UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 20-F
o
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g)
 
OF THE SECURITIES EXCHANGE ACT OF 1934
 
OR
þ
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
 
OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2007
 
OR
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
 
OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE TRANSITION PERIOD FROM    TO
 
OR
o
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d)
 
OF THE SECURITIES EXCHANGE ACT OF 1934
 
DATE OF EVENT REQUIRING THIS SHELL COMPANY REPORT
Commission file number 0-21392
AMARIN CORPORATION PLC
(Exact Name of Registrant as Specified in Its Charter)
England and Wales
(Jurisdiction of Incorporation or Organization)
First Floor, Block 3, The Oval
Shelbourne Road, Ballsbridge
Dublin 4, Ireland
(Address of Principal Executive Offices)
SECURITIES REGISTERED OR TO BE REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:
Title of Each Class
 
Name of Each Exchange on Which Registered
None
 
None
SECURITIES REGISTERED OR TO BE REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
American Depositary Shares, each representing one Ordinary Share
Ordinary Shares, 5 pence par value per share
(Title of Class)
SECURITIES FOR WHICH THERE IS A REPORTING OBLIGATION PURSUANT TO SECTION 15(d) OF THE ACT:
None.
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
139,057,370 Ordinary Shares, 5 pence par value per share
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
YES  o      NO  þ
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
YES  o      NO  þ
Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YES  þ      NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer  o      Accelerated
filer  o      Non-accelerated filer  þ
Indicate by check mark which financial statement item the registrant has elected to follow.
ITEM 17  o      ITEM 18 þ
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YES  o      NO  þ

 

 


TABLE OF CONTENTS

INTRODUCTION
3
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
4
 
PART I
 
Item 1
Identity of Directors, Senior Management and Advisers
5
Item 2
Offer Statistics and Expected Timetable
5
Item 3
Key Information
5
Item 4
Information on the Company
20
Item 4A
Unresolved Staff Comments
29
Item 5
Operating and Financial Review and Prospects
29
Item 6
Directors, Senior Management and Employees
36
Item 7
Major Shareholders and Related Party Transactions
44
Item 8
Financial Information
46
Item 9
The Offer and Listing
48
Item 10
Additional Information
49
Item 11
Quantitative and Qualitative Disclosures About Market Risk
68
Item 12
Description of Securities Other than Equity Securities
69
 
PART II
 
Item 13
Defaults, Dividend Arrearages and Delinquencies
69
Item 14
Material Modifications to the Rights of Security Holders and Use of Proceeds
69
Item15
Controls and Procedures
69
Item 16
[Reserved]
70
Item 16A
Audit Committee Financial Expert
70
Item 16B
Code of Ethics
70
Item 16C
Principal Accountant Fees and Services
70
Item 16D
Exemptions from the Listing Standards for Audit Committees
71
Item 16E
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
71
 
PART III
 
Item 17
Financial Statements
71
Item 18
Financial Statements
71
Item 19
Exhibits
71
SIGNATURES
77

 
2

 


INTRODUCTION
 
This report comprises the annual report to shareholders of Amarin Corporation plc (NASDAQCM: AMRN) and its annual report on Form 20-F in accordance with the requirements of the United States Securities and Exchange Commission, or SEC, for the year ended December 31, 2007.
 
As used in this annual report, unless the context otherwise indicates, the terms “Group”, “Amarin”, “we”, “us” and “our” refer to Amarin Corporation plc and its wholly owned subsidiary companies. Laxdale Limited, a company which we acquired in October 2004 and is now known as Amarin Neuroscience Limited, may be referred to herein as “Amarin Neuroscience” or “Laxdale.” Ester Neurosciences Limited, a company which we acquired in December 2007 may be referred to herein as “Ester Neurosciences” or “Ester”.
 
Also, as used in this annual report, unless the context otherwise indicates, the term “Ordinary Shares” refers to our Ordinary Shares, par value 5 pence per share, and the term “Preference Shares” refers to our authorized preference shares, par value 5 pence per share. As of December 31, 2007, there were no Preference Shares outstanding. Unless otherwise specified, all shares and share related information (such as per share information and share price information) in this annual report have been adjusted to give effect, retroactively, to our one-for-ten Ordinary Share consolidation effective on July 17, 2002 whereby ten ordinary shares of 10p each became one Ordinary Share of £1.00 each and to the subsequent sub-division and conversion of each issued and outstanding Ordinary Share of £1.00 each on June 21, 2004 into one ordinary share of 5 pence and one deferred share of 95 pence (and the subsequent purchase by the Company and cancellation of all such deferred shares) and each of the authorized but unissued Ordinary Shares of £1 each in the capital of the Company into 20 ordinary shares of 5 pence each.
 
In addition, as used in this annual report, the term “Debentures” refers to our 8% Convertible Debentures due 2010 which were issued on December 6, 2007 in connection with the financing of our acquisition of Ester.
 
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. Unless otherwise specified, all shares and share related information (such as per share information and share price information) in this annual report have not been adjusted to give effect to this one-for-ten Ordinary Share consolidation.
 
On May 14, 2008, we announced a private placement of Ordinary Shares for up to $60.0 million. The first tranche from new investors of $28.0 million closed on May 19, 2008 . See Item 8B “Significant changes” for further information.
 
I n this annual report, references to “pounds sterling,” “£” or “GBP£” are to U.K. currency, references to “U.S. Dollars”, “$” or “US$” are to U.S. currency, references to “euro” or “€” are to Euro currency and references to “New Israeli Shekel”, “NIS” or “shekel” are to Israeli currency.
 
This annual report contains trademarks, tradenames or registered marks owned by Amarin or by other entities, including:
 
•        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”.
 
•        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".

 
 
3

 
 
 
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
 
This annual report contains forward-looking statements about our financial condition, results of operations, business prospects and products in research and involve substantial risks and uncertainties. You can identify these statements by the fact that they use words such as “will”, “anticipate”, “estimate”, “project”, “forecast”, “intend”, “plan”, “believe” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or events. Among the factors that could cause actual results to differ materially from those described or projected herein are the following;
 
•       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; and
 
•      Growth in costs and expenses; and the impact of acquisitions, divestitures and other unusual items.

 
4

 

 
PART I
 
Item 1  Identity of Directors, Senior Management and Advisers
 
Not applicable.
 
Item 2  Offer Statistics and Expected Timetable
 
Not applicable.
 
Item 3  Key Information
 
A.  Selected Financial Data
 
General
 
The following table presents selected historical consolidated financial data. The selected historical consolidated financial data as of December 31, 2007 and 2006 and for each of the years ended December 31, 2007 and 2006 have been derived from our audited consolidated financial statements beginning on page F-1 of this annual report, prepared in accordance with International Financial Reporting Standards (“IFRS”) as adopted by the E.U. and as issued by the International Accounting Standards Board (“IASB”), which have been audited by PricewaterhouseCoopers, an independent registered public accountant firm, for the years ended December 31, 2007 and 2006.
 
The selected historical consolidated financial data as of December 31, 2005, 2004 and 2003 and for the years then ended has been derived from our audited historical financial statements prepared in accordance with generally accepted accounting principles in the United Kingdom (“U.K. GAAP”) which are not included in these financial statements.
 
Unless otherwise specified, all references in this annual report to “fiscal year” or “year” of Amarin refer to a twelve-month financial period ended December 31. We prepare our consolidated financial statements in accordance with IFRS as adopted by the E.U. and as issued by the IASB.
 
We adopted IFRS for the first time for our financial year ended December 31, 2007. Our audited Consolidated Financial Statements as of and for the year ended December 31, 2006 were originally prepared in accordance with U.K. GAAP. As part of our adoption of IFRS, we have restated our Consolidated Financial Statements in accordance with IFRS for comparative purposes.
 
During 2002 our Ordinary Shares were consolidated on a ten-for-one basis. Concurrently, we amended the terms of our American Depositary Shares, or ADSs, to provide that each ADS would represent one Ordinary Share. Previously each ADS had represented ten ordinary shares of 10p each. The new conversion ratio has been reflected in all years in the weighted average share numbers shown in the consolidated statement of operations data below. In June 2004 we converted each of our £1 Ordinary Shares into one Ordinary Share of 5 pence and one deferred share of 95 pence (with such deferred shares having been subsequently cancelled). This share conversion in 2004 did not affect the ratio as between our Ordinary Shares and our ADSs but is recorded below in the year 2004.
 
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 each.
 
On May 14, 2008, we announced a private placement of Ordinary Shares for up to $60.0 million. The first tranche from new investors of $28.0 million closed on May 19, 2008. See Item 8B “Significant changes” for further information.
 
5

 
 
Selected Consolidated Financial Data IFRS
   
2006
   
2007
 
   
(In U.S. $, thousands
except per share data
and number of shares
information)
 
Statement of Operations Data — IFRS
Net sales revenues
    500        
Total loss from operations
    (28,068 )     (40,733 )
Net loss
    (26,751 )     (38,197 )
Net loss per Ordinary Share (basic – post share split**)
    (3.25 )     (3.90 )
Net loss per Ordinary Share (basic – pre share split**)
    (0.33 )     (0.39 )
Net loss per Ordinary Share (diluted – post share split**)
    (3.25 )     (3.90 )
Net loss per Ordinary Share (diluted – pre share split**)
    (0.33 )     (0.39 )
Consolidated balance sheet data - amounts in accordance with IFRS
Working capital assets
      28,710         6,316  
Total assets
    49,559       42,254  
Long term obligations                                                                                                                     
    (110 )     (2,693 )
Capital stock (ordinary shares)
    7,990       12,942  
Total shareholders’ equity
    38,568       24,149  
Number of ordinary shares in issue (thousands – post share split**)
    9,068       13,906  
Number of ordinary shares in issue (thousands – pre share split**)
    90,684       139,057  
Denomination of each ordinary share (post share split**)
    £0.50       £0.50  
Denomination of each ordinary share (pre share split**)
    £0.05       £0.05  
 
Selected Consolidated Financial Data U.K. GAAP
   
Years Ended December 31
 
   
2003
   
2004*
as restated
   
2005*
as restated
 
   
(In U.S. $, thousands except per share
data and number of shares information)
 
Statement of Operations Data — U.K. GAAP
Net sales revenues                                                                                                       
    7,365       1,017       500  
Total loss from operations                                                                                                       
    (38,821 )     (11,875 )     (20,748 )
Loss from continuing operations                                                                                                       
    (6,200 )     (10,608 )     (20,748 )
Net (loss)/income                                                                                                       
    (19,224 )     3,229       (20,547 )
Loss from continuing operations per Ordinary Share (basic – post share split**)
    (3.63 )     (4.71 )     (4.45 )
Loss from continuing operations per Ordinary Share (basic – pre share split**)
    (0.36 )     (0.47 )     (0.45 )
Net (loss)/income per Ordinary Share (basic – post share split**)
    (11.25 )     1.43       (4.41 )
Net (loss)/income per Ordinary Share (basic – pre share split**)
    (1.13 )     0.14       (0.44 )
Net (loss)/income per Ordinary Share (diluted – post share split**)
    (11.25 )     1.43       (4.41 )
Net (loss)/income per Ordinary Share (diluted – pre share split**)
    (1.13 )     0.14       (0.44 )
Consolidated balance sheet data - amounts in accordance with U.K. GAAP
Working capital (liabilities)/assets                                                                                                       
    (39,128 )       8,651         28,673  
Total assets                                                                                                       
    47,377       23,721       46,760  
Long term obligations                                                                                                       
          (2,687 )     (180 )
Capital stock (ordinary shares)                                                                                                       
    29,088       3,206       6,778  
Total shareholders’ (deficit)/equity                                                                                                       
    (6,348 )     16,693       38,580  
Number of ordinary shares in issue (thousands – post share split**)
    1,794       3,763       7,755  
Number of ordinary shares in issue (thousands – pre share split**)
    17,940       37,632       77,549  
Denomination of each ordinary share (post share split**)                                                                                                       
    £10.00       £0.50       £0.50  
Denomination of each ordinary share (pre share split**)                                                                                                       
    £1.00       £0.05       £0.05  
 
For previously reported 2006 financial information prepared under U.K. GAAP please see our 2006 20-F filed with the SEC on March 5, 2007.
 
 
As restated for the non-cash compensation expense due to the adoption of U.K. GAAP, Financial Reporting Standard 20 “Share-based payments”.
**
On January 18, 2008, our Ordinary Shares were consolidated on a one-for-ten basis whereby ten Ordinary Shares of 5p each became one Ordinary Share of 50p. Post-split shares and share information above has been adjusted to reflect this share consolidation.
 

 
6

 

Exchange Rates
 
We changed our functional currency on January 1, 2003 from pounds sterling to U.S. Dollars to reflect the fact that the majority of our transactions, assets and liabilities were denominated in that currency. Consequently, all data provided in this annual report is in U.S. Dollars from 2003.
 
As some of our assets, liabilities and transactions are denominated in pounds sterling, euro and shekel, the rate of exchange between pounds sterling and the U.S. Dollar, between euro and U.S. Dollar and between shekel and U.S. Dollar, which is determined by supply and demand in the foreign exchange markets and affected by numerous factors, continues to impact our financial results. Fluctuations in the exchange rates between the U.S. Dollar and pounds sterling, between U.S. Dollar and euro and between the U.S. Dollar and shekel may affect any earnings or losses reported by us and the book value of our shareholders’ equity as expressed in U.S. Dollars, and consequently may affect the market price for our ADSs.
 
The following table sets forth, for the periods indicated, the average of the noon buying rate on the last day of each month during the relevant period as announced by the Federal Reserve Bank of New York for pounds sterling expressed in U.S. Dollars per pound sterling:
 
 
 
Fiscal Period
Average
Noon Buying
Rate
 
(U.S. Dollars/pound sterling)
12 months ended December 31, 2003                                                                                                                            
1.6450
12 months ended December 31, 2004                                                                                                                            
1.8356
12 months ended December 31, 2005                                                                                                                            
1.8204
12 months ended December 31, 2006                                                                                                                            
1.8434
12 months ended December 31, 2007                                                                                                                            
2.0073
 
The following table sets forth, for each of the last six months, the high and low noon buying rate during each month as announced by the Federal Reserve Bank of New York for pounds sterling expressed in U.S. Dollars per pound sterling:
 
Month
High Noon Buying Rate
Low Noon Buying Rate
 
(U.S. Dollars/pound sterling)
(U.S. Dollars/pound sterling)
     
November 2007
2.1104
2.0478
December 2007
2.0658
1.9774
January 2008
1.9895
1.9515
February 2008
1.9923
1.9405
March 2008
2.0311
1.9823
April 2008 
1.9994
1.9627
 
The noon buying rate as of May 15, 2008 was 1.9488 U.S. Dollars per pound sterling.
 
B.  Capitalization And Indebtedness
 
Not applicable.
 
C.  Reasons For The Offer And Use Of Proceeds
 
Not applicable.

