceeds of
$30,000,000 in a private placement of equity at a share price of $2.30 per
Ordinary Share. As $2.30 is below the Down-round Price, the initial
warrant exercise price has been adjusted from $4.80 to $2.99. On October
16, 2009, $3.6 million convertible bridge notes converted at $0.90 per
share (see note 35 for further details). These warrants have therefore
been re-priced again, to $1.17 per
share.
|
|
|
(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. These warrants were issued to Sunninghill Limited which is an
entity controlled by one of our non-executive directors Dr. John
Climax.
|
|
(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. These warrants were issued to Sunninghill Limited which is
an entity controlled by one of our non-executive directors Dr. John
Climax. There is a price adjustment clause in the December 2007 warrant
agreement which provides that 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 16, 2008, Amarin raised gross proceeds of $30,000,000 in the first
tranche of a private placement of equity at a share price of $2.30 per
Ordinary Share. As $2.30 is below the Down-round Price, the initial
warrant exercise price has been adjusted from $4.80 to $2.99. On October
16, 2009, $3.6 million convertible bridge notes converted at $0.90 per
share (see note 35 for further details). These warrants have therefore
been re-priced again, to $1.17 per
share.
|
|
(13)
|
The
exercise price of all options granted between December 8, 2006 and April
11, 2007 were amended to $4.40 – see note 28 to the F-section in this
annual report for further details of the options
amendment.
|
|
(14)
|
These
shares have been issued to Sofinnova Venture Partners VII, L.P., the
management company of which Dr. James I. Healy is a Managing General
Partner. Dr. James I. Healy is also a non-executive director of
Amarin.
|
|
(15)
|
These
shares have been issued to Caduceus Private Investments III, LP and
OrbiMed Associates III, LP, of whom Dr. Carl L. Gordon is a General
Partner. Dr. Carl L. Gordon is also a non-executive director of
Amarin.
|
|
(16)
|
These
shares have been issued to Thomas, McNerney & Partners II, L.P., TMP
Nominee II, LLC and TMP Associates II, L.P., of whom Dr. Eric Aguiar is a
Partner. Dr. Eric Aguiar resigned as a non-executive director
of Amarin on June 1, 2009.
|
|
(17)
|
These
shares have been issued to Panorama Capital, L.P., of whom Dr. Srinivas
Akkaraju was a former Managing Director. Dr. Srinivas Akkaraju
resigned as a non-executive director of Amarin on May 15,
2009.
|
(1)
|
Unless
otherwise noted, the persons referred to above have sole investment
power.
|
(2)
|
This
information is based on 27,046,716 Ordinary Shares outstanding, 2,052,473
warrants granted over Ordinary Shares and 2,742,852 share options granted
over Ordinary Shares as of December 31,
2008.
|
(3)
|
These
shares have been issued to Sofinnova Venture Partners VII, L.P., the
management company of which Dr. James I. Healy is a Managing General
Partner. Dr. James I. Healy is also a non-executive director of
Amarin.
|
(4)
|
These
shares have been issued to Caduceus Private Investments III, LP and
OrbiMed Associates III, LP, of which Dr. Carl L. Gordon is a General
Partner. Dr. Carl L. Gordon is also a non-executive director of
Amarin.
|
Name of Fund
|
Ordinary
Shares
|
|||
Caduceus
Private Investments III,
LP
|
3,230,107 | |||
OrbiMed
Associates III,
LP
|
30,763 |
(5)
|
These
shares have been issued to Thomas, McNerney & Partners II, L.P., TMP
Nominee II, LLC and TMP Associates II, L.P., of whom Dr. Eric Aguiar is a
Partner. Dr. Eric Aguiar resigned as a non-executive director
of Amarin on June 1, 2009.
|
Name of Fund
|
Ordinary
Shares
|
|||
Thomas,
McNerney & Partners II,
L.P
|
2,143,913 | |||
TMP
Nominee II,
LLC
|
22,391 | |||
TMP
Associates II,
L.P.
|
7,609 |
(6)
|
These
shares have been issued to Panorama Capital, L.P., of which Dr. Srinivas
Akkaraju was a former Managing Director. Dr. Srinivas Akkaraju
resigned as a non-executive director of Amarin on May 15,
2009.
|
(7)
|
Includes
warrants to purchase 162,389 Ordinary Shares, which are currently
exercisable and share options to purchase 6,000 Ordinary Shares of which
4,000 are currently exercisable. Sunninghill Limited is an entity
controlled by one of our non-executive directors, Dr. John
Climax.
|
|
The
following table shows changes over the last three years in the percentage
of the issued share capital for the Group held by major shareholders,
either directly or by virtue of ownership of
ADSs:
|
Name of Owner(1)
|
2008
|
2007
|
2006
|
|||||||||
%
|
%
|
%
|
||||||||||
Sofinnova
Ventures (1)
|
13.3 | — | — | |||||||||
Orbimed
Advisors LLC
(1)
|
12.1 | — | — | |||||||||
Thomas,
McNerney & Partners LLC (1)
|
8.0 | — | — | |||||||||
Panorama
Capital LP
(1)
|
6.8 | — | — | |||||||||
Amarin
Investment Holding Limited
|
4.0 | 7.7 | 11.0 | |||||||||
Simon
G. Kukes
|
4.7 | 6.8 | 8.3 | |||||||||
Medica
Funds
|
3.7 | 7.2 | — | |||||||||
Sunninghill
Limited
|
5.4 | 6.8 | 7.0 | |||||||||
Southpoint
|
— | — | 9.9 |
(1)
|
Eight
Series A Preference Shares have been designated for issuance and were
issued to certain investors in a private placement in May of 2008. On
October16, 2009, the eight Series A Preference Shares converted into
Ordinary Shares as a result of a private placement of ADS. Please see Item
10B for further details of the rights attached to these preference shares
and Item 8B for further details of the private
placement.
|
US$
Low*
|
|||
Fiscal
Year Ended
|
|||
December
31, 2004
|
39.90
|
5.30
|
|
December
31, 2005
|
34.00
|
10.60
|
|
December
31, 2006
|
37.40
|
12.70
|
|
December
31, 2007
|
37.80
|
2.30
|
|
December
31, 2008
|
3.59
|
0.60
|
|
Fiscal
Year Ended December 31, 2007
|
|||
First
Quarter
|
26.20
|
17.40
|
|
Second
Quarter
|
37.80
|
5.20
|
|
Third
Quarter
|
5.80
|
3.60
|
|
Fourth
Quarter
|
4.50
|
2.30
|
|
Fiscal
Year Ended December 31, 2008
|
|||
First
Quarter
|
3.59
|
1.81
|
|
Second
Quarter
|
3.07
|
1.89
|
|
Third
Quarter
|
2.05
|
0.86
|
*
|
Share
price information has been adjusted for the one-for-ten stock
consolidation which became effective on January 18,
2008.
|
|
·
|
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 (other than the Series A
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
secu-
|
·
|
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.
|
·
|
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 3
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 Specifications and related
costs.
|
·
|
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.
|
·
|
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 3 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
|
·
|
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.
|
·
|
Termination
and Separation Agreement and Release Agreement, dated August 7, 2008,
between Mr. Paul Duffy and Amarin Corporation
plc.
|
·
|
Directors
Securities Purchase Agreement dated May 13, 2008 Sunninghill Ltd, Simon
Kukes, Michael Walsh and Amarin Corporation
plc.
|
·
|
Change
Order for Additional Biostatistics & Medical Writing Work dated June
04, 2008, between Icon Clinical Research Limited and Amarin Neuroscience
Limited.
|
·
|
Consultancy
Agreement, dated August 16, 2008, between Decisionability Inc and Amarin
Neuroscience Limited.
|
·
|
Master
Services Agreement, dated August 22, 2008, between Charles River
Laboratories Preclinical Services Edinburgh Limited, Amarin Neuroscience
Limited and Amarin Pharmaceuticals Ireland
Ltd.
|
·
|
Work
Order, dated September 3, 2008, between Charles River Laboratories
Preclinical Services Edinburgh Limited, Amarin Neuroscience Limited and
Amarin Pharmaceuticals Ireland Ltd.
|
·
|
Consultancy
Agreement, dated October 10, 2008, between Icon Clinical Research Limited
and Amarin Corporation plc.
|
·
|
Supply
Agreement, dated February 23, 2009, between Nisshin Pharma Inc and Amarin
Pharmaceuticals Ireland Ltd.
|
·
|
Trial
A Letter Agreement dated February 24, 2009 between Medpace Inc and Amarin
Pharma Inc and Amarin Pharmaceuticals Ireland
Ltd.
|
·
|
Amendment
and Waiver Agreement, dated May 25, 2009 between Ester Neurosciences Ltd.
Medica II Management L.P. and Amarin Corporation
plc.
|
·
|
Amendment
number 2 to the Letter Agreement for certain initial services for certain
initial services for the Ethyl-EPA Hypertriglyceridemia Studies between
Medpace Inc and Amarin Pharma Inc and Amarin Pharmaceuticals Ireland Ltd
dated February 24, 2009, as amended on 5 May,
2009.
|
·
|
Termination
and Assignment Agreement, dated 21 July, 2009 between Elan Pharma
International Limited and Amarin Pharmaceuticals Ireland
Ltd.
|
·
|
Amendment
number 5 to the Letter Agreement for certain initial services for certain
initial services for the Ethyl-EPA Hypertriglyceridemia Studies between
Medpace Inc and Amarin Pharma Inc and Amarin Pharmaceuticals Ireland Ltd
dated 1 December, 2008, as amended on 19 January, 2009, as further amended
30 January 2009, 5 May, 2009 and 3 August,
2009.
|
·
|
Master
Services Agreement, dated September 29, 2009, between Medpace Inc and
Amarin Pharma Inc and Amarin Pharmaceuticals Ireland
Ltd.
|
·
|
Bridge
Loan Agreement, dated July 31, 2009 between Sunninghill Ltd, Thomas G.
Lynch, Simon Kukes, Michael Walsh, Midsummer Investments Limited,
Midsummer Ventures LP, David Hurley, David Brabazon, Pram Lachman and
Amarin Corporation plc. as amended by Amendment No.1 dated September 30,
2009.
|
·
|
Form
of Equity Securities Purchase Agreement dated October 12, 2009 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 36 separate Equity Securities Purchase
Agreements on October 12, 2009 all substantially similar in form and
content to this Securities Purchase Agreement pursuant to which we issued
an aggregate of 70,399,996 Ordinary Shares and warrants to purchase
35,199,996 Ordinary Shares to such
Purchasers.
|
·
|
Compromise
Agreement dated October 16, 2009 with Alan
Cooke.
|
·
|
Warrant
agreement for Thomas G. Lynch to subscribe for and purchase 500,000
Ordinary Shares of £0.50 each in Amarin Corporation plc with an exercise
price of $1.50.
|
·
|
Amendment
Agreement dated October 12, 2009, to the Form of Equity Securities
Purchase Agreement dated May 13, 2008 between Amarin Corporation plc and
the Purchasers named therein.
|
(i)
|
Irish Tax Considerations
Applicable to Irish Holders
|
•
|
a
citizen or resident of the United States, including an alien individual
who is a lawful permanent resident of the United States or who meets the
substantial presence residency test under U.S. federal income tax
laws;
|
|
•
|
a
corporation (or other entity treated as a corporation for
U.S. federal income tax purposes) that is created or organized under
the laws of the United States, any of the fifty states or the District of
Columbia, unless otherwise provided by Treasury
Regulations;
|
|
•
|
an
estate the income of which is includible in gross income for
U.S. federal income tax purposes regardless of
source; or
|
|
•
|
a
trust, if a U.S. court is able to exercise primary supervision over
its administration and one or more U.S. persons have the authority to
control all substantial decisions of the
trust.
|
•
|
a
bank, thrift, insurance company, regulated investment company, or other
financial institution or financial service company;
|
|
•
|
a
broker or dealer in securities or foreign currency;
|
|
•
|
a
person who has a functional currency other than the
U.S. dollar;
|
|
•
|
a
partnership or other flow-through entity (including a limited liability
company treated as a partnership for U.S. federal income tax
purposes);
|
|
•
|
a
U.S. corporation;
|
|
•
|
a
person subject to alternative minimum tax;
|
|
•
|
a
person who owns our ordinary shares or ADSs evidenced by ADRs as part of a
straddle, hedging transaction, conversion transaction, constructive sale
transaction or other risk-reduction
transaction;
|
•
|
a
tax-exempt entity;
|
|
•
|
investors
who own (directly, indirectly or through attribution) 10% or more of our
outstanding voting shares;
|
|
•
|
a
person who has ceased to be a U.S. citizen or to be taxed as a
resident alien; or
|
|
•
|
a
person who acquired our ordinary shares or ADSs evidenced by ADRs in
connection with employment or the performance of services
generally.
|
•
|
75%
or more of its gross income in a taxable year falls within specific
categories of passive income; or
|
|
•
|
the
average percentage of its assets in a taxable year (ordinarily determined
based on their market value) which produce passive income or are held for
the production of passive income is at least
50%.
|
•
|
Excess
distributions by us to a U.S. Holder would be taxed in a special way.
“Excess distributions” are amounts received by a U.S. Holder with
respect to our ordinary shares or ADSs in any taxable year that exceed
125% of the average distributions received by such U.S. Holder from
us in the shorter of either the three previous years or the
U.S. Holder’s holding period for the ordinary shares or ADSs before
the current taxable year. Excess distributions must be allocated ratably
to each day that a U.S. Holder has held our ordinary shares or ADSs.
A U.S. Holder would be required to include amounts allocated to the
current taxable year and years before we became a passive foreign
investment company as ordinary income. In addition, amounts allocated to
each taxable year beginning with the year we first became a passive
foreign investment company would be taxed at the highest rate in effect
for that year on ordinary income and the tax would be subject to an
interest charge at the rate applicable to deficiencies for income
tax.
|
|
•
|
The
entire amount of gain that is realized by a U.S. Holder upon the sale
or other disposition of our ordinary shares or ADSs evidenced by ADRs
would also be considered an excess distribution and would be subject to
tax as described above.
|
|
•
|
The
adjusted tax basis in our ordinary shares or ADSs evidenced by ADRs
acquired from a decedent who was a U.S. Holder of the ordinary shares
or ADSs would not be increased to equal the fair market value of such
ordinary shares or ADSs as of the date of the decedent’s death but would
instead be equal to the decedent’s adjusted tax basis, if lower. A
U.S. Holder could not avoid this result by electing to mark our
ordinary shares or ADSs to market.
|
•
|
if
the fair market value of the U.S. Holder’s ordinary shares or ADSs
exceeds the U.S. Holder’s adjusted tax basis in such ordinary shares
or ADSs as of the close of the U.S. Holder’s taxable year, the
U.S. Holder would recognize the amount of the excess as ordinary
income;
|
•
|
if
the fair market value of the U.S. Holder’s ordinary shares or ADSs is
less than the U.S. Holder’s adjusted tax basis in those ordinary
shares or ADSs as of the close of the U.S. Holder’s taxable year, the
U.S. Holder might recognize the amount of the difference as ordinary
loss. Losses would be allowed only for the amount of net mark to market
gain previously included by the U.S. Holder under the election for
prior taxable years; and
|
|
•
|
if
the U.S. Holder has elected to mark our ordinary shares or ADSs to
market for all taxable years during which the U.S. Holder owned our
ordinary shares or ADSs and we were a passive foreign investment company,
the “excess distribution” rules generally would not apply to the
U.S. Holder.
|
•
|
furnish
its taxpayer identification number (social security or employer
identification number) and certify that such number is
correct;
|
|
•
|
certify
that such U.S. Holder is not subject to backup
withholding; or
|
|
•
|
otherwise
comply with the applicable requirements of the backup withholding
rules.
|
|
·
|
foreign
exchange rates — generating translation and transaction gains and losses;
and
|
|
·
|
interest
rate risks related to financial and other
liabilities.
|
|
Refer
to Item 15T for disclosure of controls and
procedures.
|
Item
15T
|
Controls
and Procedures
|
2008
($’000)
|
2007
($’000)
|
2006
($’000)
|
|||
Audit
fees
|
382
|
516
|
357
|
||
Audit-related
fees
|
13
|
153
|
150
|
||
Tax
fees
|
29
|
43
|
18
|
||
All
other fees
|
117
|
88
|
105
|
||
Total
|
541
|
800
|
630
|
4.11
|
Stock
Purchase Agreement, dated November 30, 2001, by and among Abriway
International S.A., Beta Pharmaceuticals Corporation and the
Group(7)
|
4.12
|
Novation
Agreement, dated November 30, 2001, by and among Beta Pharmaceuticals
Corporation, Amarin Technologies S.A. and the Group(7)
|
4.13
|
Loan
Agreement, dated September 28, 2001, between Elan Pharma International
Limited and the Group(8)
|
4.14
|
Deed
of Variation, dated July 19, 2003, amending certain provisions of the Loan
Agreement between the Group and Elan Pharma International
Limited(10)
|
4.15
|
Deed
of Variation No. 2, dated December 23, 2002, between The Group and Elan
Pharma International Limited(10)
|
4.16
|
Deed
of Variation No. 3, dated January 27, 2003, between the Group and Elan
Pharma International Limited(10)
|
4.17
|
The
Group 2002 Stock Option Plan(17)
|
4.18
|
Agreement
Letter, dated October 21, 2002, between the Group and Security Research
Associates, Inc.(10)
|
4.19
|
Agreement,
dated January 27, 2003, among the Group, Elan International Services, Ltd.
and Monksland Holdings B.V.(10)
|
4.20
|
Master
Agreement, dated January 27, 2003, between Elan Corporation, plc., Elan
Pharma International Limited, Elan International Services, Ltd., Elan
Pharmaceuticals, Inc., Monksland Holdings B.V. and the
Group(10)
|
4.21
|
Form
of Warrant Agreement, dated March 19, 2003, between the Group and
individuals designated by Security Research Associates, Inc.(10) (The
Group entered into seven separate Warrant Agreements on March 19, 2003 all
substantially similar in form and content to this form of Warrant
Agreement).
|
4.22
|
Sale
and Purchase Agreement, dated March 14, 2003, between F. Hoffmann — La
Roche Ltd., Hoffmann — La Roche Inc, and the Group(10)†
|
4.23
|
Share
Subscription and Purchase Agreement dated October 28, 2003 among the
Group, Amarin Pharmaceuticals Company Limited, Watson Pharmaceuticals,
Inc. and Lagrummet December NR 911 AB (under name change to WP Holdings
AB)(12)
|
4.24
|
Asset
Purchase Agreement dated February 11, 2004 between the Group, Amarin
Pharmaceuticals Company Limited and Valeant Pharmaceuticals
International(12)†
|
4.25
|
Amendment
No. 1 to Asset Purchase Agreement dated February 25, 2004 between the
Group, Amarin Pharmaceuticals Company Limited and Valeant Pharmaceuticals
International(12)
|
4.26
|
Development
Agreement dated February 25, 2004 between the Group and Valeant
Pharmaceuticals International(12)
|
4.27
|
Settlement
Agreement dated February 25, 2004 among Elan Corporation plc, Elan Pharma
International Limited, Elan International Services, Ltd, Elan
Pharmaceuticals, Inc., Monksland Holdings BV and the
Group(12)
|
4.28
|
Debenture
dated August 4, 2003 made by the Group in favor of Elan Corporation plc as
Trustee(12)
|
4.29
|
Debenture
Amendment Agreement dated December 23, 2003 between the Group and Elan
Corporation plc as Trustee(12)
|
4.30
|
Debenture
Amendment Agreement No. 2 dated February 24, 2004 between the Group and
Elan Corporation plc as Trustee(12)
|
4.31
|
Loan
Instrument dated February 25, 2004 executed by Amarin in favor of Elan
Pharma International Limited(12)
|
4.32
|
Amended
and Restated Master Agreement dated August 4, 2003 among Elan Corporation
plc, Elan Pharma International Limited, Elan International Services, Ltd,
Elan Pharmaceuticals, Inc., Monksland Holdings BV and the Group
(11)(12)
|
4.33
|
Amended
and Restated Option Agreement dated August 4, 2003 between the Group and
Elan Pharma International Limited (11)(12)
|
4.34
|
Deed
of Variation No. 2, dated August 4, 2003, to the Amended and Restated
Distribution, Marketing and Option Agreement between Elan Pharmaceuticals,
Inc. and the Group(11)(12)
|
4.35
|
Deed
of Variation No. 4, dated August 4, 2003, to Loan Agreement between the
Group and Elan Pharma International Limited (11)(12)
|
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 the
Group(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 Rested 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 the Vendors 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
|
Loan
Note Redemption Agreement dated May, 2005 between Amarin Investment
Holding Limited and the Group.(14)
|
4.50
|
Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited and
Amarin Neuroscience Limited.(15)
|
4.51
|
Employment
Agreement with Alan Cooke, dated May 12, 2004 and amended September 1,
2005.(16)
|
4.52
|
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)
|
4.53
|
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)
|
4.54
|
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)
|
4.55
|
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)
|
4.56
|
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.*
|
4.57
|
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)
|
4.58
|
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)
|
4.59
|
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.*
|
4.60
|
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 2, The Oval, Shelbourne Road, Dublin 4, Ireland
(17)
|
4.61
|
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)
|
4.62
|
Employment
Agreement Amendment with Alan Cooke, dated February 21, 2007.
(17)
|
4.63
|
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)
|
4.64
|
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.*†
|
4.65
|
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.*
|
4.66
|
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.*
|
4.67
|
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)
|
4.68
|
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)
|
4.69
|
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)
|
4.70
|
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)
|
4.71
|
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)
|
4.72
|
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)
|
4.73
|
First
Supplemental Senior Indenture Dated December 6, 2007 between Amarin
Corporation plc and Wilmington Trust Company. Under this
Supplemental Senior Indenture, together with the senior debt indenture
dated December 6, 2007 described above, Amarin Corporation plc issued its
8% Convertible Debentures due 2010.(19)
|
4.74
|
Compromise
Agreement dated December 19, 2007 between Amarin Corporation plc and
Richard Stewart.(20)
|
4.75
|
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.
(20)†
|
4.76
|
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.*
|
4.77
|
Employment
Agreement dated April 28, 2008 with Dr Declan
Doogan.(20)
|
4.78
|
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.(20)†
|
4.79
|
Termination
and Separation Agreement and Release Agreement, dated August 7, 2008,
between Mr. Paul Duffy and Amarin Corporation plc.*
|
4.80
|
Directors
Securities Purchase Agreement dated May 13, 2008 Sunninghill Ltd, Simon
Kukes, Michael Walsh and Amarin Corporation plc*
|
4.81
|
Change
Order for Additional Biostatistics & Medical Writing Work dated June
04, 2008, between Icon Clinical Research Limited and Amarin Neuroscience
Limited*
|
4.82
|
Consultancy
Agreement, dated August 16, 2008, between Decisionability Inc and Amarin
Neuroscience Limited*
|
4.83
|
Master
Services Agreement, dated August 22, 2008, between Charles River
Laboratories Preclinical Services Edinburgh Limited, Amarin Neuroscience
Limited and Amarin Pharmaceuticals Ireland Ltd*
|
4.84
|
Work
Order, dated September 3, 2008, between Charles River Laboratories
Preclinical Services Edinburgh Limited, Amarin Neuroscience Limited and
Amarin Pharmaceuticals Ireland Ltd*
|
4.85
|
Consultancy
Agreement, dated October 10, 2008, between Icon Clinical Research Limited
and Amarin Corporation plc*
|
4.86
|
Supply
Agreement, dated February 23, 2009, between Nisshin Pharma Inc and Amarin
Pharmaceuticals Ireland Ltd*
|
4.87
|
Trial
A Letter Agreement dated February 24, 2009 between Medpace Inc and Amarin
Pharma Inc and Amarin Pharmaceuticals Ireland Ltd*
|
4.88
|
Amendment
and Waiver Agreement, dated May 25, 2009 between Ester Neurosciences Ltd.
Medica II Management L.P. and Amarin Corporation plc*
|
4.89
|
Amendment
number 2 to the Letter Agreement for certain initial services for certain
initial services for the Ethyl-EPA Hypertriglyceridemia Studies between
Medpace Inc and Amarin Pharma Inc and Amarin Pharmaceuticals Ireland Ltd
dated February 24, 2009, as amended on 5 May, 2009*
|
4.90
|
Termination
and Assignment Agreement, dated 21 July, 2009 between Elan Pharma
International Limited and Amarin Pharmaceuticals Ireland
Ltd*
|
4.91
|
Amendment
number 5 to the Letter Agreement for certain initial services for certain
initial services for the Ethyl-EPA Hypertriglyceridemia Studies between
Medpace Inc and Amarin Pharma Inc and Amarin Pharmaceuticals Ireland Ltd
dated 1 December, 2008, as amended on 19 January, 2009, as further amended
30 January 2009, 5 May, 2009 and 3 August, 2009*
|
4.92
|
Master
Services Agreement, dated September 29, 2009, between Medpace Inc and
Amarin Pharma Inc and Amarin Pharmaceuticals Ireland
Ltd*
|
4.93
|
Bridge
Loan Agreement, dated July 31, 2009 between Sunninghill Ltd, Thomas G.
Lynch, Simon Kukes, Michael Walsh, Midsummer Investments Limited,
Midsummer Ventures LP, David Hurley, David Brabazon, Pram Lachman and
Amarin Corporation plc. as amended by Amendment No.1 dated September 30,
2009*
|
4.94
|
Form
of Equity Securities Purchase Agreement dated October 12, 2009 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 36 separate Equity Securities Purchase
Agreements on October 12, 2009 all substantially similar in form and
content to this Securities Purchase Agreement pursuant to which we issued
an aggregate of 70,399,996 Ordinary Shares and warrants to purchase
35,199,996 Ordinary Shares to such Purchasers. *
|
4.95
|
Compromise
Agreement dated October 16, 2009 with Alan Cooke*
|
4.96
|
Warrant
agreement for Thomas G. Lynch to subscribe for and purchase 500,000
Ordinary Shares of £0.50 each in Amarin Corporation plc with an exercise
price of $1.50 *
|
4.97
|
Amendment
Agreement dated October 12, 2009, to the Form of Equity Securities
Purchase Agreement dated May 13, 2008 between Amarin Corporation plc and
the Purchasers named therein.*
|
8.1
|
Subsidiaries
of the Group*
|
11.1
|
Code
of Ethics(17)
|
12.1
|
Certification
of Thomas G. Lynch required by R1 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*
|
(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 21, 2002, filed with the Securities
and Exchange Commission on April 24, 2003.
|
(11)
|
These
agreements are not 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. 333–121421, 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 year ended December 31, 2005, filed with the Securities and
Exchange Commission on March 30, 2006 as amended on From 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, as amended on Form 20-F/A filed September
24, 2008
|
(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.
|
|
*
Filed herewith
|
|
†
confidential treatment requested (the confidential potions of such
exhibits have been omitted and filed separately with the Securities and
Exchange Commission).
|
Total
|
Total
|
Total
|
||||||||||||||
Note
|
2008
|
2007
|
2006
|
|||||||||||||
$’000 | $’000 | $’000 | ||||||||||||||
Revenue
|
— | — | 500 | |||||||||||||
Gross
Profit
|
5 | — | — | 500 | ||||||||||||
Research
and development expenses
|
7 | (12,954 | ) | (12,108 | ) | (15,106 | ) | |||||||||
Selling,
general and administrative expenses
|
7 | (15,226 | ) | (19,841 | ) | (13,462 | ) | |||||||||
Impairment
of intangible assets
|
6, 7 | — | (8,784 | ) | — | |||||||||||
Total
operating expenses
|
(28,180 | ) | (40,733 | ) | (28,568 | ) | ||||||||||
Operating
loss
|
(28,180 | ) | (40,733 | ) | (28,068 | ) | ||||||||||
Finance
income
|
10 | 9,627 | 2,279 | 3,344 | ||||||||||||
Finance
costs
|
11 | (2,142 | ) | (183 | ) | (2,826 | ) | |||||||||
Loss
before taxation
|
(20,695 | ) | (38,637 | ) | (27,550 | ) | ||||||||||
Tax
credit
|
13 | 674 | 837 | 799 | ||||||||||||
Loss
attributable to equity holders of the parent
|
(20,021 | ) | (37,800 | ) | (26,751 | ) | ||||||||||
U.S.
Cents
|
U.S.
Cents
|
U.S.
Cents
|
||||||||||||||
Basic
loss per ordinary share*
|
15 | (0.91 | ) | (3.86 | ) | (3.25 | ) | |||||||||
Diluted
loss per ordinary share*
|
15 | (0.91 | ) | (3.86 | ) | (3.25 | ) |
Group
|
Company
|
|||||||
Note
|
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
||
$’000
|
$’000
|
$’000
|
$’000
|
$’000
|
$’000
|
|||
Non-current
assets
|
||||||||
Property,
plant and equipment
|
17
|
595
|
595
|
314
|
5
|
19
|
25
|
|
Intangible
assets
|
16
|
19,916
|
19,916
|
9,636
|
19,916
|
19,916
|
3,765
|
|
Investments
in subsidiaries
|
18
|
—
|
—
|
—
|
62,257
|
60,136
|
22,715
|
|
Available
for sale investments
|
21
|
6
|
15
|
18
|
6
|
15
|
18
|
|
Total
non-current assets
|
20,517
|
20,526
|
9,968
|
82,184
|
80,086
|
26,523
|
||
Current
assets
|
||||||||
Inventory
|
19
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Current
tax recoverable
|
20
|
674
|
1,704
|
1,617
|
—
|
—
|
—
|
|
Other
current assets
|
20
|
1,227
|
1,721
|
1,172
|
533
|
1,059
|
770
|
|
Cash
on short-term deposits
|
3,000
|
—
|
—
|
3,000
|
—
|
—
|
||
Cash
and cash equivalents
|
11,239
|
18,303
|
36,802
|
9,550
|
17,298
|
34,719
|
||
Total
current assets
|
16,140
|
21,728
|
39,591
|
13,083
|
18,357
|
35,489
|
||
Total
assets
|
36,657
|
42,254
|
49,559
|
95,267
|
98,443
|
62,012
|
||
Non-current
liabilities
|
||||||||
Borrowings
|
22
|
—
|
2,051
|
—
|
—
|
2,051
|
—
|
|
Provisions
|
26
|
627
|
606
|
110
|
77
|
606
|
110
|
|
Derivative
financial liability
|
29
|
—
|
2,108
|
—
|
—
|
2,108
|
—
|
|
Other
liabilities
|
25
|
24
|
36
|
—
|
—
|
—
|
—
|
|
Total
non-current liabilities
|
651
|
4,801
|
110
|
77
|
4,765
|
110
|
||
Current
liabilities
|
||||||||
Trade
payables
|
23
|
1,955
|
3,462
|
2,096
|
447
|
841
|
396
|
|
Accrued
expenses and other liabilities
|
23
|
3,782
|
6,733
|
8,625
|
1,564
|
3,430
|
1,814
|
|
Provisions
|
26
|
334
|
461
|
160
|
308
|
461
|
160
|
|
Other
current derivative financial liabilities
|
24,29
|
1,037
|
—
|
—
|
1,037
|
—
|
—
|
|
Total
current liabilities
|
7,108
|
10,656
|
10,881
|
3,356
|
4,732
|
2,370
|
||
Total
liabilities
|
7,759
|
15,457
|
10,991
|
3,433
|
9,497
|
2,480
|
||
Equity
|
||||||||
Capital
and reserves attributable to equity holders of the Company
|
||||||||
Share
capital
|
28
|
25,928
|
12,942
|
7,990
|
25,928
|
12,942
|
7,990
|
|
Share
premium
|
152,273
|
147,171
|
139,313
|
152,273
|
147,171
|
136,587
|
||
Share
based payment reserve
|
30
|
19,564
|
14,931
|
4,824
|
19,564
|
14,931
|
4,824
|
|
Warrant
reserve
|
9,918
|
10,823
|
10,009
|
9,918
|
10,823
|
10,009
|
||
Equity
component of 8% convertible debt
|
—
|
145
|
—
|
—
|
145
|
—
|
||
Capital
redemption reserve
|
27,633
|
27,633
|
27,633
|
27,633
|
27,633
|
27,633
|
||
Treasury
shares
|
(217)
|
(217)
|
(217)
|
—
|
—
|
—
|
||
Foreign
currency translation reserve
|
(2,435)
|
(1,836)
|
(1,261)
|
(20,390)
|
832
|
683
|
||
Retained
earnings
|
(203,766)
|
(184,795)
|
(149,723)
|
(123,092)
|
(125,531)
|
(128,194)
|
||
Total
shareholders’ equity
|
28,898
|
26,797
|
38,568
|
91,834
|
88,946
|
59,532
|
||
Total
shareholders’ equity and liabilities
|
36,657
|
42,254
|
49,559
|
95,267
|
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 payments
|
— | — | 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 payments
|
— | — | 10,107 | — | — | — | — | — | — | 10,107 | ||||||||||||||||||||||||||||||
Warrant
issue/exercise
|
— | (2,498 | ) | — | 814 | — | — | — | — | — | (1,684 | ) | ||||||||||||||||||||||||||||
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
|
— | — | — | — | — | — | — | — | (37,800 | ) | (37,800 | ) | ||||||||||||||||||||||||||||
Total
recognized income and expense
|
— | — | — | — | — | — | — | (575 | ) | (37,800 | ) | (38,375 | ) | |||||||||||||||||||||||||||
At
December 3l, 2007 and January 1, 2008
|
12,942 | 147,171 | 14,931 | 10,823 | 145 | 27,633 | (217 | ) | (1,836 | ) | (184,795 | ) | 26,797 | |||||||||||||||||||||||||||
Share
issuances
|
12,986 | 17,014 | — | — | — | — | — | — | — | 30,000 | ||||||||||||||||||||||||||||||
Share
issuance costs
|
— | (3,693 | ) | — | — | — | — | — | — | — | (3,693 | ) | ||||||||||||||||||||||||||||
Share
based payments
|
— | — | 4,633 | — | — | — | — | — | — | 4,633 | ||||||||||||||||||||||||||||||
Fair
value of option (1)
|
— | (8,219 | ) | — | — | — | — | — | — | — | (8,219 | ) | ||||||||||||||||||||||||||||
Expiration
of warrants
|
— | — | — | (905 | ) | — | — | — | — | 905 | — | |||||||||||||||||||||||||||||
Release
of equity on 8% convertible debt
|
— | — | — | — | (145 | ) | — | — | — | 145 | — | |||||||||||||||||||||||||||||
Recognized income and
expense:
|
||||||||||||||||||||||||||||||||||||||||
Foreign
currency translation adjustment
|
— | — | — | — | — | — | — | (599 | ) | — | (599 | ) | ||||||||||||||||||||||||||||
Net
loss recognized directly in equity
|
— | — | — | — | — | — | — | (599 | ) | — | (599 | ) | ||||||||||||||||||||||||||||
Loss
for the year
|
— | — | — | — | — | — | — | — | (20,021 | ) | (20,021 | ) | ||||||||||||||||||||||||||||
Total
recognized income and expense
|
— | — | — | — | — | — | — | (599 | ) | (20,021 | ) | (20,620 | ) | |||||||||||||||||||||||||||
At
December 3l, 2008
|
25,928 | 152,273 | 19,564 | 9,918 | — | 27,633 | (217 | ) | (2,435 | ) | (203,766 | ) | 28,898 |
|
(1)
|
Retained
earnings include $7.714 million relating to the movement in fair value of
the derivative financial liability (see note 24 for further
details). This amount will be transferred to share premium on
the conclusion of this option.
|
Share
capital
|
Share
premium
|
Share
based
payment
reserve
|
Warrant
reserve
|
Equity
component
of
8%
convertible
debt
|
Capital
redemption
reserve
|
Foreign
currency
translation
reserve
|
Retained
earnings
|
Total
|
||||||||||||||||||||||||||||
US$’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 payments
|
— | — | 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 payments
|
— | — | 10,107 | — | — | — | — | — | 10,107 | |||||||||||||||||||||||||||
Warrant
issue/exercise
|
— | (2,498 | ) | — | 814 | — | — | — | — | (1,684 | ) | |||||||||||||||||||||||||
Adjustment
on asset acquisition
|
— | — | — | — | — | — | — | (371 | ) | (371 | ) | |||||||||||||||||||||||||
Fair
value of equity on 8% convertible debt
|
— | — | — | — | 145 | — | — | — | 145 | |||||||||||||||||||||||||||
Recognized income and
expense:
|
||||||||||||||||||||||||||||||||||||
Foreign
currency translation adjustment
|
— | — | — | — | — | — | 149 | — | 149 | |||||||||||||||||||||||||||
Net
loss recognized directly in equity
|
— | — | — | — | — | — | 149 | — | 149 | |||||||||||||||||||||||||||
Profit
for the year
|
— | — | — | — | — | — | — | 3,034 | 3,034 | |||||||||||||||||||||||||||
Total
recognized income and expense
|
— | — | — | — | — | — | 149 | 3,034 | 3,183 | |||||||||||||||||||||||||||
At
December 31, 2007 and January 1 2008
|
12,942 | 147,171 | 14,931 | 10,823 | 145 | 27,633 | 832 | (125,531 | ) | 88,946 | ||||||||||||||||||||||||||
Share
issuances
|
12,986 | 17,014 | — | — | — | — | — | — | 30,000 | |||||||||||||||||||||||||||
Share
issuance costs
|
— | (3,693 | ) | — | — | — | — | — | — | (3,693 | ) | |||||||||||||||||||||||||
Share
based payments
|
— | — | 4,633 | — | — | — | — | — | 4,633 | |||||||||||||||||||||||||||
Fair
value of option (1)
|
— | (8,219 | ) | — | — | — | — | — | — | (8,219 | ) | |||||||||||||||||||||||||
Expiration
of warrants
|
— | — | — | (905 | ) | — | — | — | 905 | — | ||||||||||||||||||||||||||
Release
of equity component of 8% convertible debt
|
— | — | — | — | (145 | ) | — | — | 145 | — | ||||||||||||||||||||||||||
Foreign
currency translation adjustment
|
— | — | — | — | — | — | (21,222 | ) | — | (21,222 | ) | |||||||||||||||||||||||||
Net
loss recognized directly in equity
|
— | — | — | — | — | — | (21,222 | ) | — | (21,222 | ) | |||||||||||||||||||||||||
Profit
for the year
|
— | — | — | — | — | — | — | 1,389 | 1,389 | |||||||||||||||||||||||||||
Total
recognized income and expense
|
— | — | — | — | — | — | (21,222 | ) | 1,389 | (19,833 | ) | |||||||||||||||||||||||||
At
December 31, 2008
|
25,928 | 152,273 | 19,564 | 9,918 | — | 27,633 | (20,390 | ) | (123,092 | ) | 91,834 |
|
(1)
|
Retained
earnings include $7.714 million relating to the movement in fair value of
the derivative financial liability (see note 24 for further
details). This amount will be transferred to share premium on
the conclusion of this option.
|
Group
|
Company
|
|||||||||||||||||||||||||||
Note
|
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
||||||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | |||||||||||||||||||||||
Cash
flows from operating activities
|
||||||||||||||||||||||||||||
(Loss)/Profit
after tax
|
(20,021 | ) | (37,800 | ) | (26,751 | ) | 1,389 | 3,034 | (7,352 | ) | ||||||||||||||||||
Adjustments:
|
||||||||||||||||||||||||||||
Depreciation
of property, plant and equipment
|
17 | 251 | 217 | 121 | 13 | 20 | 31 | |||||||||||||||||||||
Amortization
of intangible assets
|
16 | — | 169 | 674 | — | 58 | 232 | |||||||||||||||||||||
Impairment
of investment in subsidiary
|
18 | — | — | — | — | 4,593 | — | |||||||||||||||||||||
Impairment
of intangible assets
|
16 | — | 8,784 | — | — | 3,707 | — | |||||||||||||||||||||
Impairment
of property, plant and equipment
|
17 | 1 | — | 235 | 1 | — | 151 | |||||||||||||||||||||
Impairment
of available for sale investment
|
21 | 9 | 3 | — | 9 | 3 | — | |||||||||||||||||||||
Share
based payments
|
18, 30 | 4,633 | 5,001 | 2,201 | 830 | (640 | ) | 2,201 | ||||||||||||||||||||
Share
based payments — warrants
|
30 | — | 275 | — | — | 275 | — | |||||||||||||||||||||
Effect
of exchange rate changes on assets/liabilities and other
items*
|
335 | (560 | ) | (2,020 | ) | 657 | (858 | ) | 1,867 | |||||||||||||||||||
Interest
received
|
10 | (374 | ) | (1,252 | ) | (1,344 | ) | (341 | ) | (1,197 | ) | (1,299 | ) | |||||||||||||||
Interest
expense
|
11 | 819 | 176 | — | 819 | 176 | — | |||||||||||||||||||||
Interest
paid on finance leases
|
4 | 4 | (2 | ) | — | — | — | |||||||||||||||||||||
Decrease/(increase)
in other current assets
|
494 | (250 | ) | 282 | 526 | 10 | (75 | ) | ||||||||||||||||||||
(Decrease)/increase
in current liabilities
|
(3,955 | ) | (1,359 | ) | 2,690 | (1,755 | ) | 1,238 | (2,408 | ) | ||||||||||||||||||
(Decrease)
in other liabilities
|
— | — | (49 | ) | — | — | — | |||||||||||||||||||||
Gain
on strike off of subsidiaries
|
18 | — | — | — | — | (14,085 | ) | — | ||||||||||||||||||||
(Decrease)/increase
in provisions
|
(106 | ) | 797 | 104 | (682 | ) | 797 | (35 | ) | |||||||||||||||||||
Fair
value gain on derivative financial liability through income
statement
|
10 | (9,289 | ) | (397 | ) | — | (9,289 | ) | (397 | ) | — | |||||||||||||||||
R&D
tax credit
|
13 | (674 | ) | (837 | ) | (799 | ) | — | — | — | ||||||||||||||||||
Cash
expended on operating activities
|
(27,873 | ) | (27,029 | ) | (24,658 | ) | (7,823 | ) | (3,266 | ) | (6,687 | ) | ||||||||||||||||
Tax
refund
|
1,481 | 750 | 505 | — | — | — | ||||||||||||||||||||||
Net
cash outflow from operating activities
|
(26,392 | ) | (26,279 | ) | (24,153 | ) | (7,823 | ) | (3,266 | ) | (6,687 | ) | ||||||||||||||||
Cash
flows from investing activities
|
||||||||||||||||||||||||||||
Purchase
intangible assets
|
— | (5,810 | ) | — | — | (5,810 | ) | — | ||||||||||||||||||||
Interest
received
|
10 | 374 | 1,252 | 1,344 | 341 | 1,197 | 1,299 | |||||||||||||||||||||
Investment
in subsidiaries
|
18 | — | — | — | (19,549 | ) | (22,288 | ) | (19,524 | ) | ||||||||||||||||||
Purchases
of property, plant and equipment
|
(317 | ) | (415 | ) | (245 | ) | — | (14 | ) | (13 | ) | |||||||||||||||||
Net
cash inflow/(outflow) from investing activities
|
57 | (4,973 | ) | 1,099 | (19,208 | ) | (26,915 | ) | (18,238 | ) | ||||||||||||||||||
Cash
flows from financing activities
|
||||||||||||||||||||||||||||
Proceeds
from issue of share capital
|
28 | 30,000 | 9,685 | 26,424 | 30,000 | 9,685 | 26,424 | |||||||||||||||||||||
Proceeds
on the issue of convertible debentures
|
22 | — | 2,750 | — | — | 2,750 | — | |||||||||||||||||||||
Repayment
of convertible debt
|
22 | (2,750 | ) | — | — | (2,750 | ) | — | — | |||||||||||||||||||
Expenses
on issue of share capital
|
(3,693 | ) | (285 | ) | (2,450 | ) | (3,693 | ) | (285 | ) | (2,450 | ) | ||||||||||||||||
Expenses
on issue of convertible debentures
|
— | (20 | ) | — | — | (20 | ) | — | ||||||||||||||||||||
Repayment
of finance lease
|
(12 | ) | (7 | ) | (25 | ) | — | — | — | |||||||||||||||||||
Net
cash inflow from financing activities
|
23,545 | 12,123 | 23,949 | 23,557 | 12,130 | 23,974 | ||||||||||||||||||||||
Net
(decrease)/increase in cash and cash equivalents
|
(2,790 | ) | (19,129 | ) | 895 | (3,474 | ) | (18,051 | ) | (951 | ) | |||||||||||||||||
Cash
and cash equivalents at the beginning of the year
|
18,303 | 36,802 | 33,907 | 17,298 | 34,719 | 33,691 | ||||||||||||||||||||||
Exchange
rate gains on cash and cash equivalents
|
(1,274 | ) | 630 | 2,000 | (1,274 | ) | 630 | 1,979 | ||||||||||||||||||||
Cash
and cash equivalents at end of year
|
14,239 | 18,303 | 36,802 | 12,550 | 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.
|
|
·
|
Amendment
to IFRS 2, “Share-based
payment: vesting conditions and cancellations” (effective
retrospectively for annual periods beginning on or after January 1, 2009)
(the “Amendment to IFRS 2”). This amendment clarifies the
accounting treatment of vesting conditions and cancellations. The
Directors have undertaken an initial assessment of the financial effects
of applying IFRS 2(R) and the potential impact of this amendment on the
2008 comparative disclosures in the 2009 Annual Report on Form 20-F is
expected to be an increase in intangible assets of $1.215 million and
correspondingly an increase in the share-based payment reserve of
$1.215 million. Specifically, this arises in respect of the
fair value attributable to the Milestone Ib equity-settled share-based
payment component of the Ester Neurosciences Limited asset acquisition
which occurred on December 5, 2007 (see notes 4 and 35 for details). Under
the Amendment to IFRS 2, Milestone Ib is determined to be a non-vesting
condition. Non-vesting conditions are taken into account in
measuring the grant date fair value of share-based payments and there is
no true-up for differences between expected and actual outcomes in
subsequent periods.
|
|
·
|
IAS
23, (Amendment), “Borrowing Costs” (effective from 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 it is currently not applicable to the
Group as the Group has no borrowings and accordingly there are no
qualifying assets;
|
|
·
|
IAS
32 and IAS 1 (Amendment) “Puttable financial instruments and obligations
arising on liquidation”, (effective from January 1, 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. The Group will apply IAS 32 and IAS 1 (Amendment)
from January 1, 2009 but it is currently not applicable to the
Group;
|
|
·
|
IFRS
8, “Operating Segments” (effective from January 1, 2009). This
standard will replace IAS 14 “Segment Reporting”, and will require
additional disclosures relating to operating segments than those currently
required. The Group will apply this revised standard from the effective
date;
|
|
·
|
IAS
36 (Amendment), “Impairment of assets” (effective from January 1, 2009).
The amendment is part of the IASB’s annual improvements project published
in May 2008. Where fair value less costs to sell is calculated on the
basis of discounted cash flows, disclosures equivalent to those for
value-in-use calculation should be made. The Group will apply the
amendment and provide the required disclosure where applicable for
impairment tests from January 1,
2009;
|
|
·
|
IAS
19 (Amendment), “Employee benefits” (effective January 1, 2009). The
amendment is part of the IASB’s annual improvements project published in
May 2008. The distinction between short term and long term employee
benefits will be based on whether benefits are due to be settled within or
after 12 months of employee service being rendered. IAS 37 “Provisions,
contingent liabilities and contingent assets” requires contingent
liabilities to be disclosed, not recognized. IAS 19 has been amended to be
consistent. The Group will apply IAS 19 (Amendment) from January 1, 2009
but it is currently not applicable to the
Group;
|
|
·
|
IFRS
3 (Revised), “Business combinations”, (effective from July 1,
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. The Group will apply this revised standard from the
effective date;
|
|
·
|
Amendment
to IAS 1 “Presentation of financial statements (Revised)” (effective date
from January 1, 2009). This amendment sets overall requirements for the
presentation of financial statements, guidelines for their structure and
minimum requirements for their content. IAS 1 will have an impact on the
presentation of the financial statements of the group; however, this is
not expected to be significant.
|
|
·
|
Amendment
to IAS 27 “Consolidated and Separate financial statements” (effective date
July 1, 2009). The objective of this amendment is to enhance the
relevance, reliability and comparability of the information that a parent
entity provides in its separate financial statements and in its
consolidated financial statements for a group of entities under its
control. The introduction of this amendment is not expected to be
significant.
|
|
·
|
There
are a number of minor amendments to IFRS 7, “Financial instruments:
Disclosures”, IAS 8 “Accounting policies, changes in accounting estimates
and errors”, IAS 10 “Events after the reporting period”, IAS 18, “Revenue”
and IAS 34, “Interim financial reporting”, which are part of the IASB’s
annual improvements project published in May 2008 (not addressed above).