 
7

 

 
 
D.  Risk Factors
 
RISK FACTORS
 
You should carefully consider the risks and the information about our business described below, together with all the other information included in this annual report. You should not interpret the order in which these considerations are presented as an indication of their relative importance to you. The risks and uncertainties described below are not the only ones that we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business. If any of the following risks and uncertainties develops into actual events, our business, financial condition and results of operations could be materially and adversely affected.  In such an instance, the trading price of our ADSs and Ordinary Shares could decline.
 
We have a history of losses, and we may not be able to attain profitability in the foreseeable future.
 
We have not been profitable in four of the last five fiscal years. For the fiscal years ended December 31, 2003, 2004 and 2005, we reported (losses)/profits under U.K. GAAP of approximately $(19.2) million, $3.2 million and $(20.5) million respectively. For the fiscal years ended December 31, 2006 and 2007, we reported losses under IFRS of approximately $26.8 million and $38.2 million respectively. Unless and until marketing approval is obtained from either the U.S. Food and Drug Administration, which we refer to as the FDA, or European Medicines Evaluation Agency, which we refer to as the EMEA, for any of our products, or we are otherwise able to acquire rights to products that have received regulatory approval or are at an advanced stage of development and can be readily commercialized, we may not be able to generate sufficient revenues in future periods to enable us to attain profitability.
 
We acquired Amarin Neuroscience (formerly Laxdale Limited) on October 8, 2004 and Ester Neurosciences Limited on December 5, 2007. We continue to have limited operations, assets and financial resources. We currently have no marketable products or other source of revenues other than the Multicell out-licensing contract described herein. All of our current products are in the development stage. The development of pharmaceutical products is a capital intensive business. Therefore, we expect to incur expenses without corresponding revenues at least until we are able to obtain regulatory approval and sell our future products in significant quantities. This may result in net operating losses until we can generate an acceptable level of revenues, which we may not be able to attain. Further, even if we do achieve operating revenues, there can be no assurance that such revenues will be sufficient to fund continuing operations. Therefore, we cannot predict with certainty whether we will ever be able to achieve profitability.
 
In addition to advancing our existing development pipeline, we may also acquire rights to additional products. However, we may not be successful in doing so. We may need to raise additional capital before we can acquire any products. There is also a risk that any of our development stage products we may acquire will not be approved by the FDA or regulatory authorities in other countries on a timely basis or at all. The inability to obtain such approvals would adversely affect our ability to generate revenues.
 
The likelihood of success of our business plan must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with developing and expanding early stage businesses and the regulatory and competitive environment in which we operate.
 
Our historical financial results do not form an accurate basis for assessing our current business.
 
As a consequence of divestitures in 2003 and 2004 and our acquisition of Amarin Neuroscience in October 2004 and Ester Neurosciences Limited in December 2007, our historical financial results do not form an accurate basis upon which investors should base an assessment of our business and prospects. We are now focused on the research, development and commercialization of novel drugs for the central nervous system and cardiovascular disease.   Accordingly, our historical financial results reflect a substantially different business from that currently being conducted.
 
 
 
 

 
8

 

 
 
Our indebtedness under our 8% Convertible Debentures due 2010 could adversely affect our financial condition and our ability to respond to changes in our business.
 
As described in our Report of Foreign Issuer furnished to the SEC on December 12, 2007, on December 4, 2007, we issued $2.75 million aggregate principal amount of our 8% Convertible Debentures due 2010 to finance, in part, our acquisition of Ester Neurosciences Limited, a private pharmaceutical development company based in Israel.  We have debt service obligations under our Debentures.  These debt obligations could have significant negative consequences, including, but not limited to:
 
·  
increasing our vulnerability to general adverse economic and industry conditions;
·  
limiting our ability to obtain additional financing in the future for working capital, capital expenditures, acquisitions or other business purposes;
·  
limiting our flexibility to plan for, or react to, changes in our business and the industry in which we compete;
·  
placing us at a possible disadvantage to competitors with fewer debt obligations and competitors that have better access to capital resources; and
·  
requiring us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flow to fund working capital expenditures, research and development efforts and other general corporate purposes.
 
We may incur additional indebtedness.
 
The indenture governing the Debentures does not prohibit us from incurring substantial additional indebtedness in the future.  Any such additional indebtedness that is permitted to be secured would be effectively senior to the Debentures to the extent of the assets securing such indebtedness.  As described under the heading “Description of Debentures — Additional Covenant — Limitation on Incurrence of Subsidiary Indebtedness” in our prospectus supplement filed with the SEC on December 5, 2007, the Debentures limit the ability of our subsidiaries to incur indebtedness.  However, because they are not guaranteed by our subsidiaries (or any other third party), the Debentures are structurally subordinated to the indebtedness and other liabilities that our subsidiaries are permitted to incur.  In addition, the indenture does not contain any restrictive covenants limiting our ability to pay dividends, make any payments on junior or other indebtedness or otherwise limit our financial condition.
 
We may have to issue additional equity, leading to shareholder dilution.
 
We are committed to issue equity to the former shareholders of Amarin Neuroscience upon the successful achievement of specified milestones for the AMR101 development program (subject to such shareholders’ right to choose cash payment in lieu of equity).  Pursuant to the Amarin Neuroscience share purchase agreement, further success-related milestones will be payable as follows:
 
Upon receipt of marketing approval in the United States and Europe for the first indication of any product containing Amarin Neuroscience intellectual property as secured in the 2004 Laxdale acquisition, we must make an aggregate stock or cash payment (at the sole option of each of the sellers) of GBP£7.5 million for each of the two potential market approvals (i.e., GBP£15.0 million maximum).  In addition, upon receipt of a marketing approval in the United States and Europe for any other product using Amarin Neuroscience intellectual property as secured in the 2004 Laxdale acquisition or for a different indication of a previously approved product, we must make an aggregate stock or cash payment (at the sole option of each of the sellers) of GBP£5.0 million for each of the two potential market approvals (i.e., GBP£10.0 million maximum).  The exchange rate as of May 15, 2008 was approximately $1.9488 per GBP £ .
 
As described under the heading “Unaudited Pro Forma Financial Information” in our Report of Foreign Issuers on Form 6-K filed with the SEC on December 5, 2007, if the Monarsen Phase IIa in Myasthenia Gravis (“MG”) clinical study meets its study objectives, we are committed to pay $5 million, at Amarin’s option, in equity or cash, to the former shareholders of Ester Neurosciences Limited. In addition, upon successful completion of the Monarsen Phase II MG development program with adequate efficacy and safety data that fully supports the commencement of a Phase III clinical study in the U.S., we are committed to pay $6 million, at Amarin's option, in equity or cash, to the former shareholders of Ester Neurosciences Limited.

 
9

 

 
        In December 2007, we issued $2.75 million in aggregate principal amount of three-year convertible Debentures. The Debentures may be converted into 5.7 million ADSs commencing four months after the date of closing at a conversion price of $0.48 per ADS. 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 aforementioned convertible debentures at a price that is less than, or converts at a price that is less than, $3.66 (“Down-round Price”), then the conversion price shall be adjusted to equal 130% of the Down-round Price.
 
In addition, the Debenture holders received five-year warrants to purchase 2.3 million ADSs at an exercise price of $0.48. 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 aforementioned warrants at a price that is less than, or converts at a price that is less than, $3.66 (“Down-round Price”), then the exercise price shall be adjusted to equal 130% of the Down-round Price.
 
The convertible Debentures will be required to be repaid from the proceeds of, and the holders of the convertible Debentures will have the right to participate in, future financings of the Company, with certain exceptions.
 
Taking account for the one-for-ten consolidation of our Ordinary Shares on January 18, 2008, as at May 16, 2008 we had 2,052,473 warrants outstanding with a weighted average exercise price of $8.70 per share.  As at May 16, 2008, we also had outstanding employee options to purchase 1,475,481 Ordinary Shares at an average exercise price of $13.23 per share.
 
Additionally, in pursuing our growth strategy we will either need to issue new equity as consideration for the acquisition of products, or to otherwise raise additional capital, in which case equity, debt convertible into equity or debt instruments may be issued.  The creation of new shares may lead to dilution of the value of the shares held by our current shareholder base.
 
We have granted the initial purchasers of the Debentures the right to participate in certain of our future financings, which may restrict our ability to raise capital.
 
So long as the initial purchaser of a Debenture is the registered holder of the Debenture, such initial purchaser shall have a right, subject to certain exceptions, to participate in future equity or debt financings by us for cash on terms equal to those of other investors in such future financings.  This right is not transferable upon the sale of the Debentures by initial purchasers.  This financing participation right may restrict our ability to raise capital through equity financing in the future as it may, among other things, make potential investors less likely to enter into negotiations with us.
  
If we cannot find additional capital resources, we will have difficulty in operating as a going concern and growing our business.
 
At December 31, 2007, we had a cash balance of approximately $18.3 million. On May 14, 2008, we announced a private placement of Ordinary Shares for up to $60.0 million. The first tranche from new investors of $28.0 million closed on May 19, 2008. Based upon current business activities, we forecast having sufficient cash to fund operations for at least the next 12 months from May 19, 2008. We may also require further funds in the future to implement our long-term growth strategy of acquiring additional development stage and/or marketable products, recruiting clinical, regulatory and sales and marketing personnel, and growing our business.  Our ability to execute our business strategy and sustain our infrastructure at our current level will be impacted by whether or not we have sufficient funds. Depending on market conditions and our ability to maintain financial stability, we may not have access to additional funds on reasonable terms or at all.  Any inability to obtain additional funds when needed would have a material adverse effect on our business and on our ability to operate on an ongoing basis.
 
We may be dependent upon the success of a limited range of products.
 
On April 24, 2007, we reported top-line results from our two Phase III clinical trials of AMR101 to treat Huntington’s disease.  Study data showed no statistically significant difference in either study between AMR101 and placebo with regard to the primary and secondary endpoints at 6-months of treatment. The adverse clinical trial data on AMR101 for Huntington’s disease could materially affect our ability to develop the product for Huntington’s disease and for other therapeutic indications.  If development efforts for our products are not successful for any indications or if they are not approved by the FDA, or if adequate demand for our products are not generated, our business will be materially and adversely affected. Although we intend to bring additional products forward from our research and development efforts, even if we are successful in doing so, the range of products we will be able to commercialize may be limited. This could restrict our ability to respond to adverse business conditions. If we are not successful in developing any future product or products, or if there is not adequate demand for any such products or the market for such product develops less rapidly than we anticipate, we may not have the ability to shift our resources to the development of alternative products. As a result, the limited range of products we intend to develop could constrain our ability to generate revenues and achieve profitability.

 
10

 

 
Our ability to generate revenues depends on obtaining regulatory approvals for our products.
 
In order to successfully commercialize a product, we will be required to conduct all tests and clinical trials needed in order to meet regulatory requirements, to obtain applicable regulatory approvals, and to prosecute patent applications. The costs of developing and obtaining regulatory approvals for pharmaceutical products can be substantial. Our ability to commercialize any of our products in development is dependent upon the success of development efforts in clinical studies. If these clinical trials fail to produce satisfactory results, or if we are unable to maintain the financial and operational capability to complete these development efforts, we may be unable to generate revenues. Even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize products successfully. For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability to develop competing products. Additionally, the terms of any approvals may not have the scope or breadth needed for us to commercialize products successfully.
 
We may not be successful in developing or marketing future products if we cannot meet extensive regulatory requirements of the FDA and other regulatory agencies for quality, safety and efficacy.
 
Our long-term strategy involves the development of products we may acquire from third parties. The success of these efforts is dependent in part upon the ability of the Group, its contractors, and its products to meet and to continue to meet regulatory requirements in the jurisdictions where we ultimately intend to sell such products. The development, manufacture and marketing of pharmaceutical products are subject to extensive regulation by governmental authorities in the United States, the European Union, Japan and elsewhere. In the United States, the FDA generally requires pre-clinical testing and clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before its introduction into the market. Regulatory authorities in other jurisdictions impose similar requirements. The process of obtaining regulatory approvals is lengthy and expensive and the issuance of such approvals is uncertain. The commencement and rate of completion of clinical trials may be delayed by many factors, including:
 
the inability to manufacture sufficient quantities of qualified materials under current good manufacturing practices for use in clinical trials;
 
slower than expected rates of patient recruitment;
 
the inability to observe patients adequately after treatment;
 
changes in regulatory requirements for clinical trials;
 
the lack of effectiveness during clinical trials;
 
unforeseen safety issues;
 
delay, suspension, or termination of a trial by the institutional review board responsible for overseeing the study at a particular study site; and
 
government or regulatory delays or “clinical holds” requiring suspension or termination of a trial.
 
Even if we obtain positive results from early stage pre-clinical or clinical trials, we may not achieve the same success in future trials. Clinical trials that we conduct may not provide sufficient safety and effectiveness data to obtain the requisite regulatory approvals for product candidates. The failure of clinical trials to demonstrate safety and effectiveness for our desired indications could harm the development of that product candidate as well as other product candidates, and our business and results of operations would suffer.

 
11

 

 
Any approvals that are obtained may be limited in scope, or may be accompanied by burdensome post-approval study or other requirements. This could adversely affect our ability to earn revenues from the sale of such products. Even in circumstances where products are approved by a regulatory body for sale, the regulatory or legal requirements may change over time, or new safety or efficacy information may be identified concerning a product, which may lead to the withdrawal of a product from the market. Additionally, even after approval, a marketed drug and its manufacturer are subject to continual review. The discovery of previously unknown problems with a product or manufacturer may result in restrictions on that product or manufacturer, including withdrawal of the product from the market, which would have a negative impact on our potential revenue stream.
 
After approval, our products will be subject to extensive government regulation.
 
Once a product is approved, numerous post-approval requirements apply. Among other things, the holder of an approved NDA or other license is subject to periodic and other monitoring and reporting obligations enforced by the FDA and other regulatory bodies, including obligations to monitor and report adverse events and instances of the failure of a product to meet the specifications in the approved application. Application holders must also submit advertising and other promotional material to regulatory authorities and report on ongoing clinical trials.
 
Advertising and promotional materials must comply with FDA rules in addition to other potentially applicable federal and local laws in the United States and in other countries. In the United States, the distribution of product samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. Manufacturing facilities remain subject to FDA inspection and must continue to adhere to the FDA’s current good manufacturing practice requirements. Application holders must obtain FDA approval for product and manufacturing changes, depending on the nature of the change. Sales, marketing, and scientific/educational grant programs must also comply with the U.S. Medicare-Medicaid Anti-Fraud and Abuse Act, as amended, the U.S. False Claims Act, as amended and similar state laws. Pricing and rebate programs must comply with the U.S. Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990, as amended. If products are made available to authorized users of the U.S. Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to U.S. federal and state consumer protection and unfair competition laws. Similar requirements exist in all of these areas in other countries.
 
Depending on the circumstances, failure to meet these post-approval requirements can result in criminal prosecution, fines or other penalties, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, or refusal to allow us to enter into supply contracts, including government contracts. In addition, even if we comply with FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the FDA to modify or withdraw a product approval. Adverse regulatory action, whether pre- or post-approval, can potentially lead to product liability claims and increase our product liability exposure. We must also compete against other products in qualifying for reimbursement under applicable third party payment and insurance programs.
 
Our future products may not be able to compete effectively against those of our competitors.
 
Competition in the pharmaceutical industry is intense and is expected to increase. If we are successful in completing the development of any of our products, we may face competition to the extent other pharmaceutical companies are able to develop products for the treatment of similar indications. Potential competitors in this market may include companies with greater resources and name recognition than us. Furthermore, to the extent we are able to acquire or develop additional marketable products in the future such products will compete with a variety of other products within the United States or elsewhere, possibly including established drugs and major brand names. Competitive factors, including generic competition, could force us to lower prices or could result in reduced sales. In addition, new products developed by others could emerge as competitors to our future products. Products based on new technologies or new drugs could render our products obsolete or uneconomical.
 
Our potential competitors both in the United States and Europe may include large, well-established pharmaceutical companies, specialty pharmaceutical sales and marketing companies, and specialized neurology companies. In addition, we may compete with universities and other institutions involved in the development of technologies and products that may compete with ours. Many of our competitors will likely have greater resources than us, including financial, product development, marketing, personnel and other resources. Should a competing product obtain marketing approval prior to any of our products, this would significantly erode the projected revenue streams for our product.

 
12

 

 
The success of our future products will also depend in large part on the willingness of physicians to prescribe these products to their patients. Our future products may compete against products that have achieved broad recognition and acceptance among medical professionals. In order to achieve an acceptable level of subscriptions for our future products, we must be able to meet the needs of both the medical community and end users with respect to cost, efficacy and other factors.
 
Our supply of future products could be dependent upon relationships with manufacturers and key suppliers.
 
We have no in-house manufacturing capacity and, to the extent we are successful in completing the development of our products and/or acquiring or developing other marketable products in the future, we will be obliged to rely on contract manufacturers to produce our products. We may not be able to enter into manufacturing arrangements on terms that are favorable to us. Moreover, if any future manufacturers should cease doing business with us or experience delays, shortages of supply or excessive demands on their capacity, we may not be able to obtain adequate quantities of product in a timely manner, or at all. Manufacturers are required to comply with current NDA commitments and good manufacturing practices requirements enforced by the FDA, and similar requirements of other countries. The failure by a future manufacturer to comply with these requirements could affect its ability to provide us with product. Any manufacturing problem or the loss of a contract manufacturer could be disruptive to our operations and result in lost sales.
 
Additionally, we will be reliant on third parties to supply the raw materials needed to manufacture our potential products. Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability and quality. Any unanticipated disruption to future contract manufacture caused by problems at suppliers could delay shipment of products, increase our cost of goods sold and result in lost sales.
 
We may not be able to grow our business unless we can acquire and market or in-license new products.
 
We are pursuing a strategy of product acquisitions and in-licensing in order to supplement our own research and development activity. For example, in December 2007, we acquired the entire issued share capital of Ester Neurosciences Limited whose lead product, EN101, is currently in Phase IIa clinical development to treat myasthenia gravis, a debilitating neuromuscular disease; in March 2007, we acquired the global rights to a novel, nasal lorazepam formulation for the out-patient treatment of emergency seizures in epilepsy patients, specifically status epilepticus and acute repetitive seizures; and in May 2006, we acquired the global rights to a novel formulation of apomorphine for the treatment of “off” episodes in patients with advanced Parkinson’s disease. Our success in this regard will be dependent on our ability to identify other companies that are willing to sell or license product lines to us. We will be competing for these products with other parties, many of whom have substantially greater financial, marketing and sales resources than we do. Even if suitable products are available, depending on competitive conditions we may not be able to acquire rights to additional products on acceptable terms, or at all. Our inability to acquire additional products or successfully introduce new products could have a material adverse effect on our business.
 
In order to commercialize our future products, we will need to establish a sales and marketing capability.
 
At present, we do not have any sales or marketing capability since all of our products are currently in the development stage. However, if we are successful in obtaining regulatory approval for any product for any indication, we may directly commercialize this product for that indication in the U.S. market. Similarly, to the extent we execute our long-term strategy of expanding our portfolio by developing or acquiring additional marketable products, we intend to directly sell our neurology products in the United States. In order to market new products, we will need to add marketing and sales personnel who have expertise in the pharmaceuticals business. We must also develop the necessary supporting distribution channels. Although we believe we can build the required infrastructure, we may not be successful in doing so if we cannot attract personnel or generate sufficient capital to fund these efforts. Failure to establish a sales force and distribution network in the U.S. would have a material adverse effect on our ability to grow our business.
 
The planned expansion of our business may strain our resources.
 
Our strategy for growth includes potential acquisitions of new products for development and the introduction of these products to the market. Since we currently operate with limited resources, the addition of such new products could require a significant expansion of our operations, including the recruitment, hiring and training of additional personnel, particularly those with a clinical or regulatory background. Any failure to recruit necessary personnel could have a material adverse effect on our business. Additionally, the expansion of our operations and work force could create a strain on our financial and management resources and it may require us to add management personnel.

 
13

 

 
We may incur potential liabilities relating to discontinued operations or products.
 
In October 2003, we sold Gacell Holdings AB, the Swedish holding company of Amarin Development AB, which we refer to as ADAB, our Swedish drug development subsidiary, to Watson Pharmaceuticals, Inc. In February 2004, we sold our U.S. subsidiary, Amarin Pharmaceuticals Inc., and certain assets, to Valeant. In connection with these transactions, we provided a number of representations and warranties to Watson and Valeant regarding the respective businesses sold to them, and other matters, and we undertook to indemnify Watson and Valeant under certain circumstances for breaches of such representations and warranties. We are not aware of any circumstances which could reasonably be expected to give rise to an indemnification obligation under our agreements with either Watson or Valeant. However, we cannot predict whether matters may arise in the future which were not known to us and which, under the terms of the relevant agreements, could give rise to a claim against us.
 
We will be dependent on patents, proprietary rights and confidentiality.
 
Because of the significant time and expense involved in developing new products and obtaining regulatory approvals, it is very important to obtain patent and trade secret protection for new technologies, products and processes. Our ability to successfully implement our business plan will depend in large part on our ability to:
 
acquire patented or patentable products and technologies;
 
obtain and maintain patent protection for our current and acquired products;
 
preserve any trade secrets relating to our current and future products; and
 
operate without infringing the proprietary rights of third parties.
 
Although we intend to make reasonable efforts to protect our current and future intellectual property rights and to ensure that any proprietary technology we acquire does not infringe the rights of other parties, we may not be able to ascertain the existence of all potentially conflicting claims. Therefore, there is a risk that third parties may make claims of infringement against our current or future products or technologies. In addition, third parties may be able to obtain patents that prevent the sale of our current or future products or require us to obtain a license and pay significant fees or royalties in order to continue selling such products.
 
We may in the future discover the existence of products that infringe upon patents that we own or that have been licensed to us. Although we intend to protect our trade secrets and proprietary know-how through confidentiality agreements with our manufacturers, employees and consultants, we may not be able to prevent our competitors from breaching these agreements or third parties from independently developing or learning of our trade secrets.
 
We anticipate that competitors may from time to time oppose our efforts to obtain patent protection for new technologies or to submit patented technologies for regulatory approvals. Competitors may seek to challenge patent applications or existing patents to delay the approval process, even if the challenge has little or no merit. Patent challenges are generally highly technical, time consuming and expensive to pursue. Were we to be subject to one or more patent challenges, that effort could consume substantial time and resources, with no assurances of success, even when holding an issued patent.
 
The loss of any key management or qualified personnel could disrupt our business.
 
We are highly dependent upon the efforts of our senior management. The loss of the services of one or more members of senior management could have a material adverse effect on us. As a small company with a streamlined management structure, the departure of any key person could have a significant impact and would be potentially disruptive to our business until such time as a suitable replacement is hired. Furthermore, because of the specialized nature of our business, as our business plan progresses we will be highly dependent upon our ability to attract and retain qualified scientific, technical and key management personnel. There is intense competition for qualified personnel in the areas of our activities. In this environment, we may not be able to attract and retain the personnel necessary for the development of our business, particularly if we do not achieve profitability. The failure to recruit key scientific, technical and management personnel would be detrimental to our ability to implement our business plan.

 
14

 

 
We are subject to continuing potential product liability.
 
Although we disposed of the majority of our former products during 2003 and 2004, we remain subject to the potential risk of product liability claims relating to the manufacturing and marketing of our former products during the period prior to their divestiture. Any person who is injured as a result of using one of our former products during our period of ownership may have a product liability claim against us without having to prove that we were at fault. The potential for liability exists despite the fact that our former subsidiary, Amarin Pharmaceuticals Inc. conducted all sales and marketing activities with respect to such products. Although we have not retained any liabilities of Amarin Pharmaceuticals Inc. in this regard, as the prior holder of ownership rights to such former products, third parties could seek to assert potential claims against us. Since we distributed and sold our products to a wide number of end users, the risk of such claims could be material.
 
We do not at present carry product liability insurance to cover any such risks. If we were to seek insurance coverage, we may not be able to maintain product liability coverage on acceptable terms if our claims experience results in high rates, or if product liability insurance otherwise becomes costlier or unavailable because of general economic, market or industry conditions. If we add significant products to our portfolio, we will require product liability coverage and may not be able to secure such coverage at reasonable rates or at all.
 
Product liability claims could also be brought by persons who took part in clinical trials involving our current or former development stage products. A successful claim brought against us could have a material adverse effect on our business. Amarin does not carry product liability insurance to cover clinical trials.
 
Amarin was responsible for the sales and marketing of Permax from May 2001 until February 2004.  On May 17, 2001, Amarin acquired the U.S. sales and marketing rights to Permax from Elan.  An affiliate of Elan had previously obtained the licensing rights to Permax from Eli Lilly and Company in 1993.  Eli Lilly originally obtained approval for Permax on December 30, 1988, and has been responsible for the manufacture and supply of Permax since that date.  On February 25, 2004, Amarin sold its U.S. subsidiary, Amarin Pharmaceuticals, Inc., including the rights to Permax, to Valeant Pharmaceuticals International.
 
In late 2002, Eli Lilly, as the holder of the NDA for Permax, received a recommendation from the U.S. Food and Drug Administration (“FDA”) to consider making a change to the package insert for Permax based upon the very rare observation of cardiac valvulopathy in patients taking Permax.  While Permax has not been definitely proven as the cause of this condition, similar reports have been notified in patients taking other ergot- derived pharmaceutical products, of which Permax is an example.  In early 2003, Eli Lilly amended the package insert for Permax to reflect the risk of cardiac valvulopathy in patients taking Permax and also sent a letter to a number of doctors in the United States describing this potential risk.  Causation has not been established, but is thought to be consistent with other fibrotic side effects observed in Permax.
 
On March 29, 2007, the FDA announced that the manufacturers of pergolide drug products will voluntarily remove these drug products, including Permax, from the market.  Further information about the removal of Permax and other pergolide drug products is available on the FDA’s website.
 
During 2007, one lawsuit alleging claims related to cardiac valvulopathy and Permax was pending in the United States and currently remains pending.  Eli Lilly, Elan, Valeant, Amarin Pharmaceuticals Inc., Athena Neurosciences, Inc., and Amarin are named as defendants in this lawsuit, and are defending against the claims and allegations.  The case is currently in discovery.  In addition, a lawsuit alleging claims related to cardiac valvulopathy and Permax was filed in March 2008 and is currently pending in the United States.  Eli Lilly, Elan, Valeant, and Amarin are named as defendants in this lawsuit.  Amarin has not been formally served with the complaint from this lawsuit.
 
Two other claims related to cardiac valvulopathy and Permax and one claim related to compulsive gambling and Permax are or were being threatened against Eli Lilly, Elan, and/or Valeant, and could possibly implicate Amarin.
 
The group has reviewed the position and having taken external legal advice considers the potential risk of significant liability arising for Amarin from these legal actions to be remote. No provision is booked in the accounts at December 31, 2007.
 
The price of our ADSs and Ordinary Shares may be volatile.
 
The stock market has from time to time experienced significant price and volume fluctuations that may be unrelated to the operating performance of particular companies.  In addition, the market prices of the securities of many pharmaceutical and medical technology companies have been especially volatile in the past, and this trend is expected to continue in the future.  Our ADSs may

 
 
15

 

also be subject to volatility as a result of their limited trading market.  At December 31, 2007 we had 132,712,369 ADSs representing Ordinary Shares outstanding and 6,345,001 Ordinary Shares outstanding (which are not held in the form of ADSs). Taking account for the one-for-ten consolidation of our Ordinary Shares on January 18, 2008 we currently have 25,339,642 ADSs representing Ordinary Shares outstanding and 837,509 Ordinary Shares outstanding (which are not held in the for of ADSs). There is a risk that there may not be sufficient liquidity in the market to accommodate significant increases in selling activity or the sale of a large block of our securities. Our ADSs have historically had limited trading volume, which may also result in volatility.  During the   twelve-month period ending December 31, 2007, the average daily trading volume for our ADSs was 1,161,203 ADSs.
 
If our public float and the level of trading remain at limited levels over the long term, this could result in volatility and increase the risk that the market price of our ADSs and Ordinary Shares may be affected by factors such as:
 
·  
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.
 
The issuances of ADSs and Ordinary Shares upon the conversion or exercise of our securities will dilute the ownership interest of existing stockholders, including stockholders who had previously exercised their warrants.
 
The issuances of ADSs and Ordinary Shares in connection with the conversion of our Debentures and exercise of our warrants will dilute the ownership interest of existing stockholders.  Any sales in the public market of the ADSs and Ordinary Shares issuable upon such conversion or exercise could adversely affect prevailing market prices of our ADSs and Ordinary Shares.
 
Future sales of our ADSs and/or Ordinary Shares in the public market could lower the market price for our ADSs and/or Ordinary Shares.
 
In the future, we may sell additional ADSs and/or Ordinary Shares to raise capital or pursuant to contractual obligations.  See “— We may have to issue additional equity, leading to shareholder dilution.”   We cannot predict the size of future issuances or sales of our ADSs and/or Ordinary Shares to raise capital or the effect, if any, that they may have on the market price for our ADSs and/or Ordinary Shares.  The issuances and sales of substantial amounts of ADSs and/or Ordinary Shares, or the perception that such issuances and sales may occur, could adversely affect the market price of our ADSs and/or Ordinary Shares.
 
U.S. Holders of our Ordinary Shares or ADSs could be subject to material adverse tax consequences if we are considered a PFIC for U.S. federal income tax purposes.
 