These amendments are unlikely to have a significant impact on the Group’s
financial statements and are not expected to be
significant.
|
|
·
|
IFRIC
Interpretation 15 “Agreements for the construction of real estate”
(effective date January 1, 2009), IFRIC Interpretation 17 “Distribution of
non cash assets to owners” (effective date July 1, 2009) and IFRIC
Interpretation 18 “Transfers of assets from customers” (effective date
July, 1 2009) are effective in 2009 but will have no impact on the Groups
financial statements.
|
Plant
and
equipment
|
5-10
years
|
Short
leasehold
|
5-10
years
|
Fixtures
and
fittings
|
5
years
|
Computer
equipment
|
3
years
|
|
·
|
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”.
|
|
·
|
$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. (Milestone Ib)
|
|
·
|
$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)
|
$’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
$’000
|
Adjustments
$’000
|
Acquisition
accounting
$’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 |
No.
of Shares
(‘000)
|
$ | $’000 | ||||||||||
Fair
value of Amarin common stock issued
|
2,500 | 3.60 | 9,000 | |||||||||
Cash
payment
|
5,191 | |||||||||||
Fair
value of Amarin common stock to be issued under
Milestone Ia
|
4,756 | |||||||||||
Direct
acquisition costs
|
1,340 | |||||||||||
Cost
of investment
|
20,287 |
2008
|
||||||||||||||||
UK
& Ireland
|
US
|
Rest
of world
|
Total
|
|||||||||||||
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||
Revenue
|
— | — | — | — | ||||||||||||
Operating
expenses
|
(26,062 | ) | (1,420 | ) | (698 | ) | (28,180 | ) | ||||||||
Operating
loss
|
(26,062 | ) | (1,420 | ) | (698 | ) | (28,180 | ) | ||||||||
Finance
income
|
9,622 | — | 5 | 9,627 | ||||||||||||
Finance
costs
|
(2,142 | ) | — | — | (2,142 | ) | ||||||||||
Loss
before taxation
|
(18,582 | ) | (1,420 | ) | (693 | ) | (20,695 | ) | ||||||||
Tax
credit
|
674 | — | — | 674 | ||||||||||||
Loss
for the year
|
(17,908 | ) | (1,420 | ) | (693 | ) | (20,021 | ) | ||||||||
Other
segment items:
|
||||||||||||||||
Impairment
of property, plant
and
equipment
|
1 | — | — | 1 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
UK
& Ireland
|
US
|
Rest
of world
|
Total
|
UK
& Ireland
|
US
|
Rest
of world
|
Total
|
|||||||||||||||||||||||||
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||||||||||||
Revenue
|
— | — | — | — | 500 | — | — | 500 | ||||||||||||||||||||||||
Operating
expenses
|
(40,571 | ) | — | (162 | ) | (40,733 | ) | (28,568 | ) | — | — | (28,568 | ) | |||||||||||||||||||
Operating
loss
|
(40,571 | ) | — | (162 | ) | (40,733 | ) | (28,068 | ) | — | — | (28,068 | ) | |||||||||||||||||||
Finance
income
|
2,279 | — | — | 2,279 | 3,344 | — | — | 3,344 | ||||||||||||||||||||||||
Finance
costs
|
(183 | ) | — | — | (183 | ) | (2,826 | ) | — | — | (2,826 | ) | ||||||||||||||||||||
Loss
before taxation
|
(38,475 | ) | — | (162 | ) | (38,637 | ) | (27,550 | ) | — | — | (27,550 | ) | |||||||||||||||||||
Tax
credit
|
837 | — | — | 837 | 779 | — | — | 799 | ||||||||||||||||||||||||
Loss
for the year
|
(37,638 | ) | — | (162 | ) | (37,800 | ) | (26,751 | ) | — | (26,751 | ) | ||||||||||||||||||||
Other
segment items:
|
— | |||||||||||||||||||||||||||||||
Impairment
of intangible assets
|
(8,784 | ) | — | — | (8,784 | ) | — | — | — | — | ||||||||||||||||||||||
Impairment
of property, plant
and
equipment
|
— | — | — | — | (235 | ) | — | — | (235 | ) |
2008
|
||||||||||||||||
UK
& Ireland
|
US
|
Rest
of world
|
Total
|
|||||||||||||
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||
Segment
assets
|
16,244 | 263 | 20,150 | 36,657 | ||||||||||||
Segment
liabilities
|
(7,485 | ) | (232 | ) | (42 | ) | (7,759 | ) | ||||||||
Net
assets
|
8,759 | 31 | 20,108 | 28,898 | ||||||||||||
Other
segment items:
|
||||||||||||||||
Capital
expenditure on property, plant and equipment
|
243 | 84 | — | 327 | ||||||||||||
Depreciation
|
247 | 3 | 1 | 251 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
UK
& Ireland
|
US
|
Rest
of world
|
Total
|
UK
& Ireland
|
US
|
Rest
of world
|
Total
|
|||||||||||||||||||||||||
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||||||||||||
Segment
assets
|
22,080 | — | 20,174 | 42,254 | 49,559 | — | — | 49,559 | ||||||||||||||||||||||||
Segment
liabilities
|
(15,408 | ) | — | (49 | ) | (15,457 | ) | (10,991 | ) | — | — | (10,991 | ) | |||||||||||||||||||
Net
assets
|
6,672 | — | 20,125 | 26,797 | 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 |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Impairment
of intangible assets
|
— | 8,784 | — | |||||||||
Redundancy
|
367 | — | 277 | |||||||||
Property
|
— | — | 19 | |||||||||
Impairment
of property, plant and equipment
|
— | — | 235 | |||||||||
Total
|
367 | 8,784 | 531 |
Note
|
2008
|
2007 | ** | 2006 | ||||||||||||
$’000 | $’000 | $’000 | ||||||||||||||
Selling,
general and administrative expenses
|
||||||||||||||||
Administrative
and general expenses*
|
5,938 | 9,794 | 6,306 | |||||||||||||
Employee
benefit expenses
|
4,731 | 4,736 | 3,535 | |||||||||||||
Depreciation
of property, plant and equipment
|
251 | 217 | 121 | |||||||||||||
Operating
lease expenses
|
1,120 | 1,260 | 820 | |||||||||||||
Amortization
of intangible assets
|
— | 169 | 674 | |||||||||||||
Restructuring
costs
|
6 | — | — | 531 | ||||||||||||
Share
based payments
|
30 | 3,186 | 3,665 | 1,475 | ||||||||||||
15,226 | 19,841 | 13,462 | ||||||||||||||
Impairment
of intangible assets
|
6 | — | 8,784 | — | ||||||||||||
Total
selling, general and administrative expenses
|
15,226 | 28,625 | 13,462 | |||||||||||||
Research
and development expenses
|
||||||||||||||||
General
research and development expenses
|
8,487 | 8,563 | 12,831 | |||||||||||||
Employee
benefit expenses
|
2,653 | 2,209 | 1,549 | |||||||||||||
Restructuring
costs
|
6 | 367 | — | — | ||||||||||||
Share
based payments
|
30 | 1,447 | 1,336 | 726 | ||||||||||||
Total
research and development expenses
|
12,954 | 12,108 | 15,106 | |||||||||||||
Total
operating expenses
|
28,180 | 40,733 | 28,568 |
*
|
Included
in administration and general expenses in 2008 is a provision of $522,000
for an onerous lease on Gemini House, Ely Cambridgeshire. The lease on the
property expires in November 2014 and is currently sublet until January
2011.
|
**
|
Included
in administrative and general expenses in 2007 is a termination payment of
$908,000 to a former director and chief executive officer, Mr. Richard
Stewart, and a provision of $957,000 relating to the lease of offices at
Curzon Street, London, from which Amarin has
vacated.
|
8.
|
Directors’
emoluments
|
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Aggregate
emoluments
|
1,437 | 3,688 | 2,097 | |||||||||
Group
pension contributions to money purchase schemes
|
47 | 90 | 294 | |||||||||
1,484 | 3,778 | 2,391 |
2008
|
2007 | * | 2006 | |||||||||
$’000 | $’000 | $’000 | ||||||||||
Aggregate
emoluments
|
616 | 1,517 | 815 | |||||||||
Group
pension contributions to money purchase schemes
|
27 | 60 | 169 | |||||||||
643 | 1,577 | 984 |
2008
Number
|
2007
Number
|
2006
Number
|
||||||||||
Marketing
and
administration
|
16 | 17 | 12 | |||||||||
Research
and
development
|
11 | 8 | 6 | |||||||||
27 | 25 | 18 |
2008
|
2007
|
2006
|
|||
$’000
|
$’000
|
$’000
|
|||
Staff
costs (for the above persons):
|
|||||
Wages
and.
salaries
|
6,331
|
6,075
|
4,228
|
||
Social
security
costs
|
505
|
566
|
453
|
||
Other
pension
costs
|
548
|
304
|
403
|
||
IFRS
2 share based
payment
|
4,633
|
5,001
|
2,201
|
||
12,017
|
11,946
|
7,285
|
2008
Number
|
2007
Number
|
2006
Number
|
||||||||||
Marketing
and
administration
|
2 | 2 | 3 |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Staff
costs (for the above persons):
|
||||||||||||
Wages
and
salaries
|
743 | 677 | 1,032 | |||||||||
Social
security
costs
|
9 | 121 | 87 | |||||||||
Other
pension
costs
|
1 | 68 | 181 | |||||||||
IFRS
2 share based
payment
|
830 | 1,587 | 846 | |||||||||
1,583 | 2,453 | 2,146 |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Interest
income on short term bank deposits
|
374 | 1,252 | 1,344 | |||||||||
Fair
value gains on derivative financial liabilities (see notes 24,
29)
|
9,289 | 397 | — | |||||||||
Foreign
exchange (losses)/gains
|
(36 | ) | 630 | 2,000 | ||||||||
9,627 | 2,279 | 3,344 |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
On
future investment right
|
— | — | 2,818 | |||||||||
On
finance leases
|
4 | 4 | 2 | |||||||||
Notional
interest on 8% convertible debentures (see note 22)
|
702 | 176 | — | |||||||||
Coupon
interest on 8% convertible debentures (see note 22)
|
117 | — | — | |||||||||
Impairment
on available for sale investments (see note 21)
|
9 | 3 | 6 | |||||||||
Foreign
exchange losses
|
1,310 | — | — | |||||||||
2,142 | 183 | 2,826 |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’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
|
226 | 207 | 111 | |||||||||
Property,
plant and equipment held under finance leases
|
25 | 10 | 10 | |||||||||
Auditors
remuneration:
|
||||||||||||
Auditor’s
remuneration for audit of Company and consolidated statutory
accounts
|
282 | 444 | 408 | |||||||||
Auditor’s
remuneration for audit of subsidiaries’ statutory accounts
|
32 | 72 | 69 | |||||||||
Auditor’s
service for Sarbanes Oxley
|
— | 101 | — | |||||||||
Other
advisory services
|
13 | 52 | 4 | |||||||||
Taxation
Compliance services
|
29 | 43 | 19 | |||||||||
Taxation
Advisory services
|
117 | 88 | 85 | |||||||||
Operating
lease charges:
|
||||||||||||
Plant
and machinery
|
4 | 10 | 21 | |||||||||
Other
operating lease charges
|
1,120 | 1,250 | 799 | |||||||||
Foreign
exchange difference
|
211 | (630 | ) | (2,000 | ) |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Tax
on loss before taxation:
|
||||||||||||
United
Kingdom/Irish corporation tax at 20%:
|
||||||||||||
current
year
|
(674 | ) | (837 | ) | (799 | ) | ||||||
Total
current tax credit
|
(674 | ) | (837 | ) | (799 | ) | ||||||
Total
tax credit
|
(674 | ) | (837 | ) | (799 | ) |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Loss
before taxation
|
(20,695 | ) | (38,637 | ) | (27,550 | ) | ||||||
Loss
on ordinary activities multiplied by blended rate of corporate
tax of 20%
|
(4,139 | ) | (11,591 | ) | (8,265 | ) | ||||||
Expenses
not allowable for tax purposes
|
(1,235 | ) | 5,192 | 1,171 | ||||||||
Earnings
at passive and CGT rates
|
194 | - | - | |||||||||
Losses
carried forward
|
2,968 | - | - | |||||||||
Unrecognized
accelerated capital allowances and other timing
differences
|
1,518 | 5,981 | 7,320 | |||||||||
R&D
Tax credit (rate difference)
|
677 | 734 | 1079 | |||||||||
Difference
between UK/Irish and overseas tax rate
|
(657 | ) | 521 | 238 | ||||||||
Total
tax credit
|
(674 | ) | (837 | ) | (799 | ) |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Accelerated
capital allowances
|
(135 | ) | (19,409 | ) | (19,380 | ) | ||||||
Temporary
timing differences
|
(1,893 | ) | (3,446 | ) | (1,143 | ) | ||||||
Losses
|
(17,753 | ) | (32,499 | ) | (26,772 | ) | ||||||
(19,781 | ) | (55,354 | ) | (47,295 | ) |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Loss
for the financial year attributable to ordinary
shareholders
|
(20,021) | (37,800) | (26,751) | |||||||||
U.S.
cents
|
U.S.
cents
|
U.S.
cents
|
||||||||||
Basic
loss per ordinary share
|
(0.91) | (3.86) | (3.25) | |||||||||
Diluted
loss per ordinary share
|
(0.91) | (3.86) | (3.25) | |||||||||
Number
|
Number
|
Number
|
||||||||||
Weighted
average number of ordinary shares in issue
|
22,063,974 | 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
|
22,063,974 | 9,783,595 | 8,233,705 |
IPR&D
|
||||
$’000 | ||||
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, January 1, 2008
and December 31,
2008
|
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 | |||
Elimination
on
impairments
|
(4,629 | ) | ||
At
December 31, 2007, January 1, 2008 and December 31,
2008
|
— | |||
Net
book value at December 31,
2008
|
19,916 | |||
Net
book value at December 31,
2007
|
19,916 | |||
Net
book value at December 31,
2006
|
9,636 |
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, January 1, 2008 and December 31, 2008
|
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 | |||
Elimination
on impairments
|
(3,531 | ) | ||
At
December 31, 2007, January 1, 2008 and December 31, 2008
|
— | |||
Net
book value at December 31, 2008
|
19,916 | |||
Net
book value at December 31, 2007
|
19,916 | |||
Net
book value at December 31, 2006
|
3,765 |
|
·
|
The
amount and timing of projected future cash
flows;
|
|
·
|
The
selected discount rate;
|
|
·
|
The
outcome of research and development activities (compound efficacy, results
of clinical trials, etc.);
|
|
·
|
The
amount and timing of projected costs to develop EN101 into commercially
viable products;
|
|
·
|
The
probability of obtaining regulatory
approval;
|
|
·
|
Long-term
sales forecasts; and
|
|
·
|
Sales
erosion rates after the end of patent protection and timing of the entry
of generic competition.
|
|
·
|
Negative
outcome from research and development activities with
EN101;
|
|
·
|
Failure
to obtain regulatory approval;
|
|
·
·
|
Failure
to secure a development and marketing partner;
Failure to maintain a license from the licensor;
and
|
|
·
|
Lower
than anticipated future sales for
EN101.
|
Discount
rate
|
15%
|
Probability
of success
|
15
to 30%
|
Peak
penetration rate
|
49%
|
Population
growth rate
|
0.4%
to 0.6%
|
Prevalence
|
14/100,000
|
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 | |||||||||||||||
Disposals
|
(408 | ) | (33 | ) | (185 | ) | — | (626 | ) | |||||||||||
Foreign
exchange adjustments
|
6 | 1 | 1 | 24 | 32 | |||||||||||||||
At
December 31, 2006 and at January 1, 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 and at January 1, 2008
|
264 | 95 | 42 | 727 | 1,128 | |||||||||||||||
Additions
|
— | 26 | 15 | 286 | 327 | |||||||||||||||
Disposals
|
— | — | — | (265 | ) | (265 | ) | |||||||||||||
Foreign
exchange adjustments
|
(18 | ) | (6 | ) | (3 | ) | (48 | ) | (75 | ) | ||||||||||
At
December 31, 2008
|
246 | 115 | 54 | 700 | 1,115 | |||||||||||||||
Accumulated
depreciation
|
||||||||||||||||||||
At
January 1, 2006
|
165 | 8 | 111 | 235 | 519 | |||||||||||||||
Charge
for the year
|
17 | 13 | 21 | 70 | 121 | |||||||||||||||
Eliminated
on disposals
|
(178 | ) | (18 | ) | (128 | ) | — | (324 | ) | |||||||||||
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 3l, 2007 and January 1, 2008
|
44 | 20 | 16 | 453 | 533 | |||||||||||||||
Charge
for the year
|
48 | 20 | 16 | 167 | 251 | |||||||||||||||
Eliminated
on disposals
|
— | — | — | (264 | ) | (264 | ) | |||||||||||||
At
December 31, 2008
|
92 | 40 | 32 | 356 | 520 | |||||||||||||||
Net
book value at December 31, 2008
|
154 | 75 | 22 | 344 | 595 | |||||||||||||||
At
December 31, 2007
|
220 | 75 | 26 | 274 | 595 | |||||||||||||||
At
December 31, 2006
|
105 | 13 | 25 | 171 | 314 |
Cost
|
$’000 | |||
At
January 1,
2006
|
33 | |||
Disposals
|
(33 | ) | ||
At
December 31, 2006 and January 1,
2007
|
— | |||
Additions
|
53 | |||
At
December 31, 2007 and January 1,
2008
|
53 | |||
Additions
|
10 | |||
At
December 31,
2008
|
63 | |||
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 | |||
At
December 31, 2007 and January 1,
2008
|
10 | |||
Charge
for the
year
|
25 | |||
Disposals
|
— | |||
At
December 31,
2008
|
35 | |||
Net
book value at December 31,
2008
|
28 | |||
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 January 1, 2007
|
— | — | 259 | 259 | ||||||||||||
Additions
|
— | 8 | 6 | 14 | ||||||||||||
At
December 31, 2007 and January 1, 2008
|
— | 8 | 265 | 273 | ||||||||||||
Additions
|
— | — | — | — | ||||||||||||
Impairments
|
— | — | (265 | ) | (265 | ) | ||||||||||
At
December 31,
2008
|
— | 8 | — | 8 | ||||||||||||
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 January 1, 2007
|
— | — | 234 | 234 | ||||||||||||
Charge
for the
year
|
— | 1 | 19 | 20 | ||||||||||||
At
December 31, 2007 and January 1, 2008
|
— | 1 | 253 | 254 | ||||||||||||
Charge
for the
year
|
— | 2 | 11 | 13 | ||||||||||||
Eliminated
on
impairments
|
— | — | (264 | ) | (264 | ) | ||||||||||
At
December 31,
2008
|
— | 3 | — | 3 | ||||||||||||
Net
book value at December 31, 2008
|
— | 5 | — | 5 | ||||||||||||
At
December 31,
2007
|
— | 7 | 12 | 19 | ||||||||||||
At
December 31,
2006
|
— | — | 25 | 25 |
Cost
|
$’000 | |||
At
January 1, 2006
|
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 Amarin 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 and January 1, 2008
|
60,136 | |||
IFRS
2 re-charges to subsidiaries during the period
|
3,794 | |||
Foreign
exchange movement
|
(21,222 | ) | ||
Other
inter company movements during the year, primarily funding
|
19,549 | |||
At
December 31, 2008
|
62,257 |
|
·
|
The
amount and timing of projected future cash
flows;
|
|
·
|
The
selected discount rate;
|
|
·
|
The
outcome of research and development activities (compound efficacy, results
of clinical trials, etc.);
|
|
·
|
The
amount and timing of projected costs to develop AMR 101 into commercially
viable products;
|
|
·
|
The
probability of obtaining regulatory
approval;
|
|
·
|
Long-term
sales forecasts; and
|
|
·
|
Sales
erosion rates after the end of patent protection and timing of the entry
of generic competition.
|
|
·
|
Negative
outcome from research and development activities with AMR 101 for
Hypertriglyceridemia
|
|
·
|
Failure
to obtain regulatory approval;
|
|
·
|
Failure
to secure a development and marketing partner;
and
|
|
·
|
Lower
than anticipated future sales for AMR 101 for
Hypertriglyceridemia.
|
Discount
rate
|
15%
|
Probability
of success
|
<50%
|
Population
growth rate
|
0.9%
|
Prevalence
|
110/1,000,000
|
Country
of
incorporation |
Proportion
of
nominal value of issued share capital held by the |
|||||||||
Name
of Undertaking
|
or
registration
|
Description
of shares held
|
Group
|
Company
|
||||||
%
|
%
|
|||||||||
Amarin
Pharma Inc
|
USA
|
100
$0.01 ordinary shares
|
100 | 100 | ||||||
Amarin
Pharmaceuticals Ireland Limited
|
Ireland
|
100
€1 ordinary shares
|
100 | 100 | ||||||
Amarin
Neuroscience Limited
|
Scotland
|
4,000,000
£l 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 | ||||||||
1,212,145
NIS 0.01 “B” redeemable convertible preference shares
|
100 | 100 | ||||||||
Amarin
Finance Limited
|
Bermuda
|
11,991
$1 ordinary shares
|
100 | 100 |
Group
|
Company
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | |||||||||||||||||||
Raw
materials and consumables
|
782 | 982 | 414 | — | — | — | ||||||||||||||||||
Provision
|
(782 | ) | (982 | ) | (414 | ) | — | — | — | |||||||||||||||
Net
realizable value
|
— | — | — | — | — | — |
Group
|
Company
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | |||||||||||||||||||
Current
tax receivable
|
674 | 1,704 | 1,617 | — | — | — | ||||||||||||||||||
Other
current assets
|
||||||||||||||||||||||||
Other
debtors
|
666 | 840 | 456 | 307 | 625 | 271 | ||||||||||||||||||
Prepayments
and accrued income
|
561 | 881 | 716 | 226 | 434 | 499 | ||||||||||||||||||
1,227 | 1,721 | 1,172 | 533 | 1,059 | 770 |
Fair
value
|
$’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 | |||
Impairments
recorded in the income
statement
|
(9 | ) | ||
At
December 31,
2008
|
6 |
2008
|
2007
|
2006
|
||||||||||
$’000 | $’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
|
— | 695 | — |
Group
|
Company
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | |||||||||||||||||||
Trade
creditors
|
1,955 | 3,462 | 2,096 | 447 | 841 | 396 | ||||||||||||||||||
Current
liabilities
|
||||||||||||||||||||||||
Obligations
under finance leases
|
13 | 10 | — | — | — | — | ||||||||||||||||||
Corporation
tax payable
|
— | — | 94 | — | — | 94 | ||||||||||||||||||
Other
taxation and social security payable
|
125 | 180 | 153 | — | 60 | 45 | ||||||||||||||||||
Other
creditors
|
197 | 206 | 162 | 79 | 86 | 129 | ||||||||||||||||||
Accruals
and deferred income
|
3,447 | 6,337 | 8,216 | 1,485 | 3,284 | 1,546 | ||||||||||||||||||
3,782 | 6,733 | 8,625 | 1,564 | 3,430 | 1,814 |
Group
|
Company
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | |||||||||||||||||||
Derivative
financial liabilities
|
||||||||||||||||||||||||
In
respect of financing option
|
504 | — | — | 504 | — | — | ||||||||||||||||||
In
respect of warrants (see note 29)
|
533 | — | — | 533 | — | — | ||||||||||||||||||
1,037 | — | — | 1,037 | — | — |
At
December 31, 2008
$’000
|
At
May 13, 2008
$’000
|
|||||||
Share
price
|
$0.71 | $2.63 | ||||||
Share
price volatility
|
131 | % | 90 | % | ||||
Risk
free interest rate
|
0.041 | % | 2.2 | % | ||||
Dividend
yield
|
- | - | ||||||
Expected
period before shares are issued
|
0.16
years
|
0.55
years
|
Group
|
Company
|
||||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
||||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | ||||||||||||||||||||
Obligations
under finance leases
|
24 | 36 | — | — | — | — |
Group
|
Company
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | |||||||||||||||||||
Not
later than one year
|
13 | 13 | — | — | — | — | ||||||||||||||||||
Later
than one year and not later than five years
|
26 | 40 | — | — | — | — | ||||||||||||||||||
Less: future
finance charges on finance leases
|
(3 | ) | (7 | ) | — | — | — | — | ||||||||||||||||
36 | 46 | — | — | — | — | |||||||||||||||||||
Less: current
maturities
|
(12 | ) | (10 | ) | — | — | — | — | ||||||||||||||||
Long
term maturity
|
24 | 36 | — | — | — | — |
Onerous
lease
|
National
insurance
|
Total
|
||||||||||
$’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 | |||||||||
Charged
to the income
statement
|
957 | — | 957 | |||||||||
Released
to the income
statement
|
(41 | ) | (119 | ) | (160 | ) | ||||||
At
December 3l,
2007
|
1,067 | — | 1,067 | |||||||||
Charged
to the income
statement
|
522 | — | 522 | |||||||||
Released
to the income
statement
|
(428 | ) | — | (428 | ) | |||||||
Foreign
exchange
movement
|
(200 | ) | — | (200 | ) | |||||||
At
December 3l,
2008
|
961 | — | 961 |
Onerous
lease
|
National
insurance
|
Total
|
||||||||||
$’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 | |||||||||
Charged
to the income
statement
|
957 | — | 957 | |||||||||
Released
to the income
statement
|
(41 | ) | (119 | ) | (160 | ) | ||||||
At
December 3l,
2007
|
1,067 | — | 1,067 | |||||||||
Charged
to the income
statement
|
— | — | — | |||||||||
Released
to the income
statement
|
(497 | ) | — | (497 | ) | |||||||
Foreign
exchange
movement
|
(185 | ) | — | (185 | ) | |||||||
At
December 3l,
2008
|
385 | — | 385 |
At
December 31, 2008
|
Less
than
1
year
|
Between
1
and
2 years
|
Between
2
and
5 years
|
Over
5
years
|
||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Borrowings
(see note
22)
|
— | — | — | — | ||||||||||||
Trade
and other payables (see note 23)
|
5,724 | — | — | — | ||||||||||||
Finance
Leases (see note
25)
|
12 | 12 | 12 | — | ||||||||||||
Derivative
financial instruments (see notes 24 and 29)
|
1,037 | — | — | — |
At
December 31, 2007
|
Less
than
1
year
|
Between
1
and
2 years
|
Between
2
and
5 years
|
Over
5
years
|
||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Borrowings
|
220 | 220 | 2,970 | — | ||||||||||||
Trade
and other
payables
|
10,187 | — | — | — | ||||||||||||
Finance
Leases
|
13 | 13 | 27 | — | ||||||||||||
Derivative
financial
instruments
|
— | 2,108 | — | — |
At
December 31, 2006
|
Less
than
1
year
|
Between
1
and
2 years
|
Between
2
and
5 years
|
Over
5
years
|
||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Trade
and other
payables
|
10,627 | — | — | — |
At
December 31, 2008
|
Less
than
1
year
|
Between
1
and
2 years
|
Between
2
and
5 years
|
Over
5
years
|
||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Trade
and other
payables
|
2,011 | — | — | — | ||||||||||||
Derivative
financial
instruments
|
1,037 | — | — | — |
At
December 31, 2007
|
Less
than
1
year
|
Between
1
and
2 years
|
Between
2
and
5 years
|
Over
5
years
|
||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Borrowings
|
220 | 220 | 2,970 | — | ||||||||||||
Trade
and other
payables
|
4,271 | — | — | — | ||||||||||||
Derivative
financial
instruments
|
— | 2,108 | — | — |
At
December 31, 2006
|
Less
than
1
year
|
Between
1
and
2 years
|
Between
2
and
5 years
|
Over
5
years
|
||||||||||||
$’000 | $’000 | $’000 | $’000 | |||||||||||||
Borrowings
|
— | — | — | — | ||||||||||||
Trade
and other
payables
|
2,115 | — | — | — |
2008
|
||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
Total
|
|||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Sterling
|
— | 37 | 2,266 | 2,303 | ||||||||||||
Euro
|
— | — | 1,852 | 1,852 | ||||||||||||
U.S.
Dollar
|
— | — | 2,641 | 2,641 | ||||||||||||
NIS
|
— | — | 2 | 2 | ||||||||||||
Total
|
— | 37 | 6,761 | 6,798 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
Total
|
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
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 | 4,812 | 7,562 | — | — | 2,532 | 2,532 | ||||||||||||||||||||||||
NIS
|
— | — | 49 | 49 | — | — | — | — | ||||||||||||||||||||||||
Total
|
— | 2,796 | 12,295 | 15,091 | — | — | 10,627 | 10,627 |
2008
|
||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
Total
|
|||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Sterling
|
— | — | 585 | 585 | ||||||||||||
Euro
|
— | — | 615 | 615 | ||||||||||||
U.S.
Dollar
|
— | — | 1,848 | 1,848 | ||||||||||||
Total
|
— | — | 3,048 | 3,048 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
Total
|
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
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 | 3,594 | 6,344 | — | — | 152 | 152 | ||||||||||||||||||||||||
Total
|
— | 2,750 | 6,379 | 9,129 | — | — | 2,115 | 2,115 |
2008
|
||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
Total
|
|||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Sterling
|
2,247 | — | 197 | 2,444 | ||||||||||||
Euro
|
5,070 | — | 57 | 5,127 | ||||||||||||
U.S.
Dollar
|
3,928 | 3,000 | 184 | 7,112 | ||||||||||||
NIS
|
— | — | — | — | ||||||||||||
Total
|
11,245 | 3,000 | 438 | 14,683 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
Total
|
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
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 |
2008
|
||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
Total
|
|||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Sterling
|
1,225 | — | 23 | 1,248 | ||||||||||||
Euro
|
4,934 | — | 2 | 4,936 | ||||||||||||
U.S.
Dollar
|
3,397 | 3,000 | 54 | 6,451 | ||||||||||||
Total
|
9,556 | 3,000 | 79 | 12,635 |
2007
|
2006
|
|||||||||||||||||||||||||||||||
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
Total
|
Floating
Rate
|
Fixed
Rate
|
Non
Interest
Bearing
|
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
|
2,444 | 2,303 | ||||||
Euro
|
5,127 | 1,852 | ||||||
NIS
|
— | 2 | ||||||
7,571 | 4,157 |
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
|
4,936 | 585 | ||||||
Euro
|
1,248 | 615 | ||||||
6,184 | 1,200 |
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 2008
|
Impact
on Profit or Loss of the Group 2007
|
Impact
on Profit or Loss of the Group 2006*
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Sterling
|
14 | 420 | 1,727 | |||||||||
Euro
|
327 | 164 | 385 | |||||||||
NIS
|
— | 1 | — |
Impact
on Profit or Loss of the Company 2008
|
Impact
on Profit or Loss of the Company 2007
|
Impact
on Profit or Loss of the Company 2006*
|
||||||||||
$’000 | $’000 | $’000 | ||||||||||
Sterling
|
435 | 715 | 2,094 | |||||||||
Euro
|
63 | 64 | 452 |
2008
|
2007
|
2006
|
||||||||||
Authorized
|
$’000 | $’000 | $’000 | |||||||||
155,911,406
ordinary shares of £0.50 each (155,911,406
ordinary
shares of £0.50 each December 31, 2007 and December 31,
2006)
|
125,319 | 125,319 | 125,319 | |||||||||
8
“Series A” preference shares of £0.50 each (December 31, 2007 and December
31, 2006: nil “Series A” preference shares of
£0.50
each)
|
— | — | — | |||||||||
440,855,854
preference share of £0.05 each (December 31, 2007 and December 31, 2006:
440,855,934 preference shares of
£0.05
each)
|
40,566 | 40,566 | 40,566 | |||||||||
165,885 | 165,885 | 165,885 | ||||||||||
Allotted,
called up and fully paid
|
||||||||||||
8
“Series A” preference shares of £0.50 each (December 31, 2007 and December
31, 2006: nil “Series A” preference shares of
£0.50
each)
|
— | — | — | |||||||||
27,046,716
Ordinary Shares of £0.50 each (December 31, 2007: 13,905,737 Ordinary
Shares of £0.50 each; December 31, 2006: 9,068,423 Ordinary Shares of
£0.50 each)
|
25,928 | 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 £0.50 Ordinary Shares *
|
Note
|
Date
option Granted
|
Exercise
price per Ordinary Share *
|
Number
of share options repriced at US$2.29 per Ordinary Share
*
|
US$
|
(Note
21)
|
|||
1,000
|
3
|
07-Apr-00
|
30.00
|
—
|
1,000
|
1
|
19-Feb-01
|
61.25
|
—
|
4,500
|
3
|
04-Jun-01
|
86.50
|
—
|
1,500
|
3
|
02-Jul-01
|
100.00
|
—
|
600
|
3
|
27-Jul-01
|
128.80
|
—
|
2,150
|
3
|
23-Jan-02
|
176.50
|
—
|
1,500
|
15
|
23-Jan-02
|
176.50
|
—
|
8,000
|
5
|
18-Feb-02
|
132.60
|
—
|
2,000
|
4
|
01-May-02
|
197.00
|
—
|
1,500
|
4
|
01-May-02
|
213.00
|
—
|
500
|
4
|
19-Jul-02
|
88.10
|
—
|
1,500
|
4
|
05-Sep-02
|
33.30
|
—
|
6,000
|
4
|
06-Nov-02
|
34.60
|
—
|
3,000
|
4
|
06-Nov-02
|
31.00
|
—
|
2,666
|
5
|
06-Nov-02
|
31.00
|
—
|
1,500
|
15
|
06-Nov-02
|
31.00
|
—
|
6,593
|
5
|
24-Feb-03
|
31.70
|
—
|
4,000
|
6
|
24-Feb-03
|
31.70
|
—
|
4,000
|
2
|
29-Apr-03
|
28.20
|
—
|
1,000
|
4
|
02-Jul-03
|
33.70
|
—
|
7,000
|
3
|
21-Nov-03
|
23.80
|
—
|
37,500
|
3
|
07-Jul-04
|
8.50
|
—
|
4,000
|
2
|
21-Jul-04
|
8.40
|
—
|
5,500
|
3
|
21-Jul-04
|
8.40
|
—
|
5,000
|
3
|
21-Jul-04
|
8.40
|
—
|
2,500
|
15
|
21-Jul-04
|
8.40
|
—
|
4,000
|
3
|
08-Oct-04
|
12.50
|
—
|
1,912
|
7
|
08-Oct-04
|
12.50
|
—
|
16,999
|
8
|
08-Oct-04
|
12.50
|
—
|
2,000
|
2
|
29-Nov-04
|
24.00
|
—
|
10,000
|
3
|
28-Feb-05
|
30.40
|
—
|
10,000
|
9
|
28-Feb-05
|
30.40
|
—
|
35,000
|
10
|
28-Feb-05
|
30.40
|
—
|
1,000
|
3
|
28-Mar-05
|
24.30
|
—
|
20,000
|
11
|
10-Jun-05
|
13.00
|
—
|
6,000
|
2
|
28-Jun-05
|
10.90
|
—
|
10,000
|
3
|
28-Jun-05
|
10.90
|
—
|
20,000
|
12
|
28-Jun-05
|
10.90
|
—
|
2,000
|
3
|
13-Jul-05
|
13.70
|
—
|
2,000
|
3
|
01-Sep-05
|
14.40
|
—
|
1,000
|
3
|
09-Sep-05
|
14.20
|
—
|
2,000
|
3
|
20-Sep-05
|
14.90
|
—
|
10,000
|
18
|
27-Sep-05
|
15.00
|
—
|
1,000
|
13
|
28-Oct-05
|
13.80
|
—
|
32,500
|
14
|
02-Dec-05
|
11.60
|
—
|
1,000
|
3
|
12-Dec-05
|
11.80
|
—
|
4,000
|
3
|
11-Jan-06
|
13.50
|
—
|
8,000
|
15
|
11-Jan-06
|
13.50
|
—
|
38,100
|
3
|
12-Jan-06
|
15.30
|
—
|
5,000
|
19
|
12-Jan-06
|
15.30
|
—
|
20,000
|
3
|
16-Jan-06
|
19.50
|
—
|
8,000
|
3
|
27-Jan-06
|
27.20
|
—
|
10,000
|
3
|
03-Feb-06
|
34.60
|
—
|
2,000
|
3
|
20-Mar-06
|
32.60
|
—
|
3,000
|
2
|
07-Apr-06
|
28.60
|
—
|
4,000
|
3
|
05-May-06
|
29.50
|
—
|
2,000
|
3
|
06-Jun-06
|
23.80
|
—
|
1,000
|
3
|
10-Jul-06
|
24.00
|
—
|
1,000
|
3
|
28-Jul-06
|
24.50
|
—
|
333
|
16
|
20-Sep-06
|
26.50
|
—
|
1,000
|
3
|
25-Oct-06
|
22.30
|
—
|
236,666
|
6,21
|
08-Dec-06
|
4.40
|
236,666
|
8,000
|
15,21
|
08-Dec-06
|
4.40
|
8,000
|
833
|
16,21
|
08-Dec-06
|
4.40
|
833
|
25,000
|
19,21
|
08-Dec-06
|
4.40
|
25,000
|
2,000
|
6,21
|
08-Jan-07
|
4.40
|
2,000
|
2,000
|
6,21
|
12-Feb-07
|
4.40
|
2,000
|
2,000
|
6,21
|
19-Feb-07
|
4.40
|
2,000
|
2,000
|
6,21
|
21-Feb-07
|
4.40
|
2,000
|
17,500
|
6,21
|
23-Feb-07
|
4.40
|
17,500
|
7,500
|
15,21
|
08-Mar-07
|
4.40
|
7,500
|
7,500
|
6,21
|
15-Mar-07
|
4.40
|
7,500
|
60,000
|
17,21
|
02-Apr-07
|
4.40
|
60,000
|
65,000
|
6,21
|
09-Apr-07
|
4.40
|
65,000
|
35,000
|
6,21
|
11-Apr-07
|
4.40
|
35,000
|
5,000
|
3
|
04-Jun-07
|
6.00
|
—
|
45,000
|
3
|
02-Aug-07
|
4.40
|
—
|
15,000
|
3
|
28-Aug-07
|
4.60
|
—
|
3,000
|
3
|
11-Sep-07
|
5.20
|
—
|
5,000
|
3
|
12-Sep-07
|
5.40
|
—
|
387,000
|
3
|
13-Feb-08
|
3.19
|
—
|
200,000
|
3
|
20-May-08
|
2.60
|
—
|
1,080,000
|
3
|
20-May-08
|
2.60
|
—
|
5,000
|
3
|
07-Aug-08
|
1.58
|
—
|
100,000
|
3
|
01-Sep-08
|
1.43
|
—
|
15,000
|
20
|
01-Sep-08
|
1.43
|
—
|
2,742,852
|
470,999
|
*
|
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.
|
These
options are exercisable now and remain exercisable until February 18,
2011.
|
2.
|
These
options were granted to a former employee of Amarin Corporation plc. These
options are exercisable now and remain exercisable until May 31,
2009.
|
3.
|
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.
|
4.
|
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.
|
5.
|
These
options were immediately vested in October 2005 and expiry dated March 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 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 with an expiry of
March 31, 2009.
|
8.
|
These
options were issued to employees of Amarin Neuroscience Limited (formerly
Laxdale Limited) on the date of acquisition by the Group. All
these options are fully vested with an expiry of March 31,
2009.
|
9.
|
These
options became exercisable on the date of grant and expire 10 years from
the date of the grant.
|
10.
|
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.
|
11.
|
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.
|
12.
|
These
options became exercisable on the date of grant and expire 4 years from
the date of grant.
|
13.
|
These
options became exercisable on the date of grant and expire 5 years from
the date of grant.
|
14.
|
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.
|
15.
|
These
options were granted to former directors of Amarin Corporation plc. These
options are exercisable now and remain exercisable until May 18,
2009.
|
16.
|
These
options were granted to a former employee of Amarin Corporation plc. These
options are exercisable now and remain exercisable until June 13,
2009.
|
17.
|
These
options were granted to a former employee of Amarin Corporation plc. These
options are exercisable now and remain exercisable until August 7,
2009.
|
18.
|
These
options were granted to a former employee of Amarin Corporation plc. These
options are exercisable now and remain exercisable until March 31,
2010.
|
19.
|
These
options were granted to a former employee of Amarin Corporation plc. These
options are exercisable now and remain exercisable until March 31,
2010.
|
20.
|
These
options were granted with immediate vesting and an expiry of September 1,
2018.
|
20.
|
Following
the significant decline in the Company’s stock price as a result of the
disappointing outcome of the two Phase 3 studies of AMR101 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 $4.40.
|
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
|
50,000
|
1
|
25
February 2004
|
US$19.00
|
US$16.80
|
US$12.80
|
846,310
|
2
|
21
December 2005
|
US$14.30
|
US$11.90
|
US$9.10
|
29,400
|
3
|
26
January 2006
|
US$30.60
|
US$27.20
|
US$21.00
|
17,500
|
4
|
27
April 2007
|
US$17.90
|
US$18.20
|
US$14.90
|
61,559
|
5
|
1
June 2007
|
US$7.20
|
US$6.00
|
US$4.90
|
3,000
|
6
|
21
June 2007
|
US$6.00
|
US$5.40
|
US$3.70
|
1,000
|
7
|
29
November 2007
|
US$3.40
|
US$3.60
|
US$3.00
|
1,043,704
|
8
& 9
|
5
December 2007
|
US$4.80
|
US$3.60
|
US$2.40
|
2,052,473
|
(1)
|
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 50,000 warrants granted to Elan at a price of
$19.00 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 50,000
warrants.
|
(2)
|
During
December 2005, 913,488 warrants were issued to those investors at a rate
of approximately 35% of shares acquired. These warrants were
granted at a price of $14.30 and are exercisable from 19 June 2006 to 21
December 2010. If our trading market price is equal to or above
$47.60, 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.
|
(3)
|
During
January 2006, via the private placement referred to in note 28, 29,400
warrants were issued to those investors at a rate of approximately 35% of
shares acquired. These warrants were granted at a price of
$30.60 and are exercisable from 25 July 2006 to 26 January
2011. If our trading market price is equal to or above $102.00,
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)
|
In
April 2007, 17,500 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 $17.90 and are
exercisable from April 27, 2007 to January 17, 2014. The fair
value of these warrants was expensed to the income statement in accordance
with IFRS 2.
|
(5)
|
During
June 2007, via the registered direct offering referred to in note 28,
61,559 warrants were issued to those investors at a rate of approximately
10% of shares acquired. These warrants were granted at a price
of $7.20 and are exercisable from June 1, 2007 to May 31,
2012.
|
(6)
|
During
June 2007, 3,000 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 was expensed to the
income statement in accordance with IFRS 2. If our trading
market price is equal to or above $18.00, 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
November 2007, 1,000 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 was expensed to the income statement in accordance with
IFRS 2. These warrants were granted at a price of $3.40 and are
exercisable from November 29, 2007 to November 28,
2012.
|
(8)
|
During
December 2007, via the registered direct offering referred to in note 28,
814,538 warrants were issued to those equity investors at a rate of
approximately 50% of shares acquired and 229,166 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 $4.80 and
are exercisable from December 4, 2007 to December 3, 2012. If
our trading market price is equal to or above $9.15, 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 investors of $30.0 million
closed on May 19, 2008 (see note 28 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. On
October 16, 2009, $3.6 million convertible bridge loan notes
converted at $0.90 per share (see note 35 for further
details). These warrants have therefore been re-priced again,
to $1.17 per share.
|
(9)
|
As
these warrants have a variable price, due to the price adjustment clause
as described in paragraph 9 above, under IAS 32 “Financial instruments:
presentation” these warrants are financial
liabilities. In accordance with IAS 39 “Financial
instruments: recognition and measurement” these warrants
should be measured at fair value through the income
statement. At December 31, 2008, the warrants had a fair value
of $0.51 per share. A fair value gain of $1,575,000 is
recognized in finance income for the year ended December 31, 2008. At
December 31, 2007, the warrants had a fair value of $2.00 per
share. A fair value gain of $397,000 was recognized in finance
income for the year ended December 31, 2007. At December 5, 2007 (date of
issue) the warrants had a fair value of $2.40 per
warrant.
|
Derivative
financial liability
|
$'000
|
|||
Derivative
financial liability in respect of warrants at December 5,
2007
|
2,505 | |||
Fair
value gain on derivative financial liability
|
(397 | ) | ||
Derivative
financial liability in respect of warrants at December 31,
2007
|
2,108 | |||
Fair
value gain on derivative financial liability
|
(1,575 | ) | ||
Derivative
financial liability in respect of warrants at December 31,
2008
|
533 |
December
31, 2008
|
December
31, 2007
|
December
5, 2007
|
|
Share
price
|
$0.71
|
$3.60
|
$2.60
|
Risk
free interest rate (percentage)
|
1.551%
|
3.441%
|
3.325%
|
Volatility
(percentage)
|
113%
|
114%
|
114%
|
Contractual
life
|
5
years
|
5
years
|
5
years
|
Remaining
contractual life
|
3.93
years
|
4.93
years
|
5
years
|
Dividend
yield
|
―
|
―
|
―
|
*
|
Comparative
information for December 31, 2006 has been updated to reflect the option
exercise price amendment described
above.
|
2008
Number of
Options
|
2008
Weighted average exercise price
|
2007
Number of
Options
|
2007
Weighted average exercise price
|
2006
Number of
Options
|
2006
Weighted average exercise price*
|
||||
Number
|
$
|
Number
|
$
|
Number
|
$
|
||||
Outstanding
at December 31
|
|||||||||
Options
granted at market price
|
2,708,436
|
5.54
|
975,936
|
1.32
|
791,947
|
13.21
|
|||
Options
granted at a discount to the market price
|
14,650
|
71.04
|
69,779
|
80.14
|
69,779
|
80.14
|
|||
Options
granted at a premium to market price
|
19,766
|
68.78
|
34,766
|
52.48
|
34,766
|
52.48
|
|||
Exercisable
at December 31
|
|||||||||
Options
granted at market price
|
684,847
|
12.62
|
406,748
|
16.38
|
163,179
|
24.71
|
|||
Options
granted at a discount to the market price
|
14,650
|
71.04
|
69,779
|
80.14
|
69,779
|
80.14
|
|||
Options
granted at a premium to market price
|
19,766
|
68.78
|
34,766
|
52.48
|
34,766
|
52.48
|
*
|
Comparative
information for December 31, 2006 has been updated to reflect the option
exercise price amendment described
above.
|
Year
ended
December
31
2008
|
Year
ended
December
31
2007
|
Year
ended
December
31
2006
|
||||||||||
Risk
free interest rate (percentage)
|
2.82 | 4.58 | 4.47 | |||||||||
Volatility
(percentage)
|
110 | % | 100 | % | 98 | % | ||||||
Expected
forfeiture rate (percentage)
|
5 | % | 5 | % | 5 | % | ||||||
Dividend
yield
|
— | — | — | |||||||||
Expected
option life
|
4 | 4 | 4 | |||||||||
Forced
exercise rate (percentage)
|
10 | % | 10 | % | 10 | % | ||||||
Minimum
gain for voluntary exercise rate (percentage)
|
33 | % | 33 | % | 33 | % | ||||||
Voluntary
early exercise at a minimum gain rate (percentage)
|
50 | % | 50 | % | 50 | % |
Exercise
price ($)
|
Date
of expiry
|
Number
outstanding
at 31 December 2008
|
Number
exercisable at 31 December 2008
|
Number
outstanding
at 31 December 2007
|
Number
exercisable at 31 December 2007
|
Number
outstanding
at 31 December 2006
|
Number
exercisable at 31 December 2006
|
1.43
|
01-Sep-18
|
100,000
|
-
|
-
|
-
|
-
|
-
|
1.43
|
01-Sep-18
|
15,000
|
15,000
|
-
|
-
|
-
|
-
|
1.58
|
07-Aug-18
|
5,000
|
-
|
-
|
-
|
-
|
-
|
2.60
|
20-May-18
|
200,000
|
-
|
-
|
-
|
-
|
-
|
2.60
|
20-May-18
|
1,080,000
|
-
|
-
|
-
|
-
|
-
|
3.19
|
13-Feb-18
|
387,000
|
-
|
-
|
-
|
-
|
-
|
4.40
|
02-Aug-17
|
30,000
|
10,000
|
30,000
|
-
|
-
|
-
|
4.40
|
02-Aug-17
|
15,000
|
5,000
|
15,000
|
-
|
-
|
-
|
4.40
|
11-Apr-17
|
35,000
|
11,666
|
35,000
|
-
|
-
|
-
|
4.40
|
09-Apr-17
|
65,000
|
21,667
|
65,000
|
-
|
-
|
-
|
4.40
|
02-Apr-17
|
60,000
|
60,000
|
60,000
|
-
|
-
|
-
|
4.40
|
15-Mar-17
|
7,500
|
2,500
|
7,500
|
-
|
-
|
-
|
4.40
|
19-May-09
|
7,500
|
7,500
|
7,500
|
-
|
-
|
-
|
4.40
|
23-Feb-17
|
17,500
|
5,833
|
17,500
|
-
|
-
|
-
|
4.40
|
21-Feb-17
|
2,000
|
667
|
2,000
|
-
|
-
|
-
|
4.40
|
19-Feb-17
|
2,000
|
667
|
2,000
|
-
|
-
|
-
|
4.40
|
12-Feb-17
|
2,000
|
667
|
2,000
|
-
|
-
|
-
|
4.40
|
08-Jan-17
|
2,000
|
667
|
2,000
|
-
|
-
|
-
|
4.40
|
13-Jun-09
|
833
|
833
|
833
|
277
|
833
|
-
|
4.40
|
31-Mar-10
|
25,000
|
25,000
|
25,000
|
8,333
|
25,000
|
-
|
4.40
|
19-May-09
|
8,000
|
8,000
|
8,000
|
2,667
|
8,000
|
-
|
4.40
|
08-Dec-16
|
236,666
|
157,777
|
238,333
|
79,445
|
318,333
|
-
|
4.40
|
19-Dec-08
|
-
|
-
|
26,666
|
26,666
|
-
|
-
|
4.60
|
28-Aug-17
|
15,000
|
5,000
|
15,000
|
-
|
-
|
-
|
5.20
|
11-Sep-17
|
3,000
|
1,000
|
3,000
|
-
|
-
|
-
|
5.40
|
12-Sep-17
|
5,000
|
1,666
|
5,000
|
-
|
-
|
-
|
6.00
|
03-Jun-17
|
5,000
|
1,666
|
5,000
|
-
|
-
|
-
|
8.40
|
31-May-09
|
4,000
|
4,000
|
4,000
|
4,000
|
4,000
|
2,667
|
8.40
|
19-May-09
|
2,500
|
2,500
|
2,500
|
2,500
|
2,500
|
1,666
|
8.40
|
20-Jul-14
|
10,500
|
10,500
|
10,500
|
10,500
|
10,500
|
7,000
|
8.50
|
06-Jul-14
|
37,500
|
37,500
|
37,500
|
37,500
|
37,500
|
25,000
|
10.90
|
28-Jun-15
|
20,000
|
20,000
|
20,000
|
20,000
|
20,000
|
20,000
|
10.90
|
28-Jun-15
|
10,000
|
10,000
|
10,000
|
6,666
|
10,000
|
3,333
|
10.90
|
31-May-09
|
6,000
|
6,000
|
6,000
|
4,000
|
6,000
|
2,000
|
11.60
|
02-Dec-15
|
32,500
|
32,500
|
32,500
|
21,666
|
32,500
|
10,833
|
11.80
|
12-Dec-15
|
1,000
|
1,000
|
1,000
|
666
|
1,000
|
333
|
12.50
|
07-Oct-14
|
4,000
|
4,000
|
4,000
|
4,000
|
4,000
|
2,670
|
12.50
|
31-Mar-09
|
18,911
|
18,911
|
18,911
|
18,911
|
19,576
|
19,576
|
12.50
|
31-Jan-07
|
-
|
-
|
-
|
-
|
512
|
512
|
13.00
|
10-Jun-15
|
20,000
|
15,000
|
20,000
|
10,000
|
50,000
|
-
|
13.00
|
19-Dec-08
|
-
|
-
|
15,000
|
15,000
|
-
|
-
|
13.50
|
11-Jan-16
|
4,000
|
2,667
|
4,000
|
1,333
|
4,000
|
-
|
13.50
|
19-May-09
|
8,000
|
8,000
|
8,000
|
2,667
|
8,000
|
-
|
13.70
|
13-Jul-15
|
2,000
|
2,000
|
2,000
|
1,333
|
2,000
|
666
|
13.80
|
28-Oct-10
|
1,000
|
1,000
|
1,000
|
1,000
|
1,000
|
1,000
|
14.20
|
09-Sep-15
|
1,000
|
1,000
|
1,000
|
666
|
1,000
|
333
|
14.40
|
01-Sep-15
|
2,000
|
2,000
|
2,000
|
1,333
|
2,000
|
666
|
14.90
|
20-Sep-15
|
2,000
|
2,000
|
2,000
|
1,333
|
2,000
|
666
|
15.00
|
27-Sep-15
|
10,000
|
10,000
|
10,000
|
6,666
|
10,000
|
3,333
|
15.30
|
31-Mar-10
|
5,000
|
5,000
|
5,000
|
1,666
|
5,000
|
-
|
15.30
|
12-Jan-16
|
38,100
|
25,400
|
38,100
|
12,700
|
38,100
|
-
|
December
5, 2007
|
|
Share
price
|
$3.60
|
Risk
free interest rate
(percentage)
|
5%
|
Volatility
(percentage)
|
80%
|
Contractual
life
|
0.33
years
|
Dividend
yield
|
—
|
2008
Land
and Buildings
|
2007
Land
and Buildings
|
2006
Land
and Buildings
|
||||||||||||||||||||||
Group
|
Company
|
Group
|
Company
|
Group
|
Company
|
|||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | |||||||||||||||||||
Not
later than one year
|
929 | 322 | 1,278 | 715 | 1,235 | 687 | ||||||||||||||||||
Later
than one year and not later than five years
|
1,412 | 159 | 2,755 | 1,714 | 3,637 | 2,096 | ||||||||||||||||||
Later
than five years
|
126 | — | 496 | 496 | 741 | 741 | ||||||||||||||||||
2,467 | 481 | 4,529 | 2,925 | 5,613 | 3,524 |
2008
Land
and Buildings
|
2007
Land
and Buildings
|
2006
Land
and Buildings
|
||||||||||||||||||||||
Group
|
Company
|
Group
|
Company
|
Group
|
Company
|
|||||||||||||||||||
$’000 | $’000 | $’000 | $’000 | $’000 | $’000 | |||||||||||||||||||
Not
later than one year
|
192 | — | 265 | 265 | 1,235 | 687 | ||||||||||||||||||
Later
than one year and not later than five years
|
215 | — | 562 | 562 | 3,637 | 2,096 | ||||||||||||||||||
Later
than five years
|
— | — | — | — | 741 | 741 | ||||||||||||||||||
407 | — | 827 | 827 | 5,613 | 3,524 |
|
·
|
$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. (Milestone Ib)
|
|
·
|
$6
million payable, in cash, upon successful completion of the U.S. Phase III
clinical trial program (to include successful completion of long term
studies) enabling NDA filing for Monarsen for MG in the U.S. (Milestone
II)
|
2008
US$’000 |
2007
US$’000 |
2006
US$’000 |
||||||||||
Short-term
employee benefits
|
3,106 | 3,690 | 3,361 | |||||||||
Post-employment
benefits
|
— | 75 | — | |||||||||
Share-based
compensation
|
2,011 | 2,300 | 1,045 | |||||||||
Termination
benefits
|
— | 804 | — | |||||||||
Total
|
5,117 | 6,869 | 4,406 |
|
F.
|
Decisionability
LLP
|
Amarin
Corporation plc
|
By:
_______________________________
|
Name:
|
Title:
|
PAUL
DUFFY
|
__________________________________ |
|
AMENDED
(THE “SECURITIES
ACT”), OR REGISTERED OR QUALIFIED UNDER ANY APPLICABLE STATE
SECURITIES LAWS. THESE SECURITIES MAY NOT BE OFFERED, SOLD,
PLEDGED OR OTHERWISE TRANSFERRED EXCEPT PURSUANT TO (A) AN EFFECTIVE
REGISTRATION STATEMENT UNDER THE SECURITIES ACT IN A TRANSACTION
REGISTERED OR QUALIFIED UNDER APPLICABLE STATE SECURITIES LAWS, OR
(B) AN AVAILABLE EXEMPTION FROM SUCH REGISTRATION OR QUALIFICATION
REQUIREMENTS. UNLESS A REGISTRATION STATEMENT IS EFFECTIVE WITH
RESPECT TO THESE SECURITIES, AS A CONDITION TO PERMITTING ANY TRANSFER OF
THESE SECURITIES, EACH OF THE DEPOSITARY AND THE COMPANY MAY REQUIRE THAT
IT BE FURNISHED WITH AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE
DEPOSITARY AND THE COMPANY TO THE EFFECT THAT NO REGISTRATION OR
QUALIFICATION IS LEGALLY REQUIRED FOR SUCH
TRANSFER.
|
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:
|
_____________________________________ |
Address
for Notice of Purchaser:
|
_____________________________________ |
_____________________________________ | |
_____________________________________ |
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
|
_____________________________________ |
_____________________________________ |
_____________________________________ |
Jurisdiction
of Incorporation:
|
_____________________________________ |
Purchaser’s
EIN Number:
|
_____________________________________ |
Purchaser
|
Pro
Rata
Percentage |
First
Closing
Securities |
Aggregate
First
Closing Purchase Price |
|||
Sunninghill
Ltd.
|
60.0%
|
521,739
|
$1,200,000
|
|||
Simon
Kukes
|
37.5%
|
326,087
|
$750,000
|
|||
Michael
Walsh
|
2.5%
|
21,739
|
$50,000
|
|||
Total:
|
100%
|
869,565
|
$2,000,000
|
|
Re:
|
Amarin Corporation
plc
|
·
|
Sunninghill
Ltd.
|
·
|
Simon
Kukes
|
·
|
Michael
Walsh
|
Aramin
694/005 & 006
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
DATED
|
the
28th
May 2008
|
BETWEEN
|
Amarin
Neuroscience Limited of Magdalen Centre North, Oxford Science Park, Oxford
OX4 4GA UK ('Amarin')
|
AND
|
ICON
Clinical Research Limited of South County Business Park, Leopardstown,
Dublin 18 ('ICON')
|
|
WHEREAS:
|
A.
|
The
parties entered into an Agreement for Services on 30th
June 2005, concerning Study known as Protocol AN01.01.0012 &
AN01.01.0011 - A Multi-centre, double-blind, randomized, parallel group,
placebo-controlled trial of ethyl-epa (Ethyl-Icosapent) in patients with
Huntington's Disease (the "Agreement"). This Agreement was further amended
by various Change Order for both the US and
EU.
|
B.
|
The
parties have agreed to certain changes to the services to be provided and
the associated cost as set out
herein.
|
|
1.
|
The
parties agree to amend the Agreement to reflect changes set out in the
Appendix 1 which is attached hereto and incorporated
hereby.
|
|
2
|
The
activities and associated costs in this Change Order relate to both
protocols AN01.01.0011 (694/006) and AN01.01.0012
(694/005).
|
|
3.
|
Save
as otherwise provided in this Change Order, all the terms and conditions
of the Agreement dated the 30th
June 2005 and subsequent change orders shall remain in full force and
effect.
|
|
4.
|
The
value for completion of these activities shall be £91,818 in direct fees.
Additional tasks, including the CSR addendum for the AN01.01.0012 study,
of which an estimate is included in this cost, and any additional work on
patient narratives for both studies and any additional biostatistics work
requested will be charged on a time and materials basis as per the hourly
rates in Appendix 1. All costs will be invoiced upon completion of the
work.
|
Aramin
694/005 & 006
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
Amarin
Neuroscience Limited
|
ICON
Clinical Research Limited
|
NAME___________________
|
Ms.
Seána Hopkins
|
TITLE
___________________
|
TITLE: VP
Commercial Affairs
|
DATE____________________
|
DATE_________________
|
SIGNED_________________
|
SIGNED______________
|
Aramin
694/005 & 006
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
Item
|
Amarin
694005/694006
|
CO
Value (£)
|
Comments
/timelines
|
Date:
|
May-07
|
||
694005
extension phase efficacy analysis
|
|||
Management
|
3hrslwk
|
£615
|
2
weeks
|
SAP
|
10
hours
|
£1,026
|
SAP
Includes all time from Jan08 to 01May08 (synergy
applied)
|
TFLs
|
5
Unique Tables
|
£2,165
|
Unique
TFLs absorbs dataset programming and validation cost (visit excel
spreadsheet, last dose updates, revisit of LOCF for assessment dates,
etc.)
|
16
Replicate Tables
|
£1,728
|
||
3
Unique Listings
|
£648
|
||
4
Repeat Listings
|
£324
|
||
Total
|
£6,506
|
||
694005
extension phase safety analysis
|
|||
Management
|
3hrs/wk
|
£615
|
2
weeks
|
SAP
|
10
hours
|
£1,026
|
SAP
includes all time from Jan08 to 01 May08 (synergy
applied)
|
TFLs
|
8
Unique Tables
|
£
3,464
|
|
11
Replicate Tables
|
£1,188
|
||
1
Unique Listing
|
£216
|
||
22
Replicate Listings
|
£1,782
|
||
Total
|
£8,291
|
||
694006
extension phase efficacy analysis
|
|||
Management
|
3
hrslwk
|
£615
|
2
weeks
|
SAP
|
10
hours
|
£1,026
|
SAP
includes all time from Jan08 to 01May08 (synergy
applied)
|
TFLs
- 1
parameter
|
5
Unique Tables
|
£2,165
|
|
22
Replicate Tables
|
£2,376
|
||
6
Repeat Listings
|
£486
|
||
Total
|
£6,668
|
||
694006
extension phase safety analysis
|
|||
Management
|
3hrs/wk
|
£615
|
2
weeks
|
Aramin
694/005 & 006
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
SAP
|
10
hours
|
£1,026
|
SAP
Includes all time from Jan08 to 01 May08 (synergy
applied)
|
TFLs
|
9
Unique Tables
|
£3,897
|
|
17
Replicate Tables
|
£1,836
|
||
3
Unique Listings
|
£648
|
||
23
Replicate Listings
|
£1,863
|
||
Total
|
£9,885
|
||
694006
main phase rerun safety
|
|||
Management
|
3
hrs/wk
|
£308
|
|
Dry
Run
|
1
dry run
|
£5,103
|
|
Total
|
£5,411
|
||
694006
main phase rerun efficacy
|
|||
Management
|
3
hrs/wk
|
£308
|
|
Dry
Run
|
1
dry run
|
£5,103
|
|
Total
|
£5,411
|
||
STATS TOTAL
|
£ 42,172
|
·
|
Amarin
want the existing CSR for the double-blind phase (dated 01 June 2007) to
be updated to include the OLE study methods and results, a brief summary
of the EFA laboratory data (maximum one days work), and a revision of the
double-blind data. It has been assumed that any changes to the
double-blind data will not change the message of the existing CSR dated 01
June 2007.
|
·
|
The
cost includes the provision of a mock report including shell results
tables for client review.
|
·
|
Two
sets of consolidated client comments after the provision of Draft 1. Any
additional revisions will be charged on a timesheet
basis.
|
·
|
ICON
has provided a separate unit cost for narrative writing and updates as
required.
|
·
|
ICON
Medical Writing will not be compiling the
appendices.
|
Aramin
694/005 & 006
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
|
Patient
Narratives:
|
·
|
A
new narrative written from scratch -* £204.05 per
narrative
|
·
|
An
existing narrative QC'd against listings and SAE reports/CIOMS, and
updated à
£153.04
|
·
|
An
existing narrative QC'd against listings only, and updated à
£102.02
|
Aramin
694/005 & 006
|
|
Protocol
AN01.01.0012 & AN01.01.0011
|
28th
May 2008
|
Biostatistics
|
||
AN01.01.0011
|
||
Extension
Phase Efficacy Analysis
|
£
|
6,668
|
Extension
Phase Safety Analysis
|
£
|
9,885
|
Main
Phase Rerun Safety
|
£
|
5,411
|
Main
Phase Rerun Efficacy
|
£
|
5,411
|
AN01.01.0012
|
||
Extension
Phase Efficacy Analysis
|
£
|
6,506
|
Extension
Phase Safety Analysis
|
£
|
8,291
|
Total
Biostatistics
|
£
|
42,172
|
Medical
Writing
|
||
AN01.01.0011
CSR
|
£
|
25,844
|
AN.01.01.0012
Open-Label Extension CSR addendum
|
£
|
23,802
|
Patient
Narratives
|
Unit
Costs
|
|
Total
Medical Writing
|
£
|
49,646
|
TOTAL
|
£
|
91,818
|
|
Biostatistics
|
·
|
Senior
Statistician à
£102.58
|
|
Medical
|
·
|
Medical
Writing - à
£127.62
|
·
|
QA
à
£111.72
|
1.
|
AMARIN NEUROSCIENCE LIMITED
whose registered office is at Magdalen Centre North, Oxford Science
Park, Oxford OX4 4GA, UK (“Amarin”); and
|
2.
|
DECISIONABILITY LLC of 1
East Neck Road, Stonington, CT 06378, USA (“Consultant”).
|
(A)
|
Consultant
is engaged in the business of offering consultancy services in relation to
pharmaceutical product assessment and review, and has considerable skill,
knowledge and experience in that
field.
|
(B)
|
In
reliance upon that skill, knowledge and experience Amarin wishes to engage
the Consultant to provide services in relation to evaluation and due
diligence matters and the Consultant agrees to accept the engagement on
the following terms.
|
|
1.1
|
Consultant
shall at Amarin’s request perform the services described in Schedule 1 to
this Agreement (the “Services”).
|
|
1.2
|
For
the purposes 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 Steven Williams (the “Consultant’s
Representative”).
|
|
1.3
|
The
Consultant commenced provision of the Services on 1 January
2007.
|
|
1.4
|
Consultant
shall perform the Services in good faith, with reasonable care and skill,
in accordance with the terms of this Agreement and all applicable laws,
regulations and guidelines, including without limitation ICH-GCP, and in
accordance with the reasonable instructions of
Amarin.
|
|
1.5
|
The
Services shall be provided by the Consultant at such locations and at such
times as the parties may agree from time to
time.
|
|
1.6
|
In
the event that the Consultant’s Representative becomes for any reason
unable to perform the Services for a period in excess of 14 days, the
Consultant will promptly notify Amarin of that fact, the reason for and
the likely duration of such
inability.
|
|
1.7
|
In
the event that the Consultant and Amarin agree that the Consultant will
require additional third party resources in order to provide the Services,
the Consultant shall agree in advance in writing with
Amarin:
|
|
1.7.1
|
the
nature and identity of the third party resources that are
required;
|
|
1.7.2
|
the
fees payable to such third party
resources.
|
|
Any
such services shall be provided directly to Amarin by such third
parties.
|
|
2.1
|
In
consideration of the provision of the Services, Amarin shall pay to
Consultant during the term of this Agreement a fee of $3,000 per day,
(together with VAT thereon (if applicable)) (the “Fee”).
|
|
2.2
|
Consultant
shall submit invoices at the end of each calendar month. Invoices shall be
payable within 30 days of receipt of same by
Amarin.
|
|
2.3
|
Amarin
shall in addition reimburse the Consultant for reasonable out-of-pocket
expenses incurred in the provision of the Services agreed to in advance by
Amarin, provided that copy invoices or other evidence of such expenses can
be produced upon request. It is expressly understood by the
parties that the role may involve domestic and international
travel. Any such travel shall be conducted by the Consultant in
accordance with the Amarin Travel Policy (as may be amended from time to
time). Amarin will wherever reasonably practicable give the
Consultant at least three weeks prior notice of any international travel
requirements.
|
|
2.4
|
Consultant
shall maintain adequate records in respect of the time spent engaged in
the performance of the Services and shall produce such records in support
of each invoice.
|
|
3.1
|
During
the term of this Agreement and for a period of 7 (seven) years thereafter,
Consultant undertakes to maintain as confidential all information, data
and materials, and intellectual property disclosed by Amarin or any
Affiliate of Amarin to Consultant (the “Amarin Confidential
Information”) on or prior to the date of last signature of this
Agreement (the “Effective Date”).
|
|
“Affiliates” shall mean a
corporation or entity controlling, controlled by, or under the common
control with Amarin. For the purposes of this Agreement, “control” shall mean the
director indirect ownership of more than 50% of the issued voting shares
or other voting rights of the subject entity to elect directors, or if not
meeting the preceding criteria, any entity owned or controlled by or
owning or controlling at the maximum control or ownership right permitted
in the country where such entity
exists.
|
|
3.2
|
Amarin
Confidential Information shall not, without Amarin’s prior written
consent, be used by Consultant (or permitted by it to be used by any
person) for any purpose other than the proper performance of the
Services.
|
|
3.3
|
The
Consultant shall not, without Amarin’s prior written consent, disclose the
Amarin Confidential Information to any other person, save as may be
strictly necessary in order to perform the Services, and provided that
Consultant first ensures that such third party is under a duty of
confidentiality to the Consultant to protect the confidentiality of the
Amarin Confidential Information on no less onerous terms than as set out
in this Clause 3.
|
|
3.4
|
The
obligations of confidentiality set out in this Clause shall not apply to
any Amarin Confidential Information
which:
|
|
3.4.1
|
came
lawfully into Consultant’s possession prior to the date of
disclosure;
|
|
3.4.2
|
is
or becomes public knowledge through no fault or omission of
Consultant;
|
|
3.4.3
|
is
required to be disclosed by law, in which case Consultant shall give
Amarin as much advance notice of the proposed disclosure as is practical
(including a copy of any written
request
or order), and shall cooperate with Amarin in any effort to limit or
restrict such disclosure, via a protective order or
otherwise;
|
|
3.4.4
|
is
furnished or made known to Consultant by a third party otherwise than in
breach of any obligation of confidentiality to
Amarin;
|
|
3.4.5
|
is
independently developed by the Consultant without access to the Amarin
Confidential Information.
|
|
3.5
|
The
Consultant agrees to maintain as strictly confidential the subject matter
of this Agreement and the fact that the parties have entered into this
Agreement, and agrees to make no public announcement or publish in any
manner whatsoever any information referring to any transaction
contemplated or completed as a result of a referral pursuant to this
Agreement.
|
|
3.6
|
Amarin
does not make any representation or warranty as to the accuracy or
completeness of the Amarin Confidential
Information.
|
|
3.7
|
Save
for the right to use the Amarin Confidential Information for the sole
purpose of performing its obligations under this Agreement, the Consultant
agrees that the Amarin Confidential Information is and shall remain the
sole property of Amarin and that nothing in this Agreement shall be
understood as granting, expressly or by implication, any rights to the
Consultant under any Amarin Confidential
Information.
|
|
3.8
|
Upon
termination or expiration of this Agreement, Consultant shall promptly
return, or at Amarin’s request destroy, all Amarin Confidential
Information.
|
|
4.1
|
This
Clause 4 applies to any Data and Intellectual Property conceived,
discovered, developed, made, produced or created as a result of performing
the Services hereunder by the Consultant, its servants or agents,
including without limitation the Consultant’s
Representative.
|
|
4.2
|
Subject
to Clause 4.3, the Consultant agrees
that:
|
|
4.2.1
|
all
data, materials and reports (“Data”) conceived,
discovered, developed, made, produced or created as a result of performing
the Services hereunder and all rights therein shall be solely owned by
Amarin (the “Amarin
Data”); and
|
|
4.2.2
|
any
patent right, invention, registered design, copyright, database right,
design right, trade mark, service mark, application to register any of the
aforementioned rights, trade secret or rights (including rights of
confidentiality) in know-how (“Intellectual Property”)
conceived, discovered, developed, made, produced or created as a result of
performing the Services hereunder and all rights therein, shall be owned
exclusively by Amarin (the “Amarin Intellectual
Property”).
|
|
4.3
|
All
Intellectual Property owned by the Consultant as at the Commencement Date
(the “Consultant
Intellectual
Property”) shall continue to be owned by the Consultant, and any
improvements to the Consultant Intellectual Property conceived,
discovered, developed, made, produced or created as a result of performing
the Services hereunder, and all rights therein, shall be owned by the
Consultant.
|
|
4.4
|
The
Consultant agrees to:
|
|
4.4.1
|
hold
on trust for the benefit of Amarin any such Amarin Intellectual Property
to the extent that the same may not be, and until the same is, vested
absolutely in Amarin; and
|
|
4.4.2
|
assign
to Amarin (or as Amarin shall direct) all right, title and interest in and
to all Amarin Intellectual Property and further agrees 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 Amarin and otherwise to protect and
maintain such Amarin Intellectual
Property.
|
|
4.5
|
The
Consultant irrevocably appoints Amarin to be his attorney or agent in its
name and on its behalf to do all such acts and things and to sign all such
deeds and documents as may be necessary in order to give Amarin the full
benefit of the provisions of this Agreement and, in particular but without
limitation of this clause, the Consultant agrees that, with respect to any
third party, a certificate signed by any duly authorised officer of Amarin
that any act or thing or deed or document falls within the authority
hereby conferred shall be conclusive evidence that this is the
case.
|
|
4.6
|
The
Consultant hereby assigns to Amarin by way of future assignment of
copyright the copyright subsisting in the copyright works and in the
documents generated by the Consultant during the course of, or otherwise
related to, the provision of the
Services.
|
|
4.7
|
The
Consultant agrees to promptly disclose to Amarin any Amarin Data and
Amarin Intellectual Property conceived, developed, produced, or created as
a result of performing the Services hereunder and to provide copies of all
documents relating to same to Amarin at its request at any time whether
during or after expiry or the termination for any reason of this
Agreement.
|
|
4.7
|
Reports and Record
Retention
|
|
4.7.1
|
The
Consultant will provide reports in writing (each a “Report”) on a regular
basis.
|
|
4.7.2
|
If
for any reason any Report is not to the satisfaction of Amarin acting
reasonably, the Consultant shall reproduce such Report to the satisfaction
of Amarin.
|
|
4.7.3
|
The
Consultant shall not disclose or publish any Report prepared for Amarin,
or use the Reports for any purpose other than to perform its obligations
hereunder, without the prior written consent of
Amarin.
|
|
4.7.4
|
In
consideration of the Fee described in Clause 2, the Consultant hereby
irrevocably assigns all copyright in the Reports to
Amarin.
|
|
4.8
|
The
Consultant shall maintain all books, records, data, reports, pictures and
other documents (both in electronic and paper form) relating to the
Services (the “Records”) for the
maximum period required by law (the “Retention
Period”). The Parties agree that all Records shall
constitute Amarin Confidential Information and the provisions of Clause 3
(Confidentiality) shall apply to all such Records. Upon expiry
of the Retention Period, the Consultant shall provide all original Records
(both in electronic and paper form), and all copies thereof, to
Amarin.
|
|
5.1
|
This
Agreement shall be effective from the date of last signature of this
Agreement (the “Effective
Date”) and shall remain in force until terminated in accordance
with the terms of this Agreement.
|
|
5.2
|
Either
party shall be entitled forthwith to terminate this Agreement by notice in
writing to the other if:
|
|
5.2.1
|
that
other party commits any material breach of any of the provisions of this
Agreement and, in the case where the breach is capable of remedy, fails to
remedy the same within
fourteen
(14) days of receipt of notice from the party seeking to terminate,
specifying the breach and requiring it to be remedied;
or
|
|
5.2.2
|
the
other party makes an arrangement with its creditors or is adjudged
insolvent, bankrupt or goes into liquidation (other than for the purposes
of a bona fide reconstruction) or has a receiver appointed over most of
the other party’s property or assets or any event analogous to the
foregoing occurs in relation to the other party in any relevant
jurisdiction outside England.
|
|
5.3
|
Each
of the parties may on the giving of 30 days prior written notice terminate
this Agreement.
|
|
6.1
|
The
parties agree that the Consultant is acting as an independent contractor
to Amarin for all purposes, including without limitation for U.S. Federal
(including social security and unemployment), state and local tax
purposes, with regard to the performance of the Services hereunder and
that there is no contract of employment or partnership between the
parties.
|
|
6.2
|
The
parties agree that the Consultant’s Representative is not, and will not
become, an employee of the Company.
|
|
6.3
|
The
Consultant shall not, and shall procure that its servants and agents
including without limitation the Consultant’s Representative shall not,
without Amarin’s express prior written authority, make representations to
third parties about Amarin’s business or enter into binding obligations
with third parties on Amarin’s behalf, nor will they hold themselves out
as having authority to do so.
|
|
6.4
|
The
Consultant shall be solely responsible for paying when due all Federal,
state and local income tax, self-employment or other tax obligations
arising in connection with its consultancy for
Amarin.
|
|
6.5
|
Should
Amarin be required to pay any such tax or payment, the Consultant shall
indemnify Amarin against (and promptly reimburse it for) such tax or
payments, including any interest and penalties with respect thereto.
Should it be determined that any payment hereunder is subject to
withholding of tax under applicable law, all payments to be made hereunder
shall be net of applicable income, employment, social security or other
taxes required to be withheld
therefrom.
|
|
6.6
|
Unless
otherwise agreed in writing by the parties, the Consultant’s servants and
agents, including without limitation the Consultant’s Representative,
shall not be entitled to any salary, pension, bonus, or other fringe
benefits from Amarin.
|
|
6.7
|
The
indemnity contained in this clause 6 shall remain in full force and effect
notwithstanding termination of this Agreement by either party in any
manner whatsoever.
|
7.
|
REPRESENTATIONS
AND WARRANTIES
|
7.1
|
The
Consultant warrants and represents to Amarin
that:
|
|
7.1.1
|
the
Consultant is not currently retained by a third party to provide services
in relation to products which compete with Amarin’s products and
undertakes to promptly inform Amarin in the event that it proposes to
commence the provision of such
services;
|
|
7.1.2
|
the
performance of the Consultant’s obligations hereunder are not inconsistent
with and/or will not breach any third party obligations whether express or
implied;
|
|
7.1.3
|
the
Consultant’s Representative is sufficiently competent and has appropriate
professional skills and qualifications in order to perform the
Services;
|
|
7.1.4
|
the
Consultant will supply the Services in good faith, with reasonable care
and skill, in accordance with the terms of this Agreement and all
applicable laws regulations and guidelines, and in accordance with the
reasonable instructions of Amarin;
and
|
|
7.1.5
|
the
Consultant has agreements in place with all servants and agents, including
without limitation the Consultant’s Representative, that impose
confidentiality obligations on such servants and agents, effectively vest
in Consultant any rights such servants and agents might otherwise have in
any Intellectual Property, permit Consultant to assign all such rights to
Amarin, and otherwise enable Consultant to comply with the terms of this
Agreement.
|
|
8.1
|
Consultant
shall indemnify and hold harmless Amarin and its Affiliates and their
respective employees, agents, officers and directors from and against any
all and any claims (whether successful or otherwise), loss, liability,
damages and expenses, including reasonable attorneys’ fees and expenses
and legal costs incurred or sustained by Amarin arising out of or in
connection with any:
|
|
8.1.1
|
breach
of any representation, covenant, warranty or obligation by the Consultant
or the Consultant’s Representative hereunder;
or
|
|
8.1.2
|
negligent
or wilful act or omission or failure to comply with applicable laws and
regulations on the part of the Consultant, the Consultant’s Representative
or any of its other employees, agents, officers and directors in the
performance of this Agreement.
|
|
9.1
|
No
variation to the terms of this Agreement shall be effective unless in
writing and signed on behalf of each party by an authorised
person.
|
|
9.2
|
The
Consultant may not assign, transfer or sub-contract all or any of his
rights and obligations under this
Agreement.
|
|
9.3
|
The
Schedules to this Agreement form part of and shall be deemed to be
incorporated into this Agreement.
|
|
9.4
|
This
Agreement contains the whole agreement between the parties and supersedes
all previous agreements and understandings between the parties with
respect to the subject matter of this
Agreement.
|
|
9.5
|
This
Agreement and the obligations of the parties shall be governed by and
construed in accordance with the laws of England and subject to the
exclusive jurisdiction of the English
courts.
|
|
9.6
|
No
waiver of any right under this Agreement shall be deemed effective unless
contained in a written document signed by the party charged with such
waiver, and no waiver of any breach or failure to perform shall be deemed
to be a waiver of any future breach or failure to perform or of any other
right arising under this Agreement.
|
|
9.7
|
Neither
party to this Agreement shall be liable for delay or failure in the
performance of any of its obligations hereunder to the extent such delay
or failure results from causes beyond its reasonable control,
including, without limitation, acts of God, fires, strikes, acts of war,
or intervention of a government authority, non-availability of raw
materials, but any such delay or failure shall be remedied by such party
as soon as practicable.
|
|
9.8
|
If
any provision in this Agreement is agreed by the parties to be, or is
deemed to be, or becomes invalid, illegal, void or unenforceable under any
law that is applicable hereto:
|
|
9.8.1
|
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, with effect
from the date of such agreement or such earlier date as the parties may
agree; and
|
|
9.8.2
|
the
validity, legality and enforceability of the remaining provisions of this
Agreement shall not be impaired or affected in any
way.
|
|
9.9
|
The
provisions of Clauses 3, 4, 6, 8, 9.5 and 9.9 shall survive the
termination for any reason of this
Agreement.
|
·
|
To
provide detailed strategic portfolio assessment and
review;
|
·
|
To
provide strategic project input into Amarin’s combinatorial lipid
programme.
|
(1)
|
AMARIN NEUROSCIENCES
LTD, having its principal place of business at Magdelen Centre
North, Oxford Science Park, Oxford, OX4 4GA and its Affiliates, (‘Amarin
’);
|
(2)
|
AMARIN PHARMACEUTICALS IRELAND
LIMITED having its principal place of business at First Floor,
Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland (“APIL”);
and
|
(3)
|
CHARLES RIVER LABORATORIES
PRECLINICAL SERVICES EDINBURGH LIMITED having its principal place
of business at Elphinstone Research Centre, Tranent, Edinburgh, EH33 2NE,
UK and its Affiliates listed on Exhibit A, (“Charles
River”).
|
A.
|
Amarin
is in the business of research, developing, manufacturing and/or
distributing pharmaceutical products. Charles River is in the business of
providing clinical trial services, research services, and other services
for the pharmaceutical industries.
|
B.
|
Amarin
and Charles River desire to enter into this Agreement to provide the terms
and conditions upon which Amarin may engage Charles River from
time-to-time to provide non-clinical services including toxicology and
other services for individual projects by executing individual Work Orders
(as defined below) specifying the details of the services and the related
terms and conditions.
|
1.
|
DEFINITIONS
|
1.1.
|
“Affiliate” shall mean a
corporation or entity controlling, controlled by, or under the common
control with Amarin or Charles River, as the case may be. For the purposes
of this Agreement, “control” shall mean the direct or indirect ownership
of more than 50% of the issued voting shares or other voting rights of the
subject entity to elect directors, or if not meeting the preceding
criteria, any entity owned or controlled by or owning or controlling at
the maximum control or ownership right permitted in the country where such
entity exists.
|
1.2.
|
“Amarin Materials” shall
mean the materials provided by Amarin to Charles River, as more
particularly described in each Work
Order.
|
1.3.
|
“Change Order” shall
have the meaning given to the term in Clause
2.3.
|
1.4.
|
“Claims” shall mean all
and any claims (whether successful or otherwise), loss, liability, damages
and expenses, including reasonable attorneys’ fees and expenses and legal
costs.
|
1.5.
|
“Confidential
Information” shall mean all know-how, trade secrets, inventions
(including patent applications covering such inventions), data,
information, and any improvements, modifications, derivations, or
compilations thereto that is owned, licensed by or controlled by the
disclosing party, provided however, that Confidential Information shall
not include any information which
is:
|
1.5.1.
|
already
known to the receiving party at the time of disclosure, as evidenced by
such party’s written records, provided such information was not obtained
directly or indirectly by the receiving party from the disclosing party
pursuant to a confidentiality
agreement;
|
1.5.2.
|
publicly
known prior to or after disclosure, through no default of the receiving
party;
|
1.5.3.
|
disclosed
in good faith to the receiving party by a third party, lawfully and
contractually entitled to make such disclosure;
or
|
1.5.4.
|
is
independently discovered without the aid or application of the
Confidential Information as shall be evidenced by the written records of
the receiving party.
|
1.6.
|
“Effective Date” shall
mean the date of last signature of this
Agreement.
|
1.7.
|
“Intellectual Property Rights”
shall mean all patents, patent applications, copyrights, copyright
applications, trademarks, trade secrets, know-how and other intellectual
property rights.
|
1.8.
|
“Project” shall have the
meaning given to the term in Clause
2.2.1.
|
1.9.
|
“Project Protocol” shall
have the meaning given to the term in Clause
2.2.2.
|
1.10.
|
“Services” shall have
the meaning given to the term in Clause
2.2.2.
|
1.11.
|
“Work Orders” shall have
the meaning given to the term in Clause
2.2.1.
|
2.
|
SCOPE
OF THE AGREEMENT AND WORK ORDERS
|
2.1.
|
Scope
of Agreement
|
2.1.1.
|
This
Master Agreement allows the parties to contract for multiple projects
regarding toxicology and other non-clinical services requested by Amarin
and agreed to by Charles River through the issuance of multiple Work
Orders in accordance with the terms of this
Agreement.
|
2.2.
|
Work
Orders/Project Protocol
|
2.2.1.
|
The
specific details of each project under this Agreement (each a “Project”) shall be
separately negotiated and specified in writing in substantially the form
attached hereto in Appendix 1 (each a “Work
Order”).
|
2.2.2.
|
The
parties shall agree the terms of a protocol for each Project which will
set out the nature, design and scope of the Project and the schedule of
work to be performed or consulting services to be provided during the
course of each Project (the “Services”) (the “Project
Protocol”).
|
2.2.3.
|
Each
Work Order will include details of the Services as set out in the relevant
Project Protocol, time line, budget and payment schedule for the Services
to be provided for each Project.
|
2.2.4.
|
For
the avoidance of doubt, the terms of any Project Protocol are hereby
incorporated into the relevant Work Order and any reference to any Work
Order includes the terms of any Project Protocol set out
therein.
|
2.2.5.
|
Each
Work Order upon execution shall be incorporated into this Agreement and
shall be subject to all of the terms and conditions of this Agreement, in
addition to the specific details set forth in the Work
Order.
|
2.2.6.
|
To
the extent any terms or provisions of a Work Order conflict with the terms
and provisions of this Agreement, the terms and provisions of this
Agreement shall prevail, except to the extent that the applicable Work
Order expressly and specifically states an intent to supersede the
Agreement on a specific matter.
|
2.3.
|
Change
Orders
|
2.3.1.
|
Subject
to Clause 2.4, any material change in the details of a Work Order,
including without limitation any change to the relevant Project protocol,
shall require written amendment to the Work Order in substantially the
form attached hereto in Appendix 2 (a “Change
Order”).
|
2.3.2.
|
For
the avoidance of doubt, other than as provided in Clauses 2.3.1 and 2.4,
no other changes to, or deviations from, a Work Order, including without
limitation the relevant Project protocol, can be made without the prior
written consent of Amarin.
|
2.3.3.
|
Each
Change Order shall detail the requested changes to the applicable task,
responsibility, duty, budget, time line or other
matter.
|
2.3.4.
|
The
Change Order will become effective upon the execution of the Change Order
by both parties.
|
2.3.5.
|
Both
parties agree to act in good faith and promptly when considering a Change
Order requested by the other
party.
|
2.4.
|
Conduct
of the Project
|
2.4.1.
|
Charles
River shall provide the Services in accordance with the relevant Project
Protocol, industry standards of professional conduct, and the terms and
conditions of this Agreement.
|
2.4.2.
|
Emergency
Deviations from Project Protocol
|
(a)
|
Deviations
from a Project Protocol may be made without Amarin’s approval in an
emergency where issues of safety or welfare arise (“Emergency
Deviations”).
|
(b)
|
Additional
costs may be incurred by Charles River as a result of such Emergency
Deviations which could not have been foreseen at the time of the
preparation of the Work Order (the “Additional
Cost”).
|
(c)
|
Charles
River shall use commercially reasonable efforts to obtain Amarin’s
approval before implementing such Emergency Deviations and incurring such
Additional Cost. Should Charles River be unable to contact Amarin prior to
the implementation of the Emergency Deviation, Amarin agrees that Charles
River may proceed accordingly and be entitled to recover such Additional
Costs from Amarin upon presentation of an explanation of such Emergency
Deviations and the necessity thereof, together with any additional
information required by Amarin.
|
3.
|
MATERIALS
|
3.1.
|
Amarin
shall provide Charles River with the Amarin Materials specified in the
applicable Work Order,as well as such complete and accurate data as is
necessary to apprise Charles River of the identity, strength, purity,
stability and composition or other appropriate characteristics of each
batch, proper storage and safe handling requirements of the Amarin
Materials, including a Material Safety Data Sheet (MSDS) or equivalent
documentation.
|
3.2.
|
All
costs associated with the shipping of the Amarin Materials to Charles
River shall be the responsibility of Amarin and Charles River shall not be
responsible for any loss, damage or destruction of the Amarin Materials in
transit. Title to the Amarin Materials shall at all times
remain in Amarin.
|
3.3.
|
Charles
River acknowledges that Amarin owns the Amarin
Materials.
|
3.4.
|
Charles
River undertakes that it shall not, without the prior written consent of
Amarin:
|
3.4.1.
|
use
the Amarin Materials for any purpose other than for the Services described
in the applicable Work Order;
|
3.4.2.
|
make
any Amarin Materials available to a third
party;
|
3.4.3.
|
allow
access to the Amarin Materials by any employees or permitted consultants
except those who are directly involved in providing the Services in the
Applicable Work Order;
|
3.4.4.
|
make
any commercial use of the Amarin Materials or any composition made using
the Amarin Materials;
|
3.4.5.
|
analyse
or otherwise attempt to determine the composition of the Amarin Materials
except as agreed by the parties for the completion of the
Projects;
|
3.4.6.
|
use
the Amarin Materials for testing in or treatment of human
subjects.
|
3.5.
|
Subject
to Clause 4, upon termination of the applicable Work Order or of this
Agreement, any remaining Amarin Materials shall be returned by Charles
River to Amarin or, at Amarin’s option, destroyed, with written
certification of such destruction.
|
3.6.
|
Except
as otherwise set forth herein, the Amarin Materials are provided by Amarin
on an as-is basis and without warranty, express or implied, including any
warranty as to merchantability, title, or fitness for a particular
purpose.
|
4.
|
SAMPLES
AND RECORDS RETENTION
|
4.1.
|
Charles
River shall archive all raw material, non-clinical supply and analytical
samples (the “Samples”) and all
books, records, data, reports, pictures and other documents (both in
electronic and paper form) relating to the manufacture and supply of the
Products (the “Records”) in accordance
with the provisions of the relevant Project protocol and with Charles
River’s standard archiving terms and conditions attached hereto as
Appendix 3 (the “Retention
Period”). To the extent any terms or provisions of such
terms and conditions conflict with the terms and provisions of this
Agreement, the terms and provisions of this Agreement shall
prevail.
|
4.2.
|
The
Parties agree that all Records shall constitute Confidential Information
of Amarin and the provisions of Clause 6 shall apply to all such
Records.
|
4.3.
|
Upon
expiry of the Retention Period, Charles River shall provide all original
Records (both in electronic and paper form), and all copies thereof, to
Amarin and shall, at the direction and written request of Amarin, either
deliver all Samples to Amarin, or dispose of same, (unless such Samples
are otherwise required to be stored or maintained by Charles River as a
matter of law or regulation).
|
5.
|
PAYMENT
OF FEES AND EXPENSES
|
5.1.
|
APIL
(or APIL’s nominee) shall pay Charles River fees and reasonable and
necessary vouched expenses incurred in the performance of the Services on
the following basis:
|
5.1.1.
|
the
total cost of each Project and an estimate of the total expenses to be
incurred in relation thereto (the “Total Project Cost”)
shall be set out in the relevant Work Order and, subject to Clause 2.4, in
no event shall APIL (or APIL’s nominee) be required to pay any amount
exceeding the Total Project Cost unless otherwise agreed in writing by
both parties by Change Order(s);
|
5.1.2.
|
in
the case of any individual expense item exceeding £500, APIL’s (or APIL’s
nominee) prior written approval must be given for such
expense.
|
5.2.
|
Invoices
for fees and expenses shall be issued on a monthly basis and APIL (or
APIL’s nominee) shall pay each invoice within thirty (30) days of date of
invoice.
|
5.3.
|
All
sums referred to in each Work Order shall be exclusive of Value Added Tax
(VAT) and shall be paid by APIL (or APIL’s
nominee).
|
5.4.
|
If
any portion of an invoice is disputed, then APIL (or APIL’s nominee) shall
pay the undisputed amounts and the parties shall use good faith efforts to
reconcile the disputed amount as soon as
practicable.
|
5.5.
|
All
amounts not paid by APIL when due shall accrue interest from the
applicable due date until paid, at the rate of one percent (1%) per month.