There is a risk that we will be classified as a passive foreign investment company, or “PFIC”, for U.S. federal income tax purposes.  Our status as a PFIC could result in a reduction in the after-tax return to U.S. Holders of our Ordinary Shares or ADSs and may cause a reduction in the value of such shares.  We will be classified as a PFIC for any taxable year in which (i) 75% or more of our gross income is passive income or (ii) at least 50% of the average value of all our assets produce or are held for the production of passive income.  For this purpose, passive income includes interest, gains from the sale of stock, and royalties that are not derived in the active conduct of a trade or business.  Because we receive interest and may receive royalties, there is a risk that we will be considered a PFIC under the income test described above.  In addition, because of our cash position and our ownership of patents, there is a risk that we will be considered a PFIC under the asset test described above. While we believe that the PFIC rules were not intended to apply to companies such as us that focus on research, development and commercialization of drugs, no assurance can be given that the U.S. Internal Revenue Service or a U.S. court would determine that, based on the composition of our income and assets, we are not a PFIC currently or in the future.  If we were classified as a PFIC, U.S. Holders of our Ordinary Shares or ADSs could be subject to greater U.S. income tax liability than might otherwise apply, imposition of U.S. income tax in advance of when tax would otherwise apply, and detailed tax filing requirements that would not otherwise apply.  The PFIC rules are complex and a U.S. Holder of our Ordinary Shares or ADSs is urged to consult its own tax advisors regarding the possible application of the PFIC rules to it in its particular circumstances.
 
U.S. Holders of our Ordinary Shares or ADSs may be subject to U.S. income taxation at ordinary income tax rates on undistributed earnings and profits.
 
Given our current ownership, we expect that we will be a controlled foreign corporation, (“CFC”) for the taxable year 2008 and we may be classified as a CFC in future taxable years. If we are classified as a CFC for U.S. federal income tax purposes, any shareholder that is a U.S. person that owns directly, indirectly or by attribution, 10% or more of the voting power of our outstanding shares may be subject to current U.S. income taxation at ordinary income tax rates on all or a portion of the Company’s undistributed earnings and profits attributable to “subpart F income.” Such 10% shareholder may also be taxable at ordinary income tax rates on any gain realized on a sale of Ordinary Shares or ADSs to the extent of the Company’s current and accumulated earnings and profits attributable to such shares. The CFC rules are complex and U.S. Holders of our Ordinary shares or ADSs are urged to consult their own tax advisors regarding the possible application of the CFC rules to them in their particular circumstances.

 

 
16

 

 
 
The recent adverse clinical trial data on AMR101 for Huntington’s disease could materially affect our ability to develop AMR101 for other therapeutic indications.
 
On April 24, 2007, we reported top-line results from our two Phase III clinical trials of AMR101 to treat Huntington’s disease (“HD”).  We had conducted two Phase III double-blind, placebo-controlled studies in which HD patients were randomized to receive either placebo or 2 grams (1 gram twice daily) of AMR101 daily for six months.  Study data showed no statistically significant difference in either study between AMR101 and placebo with regard to the primary and secondary endpoints at 6-months of treatment.  These findings were inconsistent with earlier clinical trial data that showed statistical significance in a subset of HD patients with a CAG repeat length of less than or equal to 44.  This adverse clinical trial data on AMR101 for Huntington’s disease could materially affect our ability to develop AMR101 for other therapeutic indications.
 
The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.
 
We are incorporated under English law and our Ordinary Shares were admitted to trading on the AIM market of the London Stock Exchange and the IEX market of the Irish Stock Exchange on July 17, 2006. The rights of holders of Ordinary Shares and, therefore, certain of the rights of holders of ADSs, are governed by English law, including the provisions of the Companies Act 1985 (as amended) that remain in force and the Companies Act 2006 (together the “Companies Acts”), and by our memorandum and articles of association and the Group is subject to the rules of AIM and IEX. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations. The principal differences include the following:
 
Under English law, each shareholder present at a meeting has only one vote unless a valid demand is made for a vote on a poll, in which each holder gets one vote per share owned. Under U.S. law, each shareholder typically is entitled to one vote per share at all meetings. Under English law, it is only on a poll that the number of shares determines the number of votes a holder may cast. You should be aware, however, that the voting rights of ADSs are also governed by the provisions of a deposit agreement with our depositary bank.
 
Under English law, each shareholder generally has pre-emptive rights to subscribe on a proportionate basis to any issuance of shares. Under U.S. law, shareholders generally do not have pre-emptive rights unless specifically granted in the certificate of incorporation or otherwise.
 
Under English law, certain matters require the approval of 75% of the shareholders, including amendments to the memorandum and articles of association. This may make it more difficult for us to complete corporate transactions deemed advisable by our board of directors. Under U.S. law, generally only majority shareholder approval is required to amend the certificate of incorporation or to approve other significant transactions. Under the rules of AIM and IEX, certain transactions require the approval of 50% of the shareholders, including disposals resulting in a fundamental change of business and reverse takeovers. In addition, certain transactions with a party related to the Group for the purposes of the AIM rules requires that the Group consult with its nominated adviser as to whether the transaction is fair and reasonable as far as shareholders are concerned.
 
Under English law, shareholders may be required to disclose information regarding their equity interests upon our request, and the failure to provide the required information could result in the loss or restriction of rights attaching to the shares, including prohibitions on the transfer of the shares, as well as restrictions on dividends and other payments. Comparable provisions generally do not exist under U.S. law.
 
The quorum requirements for a shareholders’ meeting is a minimum of two persons present in person or by proxy. Under U.S. law, a majority of the shares eligible to vote must generally be present (in person or by proxy) at a shareholders’ meeting in order to constitute a quorum. The minimum number of shares required for a quorum can be reduced pursuant to a provision in a company’s certificate of incorporation or bylaws, but typically not below one-third of the shares entitled to vote at the meeting.
 

 
17

 

 
 
U.S. shareholders may not be able to enforce civil liabilities against us.
 
A number of our directors and executive officers and those of each of our subsidiaries, including Amarin Finance Limited, are non-residents of the United States, and all or a substantial portion of the assets of such persons are located outside the United States. As a result, it may not be possible for investors to affect service of process within the United States upon such persons or to enforce against them judgments obtained in U.S. courts predicated upon the civil liability provisions of the federal securities laws of the United States. We have been advised by our English solicitors that there is doubt as to the enforceability in England in original actions, or in actions for enforcement of judgments of U.S. courts, of civil liabilities to the extent predicated upon the federal securities laws of the United States. Amarin Finance Limited is an exempted company limited by shares organized under the laws of Bermuda. We have been advised by our Bermuda attorneys that uncertainty exists as to whether courts in Bermuda will enforce judgments obtained in other jurisdictions (including the United States) against us or our directors or officers under the securities laws of those jurisdictions or entertain actions in Bermuda against us or our directors or officers under the securities laws of other jurisdictions.
 
Foreign currency fluctuations may affect our future financial results or cause us to incur losses.
 
We prepare our financial statements in U.S. Dollars. Since our strategy involves the development of products for the U.S. market, a significant part of our clinical trial expenditures are denominated in U.S. Dollars and we anticipate that the majority of our future revenues will be denominated in U.S. Dollars. However, a significant portion of our costs are denominated in pounds sterling, euro and shekel as a result of our being engaged in activities in the United Kingdom, the European Union and Israel. As a consequence, the results reported in our financial statements are potentially subject to the impact of currency fluctuations between the U.S. Dollar on the one hand, and pounds sterling, euro or shekel on the other hand. We are focused on development activities and do not anticipate generating on-going revenues in the short-term. Accordingly, we do not engage in significant currency hedging activities in order to limit the risk of exchange rate fluctuations. However, if we should commence commercializing any products in the United States, changes in the relation of the U.S. Dollar to the pound sterling, euro and/or the shekel may affect our revenues and operating margins. In general, we could incur losses if the U.S. Dollar should become devalued relative to pounds sterling, euro and/or the shekel.
 
We do not currently have the capability to undertake manufacturing of any potential products.
 
We have not invested in manufacturing and have no manufacturing experience. We cannot assure you that we will successfully manufacture any product we may develop, either independently or under manufacturing arrangements, if any, with third party manufacturers. To the extent that we enter into contractual relationships with other companies to manufacture our products, if any, the success of those products may depend on the success of securing and maintaining contractual relationships with third party manufacturers (and any sub-contractors they engage).
 
We do not currently have the capability to undertake marketing, or sales of any potential products.
 
We have not invested in marketing or product sales resources. We cannot assure you that we will be able to acquire such resources. We cannot assure you that we will successfully market any product we may develop, either independently or under marketing arrangements, if any, with other companies. To the extent that we enter into contractual relationships with other companies to market our products, if any, the success of such products may depend on the success of securing and maintaining such contractual relationships the efforts of those other companies (and any sub-contractors they engage).
 
We have limited personnel to oversee out-sourced clinical testing and the regulatory approval process.
 
It is likely that we will also need to hire additional personnel skilled in the clinical testing and regulatory compliance process if we develop additional product candidates with commercial potential. We do not currently have the capability to conduct clinical testing in-house and do not currently have plans to develop such a capability. We out-source our clinical testing to contract research organizations. We currently have a limited number of employees and certain other outside consultants who oversee the contract research organizations involved in clinical testing of our compounds.
 
We cannot assure you that our limited oversight of the contract research organizations will suffice to avoid significant problems with the protocols and conduct of the clinical trials.
 
We depend on contract research organizations to conduct our pre-clinical and our clinical testing. We have engaged and intend to continue to engage third party contract research organizations and other third parties to help us develop our drug candidates. Although we have designed the clinical trials for drug candidates, the contract research organizations will be conducting all of our clinical trials. As a result, many important aspects of our drug development programs have been and will continue to be outside of our direct control. In addition, the contract research organizations may not perform all of their obligations under arrangements with us. If the contract research organizations do not perform clinical trials in a satisfactory manner or breach their obligations to us, the development and commercialization of any drug candidate may be delayed or precluded. We cannot control the amount and timing of resources these contract research organizations devote to our programs or product candidates. The failure of any of these contract research organizations to comply with any governmental regulations would substantially harm our development and marketing efforts and delay or prevent regulatory approval of our drug candidates. If we are unable to rely on clinical data collected by others, we could be required to repeat, extend the duration of, or increase the size of our clinical trials and this could significantly delay commercialization and require significantly greater expenditures.

 
18

 

 
Despite the use of confidentiality agreements and/or proprietary rights agreements, which themselves may be of limited effectiveness, it may be difficult for us to protect our trade secrets.
 
We rely on trade secrets to protect technology in cases when we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we require certain of our academic collaborators, contractors and consultants to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other proprietary information.
 
Potential technological changes in our field of business create considerable uncertainty.
 
We are engaged in the biopharmaceutical field, which is characterized by extensive research efforts and rapid technological progress. New developments in research are expected to continue at a rapid pace in both industry and academia. We cannot assure you that research and discoveries by others will not render some or all of our programs or product candidates uncompetitive or obsolete.
 
Our business strategy is based in part upon new and unproven technologies to the development of biopharmaceutical products for the treatment of neurological and cardiovascular disorders. We cannot assure you that unforeseen problems will not develop with these technologies or applications or that commercially feasible products will ultimately be developed by us.
 
Third-party reimbursement and health care cost containment initiatives and treatment guidelines may constrain our future revenues.
 
Our ability to market successfully our existing and future new products will depend in part on the level of reimbursement that government health administration authorities, private health coverage insurers and other organizations provide for the cost of our products and related treatments. Countries in which our products are sold through reimbursement schemes under national health insurance programs frequently require that manufacturers and sellers of pharmaceutical products obtain governmental approval of initial prices and any subsequent price increases. In certain countries, including the United States, government-funded and private medical care plans can exert significant indirect pressure on prices. We may not be able to sell our products profitably if adequate prices are not approved or reimbursement is unavailable or limited in scope. Increasingly, third-party payers attempt to contain health care costs in ways that are likely to impact our development of products including:
 
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.

 
19

 

 
We are undergoing significant organizational change. Failure to manage disruption to the business or the loss of key personnel could have an adverse effect on our business.
 
We are making significant changes to both our management structure and the locations from which we operate. As a result of this, in the short term, morale may be lowered and key employees may decide to leave, or may be distracted from their usual role. This could result in delays in development projects, failure to achieve managerial targets or other disruption to the business which could have material adverse affects on our business and results of operations.
 
Item 4  Information on the Company
 
A.  History and Development of the Company
 
Amarin Corporation plc (formerly Ethical Holdings plc) is a public limited company with its primary stock market listing in the U.S. on the NASDAQ Capital Market and secondary listings in the U.K. and Ireland on AIM and IEX, respectively. Amarin was originally incorporated in England as a private limited company on March 1, 1989 under the Companies Act 1985, and re-registered in England as a public limited company on March 19, 1993.
 
Our registered office is located at 110 Cannon Street, London, EC4N 6AR, England. Our principal executive offices are located at First Floor, Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland and our telephone number is +353-1-6699010. The directors are responsible for the maintenance and integrity of our website, www.amarincorp.com. Our principal research and development facilities are located in Oxford, England.
 
In the period from late 2003 through 2004, we executed a comprehensive restructuring of our operations. In 2003, we disposed of our drug delivery business to Watson. In 2004, we sold our U.S. sales and marketing subsidiary and the majority of our U.S. operations to Valeant and acquired the entire issued share capital of Laxdale, a research and development based neuroscience company, with particular expertise in lipid science.
 
During 2007, we initiated a cardiovascular development program, leveraging our proprietary expertise and intellectual property in lipid science to target billion dollar market opportunities such as dyslipidemia. We also focused on expanding and strengthening our research and development management team. In April 2007, we appointed Dr. Declan Doogan to the newly-created position of Head of Research and Development. Dr. Doogan was previously Senior Vice President and Head of Worldwide Development at Pfizer Global Research and Development. Since joining Amarin, Dr. Doogan has been instrumental in transforming our research and development organization and streamlining development activities from translational research through clinical operations.  Other recent additions to our management team include Dr. Keith Wood, a thirty year industry veteran as Head of Research and Development Operations and Stuart Sedlack (formerly Global Head of Negotiations for a business unit of Novartis Pharma AG) as Executive Vice President, Corporate Development.
 
In 2006 and 2007 we expanded our CNS pipeline through the acquisition of a global license to a novel sublingual apomorphine for  patients with advanced Parkinson’s disease, a novel nasal formulation of lorazepam for the out-patient treatment of emergency seizures in epilepsy patients and the addition of EN101 for myasthenia gravis via the acquisition of Ester Neurosciences Limited.
 
With respect to our Huntington’s disease program, in late 2007 we met with the FDA following the completion of a comprehensive analysis of the 12-month data from the U.S. Phase III trial of AMR101 in HD showing a statistically significant benefit with AMR101 over longer periods of treatment. The FDA indicated that one additional Phase III trial demonstrating robust results, in conjunction with the confirmatory evidence from the existing clinical data, may be sufficient clinical data to support a New Drug Application. We are also in discussions with EMEA.
 
On December, 19, 2007, Mr. Thomas Lynch was appointed Chief Executive Officer following the resignation of Mr. Richard Stewart.   Mr. Lynch joined us in January 2000 as Chairman of the Board. Between 1993 and 2004, Mr. Lynch was with Elan Corporation plc where he held a number of positions including Chief Financial Officer and Executive Vice Chairman. Also on December 19, 2007, Mr. Alan Cooke was appointed to the position of President and Chief Operating Officer.
 
In the period from late 2004 to late 2007, we completed a series of financings raising aggregate gross proceeds of approximately $96.7 million, including $18.5 million from our directors and officers.
 
 
 
20

 
 
 
B.  Business Overview
 
Our Business
 
We are committed to improving the lives of patients suffering from central nervous system and cardiovascular diseases. Our goal is to be a leader in the research, development and commercialization of novel drugs that address unmet patient needs.
 
Our recently initiated cardiovascular program capitalizes on the known therapeutic benefits of essential fatty acids in cardiovascular disease. Our CNS development pipeline includes programs in myasthenia gravis, Huntington’s disease, Parkinson’s disease, epilepsy and memory. We also have two proprietary technology platforms: a lipid-based technology platform for the targeted transport of molecules through the liver and/or to the brain, and a unique mRNA technology based on cholinergic neuromodulation.
 
The following table summarizes the status of our development pipeline:
 

 
AMR101

AMR101 is a semi-synthetic, highly purified (greater than 96%) derivative of (all-cis)-5,8,11,14,17-eicosapentaenoic acid (“ethyl-EPA”). It is a long chain highly unsaturated fatty acid (often written in short as 20:5n-3 or 20:   ω 3).

AMR101 and Derivatives for Cardiovascular Disease

We have initiated a cardiovascular development strategy to capitalize on the known therapeutic benefits of unsaturated fatty acids in cardiovascular disease. We plan to utilize our extensive know-how and experience in lipid science to develop and advance these programs.

We are planning to commence a series of clinical trials with AMR101 (ultra-pure ethyl-EPA) in dyslipidemia, particularly the treatment of high triglycerides and the evaluation of the effect of the co-administration and co-formulation of AMR101 with other cardiovascular medications.

In excess of two million patients in Japan have been prescribed ultra-pure EPA for the treatment of high triglyceride levels (a component of dyslipidemia) since its approval. The safety profile of ultra-pure EPA is very good, especially in comparison to other triglyceride lowering agents such as fibrates, statins and niacin.

 
21

 


We believe that proof of concept with AMR101 in cardiovascular disease can be established relatively quickly and inexpensively as efficacy is measured by well defined biochemical endpoints. This would enable rapid progress of effective compounds into the final stages of development.

In addition, we intend to commence investigation of new compounds from our existing development portfolio for the treatment of dyslipidemia and potentially other cardiovascular related diseases.

AMR101 Clinical Development for HD

HD is inherited as an autosomal dominant disease that gives rise to progressive, selective (localized) neural cell death associated with choreic movements and dementia. On April 24, 2007, we announced top line results from two Phase III studies with AMR101 in HD. Study data showed no statistically significant difference in either study between AMR101 and placebo with regard to the primary and secondary endpoints at 6 months of treatment.  These top-line findings were inconsistent with data from an earlier 12-month 135 patient clinical trial.

However, on November 19, 2007, Amarin announced that analysis of a comprehensive review of the 12-month data from the U.S. Phase III study showed a statistically significant difference in TMS-4 between the long term AMR101 group (12-month treatment) and those patients who had switched to AMR101 at 6-months.

In November 2007, we met with the FDA following the completion of the comprehensive review of all clinical data for AMR101 in HD. The FDA indicated that one additional Phase III trial demonstrating robust results, in conjunction with the confirmatory evidence from the existing clinical data, may be sufficient clinical data to support a New Drug Application.

We have also submitted the comprehensive review of all clinical data for AMR101 in HD to EMEA and discussions are ongoing regarding next steps.

EN101

EN101 is an orally available antisense oligonucleotide, specifically targeting the “read-through” or “R” isoform (“AChE-R”) of acetylcholinesterase (“AChE”). The molecule suppresses the production of the AChE-R protein without the negative cholinergic effects currently observed with conventional inhibitors.

Myasthenia gravis, a debilitating neuromuscular disease, is the first target indication for which EN101 is undergoing clinical development.  A Phase Ib clinical trial was conducted by Ester in 2002 to assess the safety, efficacy and pharmacokinetics of oral EN101 in MG patients. In 2004, Ester commenced a Phase IIa dose finding study in MG patients. Interim analysis from this study was announced in May 2007. Based on the results of the Phase IIa interim analysis, and the results of the Phase Ib study, EN101 appears to have a more favorable safety and efficacy profile, as well as a more favorable dosing regimen compared to the current standard of care, Mestinon (pyridostigmine).

We plan to complete the Phase IIa study and other non-clinical studies before progressing to a larger clinical study.

Sublingual Apomorphine for Parkinson’s Disease

Our novel sublingual (under the tongue) formulation of Apomorphine aims to achieve rapid absorption directly into the bloodstream after sublingual administration. Apomorphine is a particularly effective for the treatment of “off” episodes in Parkinson’s disease patients.  This novel formulation would offer patients a more user friendly alternative to the currently available injectable formulation of Apomorphine and we believe, could result in higher rates of utilization.

 
22

 



The oral bioavailability of our novel sublingual formulation had initially been demonstrated by us in a proof of concept study in human volunteers, while also showing it to being well tolerated. We subsequently progressed it through further Phase I pharmacokinetic studies and the lead formulation has now been selected for optimization in a final pharmacokinetic study.

Nasal Lorazepam

Our novel, nasal formulation of lorazepam is in development for the out-patient treatment of emergency seizures in epilepsy patients. The only treatment currently approved by the FDA for seizure emergencies in the out-patient setting is a rectal gel formulation of the drug diazepam. Diazepam gel’s use is limited by its rectal route of administration.

In early 2008, we announced the successful completion of an initial pre-clinical proof of concept study with the novel formulation. The data generated supports its further development as an out-patient treatment of emergency seizures.

AMR101 for AAMI

Following on from positive preclinical results with AMR101 in memory and cognition, in January 2008 we commenced a Phase IIa trial with AMR101 in Age Associated Memory Impairment (“AAMI”). The trial - randomized, double-blinded, and placebo-controlled - will enrol 96 patient volunteers with AAMI. Three dose strengths of AMR101 (1g, 2g, 4g) will be tested versus placebo using a computer-derived cognitive batch of tests. Initial results from the study are anticipated in the second half of 2008.

Targeted Lipid Transport Technology (“TLT”) Platform (previously Combinatorial Lipids)

We have researched and patented how to use different types of chemical linkage to attach a range of bioactive lipids either to other lipids or other drugs. The results are novel single chemical entities with predictable properties, potentially offering substantial and clinically relevant advantages over either compound alone.

This technology has application across a broad range of therapeutic areas including CNS, cardiovascular, gastrointestinal and oncology. AMR103, a novel form of levodopa in pre-clinical development for Parkinson's disease, is our lead candidate utilizing this technology.

Cholinergic Modulation and Inflammation

Ester, which was acquired by us in December 2007, also has a platform messenger RNA (“mRNA”) silencing technology based on novel and proprietary discoveries in the field of AChE, developed by Professor Hermona Soreq of the Hebrew University of Jerusalem.

Ester’s technology platform exhibits anti-inflammatory effects, including an indirect inhibitory effect on key pro-inflammatory cytokines via modulation of AChE-R, as well as a direct anti-inflammatory effect via modulation of macrophage activity mediated by interaction with the toll-like receptor or TLR signalling pathway.

Our Marketing Partners

AMR101 for HD has been partnered in the major E.U. markets with Scil Biomedical GmbH, Juste S.A.Q.F. and Archimedes Pharma Ltd.

Additionally, we are party to a license agreement dated July 21, 2003 with a marketing partner in Japan to develop, use, offer to sell, sell and distribute products in Japan utilizing certain of our intellectual property in the pharmaceutical fields of HD, depression, schizophrenia, dementia and certain less significant indications (by patient population) including the ataxias, for a period of 10 years from the date of first commercial sale or, if later, until patent protection expires.

 
23

 


In December 2005, Amarin Neuroscience entered into a worldwide exclusive license with Multicell Technologies, Inc. (“Multicell”) pursuant to which Amarin Neuroscience licensed the worldwide rights for MCT-125 to Multicell in return for a series of development based milestones and a royalty on net sales. Multicell is obliged to use reasonable good faith efforts to develop and commercialize MCT-125. Multicell is currently planning a Phase IIb trial with MCT-125 in the treatment of fatigue in patients suffering from MS.

The Financial Year

We had no revenues in 2007. Our consolidated revenues in 2006 comprise milestone payments received from Multicell and were derived from the licensing of exclusive, worldwide rights to Multicell for MCT-125 (formerly LAX-202).

For the year ended December 31, 2006, all revenues originated in the United Kingdom. No revenues were generated from licensing, development or contract manufacturing fees.

At present all of our products are in the development stage and we therefore have no products that can be marketed.

Competition

In pursuing our strategy of acquiring marketable and/or development stage neurology products, we expect to compete with other pharmaceutical companies for product and product line acquisitions, and more broadly for the distribution and marketing of pharmaceutical and consumer products. These anticipated competitors include companies which may also seek to acquire branded or development stage pharmaceutical products and product lines from other pharmaceutical companies. Most of our potential competitors will likely possess substantially greater financial, technical, marketing and other resources. In addition, we will compete for supplier manufacturing capacity with other companies, including those whose products are competing with ours. Additionally, our future products may be subject to competition from products with similar qualities. See Item 3 “Key Information — Risk Factors — Our future products may not be able to compete effectively against those of our competitors.”

Government Regulation

Any product development activities relative to AMR101 or products that we may develop or acquire in the future will be subject to extensive regulation by various government authorities, including the FDA and comparable regulatory authorities in other countries, which regulate the design, research, clinical and non-clinical development, testing, manufacturing, storage, distribution, import, export, labeling, advertising and marketing of pharmaceutical products and devices. Generally, before a new drug can be sold, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. The data are generated in two distinct development stages: pre-clinical and clinical. For new chemical entities, the pre-clinical development stage generally involves synthesizing the active component, developing the formulation and determining the manufacturing process, as well as carrying out non-human toxicology, pharmacology and drug metabolism studies which support subsequent clinical testing. Good laboratory practice requirements must be followed in order for the resulting data to be considered valid and reliable. For established molecules this stage can be limited to formulation and manufacturing process development and in vitro studies to support subsequent clinical evaluation.

The clinical stage of development can generally be divided into Phase I, Phase II and Phase III clinical trials. In Phase I, generally, a small number of healthy volunteers are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these studies is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the drug. Studies in volunteers are

 
24

 

also undertaken to begin assessing the pharmacokinetics of the drug (e.g. the way in which the body deals with the compound from absorption, to distribution in tissues, to elimination).

Phase II trials typically involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected. Phase III trials generally involve large numbers of patients from a number of different sites, which may be in one country or in several different countries or continents. Such trials are designed to provide the pivotal data necessary to establish the effectiveness of the product for its intended use, and its safety in use, and typically include comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing.

Prior to the start of human clinical studies of a new drug in the United States or, generally, for submission in support of a U.S. marketing application, an investigational new drug application, or IND, is filed with the FDA. Similar notifications are required in other countries. The amount of data that must be supplied in the IND application depends on the phase of the study. Earlier investigations, such as Phase I studies, typically require less data than the larger and longer-term studies in Phase III. A clinical plan must be submitted to the FDA prior to commencement of a clinical trial. In general, studies may begin in the U.S. without specific approval by the FDA 30-days after submission of the IND. However, the FDA may prevent studies from moving forward, and may suspend or terminate studies once initiated. Regular reporting of study progress and adverse experiences is required. During the testing phases, meetings can be held with the FDA to discuss progress and future requirements for the NDA. Studies are also subject to review by independent institutional review boards responsible for overseeing studies at particular sites and protecting human research study subjects. An independent institutional review board may prevent a study from beginning or suspend or terminate a study once initiated. Studies must also be conducted and monitored in accordance with good clinical practice and other requirements.

Following the completion of clinical trials, the data must be thoroughly analyzed to determine if the clinical trials successfully demonstrate safety and efficacy. If they do the data can be filed with the FDA in an NDA along with proposed labeling for the product and information about the manufacturing and testing processes and facilities that will be used to ensure product quality. In the US, FDA approval of an NDA must be obtained before marketing a developed product. The NDA must contain proof of safety, purity, potency and efficacy, which entails extensive pre-clinical and clinical testing.

Although the type of testing and studies required by the FDA do not differ significantly from those of other countries, the amount of detail required by the FDA can be more extensive. In addition, it is likely that the FDA will re-analyze the clinical data, which could result in extensive discussions between us and the licensing authority during the review process. The processing of applications by the FDA is extensive and time consuming and may take several years to complete. The FDA’s goal generally is to review and make a recommendation for approval of a new drug within ten months, and of a new “priority” drug within six months, although final FDA action on the NDA can take substantially longer, may entail requests for new data and/or data analysis, and may involve review and recommendations by an independent FDA advisory committee. The FDA may conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with current good manufacturing practice requirements, and may also audit data from clinical and pre-clinical trials.

There is no assurance that the FDA will act favorably or quickly in making such reviews and significant difficulties or costs may be encountered by the Group in its efforts to obtain FDA approvals. The FDA may also require post-marketing testing and surveillance to monitor the effects of approved products or it may place conditions on approvals including potential requirements or risk management plans that could restrict the commercial promotion, distribution, prescription or dispensing of products. Product approvals may be withdrawn if compliance with regulatory standards is not maintained or if problems occur following initial marketing.

In the European Union, our future products may also be subject to extensive regulatory requirements. As in the U.S., the marketing of medicinal products has for many years been subject to the granting of marketing authorizations by regulatory agencies. Particular emphasis is also being placed on more sophisticated and faster procedures for reporting of adverse events to the competent authorities.

 
25

 


In common with the U.S., the various phases of pre-clinical and clinical research are subject to significant regulatory controls. Although the regulatory controls on clinical research are currently undergoing a harmonization process following the adoption of the Clinical Trials Directive 2001/20/EC, there are currently significant variations in the member state regimes. However, all member states currently require independent institutional review board approval of interventional clinical trials. With the exception of U.K. Phase 1 studies in healthy volunteers, all clinical trials require either prior governmental notification or approval. Most regulators also require the submission of adverse event reports during a study and a copy of the final study report.