Charles River may elect to cease or suspend Services or withhold required
reports or other deliverables if APIL does not make undisputed payments
when due and payable.
|
6.
|
CONFIDENTIAL
INFORMATION/ANNOUNCEMENTS
|
6.1.
|
Upon
execution of this Agreement, and thereafter during the term hereof, Amarin
may disclose to Charles River in confidence Confidential Information
necessary or useful to the activities contemplated by this
Agreement.
|
6.2.
|
Except
as specifically authorised or permitted by this Agreement, Charles
River shall,
for a period of 10 years after termination of the applicable Work Order
keep confidential and not disclose to others (except its Affiliates), and
use only as permitted hereunder, all of the Confidential Information owned
by Amarin.
|
6.3.
|
The
parties agree that the provisions of this Clause 6 shall apply to any
Confidential Information of Amarin provided to Charles River prior to the
Effective Date and to any Confidential Information of Charles River
provided to Amarin.
|
6.4.
|
Save
as otherwise specifically provided herein, Charles River shall disclose
Confidential Information of Amarin only to those employees,
representatives and agents requiring knowledge thereof in connection with
fulfilling Charles River obligations under this
Agreement. Charles River further agrees to (i) inform all such
employees, representatives and agents of the terms and provisions of this
Agreement relating to Confidential Information and their duties hereunder,
and (ii) obtain their agreement hereto as a condition of receiving
Confidential Information, provided that such agreement shall be deemed
given in respect of such employees, representatives and agents that, at
the time of disclosure, are under existing obligations of confidentiality
no less onerous than those contained herein covering such
disclosure. Charles River 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
Amarin.
|
6.5.
|
Notwithstanding
the provisions of this Clause 6, Confidential Information may be disclosed
to the extent required by applicable laws or regulations or as ordered by
a court or other regulatory body having competent jurisdiction, provided
that if Charles River becomes legally required to disclose any
Confidential Information of Amarin hereunder, Charles River shall give
Amarin prompt notice of such requirement to enable Amarin to seek a
protective order or other appropriate remedy concerning any such
disclosure. Charles River shall fully co-operate with Amarin in connection
with Amarin’s efforts to obtain any such order or other
remedy. If any such order or other remedy does not fully
preclude disclosure, Charles River shall make such disclosure only to the
extent that such disclosure is legally
required.
|
6.6.
|
The
parties agree that the obligations of this Clause 6 are necessary and
reasonable in order to protect Amarin’s business, and Charles River agrees
that monetary damages would be inadequate to compensate Amarin for any
breach by Charles River of its covenants and agreements set forth
herein.
|
6.7.
|
The
parties agree that any such violation or threatened violation shall cause
irreparable injury to Amarin and that, in addition to any other remedies
that may be available, in law and equity or otherwise, Amarin shall be
entitled to seek injunctive relief against the threatened breach of the
provisions of this Clause 6, or a continuation of any such breach by
Charles River, specific performance and other equitable relief to redress
such breach together with damages and reasonable counsel fees and expenses
to enforce its rights hereunder.
|
6.8.
|
Subject
to Clauses 6.4 and 6.5, Charles River shall not be entitled to disclose to
third parties the existence of this Agreement or any of the terms and
conditions hereof without the prior written consent of
Amarin.
|
6.9.
|
Amarin
shall be entitled to provide a copy of this Agreement (and any related
agreements or documents) to a potential third party acquirer or other
commercialization partner provided that the relevant third
party has entered into a confidentiality agreement on terms to be agreed
between Amarin and such relevant third
party.
|
7.
|
DATA
AND INTELLECTUAL PROPERTY RIGHTS
|
7.1.
|
Any
inventions and/or techniques for carrying out the Services hereunder which
relate to the conduct of Charles River’s business that are not developed
hereunder and that are not developed using the Confidential Information of
Amarin are and shall remain Charles River’s exclusive property, including
but not limited to present and future documentation, scientific and
technical data, test procedures and other information that is owned or
licensed by Charles River.
|
7.2.
|
Charles
River shall have the right to use Control Data as part of its general
historical database. “Control Data” shall
mean data generated solely from the control animals used in the relevant
Project.
|
7.3.
|
All
Intellectual Property Rights conceived, discovered, developed, made,
produced or created as a result of performing the Services and all rights
therein (the “Project
IP”), shall be owned exclusively by APIL (or APIL’s nominee) or an
Affiliate of APIL (or APIL’s
nominee).
|
7.4.
|
Charles
River agrees to promptly disclose all such Project IP to APIL (or APIL’s
nominee) and hereby assigns to APIL (or APIL’s nominee) all right title
and interest in and to all Project
IP.
|
7.5.
|
All
data and information generated or derived by or Charles River as the
result of Services performed by Charles River under this Agreement,
including the Reports, and all rights therein (the “Project Results”) shall
be owned exclusively by APIL (or APIL’s
nominee).
|
7.6.
|
Charles
River hereby assigns to APIL (or APIL’s nominee) all rights, title and
interest in and to all Project
Results.
|
7.7.
|
Subject
to Clause 7.2, Charles River shall not be entitled to use the Project
Results or Project IP after the termination or expiry of the relevant Work
Order under which such Project Results or Project IP were created for any
purpose whatsoever without the prior written consent of
Amarin.
|
7.8.
|
Charles
River represents and warrants that each employee, agent, developer,
consultant and contractor who has access to, contributes to, or
participates in the creation of any Project Results or Project IP
hereunder during the term of this Agreement is bound by confidentiality
obligations that protect the confidentiality of such Project Results and
Project IP and shall execute an assignment or an agreement to assign in
favour of Charles River all such person’s right, title and interest in the
Project Results and Project IP.
|
7.9.
|
For
the avoidance of doubt, APIL (or APIL’s nominee) may use the Project
Results and Project IP without any restriction or additional
compensation.
|
7.10.
|
At
APIL’s cost and expense, at the completion of Services by Charles River,
all Project Results and Project IP and other materials owned by APIL (or
APIL’s nominee), regardless of the method of storage or retrieval, shall
either be delivered to APIL (or APIL’s nominee) disposed of, at the
direction and written request of APIL (or APIL’s nominee) (unless such
Project Results or materials are otherwise required to be stored or
maintained by Charles River as a matter of law or
regulation).
|
7.11.
|
Reports
|
7.11.1.
|
Charles
River will provide Amarin with regular updates by telephone and/or by
email on the progress of each Project in a timely manner and as
needed.
|
7.11.2.
|
On
completion of each Project, Charles River will provide draft and final
reports in writing on the Services conducted (each a “Report”) to Amarin in
accordance with the relevant Project
protocol.
|
7.11.3.
|
Charles
River shall not disclose or publish any Report prepared for Amarin, or use
the Reports for any purpose other than to perform its obligations
hereunder, without the prior written consent of
Amarin.
|
8.
|
REGULATORY
COMPLIANCE
|
8.1.
|
Charles
River represents and warrants that all Services will be conducted in
compliance with all applicable laws, rules and regulations, including
without limitation Good Laboratory Practice (GLP) and Good Clinical
Practice (GCP) regulations and guidelines as appropriate, and in
compliance with the applicable International Committee of Harmonization
guidelines, United Kingdom Medicines and Healthcare Products Regulatory
Agency (MHRA) guidelines, and the United States Food and Drug
Administration’s Code of Federal Regulations Title 21, parts 11, 50, 56,
54, 58, and 312 and all other applicable laws, regulations and guidelines,
including for the avoidance of doubt, all laws, regulations and guidelines
relating to data protection.
|
8.2.
|
If
any governmental or regulatory authority gives any party any notice to
take any regulatory action with respect to any Project or Services
provided under this Agreement, the notified party shall promptly notify it
to the other party, and both parties shall cooperate in answering such
regulatory action.
|
8.3.
|
Upon
reasonable advance notice and at such times as shall be agreed with
Charles River, such agreement not to be unreasonably withheld or delayed,
Charles River shall make (and where relevant shall procure that any
permitted subcontractor shall make) that portion of its facility where the
Services are conducted available for inspection by Amarin’s duly qualified
employee, or by a duly qualified consultant, contractor or agent of
Amarin, or by the relevant governmental or regulatory
authority. The investigation shall be limited to determining
whether there is compliance with GCP and other requirements of any
applicable laws, regulations and
guidelines.
|
8.4.
|
Charles
River shall provide the Amarin with a list of all of Charles River
standard operating procedures (“SOPs”) relevant to the
Services. Amarin shall be entitled to review all such SOPs
during an audit of the Charles River
facility.
|
8.5.
|
Charles
River shall promptly notify Amarin of any material breach of any
applicable laws, regulations or guidelines or SOPs that could potentially
invalidate any Project.
|
9.
|
REPRESENTATIONS
AND WARRANTIES
|
9.1.
|
Charles
River represents and warrants as
follows:
|
9.1.1.
|
it
will render the Services under this Agreement and any Work Order in
accordance with applicable professional standards and will make
commercially reasonable efforts to produce a consistently high level of
accuracy and expertise, and in accordance with the terms of this
Agreement;
|
9.1.2.
|
personnel
assigned to perform Services under this Agreement and any Work Order shall
have the skills necessary to efficiently perform such Services in
accordance with the terms of this
Agreement;
|
9.1.3.
|
it
shall make its commercially reasonable efforts to provide the Services in
accordance with the time lines set out in the relevant Work
Orders;
|
9.1.4.
|
it
is not a party to any agreement which would prevent it from fulfilling its
obligations under this Agreement and that during the term of this
Agreement, Charles River agrees that it will not enter into any agreement
to provide services which would in any way prevent it from providing
Services contemplated under this Agreement and any Work
Order.
|
9.2.
|
THE
WARRANTIES BY CHARLES RIVER SET FORTH IN THIS SECTION ARE IN LIEU OF ANY
AND ALL OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED OR STATUTORY
INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OR FOR NON-INFRINGEMENT OF A PATENT,
TRADEMARK OR OTHER INTELLECTUAL PROPERTY
RIGHT.
|
9.3.
|
Amarin
warrants that it owns, licences or controls, or is otherwise entitled to
use, all rights, title and interest in the Amarin Materials and the
intellectual property related
thereto.
|
10.
|
INDEMNIFICATION
|
10.1.
|
Subject
to Clause 10.3, Amarin shall indemnify and hold harmless Charles River and
its Affiliates and their respective employees, agents, officers and
directors from and against any Claims incurred or sustained by Charles
River and its Affiliates and their respective employees, agents, officers
and directors arising out of the Services performed under this Agreement
including without limitation any Claims arising
from:
|
10.1.1.
|
the
research, development, manufacture, distribution, use, sales or other
disposition by Amarin or APIL of the Amarin Materials;
or
|
10.1.2.
|
any
personal injury sustained by an Amarin employee, agent, officer, or
consultant related to contact with animals, tissues, samples or specimens
during visits to Charles River’s facilities or after delivery of any
animals, tissues, samples or specimens to
Amarin;
|
10.1.3.
|
breach
of any representation, covenant, warranty or obligation by Charles
River under this Agreement;
or
|
10.1.4.
|
negligent
act or omission or wilful misconduct on the part of Charles River or any
of its agents or employees in the performance of this
Agreement;
|
10.2.
|
Subject
to Clause 10.3, Charles River shall indemnify and hold harmless Amarin and
its Affiliates and their respective employees, agents, officers and
directors from and against any Claims incurred or sustained by Amarin and
its Affiliates and their respective employees, agents, officers and
directors arising out of or in connection with
any:
|
10.2.1.
|
breach
of any representation, covenant, warranty or obligation by Charles River
under this Agreement; or
|
10.2.2.
|
negligent
act or omission or wilful
misconduct on the part of Charles River or any of its respective
employees, agents, officers and directors in the performance of this
Agreement;
|
10.3.
|
The
party seeking an indemnity shall:
|
10.3.1.
|
fully
and promptly notify the other party of any claim or proceedings, or
threatened claim or proceedings;
|
10.3.2.
|
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;
|
10.3.3.
|
co-operate
in the investigation and defence of such claim or proceedings;
and
|
10.3.4.
|
take
all reasonable steps to mitigate any loss or liability in respect of any
such claim or proceedings.
|
10.4.
|
NOTWITHSTANDING
ANYTHING TO THE CONTRARY IN THIS AGREEMENT, AMARIN AND CHARLES RIVER 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 CONSEQUENTIAL, SPECIAL OR 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.
|
10.5.
|
Charles
River’s liability under this Agreement, regardless of the form of action,
shall not exceed the total amount paid under the Work Order under which
such liability arises.
|
10.6.
|
Intentionally
omitted
|
10.7.
|
Subject
to Clause 10.2, in no event shall Charles River be liable for any damages
arising from or in connection with any decision by Amarin or APIL or any
third party to further research, develop or market the Amarin Materials or
any derivative or product or service related thereto or the use of the
Amarin Materials or any product or derivative or service related
thereto.
|
10.8.
|
Insurance
|
10.8.1.
|
Charles
River shall, at its own cost and expense, obtain and maintain in full
force and effect the following insurance during the term of this
Agreement:
|
(a)
|
General
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to $5,000,000;
|
(b)
|
Employers
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to $13,000,000 per
accident;
|
(c)
|
Products
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to $5,000,000;
|
(d)
|
Professional
Services Errors & Omissions Liability Insurance with per-occurrence
limit of not less than an amount equivalent to
$5,000,000.
|
10.8.2
|
Amarin
shall, at its own cost and expense, obtain and maintain in full force and
effect the following insurance during the term of this
Agreement:
|
(a)
|
General
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to €5,000,000;
|
(b)
|
Employers
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to €13,000,000 per
accident;
|
(c)
|
Products
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to €5,500,000.
|
10.8.3
|
Each
party shall furnish certificates of insurance evidencing the required
insurance policies to the other as soon as practicable after the Effective
Date and within 30 days after renewal of such policies. In the
event that any of the required policies of insurance are written on a
claims made basis, then each party shall use reasonable endeavours to
ensure that such policies shall be maintained during the entire Term and
for a period of not less than 3 years following the expiration or
termination of this Agreement. Each insurance policy that is
required under this Agreement shall be obtained from an insurance carrier
with an A.M. Best rating of at least A-VII. Each party shall
notify the other party in writing at least 30 days prior to the expiration
or termination of such coverage. Each party shall ensure that
each of the required policies include a general indemnity to principal
clause.
|
11.
|
PUBLICATION
|
11.1.
|
It
is acknowledged and agreed by Charles River that publication of the
Project Results or Project IP in whole or in part shall be within the sole
and absolute discretion of Amarin, and that Charles River shall not
publish or refer to any Project Results or Project IP, in whole or in
part, without the prior expressed written consent of Amarin. Neither party
will use the other party's name in connection with any publication or
promotion without the other party's prior, written
consent.
|
12.
|
TERMINATION
|
12.1.
|
This
Agreement shall commence on the Effective Date and shall continue for five
(5) years or until terminated by either party in accordance with this
Clause 12.
|
12.2.
|
This
Agreement or any Work Order may be terminated without cause by Amarin at
any time during the term of the Agreement on thirty (30) days prior
written notice to Charles River.
|
12.3.
|
In
addition to the rights of termination provided for elsewhere in this
Agreement, each party shall be entitled forthwith to terminate this
Agreement by written notice to the others
if:
|
12.3.1.
|
either
party commits any material breach of any provisions of this agreement, and
in the case of a breach capable of remedy, fails to cure the same within
30 days after receipt of a written notice giving full particulars of the
breach and requiring it to be cured;
or
|
12.3.2.
|
any
party goes into liquidation (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
such party under this Agreement);
or
|
12.3.3.
|
an
encumbrancer takes possession or a receiver is appointed over any of the
property or assets of the any party;
or
|
12.3.4.
|
any
proceedings are filed or commenced by any party under bankruptcy,
insolvency or debtor relief laws or anything analogous to any of the
foregoing under the laws of any jurisdiction occurs in relation to such
party.
|
12.3.5.
|
For
the purposes of Clause 12.3.1, a breach will be considered capable of
being cured if the party in breach can comply with the provision in
question in all respects other than as to time of performance (provided
that time of performance is not of the
essence).
|
12.4.
|
The
written termination notice shall identify the specific Work Order or Work
Orders that are being terminated.
|
12.5.
|
Upon
receipt of a termination notice from Amarin, Charles River shall cease
performing any work not necessary for the orderly close out of the
affected Projects or for the fulfillment of regulatory
requirements.
|
12.6.
|
In
case of termination of this Agreement or any Work Order after the
completion of a certain Work Order and before the commencement of any
activities by Charles River for a subsequent Work Order, then Amarin shall
not be required to make any payment to Charles River for such subsequent
Work Order.
|
12.7.
|
In
the event this Agreement or a particular Work Order is terminated before
any such Work Order is completed, Amarin shall pay Charles River for all
Services performed in accordance with any such affected Work Order
hereunder, and reimburse Charles River for all reasonable and necessary
expenses to which Charles River has committed in performing those Services
and which cannot be cancelled, as evidenced in writing by Charles River,
together with any additional information required by
Amarin.
|
12.8.
|
Upon
the termination of this Agreement or any Work Order, Charles River shall
deliver to Amarin all data and materials provided by Amarin to Charles
River for the conduct of Services under the terminated Work Orders, and
Charles River shall also deliver to Amarin all Project Results and any
other data, information and documentation produced as the result of
Services performed by Charles River under the terminated Work Orders in
accordance with Clause 7.10.
|
13.
|
MISCELLANEOUS
|
13.1.
|
This
Agreement shall be governed by and construed in accordance with the laws
of England.
|
13.2.
|
No
waiver of any right under this Agreement shall be deemed effective unless
contained in a written document signed by the party charged with such
waiver, and no waiver of any breach or failure to perform shall be deemed
to be a waiver of any future breach or failure to perform or of any other
right arising under this Agreement.
|
13.3.
|
Other
than with respect to the payment of any amounts due hereunder, neither
party to this Agreement shall be liable for delay or failure in the
performance of any of its obligations hereunder to the extent such delay
or failure results from causes beyond its reasonable control, including,
without limitation, acts of God, fires, strikes, acts of war, or
intervention of a government authority, non-availability of raw materials,
but any such delay or failure shall be remedied by such party as soon as
practicable.
|
13.4.
|
Charles
River shall not subcontract with a third party to perform the Services
without the prior written consent of Amarin, which consent shall not be
unreasonably withheld. Should Charles River subcontract with any third
party upon such written consent of Amarin, Charles River represents and
warrants that such third-party subcontractor shall comply with all
obligations of Charles River under this Agreement and any Work Order,
including but not limited to, obligations of confidentiality and ownership
rights of the Project Results and Project IP, and Charles River shall
remain fully liable for its and such third party’s performance of the
Services and the obligations of Charles River
hereunder.
|
13.5.
|
Amarin
may assign this Agreement to an Affiliate or a third party without the
consent of Charles River. Charles River shall not be entitled
to assign this Agreement.
|
13.6.
|
Nothing
contained in this Agreement is intended or is to be construed to
constitute Charles River and Amarin as partners or members of a joint
venture. None of the parties hereto shall have
any
|
13.7.
|
No
amendment, modification or addition hereto shall be effective or binding
on any party unless set forth in writing and executed by a duly authorised
representative of each of the
parties.
|
13.8.
|
Any
notice to be given under this Agreement shall be sent in writing in
English by overnight courier, registered airmail or telecopied
to:
|
13.8.1.
|
or
to such other address(es) and telecopier numbers as may from time to time
be notified by any of the parties to the others
hereunder.
|
13.8.2.
|
Any
notice sent by overnight courier, registered mail or telecopier shall be
deemed to have been delivered upon receipt by the
addressee.
|
13.9.
|
If
any provision in this Agreement is agreed by the parties to be, or is
deemed to be, or becomes invalid, illegal, void or unenforceable under any
law that is applicable hereto:
|
13.9.1.
|
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, with effect
from the date of such agreement or such earlier date as the parties may
agree; and
|
13.9.2.
|
the
validity, legality and enforceability of the remaining provisions of this
Agreement shall not be impaired or affected in any
way.
|
13.10.
|
This
Agreement sets forth all of the agreements and understandings between the
parties with respect to the subject matter hereof, and supersedes and
terminates all prior agreements and understandings between the parties
with respect to the subject matter
hereof.
|
|
13.11.
|
At
the request of any of the party, the other parties shall (and shall use
reasonable efforts to procure that any other necessary third parties
shall) execute and do all such documents, acts and things as may
reasonably be required subsequent to the signing of this Agreement for
assuring to or vesting in the requesting party the full benefit of the
terms hereof.
|
13.12.
|
The
provisions of Clauses 3.3, 4, 6, 7, 8, 9, 10, 11, 13.1, 13.11, 13.13, 15
and this Clause 13.12 shall survive the termination of this Agreement or
any Work Order.
|
13.13.
|
A
person who is not a party to this Agreement has no right under the
Contracts (Rights of Third parties) Act 1999 to enforce any term of this
Agreement, but this does not affect any right or remedy of a third party
which exists or is available apart from that
Act.
|
14.
|
Employee
Solicitation. Amarin agrees that, during the term of a
Work Order and for a period of one hundred eighty (180) days thereafter,
Amarin will not solicit for hire or hire as an employee, or engage as an
independent contractor, any employee of Charles River who has been
involved in rendering services on the Services, without the prior written
consent of Charles River. In the event of such solicitation, hiring or
engagement, in addition to any other remedy Charles River may have, Amarin
shall pay to Charles River an amount equal to such employee’s annual
salary.
|
15.
|
Dispute
Resolution.
|
15.1.
|
Any
controversy, claim or dispute arising out of this Agreement shall first be
submitted in writing by both parties to the Chief Executive Officer of
Amarin and the Chief Executive Officer of Charles River for resolution,
who may call on others to advise them as they see
fit.
|
15.2.
|
If
they fail to resolve the dispute within twenty-eight (28) days of such
submission, any such dispute shall be finally settled by arbitration in
London, United Kingdom, in accordance with the rules of the International
Chamber of Commerce (ICC) then in effect, by
three (3) commercial arbitrators with substantial experience in the
pharmaceutical field.
|
15.3.
|
Each
party shall appoint one arbitrator who at their turn shall nominate the
chairperson, who shall be qualified in English law. If a Party
does not appoint its arbitrator within fifteen (15) days following the
expiry of the twenty-eight (28) day period, then such arbitrator shall be
selected on an expedited basis in accordance with the rules of the
ICC. Any arbitrator so selected shall have substantial
experience in the pharmaceutical
industry.
|
15.4.
|
The
arbitrators shall have the authority to allocate between the parties the
costs of arbitration (including service fees, arbitrator fees and all
other fees related to the arbitration) in such equitable manner as the
arbitrators may determine.
|
15.5.
|
The
scope of the authority of the arbitrators is limited to the strict
application of law.
|
15.6.
|
The
parties shall make sure that, except as may be otherwise required by law,
its witnesses or the arbitrators will not disclose the existence, content
or results of the arbitration hereunder without the prior written consent
of the other party.
|
15.7.
|
The
prevailing party in the arbitration shall be entitled to receive
reimbursement of its reasonable expenses (including reasonable attorneys’
fees, expert witness fees and all other expenses) incurred in connection
therewith.
|
15.8.
|
Judgment
upon the award so rendered may be entered in a court having jurisdiction
or application may be made to such court for judicial acceptance of any
award and an order of enforcement, as the case may
be.
|
(1)
|
AMARIN NEUROSCIENCE LTD
of 1st
Floor, Magdalen Centre North, The Oxford Science Park, Oxford, OX4 4GA
(“Amarin”)
|
(2)
|
AMARIN PHARMACEUTICALS IRELAND
LIMITED having its principal place of business at First Floor,
Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland (“APIL”)
|
(3)
|
CHARLES RIVER LABORATORIES
PRECLINICAL SERVICES EDINBURGH LIMITED having its principal place
of business at Elphinstone Research Centre, Tranent, Edinburgh, EH33 2NE,
UK ("Charles River
")
|
A
|
Amarin,
APIL and Charles River are bound by the terms of the Master Services
Agreement dated XXXX 2007 between Amarin and Charles River (the "Master Services
Agreement").
|
Signed:
...................................................
|
Date:
..............................................
|
Name: ....................................................
|
Position:
.........................................
|
Signed:
...................................................
|
Date:
..............................................
|
Name: ....................................................
|
Position:
.........................................
|
Signed:
....................................................
|
Date:
................................................
|
Name:
.....................................................
|
Position:
..........................................
|
Critical
Milestones
|
Estimated
Date
|
·
|
All
invoices will be issued in Pound Sterling and are to be paid in Pound
Sterling.
|
·
|
The
total cost for the Services detailed in this Work Order is
[ ] and the total estimated related expenses have
been detailed in Schedule 4.
|
·
|
The
authorised Amarin contact shall be Trevor Wyeth. The authorised Charles
River contact for this work shall be
[ ].
|
·
|
All
invoices will state the Amarin protocol number, activity performed,
purchase order number (if available), contact name and will be submitted
to the following address:
|
Description
|
Unit
Description |
Total
Units |
Unit
Cost |
Budget
Total
(£)
|
|
Grand
Total
|
Amarin
|
|
Amarin
Contact
|
Charles
River
|
|
Charles
River Contact
|
Amarin
Project Reference:
|
|
MSA
Date:
|
DD
MMM YYYY
|
Work
Order Date:
|
DD
MMM YYYY
|
Date
Change Requested:
|
DD
MMM YYYY
|
Date
to Implement Change:
|
DD
MMM YYYY
|
Original
Contract
Value £
|
|
Change
History
|
Change
Value
|
[insert
details of changes to Project Protocol, budget, timelines, payment
schedule]
|
1.
|
All
raw data, study documentation, protocols, interim and final reports,
specimens generated as a result of a preclinical Study or case histories
generated as a result of a clinical Study that the Sponsor
requests be held in Company’s archive facility or that Applicable Law
requires be held in Company’s archive facility shall
hereinafter be referred to as “Materials”. Company agrees to
comply with industry standards in connection with the storage of the
Materials and adhere to all Applicable Law with respect to the storage of
the Materials.
|
2.
|
Company
shall store the Materials at its current storage rates, which may be
increased on an annual basis. If the Materials require
additional and/or special storage requirements, additional charges for
storage shall be assessed and invoiced to Sponsor. Invoices
shall be due and payable ten (10) days from the date of the invoice and
Sponsor agrees to pay all invoices
submitted.
|
3.
|
Company’s
liability for archival services under this Agreement, regardless of the
form of action, shall not exceed the fee paid for one year’s storage of
the Materials. In no event shall Company be liable for
penalties or liquidated damages or for special, indirect, consequential
punitive, exemplary or incidental damages of any type or kind (including,
without limitation, lost profits) in connection with the storage of the
Materials. Company shall have no liability for loss of
specimens or information beyond its reasonable control, including losses
caused by loss of refrigeration.
|
4.
|
The
Materials shall be archived for the period set forth in the Supporting
Documents (the “Retention Period”). Upon the expiration of the
Retention Period, Company shall contact Sponsor to determine disposition
of the Materials as follows: (a) extended storage of the Materials; (b)
return of the Materials to Sponsor at Sponsor’s expense to be archived in
accordance with Applicable Law or (c) disposal of Materials at Sponsor’s
expense. If Sponsor requests Company to continue to store the
Materials and Company agrees, the cost for storage of the Materials shall
continue to be invoiced to Sponsor at Company’s then current
rates. If Sponsor fails to give such instructions, Company
shall so notify Sponsor, and if such instructions are still not
forthcoming within thirty (30) days of said notification, then Company
shall have the option of (i) continuing storage of the Materials, which
will be deemed to have been authorized for an additional period of not
less than one (1) year, or (b) Company may return the Materials to Sponsor
at Sponsor’s expense or (c) dispose of the Materials at Company’s expense
provided regulatory retention periods have expired. Sponsor
shall be liable for storage charges until the Materials are returned to
Sponsor. At any time while the Materials are in transit to
Sponsor, all risk of loss or exposure to the Materials shall be borne by
Sponsor.
|
5.
|
Company
will not release the Materials to any third party, without Sponsor's
written permission unless such disclosure is compelled by valid subpoena
or Applicable Law. If such disclosure is requested, Company
shall use its commercially reasonable efforts to provide Sponsor with
written notice prior to such release. Prior to release or
inspection of any Materials by Sponsor or its agents, Sponsor shall
provide all reasonable documentation requested by
Company.
|
(1)
|
AMARIN NEUROSCIENCE LTD
of 1st Floor, Magdalen Centre North, The Oxford Science Park Oxford,
OX44GA(“Amarin”)
|
(2)
|
AMARIN PHARMACEUTICALS IRELAND
LIMITED having its principal place of business at First Floor,
Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland (“APIL”)
|
(3)
|
CHARLES RIVER LABORATORIES
PRECLINICAL SERVICES EDINBURGH LIMITED having its principal place
of business at Elphinstone Research Centre, Tranent, Edinburgh, EH33 2NE,
UK (“Charles
River”)
|
A
|
Amarin,
APIL and Charles River are bound by the terms of the Master Services
Agreement dated 25 August 2008 between Amarin and Charles River (the
“Master Services
Agreement”)
|
B
|
The
terms and conditions of the Master Services Agreement govern this Project Work
Order in respect to the following project: [AMR101: 14 Day Dose
Range Finding Toxicity Study in Dogs by Oral Gavage Administration]
(the “Project”),
with the following additional provisions
applying:
|
Schedule
1
|
Project
Protocol
|
Schedule
2
|
Timelines
|
Schedule
3
|
Budget
and Payment Schedule
|
Schedule
4
|
Budget
Breakdown
|
Signed
________________________________
|
Date
___________________________
|
Name ________________________________
|
Position
________________________
|
Signed
________________________________
|
Date
___________________________
|
Name ________________________________
|
Position
________________________
|
Signed
________________________________
|
Date
___________________________
|
Name ________________________________
|
Position
________________________
|
Animal
Arrival (Stock):
|
10
April 2008
|
First
day of dosing (Day 1):
|
16
September 2008
|
Last
day of dosing (Day 14):
|
29
September 2008
|
Terminal
necropsies (Day 15):
|
30
September 2008
|
Completion
of Experimental Work:
|
30
September 2008
|
Non-QA
Draft Report:
|
21
November
|
·
|
All
invoices will be issued in Pound Sterling and are to be paid in Pound
Sterling.
|
·
|
The
total cost far the Services detailed In this Work Order is £26,000 and the
total estimated related expanses have been detailed in Schedule
4.
|
·
|
The
authorised Amarin contact shall be Trevor
Wyeth.
|
·
|
The
authorised Charles River contact for this work shall be Catherine
Nichols.
|
·
|
All
invoices will state the Amarin protocol number, activity performed,
purchase order number (if available), contact name and will be submitted
to the following address:
|
Amarin
Neurosciences Ltd
1st
Floor
Magdalen
Centre North
The
Oxford Science Park
Oxford
OX4
4GA
With
a copy sent to:
Amarain
Pharmaceuticals Ireland Limited
1st
Floor, Block 3
The
Oval
Shelbourne
Road
Ballsbridge
Dublin
4
Ireland
|
Signature
of Contract:
|
30%
of Budget - £7,800
|
Start
of Experimental Work:
|
40%
of Budget - £10,400
|
Completion
of Experimental Work:
|
20%
of Budget - £5,200
|
Unaudited
Drafted Report:
|
10%
of Budget - £2,600
|
Purchase
and Pretrial housing of Animals
|
3,000
|
Study
Management & Reporting
|
12,300
|
Formulation,
including test item receipt
|
1,000
|
Housing,
Dosing and animal room data collection
|
4,000
|
Necropsy
|
1,700
|
Clinical
Pathology
|
4,000
|
Grand
Total
|
26,000
|
(1)
|
Amarin Corporation plc
whose place of business is First Floor, Block 3, the Oval, Shelbourne
Road, Ballsbridge, Dublin 4 (“Amarin”)
|
(2)
|
ICON Clinical Research
Limited whose registered office is at South County Business Park,
Leopardstown, Dublin 18 (“ICON”).
|
(A)
|
Whereas
Amarin is running a project entitled EN101 Phase IIa (the “Project”).
|
(B)
|
Whereas
Amarin requires a consultant with a certain skill set to assist in the
performance of the Project.
|
(C)
|
Whereas
ICON has personnel which have such a skill
set.
|
1.
|
CONSULTANCY
SERVICES
|
1.1
|
ICON
will provide and Amarin accepts Gerardine Doorley, as Project Manager (the
“Consultant”), who will be assigned to the Project, with support provided
as necessary by ICON personnel Josephine Coyle and Aisling Barry (the
“Additional Personnel”). The Consultant will be located either Amarin’s
premises at First Floor, Block 3, the Oval, Shelbourne Road, Ballsbridge,
Dublin 4 or ICON’s premises at South County Business Park, Leopardstown,
Dublin 18 (the “Premises”) as determined
by Amarin from time to time subject to the terms and conditions set out
below.
|
2.
|
DURATION
|
2.1
|
ICON
commenced the provision of the Services (as such term is defined below in
Clause 3.1) on 1st
of August 2008.
|
2.2
|
The
term of this Agreement shall commence on the Effective Date and shall
continue until 31st
of January 2009 unless terminated earlier in accordance with section 7 or
the term may be extended further upon written agreement by both parties
(the “Term”).
|
2.3
|
The
terms of this Agreement shall be deemed to apply to any Services provided
to Amarin prior to the Effective
Date.
|
3.
|
CONSULTANT
SERVICES
|
3.1
|
For
the period of the Term the Consultant is retained by Amarin on a part-time
basis to provide the project management services specified in the Schedule
attached hereto (the “Services”) to Amarin
during normal business hours for up to thirty two hours during each week
of this
|
3.2
|
ICON
agrees that the Consultant shall use her best commercial efforts to ensure
that tasks marked 1 to 3 inclusive in the Schedule (Appendix I) are
completed by the 31st
of August 2008. Provided however neither ICON nor the
Consultant shall be responsible for a failure to meet its obligations or
timelines under this Agreement to the extent caused by the following: (i)
materially inaccurate data; (ii) any failure by Amarin to meet its
obligations stated in this Agreement; (iii) any failure of equipment,
facilities or services not controlled or supplied by ICON; (iv) failure to
timely receive required data, documents, materials or information; or (v)
lack of availability or access to relevant Amarin or other third party
personnel.
|
3.3
|
ICON
shall, and shall procure that the Consultant and the Additional Personnel
shall, perform the Services in good faith, with reasonable care and skill,
in accordance with the terms of this Agreement and all applicable laws
regulations and guidelines, and in accordance with the reasonable
instructions of Amarin.
|
3.4
|
In
the event that the Consultant becomes for any reason unable to perform the
Services for a period in excess of 14 days, ICON will promptly notify
Amarin of that fact, the reason for and the likely duration of such
inability, and if the Consultant is unable for any reason to perform the
Services for a period in excess of 14 days during this Agreement, Amarin
will be entitled to treat this Agreement as frustrated and accordingly
terminated with immediate effect without compensation other than the
payment of Fees and expenses in accordance with the terms of this
Agreement.
|
3.5
|
In
the event that ICON and Amarin agree that the Consultant will require
additional third party resources in order to provide the Services, ICON
shall agree in advance in writing with
Amarin:
|
3.5.1
|
the
nature and identity of the third party resources that are
required;
|
3.5.2
|
the
fees payable to such third party
resources.
|
4.
|
AMARIN’S
OBLIGATIONS
|
4.1
|
Amarin
shall at the start of the Project provide to Consultant, an appropriate
orientation of the Project.
|
4.2
|
Amarin
will assist and support the Consultant to ensure that she obtains all the
necessary information and access to the required
personnel.
|
4.3
|
During
the term of this Agreement, and for one year thereafter, (the “Restricted Period”),
Amarin agrees not to solicit directly or indirectly, the Consultant for
employment with Amarin whether as an employee, independent contractor or
otherwise. If Amarin breaches this provision, it agrees to pay
ICON one year of the Consultant’s salary, to be calculated as the base
salary at the time of the Consultant’s departure from ICON, plus any
bonuses and incentive paid within the 12 months prior to the Consultant’s
termination of employment from ICON, but in no event less than one year’s
salary.
|
5.1
|
ICON
shall, in respect of the services set out in the Schedule be paid the sum
of:
|
–
|
€163
per hour or part thereof for Geraldine Doorley – Clinical Project
Manager
|
–
|
€193
per hour or part thereof for Aisling Barry – Associate Director Clinical
Operations
|
–
|
€240
per hour or part thereof for Josephine Coyle – VP Corporate
QA
|
6.
|
EXPENSES
|
6.1
|
Amarin
shall reimburse ICON/Consultant for all out of pocket expenses reasonably
incurred by her in the proper provision of her services for the Project
hereunder to include but not limited to travel costs, petrol and
subsistence expenses provided that on request the Consultant shall provide
Amarin with such vouchers or other evidence of actual payment of such
expenses as Amarin may reasonably
require.
|
7.
|
TERMINATION
|
7.1
|
Without
limitation either party may by notice in writing immediately terminate
this Agreement if the other party shall be in breach of any of the terms
of this Agreement which, in the case of a breach capable of remedy, shall
not have been remedied by the defaulting party within 21 days of receipt
by the defaulting party of a notice from the other party specifying the
breach and requiring its remedy;
|
7.2
|
Amarin may
by notice in writing immediately terminate this Agreement if the
Consultant shall:
|
7.2.1
|
be
guilty of gross misconduct and/or any serious or persistent negligence in
the provision of her services
hereunder;
|
7.2.2
|
fail
or refuse after written instruction to provide the services reasonably and
properly required of her hereunder;
|
7.2.3
|
conduct
herself in any manner which, in the reasonable opinion of Amarin, brings
or is likely to bring Amarin into disrepute by
association.
|
7.3
|
With
effect from two months after the Effective Date, Amarin may terminate this
Agreement on 30 days notice in writing to
Consultant.
|
8.
|
CONFIDENTIAL
INFORMATION
|
8.1
|
During
the term of this Agreement and for a period of 7 (seven) years thereafter,
each of the parties (each a “Recipient”) undertakes
to maintain as confidential all information, data and materials, and
intellectual property disclosed to it by the other party (the “Disclosing Party”) on
or prior to the date of this Agreement (“Confidential
Information”).
|
8.2
|
“Affiliates” shall mean,
in respect of each party, a corporation or entity controlling, controlled
by, or under the common control with such party. For the purposes of this
Agreement, “control” shall mean the direct or indirect ownership of more
than 50% of the issued voting shares or other voting rights of the subject
entity to elect directors, or if not meeting the preceding criteria, any
entity owned or controlled by or owning or controlling at the maximum
control or ownership right permitted in the country where such entity
exists.
|
8.3
|
Confidential
Information shall not, without the Disclosing Party’s prior written
consent, be used by the Recipient (or permitted by it to be used by any
person) for any purpose other than the proper performance of its
obligations under this Agreement.
|
8.4
|
Each
Recipient shall not, without the Disclosing Party’s prior written consent,
disclose Confidential Information of the Disclosing Party to any other
person, save as may be strictly necessary in order to perform the
Services, and provided that the Recipient first ensures that such third
party is under a duty of confidentiality to the Recipient to protect the
confidentiality of the Confidential Information on no less onerous terms
than as set out in this Clause 8.
|
8.5
|
The
obligations of confidentiality set out in this Clause shall not apply to
any Confidential Information which:
|
8.5.1
|
came
lawfully into the Recipient’s possession prior to the date of
disclosure;
|
8.5.2
|
is
or becomes public knowledge through no fault or omission of the
Recipient;
|
8.5.3
|
is
required to be disclosed by law, 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;
|
8.5.4
|
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;
|
8.5.5
|
is
independently developed by the Recipient without access to the
Confidential Information, as evidenced in writing by the
Recipient.
|
8.6
|
Each
party agrees to maintain as strictly confidential the subject matter of
this Agreement and the fact that the parties have entered into this
Agreement and ICON agrees not to make any public announcement or publish
in any manner whatsoever any information relating thereto, without the
prior written consent of Amarin.
|
8.7
|
Neither
party makes any representation or warranty as to the accuracy or
completeness of its Confidential
Information.
|
8.8
|
Save
for the right to use Confidential Information for the sole purpose of
performing its obligations under this Agreement, each party agrees that
Confidential Information is and shall remain the sole property of the
Disclosing Party and that nothing in this Agreement shall be understood as
granting, expressly or by implication, any rights to the Recipient under
any Confidential Information.
|
8.9
|
Upon
termination or expiration of this Agreement, each party shall promptly
return, or at the other party’s request destroy, all Confidential
Information of such other party.
|
9.
|
OWNERSHIP
OF DATA AND INTELLECTUAL PROPERTY
RIGHTS
|
9.1
|
This
Clause 9 applies to any Data and Intellectual Property conceived,
discovered, developed, made, produced or created as a result of performing
the Services hereunder by ICON, its servants or agents, including without
limitation the Consultant and the Additional
Personnel.
|
9.2
|
ICON
agrees that all data, materials and reports (“Data”) conceived,
discovered, developed, made, produced or created as a result of performing
the Services hereunder and all rights therein shall be solely owned by
Amarin.
|
9.3
|
ICON
agrees that any patent right, invention, registered design, copyright,
database right, design right, trade mark, service mark, application to
register any of the aforementioned rights, trade secret
or
|
9.4
|
ICON
hereby assigns to Amarin by way of future assignment of copyright the
copyright subsisting in the copyright works and in the documents generated
by the Consultant during the course of, or otherwise related to, the
provision of the Services.
|
9.5
|
The
Consultant agrees to promptly disclose to Amarin any Data and Intellectual
Property conceived, developed, produced, or created as a result of
performing the Services hereunder and to provide copies of all documents
relating to same to Amarin at its request at any time whether during or
after expiry or the termination for any reason of this
Agreement.
|
9.6
|
Notwithstanding
the foregoing, any Intellectual Property and Data which have been
independently developed or improved during the term of this Agreement by
ICON or the Consultant without use of the Amarin Confidential Information
and which relate solely to ICON’s business or operations shall remain the
sole and exclusive property of ICON and Amarin shall hold same
in strictest confidence.
|
10
|
REPRESENTATIONS,
WARRANTIES AND INDEMNIFICATION
|
10.1
|
ICON
represents and warrants to Amarin
that:
|
10.1.1
|
the
performance of ICON’S obligations hereunder are not inconsistent with
and/or will not breach any third party obligations whether express or
implied;
|
10.1.2
|
the
Consultant and the Additional Personnel are sufficiently competent and has
appropriate professional skills and qualifications in order to perform the
Services; and
|
10.1.3
|
ICON
has agreements in place with all servants and agents, including without
limitation the Consultant and the Additional Personnel, that impose
confidentiality obligations on such servants and agents, effectively vest
in ICON any rights such servants and agents might otherwise have in any
Intellectual Property, permit ICON to assign all such rights to Amarin,
and otherwise enable ICON to comply with the terms of this
Agreement.
|
10.2
|
As
the Consultant will be the responsibility of and under the direct control
and supervision of Amarin during the Term, Amarin hereby agrees
to defend, indemnify, and hold harmless ICON and its respective employees
and agents (collectively referred to as “ICON Indemnitees”) against and
from any claims, proceedings, or actions brought by
Consultant or third parties against an ICON Indemnitee arising out
of the performance of the Services pursuant to this Agreement (in
particular but
|
10.2.1
|
the
negligence or wilful misconduct of Consultant, the Additional Personnel or
ICON in the performance of its obligations under this Agreement;
or
|
10.2.2
|
any
breach of any representation, warranty, obligation or covenant of ICON
under this Agreement.
|
10.3
|
ICON
shall indemnify Amarin and its respective employees and agents
(collectively referred to as “Amarin Indemnitees”) against and from any
Claims brought against an Amarin Indemnitee, to the extent that any such
claim, proceeding or action arises
from:
|
10.3.1
|
the
negligence or wilful misconduct of Consultant, the Additional Personnel or
ICON in the performance of their obligations under this Agreement;
or
|
10.3.2
|
any
breach of any representation, warranty, obligation or covenant of ICON
under this Agreement
|
10.4
|
The
party seeking an indemnity shall:
|
10.4.1
|
fully
and promptly notify the other party of any claim or proceedings, or
threatened claim or proceedings;
|
10.4.2
|
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;
|
10.4.3
|
co-operate
in the investigation and defence of such claim or proceedings;
and
|
10.4.4
|
take
all reasonable steps to mitigate any loss or liability in respect of any
such claim or proceedings.
|
|
10.5
|
The
parties shall at their own expense obtain and maintain insurance of a type
and amount adequate to cover all loss, damage, liability or costs in
respect of which they are liable to indemnify the other under the
provisions of this Agreement and shall not do or omit any act, matter or
thing which may prejudice or render voidable any such
insurance. Each party will, upon the request of the other,
provide such other party with evidence of the insurance as such other
party may reasonably require
|
11.1
|
ICON
accepts no responsibility for any supplies and/or equipment supplied by
Amarin to the Consultant for use during the work covered by this
Agreement, provided that such supplies and/or equipment, is not damaged by
the negligence or wilful misconduct of
Consultant.
|
11.2
|
Neither
party shall be liable to the other for loss, damage, or liability in
respect of loss of profits, business or revenue loss, special, indirect or
consequential loss (even if foreseeable or in the contemplation of either
party).
|
12
|
NOTICE
|
12.1
|
Any
notice required by this Agreement to be given by either party to the other
shall be in writing and shall be served by sending the same by electronic
mail, registered post or recorded delivery to the last known address of
the other party and any receipt issued by the postal authorities shall be
conclusive evidence of the fact and date of posting of any such
notice.
|
13
|
ENTIRE
AGREEMENT
|
13.1
|
This
Agreement sets out the entire agreement of the parties and supersedes all
prior agreements and understandings relating to its subject
matter.
|
14.1
|
This
Agreement shall be construed by and enforced in accordance with the laws
of the Republic of Ireland and shall be subject to the exclusive
jurisdiction of the Irish courts.
|
15.
|
INDEPENDENT
CONTRACTOR
|
|
15.1
|
In
the performances of all services here under, ICON, Consultant and
Additional Personnel shall be deemed independent contractors as such and
the parties agree that Consultant and Additional
Personnel are not, and will not become, employees of Amarin and
shall not be entitled to any benefits applicable to an employee of
Amarin.
|
15.2
|
Neither
party is authorized or empowered to act as an agent for the
other for any purpose and shall not on behalf of the other enter into any
contract, warranty or representation as to any matter. Neither
party shall be bound by the acts or conduct of the
other.
|
15.3
|
The
Parties agree that ICON shall be responsible for all payments to the
Consultant and the Additional Personnel for their services to ICON for the
purposes of this Agreement.
|
15.4
|
ICON
shall be solely responsible for paying when due all income tax, pay
related social insurance, or similar contributions in respect of any
payments to the Consultant and the Additional Personnel arising in
connection with the provision of the Services hereunder, or otherwise
under this Agreement.
|
15.5
|
Should
Amarin be required to pay any such tax or payment, ICON shall indemnify
Amarin against (and promptly reimburse it for) such tax or payments,
including any interest and penalties with respect
thereto. Should it be determined that any payment hereunder is
subject to withholding of tax under applicable law, all payments to be
made hereunder shall be net of applicable income, employment, social
security or other taxes required to be withheld
therefrom.
|
15.6
|
The
indemnity contained in this clause 15 shall remain in full force and
effect notwithstanding termination of this Agreement by either party in
any manner whatsoever.
|
15.
|
SEVERABILITY
|
|
15.1
|
The
invalidity or unenforceability of any term or provision of this Agreement
shall not affect the validity or enforceability of any other term or
provision hereof.
|
|
16.1
|
No
waiver of any term, provision or condition of this Agreement whether by
conduct or otherwise in any one or more instances shall be deemed to be or
construed as a further or continuing waiver of any such term, provision or
condition, or of any other term, provision or condition of this
Agreement.
|
17.
|
FORCE
MAJEURE
|
|
17.1
|
Neither
ICON nor Amarin shall be liable for any failure to perform as required by
this Agreement, to the extent that such failure to perform is caused due
to circumstances reasonably beyond either party's control, such as labour
disturbances or disputes of any kind, accidents, failure of any
governmental approval required for full performance, civil disorders or
commotions, acts of aggression, acts of God, energy or other conservation
measure, explosions, failure of utilities, mechanical breakdowns, material
shortages, disease, or other such
occurrence.
|
|
18.1
|
No
variation to the terms of this Agreement shall be effective unless in
writing and signed on behalf of each party by an authorised
person.
|
18.2
|
ICON
may not assign, transfer or sub-contract all or any of its rights and
obligations under this
Agreement.
|
18.3
|
The
Schedules to this Agreement form part of, and shall be deemed to be
incorporated into, this Agreement.
|
18.4
|
At
the request of either party, the other party shall (and shall use
reasonable efforts to procure that any other necessary third parties
shall) execute and do all such documents, acts and things as may
reasonably be required subsequent to the signing of this Agreement for
assuring to or vesting in the requesting party the full benefit of the
terms hereof.
|
18.5
|
The
provisions of Clauses 4.3, 8, 9, 10, 11, 14, 15, 18.4 and 18.5 shall
survive the termination for any reason of this
Agreement.
|
AMARIN
CORPORATION PLC
|
ICON
CLINICAL RESEARCH LIMITED
|
|
Signed______________________
|
Signed______________________
|
|
Title________________________
|
Title________________________
|
|
Date________________________
|
Date________________________
|
|
APPENDIX
I
|
|
SCHEDULE
OF SERVICES
|
|
TASKS
|
1.
|
Oversee
the completion of study data analysis being managed by
Quanticate,
|
a.
|
including
working with appropriate Amarin personnel to agree on the ‘per protocol’
group and ‘intent to treat group’ from which the analysis can be
run
|
b.
|
ensure
any data queries raised by Quanticate are addressed as quickly as
possible, in conjunction with Ester
personnel
|
2.
|
Understand
the extent to which plasma samples were taken (facilitating measurement of
AChE-R) from patients and overseeing the process to have the data
analyzed, where possible.
|
3.
|
Oversee
the process of addressing the issues raised by the Adamas audit on the
study, in conjunction with Ester
personnel.
|
4.
|
Oversee
the completion of a top line EN101 Phase IIa study
report.
|
5.
|
Oversee
the process of handling further correspondence with the MHRA, following
the notification of breach.
|
6.
|
Oversee
the completion and interpretation of any other audits being conducted
(IMP, site visits).
|
7.
|
Resolving
need for reporting breach to authorities in Israel and Serbia and managing
that process.
|
8.
|
Other
tasks as the parties may agree in
writing
|
1
|
DEFINITIONS
|
2
|
2
|
DUTIES
|
3
|
3
|
ORDER, ACCEPTANCE AND
DELIVERY
|
4
|
4
|
ROLLING FORECAST
|
5
|
5
|
PRICE AND MILESTONE
PAYMENTS
|
6
|
6
|
WORKING GROUP
|
7
|
7
|
TECHNICAL AGREEMENT
|
7
|
8
|
LONG-TERM SUPPLY AGREEMENT
|
7
|
9
|
TECHNOLOGY TRANSFER
|
7
|
10
|
WARRANTIES
|
8
|
11
|
SHIPPING TERM / TITLE AND
RISK
|
9
|
12
|
CONFIDENTIAL INFORMATION
|
9
|
13
|
FORCE MAJEURE
|
11
|
14
|
TERM
|
11
|
15
|
TERMINATION
|
11
|
16
|
CONSEQUENCES OF TERMINATION
|
12
|
17
|
ASSIGNMENT
|
12
|
18
|
MISCELLANEOUS
|
12
|
1
|
DEFINITIONS
|
1.1
|
In
this Agreement the following definitions shall apply, unless the context
requires otherwise:
|
2
|
DUTIES
|
2.1
|
During
the term of this Agreement, Nisshin shall manufacture at its manufacturing
plant, and supply to Amarin its requirements of the Products pursuant to
the terms and conditions of this
Agreement.
|
2.2
|
Nisshin
shall not knowingly export, sell or distribute the Products to any company
who sell or distribute E-EPA in the
Territory.
|
2.3
|
This
Agreement does not impose any restriction of any nature on Amarin
obtaining a supply of E-EPA from suppliers other than Nisshin or from
itself manufacturing E-EPA.
|
2.4
|
Nisshin
shall ensure that the Products meet the
Specifications.
|
2.5
|
Amarin
shall purchase the Minimum Purchase Requirements of the Products from
Nisshin as specified in Schedule
One.
|
2.6
|
Amarin
shall make sure that all payments for these purchases are made without
delay.
|
2.7
|
Nisshin
shall provide reasonable assistance to Amarin for the purpose of Amarin's
import clearances in respect of the
Products.
|
2.8
|
Regulatory
|
2.8.1
|
Save
as otherwise agreed in writing with Amarin, Nisshin shall maintain the US
DMF and the EU DMF currently in
place.
|
2.8.2
|
Each
party shall promptly notify the other party of any notification received
from a regulatory agency, such as a relevant government health authority,
to conduct an inspection of the manufacturing site(s) or other facilities
used by Nisshin in the development, manufacturing, packaging, storage or
handling of the Product. Copies of all applicable
correspondence with the regulatory agency will be provided to the other
party.
|
2.8.3
|
Nisshin
shall make that portion of its facility where the Products are
manufactured, tested or stored, including related record and reference
samples, available for:
|
2.8.4
|
Following
full consultation with Amarin, Nisshin will be responsible for responding
to any notifications or inspections concerning the supply of the Product
by the FDA or EMEA.
|
3
|
ORDER,
ACCEPTANCE AND DELIVERY
|
3.1
|
Amarin
may, at any time, but no later than ninety (90) days before the specified
date of shipment of the Products, issue to Nisshin individual purchase
orders ("Order") for the Products to be delivered to
Amarin. Each Order, upon acceptance by Nishhin, shall
constitute a definitive individual contract for the sale and delivery of
Products. Nisshin shall issue an acceptance or rejection of the Order
within two (2) weeks from Nisshin’s receipt of the
Order.
|
3.2
|
Nisshin
and Amarin shall perform its respective obligations under the individual
contracts.
|
3.3
|
Amarin
shall inspect the Products within fifteen (15) days of receipt of the
Product and may reject any Products that fail to meet the Specifications,
have defects or are damaged in any way. Any Product not
rejected within fifteen (15) days shall be deemed to have been accepted by
Amarin ("Acceptance"). For the avoidance of doubt, Nisshin
shall also be responsible for latent defects in the Products which become
apparent after Acceptance, provided that such defect shall be notified to
Nisshin in writing without delay and not later than three (3) months from
the receipt of the Products by
Amarin.
|
3.4
|
Notwithstanding
the provisions of the above Clause, Amarin may, at its own discretion,
have a third party conduct the inspection of the Product. Under such
circumstances, Amarin will have thirty (30) days from receipt of the
Product to reject any Products that fail to meet the Specifications, have
defects or are damaged in any way.