In the European Union, approval of new medicinal products can be obtained through one of three processes. The first such process is known as the mutual recognition procedure. An applicant submits an application in one European Union member state, known as the reference member state. Once the reference member state has granted the marketing authorization, the applicant may choose to submit applications in other concerned member states, requesting them to mutually recognize the marketing authorizations already granted. Under this mutual recognition process, authorities in other concerned member states have 55 days to raise objections, which must then be resolved by discussions among the concerned member states, the reference member state and the applicant within 90 days of the commencement of the mutual recognition procedure. If any disagreement remains, all considerations by authorities in the concerned member states are suspended and the disagreement is resolved through an arbitration process. The mutual recognition procedure results in separate national marketing authorizations in the reference member state and each concerned member state.

The second procedure in the European Union for obtaining approval of new medicinal products is known as the centralized procedure. This procedure is currently mandatory for products developed by means of a biotechnological process and optional for new active substances and other “innovative medicinal products with novel characteristics.” Under this procedure, an application is submitted to the European Agency for the Evaluation of Medical Products. Two European Union member states are appointed to conduct an initial evaluation of each application. These countries each prepare an assessment report, which reports are then used as the basis of a scientific opinion of the Committee on Proprietary Medical Products. If this opinion is favorable, it is sent to the European Commission which drafts a decision. After consulting with the member states, the European Commission adopts a decision and grants a marketing authorization, which is valid throughout the European Union and confers the same rights and obligations in each of the member states as a marketing authorization granted by that member state.

The third, and most recently introduced procedure in the European Union, is known as the decentralized procedure. This is similar to the mutual recognition procedure described above, but with some differences: notably in the time key documents are provided to concerned member states by the reference member state, the overall timing of the procedure and the possibility of “clock stops” during the procedure.

The European Union is currently expanding, with a number of Eastern European countries joining recently and expected to join over the coming years. Several other European countries outside the European Union, particularly those intending to accede to the European Union, accept European Union review and approval as a basis for their own national approval.

Following approval of a new product, a pharmaceutical company generally must engage in various monitoring activities and continue to submit periodic and other reports to the applicable regulatory agencies, including any cases of adverse events and appropriate quality control records. Modifications or enhancements to the products or labeling, or changes of site of manufacture are often subject to the approval of the FDA and other regulators, which may or may not be received or may result in a lengthy review process.

Prescription drug advertising and promotion is subject to federal, state and foreign regulations. In the U.S., the FDA regulates all company and prescription drug product promotion, including direct-to- consumer advertising. Promotional materials for prescription drug products must be submitted to the FDA in conjunction with their first use. Use of volatile materials may lead to FDA enforcement actions. Any distribution of prescription drug products and pharmaceutical samples must comply with the U.S. Prescription Drug Marketing Act, or the PDMA, a part of the U.S. Federal Food, Drug, and Cosmetic Act.

 
26

 


In the U.S., once a product is approved its manufacture is subject to comprehensive and continuing regulation by the FDA. The FDA regulations require that products be manufactured in specific approved facilities and in accordance with current good manufacturing practices, and NDA holders must list their products and register their manufacturing establishments with the FDA. These regulations also impose certain organizational, procedural and documentation requirements with respect to manufacturing and quality assurance activities. NDA holders using contract manufacturers, laboratories or packagers are responsible for the selection and monitoring of qualified firms. These firms are subject to inspections by the FDA at any time, and the discovery of violative conditions could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed or tested by them.

The distribution of pharmaceutical products is subject to additional requirements under the PDMA and equivalent laws and regulations in other jurisdictions. For instance, states are permitted to require registration of distributors who provide products within their state despite having no place of business within the state. The PDMA also imposes extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

Manufacturing, sales, promotion, and other activities following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including, in the U.S., the Centers for Medicare & Medicaid Services, other divisions of the Department of Health and Human Services, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, and state and local governments. Sales, marketing and scientific/educational programs must also comply with the U.S. Medicare-Medicaid Anti-Fraud and Abuse Act and similar state laws. Pricing and rebate programs must comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. The handling of any controlled substances must comply with the U.S. Controlled Substances Act and Controlled Substances Import and Export Act. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act. Manufacturing, sales, promotion and other activities are also potentially subject to federal and state consumer protection and unfair competition laws.

The failure to comply with regulatory requirements subjects firms to possible legal or regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result in criminal prosecution, fines or other penalties, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of product approvals, or refusal to allow a firm to enter into supply contracts, including government contracts. In addition, even if a firm complies with FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the FDA to modify or withdraw a product approval. Prohibitions or restrictions on sales or withdrawal of future products marketed by us could materially affect our business in an adverse way.

Changes in regulations or statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example:

·  
changes to our manufacturing arrangements;

·  
additions or modifications to product labeling;

·  
the recall or discontinuation of our products; or

·  
additional record-keeping requirements.

 
27

 



If any such changes were to be imposed, they could adversely affect the operation of our business.

Manufacturing and Supply

Amarin Neuroscience Limited is currently responsible for the supply of the clinical supplies of AMR101, through its sub-contractors, and will be responsible for the commercial manufacturing and supply of AMR101 should the FDA approve this compound. All supplies of the bulk compound (ethyl-EPA), which constitutes the only pharmaceutically active ingredient of AMR101, are currently purchased from Nisshin Pharma, Inc., a currently qualified manufacturer, pursuant to a supply agreement whereby the supply is at a fixed price. The main raw material that constitutes ethyl-EPA is a naturally occurring substance which is sourced from marine life. The manufacturing processes that are applied by Nisshin to such raw material are proprietary to Nisshin and produce a pharmaceutical grade compound at a level of purity of at least 95%. We are aware that certain other manufacturers have the ability to produce ethyl-EPA to a similar level of purity.

Patents and Proprietary Technology

We believe that patent protection of our technologies, processes and products is important to our future operations. The success of our products may depend, in part, upon our ability to obtain strong patent protection. There can however be no assurance that:

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.

When deemed appropriate, we intend to vigorously enforce our patent protection and intellectual property rights.

Our strategy is to file patent applications where we think it is appropriate to protect and preserve the proprietary technology and inventions considered significant to our business. We have patents covering our various compounds and their uses. These include use patents issued for the method of treating a number of CNS and cardiovascular disorders with highly pure forms of EPA and composition of matter patents relating to potential second generation technology platforms. We will also rely upon trade secrets and know-how to retain our competitive position. We will file patent applications either on a country-by-country basis or by using the European or international patent cooperation treaty systems. The existence of a patent in a country may provide competitive advantages to us when seeking licensees in that country. In general, patents granted in most European countries have a twenty-year term, although in certain circumstances the term can be extended by supplementary protection certificates. We may be dependent in some cases upon third party licensors to pursue filing, prosecution and maintenance of patent rights or applications owned or controlled by those parties.

It is possible that third parties will obtain patents or other proprietary rights that might be necessary or useful to us. In cases where third parties are first to invent a particular product or technology, it is possible that those parties will obtain patents that will be sufficiently broad so as to prevent us from utilizing such technology. In addition, we may use unpatented proprietary technology, in which case there would be no assurance that others would not develop similar technology. See Item 3 “Key Information — Risk Factors — We will be dependent on patents, proprietary rights and confidentiality, and — Potential technological changes in our field of business create considerable uncertainty”.
 
C.  Organizational Structure

At December 31, 2007, we had the following subsidiary undertakings:

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%

 

 
28

 


 
D.  Property, Plant and Equipment

The following table lists the location, use and ownership interest of our principal properties as of May 19, 2008:

 
Location
 
Use   
 
Ownership             
 
Size
(sq. ft.)
Ely, Cambridgeshire, England
 Ground Floor                                                                                                
 
Offices
 
 
Leased and sub-let
 
 
7,135
 First Floor                                                                                                
Offices
 
Leased and sub-let
 
2,800
Godmanchester, Cambridgeshire,
 England                                                                                                
 
Offices
 
 
Leased and sub-let
 
 
7,000
London, England                                                                                                
Offices
 
Leased
 
2,830
Oxford, England                                                                                                
Offices
 
Leased
 
3,000
Dublin, Ireland                                                                                                
Offices
 
Leased
 
3,251

We vacated the premises in Ely, Cambridgeshire in July 2001 and have sub-let the lease for this space. We have sub-let the lease in Godmanchester to Phytopharm plc who occupy the premises on a “held over” basis under the terms of a lease, the term of which expired in January 2002.

On April 27, 2001, we signed a lease covering approximately 2,830 square feet of office space located at 7 Curzon Street, London, Mayfair, W1J 5HG, England. This lease expires in March 2010.

On July 4, 2006, we signed a lease covering approximately 3,000 square feet of office space located at 1st Floor, Magdalen Centre North, Oxford Science Park, Oxford, OX4 4GA, England. This lease expires in July 2009.

On January 22, 2007, we signed a lease covering approximately 3,251 square feet of office space located at 1st   Floor, Block 3, The Oval, Shelbourne Road, Dublin 4, Ireland. This lease expires December 2026 and can be terminated in 2012.

We have no manufacturing capacity at any of the above properties.

Item 4A  Unresolved Staff Comments

None.

Item 5  Operating and Financial Review and Prospects

A.  Operating Results

The following discussion of operating results should be read in conjunction with our selected financial information set forth in Item 3 “Key Information — Selected Financial Data” and our consolidated financial statements and notes thereto beginning on page F-1 of this annual report.

Comparison of Fiscal Years Ended December 31, 2007 and December 31, 2006

Overview

We have undergone significant change over the last two years, including the initiation of a cardiovascular development program and the completion of a number of acquisitions in the CNS area.

During 2007, we initiated a cardiovascular development program leveraging our proprietary expertise and intellectual property in lipid science to target billion dollar market opportunities such as dyslipidemia. We also focused on expanding and strengthening our research and development management team. In April 2007, we appointed Dr. Declan Doogan to the newly-created position of Head of Research and Development. Dr. Doogan was Senior Vice President and Head of Worldwide Development at Pfizer Global Research and Development. Since joining Amarin, Dr. Doogan has been instrumental in transforming our research and development organization and streamlining development activities from translational research through clinical operations. Other recent additions to our management team include Dr. Keith Wood, a thirty year industry veteran as Head of Research and Development Operations and Stuart Sedlack, (formerly Global Head of Negotiations for a business unit of Novartis Pharma AG), as Executive Vice President, Corporate Development.
 

 
29

 

 
In 2007 and 2006 we expanded our CNS pipeline through the acquisition of a global license to a novel sublingual apomorphine for the treatment of “off” episodes in patients with advanced Parkinson’s disease, a novel nasal formulation of lorazepam for the out-patient treatment of emergency seizures in epilepsy patients and the acquisition of Ester Neurosciences Limited. Ester’s lead product, EN101, an AChE-R mRNA inhibitor, currently in Phase IIa clinical development, represents an important therapeutic approach to treat myasthenia gravis, a debilitating neuromuscular disease. An interim analysis of this Phase IIa study suggests EN101 may have superior efficacy, longer duration of action, and a more favorable side effect profile and dosing regimen, as compared with current first line treatment. The acquisition also provides Amarin with access to a platform messenger RNA (mRNA) silencing technology which targets the cholinergic pathway, and a promising preclinical program in neurodegeneration and inflammation.

With respect to our HD program, in late 2007, we met with the FDA following the completion of a comprehensive analysis of the 12-month data from the U.S. Phase III trial of AMR101 in Huntington’s disease showing a statistically significant benefit with AMR101 over longer periods of treatment. The FDA indicated that one additional Phase III trial demonstrating robust results, in conjunction with the confirmatory evidence from the existing clinical data, may be sufficient clinical data to support a New Drug Application. This positive analysis followed the disappointing results announced in April 2007, which showed no difference between AMR101 and placebo after six months of treatment. We are also in discussions with EMEA.
 
On December, 19, 2007, Mr. Thomas Lynch was appointed Chief Executive Officer following the resignation of Mr. Richard Stewart.   Mr. Lynch joined us in January 2000 as Chairman of the Board. Between 1993 and 2004, Mr. Lynch was with Elan Corporation plc where he held a number of positions including Chief Financial Officer and Executive Vice Chairman.  Also on December 19, 2007, Mr. Alan Cooke was appointed to the position of President and Chief Operating Officer.

Revenue

We recorded no revenue in 2007. During 2006, we earned milestone revenue of $0.5 million under a license agreement signed with Multicell in 2005, pursuant to which we granted the exclusive, worldwide rights to LAX-202 (renamed MCT-125) for the treatment of fatigue in patients suffering from multiple sclerosis.

Research and Development

The U.S. and E.U. AMR101 trials into Huntington’s disease were completed in the first quarter of 2007 with final data available in November 2007. Research and development expense decreased by $3.0 million to $12.1 million compared to 2006’s research and development expense of $15.1 million. The completion of the AMR101 trials into Huntington’s disease was the primary reason for the fall in research and development expense in 2007. The decrease in research and development expense was partly offset by costs incurred on our two Parkinson’s disease programs, our epilepsy and memory programs and the initiation of our new cardiovascular program.

General and Administrative

General and administrative expenses were $28.6 million in 2007 compared with $13.5 million in 2006, an increase of $15.1 million. The increase in general and administrative expenses over 2006 is mainly due to the $8.8 million impairment of intangible assets, an increase in share based compensation expenses of $2.8 million, reorganization costs associated with the departure of our former chief executive officer and the planned vacation of our offices in London, increased personnel costs and the significant level of business development activities during the year.


Finance income

Finance income for 2007 was $1.9 million compared to $3.3 million for 2006. The 2007 finance income comprises interest and similar income of $1.3 million which was earned from cash balances held on deposit. We hold cash denominated in pounds sterling, U.S. Dollars and euro. In 2007, a gain of $0.6 million was recorded from holding pounds sterling and euro as the U.S. Dollar weakened relative to both currencies, compared to a $2.0 million gain in 2006. We manage foreign exchange risk by holding our cash in the currencies in which we expect to incur future cash outflows.

 
30

 


 
Finance costs

Finance costs for 2007 were $0.2 million compared to $2.8 million for 2006. Finance costs in 2007 relate to the fair value of interest expense on the convertible debentures issued in December 2007. Finance costs for 2006 relate to the future investment right which was granted under the May 2005 financing. The future investment right was settled in March 2006. A charge of approximately $2.8 million was recorded in 2006, being the movement in the fair value of the future investment right from January 1, 2006 to March 15, 2006.

Taxation

A research and development tax credit of $0.8 million was recognized in the year ended December 31, 2007. An amount of $0.8 million was also recognized in 2006. Under U.K. tax law, qualifying companies can surrender part of their tax losses in return for a cash refund.

Critical Accounting Policies

Our significant accounting policies are described in Note 2 to the consolidated financial statements beginning on page F-1 of this annual report. Our consolidated financial statements are presented in accordance with IFRS as adopted by the E.U. and as issued by the IASB. All professional accounting standards effective as of December 31, 2007 have been taken into consideration in preparing the consolidated financial statements. These accounting principles require us to make certain estimates, judgments and assumptions. We believe that the estimates, judgments and assumptions upon which we rely are reasonable based upon information available to us at the time these estimates, judgments and assumptions are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities as of the date of our consolidated financial statements, as well as the reported amounts of revenues and expenses during the periods presented. To the extent there are material differences between these estimates, judgments or assumptions and actual results, our financial statements will be affected. The significant accounting policies that we believe are the most critical to aid in fully understanding and evaluating our reported financial results include the following:

intangible assets and research and development expenditure;

foreign currency; and

revenue recognition.