|
3.5
|
Claims
for latent defects, not discovered during the aforementioned inspections
protocols in Clauses 3.3 and 3.4, shall be made in writing within 3 days
of discovery. Failure to make a timely claim in the aforementioned manner
shall constitute and shall be deemed to be Acceptance of the delivery by
Amarin and a waiver of right to claim by
Amarin.
|
4
|
ROLLING
FORECAST
|
4.1
|
Prior
to the first Marketing Approval, but not later than thirty (30) days
following the Commencement Date, Amarin shall provide Nisshin with a
twelve (12) month demand forecast. Thereafter, until Amarin’s submission
of a regulatory filing for Marketing Approval, Amarin shall provide
Nishhin with twelve (12) month demand forecasts on an annual
basis.
|
4.2
|
Within
two hundred and ten (210) days following Amarin's submission of a
regulatory filing for Marketing Approval in the US or EU, Amarin shall
provide Nisshin with a binding order for its launch stocks
requirements. Thereafter, Amarin shall, on a monthly basis,
provide Nisshin with a written rolling forecast for the following 12-month
period.
|
4.3
|
The
forecast amount for the first three months of the rolling forecast
stipulated in the Clause immediately above shall constitute binding
orders. The forecast amounts for the remaining nine months of
such rolling forecast, i.e., months 4-12, shall be non-fixed forecast
amounts. Amarin has the right to vary the forecast amounts for
months 4, 5 and 6 by +/-25%. Amarin may vary the forecast
amounts for months 7-12 without limitation. Nisshin shall not be obligated
to supply Products in excess of the binding forecast amounts contained in
the rolling forecasts.
|
5
|
PRICE
AND MILESTONE PAYMENTS
|
5.1
|
The
Price and Milestone Payments shall be as set forth in Schedule
One.
|
5.2
|
Nisshin
shall issue the invoice for the Product supplied in each shipment to
Amarin within 10 days from the date of each shipment. Amarin
shall pay the invoice amount for the Products delivered to it in
accordance with this Agreement into an account designated by Nisshin
within 30 days from the date of the corresponding invoice
issued
|
5.3
|
In
the event Amarin fails to pay the Price of any of its purchases by the due
date provided in Clause 5.2 above, Nisshin is entitled, at its own
discretion, to suspend dispatching the Products or to withhold from
accepting Amarin’s Order until Amarin makes full payment with interest
from the due date to the date of payment calculated using an annual
interest rate of 6% per annum.
|
5.4
|
Amarin
shall reimburse Nisshin's reasonable costs for preparing and maintaining
the DMF prior to Amarin's receipt of each relevant Marketing Approval in
both US and EU.
|
5.5
|
Amarin
will reimburse to Nisshin all reasonable costs specifically related to
preparing for an inspection of any facility by a regulatory authority and
audit of any facility by any consultant with regard to cGMP, including but
not limited to interpreter’s fees for the inspection and
audit.
|
6
|
WORKING
GROUP
|
6.1
|
The
Parties shall form a joint working group (the "Working Group") to address
issues related to their future relationship for long term supply after
April 2012, including: (a) Long-Term Supply Agreement; (b) pricing; (c)
supply chain structure; (d) capacity expansion; (e) investment
requirements; (f) third party agreements (g) technology transfer; and (h)
the possible formation of a new business entity to supply Product to
Amarin. As more fully described in Clause 8, the Working Group
will make all reasonable efforts to review and discuss feasibility of such
long term supply relationship between the Parties by addressing the issues
outlined above by June 30, 2010 whether or not it is feasible for the
Parties to agree a long-term plan for supplying the
Product.
|
6.2
|
The
Working Group shall consist of the appropriate representatives from each
party having requisite authority to speak on behalf of each respective
company, provided, however, that the Working Group is not responsible nor
is it entrusted to establish business policy or to make decisions on
behalf of either Party. The number of representatives can be expanded with
the mutual agreement of both Parties. Each Party bears its own costs in
acting as part of the Working
Group.
|
6.3
|
The
Working Group shall meet in person as soon as practicable after the
Commencement Date and on a regular basis thereafter. The
Working Group shall hold discussions via meetings, teleconferences and
e-mail as appropriate and necessary to discuss in good faith the issues
set forth in Clause 6.1 of this Agreement. In the first
meeting, the Working Group will set the specific agenda and timing/venue
for the second meeting. The second meeting will set the specific agenda
and timing/venue for the third meeting, and so forth, provided, however,
that any meeting can be re-scheduled flexibly taking into account either
Party’s situation.
|
6.4
|
The
Working Group shall have no power or authority to enter into any binding
agreements on behalf of either
Party.
|
7
|
TECHNICAL
AGREEMENT
|
7.1
|
After
the Commencement Date, the Parties will initiate the negotiation for the
Technical Agreement, which is necessary for any review by any regulatory
authority in advance of
|
8
|
LONG-TERM
SUPPLY AGREEMENT
|
8.1
|
Pursuant
to Clause 6.1, the Parties shall conclude discussions no later than June
30, 2010 with regard to the Long-Term Supply Agreement for the supply of
the Products by Nisshin to Amarin. If the Parties agree to the
future supply scheme, the Parties will in good faith negotiate for the
terms of the Long-Term Supply Agreement. The Long-Term Supply
Agreement will determine how the Products are supplied after April 1,
2012.
|
9
|
TECHNOLOGY
TRANSFER
|
9.1
|
If
this Agreement has not been terminated by Nisshin
in accordance with Clause 15.1 of this Agreement (where Amarin has
committed a material breach of the terms of this Agreement and has failed
to remedy such breach within 60 days of receiving the relevant written
notice from Nisshin pursuant to Clause 15.1), or in accordance with
Clause 15.2 of this Agreement, in the event that the Long-Term Supply
Agreement is not executed by the Parties on or before December 31, 2010,
Nisshin will transfer the technology necessary and performed at Nisshin’s
current site to manufacture the Products upon the request of Amarin, to
Amarin or an entity established or designated by Amarin (which will
include transferring the DMF).
|
9.2
|
Nisshin
shall also be obliged to transfer the technology stipulated in Clause 9.1
upon the request of Amarin, to Amarin or to an entity established or
designated by Amarin if Amarin gives Nisshin notice of termination of the
Agreement under Clause 15.1 or 15.2, or if Nisshin gives Amarin notice of
termination of the Agreement under Clause 15.4.
|
9.3
|
Amarin
will be responsible for any and all costs associated with the
aforementioned transfer of technology. The other terms and
conditions of the transfer of technology will be discussed
separately. When the transfer of technology process is being
conducted, except for where the transfer of technology is triggered by
Nisshin giving Amarin notice of termination of the Agreement under Clause
15.4, Nisshin will work with Amarin to use best efforts to try to ensure
that there is no interruption in the supply of the Products to Amarin. If
the transfer of technology would not be completed during the term of this
Agreement, the Parties will consult each other in
good faith on
how to deal with the case,
including an
extension of this Agreement for a period of time which
the
Parties consider necessary to complete the transfer of
technology.
|
9.4
|
Amarin
agrees and confirms that the technology transfer provided in this Clause 9
will be Nisshin’s sole obligation in case the Long-Term Supply Agreement
is not executed on or before December 31,
2010.
|
10
|
WARRANTIES
|
10.1
|
Nisshin
hereby warrants that any Products manufactured pursuant to this Agreement
shall comply with the Specifications and all requirements of
cGMP.
|
10.2
|
Amarin
and Nisshin hereby represent and warrant to each other, as of the date of
this Agreement, as follows:
|
10.2.1
|
Each
Party has the right to enter into this
Agreement.
|
10.2.2
|
There
are no agreements between either Amarin or Nisshin and any third party
that conflict with this Agreement in the
Territory.
|
10.3
|
Nisshin
does not make and hereby disclaims any warranty with respect to the
Products other than the warranty set forth in Clauses 10.1 and 10.2,
whether expressed or implied.
|
10.4
|
Each
Party shall promptly notify the other Party of any breach of warranties
set forth in Clauses 10.1 to 10. 2.
|
10.5
|
If
any Products are not manufactured in accordance with the Specifications,
Nisshin at its sole option shall:
|
10.5.1
|
at
Nisshin’s cost, supply replacement of the Products conforming with Clause
10.1; or
|
10.5.2
|
refund
the Price or any part of the Price corresponding to the Products that does
not meet Specifications.
|
11
|
SHIPPING
TERM / TITLE AND RISK
|
11.1
|
Nisshin
shall ship the Products FOB Tokyo, as defined in Incoterms
2000.
|
11.2
|
Title
to the Products shall pass from Nisshin to Amarin upon the delivery of the
Products to the Destination in accordance with the
Order.
|
11.3
|
Nisshin
will be responsible for organizing the transport by air and insurance
arrangements for the delivery of the Products from the site of manufacture
to the Destination. Amarin will reimburse Nisshin for the costs of the
transport and insurance arrangements for the said delivery of the Products
from the site of manufacture to the
Destination.
|
12
|
CONFIDENTIAL
INFORMATION
|
12.1
|
The
Parties shall keep Confidential Information strictly confidential, shall
not disclose it to any third party other than Bizen Chemical Ltd., and
Nisshin Seifun Group Inc., the current parent company of Nisshin. Save as
otherwise specifically provided herein, the Parties shall only disclose
Confidential Information to those of its employees, representatives and
agents requiring knowledge thereof in connection with fulfilling that
Party's obligations under this
Agreement.
|
12.2
|
The
Parties further agree to inform all such employees, representatives and
agents of confidential nature of the Confidential Information and their
duties hereunder and make reasonable measures to make employees,
representatives and agent comply with the duties
hereunder.
|
12.3
|
Notwithstanding
the provisions of this Clause 12, if one of the Parties
(“Disclosing
|
12.4
|
The
Parties shall use the Confidential Information exclusively for performance
of this Agreement and for no other
purpose.
|
12.5
|
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.
|
12.6
|
The
Parties agree that the obligations of this Clause 12 are necessary and
reasonable in order to protect the Parties' respective
businesses.
|
12.7
|
The
Parties agree that any such violation or threatened violation may cause
irreparable injury to a Party and that, in addition to any other remedies
that may be available, each Party shall be entitled to seek injunctive
relief against the threatened breach of the provisions of this Clause 12,
or a continuation of any such breach by the other Party, specific
performance and other such relief to redress such breach together with
damages and reasonable counsel fees and expenses to enforce its rights
hereunder.
|
12.8
|
Subject
to Clause 12.3, no announcement or public statement concerning the
existence, subject matter or any term of this Agreement shall be made by
or on behalf of any Party without the prior written approval of the other
Party.
|
12.9
|
Amarin
shall obtain Nisshin’s prior written consent if Amarin needs to disclose
this Agreement to a potential third party purchaser or commercialisation
partner or current or future Amarin investor (collectively “Potential
Partner”), provided that the relevant third party has entered into a
confidentiality agreement on terms no less protective than the terms of
this Clause 12. When Amarin wishes to obtain such Nisshin’s consent,
Amarin will provide advance written notification to Nisshin of identity of
such third party with the relevant information of the third party. Nisshin
will make response to the notification as soon as practicable.
If Nisshin decides not to agree to provide its consent, Nisshin
will provide Amarin with a written reason why such consent was
withheld.
Notwithstanding the foregoing, Nisshin will not withhold, condition or
delay its consent hereunder if the Potential Partner’s primary line of
business is in the area of pharmaceuticals or
biotechnology.
|
12.10
|
Amarin
shall indemnify Nisshin against any claims, costs (including legal costs,
expenses), liabilities, losses (including loss of profit), damages or
expenses arising out of, or in connection with the disclosure of this
Agreement pursuant to Clause 12.9.
|
13
|
FORCE
MAJEURE
|
13.1
|
If
either Party is prevented or delayed in the performance of any of its
obligations under this Agreement as a result of acts of God, war, fire,
earthquake, or other natural disaster beyond the reasonable control of a
Party that has not occurred as a result of its act, omission or negligence
and which was not reasonably foreseeable ("Force Majeure Event"), it shall
notify the other Party, in writing, of the same as soon as
practicable. The affected Party shall use its reasonable
endeavours to remove or overcome such Force Majeure Event as quickly as
possible and shall also use its reasonable endeavours to mitigate the
impact of such Force Majeure Event of the other Party. Subject
to Clause 13.3, if a Party shall have fully complied with its obligations
under this Clause 13.1, it shall be excused from performance of its
unfulfilled obligations under this Agreement from the date of such notice
until such Force Majeure Event no longer
pertains.
|
13.2
|
A
Force Majeure Event will include any issue either Party has with its
subcontractors or suppliers of raw materials, intermediates and packaging
components, which were caused by one of the Force Majeure Events described
in Clause 13.1.
|
13.3
|
If
a Force Majeure Event prevents the performance by a Party of any
obligations hereunder for a continuous period in excess of 12 weeks, the
other Party shall be entitled to terminate this Agreement by written
notice at any time after such 12 week period provided the relevant Force
Majeure Event is continuing at the time such notice is
given.
|
14
|
TERM
|
14.1
|
This
Agreement shall be effective from the Commencement Date until March 31,
2012.
|
15
|
TERMINATION
|
15.1
|
This
Agreement may be terminated by either Party by giving to the other Party a
notice in writing if the other Party commits a material breach of the
terms of this Agreement and (where such breach is capable of remedy) fails
to remedy such breach within 60 days of receiving a written notice from
the terminating Party specifying the breach and requiring its
remedy.
|
15.2
|
This
Agreement may be terminated by either Party immediately by giving a
written notice to the other, if:
|
15.2.1
|
a
petition is filed by or against the other Party for commencement of
bankruptcy proceeding (hasan-tetsuzuki-kaishi), commencement of corporate
reorganization proceeding (kaishakousei-tetsuzuki-kaishi), commencement of
civil rehabilitation proceeding
(minjisaisei-tetsuzuki-kaishi), or any other insolvency
proceeding;
|
15.2.2
|
the
other Party is subject to seizure (sashiosae), sequestration
(kari-sashiosae), preservative attachment (hozen-sashiosae), commencement
of public auction (keibai),
or other compulsory execution (kyousei-shikkou) or foreclosure
(tanpoken-jikkou) proceeding against material assets of the other
Party;
|
15.2.3
|
the
other Party is unable to pay its debts in the normal course of business;
or
|
15.2.4
|
there
is a Change of Control of the other
Party.
|
15.3
|
Notwithstanding
the provisions of Clause 15.1, this Agreement may be terminated by Nisshin
by giving Amarin 30 days notice in writing, if Amarin fails to perform its
duty as set forth in Clause 2.5, unless, within such 30 days, Amarin pays
to Nisshin the amount corresponding to the unfulfilled purchases according
to the minimum purchase quantities at the Price stated in Schedule
One.
|
15.4
|
This
Agreement may be terminated by Nisshin by giving Amarin notice in writing
without Nisshin incurring any liability or obligation whatsoever (except
the obligations under Clause 9), if Nisshin is unable to continue
manufacturing and supplying the Products to Amarin in accordance with its
requirement due to disruption of supplies of raw materials or
intermediates, which disruption cannot be recovered within reasonable
time, provided that Nisshin shall without delay inform Amarin of
occurrence of such event in order to give Amarin an opportunity to seek
alternative sources.
|
16
|
CONSEQUENCES
OF TERMINATION
|
16.1
|
In
the event that this Agreement is terminated, neither Party shall be
entitled to compensation of damages for lost profits arising out of the
termination of this Agreement.
|
16.2
|
Notwithstanding
any provisions herein to the contrary, in the event that this Agreement is
terminated for any reason, Amarin shall purchase and take delivery of all
the Products manufactured by Nisshin according to Orders placed by Amarin
at the Price stipulated herein, and shall purchase, at cost, all stocks of
the Products either manufactured or in the process of being manufactured
for Amarin, including unused intermediates that Nisshin
stores.
|
17
|
ASSIGNMENT
|
17.1.
|
either
Party may assign this Agreement, in whole or in part, to an affiliate of
the assigning Party; provided, that the assigning Party guarantees the
performance of such affiliate hereunder;
and
|
17.2
|
Amarin
may assign this Agreement, in whole, to the Potential Partner disclosed
under
this Agreement pursuant to Clause 12.9 who acquires, by merger,
sale of assets or otherwise, all or substantially all of the business of
the assigning Party in which the subject matter of this Agreement is
included.
|
18
|
MISCELLANEOUS
|
18.1
|
All
notices, consents, approvals or other communications hereunder shall be in
writing
|
18.2
|
Nothing
in this Agreement shall constitute or be deemed to constitute the creation
of a partnership, agency, or employer/employee relationship between the
parties.
|
18.3
|
This
Agreement, together with the Specifications and the Schedules attached
hereto, constitutes the entire agreement and understanding of the parties
and supersedes any previous agreement between Nisshin and Amarin in
relation to the subject matter of this Agreement. This Agreement,
the Specification, and the Schedules attached hereto or any order may only
be modified only by a written document signed on behalf of each of the
parties. If there are any inconsistencies between the terms and
conditions of this Agreement and the terms and conditions set forth in any
quotation, order, acknowledgement or invoice, the terms and conditions of
this Agreement shall prevail.
|
18.4
|
If
any provision of this Agreement is held by any court or other competent
authority to be invalid or unenforceable in whole or in part, it shall be
deemed severed from this Agreement and the validity of the other
provisions and the remainder of the provision in question shall not be
affected.
|
18.5
|
This
Agreement shall be governed by and construed in accordance with the laws
of Japan.
|
18.6
|
The
parties hereto shall submit to the exclusive jurisdiction of the Tokyo
District Court of Japan with respect to any dispute arising from this
Agreement.
|
NISSHIN
PHARMA, INC.
|
By:
____________________________________ Date: ,
2009
|
Name:
Toshinori Shiragami
|
Title: President
|
AMARIN
PHARMACEUTICALS IRELAND LTD.
|
By:
____________________________________ Date: ,
2009
|
Name:
Alan Cooke
|
Title: Director
|
[***********] for the
part after the first five (5) metric tons,
|
||
but
not excess eight (8) metric tons, and
|
||
[***********] for the
part after the eight (8) metric tons,
|
||
but
not excess twelve (12) metric
tons.
|
a)
|
2008-2009
|
1.62
metric tons
|
|
b)
|
2009-2010
|
1.08
metric tons
|
|
c)
|
2010-2011
|
3.24
metric tons
|
|
d)
|
2011-2012
|
3.24
metric tons
|
Shareholder
|
Shares
|
Basic %
|
Sofinnova Venture Partners VII, LP
|
3,586,957
|
13.26%
|
Orbimed Advisors LLC
|
3,260,870
|
12.06%
|
Thomas, McNerney & Partners
LLC
|
2,173,913
|
8.04%
|
Panorama Capital LP
|
1,847,826
|
6.83%
|
Sunninghill Limited
|
1,465,755
|
5.42%
|
Simon Kukes
|
1,277,695
|
4.72%
|
Longitude Venture Partners,
LP
|
1,086,957
|
4.02%
|
Amarin Investment Holding
Limited
|
1,072,906
|
3.97%
|
Fountain Healthcare Partners
Fund
|
217,391
|
0.80%
|
Michael Walsh
|
74,828
|
0.28%
|
Total
|
16,065,098
|
59.40%
|
1
|
Initial
Trial A Services
|
1.1
|
Medpace
shall perform the Initial Trial A Services in compliance with all
applicable laws regulations and guidelines, including without limitation
the Federal Food, Drug and Cosmetic Act and the regulations promulgated
pursuant thereto, cGCP, and all future amendments thereto, and all other
applicable laws, regulations and guidelines in all relevant jurisdictions
the timelines and specific roles and responsibilities of Medpace and
SPONSOR as set out in Schedule A, and the relevant standard operating
procedures of Medpace
|
1.2
|
Upon
signature of this Letter Agreement, Medpace shall provide’ SPONSOR with
copies of the standard operating procedures, of Medpace relevant to the
performance of the Initial Trial A Services as listed in Schedule
B.
|
1.3
|
“cGCP”
shall mean the ICH Harmonized Tripartite Guideline for Good Clinical
Practice and any subsequent versions thereof, together with such other
good clinical practice requirements as are specified in the Federal Food,
Drug and Cosmetic Act, 21 U.S.C., applicable sections of Title 21 Code, of
Federal Regulations, and any subsequent versions
thereof.
|
2
|
Confidentiality
|
2.1
|
The
terms and conditions of the confidentiality agreement between Medpace and
Amarin Corporation plc (an Affiliate of SPONSOR and APIL (as such term is
defined in Paragraph 8.2 below))
|
3
|
Rights
in Property and Patent Rights
|
3.1
|
All
materials documents, data, software and information of every kind and
description and all electronic data files containing all such materials,
documents, data, software and
information:
|
3.1.1
|
supplied
to Medpace by SPONSOR or any of its Affiliates;
or
|
3.1.2
|
prepared,
developed, generated, derived or otherwise created by Medpace pursuant to
this Letter Agreement, (except for the Medpace IP (as such term is defined
below))
|
3.2
|
SPONSOR
and its Affiliates shall have the right to make whatever use they deem
desirable of any Study Results. Medpace shall, not, without the
prior written consent of SPONSOR, publish, disseminate, or otherwise
disclose to any third party any Study Results (except such disclosure as
may be required by law, and in such case only to the extent required by
law), or use any such Study Results for any purpose other than the
performance of this Letter
Agreement.
|
3.3
|
Any
inventions or other intellectual property, including without limitation
protectable copyrights and trademarks, that may evolve from, the Study
Results or as the result of Initial Trial A Services performed by Medpace,
under this Letter Agreement shall belong exclusively to SPONSOR, and
Medpace agrees to assign all its rights in all such inventions and/or
other intellectual property to SPONSOR consistent with the obligations set
forth in Paragraph 3.6 below.
|
3.4
|
SPONSOR
acknowledges that all computer programs, software, applications, databases
(excluding for the avoidance of doubt all electronic files containing all
Study Results), proposals and other documentation generally used by
Medpace that:
|
3.4.1
|
have
been independently developed without the benefit of any information
provided by SPONSOR (including without limitation any SPONSOR data,
information, materials or Confidential Information of SPONSOR (or
derivatives thereof)); and
|
3.4.2
|
have
not been developed solely for
SPONSOR,
|
3.5
|
Medpace
shall disclose promptly to sponsor any and all inventions, discoveries,
know-how and improvements conceived or made by Medpace while providing
Initial Trial A Services to
|
3.6
|
Subject
to Paragraph 3.4, all Study IP shall belong exclusively to SPONSOR, and
Medpace agrees to assign all its interest therein to SPONSOR or its
nominee whenever requested to do so by SPONSOR. Medpace shall
execute any and all applications, assignments, or other instruments and
give testimony which SPONSOR shall deem necessary to apply for and obtain
a patent in the United States of America and/or other applicable
jurisdiction or of any foreign country or to protect otherwise SPONSOR’s
interests and shall compensate Medpace on a reasonable basis for the time
devoted to said activities and reimburse it for reasonable out-of-pocket
expenses incurred.
|
4
|
Payments
|
4.1
|
All
payments will be payable to Medpace Inc. (Tax ID No. 75-3033627) and
sent to:
|
4.2
|
Payments
will be made by SPONSOR on the following
basis:
|
4.2.1
|
SPONSOR
shall pay Medpace fees for the provision of the Initial Trial A Services
(the “Initial Trial a Services Fees”) up to a maximum of US$1,413,974●
(the “Total Initial Trial A Services
Fees”).
|
4.2.2
|
In
no event shall SPONSOR be required to pay any amount exceeding the total
Initial Trial A Services Fees unless otherwise agreed in writing by the
parties.
|
4.2.3
|
SPONSOR
shall reimburse Medpace for reasonable and necessary expenses and
pass-through costs incurred by Medpace in providing the Initial Trial A
Services (“Initial Trial A Services Pass-through
Costs”).
|
4.2.4
|
In
the case of any individual Initial Trial A Services Pass-through Cost
exceeding US$5000, SPONSOR’s prior written approval must be given for such
cost:
|
4.2.5
|
All
Initial Trial A Services Pass-through Costs invoiced by Medpace must be
accompanied by appropriate documentary evidence as, required by SPONSOR,
such as receipts or other documentation reasonably acceptable to
SPONSOR.
|
4.2.6
|
Upon
execution of the relevant Task Orders, SPONSOR shall retrospectively
determine the difference between the Initial Trial A Services Fees and
Initial Trial A Services Pass-through Costs as agreed in the relevant Task
Orders and all amounts paid by SPONSOR to Medpace under this Letter
Agreement and any difference shall be credited against future amounts
owing by SPONSOR under such Task
Orders.
|
4.2.7
|
In
the event that this Letter Agreement is terminated for any reason, other
than termination by SPONSOR for breach by Medpace of its obligations
hereunder, and the parties do not execute the MSA and the Initial Trial A
Task Order, Medpace shall, within 30 days of the date of termination,
provide a written account to SPONSOR of all outstanding Initial
Trial A Services Fees, Initial Trial A Services Pass-through Costs and all
non-cancelable
|
4.2.8
|
APIL
shall be authorized by SPONSOR to receive invoices and to make remittances
on behalf of SPONSOR under this Agreement. All invoices should
be addressed to APIL at the following
address
|
5
|
Master
Services Agreement and Task Orders
|
5.1
|
When
and if SPONSOR and Medpace execute the MSA and the Initial Trial A Task
Order, this Letter Agreement shall be deemed terminate and superseded by
the MSA and the Initial Trial A Task
Order.
|
5.2
|
Upon
execution of the MSA and the Initial Trial A Task Order, the terms and
provisions of the MSA and the Initial Trial A Task Order shall apply to
all Initial Trial A Services provided by Medpace
hereunder.
|
5.3
|
The
MSA and all necessary Task Orders must be executed by the parties before
any dosing of Study subjects may
commence.
|
5.4
|
For
the avoidance of doubt, nothing contained in this Letter Agreement shall
be construed by implication or otherwise, as an obligation upon SPONSOR,
APIL or Medpace to negotiate or enter into any further agreement or
arrangement relating to the Studies or any other clinical study, including
without limitation: the- MSA and any Task
Order.
|
6
|
Scope
of Letter Agreement
|
6.1
|
Medpace
shall perform the Initial Trial A Services described in Schedule A in
accordance with the terms of this Letter Agreement. For such
initial Trial A Services, SPONSOR shall pay Medpace the amounts and on the
terms set forth in Schedule A. It is understood that Medpace
shall not make any financial commitments extending beyond the amounts
stated in Schedule A until (and to the extent permitted) the MSA and the
relevant Task Order(s) have been executed by the parties. If a
financial commitment is required by Medpace beyond those stated in
Schedule A, and prior to-the
execution of the MSA and the relevant Task Order(s), such action will
require written consent in advance by
SPONSOR.
|
7
|
Term
and Termination
|
7.1
|
The
parties agree that this Letter Agreement shall be binding upon the parties
with effect from the Effective Date and shall continue in full force and
effect until terminated by the parties in accordance with the terms of
this Letter Agreement.
|
7.2
|
SPONSOR
will have the right to request Medpace to immediately cease providing the
Initial Trial A Services and to forthwith terminate this Letter Agreement
and to forthwith terminate all negotiations regarding the MSA and any Task
Orders at any time by advising Medpace orally and in
writing.
|
7.3
|
Medpace
will have the right to stop its work and terminate this Letter Agreement
only if SPONSOR is in default of its payment obligations under Schedule A
and does not pay such amount in full within 10 days after written
notice.
|
7.4
|
This
Letter Agreement will automatically
terminate:
|
7.4.1
|
upon
execution of the MSA And the Initial Trial A Task Order;
or
|
7.4.2
|
in
the event that SPONSOR OR and Medpace do not execute the MSA and the
Initial Trial A Task Order within 60 days from the Effective Date, upon
the 60th day after the Effective
Date.
|
7.5
|
In
the event of termination, other than in the case of termination upon
execution of the MSA and the Initial Trial A Task
Order:
|
7.5.1
|
MEDPACE
shall use its best efforts to reduce the costs incurred by SPONSOR as a
result, of such termination;
|
7.5.2
|
all
Study Results and Study IP shall either be delivered to SPONSOR, or
disposed of, at the direction and written request of
SPONSOR;
|
7.5.3
|
save
for those paragraphs that expressly deemed to survive termination of this
Letter Agreement, the Letter Agreement shall terminate and be of no
further force or effect and SPONSOR, APIL and Medpace shall have no
further obligations to each other whatsoever under this Letter
Agreement.
|
8
|
Indemnification
and Insurance
|
8.1
|
SPONSOR
shall indemnify, defend and hold harmless Medpace from and against any and
all damages, losses, liabilities, costs or expenses (collectively
“Damages”), resulting or arising from any third-party claims, demands,
assessments, actions, suits, investigations or proceedings (collectively
“Claims”), relating to or arising from or in connection with this Letter
Agreement or the Initial Trial A Services (including but not limited to
any Damages arising from or in connection with any study, test, device,
product of potential product to which this Letter Agreement relates), to
the extent such Claims or Damages have not resulted from Medpace’s
negligent act or omission, or willful misconduct, or a breach of any
applicable law, regulation or guideline, or breach of this Letter
Agreement by Medpace.
|
8.2
|
Medpace
agrees to indemnify, defend and hold harmless SPONSOR and its Affiliates
from and against any and all Damages resulting or arising from Claims
relating to or arising from or in
|
8.3
|
Nothing
in this; Letter Agreement shall limit the liability of any Party for
fraud, or limit the liability of any Party to any third party under
applicable laws where any act, or omission of any Party results in death
or personal injury.
|
8.4
|
Any
Party providing indemnification under this Letter Agreement shall have the
right to control the defense and settlement of any Claims or
Damages. The indemnified party shall have’ the right to obtain
separate legal counsel at its own expense if it so chooses. The
indemnifying party shall not unreasonably withhold consent for settlement
and the indemnified party shall reasonably cooperate in the defense of any
Claims or Damages and provide prompt notice to the indemnifying party of
any Claims or Damages for which indemnification is sought, and shall
reasonably and regularly consult with the indemnified party in relation to
the progress and status of such Claim or Damages. Save as
aforesaid, neither the indemnifying party nor the party to be indemnified
shall acknowledge the validity of, compromise or otherwise settle any
Claim without the prior written consent of the other, which consent shall
not be unreasonably withheld. The Party seeking indemnification
shall take all reasonable steps to mitigate any loss, or liability in
respect of any such Claim or
Damages.
|
8.5
|
Notwithstanding
the terms of this paragraph 8, in 00 event shall SPONSOR or Medpace be
liable 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 consequential, special or incidental or punitive loss
or damage whether for loss of current or future profits, loss of
enterprise value or otherwise) and whether occasioned by thenegligence of
the respective parties, their employees or agents or otherwise, even if
the breaching party has been advised of the possibility of such
damages.
|
8.6
|
Medpace
shall at its own expense obtain and maintain insurance of a type and
amount adequate to cover all loss,, damage, liability or costs in respect
of which it is liable to indemnify Sponsor under the provisions of this
Letter Agreement and shall not do or omit any act, matter or thing which
may prejudice or render voidable any such insurance. Such
insurance shall be for an amount of not less than €7,500,000 per claim and
in aggregate. Medpace will, immediately upon the, request of
SPONSOR, provide SPONSOR with evidence of the insurance as SPONSOR may
reasonably require.
|
9
|
Publicity
|
9.1
|
Medpace
shall not make any public announcements concerning this Letter Agreement
or the subject matter hereof, nor use SPONSOR’s name, logo or trademark in
any communication, release, notice or other publication, without the prior
written consent of SPONSOR.
|
10
|
Miscellaneous
|
10.1
|
This
Letter Agreement and the performance hereof shall be governed, interpreted
and construed in all respects by the internal laws of the State of New
York. All disputes and claims arising under this Letter
Agreement shall be resolved exclusively in a court of applicable
jurisdiction located in New York, New York and each Party consents to the
venue of any such action.
|
10.2
|
Medpace
may not subcontract any portion of the Initial Trial A Services hereunder
without the prior written consent of SPONSOR. Should Medpace
subcontract with any third party upon such written consent of SPONSOR,
Medpace represents and warrants that such third-party subcontractor shall
comply with all obligations of Medpace under this Letter Agreement,
including but not limited to, obligations of confidentiality and ownership
rights of the Study Results and Study IP, and Medpace shall remain fully
liable for its and such third party’s performance of the Initial Trial A
Services and the obligations of Medpace
hereunder.
|
10.3
|
The
provisions of paragraphs 2, 3, 5.2, 8, 9, 10.1, 10.6 and this paragraph
10.3 shall survive the termination of this Letter
Agreement.
|
10.4
|
Medpace
shall not assign this Letter Agreement without the prior written consent
of SPONSOR.
|
10.5
|
This
Letter Agreement shall not be amended, modified or supplemented in any way
except in writing and signed by a duly authorized representative of
SPONSOR, APIL and Medpace.
|
10.6
|
At
the request of any of the parties, the other parties shall (and shall use
reasonable efforts to procure that any other necessary third parties
shall) execute and do all such documents, acts and things as may
reasonably be required subsequent to the signing of this Letter Agreement
for assuring to or vesting in the requesting party the full benefit of the
terms hereof.
|
10.7
|
At
the request of any of the parties, the other parties shall (and shall use
reasonable efforts to procure that any other necessary, third parties
shall) execute and do all such documents, acts, and things as may
reasonably be required
subsequent to, the signing of this Letter
Agreement for assuring to or vesting in the
requesting party the full benefit of the terms
hereof.
|
Item
|
Amount
|
eCRF
Development
|
$15,112.00
|
Project
Specific Training
|
$8,818.00
|
Regulatory
Agency Clinical
Trial Submissions
|
$112,542.00
|
IVRS
Development
|
$26,830.00
|
Investigator
and Vendor Contract Negotiation
|
$45,686.00
|
Investigator
Files Setup
|
$20,198.00
|
Initial
Essential Document Collection
|
$146,303.00
|
Project
Management
|
$365,601.00
|
Conference
Calls
|
$31,121.00
|
Pre-Study
Visits
|
$44,640.00
|
Monitoring
Plan Development and Maintenance
|
$8,558.00
|
Data
Management Manual,
|
$9,735.00
|
Database
Development
|
$29,018.00
|
Total
|
$864,162.00
|
Item
|
Amount
|
Investigator
Meeting Planner and Travel Fees
|
$264,878.00
|
Central
IRB Fees
|
$27,750.00
|
Investigator
Payments
|
$127,500.00
|
Medpace
Reference Laboratories Fees
|
$35,315.00
|
EDC
Vendor Fees
|
$77,069.00
|
Total
|
$532,512.00
|
Item
|
Amount
|
Monitoring
travel
|
$16,000.00
|
Conference
Calls
|
$800.00
|
Misc.
Printing/Copying/Shipping
|
$500.00
|
Total
|
$17,300.00
|
Note:
|
Pass-through
costs listed above are not exhaustive and may include, but are nor limited
to, CRF printing costs, courier costs, teleconference fees, drug packaging
and labeling, pharmacy fees, travel costs, subsistence costs, and
accommodation costs. Escrow costs listed above may not be
exhaustive.
|
Note:
|
Medpace
service-fees will be billed in two payments; 50% at signing and 50% twenty
days after signing. Escrow costs will be billed, at
signing. Pass-through costs will be billed
monthly.
|
Medpace
SOP
Index
|
|||
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
Biometrics
|
|||
GL-BS-01-84
|
Data
Analysis Plan
|
1/31/2008
|
N/A
|
GL-BS-02-S4,1
|
Analysis
Validation and Generation
|
1/31/2008
|
N/A
|
GL-BS-03-34
|
Data
Listing Validation and Generation
|
1/31/2008
|
N/A
|
GL-BS-04-S4
|
Randomization
Code
|
1/31/2008
|
N/A
|
GL-BS-05-S4
|
Interim
Analysis:
|
1/31/2008
|
N/A
|
Clinical
Operations
|
|||
BE-CO-01-S1
|
Clinical
Trial Submissions in Belgium
|
4/4/2008
|
N/A
|
GL-CO-01-S4.4
|
Trial
Document Management
|
3/1/2007
|
11/01/2008
|
GL-CO-02-S3,1
|
Protocol
Review
|
3/26/2007
|
11/01/2008
|
GL-CO-03-S3.2
|
Investigator
Meeting
|
3/26/2007
|
11/01/2008
|
GL-CO-05-S4.1
|
Study
Initiation Visit
|
3/2/2007
|
N/A
|
GL-GO-05-S5
|
Study
Initiation Visit
|
2/12/2009
|
N/A
|
GL-GO-06-S4.3
|
Monitoring
Plan Development
|
1/12/2007
|
11/01/2008
|
GL-GO-06-S5
|
Monitoring
Plan Development
|
2/5/2009
|
N/A
|
GL-CO-07-S4.2
|
Investigational
Product Tracking.
|
5/31/2007
|
11/01/2008
|
GL-CO-08-S9
|
Monitoring
Visit
|
12/21/2004
|
N/A
|
GL-CO-09-S4
|
Documenting
Protocol Deviations
|
1/10/2009
|
N/A
|
GL-CO-11-S4
|
Reporting
and Managing Problem Issues at a Clinical Research Site
|
3/30/2009
|
N/A
|
GL-CO-12-S3.1
|
Study
Closeout
|
4/15/2007
|
N/A
|
GL-CO-13-S4.2
|
Study
Site Close-out Visit
|
2/15/2007
|
12/5/2008
|
GL-CO-14-S2.2
|
Archiving
of Study Material
|
3/1/2007
|
N/A
|
GL-CO-15-S3
|
Recruitment
and Retention Plan
|
6/2/2008
|
N/A
|
GL-CO-16-S5.1
|
Clinical
Research Associate Orientation and Continuing Education
Processes
|
9/21/2008
|
N/A
|
GL-CO-18-S3.2
|
Clinical
Trial Manager Orientation and Evaluation Process
|
4/9/2007
|
12/5/2008
|
GL-CO-19-S2.1
|
Projection
Evaluation
|
4/15/2007
|
N/A
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
GL-CO-20-S5.1
|
General
Study Start-up
|
4/10/2008
|
N/A
|
GL-CO-21-S4
|
Trial
Master File – Essential Documents
|
4/10/2008
|
N/A
|
GL-CO-22-S3.2
|
Updated
and Additional Essential Documents
|
3/12/2007
|
12/5/2008
|
GL-CO-23-S5.2
|
Translation
of Essential Documents
|
2/25/2008
|
12/5/2008
|
GL-CO-24-S4
|
Informed
Consent Form
|
4/10/2008
|
N/A
|
GL-CO-25-S4
|
Pre-study
Visit
|
3/1/2007
|
N/A
|
GL-CO-26-S3.1
|
Selecting
Study Principal Investigators
|
12/1/2007
|
12/5/2008
|
GL-CO-27-S3.2
|
Quality
Control of Essential Documents
|
3/12/2007
|
12/5/2008
|
GL-CO-28-S3.2
|
Lead
Clinical Research Associate
|
9/21/2008
|
N/A
|
GL-CO-29-S4
|
Clinical
Research Associate Oversight
|
9/21/2008
|
N/A
|
GL-CO-30-S6
|
FDA
Compliance Checks
|
10/20/2008
|
N/A
|
GL-CO-31-S4.1
|
Investigational
Product Storage
|
9/28/2008
|
N/A
|
GL-CO-32-S2
|
Clinical
Trial Submissions
|
4/10/2008
|
N/A
|
GL-CO-33-S1.2
|
Project
Training/Project and Investigative Site Hand-over Process
|
11/16/2007
|
N/A
|
GL-CO-33-S2
|
Project
Training/Project and Investigative Site Hand-over Process
|
3/1/2009
|
N/A
|
GL-CO-34-S2.1
|
Internal
Quality Check (QC) of Study Files in the Document Center
|
11/15/2007
|
12/5/2008
|
GL-CO-35-S1.1
|
Conference
Call and Meeting Conduct
|
9/10/2007
|
N/A
|
GL-CO-36-S1.3
|
Site
Feasibility
|
12/1/2007
|
N/A
|
GL-CO-37-S1
|
Document
Quality Control
|
7/11/2008
|
N/A
|
In-Co-01S1.1
|
Clinical
Trial Submissions in India
|
2/21/2008
|
N/A
|
Corporate
Affairs
|
|||
GL-CA-01-S1
|
Document
Room Maintenance
|
1/16/2008
|
N/A
|
GL-CA-02-S1
|
Authorized
Signatory Tables
|
7/3/2008
|
N/A
|
GL-CA-03-S1
|
Entry
Structure and Controls
|
7/9/2008
|
N/A
|
GL-CA-04-S2.1
|
Corporate
Records Retention
|
12/24/2008
|
N/A
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
GL-CA-05-S1
|
Non-Study
Contracts Indexing and Tracking
|
7/16/2008
|
N/A
|
US-CA-01-S1
|
Board
of Directors Meetings
|
7/7/2008
|
N/A
|
US-CA-02-S1
|
Annual
and Special Shareholder Meetings
|
7/11/2008
|
N/A
|
Data
Management
|
|||
Gl-DM-02-S14
|
Data
Entry System
|
1/31/2008
|
N/A
|
Gl-DM-02-S15
|
Data
Entry System
|
2/18/2009
|
N/A
|
Gl-DM-03-S11
|
Edit
Check Specifications
|
1/20/2008
|
N/A
|
Gl-DM-04-S12
|
CRF
Processing and Data Entry
|
1/25/2008
|
N/A
|
Gl-DM-06-S13
|
Database
Cleanup
|
1/25/2008
|
N/A
|
Gl-DM-08-S10
|
Coding
Process
|
1/20/2008
|
N/A
|
Gl-DM-09-S10
|
Edit
Check System
|
1/31/2008
|
N/A
|
Gl-DM-12-S9
|
External
Data Base Import System
|
1/31/2008
|
N/A
|
Gl-DM-13-S7
|
Database
Generation System
|
1/31/2008
|
N/A
|
Gl-DM-15-S3
|
SAS
Programming Conventions
|
1/31/2008
|
N/A
|
Gl-DM-17-S2
|
Database
Quality Control Review
|
1/25/2008
|
N/A
|
Gl-DM-17-S3
|
Data
Quality Control Review
|
2/15/2009
|
N/A
|
Gl-DM-20-S2
|
Electronic
Data Capture System Administration
|
1/31/2008
|
N/A
|
ECG
Core Laboratory
|
|||
GL-EL-01-S1.1
|
ECG
Shipment, Tracking, and Qualification
|
9/19/2007
|
11/26/2008
|
GL-EL-02-S1.1
|
ECG
Electronic Receipt and Processing
|
9/19/2007
|
11/26/2008
|
GL-EL-03-S1.1
|
ECG
Data Review and Cleanup
|
9/19/2007
|
11/26/2008
|
GL-EL-04-S1.1
|
ECG
Data Format and Delivery
|
9/19/2007
|
11/26/2008
|
GL-EL-05-S1
|
ECG
Study Set Up
|
10/31/2008
|
N/A
|
GL-EL-06-S1
|
Continuous
Electrocardiogram Data Receipt and Processing
|
10/31/2008
|
N/A
|
GL-EL-07-S1
|
H-Scribe
Study Set Up
|
10/31/2008
|
N/A
|
Finance
|
|||
GL-AA-02-S1
|
Payroll
|
4/30/2007
|
N/A
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
GL-AC-01-S2.1
|
General
ledger System Management
|
3/15/2007
|
N/A
|
GL-AC-03-S3
|
Procurement
|
3/31/2007
|
N/A
|
GL-AC-06-S6
|
Accounts
Receivable
|
3/31/2007
|
N/A
|
GL-AC-11-S2.1
|
Revenue
Recognition
|
5/4/2007
|
N/A
|
GL-AC-15-S3
|
Site
Payments
|
5/15/2008
|
N/A
|
General
|
|||
GL-GN-01-S15.1
|
Procedures
for Standard Operating Procedures
|
4/30/2008
|
N/A
|
GL-GN-02-S3
|
Training
& Development
|
11/30/2008
|
N/A
|
GL-GN-03-S1.2
|
Office
Security
|
9/19/2007
|
6/5/2008
|
GL-GN-06-S4
|
Customer
Service
|
12/19/2008
|
N/A
|
GL-GN-07-S3.1
|
Correspondence
Distribution
|
9/26/2005
|
11/14/2008
|
HR
& Administration
|
|||
GL-HR-01-S1.2
|
Employment
|
7/14/2008
|
N/A
|
GL-HR-02-S1
|
Employee
Compensation
|
7/14/2008
|
N/A
|
Information
Technology
|
|||
GL-IT-01-S14
|
Study
Setup
|
5/30/2008
|
N/A
|
GL-IT-02-S14.2
|
System
Validation
|
1/28/2008
|
N/A
|
GL-IT-03-S9.1
|
Transfer
of Electronic Record
|
3/1/2008
|
N/A
|
GL-IT-04-S13.2
|
System
Maintenance
|
1/28/2008
|
N/A
|
GL-IT-05-S12.1
|
System
Security
|
1/25/2008
|
N/A
|
GL-IT-06-S9.1
|
Disaster
Recovery Plan
|
1/31/2008
|
N/A
|
GL-IT-08-S6
|
21
CFR Part 11 Compliance
|
1/28/2008
|
N/A
|
GL-IT-09-S13
|
System
Development Life Cycle
|
1/28/2008
|
N/A
|
GL-IT-S14.1
|
Change
Control
|
1/28/2008
|
N/A
|
GL-IT-11-S10
|
System
Backup, Restore, and Archive
|
1/28/2008
|
N/A
|
GL-IT-12-S4.2
|
Request
for Hardware, Software, and Support
|
1/25/2008
|
N/A
|
GL-IT-13-S3
|
Directory
Structure and Naming Conventions
|
3/1/2008
|
N/A
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
GL-IT-14-S3
|
Computer
System Set Up
|
3/1/2008
|
N/A
|
GL-IT-17-S2.2
|
Clin
Trak IVRS Randomization Procedure
|
3/30/2007
|
10/6/2006
|
GL-IT-18-S2.1
|
Clin
Trak IVRS Subject Tracking Study Implementation
|
3/30/2007
|
10/6/2008
|
GL-IT-19-S2.1
|
Clin
Trak IVRS Study Support and Maintenance
|
3/31/2007
|
10/6/2008
|
US-IT-15-S4
|
Message
Notification
|
3/1/2008
|
N/A
|
IVRS
|
|||
GL-IV-01-S2
|
IVRS
Study Setup Validation
|
12/10/2008
|
N/A
|
Marketing
& BD
|
|||
GL-MK-01-S3.2
|
Request
For Proposal Handling and Proposal Preparation
|
12/11/2006
|
N/A
|
GL-MK-02-S3
|
Sponsor
Contract Handling
|
4/25/2008
|
N/A
|
GL-MK-03-S3
|
Change
in Scope Process
|
3/1/2008
|
N/A
|
GL-MK-04-S3
|
Press
Release Process
|
1/31/2008
|
N/A
|
GL-MK-05-S2
|
Procedures
for Site Contracts
|
3/1/2008
|
N/A
|
Medical
Writing
|
|||
GL-MW-01-S8
|
Clinical
Study Report
|
3/10/2008
|
N/A
|
GL-MW-04-S4
|
Preparation
of the Study Protocol
|
3/10/2008
|
N/A
|
GL-MW-07-S6
|
Procedures
for Compiling Appendices
|
3/10/2008
|
N/A
|
GL-MW-08-S6
|
Document
Quality Control
|
3/10/2008
|
N/A
|
Quality
Assurance
|
|||
BE-QA-01-S1
|
Disaster
Recovery Plan - Belgium Facilities
|
10/25/2008
|
NA
|
BE-QA-02-S1
|
Diesel
Power Generator
|
10/12/2008
|
NA
|
BE-QA-03-S1
|
Freezer
CO2 Backup System
|
12/12/2008
|
NA
|
GL-QA-01-S13
|
Investigative
Site Audit
|
6/2/2008
|
NA
|
GL-QA-04-S11
|
System
Audits
|
5/5/2008
|
NA
|
GL-QA-05-S9
|
Regulatory
Authority Inspections
|
4/20/2008
|
NA
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
GL-QA-06-S9
|
Prevention
and Detection of Fraud and Other Misconduct
|
10/20/2008
|
NA
|
GL-QA-07-S3.2
|
Sponsor
Audit Preparation
|
1/31/2008
|
NA
|
GL-QA-08-S4
|
Good
Documentation Practices
|
1/31/2008
|
NA
|
GL-QA-09-S3
|
Quality/Assurance
Oversight Plan
|
5/1/2008
|
NA
|
GL-QA-10-S3
|
Vendor
Audits
|
5/5/2008
|
N/A
|
GL-QA-11-S1
|
Confidentiality
of Data/HIPAA
|
12/15/2008
|
N/A
|
NA-QA-01-S1
|
QA
Responsibilities for GLP Compliance
|
10/31/2008
|
N/A
|
NA-QA-02-S1
|
Quality
Assurance Good Laboratory Practice Inspection and Audit
Program
|
11/30/2008
|
N/A
|
NA-QA-03-S1.2
|
QA
Statement for GLP Study Reports
|
10/31/2008
|
N/A
|
NA-QA-04-S1
|
Generation
and Maintenance of the Master Schedule
|
10/31/2008
|
N/A
|
Regulatory
Affairs
|
|||
US-RA-05-S10
|
New
Drug Applications
|
8/15/2008
|
N/A
|
US-RA-12-S3
|
Investigational
New Drug Application Submission Process
|
3/15/2008
|
N/A
|
Safety
|
|||
GL-SA-01-S5
|
Serious
Adverse Event Reporting
|
1/20/2008
|
N/A
|
GL-SA-02-S7
|
Withdrawal
due to Adverse Event and Other Event Reporting
|
1/20/2008
|
N/A
|
GL-SA-03-S4
|
Study
Report Narratives
|
1/20/2008
|
N/A
|
GL-SA-04-S3
|
Safety
Reporting to Regulatory Authorities
|
1/20/2008
|
N/A
|
GA-SA-05-S3
|
Managing
Adverse Events/Reactions in Blinded Clinical Trials
|
1/20/2008
|
N/A
|
GL-SA-06-S3
|
Reconciliation
of Serious Event Data
|
1/20/2008
|
N/A
|
GL-SA-07-S1
|
Safety
Event Reporting System Project Set Up
|
9/19/2008
|
N/A
|
Strategic
Development
|
|||
GL-SD-01-S2
|
Managing
Strategic Transactions
|
1/31/2009
|
N/A
|
AMARIN
CORPORATION, PLC
ESTER
NEUROSCIENCES LTD.
MEDICA
II MANAGEMENT L.P.
(AS
THE SELLERS’ REPRESENTATIVE)
|
(1)
|
AMARIN CORPORATION, PLC,
a public limited company incorporated under the laws of England and Wales
(the “Buyer”);
|
(3)
|
MEDICA II MANAGEMENT
L.P., a Cayman Islands limited partnership, in its capacity as the
Sellers’ Representative appointed pursuant to Section 13 of that certain
Stock Purchase Agreement dated December 5, 2007 between Buyer, the
Security Holders (each a “Seller” and collectively
the “Sellers”) of
the Company, the Company, and
the Sellers' Representative.
|
A.
|
The
Buyer, the Sellers, the Company and
the Sellers' Representative entered into a Stock Purchase Agreement dated
December 5, 2007, as subsequently amended by Amendment No. 1 (“Amendment No.
1”) to Stock Purchase Agreement dated April 7, 2008
(together the “SPA”).
|
B.
|
The
Buyer is continuing various activities to conclude its auditing and
reporting of the Phase IIa Clinical
Study.
|
C.
|
The
Buyer announced in September 2008 that following a change in strategic
direction, the Buyer would seek partnerships for its CNS pipeline,
including Monarsen in MG. At the date of this Agreement, the
Buyer does not intend to conduct any new development work on Monarsen but
intends to seek to enter into an agreement with a third party partner
whereby such third party partner would conduct any such development work
in the future.
|
D.
|
The
parties hereto acknowledge that it is necessary to agree a number of
amendments to, and waivers under, the SPA to reflect the circumstances
described in Recitals C and E and to facilitate the Buyer’s intention to
seek a future partnership for Monarsen in
MG.
|
E.
|
The
Buyer has agreed to make a settlement payment to the Sellers in the form
of Buyer Ordinary Shares and to amend certain provisions of the SPA
relating to the Escrow Fund in consideration of the Sellers’
Representative and each of the Sellers agreeing to the amendments and
waivers referred to herein and to terminate and extinguish any obligations
of the Buyer to pay the Milestone Ia Consideration to the Sellers pursuant
to the SPA (all of the foregoing as set forth in detail under Section
2).
|
F.
|
The
parties hereto have also agreed certain terms which supplement the SPA and
which are also set forth in this
Agreement.
|
1
|
DEFINITIONS / REPRESENTATIONS AND
WARRANTIES
|
1.1
|
Definitions:
|
1.2
|
Representations and
Warranties of Sellers’
Representative:
|
|
1.2.1
|
the
Sellers’ Representative continues to hold all the authorities and powers
granted by the Sellers to the Sellers’ Representative under Section 13 of
the SPA;
|
1.2.2
|
the
Sellers’ Representative has full authority and power to enter into this
Agreement on behalf of each Seller and has all necessary authority and
power to bind each Seller to each of the provisions of this
Agreement;
|
1.2.3
|
all
necessary corporate, shareholder and other legal action has been taken by
the Sellers’ Representative to authorize the execution, delivery and
performance by it of this Agreement. The Sellers’
Representative has duly executed and delivered this Agreement. This
Agreement is the legal, valid and binding obligation of the Sellers’
Representative, enforceable against it in accordance with its respective
terms, except as enforceability of such objections may be limited by
bankruptcy, insolvency, reorganization, moratorium and other similar laws
now or hereafter in effect relating to or limiting creditors’ rights
generally and general principles of equity relating to the availability of
specific performance and injunctive and other forms of equitable
relief;
|
|
1.2.4
|
the
Sellers’ Representative will execute this Agreement in its capacity as the
Sellers’ Representative and, based on its authority as such, as agent and
attorney-in-fact of each Seller (so appointed under Section 13 of the
SPA); and
|
|
1.2.5
|
the
Sellers’ Representative acknowledges that the Buyer is entering into this
Agreement with each of the Sellers in reliance on the provisions of
Section 13 of the SPA (including, without limitation, Section 13(g) of the
SPA) and the representations and warranties of the Sellers’ Representative
set forth in this Section 1.2.
|
1.3
|
Representations
and Warranties of Buyer:
|
|
1.3.1
|
Organization
and Good Standing: The Buyer
has been duly incorporated and is validly existing as a public limited
company under the laws of England and Wales and has all necessary
corporate power and authority to perform all of its obligations under this
Agreement.
|
|
|
1.3.2
|
Power
and Authorization: The
Buyer has all requisite power and authority to execute and deliver this
Agreement, to perform its obligations hereunder and to carry out the
transactions contemplated hereby. All necessary corporate, shareholder and
other legal action has been taken by the Buyer to authorize the execution,
delivery and performance by it of this Agreement. The Buyer has
duly executed and delivered this Agreement. This Agreement is the legal,
valid and binding obligation of the Buyer, enforceable against it in
accordance with its respective terms, except as enforceability of such
objections may be limited by bankruptcy, insolvency, reorganization,
moratorium and other similar laws now or hereafter in effect relating to
or limiting creditors’ rights generally and general principles of equity
relating to the availability of specific performance and injunctive and
other forms of equitable relief.
|
|
1.3.3
|
Buyer
Ordinary Shares: As of the Effective Date, subject to
Section 2.1.1, upon issuance and delivery of the Buyer Ordinary Shares
comprising the Settlement Payment: (a) such Buyer Ordinary Shares will
have been duly authorized and validly issued and will be fully paid and
non-assessable, will have been issued in compliance with all applicable
English laws and the
|
1.4
|
Representations
and Warranties of each
Seller:
|
|
1.4.1
|
Organization
and Good Standing: Such Seller
is duly organized, validly existing and in good standing under the laws of
its jurisdiction of incorporation, formation or organization, as
applicable, and has (as applicable) all necessary corporate, partnership
or limited liability company power and authority, as the case may be, to
perform all of its obligations under this
Agreement.
|
|
1.4.2
|
Power
and Authorization: Such Seller
has all legal right, power, authority and legal capacity to execute and
deliver this Agreement, to perform its obligations hereunder and to carry
out the transactions contemplated
hereby.
|
|
1.4.3
|
Status
of Shareholder: Such
Seller is not a “U.S. Person” as defined by Rule 902 of Regulation S
promulgated under the Securities Act, was not formed (if an entity) by a
“U.S. Person” as defined by United States jurisdiction, and was not formed
(if an entity) for the purpose of investing in securities not registered
under the Securities Act. Such Seller is not acquiring the
Buyer Ordinary Shares for the benefit of a “U.S. Person” as defined by
Rule 902 of Regulation S. Such Seller is outside the United
States. Such Seller acknowledges, agrees and covenants that it
will not engage in hedging transactions with regard to Buyer Ordinary
Shares prior to the expiration of the distribution compliance period
specified in Rule 903 of Regulation S promulgated under the Securities
Act, unless in compliance with the Securities Act. Absent
another exemption from registration, such Seller will not resell Buyer
Ordinary Shares to “U.S. Persons” or within the United States, unless
pursuant to registration of such Buyer Ordinary Shares under the
Securities Act.
|
|
1.4.4
|
Reliance
Upon Seller’s Representations: Such
Seller understands that the issuance and sale thereto of Buyer Ordinary
Shares will not be registered under the Securities Act on the ground that
such issuance and sale will be exempt from registration under the
Securities Act pursuant to Regulation S promulgated under the Securities
Act and that Buyer’s reliance on such exemption is based on each Seller’s
representations set forth herein.
|
|
1.4.5
|
Receipt
of Information: Such
Seller has had an opportunity to ask questions and receive answers from
Buyer regarding the terms and conditions of the issuance and sale of the
Buyer Securities and the business, properties, prospects and financial
condition of Buyer and to obtain any additional information requested, and
has received and considered all information such Seller deems relevant to
make an informed decision to purchase Buyer Securities. Neither
such inquiries nor any other investigation conducted by or on behalf of
such Seller or its representatives or counsel shall modify, amend or
affect such Seller’s right to rely the Buyer’s representations and
warranties contained in this
Agreement.
|
|
1.4.6
|
Restricted
Securities: Such
Seller understands that the Buyer Ordinary Shares have not been registered
under the Securities Act and such Seller will not sell, offer to sell,
assign, pledge, hypothecate or otherwise transfer any of the Buyer
Ordinary Shares during the 40 days following the Effective
Date. Such Seller agrees that Buyer may place stop transfer
orders with Citibank N.A. (the “Transfer
Agent”) (or any other transfer agent) with respect to the Buyer
Ordinary Shares in order to implement the restrictions on transfer set
forth in this Agreement.
|
|
1.4.7
|
Independent
Investment: Such
Seller acknowledges that it is aware of its obligations as a beneficial
owner of Buyer Ordinary Shares pursuant to Section 12(d) of the Exchange
Act.
|
1.5
|
No
other Representations
and Warranties:
|
2
|
SETTLEMENT PAYMENT / RELEASE OF
ESCROW FUND
|
2.1
|
The
Buyer has agreed with the Sellers’ Representative and the Sellers to make
a settlement payment (the “Settlement Payment”) to
the Tax Trustee for the Sellers in the form of 1,315,789 Buyer Ordinary
Shares in consideration of the agreement of the Sellers’ Representative
and of each Seller to the amendment, termination and waiver of certain
provisions of the SPA (as set forth in this Agreement) and subject to the
following additional terms:
|
|
2.1.1
|
as
soon as practicable following the date hereof, taking into account the
then relevant issues arising under U.S. securities laws, but not later
than 60 days hereafter, the Buyer shall issue to the Tax
Trustee (the date of such issuance, the "Effective Date")
1,315,789 Buyer Ordinary Shares that are freely tradeable on Nasdaq
(pursuant to an effective Buyer registration statement, Regulation S or
other applicable exemption from registration under the Securities Act) in
discharge of the obligation to pay the Settlement Payment under Section
2.1;
|
|
2.1.2
|
for
the avoidance of doubt, and as a consequence of the amendment to the SPA
set forth in Section 2.2, no amount of the Settlement Payment will be paid
by the Buyer to the Escrow Agent for deposit to the Escrow
Fund;
|
|
2.1.3
|
all
and any obligations of the Buyer to pay to the Sellers the Milestone Ia
Consideration pursuant to Section 2.1(d) and Section 9.2 of the SPA shall
be extinguished in full and, with effect from the Effective Date and at
all times thereafter, the Buyer shall have no liability of any nature to
any Seller under Section 2.1(d) and/or Section 9.2 of the SPA or otherwise
in respect of the Milestone Ia Consideration;
and
|
|
2.1.4
|
subject
to Section 3.4.1 and Section 3.5.5, the Sellers’ Representative on behalf
of each Seller (pursuant to Section 14.5 of the SPA), and each Seller,
hereby fully waives all of its rights of any nature whatsoever, on a
perpetual basis, to require or enforce performance by the Buyer of the
requirements of Section 2.1(h), Section 2.1(e) and/or Section 2.1(f) of
the SPA (“SPA Future
Waiver”) and the Buyer shall have no liability of any nature to the
Sellers following the Effective Date for breach of, or absence of
performance of, any of the provisions of Section 2.1(h), Section 2.1(e)
and/or Section 2.1(f) of the SPA.
|
2.2
|
The
Buyer and the Sellers’ Representative agree that on the expiry
of the Escrow Period as such term has been originally defined in the SPA,
i.e., on June 6, 2009, the parties shall execute and deliver the Final
Instruction to Escrow Agent, in the form of Exhibit
2.2 hereto, informing the Escrow Agent that the parties irrevocably
instruct the Escrow Agent to pay to the Sellers on such date all of the
Remaining Escrow Fund in the manner set forth in the Escrow
Agreement.
|
|
2.2.1
|
any
and all of Buyer's rights and remedies for any Damages incurred as set
forth in the Terminated Section 12 Provisions ("Covered Liabilities")
shall terminate, and neither Buyer nor any Buyer Indemnified Party shall
have any other claims, rights or remedies against any of the Sellers after
the Effective Date, whether under the SPA or under any applicable law or
otherwise, for such Covered
Liabilities.
|
|
2.2.2
|
any
and all of Sellers’ rights and remedies for any Damages incurred as set
forth in the Terminated Section 12 Provisions ("Covered Liabilities")
shall terminate, and none of the Sellers nor any Seller Indemnified Party
shall have any other claims, rights or remedies against the Buyer after
the Effective Date, whether under the SPA or under any applicable law or
otherwise, for such Covered
Liabilities.
|
3
|
FUTURE DEVELOPMENT OF MONARSEN
/ INTENTION TO PARTNER
MONARSEN
|
3.1
|
It
is acknowledged by the Sellers’ Representative and each Seller that the
intentions of the Buyer as at the date hereof and the Effective Date as
regards any future development and/or commercialization activities in
respect of Monarsen are as follows:
|
|
3.1.1
|
the
Buyer is currently completing certain activities to finalise the Buyer’s
auditing and reporting of the Phase IIa Clinical Study and, save the
completion of such activities and the activities described in Section
3.1.3 below, the Buyer does not intend to conduct any additional
development and/or commercialization activities on Monarsen, (including,
without limitation, any MG Phase II Development Program, US Phase III
Clinical Study or Phase III Clinical
Study);
|
|
3.1.2
|
as
a result of the Buyer’s cessation of all development activities on
Monarsen as described in Section 3.1.1 above, and save in the
circumstances outlined in Section 3.5.5 below where the Buyer would
re-commence development activities on Monarsen in MG, Milestone Ib and
Milestone II will not be achieved by the Buyer in the future and the
potential for future payment to the Sellers of such milestones will be as
set forth in Section 3.3;
|
|
3.1.3
|
as
more fully described in Section 3.3, the Buyer intends to seek to enter
into an agreement (the “Proposed Partnership
Agreement”) with a third party partner whereby such third party
partner would conduct future development and/or commercialization
activities on Monarsen in MG PROVIDED
HOWEVER that the parties hereto agree that the provisions of this
first paragraph of Section 3.1.3 and the provisions of Section 3.3 are
only expressions of the Buyer’s intentions and no such provision comprises
or contains any legally binding obligation on the
Buyer.
|
3.2
|
Upon
agreement with the Sellers’ Representative, the Sellers’ Representative
will make available to the Buyer a certain portion of the
business time of Prof. Eli Hazum as may be reasonably required
by the Buyer to enable the Buyer to conclude the Buyer’s auditing and
reporting of the Phase IIa Clinical Study and to make any reports to, or
respond to any queries of, or in relation to any inspections or
investigations of, any regulatory authority in Europe, the USA or any
other jurisdiction in relation to the Phase IIa Clinical
Study.
|
3.3
|
The
Buyer intends to seek to negotiate with any potential third party partner
which is an experienced company in the business of developing drugs
(“Third Party
Partner”) to include the following terms in the Proposed
Partnership Agreement:
|
|
3.3.1
|
the
Third Party Partner would have direct obligations to the Sellers,
including diligence obligations as regards future development activities
relating to Monarsen in MG identical to the Diligence Obligation set forth
in Section 2.1(h) of the SPA, and including reporting and audit
obligations (provided, however, that if the Third Party Partner is not a
publicly traded company, then its reporting and audit obligations shall be
broadened as required to provide Sellers' Representative reasonable
comfort in such circumstances);
|
|
3.3.2
|
the
Third Party Partner would have an obligation to pay to the Sellers a
milestone payment of [********]2 in cash within 14
days after the Milestone Ib Date (the "First Payment Date") and
would assume the obligations to the Sellers as regards Milestone II set
forth in Section 2.1(f) of the SPA (other than Section 2.1(f)(iv) of the
SPA, which is hereby terminated);
|
|
3.3.3
|
if
in the negotiation of the matters described in Section 3.3.2, the Third
Party Partner is not agreeable to pay to the Sellers a milestone payment
of [********] in
cash on the First Payment Date, and is only agreeable to pay a cash
milestone that is less than [********] (“Reduced Milestone Ib
Payment”) resulting in a shortfall amount (the “Milestone Ib Shortfall
Amount”), without prejudice to the provisions of Section 3.4.2, the
Buyer intends to seek to negotiate with the Third Party Partner an
addition to the Milestone II Consideration whereby the Third Party Partner
would assume the obligations to the Sellers as regards Milestone II set
forth in Section 2.1(f) of the SPA (other than Section 2.1(f)(iv) of the
SPA, which is hereby terminated) and agree to pay an additional cash
payment to the Sellers within 14 days after the Milestone II Date, in
addition to the Milestone II Consideration, equal to the Milestone Ib
Shortfall Amount (“Additional Milestone II
Consideration”); and
|
|
3.3.4
|
the
Third Party Partner would have direct obligations to the Buyer, separate
and distinct from the Third Party Partner’s obligations described in
Section 3.3.1 above, including diligence obligations and payment
obligations.
|
3.4
|
If
the Buyer executes a Proposed Partnership Agreement, the following
additional provisions shall apply as between the Buyer and the
Sellers:
|
|
3.4.1
|
without
prejudice to Section 2.1.4, all and any obligations of the Buyer to pay to
the Sellers the Milestone Ib Consideration pursuant to Section 2.1(e) and
Section 9.2 of the SPA; and/or the Milestone II Consideration pursuant to
Section 2.1(f) of the SPA; and the provisions of Section 2.1(h), shall be
terminated and extinguished in full and, with effect from the effective
date of the Proposed Partnership Agreement and at all times thereafter,
the Buyer shall have no liability of any nature to any Seller under
Section 2.1(e) and Section 9.2 of the SPA in respect of the Milestone Ib
Consideration, or under Section 2.1(f) of the SPA in respect of the
Milestone II Consideration, or under any of the provisions of Section
2.1(h);
|
3.4.2
|
in
the event that, under the Proposed Partnership Agreement, the Third Party
Partner does not agree to pay to the Sellers a milestone payment of [********] in cash on
the First Payment Date, or to assume the obligations to the Sellers as
regards Milestone II set forth in Section 2.1(f) of the SPA (other than
Section 2.1(f)(iv) of the SPA, which is hereby terminated), then Buyer
agrees to make advance payments (“Shortfall Advance
Payment(s)”) to each Seller equal to its portion (as set forth on
the Shortfall Advance Payment Allocation
Schedule) in cash, of the following
amounts:
|
|
(1)
|
the
amount that reflects the difference between [********] and the
aggregate amount actually paid to the Sellers by the Third Party Partner
on the First Payment Date; and
|
|
(2)
|
the
amount that reflects the difference between [********] (or [********], as may be
applicable under Section 2.1(f)(ii) of the SPA) and the aggregate amount
actually paid to the Sellers by the Third Party Partner on the Milestone
II Date (or the other applicable payment date), as applicable, plus the
Additional Milestone II Consideration (“Actual Milestone II
Consideration”);
|
|
3.4.3
|
in
addition, the Buyer shall pay to each Seller a payment (the “Accelerated Payment”)
equal to its portion (as set forth on the Accelerated Payment Allocation
Schedule) in cash, of [**] of any MG Phase II
Third Party Partner Consideration actually received from the Third Party
Partner within 10 Business Days after such MG Phase II Third Party Partner
Consideration has been actually received by the Buyer or its
Affiliates;
|
|
3.4.4
|
if
the Buyer is paid milestone or license payments by the Third Party Partner
under the Proposed Partnership Agreement that are not in the form of cash,
save in the case of Non-MG Sub-license Fees (which are governed by Section
2.1(g) of the SPA), the parties hereto will negotiate in good faith to
agree terms as to how to value such payments under this
Agreement.
|
3.5
|
Subject
to the provisions of Sections 3.5.1 to 3.5.5, if the Buyer has not
executed the Proposed Partnership Agreement on the date which is [**] months following
the date hereof (the “[**] Month Trigger
Date”), within 30 days of the such date (the “Ultimate Transfer
Date”), the Seller's Representative may, but is not bound to,
request in writing that, in accordance with the termination agreement
described in Sections 3.5.1 and 3.5.2, the Buyer shall transfer to the
Sellers’ Representative (or such persons as directed by the Sellers’
Representative) all of its right, title and interest in the entire issued
share capital of the Company:
|
|
3.5.1
|
prior
to any transfer of the share capital of the Company by the Buyer to the
Sellers’ Representative (or such persons as directed by the Sellers’
Representative), the parties hereto shall enter into a termination
agreement (the “Termination Agreement”)
, whereby the shares will be transferred by the Buyer to the Sellers’
Representative (or such persons as directed by the Sellers’
Representative), without consideration, subject to the representations and
warranties of the Buyer set forth in Section 3.5.2 and otherwise on an “as
is” basis; the SPA will be terminated in full and the parties hereto will
agree mutual, full and perpetual waivers and releases under the SPA
(pursuant to provisions in identical form to the waivers and releases set
forth in Section 4); and, subject to Section 3.5.2, the Sellers’
Representative and each Seller will fully indemnify the Buyer in relation
to any claims taken by any third party against the Buyer at any time
following the Ultimate Transfer Date relating to any activities of the
Company, past, present or future;
|
|
3.5.2
|
in
addition, the Buyer shall confirm to the Sellers’ Representative and the
Sellers in the Termination Agreement (and provide any documentation
reasonably required by the Sellers’ Representative to support such
confirmations) that as of the Ultimate Transfer Date, (a) the shares of
the Company being transferred to the Sellers’ Representative or to another
person on its behalf are free and clear of any Encumbrances; (b) the
Company owns the patents listed in Exhibit 3.5.2 and has no other assets;
(c) such patents are owned free and clear of any Encumbrances and (d) the
Company owes no monies to any third party; and the Buyer shall also
confirm to the Sellers’ Representative whether any claims or proceedings
are pending or threatened against the Company on the Ultimate Transfer
Date or whether the Buyer has any other liability to any third party of
which the Buyer is actually aware;
|
|
3.5.3
|
notwithstanding
the aforesaid, prior to the [**]4 Month Trigger
Date, the Buyer shall be entitled to notify the
Sellers’ Representative (such written notice to be accompanied
by supporting evidence), of its desire to extend the [**] Month Trigger Date
to the date which is [**]
months thereafter (the “[**] Month Trigger
Date”) which extension shall be approved by the Sellers’
Representative (such approval not to be unreasonably withheld or delayed)
in circumstances where the Buyer can demonstrate to the Sellers'
Representative’s satisfaction that it has made substantial progress
towards the execution of the Proposed Partnership Agreement and that
execution of such Proposed Partnership Agreement is reasonably likely
within such [**]-month period; if
such extension is approved, the Ultimate Transfer Date shall be
similarly extended;
|
|
3.5.4
|
notwithstanding
the aforesaid, prior to the [**] Month Trigger Date,
the Buyer shall be entitled, to notify the Sellers’ Representative in
writing (such written notice to be accompanied by supporting evidence) of
its desire to extend the [**] Month Trigger Date
to the date which is [**]
months thereafter (the “[**] Month Trigger
Date”), which extension shall be approved by the Sellers’
Representative (such approval not to be unreasonably withheld or delayed)
in circumstances where the Buyer can demonstrate to the Sellers'
Representative’s satisfaction, that the execution of the Proposed
Partnership Agreement is reasonably likely within such [**] -month period; if
such extension is approved, the Ultimate Transfer Date shall be similarly
extended;
|
|
3.5.5
|
if
prior to the [**]
Month Trigger Date the Buyer notifies the Seller in writing that it
has determined that it will re-commence development activities on Monarsen
in MG, then, subject to the Sellers’ Representative consenting in writing
to the Buyer re-commencing development activities on Monarsen in MG (such
consent not to be unreasonably withheld or delayed), such development
activities will re-commence and all of the provisions of this Clause 3.5,
save this Section 3.5.5, and the SPA Future Waiver shall forthwith
terminate, no transfer of the share capital as described above will occur
thereafter, and with effect from the date of the afore-mentioned consent
of the Sellers’ Representative, the Buyer shall be fully bound by, and
liable for any breach of, the provisions of Sections 2.1(h), Section
2.1(e) and Section 2.1(f) of the SPA, without any change. For
the avoidance of doubt, the re-commencement of development activities by
the Buyer under this Section 3.5.5 shall not in itself trigger any payment
by the Buyer to the Sellers.
|
3.6
|
From
the date hereof until the earlier of (i) the execution of the Proposed
Partnership Agreement, or (ii) the execution of the Termination Agreement,
or (iii) the notice of Buyer to the Sellers' Representative as set forth
in Section 3.5.5, the Buyer shall report in writing to the Sellers’
Representative, on a six monthly basis, providing an update of the
progress of its activities in that period in relation to the negotiation
and execution of a Proposed Partnership Agreement. Such reports shall be
provided to the Sellers’ Representative not later than the 15th day
following June 30, 2009 and the end of each six month period thereafter.
Further, a full and complete copy of any Proposed Partnership Agreement,
if executed, shall be delivered to the Sellers’ Representative, together
with a summary of the financial terms of any agreement entered into by the
Buyer and the Third Party Partner contemporaneously with, or within 3
months prior to or following the date of the Proposed
Partnership Agreement.
|
4
|
WAIVER OF ACCRUED RIGHTS /
MUTUAL RELEASES
UNDER SPA
|
4.1
|
With
effect from the Effective Date, each party to the SPA and each of its
Affiliates (each a “Releasor”)
hereby:
|
|
4.1.1
|
waives
any accrued rights that Releasor may have accrued against the other
parties to the SPA and each of its Affiliates, officers, directors,
representative, agents and employees and the assigns and successors in
interest of any of the foregoing entities (“Releasees”), whether
known or unknown, foreseen or unforeseen, fixed or contingent, of any
nature whatsoever from the beginning of time to the Effective Date under
the SPA or otherwise; and
|
|
4.1.2
|
fully
and finally releases and discharges the Releasees from any and all manner
of actions, claims, promises, debts, sums of money, demands, obligations,
in law or in equity, directly or indirectly, whether known or unknown,
foreseen or unforeseen, fixed or contingent, of any nature whatsoever that
Releasor may have by reason of any act, omission, matter, provision, cause
or thing whatsoever from the beginning of time to the Effective Date under
the SPA or otherwise.
|
|
For
the avoidance of doubt, all shares, monies and other consideration due to
the Sellers hereunder shall be issued or paid by the Buyer, when due, to
the Tax Trustee in accordance with Section 13(h) of the
SPA.
|
6
|
NO OTHER AMENDMENTS
|
SIGNED
|
|
By:
|
/s/ Thomas Lynch
|
for
and on behalf of
|
|
AMARIN
CORPORATION, PLC
|
|
SIGNED
|
|
By:
|
/s/ Alan Cooke
|
for
and on behalf of
|
|
ESTER
NEUROSCIENCES LTD.
|
|
SIGNED
|
|
By:
|
/s/ Ehud Geller
|
for
and on behalf of
|
|
MEDICA
II MANAGEMENT L.P
|
|
(AS
THE SELLERS’ REPRESENTATIVE)
|
Amarin
Corporation plc
|
Medica
II Management L.P., as Sellers’
Representative
|
SIGNED
|
|
By:
|
|
for
and on behalf of
|
|
AMARIN
CORPORATION, PLC
|
|
SIGNED
|
|
By:
|
|
for
and on behalf of
|
|
MEDICA
II MANAGEMENT L.P
|
|
(AS
THE SELLERS’ REPRESENTATIVE)
|
Family: 1961
|
Title:
|
Genetically
Engineered Human Cholinesterases
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1390
|
Zakut
Haim
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
1961-00
|
Priority
|
Abandoned
|
Israel
|
21/03/1989
|
89703
|
31/10/2001
|
Aug-01
|
02/03/2002
|
89703
|
||
1961-00
|
Priority
|
Abandoned
|
Israel
|
21/03/1989
|
89703
|
31/10/2001
|
Aug-01
|
02/03/2002
|
89703
|
||
1961-01
|
Abandoned
|
Canada
|
21/03/1990
|
2,012,720-1
|
20/09/1990
|
||||||
1961-02
|
Abandoned
|
US
|
20/03/1990
|
07/496,554
|
|||||||
1961-03
|
Abandoned
|
Europe
|
20/03/1990
|
90105274
|
14/06/1995
|
388906
|
|||||
1961-04
|
Abandoned
|
France
|
20/03/1990
|
90105274
|
14/06/1995
|
388906
|
|||||
1961-05
|
Abandoned
|
Switzerland
|
20/03/1990
|
90105274
|
14/06/1995
|
388906
|
|||||
1961-06
|
Abandoned
|
Great
Britain
|
20/03/1990
|
90105274.6
|
14/06/1995
|
388906
|
|||||
1961-07
|
Abandoned
|
Germany
|
20/03/1990
|
90105274.6
|
14/06/1995
|
69020019
|
|||||
1961-08
|
CIP
|
Granted
|
US
|
08/02/1993
|
08/111,314
|
21/01/1997
|
5,595,903
|
|
Family: 2042
|
Title:
|
Synthetic
Antisense Deoxyoligonucleotide and Pharmaceutical Compositions
Containing the Same
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1513
|
Eckstein
Fritz
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2042-00
|
Priority
|
Granted
|
Israel
|
15/04/1992
|
101600
|
29/02/2000
|
JOURNAL
11/99
|
30/05/2000
|
101600
|
||
2042-01
|
PCT
|
Exhausted
|
PCT
|
15/04/1993
|
PCT/EP93/00911
|
28/10/1993
|
WO
93/21202
|
||||
2042-02
|
NP
|
Abandoned
|
Japan
|
15/04/1993
|
517984/93
|
||||||
2042-03
|
NP
|
Granted
|
Europe
|
15/04/1993
|
93911467.4
|
05/04/1997
|
EP
0636137 B1
|
||||
2042-04
|
NP
|
Abandoned
|
Australia
|
15/04/1993
|
40399/93
|
14/12/1995
|
665087
|
||||
2042-05
|
NP
|
Abandoned
|
US
|
12/01/1994
|
08/318,826
|
04/06/1999
|
5,891,725
|
||||
2042-06
|
NP
|
Granted
|
Canada
|
15/04/1993
|
2,118,235
|
15/7/2008
|
2118235
|
||||
2042-07
|
CIP
|
Granted
|
US
|
05/02/1998
|
08/850,347
|
29/08/2000
|
6,110,742
|
||||
2042-08
|
NP
|
Granted
|
France
|
15/04/1993
|
03/12/1997
|
636137
|
|||||
2042-09
|
NP
|
Granted
|
Great
Britain
|
15/04/1993
|
93911467.4
|
02/01/1995
|
03/12/1997
|
636137
|
|||
2042-10
|
NP
|
Granted
|
Germany
|
15/10/1994
|
93
911467.4
|
02/01/1995
|
03/12/1997
|
693
08 833.8-08
|
|
Family: 2098
|
Title:
|
Transgenic
Animal Assay System for Anticholinesterases
Substances
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1777
|
Shani
Moshe
|
|
1390
|
Zakut
Haim
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2098-00
|
Priority
|
Abandoned
|
US
|
28/02/1994
|
08/202,755
|
||||||
2098-01
|
CIP
|
Abandoned
|
US
|
09/01/1995
|
08/370,156
|
03/08/1999
|
5,932,780
|
||||
2098-02
|
PCT
|
Exhausted
|
PCT
|
28/02/1995
|
PCT/US95/02806
|
31/08/1995
|
WO
95/23158
|
||||
2098-03
|
NP
|
Abandoned
|
Europe
|
28/02/1995
|
95913580.7
|
||||||
2098-04
|
CIP
|
Granted
|
US
|
06/03/1997
|
08/814,095
|
15/02/2000
|
6,025,183
|
Family: 2151
|
Title:
|
A
Method and Composition for Enabling Passage Through
BBB
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1882
|
Friedman
Alon
|
|
1881
|
Kaufer
Daniela
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2151-00
|
Priority
|
Expired
|
US
|
20/11/1996
|
60/031,194
|
||||||
2151-01
|
Priority2
|
Expired
|
US
|
12/12/1996
|
60/035,266
|
||||||
2151-02
|
PCT
|
Exhausted
|
PCT
|
20/11/1997
|
PCT/US97/21696
|
28/05/1998
|
WO
98/22132
|
||||
2151-03
|
From
Priority
|
Granted
|
US
|
20/11/1997
|
08/975,084
|
07/10/2001
|
6,258,780
|
||||
2151-04
|
NP
|
Granted
|
Israel
|
20/11/1997
|
129990
|
24/01/2005
|
Pat
Journal 11/2004
|
25/04/2005
|
129990
|
||
2151-05
|
NP
|
Abandoned
|
Australia
|
20/11/1997
|
53642/98
|
06/10/1998
|
04/12/2001
|
732043
|
|||
2151-06
|
NP
|
Abandoned
|
Canada
|
20/11/1997
|
2,272,280
|
||||||
2151-07
|
NP
|
Abandoned
|
Europe
|
20/11/1997
|
97950711.8
|
||||||
2151-08
|
NP
|
Filed
|
Japan
|
20/11/1997
|
10-523989
|
Family: 2304
|
Title:
|
Synthetic
Antisense Oligodeoxynucleotides and Pharmaceutical Compositions Containing
them
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1513
|
Eckstein
Fritz
|
|
1882
|
Friedman
Alon
|
|
1881
|
Kaufer
Daniela
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2304-00
|
Priority
|
Expired
|
US
|
12/12/1996
|
60/035,266
|
||||||
2304-01
|
PCT
|
Exhausted
|
PCT
|
12/12/1997
|
PCT/US97/23598
|
18/06/1998
|
WO
98/26062
|
||||
2304-02
|
CIP
|
Granted
|
US
|
12/12/1997
|
08/990,065
|
19/09/2000
|
6,121,046
|
||||
2304-03
|
NP
|
Allowed
|
Israel
|
12/12/1997
|
130162
|
||||||
2304-04
|
NP
|
Granted
|
Australia
|
12/12/1997
|
53856/98
|
14/12/2000
|
727611
|
||||
2304-05
|
NP
|
Examination
|
Canada
|
12/12/1997
|
2,274,985
|
||||||
2304-06
|
NP
|
Granted
|
Europe*
|
12/12/1997
|
97950993.2
|
15/09/1999
|
951536
|
24/1/2007
|
EP0951536
|
||
2304-07
|
NP
|
Filed
|
Japan
|
12/12/1997
|
10-527069
|
||||||
2304-08
|
CIP
|
Abandoned
|
US
|
09/572,630
|
Family: 2325
|
Title:
|
Antisense
and Non-Catalytic Properties
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1118
|
Soreq
Hermona
|
v
|
Licensee
|
|||||||||||
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2325-00
|
Priority
|
Expired
|
US
|
03/06/1997
|
60/040,203
|
||||||
2325-01
|
PCT
|
Exhausted
|
PCT
|
03/06/1998
|
PCT/US98/04503
|
09/11/1998
|
WO
98/39486
|
||||
2325-02
|
NP
|
Abandoned
|
Australia
|
03/06/1998
|
64521/98
|
AB
|
|||||
2325-03
|
NP
|
Abandoned
|
Canada
|
03/06/1998
|
2,283,068
|
||||||
2325-04
|
NP
|
Granted
|
US
|
03/06/1998
|
09/380,532
|
11/05/2002
|
6,475,998
|
||||
2325-05
|
NP
|
Abandoned
|
Europe
|
98910229.8
|
Abandoned
|
Family: 2356
|
Title:
|
Use
of A Specific AChE Peptide (I4) As A Growth
Factor
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1969
|
Deutch
Varda
|
|
1382
|
Eldor
Amiram
|
|
1970
|
Grisaru
Dan
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2356-00
|
Priority
|
Granted
|
Israel
|
31/05/1999
|
130224
|
19/02/2004
|
Pat
Journal 12/2003 |
20/05/2004
|
130224
|
||
2356-01
|
From
Priority
|
Abandoned
|
Israel
|
09/02/1999
|
131707
|
||||||
2356-02
|
PCT
|
Exhausted
|
PCT
|
31/05/2000
|
PCT/IL00/00311
|
12/07/2000
|
WO
00/73427
|
||||
2356-03
|
CIP
|
Granted
|
US
|
30/11/2001
|
09/998,042
|
20/02/2003
|
US-2003-0036632-A1
|
27/06/2006
|
7,067,486
|
||
2356-04
|
CIP
of CIP
|
Published
|
US
|
04/11/2006
|
11/401,670
|
22/03/2007
|
US-2007-0065882-A1
|
Family: 2463
|
Title:
|
Novel
Uses of Antibodies Against Ache and Peptides
thereof
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1882
|
Friedman
Alon
|
|
1881
|
Kaufer
Daniela
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2463-00
|
Priority
|
Abandoned
|
Israel
|
31/05/1999
|
130225
|
||||||
2463-01
|
PCT
|
Exhausted
|
PCT
|
31/05/2000
|
PCT/IL00/00312
|
12/02/2000
|
WO
00/73343
|
||||
2463-02
|
NP
|
Granted
|
US
|
31/05/2000
|
09/980,263
|
20/06/2006
|
7,063,948
|
||||
2463-03
|
NP
|
Granted
|
Europe
|
31/05/2000
|
931517.7
|
20/03/2002
|
1187853
|
23/02/2005
|
1187853
|
||
2463-04
|
NP
|
Filed
|
Canada
|
31/05/2000
|
2,371,675
|
||||||
2463-05
|
NP
|
Allowed
|
Israel
|
31/05/2000
|
146850
|
||||||
2463-06
|
DIV
|
Published
|
US
|
02/10/2006
|
11/352,073
|
06/08/2006
|
US-2006-0121536-A1
|
Family: 2584
|
Title:
|
Antisense
Oligonucleotide Against Human Ache and Uses thereof AS3
(EN101)
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2584-00
|
Priority
|
Filed
|
Israel
|
24/05/2001
|
143379
|
||||||
2584-01
|
PCT
|
Exhausted
|
PCT
|
24/05/2002
|
PCT/IL02/00411
|
01/09/2003
|
WO
03002739
|
||||
2584-02
|
CIP
of NP
|
Granted
|
US
|
27/03/2003
|
10/402,016
|
20/11/2003
|
US-2003-0216344-A1
|
07/11/2006
|
7,074,915
|
||
2584-03
|
NP
|
Examination
|
Europe
|
24/05/2002
|
2726406.8
|
25/02/2004
|
1390493
|
||||
2584-04
|
NP
|
Filed
|
Canada
|
24/05/2002
|
2,458,806
|
||||||
2584-05
|
NP
|
Allowed
|
Australia
|
24/05/2002
|
20002256873
|
18/10/2007
|
20002256873
|
||||
2584-06
|
NP
|
Filed
|
Japan
|
24/05/2002
|
2003-509100
|
||||||
2584-07
|
NP
|
Examination
|
India
|
24/05/2002
|
01497/KOLNP/2003
|
||||||
2584-08
|
NP
|
Examination
|
New
Zealand
|
24/05/2002
|
529549
|
||||||
2584-09
|
DIV
of CIP
|
Published
|
US
|
02/01/2006
|
11/346,145
|
08/10/2006
|
US-2006-0178333-A1
|
Family: 2806
|
Title:
|
Ache
Antisense Deoxyoligonucleotide As Anti-Inflammatory
Agent
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
3170
|
Yirmiya
Raz
|
|
1118
|
Soreq
Hermona
|
v
|
Family: 2816
|
Title:
|
ARP
As an Inducer of Granulocytopoiesis, Uses and Methods thereof
(Hematopoietic Stem Cells)
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1969
|
Deutch
Varda
|
|
1970
|
Grisaru
Dan
|
|
2637
|
Perry
Chava
|
|
2638
|
Pick
Marjorie
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2816-00
|
Priority
|
Filed
|
Israel
|
02/12/2004
|
160376
|
Tel-Aviv
Sourasky Medical Center
|
50
|
||||
2816-01
|
PCT
|
Exhausted
|
PCT
|
02/10/2005
|
PCT/IL2005/000185
|
Tel-Aviv
Sourasky Medical Center
|
50
|
||||
2816-02
|
NP
|
Filed
|
US
|
02/10/2005
|
10/589,116
|
27/9/2007
|
2007/0224181A1
|
Tel-Aviv
Sourasky Medical Center
|
50
|
Family:
|
Title:
|
ANTISENSE
OLIGONUCLEOTIDES AGAINST ACETYLCHOLINESTERASE FOR TREATING INFLAMMATORY
DISEASES
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
Eli
Hazum
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
Priority
|
Filed
|
US
|
04/10/2006
|
60/790,546
|
|||||||
PCT
|
Exhausted
|
PCT
|
29/3/2007
|
PCT/IL2007/000413
|
18/10/2007
|
WO2007/116395
|
|||||
NP
|
Filed
|
US
|
10/08/2008
|
12/296,455
|
|||||||
NP
|
Filed
|
Australia
|
29/3/2007
|
2007237059
|
|||||||
NP
|
Filed
|
New
Zealand
|
29/3/2007
|
571861
|
|||||||
NP
|
Filed
|
Europe
|
29/3/2007
|
PCT/IL2007/000413
|
|||||||
NP
|
Filed
|
Canada
|
29/3/2007
|
PCT/IL2007/000413
|
|||||||
NP
|
Filed
|
Israel
|
29/3/2007
|
194431
|
|||||||
NP
|
Filed
|
Japan
|
29/3/2007
|
PCT/IL2007/000413
|
1.
|
the
following activities (the “Additional Activities”)
will be deemed to be added to Schedule A of the Initial Trial Services
Letter Agreement:
|
Item
|
Amount
|
Purchase
of packaging components, project management,
|
$125,000
|
design
of labels
|
2.
|
the
Additional Activities shall be deemed to be Initial Trial A Services, as
such term is defined in the Initial Trial A Services Letter
Agreement;
|
3.
|
the
fees payable for the provision of the Additional Activities shall be
deemed to be included in the Total Initial Trial A Services Fees and
accordingly, the Total Trial A Service Fees shall remain unchanged;
and
|
4.
|
all
other provisions of the Initial Trial A Services Letter Agreement shall
remain unchanged and in full force and
effect.
|
ELAN
PHARMA INTERNATIONAL LIMITED
AND
AMARIN
PHARMACEUTICALS IRELAND LIMITED
|
TERMINATION
AND ASSIGNMENT AGREEMENT
|
1.
|
Definitions
and Interpretation
|
1
|
2.
|
Termination
of Agreement
|
3
|
3.
|
Assignment
and Transfer
|
3
|
4.
|
Consideration
|
4
|
5.
|
Effecting
Transfer
|
4
|
6.
|
Material
Agreements
|
5
|
7.
|
No
Assumption of Obligations
|
5
|
8.
|
Representations,
Warranties and Indemnification
|
6
|
9.
|
Miscellaneous
Provisions
|
8
|
Schedule
1
|
Material
Agreements
|
12
|
Schedule
2
|
Project
Materials
|
13
|
(1)
|
ELAN
PHARMA INTERNATIONAL LIMITED, a
limited liability company incorporated under the laws of Ireland, whose
registered office is at Monksland, Athlone, Co. Westmeath, Ireland (“Elan”);
and
|
(2)
|
AMARIN
PHARMACEUTICALS IRELAND LIMITED , a
limited liability company incorporated under the laws of Ireland, whose
registered office is at First Floor, Block 3, The Oval, Shelbourne Road,
Ballsbridge, Dublin 4, Ireland (“Amarin”)
|
(A)
|
Elan
and Amarin entered into a Development and License Agreement (dated 6 March
2007) relating to the joint development and commercialization of a
pharmaceutical product containing the active drug substance known as
lorazepam which incorporates Elan Intellectual Property, as defined
therein (the “Development
and License Agreement”).
|
(B)
|
Elan
and Amarin now wish to terminate the Development and License Agreement and
to transfer any other assets and/or rights which Amarin currently
maintains and Elan wishes to acquire in reference to the development and
commercialization of Product, Product Intermediate or Device (as said
terms are defined in the Development and License Agreement) with effect
from the Termination Date in accordance with the terms and conditions set
out below.
|
1.
|
DEFINITIONS AND
INTERPRETATION
|
1.1.
|
Definitions.
|
1.1.1
|
Except
where expressly provided to the contrary in this Termination and
Assignment Agreement, all capitalised terms used in this Termination and
Assignment Agreement shall have the same meanings as are assigned thereto
in the Development and License
Agreement.
|
1.1.2
|
“Amarin Intellectual Property
Rights” means (a) Amarin Intellectual Property, comprising for the
avoidance of doubt Amarin Improvements (which in turn includes Amarin’s
interest in the Joint Compound Improvements), Amarin Know-How and Amarin
Patents; and (b) all of Amarin’s rights (if any) in and to the Project
Materials.
|
1.1.3
|
“Encumbrance” means any
mortgage, charge, pledge, lien, option, restriction, right of first
refusal, right of pre-emption, third party right or interest, any other
encumbrance or security interest of any kind and any other type of
preferential arrangement (including title, transfer and retention
arrangements) having similar
effect.
|
1.1.4
|
“Material Agreements”
shall mean any agreements which currently exist between Amarin and a third
party relating to the development or commercialization of Product
Intermediate, Product or Device, including those set forth in Schedule
1.
|
1.1.5
|
“Neurostat Agreement”
means the Agreement dated January 18, 2007 for the termination and release
of certain confidentiality obligations between Neurostat Pharmaceuticals
Inc., Amarin Pharmaceuticals Ireland Limited, Amarin Corporation plc and
Tim Lynch
|
1.1.6
|
“Neurostat Know How”
means the Licensed Know How (if any), as such term is defined in the
Neurostat Agreement
|
1.1.7
|
“Project Materials” shall
mean all materials owned, held and/or controlled by Amarin, whether in
electronic or hard copy form, in reference to Product Intermediate,
Product or Device, including:
|
·
|
Amarin
Compound Data (as such term is defined in the Development and License
Agreement)
|
·
|
pharmacology,
pharmacokinetics and toxicology information relating to the Compound,
Product Intermediate, Product or Device not already covered by Amarin
Compound Data;
|
·
|
draft
or final study protocols which describe the details of approach and
experimental design of Product Intermediate, Product or Device not already
included in Amarin Compound Data;
|
·
|
draft
or final study reports which present data, charts and figures generated
from any preclinical studies relating to Product Intermediate, Product or
Device not already included in Amarin Compound
Data;
|
·
|
any
correspondence or notes relating to any communication with any patent
offices, Regulatory Authorities, consultants or other third parties with
respect to any filings, development, commercialization or other plans
associated with the development and/or commercialization of Product
Intermediate, Product or Device.
|
1.1.8
|
“Termination and Assignment
Agreement” means this termination and assignment agreement,
including its recitals.
|
1.1.9
|
“Termination Date” shall
mean the date of the last party to sign this Termination
Agreement.
|
1.1.10
|
“Workplans” shall mean
all work plans agreed and executed by the parties pursuant to the
Development and License Agreement, including but not limited to those
workplans executed in November 2007, January 2008 and August
2008.
|
1.2.
|
Interpretation. In
this Termination and Assignment
Agreement:
|
1.2.1
|
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 Termination and
Assignment Agreement.
|
1.2.2
|
The
headings in this Termination and Assignment Agreement are inserted for
convenience only and do not affect its
construction.
|
1.2.3
|
The
expressions “include”, “includes”, “including”, “in particular” and
similar expressions shall be construed without
limitation.
|
2.
|
TERMINATION OF
AGREEMENT
|
2.1.
|
The
Development and License Agreement and all Workplans are hereby terminated
with effect from the Termination
Date.
|
2.2.
|
Subject
to Clause 2.3 below, as of the Termination Date the Development and
License Agreement shall terminate and be of no further legal force and
effect and all rights granted to Amarin by Elan under that agreement shall
cease and revert to Elan. In particular, but without prejudice
to the generality of the foregoing, with effect from the Termination Date,
the Elan License granted in Clause 2.1 of the Development and License
Agreement and the options granted to develop and obtain additional license
rights to Expanded Formulations set out in Clause 2.4 of the Development
and License Agreement shall terminate and be of no further effect, and any
purported exercise of such an option prior to the Termination Date shall
be void and of no effect.
|
2.3.