Intangible assets and research and development expenditure

In-process research and development

Acquired in-process research and development (“IPR&D”) is stated at cost less accumulated amortization and impairments. Acquired IPR&D arising on acquisitions is capitalized and amortized on a straight-line basis over its estimated useful economic life. The useful economic life commences upon generation of economic benefits relating to the acquired IPR&D.

Capitalization policy

Costs incurred on development projects (relating to the design and testing of new or improved products) are recognized as intangible assets when the following criteria are fulfilled: completing the asset so it will be available for use or sale is technically feasible; management intends to complete the intangible asset and use or sell it; an ability to use or sell the intangible asset; it can be demonstrated how the intangible asset will generate probable future economic benefits; adequate technical; financial and other resources to complete the development and to use or sell the intangible asset are available; and the expenditure attributable to the intangible asset during its development can be reliably measured. To date, development expenditures have not met the criteria for recognition of an internally generated intangible asset.

 
31

 


Intangible assets not yet available for use are not subject to amortization but are tested for impairment at least annually. An impairment loss is recognized if the carrying amount of an asset exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. Value in use is calculated by discounting the expected future cash flows obtainable as a result of the asset’s continued use.

Research and development expenditure

On an ongoing basis the Group undertakes research and development, including clinical trials to establish and provide evidence of product efficacy. Clinical trial costs are expensed to the income statement on a systematic basis over the estimated life of trials to ensure the costs charged reflect the research and development activity performed. To date, all research and development costs have been written off as incurred and are included within operating expenses, as disclosed in Note 6. Research and development costs include staff costs, professional and contractor fees, inventory, and external services.

Foreign currency

Functional and presentation currencies

Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The Consolidated Financial Statements are presented in U.S. Dollars, which is the Company’s functional and presentation currency.

Transactions and balances

Transactions in foreign currencies are recorded at the exchange rate prevailing at the date of the transaction.  The resulting monetary assets and liabilities are translated into the appropriate functional currency at exchange rates prevailing at the balance sheet date and the resulting gains and losses are recognized in the income statement. Foreign exchange gains and losses resulting from the settlement of such transactions are recognized in the income statement.

Group companies

The results and financial position of all the Group entities (none of which has the currency of a hyper-inflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:

(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.

Monetary items that are receivable or payable to a foreign operation are treated as a net investment in the foreign operation by the Company as settlement is neither planned nor likely to occur in the foreseeable future. On consolidation, exchange differences arising from the translation of the net investment in foreign operations, and of borrowings and other currency instruments designated as hedges of such investments, are taken to shareholders’ equity. When a foreign operation is partially disposed or sold, exchange differences that were recorded in equity are recognized in the income statement as part of the gain or loss on sale.

Goodwill and fair value adjustments arising on the acquisition of a foreign entity are treated as assets and liabilities of the foreign entity and translated at the closing rate.

Revenue

Revenue from the sale of goods is measured at the fair value of the consideration received or receivable, net of returns and allowances, trade discounts and volume rebates.  Revenue is recognized when the significant risks and rewards of ownership have been transferred to the buyer, recovery of the consideration is probable, the associated costs and possible return of goods can be estimated reliably, and there is no continuing management involvement with the goods.

 
32

 


Revenue from technology licensing to third parties is recognized when earned and non-refundable, through the achievement of specific milestones set forth in the applicable contract, when there is no future obligation with respect to the revenue and receipt of the consideration is probable, in accordance with the terms prescribed in the applicable contract.

Royalty income is recognized when earned, based on related sales of products under agreements providing for royalties.

Impact of Inflation

Although our operations are influenced by general economic trends, we do not believe that inflation had a material impact on our operations for the periods presented.

Foreign Currency

The U.S. Dollar is the functional currency for the Company. A percentage of our expenses, assets and liabilities are denominated in currencies other than our functional currency. Fluctuations in exchange rates may have a material adverse effect on our consolidated results of operations and could also result in exchange gains and losses. We cannot accurately predict the impact of future exchange rate fluctuations on our consolidated results of operations. We aim to minimize our foreign currency risk by holding cash balances in the currencies in which we expect to incur future cash outflows.

Governmental Policies

We are not aware of any governmental, economic, fiscal, monetary or political policies that have materially affected or could materially affect, directly or indirectly, our operations or investments by U.S. shareholders.

B.  Liquidity and Capital Resources

Our capital requirements relate primarily to clinical trials, employee infrastructure and working capital requirements. Historically, we have funded our cash requirements primarily through the public and private sales of equity and debt securities. As of December 31, 2007, we had approximately $18.3 million in cash representing a decrease of $18.5 million compared to December 31, 2006. On May 14, 2008, we announced a private placement of Ordinary Shares for up to $60.0 million. The first tranche from new investors of $28.0 million closed on May 19, 2008, see Item 8B - "Significant Changes" in this annual report for further details. Based upon current business activities, we forecast having sufficient cash to fund operations for at least the next 12 months from May 19, 2008.

Over the two years ended December 31, 2007, we have received $34.0 million in cash from the issuance of shares and $2.75 million in convertible debentures, from equity and debt financings.

Cash

As of December 31, 2007, we had approximately $18.3 million in cash compared with $36.8 million as of December 31, 2006. Our cash has been invested primarily in U.S. Dollar, pounds sterling and euro denominated money market and checking accounts with financial institutions in the U.K., Ireland and Israel, having a high credit standing.

Cash flows expended on operating activities were $26.3 million for the year ended December 31, 2007 as compared with $24.2 million for the year ended December 31, 2006.

The operating cash flows expended on operating activities reflect funding of the net loss of $38.2 million adjusted for a non-cash impairment charge on intangible assets of $8.8 million, non-cash depreciation and amortization of $0.4 million, non-cash inflow in respect of share based compensation of $5.3 million, net outflow of interest, foreign exchange and other items of $1.6 million and net outflow on working capital of $0.8 million. In 2006, the operating cash flows expended on operating activities reflect funding of the net loss of $26.8 million adjusted for non-cash depreciation and amortization of $0.8 million, a non-cash fixed asset impairment and disposals of $0.3 million, a non-cash inflow in respect of share based compensation of $2.2 million, net outflow of interest, foreign exchange and other items of $3.4 million and a net inflow on working capital of $3.0 million.

Cash out flows expended on investing activities were $5.0 million in 2007 as compared to cash inflows of $1.1 million generated in 2006. Our investing activities related to the purchase of intangible assets, property, plant and equipment and interest received.

 
33

 


Cash inflows from financing activities in 2007, net of related expenses, were $12.1 million, compared to cash inflows from financing activities in 2006 net of related expenses, of $24.0 million. Gross receipts from financing activities in 2007 comprised two equity financings yielding $9.1 million, gross proceeds on the issue of convertible debentures $2.75 million and other warrant and option exercises of $0.6 million, offset by issuance costs of $0.3 million. Net cash provided by financing activities in 2006 comprised two financings yielding $20.8 million, shares issued pursuant to certain pre-existing contractual commitments yielding $4.2 million and other warrant and option exercises of $1.4 million, offset by issuance costs of $2.5 million.

On December 4, 2007, we accepted subscriptions of $5.4 million from institutional and other accredited investors for approximately 16.3 million Ordinary Shares in the form of ADSs in a registered direct offering at a purchase price of $0.33 per share and issued warrants to purchase approximately 8.1 million Ordinary Shares at an exercise price of $0.48 per share. The net proceeds of our December registered offering (taking into account professional advisers’ fees associated with filing the related registration statement, cash fees of our placement agent and government stamp duty but not our travel, printing or other expenses) were approximately $5.1 million.

On June 1, 2007, we issued approximately 6.2 million ordinary shares and warrants to purchase approximately 0.6 million shares with an exercise price of $0.72 per share in a registered direct offering, in consideration for $3.7 million.

On October 23, 2006, we accepted subscriptions of $18.7 million from institutional and other accredited investors for approximately 9.0 million Ordinary Shares in the form of ADSs in a registered direct offering at a purchase price of $2.09 per share. The net proceeds of our October registered offering (taking into account professional advisers’ fees associated with filing the related registration statement, cash fees of our placement agent and government stamp duty but not our travel, printing or other expenses) were approximately $17.3 million.

On March 31, 2006, we issued approximately 2.4 million Ordinary Shares in the form of ADSs in consideration for $4.2 million raised in a registered direct financing which was completed pursuant to pre-existing contractual commitments arising from a previously completed financing in May 2005.

On January 23, 2006, we issued a total of approximately 0.9 million Ordinary Shares in the form of ADSs and issued warrants to purchase approximately 0.3 million Ordinary Shares at an exercise price of $3.06 in consideration for $2.1 million raised in the January 23, 2006, private equity placement.

At December 31, 2007, we had total debt of $2.75 million with a cash maturity in 2010. We had no debt at December 31, 2006.

All treasury activity is managed by the corporate finance group. Cash balances are invested in short-term money market deposits, either U.S. Dollars, pounds sterling, euro or shekel. No formal hedging activities are undertaken as cash balances are maintained in currencies that match our anticipated financial obligations and forecast cash flows.

C.  Research and Development

Amarin has in-house research and development capability and expertise, supplemented by retained external consultants. Costs classified as research and development are written off as incurred, as are patent costs. Such costs include external trial costs, clinical research organization costs, staff costs, professional and contractor fees, materials and external services. Details of amounts charged in the two years ended December 31, 2007 and December 31, 2006, are disclosed above. Specifically, we incurred $12.1 million in 2007. In 2006, we incurred costs of $15.1 million. Our expenditure will be increasingly focused on the research, development and commercialization of novel drugs for CNS disorders and cardiovascular diseases.

Amarin is initiating a series of cardiovascular preclinical and clinical programs to capitalize on the known therapeutic benefits of essential fatty acids in cardiovascular disease. Amarin’s CNS development pipeline includes programs in myasthenia gravis, Huntington’s disease, Parkinson’s disease, epilepsy and memory. Amarin also has two proprietary technology platforms: a lipid-based technology platform for the targeted transport of molecules through the liver and/or to the brain, and a unique mRNA technology based on cholinergic neuromodulation.


 
34

 



D.  Trend Information

In 2004, we changed our business model and have had no other sources of revenue since then other than revenue pursuant to our out-licensing contract with Multicell. Until we are able to market a product or secure revenue from licensing sources, this trend is expected to continue. We refer users to Items 4B “Business Overview”, 5A “Operating Results” and 5B “Liquidity and Capital Resources”.

E.  Off Balance Sheet Transactions

Although there are no disclosable off balance sheet transactions, there have been transactions involving contingent milestones — see “Note 30 — Financial Commitments” in the financial statements.

F.  Contractual Obligations

The following table summarizes our payment obligations as of December 31, 2007. The operating lease obligations primarily represent rent payable on properties leased by the Group. Some of the properties leased by the Group have been sub-let and generate rental income. Purchase obligations relate to manufacturing contracts with a third party for the production of our products.

 
Payments Due by Period in $000’s
 
 
Total
 
Less than
1 Year
 
1-2
Years
 
2-3
Years
 
3-4
Years
 
4-5
Years
 
 
Thereafter
Long-term debt
2,750
 
 
 
2,750
 
 
 
Capital/finance lease
 
 
 
 
 
 
Operating lease
4,529
 
1,278
 
1,145
 
755
 
572
 
283
 
496
Purchase obligations
674
 
674
 
 
 
 
 
Other long-term creditors
 
 
 
 
 
 
Total
7,953
 
1,952
 
1,145
 
3,505
 
572
 
283
 
496

There are no capital commitments relating to the AMR101 development project. However, under the purchase agreement for Laxdale, upon the attainment of specified development milestones, we will be required to issue additional Ordinary Shares to the selling shareholders or make cash payments (at the sole option of each of the selling shareholders) and we will be required to make royalty payments of 6% on future sales of AMR101 (consisting of 5% payable to Scarista Limited and 0.5% payable to each of Dr. Malcolm Peet and Dr. Krishna Vaddadi). The final purchase price will be a function of the number of Ordinary Shares of Amarin issued at closing and actual direct acquisition costs, together with contingent consideration which may become payable, in the future, on the achievement of certain approval milestones. Upon receipt of marketing approval in the United States and Europe for the first indication of any product containing Amarin Neuroscience intellectual property, we must make an aggregate stock or cash payment (at the sole option of each of the sellers) of GBP£7.5 million for each of the two potential market approvals (i.e., GBP£15.0 million maximum).  In addition, upon receipt of a marketing approval in the United States and Europe for any other product using Amarin Neuroscience intellectual property or for a different indication of a previously approved product, we must make an aggregate stock or cash payment (at the sole option of each of the sellers) of GBP£5.0 million for each of the two potential market approvals (i.e., GBP£10.0 million maximum). The exchange rate as of May 15, 2008 was approximately $1.9488 per GBP £ .

Following the acquisition of Ester Neurosciences Limited on December 5, 2007, if the Monarsen Phase II in MG clinical study meets its study objectives we are commmitted to pay $5 million at Amarin's option in equity or cash, to the former shareholders of Ester Neurosciences Limited. In addition, upon successful completion of the 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., we are committed to pay $6 million in equity or cash, at Amarin’s option to the former shareholders of Ester Neurosciences Limited. A further $6 million will become payable on the 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. Such additional consideration may be paid in cash.

Final payments due to the University of Rochester and Icon pursuant to the now completed trials for AMR101 in HD are as follows:
 
 
Estimated Payments Due by Period in $000’s from 1 January 2008
 
 
Total          
 
Less than
1 Year             
 
1-2
Years             
 
2-3
Years             
 
3-4
Years             
 
4-5
Years             
 
 
Thereafter
Clinical research
2,825
 
2,825
 
 
 
 
 


 
35

 


Item 6  Directors, Senior Management and Employees

A.  Directors and Senior Management

The following table sets forth certain information regarding our officers and directors as of December 31, 2007. A summary of the background and experience of each of these individuals follows the table.