|
Notwithstanding,
and in substitution for, the provisions of Clause 13 (Consequences of
Termination) of the Development and License
Agreement:
|
2.3.1
|
All
representations and warranties contained in the Development and License
Agreement insofar as appropriate remain in full force and
effect;
|
2.3.2
|
The
provisions of the Development and License Agreement regarding
confidentiality and non-use of materials or confidential information in so
far as these provisions apply to Amarin shall remain in effect for a
further period of [*******]1 from the
Termination Date; and for the avoidance of doubt in applying the
foregoing, all confidential information transferred to Elan under this
Termination and Assignment Agreement shall be considered Confidential
Information of Elan and not Confidential Information of
Amarin;
|
2.3.3
|
The
provisions of the Development and License Agreement regarding
non-competition set out in Clause 4.1 and 4.2 and 4.4 thereof with respect
to Amarin alone shall remain in effect for a further period of one (1)
year from the Termination Date;
|
2.3.4
|
To
the extent that any Claim is made in respect of any Product Intermediate,
Product or Device used, distributed or administered prior to the
Termination Date, the indemnification provisions set forth in Clause 14.5
of the Development and License Agreement shall remain in full force and
effect; and
|
2.3.5
|
Any
other provision of the Development and License Agreement, which is
necessary to survive to effectuate Clauses 2.3.1 through 2.3.4 of this
Termination Agreement, shall survive
termination.
|
|
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH
OMISSIONS.
|
3.
|
ASSIGNMENT AND
TRANSFER
|
3.1.
|
On
the Termination Date, Amarin shall transfer and supply to Elan and Elan
shall acquire all right, title and interest in the Project Materials, free
from Encumbrances.
|
3.2.
|
On
the Termination Date, Amarin shall transfer and assign all rights, title
and interest in Amarin Intellectual Property Rights to Elan free from
Encumbrances.
|
4.
|
CONSIDERATION
|
4.1.
|
Payment. In
consideration of Amarin’s entry into and performance of this Termination
and Assignment Agreement, Elan shall pay to Amarin the sum of US$700,000
(seven hundred thousand United States dollars). All payments due hereunder
shall be made in US dollars to the designated bank account of Amarin in
accordance with such reasonable written instructions as Amarin shall
provide.
|
4.2.
|
VAT. Payments
made by Elan pursuant to Clause 4.1 of this Termination and Assignment
Agreement are exclusive of VAT which will be additionally payable by Elan
in the event that VAT applies to this payment, provided that Amarin will
issue an appropriate VAT invoice to support any such VAT
charge. As Elan holds a valid VAT 13B authorization
(authorization number: 90/11298/102009) the parties acknowledge that VAT
will not be charged on this
transaction.
|
4.3.
|
Withholding. Any
income or other taxes which Elan is required by law to withhold from
amounts payable to Amarin under this Termination and Assignment Agreement
shall be deducted from the amount of such payments due to
Amarin. Any such tax required to be withheld shall be an
expense of and borne solely by Amarin. Elan shall promptly
provide Amarin with a certificate or other documentary evidence of such
withholding.
|
5.
|
EFFECTING
TRANSFER
|
5.1.
|
To
the extent that it has not already done so prior to the Termination Date,
Amarin shall as soon as reasonably practicable and in any event within
fifteen (15) days after the Termination Date provide to
Elan:
|
5.1.1
|
originals
and copies of all Project Materials, except that Amarin may retain one (1)
copy solely for the purposes of ensuring compliance with this Termination
and Assignment Agreement;
|
5.1.2
|
copies
of all Material Agreements;
|
5.1.3
|
an
itemised list of all Project Materials together with confirmation that
such list is complete and accurate.
|
5.2.
|
All
items referred to in Clause 5.1 shall be delivered
to:
|
|
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH
OMISSIONS.
|
5.3.
|
Within
fifteen (15) days after the Termination Date Amarin shall provide to Elan
an officer’s certificate confirming that the provisions of Clauses 5.1
have been duly complied with.
|
6.
|
MATERIAL
AGREEMENTS
|
6.1.
|
The
parties hereby acknowledge that Elan does not assume any liability or
obligation under the Material Agreements or any other agreement between
Amarin and a Third Party except as expressly set forth in this Clause
6. Amarin further agrees to indemnity and hold harmless Elan
for any obligations or liabilities arising from any circumstance or breach
by Amarin of the Material
Agreements.
|
6.2.
|
As
and when requested by Elan in respect of any Material Agreement, Amarin
shall either:
|
6.2.1
|
assign
such Material Agreement to Elan for no further consideration, except that
Elan shall be responsible for the performance of Amarin’s obligations
thereunder as from the time of assignment;
or
|
6.2.2
|
use
commercially reasonable efforts to terminate such Material
Agreement.
|
6.3.
|
In
the event that Elan wishes to assume a Material Agreement but Amarin is
not entitled to assign it without the consent of the
counter-party:
|
6.3.1
|
Elan
and Amarin shall use commercially reasonable efforts to procure the
expeditious assignment or novation of such Material
Agreement;
|
6.3.2
|
unless
and until such Material Agreement is assigned or
novated:
|
6.3.2.1
|
Elan
shall perform Amarin’s obligations under the Material Agreement in
question as Amarin’s sub-contractor, if such sub-contracting is
permissible under the Material Agreement in
question;
|
6.3.2.2
|
if
such sub-contracting is not permissible, Amarin shall duly perform all of
its obligations under the Material Agreement at Elan’s expense;
and
|
6.3.2.3
|
Amarin
shall hold the benefit of the Material Agreement on trust for Elan
absolutely, account to Elan for it promptly on demand and otherwise
operate the Material Agreement in such manner as Elan may lawfully
specify.
|
6.4
|
Amarin
hereby grants to Elan an exclusive, worldwide royalty-free sub-license to
use the Neurostat Know How to research, develop, use, make, have made,
import, offer for sale, sell and otherwise dispose of Products (as defined
in the Neurostat Agreement) with respect to which Amarin obtained rights
pursuant to the Development and License Agreement. Except to
the extent that Amarin’s license to the Neurostat Know How may be
revocable by the counter-parties thereto, such sub-license shall be
irrevocable.
|
7.
|
NO ASSUMPTION OF
OBLIGATIONS
|
7.1.
|
Generally. Elan
does not assume any liabilities of Amarin outstanding as of the
Termination Date, whether actual or
contingent.
|
7.2.
|
Employees. Elan
and Amarin acknowledge and agree that this Termination and Assignment
Agreement and the transactions contemplated by it are not intended to
constitute the transfer of an undertaking or any part thereof for the
purposes of the Transfer of Undertakings (Protection of Employment)
Regulations 2006 (SI 2006/246) (“TUPE”). As
between Elan and Amarin, Amarin shall remain solely responsible for its
employees, including all those employees whose duties include or have ever
included activities contemplated by the Development and License
Agreement.
|
7.3.
|
Indemnity. Amarin
shall indemnify and keep indemnified Elan against all moneys, actions,
proceedings, costs, claims, demands, damages and expenses made by or due
to any employee or former employee of Amarin in respect of or arising out
of the transactions contemplated by this Termination and Assignment
Agreement.
|
8.
|
REPRESENTATIONS,
WARRANTIES AND
INDEMNIFICATION
|
8.1.
|
Amarin. Amarin
represents and warrants to Elan as of the Termination Date as
follows:
|
8.1.1
|
Organisation and
Authority. Amarin is a limited liability company duly
incorporated and validly existing in Ireland. Amarin has all
the requisite legal and corporate power and authority to enter into this
Termination and Assignment Agreement and perform its obligations under
this Termination and Assignment Agreement. This Termination and
Assignment Agreement is the valid and binding obligation of the Purchaser,
enforceable against it in accordance with its terms except as limited by
applicable insolvency and other laws of general application affecting the
enforcement of creditors’ rights
generally.
|
8.1.2
|
No
Conflicts. There are no agreements between Amarin and
any third party that conflict with this Termination and Assignment
Agreement.
|
8.1.3
|
Approvals. No
permit, authorisation, consent or approval of or by, or any notification
of or filing with, any person is required in connection with the
execution, delivery or performance of this Termination and Assignment
Agreement by Amarin.
|
8.1.4
|
Standing. To
the best knowledge of Amarin, no order has been made or petition presented
or resolution passed for the winding up of Amarin. To the best
knowledge of Amarin, no distress, execution or other process has been
levied on any of the assets of Amarin. No power to appoint a
receiver has been exercised or has arisen in respect of the business or
any of the assets of Amarin and there is no unfulfilled or unsatisfied
judgment or Court order outstanding against any of them. None
of the foregoing statements in this Clause 8.1.4 will be rendered false by
the execution, delivery or performance of this Termination and Assignment
Agreement by Amarin.
|
8.1.5
|
Third Party
Rights. To the best knowledge of Amarin, without having
conducted any special search, no third party (including any counterparty
to a Material Agreement) has or will have any rights which may be
infringed by the importation, use, making, having made, offering for sale
or sale of Product or Product
Intermediate.
|
8.1.6
|
Employees. No
employee of Amarin or any of its Affiliates is wholly or principally
engaged in the development and/or future commercialisation of Product or
Product Intermediate.
|
8.1.7
|
Grants. Amarin
has not done or failed to do any act or thing which could result in all or
any part of a government grant or other similar payment or allowance, in
each case wholly or partly related to the development and/or future
commercialisation of Products, made or due to be made by it becoming
repayable or being forfeited by it, nor will the execution, delivery or
performance of this Termination and Assignment Agreement by Amarin result
in such a repayment or forfeiture.
|
8.1.8
|
Operation of
Development and License Agreement. Amarin has conducted
all activities under the Development and License Agreement in accordance
with all applicable laws and
regulations.
|
8.1.9
|
Intellectual
Property. There is no Amarin Intellectual Property,
comprising for the avoidance of doubt Amarin Improvements (which in turn
includes Amarin’s interest in the Joint Compound Improvements), Amarin
Know-How and Amarin Patents. To the best of Amarin’s knowledge,
neither Neurostat Pharmaceuticals Inc. nor Tim Lynch own or control any
patent rights relating to or disclosing Product or Product
Intermediate.
|
8.1.10
|
Litigation. There
are no claims or actions pending or threatened against Amarin, or any
person for whom Amarin is vicariously liable, arising out of the conduct
of its activities under the Development and License Agreement and/or the
development and/or commercialisation of the Products, and there is no
circumstance of which Amarin is aware which is likely to give rise to such
a claim or action.
|
8.2.
|
Elan. Elan
represents and warrants to Amarin as of the Termination Date as
follows:
|
8.2.1
|
Organisation and
Authority. Elan is a limited liability company duly
incorporated and validly existing in Ireland. Elan has all the
requisite legal and corporate power and authority to enter into this
Termination and Assignment Agreement and perform its obligations under
this Termination and Assignment Agreement. This Termination and
Assignment Agreement is the valid and binding obligation of the Purchaser,
enforceable against it in accordance with its terms except as limited by
applicable insolvency and other laws of general application affecting the
enforcement of creditors’ rights
generally.
|
8.2.2
|
No
Conflicts. There are no agreements between Elan and any
third party that conflict with this Termination and Assignment
Agreement.
|
8.2.3
|
Approvals. No
permit, authorisation, consent or approval of or by, or any notification
of or filing with, any person is required in connection with the
execution, delivery or performance of this Termination and Assignment
Agreement by Elan.
|
8.3.
|
Indemnification. Each
of the parties shall indemnify and hold harmless the other party against
all and any claims (whether successful or otherwise), loss, liability,
damages and expenses, including reasonable legal fees and expenses
(together, “Claims”) insofar as they
arise out of any breach by the first party of any of its obligations or
warranties under this Termination and Assignment Agreement or from the
first party’s fraud or wilful
misconduct.
|
8.4.
|
Conduct of
Claims. The party seeking an indemnity
shall:
|
8.4.1
|
fully
and promptly notify the other party of any Claim or proceedings, or
threatened Claim or proceedings;
|
8.4.2
|
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;
|
8.4.3
|
co-operate
in the investigation and defence of such Claim or proceedings;
and
|
8.4.4
|
take
all reasonable steps to mitigate any loss or liability in respect of any
such Claim or proceedings.
|
8.5.
|
Release.
|
8.5.1
|
Subject
to Clause 8.5.2, with effect from the date hereof, each party and each of
its Affiliates (“Releasor”):
|
8.5.1.1
|
waives
any accrued rights that Releasor may have accrued against the other party,
whether known or unknown, foreseen or unforeseen, fixed or contingent, of
any nature whatsoever from the beginning of time to the date hereof under
the Development and License Agreement;
and
|
8.5.1.2
|
fully
and finally releases and discharges that party from any and all manner of
actions, claims, promises, debts, sums of money, demands, obligations, in
law or in equity, directly or indirectly, whether known or unknown,
foreseen or unforeseen, fixed or contingent, of any nature whatsoever that
Releasor may have by reason of any act, omission, matter, provision, cause
or thing whatsoever from the beginning of time to the date hereof under
the Development and License
Agreement.
|
8.5.2
|
Neither
party or any other Releasor waives, releases or discharges any obligation
arising under or specifically set forth in this Termination and Assignment
Agreement, including obligations which continue in force pursuant to
Clause 2.3. Further, Elan does not waive any right it has or
may have, or release or discharge any liability which Amarin has or may
have, pursuant to Clause 15 of the Development and License Agreement
(confidentiality), but Elan acknowledges as of the Termination Date that
it has no knowledge of any breach of that provision by
Amarin.
|
8.6.
|
Extension of
Indemnification Etc. Where this Termination and
Assignment Agreement provides for the indemnification of a party to this
Termination and Assignment Agreement or for the limitation of a party’s
liability or for the release of a party from liability, such
indemnification and/or limitation and/or release (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.
|
9.
|
MISCELLANEOUS
PROVISIONS
|
9.1.
|
Assignment. This
Termination and Assignment Agreement may be freely assigned by
Elan. Amarin may not assign any of its rights or obligations
under this Termination and Assignment
Agreement.
|
9.2.
|
Parties
Bound. This Termination and Assignment Agreement shall
be binding upon and run for the benefit of the parties, their successors
and permitted assigns.
|
9.3.
|
Relationship of the
Parties. In this Termination and Assignment Agreement,
nothing shall be deemed to constitute a partnership between the parties,
or any of them, or make any party an agent for any other party, for any
purpose whatsoever.
|
9.4.
|
Entire
Agreement. This Termination and Assignment Agreement
constitutes the entire agreement and understanding between the parties
with respect to their subject matter, and except as expressly provided,
supersede all prior representations, writings, negotiations or
understandings with respect to that subject
matter.
|
9.5.
|
Costs. Each
party shall bear its own legal and professional advisers’ costs and
expenses incurred in connection with the negotiation and entering into of
this Termination and Assignment
Agreement.
|
9.6.
|
Severability. If
any provision in this Termination and Assignment 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 Termination and Assignment Agreement shall not be impaired or
affected in any way.
|
9.7.
|
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 Termination and Assignment
Agreement.
|
9.8.
|
Counterparts. This
Termination and Assignment 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
Termination and Assignment
Agreement.
|
9.9.
|
Notices.
|
9.9.1
|
A
notice under or in connection with this Termination and Assignment
Agreement (a “Notice”):
|
9.9.1.1
|
shall
be in writing; and
|
9.9.1.2
|
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:
|
9.9.2
|
The
address referred to in Clause 9.9.1.2
is:
|
|
Address:
Fax:
|
Elan
Pharma International Limited
Monksland
Athlone
Co.
Westmeath
Ireland [**********]3 |
|
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH
OMISSIONS.
|
|
Address:
Fax:
|
Amarin
Pharmaceuticals Ireland Limited
First
Floor
Block
3
The
Oval
Shelbourne
Road
Ballsbridge
Dublin
4
Ireland
+353 1 669
9028
|
9.9.3
|
Notice
is deemed given:
|
9.9.3.1
|
if
delivered personally, when the person delivering the notice obtains the
signature of a person at the address referred to in Clause
9.9.1.2;
|
9.9.3.2
|
if
sent by post, except air mail, six Business Days after posting
it;
|
9.9.3.3
|
if
sent by air mail, two Business Days after posting
it;
|
9.9.3.4
|
if
sent by fax, when confirmation of its transmission has been recorded by
the sender's fax machine.
|
9.10.
|
Confidentiality and
Announcements. The parties shall treat this Termination
and Assignment Agreement as confidential. No announcement or public
statement concerning the existence, subject matter or any term of this
Termination and Assignment Agreement, or its performance, shall be made by
or on behalf of any party without the prior written approval of the
other.
|
9.11.
|
Required
Disclosures. 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 Termination and Assignment
Agreement, or to disclose Confidential Information that the Disclosing
Party is required to make or disclose pursuant
to:
|
9.11.1
|
A
valid order of a court or Governmental
Authority
|
9.11.2
|
Any
other requirement of law or any securities or stock
exchange;
|
9.12.
|
Other
Disclosures. Each of the parties shall be entitled to
provide a redacted copy of this Termination and Assignment Agreement, to
be agreed between the parties, to establish the termination of the
Development and License Agreement and assignment of rights under this
Termination and Assignment Agreement to third parties, as may be required
by each party to conduct its commercial
business.
|
9.13.
|
Waivers. A
failure to exercise or delay in exercising a right or remedy provided by
this Termination and Assignment 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 Termination and Assignment Agreement or by law prevents
further exercise of the right or remedy or the exercise of another right
or remedy.
|
9.14.
|
Variations. No
variation of this Termination and Assignment Agreement shall be effective
unless it is made in writing and signed by each of the
parties.
|
9.15.
|
Governing Law and
Jurisdiction. This Termination and Assignment Agreement
shall be governed by and construed in accordance with the laws of Ireland,
and shall be subject to the non-exclusive jurisdiction of the Irish
courts.
|
|
SCHEDULE
1MATERIAL AGREEMENTS
|
|
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH
OMISSIONS.
|
|
SCHEDULE
2PROJECT MATERIALS
|
|
5
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH
OMISSIONS.
|
|
Duly
authorised for and on behalf of
|
|
Duly
authorised for and on behalf of
|
|
AMARIN
PHARMACEUTICALS IRELAND LIMITED
|
1.
|
Direct
Fees
|
·
|
Medpace
will perform CRF Development for the 0017 study, and Amarin will pay
Medpace $11,019.58 for this
service.
|
·
|
Medpace
will perform IVRS Development for the 0017 study, and Amarin will pay
Medpace $25,890.00 for this
service.
|
·
|
Medpace
will perform ICF services for the 0017 study, and Amarin will pay Medpace
$2,772.00 for this service.
|
·
|
Medpace
will Negotiate Site Budgets for the 0017 study, and Amarin will pay
Medpace $40,710.00 for this
service.
|
·
|
Medpace
will provide Study Master Files for the 0017 study, and Amarin will pay
Medpace $13,068.00 for this
service.
|
·
|
Medpace
will Collect Regulatory Documents for the 0017 study, and Amarin will pay
Medpace $70,136.93 for this
service.
|
·
|
Medpace
will perform Project Management for the 0017 study, and Amarin will pay
Medpace $99,566.71 for this
service.
|
·
|
Medpace
will conduct Teleconferences with the Sponsor for the 0017 study, and
Amarin will pay Medpace $2,568.00 for this
service.
|
·
|
Medpace
will perform Qualification Visits for the 0017 study, and Amarin will pay
Medpace $23,120.00 for this
service.
|
·
|
Medpace
will provide a Monitoring Plan for the 0017 study, and Amarin will pay
Medpace $1,106.80 for this service.
|
·
|
For
the Direct Fees listed above, Amarin will pay Medpace $289,958.01 for
the Initial
Trial 0017 Services Letter Agreement upon signature of this Amendment
#5.
|
2.
|
Pass
Through
|
·
|
Pass
Through costs for Monitoring Travel have been added in the amount of
$10,000.00.
|
·
|
Pass
Through costs for Conference Calls have been added in the amount of
$200.00.
|
·
|
For
the Pass Through costs listed above, Amarin will pay Medpace $10,200.00
for the Initial
Trial 0017 Services Letter Agreement upon signature of this Amendment
#5.
|
3.
|
Escrow
Fees
|
·
|
Escrow
Fees for Central IRB have been added in the amount of
$49,841.99.
|
·
|
For
the Escrow Fees listed above, Amarin will pay Medpace $49,841.99 for
the Initial
Trial 0017 Services Letter Agreement upon signature of this Amendment
#5.
|
1.
|
DEFINITIONS
|
1.1.
|
“Affiliate” shall mean a
corporation or entity controlling, controlled by, or under the common
control with SPONSOR, APIL, or MEDPACE, as the case may be. For the
purposes of this Agreement, “control” shall mean the direct or indirect
ownership of more than 50% of the issued voting shares or other voting
rights of the subject entity to elect directors, or if not meeting the
preceding criteria, any entity owned or controlled by the subject entity,
or owning or controlling the subject entity, at the maximum control or
ownership right permitted in the country where such entity
exists.
|
1.2.
|
“Clinical Study” shall
mean each human subject research study to be conducted by MEDPACE on
behalf of SPONSOR in accordance with
the
|
1.3.
|
“FDA” shall mean the
United States Food and Drug
Administration.
|
1.4.
|
“GCP” shall mean the ICH
Harmonised Tripartite Guideline for Good Clinical Practice and any
subsequent versions thereof, together with such other good clinical
practice requirements as are specified in the Federal Food, Drug and
Cosmetic Act, 21 U.S.C, applicable sections of Title 21 Code of Federal
Regulations, and any subsequent amendments thereof, and all local
equivalents thereof.
|
1.5.
|
“GLP” shall mean current
Good Laboratory Practice, as detailed in Title 21 Code of Federal
Regulations, Part 58, and the ICH Quality Guidelines, and any subsequent
amendments thereof, and all local equivalents
thereof.
|
1.6.
|
“GMP” shall mean current
Good Manufacturing Practice, as detailed in Title 21 Code of Federal
Regulations, Part 210 and Part 211, and the ICH Quality Guidelines, and
any subsequent amendments thereof, and all local equivalents
thereof.
|
1.7.
|
“Institution” shall mean
the clinical research site at which a particular Investigator conducts a
Clinical Study.
|
1.8.
|
“Investigator” shall
mean the individual who actually conducts a Clinical Study (i.e. under
whose immediate direction the Study Drug(s) is administered or dispensed
to a Study Subject).
|
1.9.
|
“Payment Schedule” shall
have the meaning given to the term in Section
2.1.3.
|
1.10.
|
“Project Schedule” shall
have the meaning given to the term in Section
2.1.3.
|
1.11.
|
“Project” shall have the
meaning given to the term in Section
2.1.1.
|
1.12.
|
“Project Documents”
shall mean, with respect to each Project, all documents other than
the Project Protocol and Task Orders that are prepared by SPONSOR and/or
MEDPACE, which instruct, provide information or otherwise explain the
conduct of such Project.
|
1.13.
|
“Project Protocol” shall
mean the document which describes the Project objectives, design,
methodology, statistical considerations and organization of a
Project.
|
1.14.
|
“Regulatory Agency”
means any governmental or regulatory authority in any relevant
jurisdictions having jurisdiction over the subject matter of the Projects,
including without limitation the
FDA.
|
1.15.
|
“Regulatory
Requirements” means
those laws, regulations, codes of conduct and guidelines applicable in the
countries in which each Project is being conducted or that are applicable
to the class of pharmaceutical product being tested or clinical specialty
involved, and any subsequent modifications or amendments
thereto.
|
1.16.
|
“Services” shall have
the meaning given to the term in Section
2.1.1.
|
1.17.
|
“SOPs” shall mean
standard operating procedures.
|
1.18.
|
“Study Drug(s)” shall
mean, with respect to each Clinical Study, the active drug(s) and placebo
that is the subject of such Clinical Study, as more particularly described
in the Task Order applicable
thereto.
|
1.19.
|
“Study Personnel” shall
have the meaning given to the term in Section
3.2.1.
|
1.20.
|
“Study Subjects” shall
mean an individual who participates in a Clinical Study as a recipient of
Study Drug(s).
|
1.21.
|
“Subcontractor” shall
have the meaning given to the term in Section
2.5.3.
|
1.22.
|
Further
Definitions:
|
Definition
|
Section
|
Advance
Payment
|
7.3.1
|
Change
Order
|
6.1
|
Claims
|
17.1
|
Clinical
Study Agreement
|
3.3.1
|
Damages
|
17.1
|
Final
Pass-through Costs Invoice
|
7.2.10
|
Internal
Audit
|
19.1.4.1
|
Internal
Audit Report
|
19.1.4.1
|
Investigator
Expenses
|
7.2.4
|
Investigator
Fees
|
7.2.4
|
Medpace
Confidential Information
|
11.2
|
Medpace
Expenses
|
7.2.4
|
Medpace
Fees
|
7.1
|
Medpace
SOPs
|
19.2.1.1
|
Regulatory
Inspection
|
19.1.5
|
Pass-Through
Costs
|
7.2.1
|
Project
Budget
|
2.1.3
|
Project
IP
|
13.1
|
Project
Records
|
15.1
|
Project
Results
|
12.1
|
Sponsor
Confidential Information
|
11.1
|
Sponsor
Inspection
|
19.1.3
|
Subcontractor
SOPs
|
19.2.2.1
|
Term
|
9.1
|
Task
Order
|
2.1.2
|
Task
Order Change
|
6.1
|
Total
Medpace Fees
|
7.1.2
|
2.
|
PROJECT
SPECIFICATIONS AND CONDUCT OF
PROJECT
|
2.1.
|
Task
Orders
|
2.1.1.
|
MEDPACE
hereby agrees to perform certain services for SPONSOR for certain
projects, including without limitation certain Clinical Studies, (each a
“Project”) from time to time in accordance with the terms of this
Agreement, the relevant Task Order and the relevant Project Protocol (the
“Services”).
|
2.1.2.
|
The
precise Services to be performed by MEDPACE shall be mutually agreed upon
by the Parties and set forth in one or more task orders (each a “Task
Order”), in substantially the form attached hereto as Exhibit
A.
|
2.1.3.
|
Each
Task Order shall be signed by an authorized representative of each Party
and shall include detailed information concerning a given Project,
including a description of the specific services to be provided, Project
milestones and target completion dates (“Project Schedule”), a detailed
budget (“Project Budget”), a schedule of payments related to the Project
Schedule and the Project Budget (“Payment Schedule”), and a copy of the
relevant Project Protocol.
|
2.1.4.
|
Each
Task Order shall contain a transfer of obligations list in conjunction
with the relevant Task Order and consistent with the regulations set forth
in 21 C.F.R. Section 312, Subpart D (Responsibilities of Sponsors and
Investigators) and all other Regulatory Requirements. Any
responsibilities not specifically transferred in the transfer of
obligations list shall remain the regulatory responsibility of
SPONSOR.
|
2.2.
|
Conduct
of the Project
|
2.2.1
|
the
terms of this Agreement;
|
2.2.2
|
all
specifications, requirements and timelines established in the relevant
Task Orders;
|
2.2.3
|
the
relevant Project Protocol, and all amendments
thereto;
|
2.2.4
|
all
agreed SOPs;
|
2.2.5
|
GMP
and GCP; and
|
2.2.6
|
all
Regulatory Requirements
|
2.3.
|
Project
Protocol
|
2.3.1.
|
For
the avoidance of doubt, MEDPACE shall not be entitled to make or implement
any amendment to any Project Protocol without the prior written consent of
SPONSOR.
|
2.4.
|
Personnel
|
2.4.1.
|
MEDPACE
shall arrange for appropriately qualified personnel to support its
obligations under this Agreement, the relevant Task Order and the relevant
Project Protocol (“Medpace
Personnel”).
|
2.4.2.
|
MEDPACE
shall be responsible for ensuring that all Medpace Personnel are qualified
by education, training and experience to perform their respective
obligations under this Agreement, the relevant Task Order and the relevant
Project Protocol.
|
2.4.3.
|
MEDPACE
shall provide to all relevant Medpace Personnel, subject to the
confidentiality provisions of Section 11 of this Agreement, copies of the
relevant Project Protocol and the Project
Documents.
|
2.4.4.
|
MEDPACE
shall be responsible for ensuring, at the beginning of each Project, and
on an ongoing basis during such Project, that Medpace Personnel are fully
informed regarding the Study Drug(s), the conduct of the Project pursuant
to the relevant Task Order and Project Protocol, and such Medpace
Personnel’s obligations with respect to this Agreement, the relevant Task
Order, and the relevant Project Protocol, including compliance with all
Regulatory Requirements.
|
2.4.5.
|
MEDPACE
shall remain fully liable for its, and all Medpace Personnel’s performance
of its, obligations hereunder.
|
2.4.6.
|
Key
personnel for both SPONSOR and MEDPACE shall be identified in the
applicable Task Order for each Project. Prior to their
appointment by MEDPACE, SPONSOR shall have the right to review and approve
the qualifications of key Medpace Personnel, which approval shall not be
unreasonably withheld. SPONSOR shall,
acting
|
2.4.7.
|
MEDPACE
shall maintain a consistently high skill level among all key Medpace
Personnel (including without limitation any replacement key Medpace
Personnel), consistent with its warranty in Section
8.2.4.
|
2.5.
|
Subcontractors
|
2.5.1.
|
This
Section 2.5 shall apply to the appointment of all subcontractors other
than Institutions, Investigators and Study Personnel by
MEDPACE. Sections 3.2 and 3.3 shall apply to the appointment of
Institutions, Investigators and Study Personnel by
MEDPACE.
|
2.5.2.
|
MEDPACE
may not subcontract any portion of the Services hereunder without the
prior written consent of SPONSOR.
|
2.5.3.
|
Should
MEDPACE subcontract with any third party upon such written consent of
SPONSOR (each a “Subcontractor”), MEDPACE shall procure that such
Subcontractors comply with all obligations of MEDPACE under this Agreement
and any Task Order. The term Subcontractor does not include Institutions,
Investigators and Study Personnel.
|
2.5.4.
|
MEDPACE
shall remain fully liable for its and such Subcontractor’s performance of
the Services and the obligations of MEDPACE
hereunder.
|
2.5.5.
|
Prior
to the appointment of any Subcontractor by MEDPACE, MEDPACE shall provide
SPONSOR with such details as may be required by SPONSOR regarding the
evaluation of such Subcontractor by
MEDPACE.
|
2.6.
|
Progress
Reporting
|
2.6.1.
|
MEDPACE
shall maintain appropriate systems to provide SPONSOR with regular
information regarding the progress of the obligations transferred as
detailed in appropriate Task
Orders.
|
2.7.
|
Data
Handling
|
2.7.1.
|
MEDPACE
shall use validated electronic data processing systems and
maintain documentary evidence of this
validation.
|
2.7.2.
|
MEDPACE
shall undertake the processing of Study data in accordance with agreed
SOPs, the relevant Task Orders, the relevant Project Protocols, and all
Regulatory Requirements. In particular, MEDPACE must at least
have adequate access controls, back-up procedures, data integrity and
validation checks, audit procedures and security training to enable
compliance with its obligations.
|
2.7.3.
|
MEDPACE
shall make available to SPONSOR descriptions of MEDPACE’S physical and
data security measures, standards and compliance requirements, and such
other information as may be requested by
SPONSOR.
|
3.
|
CLINICAL
STUDIES
|
3.1
|
Commencement
of Clinical Studies
|
3.1.1
|
MEDPACE
shall not commence patient recruitment for a Clinical Study until all
appropriate regulatory approvals as detailed in the relevant Task Order
have been obtained by SPONSOR and
MEDPACE.
|
3.1.2
|
MEDPACE
shall not commence Study Drug shipment to Investigator sites without the
prior written approval of SPONSOR.
|
3.2
|
Institutions,
Investigators and Study Personnel
|
3.2.1
|
Subject
to the consent of SPONSOR, MEDPACE shall select appropriate Institutions
and appropriately qualified clinical Investigators and study personnel
(“Study Personnel”) to conduct each Study in accordance with this
Agreement, the relevant Task Order and the relevant Project
Protocol.
|
3.2.2
|
Prior
to conducting any Investigator meetings, MEDPACE shall agree with SPONSOR
the extent to which SPONSOR wishes to be involved in such Investigator
meetings.
|
3.2.3
|
MEDPACE
shall be responsible for ensuring that all Investigators and Study
Personnel are qualified by education, training and experience to perform
their respective obligations under this Agreement, the relevant Task Order
and the relevant Project Protocol.
|
3.2.4
|
MEDPACE
shall provide to all Investigators and relevant Study Personnel, subject
to the confidentiality provisions of Section 11
of
|
3.2.5
|
MEDPACE
shall be responsible for ensuring, at the beginning of each Project, and
on an ongoing basis during such Project, that Investigators and Study
Personnel are fully informed regarding the Study Drug(s), the conduct of
the Project pursuant to the relevant Task Order and Project Protocol, and
such Study Personnel’s obligations with respect to this Agreement, the
relevant Task Order, and the relevant Project Protocol, including
compliance with all Regulatory
Requirements.
|
3.3
|
Clinical
Study Agreements
|
3.3.1
|
MEDPACE
shall ensure that, prior to the commencement of each Clinical Study, a
clinical study agreement, in substantially the form set out in Exhibit B,
(each a “Clinical Study Agreement”) shall be put in place with each
Institution (and, if applicable, each
Investigator).
|
3.3.2
|
MEDPACE
shall procure compliance by each Institution and each Investigator with
the Clinical Study Agreement.
|
3.4
|
Deviation
from Project Protocol
|
3.4.1
|
MEDPACE
shall not deviate from the relevant Project Protocol without SPONSOR’s
prior written consent, provided however that MEDPACE may deviate from such
Project Protocol when necessary to protect the safety, rights or welfare
of any Study Subjects.
|
3.4.2
|
MEDPACE
shall notify SPONSOR of any such deviations in accordance with Regulatory
Requirements and the notification obligations set out in the relevant Task
Order and Project Protocol.
|
4.
|
PROJECT
SCHEDULE
|
4.1
|
Each
Task Order shall contain a Project Schedule setting out Project timelines,
milestones and/or target dates for completion of a Project or a portion
thereof. In
all events, MEDPACE shall use its best efforts to comply with the Project
Schedule in each Task Order.
|
4.2
|
If
at any time either Party anticipates a delay in meeting the timelines for
a given Task Order as set forth in its Project Schedule, either due to
changes to the Services requested by SPONSOR, or other causes, then the
anticipating Party shall promptly notify the other Party in writing,
specifying the reason for the delay and the anticipated effect upon the
timelines, milestones or other
|
5.
|
NON-COMPLIANCE
BY MEDPACE
|
5.1
|
In
the event that MEDPACE fails to conduct the Projects and/or perform the
Services in accordance with the terms of this Agreement, the relevant Task
Orders, and the relevant Project Protocols, MEDPACE shall use its best
efforts to remedy such failure (whether by repeating the Services in
question or some other action as approved in advance by SPONSOR) at no
additional cost to SPONSOR, provided that such failure is not as a result
of SPONSOR’s delay or failure to provide agreed deliverables under the
relevant Task Order or Project
Protocol.
|
5.2
|
In
the event of a dispute as to whether or not MEDPACE has failed to
conduct the Projects and/or perform the Services in accordance
with the terms of this Agreement, the relevant Task Orders, and the
relevant Project Protocols, such dispute shall be referred to the CEO of
MEDPACE and the Head of R&D of
SPONSOR.
|
5.3
|
For
the avoidance of doubt, nothing in this Section 5 shall affect SPONSOR’s
right to terminate this Agreement under Section 9
below.
|
6.
|
CHANGE
ORDERS
|
6.1
|
Any
change in the details of a Task Order or the assumptions upon which the
Task Order is based (each a “Task Order Change”) may require changes in
the Project Budget, Payment Schedule or Project Schedule. Every
such change shall require a written amendment to the Task Order (each a
“Change Order”). Each Change Order shall be in substantially
the form set out in Exhibit C and shall detail the requested changes to
the applicable task, responsibility, duty, budget, timeline or other
matter. The Change Order will become effective upon the
execution of the Change Order by the Parties, and the Change Order will
specify the period of time within which MEDPACE must implement the
changes. The Parties agree to act in good faith and promptly
when considering a Change Order requested by another Party but no Party is
obligated to execute a Change Order. No Change Order shall
become effective unless and until it is signed by the
Parties. Any Task Order Changes that result in additional
charges shall be reflected in the Change Order to the affected Task Order,
Project Budget or Payment Schedule.
|
6.2
|
The
Parties will use best efforts to ensure a Change Order has been executed
by the Parties prior to the implementation of any Task Order
Change. At a minimum, Medpace will notify the Sponsor in
advance of any additional costs
|
6.3
|
The
parties agree that:
|
6.3.1
|
MEDPACE
shall be responsible for all incremental costs which are incurred directly
as a result of any Task Order Change requested by MEDPACE;
and
|
6.3.2
|
SPONSOR
shall be responsible for all incremental costs which are incurred directly
as a result of any Task Order Change requested by
SPONSOR.
|
7.
|
PROJECT
BUDGET, PAYMENT SCHEDULE, AND TERMS
|
7.1
|
MEDPACE
Fees
|
7.1.1
|
APIL
agrees to pay MEDPACE fees for Services rendered (“MEDPACE Fees”) pursuant
to the Project Budget and Payment Schedules included in each Task
Order.
|
7.1.2
|
The
total Medpace Fees for each Project (the “Total MEDPACE Fees”) shall be
set out in the relevant Task Order and in no event shall APIL be required
to pay any amount exceeding the Total MEDPACE Fees unless otherwise agreed
in writing by both parties by Change Order(s) in accordance with Section 6
above.
|
7.1.3
|
MEDPACE
shall issue invoices in respect of MEDPACE Fees in accordance with the
Payment Schedule.
|
7.2
|
Pass-through
Costs
|
7.2.1
|
APIL
agrees to reimburse MEDPACE for reasonable and necessary pass-through
costs identified in the Task Order and incurred by MEDPACE in providing
the Services in accordance with the relevant Task Order (“Pass-through
Costs”).
|
7.2.2
|
Pass-through
costs incurred by MEDPACE that are (i) in addition to the total
Pass-through Costs identified in the relevant Task Order, or (ii) that are
not notified in accordance with Section 6.2, shall not be recoverable by
MEDPACE without the prior written
approval of Amarin.
|
7.2.3
|
Pass-through
Costs will be reimbursed by APIL on a direct cost basis i.e. without any
mark up being added by MEDPACE.
|
7.2.4
|
Pass-through
Costs include, but are not limited to, Investigators’ fees (“Investigator
Fees”), reasonable and necessary expenses incurred by Investigators
(“Investigator Expenses”), reasonable and necessary expenses incurred by
Medpace employees (“Medpace Expenses”), CRF printing costs, courier costs,
teleconference fees, drug packaging and labeling and pharmacy
fees.
|
7.2.5
|
MEDPACE
shall agree Investigator Fees with each Investigator based upon industry
standard rates in the relevant jurisdiction where such Investigator is
located. Upon the request of SPONSOR, MEDPACE shall provide
such information as may be reasonably requested by SPONSOR to evidence
that such Investigator Fees are based upon the relevant industry standard
rates.
|
7.2.6
|
All
Medpace Expenses must comply with the MEDPACE Travel and Expenses Policy,
as approved by SPONSOR on the Effective Date. MEDPACE shall
promptly notify SPONSOR of any amendments to such
policy. Medpace Expenses that are incurred other than in
accordance with such policy shall not be recoverable by
MEDPACE.
|
7.2.7
|
All
Pass-through Costs invoiced by MEDPACE must be accompanied by appropriate
documentary evidence as required by SPONSOR, such as receipts or other
documentation reasonably acceptable to SPONSOR. Invoices in
respect of Pass-through Costs shall be further analyzed into the following
categories; (i) Investigator Fees, (ii) Investigator Expenses and (iii)
other Pass-through Costs.
|
7.2.8
|
In
the case of any individual Pass-through Cost item (excluding Investigator
Fees) exceeding US$5,000 that is not identified in the relevant Task
Order, SPONSOR’s prior written approval must be given for such
expense.
|
7.2.9
|
MEDPACE
shall issue invoices in respect of Pass-through Costs on a monthly
basis.
|
7.2.10
|
With
respect to each Clinical Study, MEDPACE shall use best efforts to issue a
final invoice in respect of all outstanding Pass-through Costs (the “Final
Pass-through Costs Invoice”) within 90 days of the issue by MEDPACE of the
final signed form of Clinical Study Report in accordance with the relevant
Task Order; provided that MEDPACE agrees that it shall issue the Final
Pass-through Costs Invoice within a maximum of 120 days of the issue by
MEDPACE of the final signed form of Clinical Study Report in accordance
with the relevant Task Order. For the avoidance of doubt, once
the Final Pass-through Costs Invoice has been issued by MEDPACE, MEDPACE
shall not be entitled to recover any additional pass-through
costs.
|
7.3
|
Advance
Payments
|
7.3.1
|
If
SPONSOR and MEDPACE agree in writing in the relevant Task Order(s) that as
part of the Services to be provided under such Task Order(s) that MEDPACE
is to enter into agreements with third parties, which include but are not
limited to third party advance payments for investigator meetings,
vendors, Study Site payments and any payments to investigators,
institutions, and site maintenance organizations for services performed
that relate to a Study, and obligate itself to making payments to such
third parties for services rendered in conducting a Study (as defined in
the relevant Task Order(s)), then SPONSOR shall escrow in advance all
funds necessary for MEDPACE to meet its current payment obligations under
such agreements and those obligations for the upcoming fiscal quarter
(including non-cancellable expenses) (an “Advance
Payment”). The request for an Advance Payment should be
accompanied by appropriate documentation supporting such a
request.
|
7.3.2
|
APIL
shall make such Advance Payments to MEDPACE within 5 days after receipt of
a written invoice in respect of same. Within 5 days of each quarter end,
Medpace will provide a statement reconciling Advance Payments made by
Sponsor with disbursements of same by
Medpace.
|
7.3.3
|
For
the avoidance of doubt, this Section 7.3 is without prejudice to Section
7.2.
|
7.4
|
Subject
to Section 7.3.2, APIL shall make payments to MEDPACE within 30 days after
receipt of a written invoice and such supporting documentation as required
by SPONSOR. A monthly interest rate of 1% above LIBOR will be applied to
invoices that remain outstanding for longer than 45
days.
|
7.5
|
An
exchange rate of 1US Dollar to 1.45 Euro will be included in each Task
Order. Exchange rates will be monitored on a monthly
basis. In the event of exchange rate fluctuations exceeding +/-
2%, all ex-US Pass-through Costs will be adjusted
accordingly.
|
7.6
|
All
sums referred to in each Work Order shall be exclusive of Value Added Tax
(VAT).
|
7.7
|
APIL
shall be authorised to receive invoices and to make remittances under this
Agreement. All invoices should be addressed to APIL at the
following address:
|
8.
|
WARRANTIES
AND REPRESENTATIONS
|
8.1
|
Acknowledgements:
|
8.2
|
Representations,
Warranties and Covenants of MEDPACE
|
8.2.1
|
MEDPACE
represents and warrants that it is a corporation with its principal office
and place of business at 4620 Wesley Avenue, Cincinnati, Ohio 45212, duly
organized, validly existing and in good standing in its place of
organization, and is duly qualified to do
business.
|
8.2.2
|
MEDPACE
represents and warrants that the execution and delivery of this Agreement
has been validly authorized by all necessary corporate action and that
this Agreement represents the valid binding agreement of MEDPACE
enforceable in accordance with its terms. The execution,
delivery and performance of this Agreement will not violate any
organizational document governing MEDPACE, any agreement to which MEDPACE
is a party, or any law or court or governmental order, holding or writ by
which MEDPACE is bound.
|
8.2.3
|
MEDPACE
further warrants that it shall render the Services requested by SPONSOR in
accordance with high professional standards, GCP, GLP, and GMP, the agreed
SOPs, this Agreement, the Task Orders, the Project Protocols, and, without
prejudice to the foregoing, the standard of care customary in the contract
research organization industry.
|
8.2.4
|
MEDPACE
represents and warrants that the personnel assigned to perform Services
rendered under this Agreement shall be qualified and professionally
capable of performing the Services in accordance with this Agreement, the
relevant Task Order, and the relevant Project Protocol, and shall devote
such time as is necessary to perform the Services in accordance with this
Agreement, the relevant Task Order (including the relevant Project
Schedule), and the relevant Project
Protocol.
|
8.2.5
|
MEDPACE
further represents and warrants that it shall perform the Services in
compliance with all Regulatory Requirements, including, without
limitation, the Federal Food, Drug and Cosmetic Act and
the regulations promulgated pursuant thereto, and all future amendments
thereto, and all other applicable Regulatory Requirements in all relevant
jurisdictions.
|
8.2.6
|
MEDPACE
represents and warrants that there is no litigation, regulatory
investigation or proceeding, administrative hearing or any other similar
proceeding pending or threatened against MEDPACE which could adversely
affect MEDPACE’s ability to perform the
Services.
|
8.2.7
|
MEDPACE
covenants that each employee, agent, developer, consultant and contractor
who has access to, contributes to, or participates in the creation of any
Project Results or Project IP hereunder (as such terms are defined in
Sections 12 and 13 below) during the Term shall execute a confidentiality
agreement in favour of MEDPACE that protects the confidentiality of such
Project Results and Project IP and shall execute an assignment or other
agreement to assign in favour of MEDPACE all such person’s right, title
and interest in the Project Results and Project
IP.
|
8.3
|
Representations
and Warranties of SPONSOR and APIL
|
8.3.1
|
SPONSOR
represents and warrants that it is a corporation with its principal office
and place of business at Mystic Packer Building, 12 Roosevelt Avenue,
Mystic, Connecticut, CT 06355, duly organized, validly existing and in
good standing in its place of organization, and is duly qualified to do
business
|
8.3.2
|
APIL
represents and warrants that it is a corporation with its principal office
and place of business at 1st Floor, Block 3, The Oval, Shelbourne Road,
Ballsbridge, Dublin 4, Ireland, duly incorporated and validly existing in
its place of incorporation.
|
8.3.3
|
SPONSOR
and APIL each represents and warrants that the execution and delivery of
this Agreement has been validly authorized by
all
|
8.3.4
|
SPONSOR
and APIL each represents and warrants that there is no litigation,
regulatory investigation or proceeding, administrative hearing or any
other similar proceeding pending or threatened against SPONSOR or APIL
which could adversely affect SPONSOR’s or APIL’s ability to perform its
obligations under this Agreement or any Task
Order.
|
9.
|
TERM
AND TERMINATION
|
9.1
|
Term
|
9.1.1
|
The
Agreement shall commence on the Effective Date and shall continue in full
force and effect until terminated by the Parties in accordance with the
terms hereof (the “Term”).
|
9.2
|
Termination by
SPONSOR
|
9.2.1
|
SPONSOR
may forthwith terminate this Agreement or any Task Order with or without
cause immediately upon giving MEDPACE written notice of such
termination.
|
9.3
|
Termination by
MEDPACE
|
9.3.1
|
MEDPACE
may terminate a Task Order upon giving SPONSOR written notice of such
termination only if SPONSOR is in material breach of its obligations
thereunder and has not cured such default within 10 days after receipt of
written notice if the default is the failure to pay MEDPACE any amount due
thereunder or within 30 days after receipt of written notice in the event
of any other default.
|
9.4
|
Consequences of
Termination
|
9.4.1
|
Upon
receipt by MEDPACE and/or SPONSOR of a termination notice, the Parties
shall cooperate in good faith to agree on a plan to expeditiously conclude
activities with respect to such
matter.
|
9.4.2
|
As
soon as practicable after receipt of such notice, MEDPACE shall transfer
to SPONSOR all Project Records, Project Results, Project Documents, unused
Study Drug, SPONSOR Confidential Information, and all other data and
information in MEDPACE’s possession in
any
|
9.4.3
|
In
the event of any termination of a Task Order before completion, MEDPACE
shall use its best efforts to reduce the costs incurred by SPONSOR as a
result of such early termination.
|
9.4.4
|
Other
than in the event of termination by SPONSOR of this Agreement or any
particular Task Order for breach of this Agreement by MEDPACE, as soon as
reasonably practicable following receipt of a termination notice, MEDPACE
shall submit an itemized accounting of Services performed, MEDPACE
Expenses, MEDPACE Fees, Investigator Expenses, Investigator Fees and other
non-cancelable Pass-through Costs actually incurred by MEDPACE pursuant to
the performance of such Services, and payments received by MEDPACE from
SPONSOR, together with any additional information required by
SPONSOR, in order to determine the balance to be paid by the
Parties to each other. Such balance shall be paid within 30
days of approval by SPONSOR of such itemized accounting by
MEDPACE. For the avoidance of doubt, this Section 9.4.4 is
without prejudice to Section
7.2.10.
|
9.4.5
|
Upon
termination for any reason of this Agreement or any Task Orders relating
to a particular Study, MEDPACE shall immediately terminate all relevant
Clinical Study Agreements that are in place at the date of such
termination.
|
9.4.6
|
For
the avoidance of doubt, the provisions of Section 15.4 shall apply to all
queries raised by SPONSOR relating to the Projects after termination of
this Agreement or any Task Order.
|
9.5
|
In
the event that a Clinical Study is terminated by SPONSOR prior to
completion for reasons related to the safety and welfare of the Study
Subjects, MEDPACE shall notify the relevant regulatory authorities and
ethics committees in accordance with the applicable Regulatory
Requirements.
|
10.
|
COMMUNICATIONS
|
10.1
|
Any
notice required or permitted under this Agreement shall be in writing and
shall be deemed given if (i) delivered personally, (ii) mailed by prepaid,
first class, certified mail, return receipt requested, or (iii) sent by
express courier service, to the Party to be notified at the addresses set
forth below (or such other address as shall be designated by written
notice); provided that all notices shall be effective upon receipt
thereof:
|
10.2
|
If
to MEDPACE:
|
11.1
|
SPONSOR,
may provide confidential information to MEDPACE during the course of this
Agreement. All information provided by SPONSOR, or any of its
Affiliates on or prior to the date of this Agreement or data generated,
derived or collected by MEDPACE for SPONSOR during the course of
performance of the Services is deemed to be the confidential information
of SPONSOR (“SPONSOR Confidential Information”). SPONSOR
Confidential Information shall include but is not limited to all
information, data and materials, and intellectual property, and any
non-public information pertaining to SPONSOR’s business practices or other
proprietary information. During the Term and for a period of 10
(ten) years thereafter, MEDPACE undertakes to treat all SPONSOR
Confidential Information as confidential and MEDPACE shall not disclose
SPONSOR Confidential Information to any third party, or use SPONSOR
Confidential Information for any purpose other than for those set forth
under this Agreement or a Task Order, without the prior written consent of
SPONSOR.
|
11.1.1
|
MEDPACE
shall ensure by binding written agreement that its employees, agents, and
approved independent contractors involved in the Services (including,
without limitation, all Investigators) and any third parties to whom
MEDPACE intends to disclose the
SPONSOR
|
11.1.2
|
MEDPACE
shall exercise all due care to prevent the unauthorized disclosure and use
of SPONSOR Confidential
Information.
|
11.1.3
|
MEDPACE
agrees that its will be responsible for any breach of this Agreement by
any officers or employees or approved independent contractors of MEDPACE
(including, without limitation all Institutions and Investigators) and
agrees to take, at MEDPACE’s sole expense, all necessary measures to
restrain officers and employees and approved independent contractors of
MEDPACE (including, without limitation all Institutions and Investigators)
from prohibited or unauthorized disclosure or use of SPONSOR Confidential
Information (including, without limitation, the initiation of court
proceedings).
|
11.2
|
MEDPACE
Confidential Information.
|
11.2.1
|
SPONSOR
shall ensure by binding written agreement that its employees, agents, and
approved independent contractors involved
in
|
11.2.2
|
SPONSOR
shall exercise all due care to prevent the unauthorized disclosure and use
of confidential information associated with the
Services.
|
11.2.3
|
SPONSOR
agrees that its will be responsible for any breach of this Agreement by
any officers or employees or approved independent contractors of SPONSOR
and agrees to take, at SPONSOR’s sole expense, all necessary measures to
restrain officers and employees and approved independent contractors of
SPONSOR from prohibited or unauthorized disclosure or use of MEDPACE
Confidential Information (including, without limitation, the initiation of
court proceedings).
|
11.3
|
These
confidentiality and nondisclosure provisions shall not apply
to:
|
11.3.1
|
information
which has become lawfully known to the receiving Party before the date
hereof, otherwise than in breach of any obligation of confidentiality to
the disclosing Party, or which is independently discovered, after the date
hereof, without the aid, application or use of the confidential
information, as evidenced by written
records;
|
11.3.2
|
information
which is in the public domain on the date hereof or subsequently becomes
publicly available through no fault or action of the receiving Party;
or
|
11.3.3
|
information,
which is disclosed to the receiving Party by a third party after the date
hererof, authorized to disclose it.
|
11.4
|
Subject
to Section 11.6, if the receiving Party is requested to disclose
confidential information of the disclosing Party or the terms of this
Agreement in connection with a legal or administrative proceeding or
otherwise to comply with a requirement under applicable Regulatory
Requirements, the
|
11.5
|
SPONSOR
shall be entitled to provide a copy of this Agreement (and any related
agreements or documents) to a potential third party acquirer, investor or
other commercialization partner provided that the relevant third party has
entered into a confidentiality agreement on terms to be agreed between
SPONSOR and such relevant third
party.
|
11.6
|
Subject
to Section 11.7, SPONSOR shall be entitled to issue any release,
disclosure or filing relating to this Agreement required by applicable
Regulatory Requirements or the rules or regulations of any stock exchange
on which the securities of SPONSOR or an Affiliate of SPONSOR are
listed.
|
11.7
|
Upon
receipt of written approval from MEDPACE, such approval not to be
unreasonably withheld, SPONSOR shall be entitled to issue any press
release regarding the execution of this
Agreement.
|
12.
|
RIGHTS
IN PROPERTY
|
12.1
|
All
materials, documents, data, software and information of every kind and
description, including without limitation all Study reports and Study
data, and all electronic data files containing all such materials,
documents, data, software and
information:
|
12.1.1
|
supplied
to MEDPACE by SPONSOR, APIL or any of their Affiliates;
or
|
12.1.2
|
prepared,
developed, generated, derived or otherwise created by MEDPACE pursuant to
this Agreement, (except for the MEDPACE procedural manuals and documented
standard operating procedures pre-existing as of the Effective
Date),
|
12.2
|
APIL
and its Affiliates shall have the right to make whatever use they deem
desirable of any Project Results. MEDPACE shall not, without
the prior written consent of SPONSOR, publish, disseminate, or otherwise
disclose to any third party any Project Results or Project IP (as such
term is defined in Section 13.1), or use any such Project Results or
Project IP for any purpose other than the performance of this
Agreement.
|
12.3
|
Any
inventions or other intellectual property, including without limitation
patents, patent applications, protectable copyrights and trademarks, that
may evolve from the Project Results or as the result of Services performed
by MEDPACE under this Agreement shall belong exclusively to APIL and
MEDPACE agrees to assign all its rights in all such inventions and/or
other intellectual property to APIL consistent with the obligations set
forth in Article 13 below.
|
12.4
|
SPONSOR
and APIL acknowledges that all computer programs, software and
applications, databases (excluding for the avoidance of doubt all
electronic files containing any Project Results), and MEDPACE procedural
manuals and documented standard operating procedures
that:
|
12.4.1
|
have
been independently developed without the benefit of any information
provided by SPONSOR (including without limitation any SPONSOR data,
information, materials or SPONSOR Confidential Information (or derivatives
thereof)); and
|
12.4.2
|
have
not been developed for SPONSOR,
|
13.
|
PATENT
RIGHTS
|
13.1
|
MEDPACE
shall disclose promptly to SPONSOR any and all inventions, discoveries,
know-how and improvements conceived or made by MEDPACE while providing
Services to SPONSOR pursuant to the Agreement, whether or not constituting
an improvement, alteration, enhancement, modification, or extension of use
of SPONSOR’s proprietary rights (“Project
IP”).
|
13.2
|
Subject
to Section 12.4, all Project IP shall belong exclusively to APIL, and
MEDPACE agrees to assign all its interest therein to APIL or its nominee;
whenever requested to do so by SPONSOR or APIL. MEDPACE
shall
|
14.
|
PUBLICITY
|
14.1
|
MEDPACE
shall not make any public announcements concerning this Agreement or the
subject matter hereof, nor use SPONSOR’s name, logo or trademark in any
communication, release, notice or other publication, without the prior
written consent of SPONSOR.
|
14.2
|
Save
as provided in Section 11.6, SPONSOR may not use MEDPACE’s name, logo or
trademark in any communication, release, notice or other publication
without the express prior written consent of
MEDPACE.
|
14.3
|
Publication
of any Project Results or Project IP from any Project or any information
relating thereto (including that any such Project has commenced, taken
place, or completed) shall, subject only to disclosure requirements
imposed by applicable Regulatory Requirements, be within the sole and
absolute discretion of the SPONSOR and MEDPACE shall not make any
publication in relation thereto without the prior written consent of
SPONSOR.
|
14.4
|
Without
prejudice to any other provisions of this Agreement, MEDPACE recognizes
that Amarin Corporation plc (“Amarin”), an Affiliate of SPONSOR, is a
publicly limited company listed on NASDAQ. Project Results will
likely comprise material non-public information of Amarin and the
strictest procedures will require to be followed by MEDPACE and SPONSOR to
safeguard the confidentiality of all such information prior to any
disclosure by Amarin or any Affiliate of Amarin. SPONSOR and
MEDPACE shall agree a policy which the Parties will be required to follow
as regards communication between SPONSOR and MEDPACE of any Project
Results prior to Amarin’s ultimate public disclosure of
same.
|
15.
|
SECURITY
AND DISPOSITION OF PROJECT FILES
|
15.1
|
MEDPACE
shall use best efforts, including, but not limited to, periodic backup of
computer files, to prevent the loss or alteration of the Project Results,
SPONSOR Confidential Information, case report forms, and all other SPONSOR
materials, documentation and correspondence (“Project
Records”). MEDPACE shall comply in all respects with all
applicable Regulatory Requirements concerning the validation, maintenance,
creation and storage of records, including electronic
records.
|
15.2
|
At
appropriate time points or upon completion of Services under a Task Order
or upon the written request of SPONSOR, MEDPACE shall transfer all Project
Records to SPONSOR. MEDPACE shall have the right to retain one
copy of any Project Records necessary solely to meet applicable Regulatory
Requirements or MEDPACE’s own internal audit requirements, so long as it
continues to maintain the confidentiality requirements of Article
11.
|
15.3
|
Project
Records shall be retained by MEDPACE for the period required under
applicable Regulatory Requirements. Thereafter, MEDPACE shall,
at the written request of SPONSOR, return or destroy such Project Records
in accordance with the written instructions of
SPONSOR.
|
15.4
|
After
the completion of each Project, MEDPACE shall provide all reasonable
assistance in relation to any subsequent questions raised by SPONSOR or
its Affiliates. MEDPACE shall charge SPONSOR for all such
data queries at the rate specified in the relevant Task
Order.
|
16.
|
SPONSOR
OBLIGATIONS
|
16.1
|
SPONSOR
acknowledges that the performance of the Services by MEDPACE will require
the co-operative involvement of SPONSOR and MEDPACE, and SPONSOR hereby
agrees to provide such assistance as may be reasonably necessary to enable
MEDPACE to perform the Services.
|
17.
|
INDEMNIFICATION
|
17.1
|
Indemnification
by SPONSOR
|
17.2
|
Indemnification
by MEDPACE
|
17.3
|
Limitation
for fraud etc
|
17.4
|
Process
for Indemnification, Defense and/or Settlement of
Claims
|
17.5
|
Insurance
|
17.5.1
|
MEDPACE
shall, at its own cost and expense, obtain and maintain in full force and
effect the following insurance during the
Term:
|
17.5.1.1
|
General
Liability Insurance with a per-occurrence limit of not less than
$1,000,000;
|
17.5.1.2
|
Employers
Liability Insurance with a per-occurrence limit of not less than
$1,000,000 per accident;
|
17.5.1.3
|
Professional
Services Errors & Omissions Liability Insurance with per-occurrence
limit of not less than $10,000,000.
|
17.5.2
|
SPONSOR
shall, at its own cost and expense, obtain and maintain in full force and
effect the following insurance during the
Term:
|
17.5.2.1
|
General
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to €5,000,000;
|
17.5.2.2
|
Employers
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to €13,000,000 per
accident;
|
17.5.2.3
|
Products
Liability Insurance (for clinical trial activity only) with a
per-occurrence limit of not less than an amount equivalent to
€7,500,000.
|
17.5.3
|
MEDPACE
and SPONSOR shall furnish certificates of insurance evidencing the
required insurance policies to the other as soon as practicable after the
Effective Date and within 30 days after renewal of such
policies. In the event that any of the required policies of
insurance are written on a claims made basis, then MEDPACE and SPONSOR
shall ensure that such policies shall be maintained during the entire Term
and shall use reasonable endeavours to ensure that such policies shall be
maintained for a period of not less than 3 years following the expiration
or termination of this Agreement. Each insurance policy that is
required under this Agreement shall be obtained from an insurance carrier
with an A.M. Best rating of at least A-VII. MEDPACE and SPONSOR
shall ensure that each of the required policies include a general
indemnity to principal clause.
|
17.5.4
|
With
respect to each Project, MEDPACE shall, prior to the commencement of any
Services in relation thereto, inform SPONSOR of any discrepancies between
its insurance cover and the policy exclusions thereunder and the relevant
Project Protocol.
|
18.
|
LIMITATION
OF LIABILITY
|
18.1
|
Notwithstanding
the terms of Article 17 above, in no event shall SPONSOR or MEDPACE be
liable 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 consequential, special or incidental or punitive loss
or
|
19.
|
MONITORING,
INSPECTIONS, AUDITS AND
NOTIFICATIONS
|
19.1
|
Inspections/Audits
|
19.1.1
|
Subject
to Section 19.1.2, SPONSOR shall have the right, upon at least ten (10)
business days’ prior written notice to MEDPACE, to examine the standard
operating procedures, quality systems, facilities, books, records, papers,
files and documentation, including computer files, data bases and records,
at MEDPACE’s facilities and the facilities of any Subcontractors, to
determine the adequacy of such records, to ensure the Services are being
performed in accordance with this Agreement, the approved Task Orders and
all applicable Regulatory Requirements, and/or to examine the financial
records of MEDPACE as may be reasonably necessary to verify Pass-through
Costs incurred during the performance of the Services. Such
inspections and audits (each a “SPONSOR Inspection”) shall be conducted
during normal business hours.
|
19.1.2
|
In
the event that SPONSOR suspects that MEDPACE, or any Subcontractor, may be
in breach of this Agreement, including without limitation its obligations
to comply with GMP and/or GCP (as applicable), SPONSOR shall have the
right, upon at least three (3) business days’ prior written notice to
MEDPACE, to conduct a SPONSOR Inspection at MEDPACE’s facilities and the
facilities of any Subcontractor.
|
19.1.3
|
If
any Regulatory Agency requests to inspect any books, records, data of
MEDPACE or any Subcontractor, relating to the Services, MEDPACE shall
immediately notify SPONSOR and shall promptly notify SPONSOR of the
outcome of any such inspection (each a “Regulatory Inspection”) within
five (5) business days of such outcome becoming known to
MEDPACE.
|
19.1.4
|
Internal
Audits
|
19.1.4.1
|
In
the event that MEDPACE or any Subcontractor, conducts an internal audit
that relates in any way to the Services (an “Internal Audit”) at the
request and expense of SPONSOR, then MEDPACE shall, and shall procure that
all relevant Subcontractors shall, furnish to SPONSOR a copy of the final
report in respect of such Internal Audit (the “Internal
Audit
|
19.1.4.2
|
In
the event that MEDPACE or any Subcontractor conducts an Internal Audit at
its own expense, then MEDPACE shall, and shall procure that such
Subcontractor shall, furnish to SPONSOR a copy of the Internal Audit
Report in a timely fashion once such report has been issued, provided that
MEDPACE shall, and shall procure that such Subcontractor shall, notify
SPONSOR of any critical findings in such Internal Audit Report within
three (3) days of the Internal Audit Report being
issued.
|
19.1.5
|
MEDPACE
shall, and shall procure that all Subcontractors shall, provide all
necessary assistance including making available members of its staff and
providing access to all relevant facilities and all requested records, to
facilitate such SPONSOR Inspections, Regulatory Inspections and Internal
Audits.
|
19.1.6
|
Except
as otherwise agreed in writing with SPONSOR, MEDPACE shall at its own cost
and expense, and shall procure that each Subcontractor shall at its own
cost and expense, take all reasonable steps required by SPONSOR or any
relevant Regulatory Agency to cure any deficiencies found in any relevant
Internal Audit, SPONSOR Inspection, Regulatory Inspection, or other
inspection or investigation within ten (10) business days of the relevant
report being issued or of MEDPACE or the relevant
Subcontractor, becoming aware of such
deficiency.
|
19.1.7
|
For
the avoidance of doubt, the rights of SPONSOR relating to inspections and
audits as set out in this Section 19.1 shall apply to any third party
acting on behalf of SPONSOR, provided there is a confidentiality agreement
in place between SPONSOR and such third party on terms to be agreed
between SPONSOR and such third
party.
|
19.2
|
Standard
Operating Procedures
|
19.2.1
|
MEDPACE
SOPs
|
19.2.1.1
|
MEDPACE
shall, promptly following the Effective Date, provide SPONSOR with a list
of all of SOPs of MEDPACE relating to the performance of the Services (the
“MEDPACE SOPs”).
|
19.2.1.2
|
On
an annual basis thereafter, MEDPACE shall provide SPONSOR with an updated
list of MEDPACE SOPs.
|
19.2.1.3
|
MEDPACE
shall promptly notify SPONSOR of any material updates to the MEDPACE SOPs
that are made during the period between each annual
update.
|
19.2.1.4
|
Upon
request from SPONSOR, MEDPACE shall provide copies of the MEDPACE SOPS to
SPONSOR.
|
19.2.2
|
Subcontractor
SOPs
|
19.2.2.1
|
MEDPACE
shall procure that, promptly following the date upon which a Subcontractor
commences the performance of Services, each Subcontractor shall provide
SPONSOR with a list of all SOPs of such Subcontractors relating to the
performance of the Services (the “Subcontractor
SOPs”).
|
19.2.2.2
|
MEDPACE
shall procure that, on an annual basis thereafter, each Subcontractor
shall provide SPONSOR with an updated list of Subcontractor
SOPs.
|
19.2.2.3
|
MEDPACE
shall procure that each Subcontractor shall promptly notify SPONSOR of any
material updates to the Subcontractor SOPs that are made during the period
between each annual update.
|
19.2.2.4
|
Upon
request from SPONSOR, MEDPACE shall procure that each Subcontractor shall
provide copies of the Subcontractor SOPS to
SPONSOR.
|
19.2.3
|
MEDPACE
shall not, and shall procure that each Subcontractor shall not, commence
the performance of any Services until SPONSOR has approved the relevant
SOPs of MEDPACE and the relevant
Subcontractors.
|
19.3
|
Oversight
of the Projects
|
19.3.1
|
MEDPACE
will actively oversee the progress of the Projects, and ensure that they
are conducted, recorded, and reported in accordance with this Agreement,
applicable Task Orders, the agreed SOPs, GCP, GLP, GMP, and other
applicable Regulatory Requirements. Any deviations will be recorded and
reported to SPONSOR as defined in the relevant Task
Orders.
|
19.3.2
|
MEDPACE
shall, and shall procure that all Subcontractors shall, at all times make
available to SPONSOR, or to the responsible Regulatory Agency, relevant
records, programs and data as may reasonably be requested by SPONSOR or
which is the subject of a Task
Order.
|
19.3.3
|
MEDPACE
shall procure that SPONSOR shall have the right at any time to visit any
of the facilities where MEDPACE and the Subcontractors are performing any
of the Services in order to monitor the operations of MEDPACE and the
Subcontractors hereunder.
|
19.3.4
|
During
such monitoring visits, SPONSOR shall have the right to inspect the work
being done and materials used, to observe the procedures being followed,
to examine the books, records and other data relevant to the
Services.
|
19.4
|
Notification
of suspected fraud or misconduct
|
19.4.1
|
Subject
to Section 19.4.2, MEDPACE shall adhere to all Regulatory Requirements
with respect to notification to SPONSOR regarding suspected fraud or
misconduct by MEDPACE, any Institution, Investigator or Subcontractor in
the conduct of any Project.
|
19.4.2
|
MEDPACE
shall notify SPONSOR within one (1) business day of becoming aware of any
suspected fraud or misconduct in the conduct of any
Project.
|
19.4.3
|
Where
any Subcontractor suspects any fraud or misconduct in the conduct of any
Project, Medpace shall procure that such Subcontractor shall notify
SPONSOR and MEDPACE within one (1) business day of becoming aware of any
suspected fraud or misconduct in the conduct of any
Project.
|
19.4.4
|
If
the initial notification is verbal, written confirmation shall be sent to
SPONSOR by MEDPACE, and where applicable by the relevant Subcontractor,
within one (1) working day of such initial
notification.
|
19.5
|
Institutions/Investigators
|
19.5.1
|
MEDPACE
acknowledges that, under the Clinical Study Agreement, Institution is
obliged to make certain notifications to MEDPACE regarding the outcome of
inspections carried out by Institution and/or by any regulatory agencies,
that MEDPACE has certain rights to conduct certain inspections and audits
of Institutions and/or Investigator, and that MEDPACE has certain rights
to oversee the progress of the
Study.
|
19.5.2
|
MEDPACE
shall immediately notify SPONSOR of any notifications it receives from any
Institution regarding such inspections by Institution and/or any
Regulatory Agency, or the outcome of any inspection or audit conducted by
MEDPACE of the Institution and/or Investigator, or of any observations
MEDPACE makes while overseeing the Study, as soon as it becomes aware of
same.
|
20.
|
DEBARMENT
|
|
20.1
MEDPACE hereby represents, warrants, and certifies that neither it nor any
of its officers, directors, owners, principals or employees has been or
will be at any relevant time hereunder debarred by any Regulatory Agency
under any applicable Regulatory Requirement, including without limitation
by the FDA under Section 306 of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. §335a.
|
20.2
|
MEDPACE
hereby represents, warrants, and certifies that it has not and shall not
use in any capacity the services of any individual, corporation,
partnership, or association (including without limitation any Institution,
Investigator or Study Personnel)
who:
|
20.2.1
|
is
under investigation by any Regulatory Agency under any applicable
Regulatory Requirement, including without limitation by the FDA, for a
debarment action or is presently debarred pursuant to Section 306 (a)
and/or Section 306 (b) of the Federal Food Drug and Cosmetic Act (21
U.S.C. 335(a) and b) as published in the Federal Register (FR));
or
|
20.2.2
|
has
a disqualification hearing pending or has been disqualified by any
Regulatory Agency under any Regulatory Requirement, including without
limitation the FDA, pursuant to US 21 CFR Section 312.70 or its successor
provisions.
|
|
20.3
|
If,
during the term of this Agreement, any person or entity referred to in
Section 20.1 or Section 20.2:
|
|
20.3.1
|
comes
under investigation by any Regulatory Agency, including without limitation
the FDA, for debarment or disqualification;
or
|
|
20.3.2
|
is
debarred or disqualified by any Regulatory Agency, including without
limitation the FDA; or
|
|
20.3.3
|
engages
in any conduct or activity which could lead to any of the above mentioned
disqualification or debarment
actions;
|
|
MEDPACE
shall immediately notify SPONSOR in writing of
same.
|
21.
|
NON
SOLICITATION
|
22.
|
ENTIRE
AGREEMENT AND
AMENDMENTS/MODIFICATIONS
|
23.
|
GOVERNING
LAW
|
24.
|
NO
WAIVER
|
25.
|
INDEPENDENT
CONTRACTOR
|
27.
|
SEVERABILITY
|
27.1
|
If
any provision in this Agreement is agreed by the Parties to be, or is
deemed to be, or becomes invalid, illegal, void or unenforceable under any
law that is applicable hereto:-
|
27.1.1
|
such
provision will be deleted; and
|
27.1.2
|
the
validity, legality and enforceability of the remaining provisions of this
Agreement shall not be impaired or affected in any
way.
|
28.
|
ASSIGNMENT
|
28.1
|
Except
as set forth herein, no Party shall assign this Agreement or any Task
Order except with the express prior written consent of the other
Party.
|
28.2
|
Notwithstanding
anything contained herein, SPONSOR and APIL may assign this Agreement
and/or any Task Order to any Affiliate or to a Successor, without the
prior written consent of MEDPACE.
|
28.3
|
As
used herein, “Successor” means any entity which acquires all or
substantially all of the assets or shares of a Party or any entity into
which a Party is merged.
|
29.
|
CONFLICTS
BETWEEN AGREEMENTS
|
30.
|
FURTHER
ASSURANCES
|
31.
|
SURVIVING
PROVISIONS
|
1.
|
Scope of
Work: MEDPACE shall perform the services described in
the Scope of Work, attached hereto as Appendix 2, in accordance with the
Project Schedule, attached hereto as Appendix 3 and any other documents
attached to and specifically referenced in this Task Order
(“Services”)
|
2.
|
Compensation: For
performance of these Services, SPONSOR shall pay to MEDPACE an amount
equal to the Project Budget set forth in Appendix 4, which amount shall be
payable pursuant to the Payment Schedule set forth in Appendix
5. The Project Budget is provided for cost analysis
purposes. It is agreed that all fees are fixed prices unless
the underlying assumptions (including without limitation trial duration,
number of sites/patients, services provided) change and all such changes
shall be agreed and documented in a Change Order in accordance with
Section 6 of the MSA. After staff are assigned, costs are
incurred based upon allocation of staff
capacity. The
|
3.
|
Transfer of
Obligations: Sponsor Obligations transferred to MEDPACE
by SPONSOR (consistent with the regulations set forth in 21 C.F.R. Section
312, Subpart D) and all other Regulatory Requirements are identified in
Appendix 6.
|
4.
|
Master Services
Agreement. The provisions of the Master Services Agreement are
hereby expressly incorporated by reference into and made a part of this
Task Order. Defined terms used in this Task Order shall have
the meaning given to such terms in the Master Services Agreement unless
defined otherwise herein. In the event of any conflict between
any provisions of this Task Order and the Master Services Agreement, the
provisions of the Master Services Agreement shall
prevail.
|
(1)
|
AMARIN PHARMA INC whose
principal place of business is at Mystic Packer Building, 12 Roosevelt
Avenue Mystic, Connecticut, CT 06355 (“SPONSOR”);
|
(2)
|
AMARIN PHARMACEUTICALS IRELAND
LIMITED whose registered office is at 1st
Floor, Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland
(“APIL”);
and
|
(3)
|
MEDPACE INC., of 4620
Wesley Avenue, Cincinnati, Ohio 45212, US (“MEDPACE”)
|
A.
|
SPONSOR,
APIL and MEDPACE are bound by the terms of the Master Services Agreement
dated ________________, 2009 (the “Master
Agreement”).
|
B.
|
SPONSOR,
APIL and MEDPACE executed a task order on ________________,
200_ (the “Task
Order”).
|
C.
|
SPONSOR,
APIL and MEDPACE now wish to amend certain details of the Task Order on
the terms as set out below.
|
1
|
The
parties agree to amend the Task Order as
follows:
|
Details
of Change Required
|
Change
Value
|
[insert
details of changes to budget, timelines, payment
schedule]
|
|
Date
to Implement Change:
|
DD
MMM YYYY
|
2
|
Except
as expressly set forth in this Change Order, all other terms and
conditions of the Master Agreement and the Task Order remain the
same.
|
3
|
Unless
otherwise defined herein, all defined terms used in this Change Order
shall have the meaning given to such terms in the Master Agreement and the
Task Order.
|
|
SIGNED
BY
|
|
If
to the Company:
|
Amarin
Corporation plc
7
Curzon Street
London
W1J 5HG
England
Attention: Chief
Financial Officer
Fax: 44-20-7499-9004
|
|
With
copies to:
|
Cahill
Gordon & Reindel LLP
80 Pine Street New
York, New York 10005
Attention: Christopher
T. Cox, Esq.
Fax:
(212) 378-2416
|
|
If
to a Lender:
|
To
the address of such Lender set forth on Exhibit
A
|
COMPANY:
|
AMARIN
CORPORATION PLC
|
By:
_________________________________
|
Name:
|
Title:
|
LENDERS:
|
SUNNINGHILL
LIMITED
|
By:
__________________________
|
Name:
|
Title:
|
MIDSUMMER
VENTURES, LP
|
By:
__________________________
|
Name:
|
Title
|
MIDSUMMER
INVESTMENT, LIMITED
|
By:
___________________________
|
Name:
|
Title:
|
___________________________ |
Name: David Brabazon
|
___________________________ |
Name: David Hurley
|
___________________________ |
Name: Thomas G. Lynch
|
___________________________ |
Name: Dr.
Simon Kukes
|
___________________________ |
Name: Maximus Lachman
|
___________________________ |
Name: Samson Lachman
|
Name
and Address of Lender
|
Loan
Amount
|
|
Sunninghill
Limited
Po
Box 76
Kleinwort
Bonson House Wests Centre
St.
Helier
Jersey
JE4
8PQ
|
$3,000,000
|
|
Midsummer
Ventures, LP
295
Madison Avenue
38th
Floor New York
N.Y.
10017
|
$750,000
|
|
Midsummer
Investment, Limited
295
Madison Avenue
38th
Floor New York
N.Y.
10017
|
$750,000
|
|
David
Brabazon
47
Mount Prospect Avenue
Clontarf
Dublin
3
|
$175,000
|
|
David
Hurley
Silvermere
Killiney
Heath
Killiney
Co
Dublin
|
$175,000
|
|
Thomas
G. Lynch
Dalraida,
Claremont
Road
Foxrock
Dublin
18
Ireland
|
$250,000
|
|
Dr.
Simon Kukes
Samara
Nafta
Smolensky
Blvd
4
Moscow
119034
Russia
|
$250,000
|
Maximus
Lachman
298
Greenway Road
Ridgewood
New
Jersey 07450, USA
|
$75,000
|
Samson
Lachman
298
Greenway Road
Ridgewood
New
Jersey 07450, USA
|
$75,000
|
COMPANY:
|
AMARIN
CORPORATION PLC
|
By:
___________________________
|
Name:
|
Title:
|
COMPANY:
|
AMARIN
CORPORATION PLC
|
By:
____________________________
|
Name:
|
Title:
|
________________________________
|
Name
of Holder
|
By:
________________________________
|
Name:
|
Title:
|
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: ______________________
|
Amarin
Corporation plc
7
Curzon Street
London
W1J 5HG
England
Facsimile: 44-20-7499-9004
Attn: Chief
Financial Officer
cc: General
Counsel
|
Cahill
Gordon & Reindel LLP
80
Pine Street
New
York, New York 10005-1702
Facsimile: 212-378-2198
Attn: William
M. Hartnett, Esq.
|
Purchaser
|
Per
Unit Purchase Price
|
Closing
Purchase Price
|
Shares
|
Warrants
|
Pro
Rata Percentage
|
Caduceus
Private Investments III, LP
|
$1.00
|
$6,933,962
|
6,933,962
|
3,466,981
|
9.85%
|
OrbiMed
Associates III, LP
|
$1.00
|
$66,038
|
66,038
|
33,019
|
0.09%
|
Sofinnova
Venture Partners VII, L.P.
|
$1.00
|
$7,000,000
|
7,000,000
|
3,500,000
|
9.94%
|
Longitude
Venture Partners, L.P.
|
$1.00
|
$3,431,226
|
3,431,226
|
1,715,613
|
4.87%
|
Longitude
Capital Associates, L.P.
|
$1.00
|
$68,774
|
68,774
|
34,387
|
0.10%
|
Fountain
Healthcare Partners Fund 1, L.P.
|
$1.00
|
$5,000,000
|
5,000,000
|
2,500,000
|
7.10%
|
Stichting
Depositary APG Developed Markets Equity Pool
|
$1.00
|
$7,250,000
|
7,250,000
|
3,625,000
|
10.30%
|
Abingworth
Bioventures V L.P.
|
$1.00
|
$7,500,000
|
7,500,000
|
3,750,000
|
10.65%
|
Abingworth
Bioventures V Co-Invest Growth Equity Fund LP
|
$1.00
|
$7,500,000
|
7,500,000
|
3,750,000
|
10.65%
|
Abingworth
Bioequities Master Fund Limited
|
$1.00
|
$2,000,000
|
2,000,000
|
1,000,000
|
2.84%
|
Biomedical
Offshore Value Fund, Ltd.
|
$1.00
|
$2,414,000
|
2,414,000
|
1,207,000
|
3.43%
|
Biomedical
Value Fund, L.P.
|
$1.00
|
$4,686,000
|
4,686,000
|
2,343,000
|
6.66%
|
Visium
Balanced Master Fund, Ltd.
|
$1.00
|
$2,400,000
|
2,400,000
|
1,200,000
|
3.41%
|
Opus
Point Healthcare Innovations Fund, L.P.
|
$1.00
|
$225,000
|
225,000
|
112,500
|
0.32%
|
Opus
Point Healthcare Value Fund, L.P.
|
$1.00
|
$225,000
|
225,000
|
112,500
|
0.32%
|
Opus
Point Healthcare (Low Net) Fund, L.P.
|
$1.00
|
$100,000
|
100,000
|
50,000
|
0.14%
|
Opus
Point Capital Preservation Fund, L.P.
|
$1.00
|
$200,000
|
200,000
|
100,000
|
0.28%
|
Capital
Ventures International
|
$1.00
|
$900,000
|
900,000
|
450,000
|
1.28%
|
Cummings
Bay Capital
|
$1.00
|
$170,000
|
170,000
|
85,000
|
0.24%
|
Geneve
Corp.
|
$1.00
|
$80,000
|
80,000
|
40,000
|
0.11%
|
BioHedge
Holdings Limited
|
$1.00
|
$94,676
|
94,676
|
47,338
|
0.13%
|
Rosalind
Capital Partners, L.P.
|
$1.00
|
$155,324
|
155,324
|
77,662
|
0.22%
|
Boxer
Capital LLC
|
$1.00
|
$3,250,000
|
3,250,000
|
1,625,000
|
4.62%
|
RCG
PB Ltd.
|
$1.00
|
$337,500
|
337,500
|
168,750
|
0.48%
|
Ramius
Enterprise Master Fund Ltd.
|
$1.00
|
$112,500
|
112,500
|
56,250
|
0.16%
|
RA
Capital Healthcare Fund, L.P.
|
$1.00
|
$3,374,020
|
3,374,020
|
1,687,010
|
4.79%
|
Blackwell
Partners, LLC
|
$1.00
|
$425,980
|
425,980
|
212,990
|
0.61%
|
Sunninghill
Limited
|
$0.90
|
$2,000,000
|
2,222,222
|
1,111,111
|
3.16%
|
Midsummer
Ventures, LP
|
$0.90
|
$500,000
|
555,555
|
277,777
|
0.79%
|
Midsummer
Investment, Limited
|
$0.90
|
$250,000
|
277,777
|
138,888
|
0.39%
|
David
Brabazon
|
$0.90
|
$175,000
|
194,444
|
97,222
|
0.28%
|
David
Brabazon
|
$1.00
|
$180,000
|
180,000
|
90,000
|
0.26%
|
David
Hurley
|
$0.90
|
$175,000
|
194,444
|
97,222
|
0.28%
|
David
Hurley
|
$1.00
|
$90,000
|
90,000
|
45,000
|
0.13%
|
Thomas
G. Lynch
|
$0.90
|
$250,000
|
277,777
|
138,888
|
0.39%
|
Dr.
Simon Kukes
|
$0.90
|
$250,000
|
277,777
|
138,888
|
0.39%
|
Eunan
Maguire
|
$1.00
|
$180,000
|
180,000
|
90,000
|
0.26%
|
Anthony
Russell Roberts
|
$1.00
|
$50,000
|
50,000
|
25,000
|
0.07%
|
Total:
|
$70,000,000
|
70,399,996
|
35,199,996
|
100.00%
|
No.
W___
|
October
[ ],
2009
|
AMARIN
CORPORATION PLC
|
|
By:
_________________________
Name:
Title: Director
|
Address: Amarin
Corporation plc
First
Floor, Block 3
The
Oval, Shelbourne Road
Ballsbridge,
Dublin 4
Ireland
Facsimile: 353
(1) 6699 028
|
In
the presence of a witness
|
By:
_________________________
Name:
Title:
|
Occupation:
Address:
|
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:___________________
|
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)
|
Re:
|
Amarin Corporation
plc
|
·
|
Caduceus
Private Investments III, LP
|
·
|
OrbiMed
Associates III, LP
|
·
|
Sofinnova
Venture Partners VII, L.P.
|
·
|
Longitude
Venture Partners, L.P.
|
·
|
Fountain
Healthcare Partners Fund 1, L.P.
|
·
|
[include
other Purchasers]
|
(1)
|
AMARIN
CORPORATION plc
|
|
(2)
|
ALAN
COOKE
|
(1)
|
AMARIN CORPORATION plc
whose registered office is at 110 Cannon Street, London, EC4N 6AR, England
(the "Company");
|
(2)
|
Alan Cooke (the "Employee")
|
(A)
|
The
Company anticipates consummating an equity financing pursuant to a
Securities Purchase Agreement with various investors (such consummation,
the “Closing”).
|
(B)
|
Following
consultation with the Employee, the parties agree that the Employee's
employment with the Company will terminate by reason of redundancy on the
Termination Date.
|
(B)
|
Without
any admission of liability on the part of the Company, the Company and the
Employee have agreed the terms set out in this Agreement in settlement of
the Claims and all and any other claims which the Employee has or may have
against the Company or any Associated Companies or against any employees
or officers of any such company arising out of or in connection with his
employment or termination of employment with the Company or any Associated
Company.
|
(C)
|
The
Company is entering into this Agreement on its own behalf and as agent for
any Associated Company.
|
(a)
|
any
Holding Company of the Company; or
|
(b)
|
any
direct or indirect Subsidiary of the Company or any such Holding
Company;
|
1.
|
CONFIDENTIALITY
|
1.1
|
The
Employee and the Company agree to keep the terms of this Agreement
confidential, save (i) where disclosure is required to the Revenue
Commissioners, (ii) where required by law or as a result of any
regulatory filing or disclosure requirement (to include, without
limitation, all applicable SEC filings), and (ii) where necessary or
appropriate to give effect to this Agreement,
to:
|
(a)
|
the
Employee's legal or professional advisers or family, provided that they
agree to keep the information confidential;
or
|
(b)
|
the
Company's legal or professional
advisers.
|
1.2
|
The
Employee undertakes that the Employee shall not (except where authorised
by the Company or obliged by law) reveal to any person, company, employer
or organisation or use for his or her own or another person’s or
organisation’s benefit any confidential information concerning the
dealings, affairs, business, strategies, computer systems, plans,
forecasts, accounts, or finances of the Company or any Associated Company
or its or their customers.
|
2.
|
EFFECTIVENESS
|
2.1
|
The
provisions of Clauses 1, 2 and 10-12 of this Agreement will be effective
from the Signing Date and shall survive indefinitely whether or not the
Effective Date shall occur.
|
2.2
|
Clauses
3-9 of this Agreement shall not become effective until, but shall become
automatically effective upon, the Effective Date. If the Closing (and thus
the Effective Date) does not occur by October 31, 2009, then such clauses
shall become void and no party hereto shall have any liability to any
other party hereto, or to any Associated Company of the Company, with
respect to such clauses.
|
3.
|
WARRANT
ISSUANCE
|
3.1
|
The
Company will, without any admission of liability whatsoever on behalf of
itself and its Associated Companies, issue to the Employee the Warrant
Issuance on the Closing or no later than the Termination
Date.
|
3.3
|
The
Company hereby grants to the Employee registration rights with respect to
the resale of Ordinary Shares issued upon exercise of the Warrants granted
pursuant to this compromise agreement, such registration rights having the
same terms as those contained in Article 6 of October 12, 2009 Securities
Purchase Agreement (the "SPA") as if such Warrants had been purchased
thereunder. Notwithstanding the foregoing, unless the SPA is amended
to permit otherwise, (i) the Employee shall not be entitled to exercise
piggy back rights with regard to the registration statement contemplated
by the SPA and (ii) the Employee's rights to piggy back on any other
registration statements shall be subordinate to the piggy back rights of
the purchasers under the SPA. To the extent permitted, the Company
covenants to register such Ordinary Shares on Form S-8 as promptly as
practicable following the closing of the transactions contemplated by the
SPA.
|
4.
|
PAYMENTS
|
4.1
|
The
Company will provide such notice of termination of employment to the
Employee (contractual or statutory, whichever is the greater) as is
applicable on October 31st 2009. The
Employee will be paid in lieu of such notice for all unexpired notice on
the Termination Date. This will amount to a termination payment
of €375,000. All payments are subject to tax and other deductions as
required by law. This Agreement shall be a full and final settlement of
the Claims and all other claims which the Employee has or may have
(whether now or at any time in the future) against the Company or any
Associated Company arising out of his employment or the termination of his
employment. The Employee's employment will terminate on the Termination
Date and the Company will issue and send a form P45 to the Employee on the
Termination Date.
|
4.2
|
The
Employee acknowledges and accepts that the benefits in this
Agreement include, if applicable, any statutory redundancy
payment.
|
4.3
|
Where
applicable, the Employee will continue to receive his or her salary and
other contractual benefits up to the Termination Date on the usual basis,
subject to the normal deductions for income tax and PRSI. Payment shall be
made in accordance with the usual payroll cycle and the final payment
shall be made on Termination Date.
|
4.4
|
The
Company shall reimburse the Employee for all business expenses properly
and reasonably incurred by the Employee up to the Termination Date,
subject to his or her compliance with the Company's rules and procedures
relating to expenses and the production of satisfactory
receipts.
|
5.
|
CONSULTING
|
5.1
|
In
advance of the Termination Date, the Company and the Employee will
endeavour to agree a consulting agreement to take effect from October 31,
2009, subject to formal execution of a consulting
agreement.
|
6.
|
NON-DISPARAGEMENT
|
6.1
|
Other
than as may be reasonably necessary for the purposes of enforcing the
terms of this Agreement, the parties undertake not to make or cause to be
made (directly or indirectly):
|
(a)
|
any
derogatory or disparaging statement about the other, and in the Employee’s
case about any Associated Company or any of the officers, employees or
shareholders of the Company or any Associated Company;
or
|
(b)
|
save
for the filings or disclosures as set out at clause 1.1 above, any comment
to the press or other media or any other public statement concerning the
Employee’s employment, the termination of his employment or the
Claims.
|
6.2
|
The
Employee and the Company agree that any covenants in this Clause 6 shall
survive indefinitely after the Termination
Date.
|
7.
|
SETTLEMENT
AND WAIVER
|
7.1
|
The
purpose of this Agreement is to settle fully and finally any of the Claims
the Employee may have whatsoever against the Company or any Associated
Companies (or any of their respective officers, directors or shareholders)
arising from his employment or termination of employment with the Company
or any Associated Companies, it not being admitted by the Company (either
for itself or any Associated Company) that he has any such
Claim.
|
7.2
|
The
purpose of this Agreement is to settle fully and finally any claims the
Company or any Associated Companies (or any of their respective officers,
directors or shareholders) may have whatsoever against the Employee
arising from his employment or termination of employment with the Company
or any Associated Companies, it not being admitted by the Employee that
the Company or any Associated Companies (or any of their respective
officers, directors or shareholders) has any such
Claim.
|
7.3
|
The
terms contained in this Agreement are in full and final settlement of the
Claims and the Employee represents to the Company that the Employee
accepts the terms of this Agreement in full and final settlement of the
Claims.
|
7.4
|
The
Employee represents to the Company that the Employee accepts the terms of
this Agreement in full and final settlement of any claims that the
Employee has or may have against the Company or any Associated Company (or
any of their respective officers, directors or shareholders) relating to
his or her employment, the termination of his or her employment or any
other matter including (without limitation) any action that might be
commenced before a rights commissioner, any employment tribunal or similar
or any court of law in respect of any or all of the following
claims:
|
(a)
|
Any
common law claims, including for wrongful dismissal, breach of contract or
tort claims (including, without limitation, any personal injury
claims);
|
(b)
|
Unfair
or constructive dismissal under the Unfair Dismissals Acts
1977-2007;
|
(c)
|
Unlawful
deduction from wages under the Payment of Wages Act 1991;
or
|
(d)
|
Any
other claims under the Redundancy Payments Acts 1967 to 2003, the
Protection of Employees Act 1977, the Minimum Notice and Terms of
Employment Acts 1973 to 2001, the Organisation of Working Time Act 1997,
Protection of Employees (Fixed-
|
7.5
|
The
Employee warrants and further represents that the Claims are all of the
claims that have been or will be contemplated by the
Employee.
|
7.6
|
The
Employee hereby agrees that, except for sums and matters referred to in
this Agreement, no other sums are due to him from the Company or any
Associated Company.
|
8.
|
SHARE
OPTIONS
|
9.
|
RETURN
OF PROPERTY
|
10.
|
INDEPENDENT
LEGAL ADVICE
|
11.
|
WHOLE
AGREEMENT
|
12.
|
GOVERNING
LAW ETC.
|
12.1
|
This
Agreement shall be governed by and construed in accordance with the laws
of Ireland and the Irish courts shall have exclusive jurisdiction for all
purposes connected with this
Agreement.
|
SIGNED ………………………………………………………………………..
|
For and on behalf of the
Company
|
DATED ………………………………………………………………………..
|
SIGNED ………………………………………………………………………..
|
DATED ………………………………………………………………………..
|
No.
W___
|
October
16, 2009
|
AMARIN
CORPORATION PLC
|
By:
_______________________________
Name:
Title: Director
|
Address: Amarin
Corporation plc
First Floor, Block 3
The Oval, Shelbourne
Road
Ballsbridge, Dublin
4
Ireland
Facsimile: 353 (1)
6699 028
|
In
the presence of a witness
|
By:
______________________________
Name:
Title:
|
Occupation:
Address:
|
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:___________________
|
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)
|
No.
W ___
|
October
16, 2009
|
AMARIN
CORPORATION PLC
|
By:
_________________________________
Name:
Title: Director
|
Address:Amarin
Corporation plc
First Floor, Block 3
The Oval, Shelbourne
Road
Ballsbridge, Dublin
4
Ireland
Facsimile: 353 (1)
6699 028
|
In
the presence of a witness
|
By:
_______________________________
Name:
Title:
|
Occupation:
Address:
|
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:___________________
|
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)
|
|
(B)
|
Each
Series A Preference Share held by each of the Series A Holders shall
automatically convert into one Ordinary Share, and the rights and
obligations of the Series A Preference Shares shall terminate, immediately
upon the occurrence of a Special Rights Termination
Event.
|
|
(y)
|
“Special Rights Termination
Event” shall mean the consummation of the New Equity
Financing.
|
|
(z)
|
“New Equity Financing”
shall mean the equity financing contemplated by the Memorandum of Terms
dated September 30, 2009 among the Company and the other parties
thereto.”
|
AMARIN
CORPORATION PLC
|
By: ______________________________________
|
Name:
|
Title:
|
HOLDERS,
HOLDERS OF PREFERENCE SHARES AND INVESTORS
|
PURCHASERS:
|
|
Caduceus
Private Investments III, LP
By:
OrbiMed Capital GP III LLC
Its: General
Partner
By:
___________________________
Name:
Carl L. Gordon
Title:
OrbiMed
Associates III, LP
By:
OrbiMed Advisors LLC
Its: General
Partner
By:
___________________________
Name:
Carl L. Gordon
Title:
Sofinnova
Venture Partners VII, L.P.
By:
Sofinnova Management VII, L.L.C.
Its:
General Partner
By:
___________________________
Name:
James I. Healy
Title: Managing
General Partner
|
Caduceus
Private Investments III, LP
By:
OrbiMed Capital GP III LLC
Its: General
Partner
By:
___________________________
Name:
Carl L. Gordon
Title:
OrbiMed
Associates III, LP
By:
OrbiMed Advisors LLC
Its: General
Partner
By:
___________________________
Name:
Carl L. Gordon
Title:
Sofinnova
Venture Partners VII, L.P.
By:
Sofinnova Management VII, L.L.C.
Its:
General Partner
By:
___________________________
Name:
James I. Healy
Title: Managing
General Partner
|
|
[Signatures continued on next page] |
Longitude
Venture Partners, L.P.
By:
Longitude Capital Partners, LLC
Its:
General Partner
By:
___________________________
Name:
Title:
|
Longitude
Venture Partners, L.P.
By:
Longitude Capital Partners, LLC
Its:
General Partner
By:
___________________________
Name:
Title:
|
|
Panorama
Capital, L.P., a Delaware limited partnership
By:
Panorama Capital Management LLC, a Delaware limited liability
company
Its: General
Partner
By:
___________________________
Name:
Title:
|
Panorama
Capital, L.P., a Delaware limited partnership
By:
Panorama Capital Management LLC, a Delaware limited liability
company
Its: General
Partner
By:
___________________________
Name:
Title:
|
|
Thomas,
McNerney & Partners II, L.P.
By:
Thomas, McNerney & Partners II, LLC
Its:
General Partner
By:
___________________________
Name: Eric
Aguiar
Title: Manager
|
Thomas,
McNerney & Partners II, L.P.
By:
Thomas, McNerney & Partners II, LLC
Its:
General Partner
By:
___________________________
Name: Eric
Aguiar
Title: Manager
|
|
TMP
Nominee II, LLC
By:
___________________________
Name: James
Thomas
Title: Manager
|
TMP
Nominee II, LLC
By:
___________________________
Name: James
Thomas
Title: Manager
|
|
TMP
Associates II, L.P.
By: Thomas,
McNerney & Partners II, LLC
Its: General
Partner
By:
___________________________
Name: Eric
Aguiar
Title: Manager
|
TMP
Associates II, L.P.
By: Thomas,
McNerney & Partners II, LLC
Its: General
Partner
By:
___________________________
Name: Eric
Aguiar
Title: Manager
|
|
Fountain
Healthcare Partners I, L.P.
By:
Fountain Healthcare Partners Ltd.
Its:
General Partner
By:
___________________________
Name:
Manus Rogan
Title: Managing
Partner
|
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%
|
|
Amarin
Pharma
Inc
|
USA
|
100%
|