Name
 
Age
 
Position
Thomas Lynch
 
51
 
Chairman and Chief Executive Officer
Alan Cooke
 
37
 
President, Chief Operating Officer and Director*
Dr. Declan Doogan
 
56
 
Head, Research & Development and Director
John Groom
 
69
 
Non-Executive Director
Anthony Russell-Roberts
 
62
 
Non-Executive Director
Dr. William Mason
 
56
 
Non-Executive Director
Dr. Simon Kukes
 
51
 
Non-Executive Director
Dr. Michael Walsh
 
56
 
Non-Executive Director
Dr. Prem Lachman
 
47
 
Non-Executive Director
Dr. John Climax
 
55
 
Non-Executive Director
Prof. William Hall
 
58
 
Non-Executive Director
Tom Maher
 
41
 
General Counsel and Company Secretary
Conor Dalton
 
43
 
Vice President, Finance & Principal Accounting Officer

* Mr. Cooke also acts as Chief Financial Officer

Mr. Thomas Lynch joined Amarin in January 2000 as Chairman of the Board. Between 1993 and 2004, Mr. Lynch was with Elan Corporation plc where he held a number of positions including Chief Financial Officer and Executive Vice Chairman. Mr. Lynch spear-headed Elan’s transition from a drug delivery technology provider to a fully integrated pharmaceutical company, through a number of acquisitions, including Athena Neurosciences, Inc. The Athena acquisition brought Elan its programs in multiple sclerosis, autoimmune diseases and Alzheimer’s disease. Mr. Lynch was also a founder of the specialty pharmaceutical company, Warner Chilcott plc. Mr. Lynch is and has been a board member of a number of biotechnology and healthcare companies.

Mr. Alan Cooke joined Amarin in May 2004 as Chief Financial Officer and was subsequently promoted to President and Chief Operating Officer. Prior to joining Amarin, he held a number of positions over a period of approximately eight years at Elan Corporation, plc, including Vice President, Global Strategic Planning. Mr Cooke is a fellow of the Institute of Chartered Accountants (Ireland) and worked four years with KPMG, Dublin. Mr. Cooke is a member of the Amarin Board of Directors.

Dr. Declan Doogan joined us on April 10, 2007 as Head, Research and Development and was appointed as an Executive Director December 19, 2007. Prior to joining us, Dr. Doogan was Senior Vice President and Head of Worldwide Development at Pfizer Global Research & Development. In recent years, he held a number of senior positions in Pfizer in the US and the UK. Dr. Doogan joined Pfizer in 1982, where he led the Zoloft clinical development program. He held positions in the UK and in Japan, where he was initially Medical Director and later head of the company’s development organization. Dr. Doogan holds Visiting Professorships at Harvard, Glasgow and Kitasato University in Japan. In addition, Dr. Doogan holds a number of non-executive directorships in the US and the U.K. Dr. Doogan received his medical degree from Glasgow University in 1975. He is a Fellow of the Royal College of Physicians of Glasgow and the Faculty of Pharmaceutical Medicine in the U.K.

Mr. John Groom joined us as a Non-Executive Director on May 29, 2001. Mr. Groom served as President and Chief Operating Officer of Elan Corporation plc from July 1996 until his retirement in January 2001. Mr. Groom was President, Chief Executive Officer and Director of Athena Neurosciences, Inc. prior to its acquisition by Elan in 1996. Mr. Groom serves on the board of directors of Neuronyx Inc. and CV Therapeutics Europe Ltd.

Mr. Anthony Russell-Roberts joined us as a Non-Executive Director on April 7, 2000. He has held the position of Administrative Director of The Royal Ballet at the Royal Opera House since 1983. Prior to that, he was Artistic Administrator of the Paris Opera from 1981 after five years of work in the lyric arts in various theatres. Mr. Russell-Roberts’ earlier business career started as a general management trainee with Watney Mann, which was followed by eight years with Lane Fox and Partners, as a partner specializing in commercial property development. He holds an M.A. degree in Politics, Philosophy, and Economics from Oxford University and was awarded a CBE in 2004.

 
36

 


Dr. William Mason was appointed Lead independent Director on February 4, 2008. Dr. Mason has served as a non-executive board member of Amarin since July 19, 2002, is Chairman of the Company’s Audit Committee and a member of Amarin’s Nominations Committee. Dr. Mason received his B.Sc. from Case Western Reserve University in the United States and his doctorate in physiology from Trinity College, Cambridge, UK in 1977. For twenty years he led a program of neuroscience-focused medical research in Cambridge. Dr. Mason also played an active role as a member of the Advisory Council on Science and Technology (ACOST) in the UK Cabinet Office of HM Government, developing government policy to create a highly qualified scientific and technical manpower base in the UK. He has founded successful high technology biomedical companies and has extensive commercial transactional experience in the healthcare and life sciences sector. He maintains strong links with the healthcare investment community. Currently, Dr. Mason is Chairman of OrthoMimetics Ltd., Zygem Ltd., Camlab Ltd. and Team Consulting Ltd., and is a director of Sage Healthcare Ltd. and Sphere Medical Ltd. He is also a member of the 3i Independent Director’s Program

Dr. Simon Kukes was appointed a director on January 1, 2005. Dr. Kukes is an American citizen. Dr. Kukes is the CEO at Samara-Nafta, a Russian oil company, partnering with Hess Corporation; a U.S. based international oil company. He was President and Chief Executive of Tyumen Oil Company (TNK) from 1998 until its merger with British Petroleum (BP) in 2003. He then joined Yukos Oil as chairman. He also served as chief executive of Yukos from 2003 until June 2004. In 1999, he was voted one of the Top 10 Central European Executives by the Wall Street Journal Europe and in 2003 he was named by The Financial Times and PricewaterhouseCoopers as one of the 64 most respected business leaders in the world. Dr. Kukes has a primary degree in Chemical Engineering from the Institute for Chemical Technology, Moscow and a PhD in Physical Chemistry from the Academy of Sciences, Moscow and was a Post-Doctoral Fellow of Rice University, Houston, Texas. He is the holder of more than 130 patents and has published more than 60 scientific papers.

Dr. Michael Walsh was appointed a director on January 1, 2005. Dr. Walsh is an executive director of International Investment and Underwriting (“IIU”), a private equity firm based in Dublin. Dr. Walsh is Chairman of Irish Nationwide Building Society, one of Ireland’s main mortgage providers. He is a non-executive director of a number of companies including Daon, a company involved in biometric authentication and Atlantic Bridge Ventures technology oriented venture capital company. Dr. Walsh has a Bachelor of Commerce and a Master of Business Studies degrees from University College Dublin and MBA and PhD degrees from the Wharton School, University of Pennsylvania. Prior to IIU, he was an executive director of NCB Group Ltd, one of Ireland’s leading stockbrokers. He was previously Professor of Banking and Finance at University College Dublin.

Dr. Prem Lachman was appointed a director on August 4, 2005. Dr. Lachman is a founder and general partner of Maximus Capital, $100 million healthcare investment management company focused on investments in the biotechnology and pharmaceutical industries. Dr. Lachman was formerly a general partner at the Galleon Group from 1998 until 2001 and prior to that was a managing director in the Investment Research Department at Goldman Sachs & Co. Dr. Lachman received his M.D. degree from the Mount Sinai School of Medicine in May 1986.

Dr. John Climax was appointed a non-executive director of Amarin on March 20, 2006. Dr. Climax was a founder of Icon plc, serving as a Director and Chief Executive Officer of Icon and its subsidiaries since June 1990. In November 2002, he was appointed Executive Chairman. Dr. Climax received his primary degree in pharmacy in 1977 from the University of Singapore, his masters in applied pharmacology in 1979 from the University of Wales and his PhD in clinical pharmacology from the National University of Ireland in 1982. Dr. Climax is an adjunct Professor at the Royal College of Surgeons, Dublin and Chairman of the Human Dignity Foundation, a Swiss based charity.

Professor William Hall was appointed as a Non-Executive Director on February 23, 2007. Professor Hall is Professor of Medicine, School of Medicine and Medical Sciences and Director of the National Virus Reference Library at University College Dublin. Professor Hall completed his PhD at Queen’s University of Belfast in 1974 and his M.D. at Cornell University Medical College, New York in 1984. Professor Hall held various Faculty positions at the Rockefeller University in New York before returning to Ireland. Present positions held by Professor Hall include Consultant Microbiologist, St Vincent’s University Hospital, Dublin, Professor, and Professor of Medicine, School of Medicine and Medical Sciences and Director of the Centre for Research in Infectious Diseases and the National Virus Reference Laboratory. Professor Hall is a Fellow of the American Academy of Microbiology, the Infectious Diseases Society of America, the Royal College of Physicians (Ireland) and the Royal College of Pathologists (U.K.).

Mr. Tom Maher was appointed General Counsel and Company Secretary in February 2006, having commenced working with the Group on a part-time basis in July 2005. Mr. Maher was previously a partner at Matheson Ormsby Prentice Solicitors, Dublin. Prior to Matheson Ormsby Prentice, Mr. Maher worked at Elan Corporation plc where he held the position of Vice President of Legal Affairs. Mr. Maher commenced his legal career at A&L Goodbody Solicitors, Dublin. He holds a law degree from Trinity College Dublin and is an Irish qualified solicitor.

Mr. Conor Dalton was appointed Vice-President, Finance in May 2005. Prior to joining Amarin, Mr. Dalton spent approximately eight years with Elan Corporation, most recently as Director of Finance. Mr. Dalton is a fellow of the Chartered Association of Certified Accountants.

There is no family relationship between any director or executive officer and any other director or executive officer.


 
37

 

 
B.  Compensation

General

Our directors who serve as officers or employees receive no compensation for their service as members of our board of directors. Directors who are not officers or employees receive £25,000 ($50,000) per annum save for the Chairman of the Board who receives £40,000 ($80,000), Chairman of the Audit Committee who receives £40,000 ($80,000), Chairman of the Remuneration Committee who receives £40,000 ($80,000) and Lead Independent Director who receives £20,000 ($40,000) and such options to acquire Ordinary Shares for their service as non-executive members of the board of directors as the Remuneration Committee of the board of directors may from time to time determine. Mr. Lynch has to date waived all of his rights with respect to option grants to directors that were proposed during his tenure as a director. Mr. Groom waived emoluments in respect of the years ended December 31, 2007 and 2006.
 
On December 19, 2007, Mr. Richard Stewart resigned as Chief Executive Officer and Executive Director of Amarin. Pursuant to the terms of a compromise agreement between Amarin and Mr. Stewart, Amarin agreed to pay Mr. Stewart £402,500 ($804,000) in respect of a termination payment and bonus, £10,673 ($21,000) in respect of 10 days accrued but untaken holiday entitlement, other expenses of £4,000 ($8,000) and £37,338 ($75,000) in respect of accrued pension entitlement up to the date of termination, December 19, 2007. These amounts are included in the table below.
 
For the year ended December 31, 2007, all of our directors and senior management as a group received total compensation of $4,569,000 and in addition, directors and senior management were issued options to purchase a total of 1,025,000 Ordinary Shares during such period. See “— Share Ownership” below for the specific terms of the options held by each director and officer.

With the exception of Mr. Stewart, Mr. Cooke and Dr. Doogan, there are no sums set aside or accrued by us for pension, retirement or similar benefits for directors. We do make contributions to certain of our employees’ and officers’ pensions during the term of their employment with us.

Compensation paid and benefits granted to our directors during the year ended December 31, 2007 are detailed below:

Directors’ detailed emoluments
 
 
 
Name
 
Salary
& fees
   
Benefits
in kind
   
Annual
bonus
   
2007
Total
 
      $000       $000       $000       $000  
Thomas Lynch (Chairman and Chief Executive Officer)*
    482             390       872  
Richard Stewart (Former Chief Executive Officer)**
    1,249       18       250       1,517  
Alan Cooke (President & Chief Operating Officer)**
    401       4       227       632  
Dr. Declan Doogan (Head, Research & Development)**
    140             105       245  
John Groom
                       
Anthony Russell-Roberts
    100                   100  
Dr. William Mason
    80                   80  
Dr. Simon Kukes
    50                   50  
Dr. Michael Walsh
    50                   50  
Dr. Prem Lachman
    50                   50  
Dr. John Climax
    50                   50  
Prof. William Hall
    42                   42  
      2,694       22       972       3,688  
 
__________
 
Benefits in kind include medical and life insurance for each executive director. No expense allowances were provided to the directors during the year.

Fees in respect of a Consultancy Agreement with Mr. Thomas Lynch. See “Item 7B — Related Party Transactions. Included above is Mr. Lynch’s bonus payment’s for 2006 and 2007.
   
**
In addition to the above, Mr. Stewart, Mr. Cooke and Dr. Doogan had pension contributions paid into their personal scheme or accrued by the Group in 2007 of $60,000, $22,000 and $8,000 respectively. Mr. Stewart’s payment, which is in excess of his normal entitlement under the Group’s pension scheme arrangements, was approved by the Remuneration Committee.
   
On December 19, 2007, Mr. Richard Stewart resigned as Chief Executive Officer and Executive Director of Amarin. Pursuant to the terms of a compromise agreement between Amarin and Mr. Stewart, Amarin agreed to pay Mr. Stewart £402,500 ($804,000) in respect of a termination payment and bonus, £10,673 ($21,000) in respect of 10 days accrued but untaken holiday entitlement, other expenses of £4,000 ($8,000) and £37,338 ($75,000) in respect of accrued pension entitlement up to the date of termination, December 19, 2007.  These amounts are included in Mr. Stewart's emoluments above.


 
38

 

The Amarin Corporation plc 2002 Stock Option Plan

The Amarin Corporation plc 2002 Stock Option Plan came into effect on January 1, 2002. The term of the plan is ten years, and no award shall be granted under the plan after January 1, 2012.

The plan is administered by the remuneration committee of our board of directors. A maximum of 8,000,000 Ordinary Shares may be issued under the original plan. This limit was increased to 8,986,439 Ordinary Shares by the remuneration committee of the Group on December 6, 2006, pursuant to section 4(c) of the Plan to prevent dilution of the potential benefits available under the Plan as a result of certain discounted share issues. This limit was further increased to 12,000,000 Ordinary Shares at an Extraordinary General Meeting held on January 25, 2007. This limit was further increased to 18,000,000 Ordinary Shares at an Annual General Meeting held on July 19, 2007. Employees, officers, consultants and independent contractors are eligible persons under the plan. The remuneration committee may grant options to eligible persons. In determining which eligible persons may receive an award of options and become participants in the plan, as well as the terms of any option award, the remuneration committee may take into account the nature of the services rendered to us by the eligible persons, their present and potential contributions to our success or such other factors as the remuneration committee, at its discretion, shall deem relevant.

Two forms of options may be granted under the plan: incentive stock options and non-qualified stock options. Incentive stock options are options intended to meet the requirements of Section 422 of the U.S. Internal Revenue Code of 1986, as amended. Non-qualified stock options are options which are not intended to be incentive stock options.

As a condition to the grant of an option award, we and the recipient shall execute an award agreement containing such restrictions, terms and conditions, if any, as the remuneration committee may require. Option awards are to be granted under the plan for no cash consideration or for such minimal cash consideration as may be required by law. The exercise price of options granted under the plan shall be determined by the remuneration committee; however the plan provides that the exercise price shall not be less than 100% of the fair market value, as defined under the plan, of an Ordinary Share on the date that the option is granted. The consideration to be paid for the shares under option shall be paid at the time that the shares are issued. The term of each option shall end ten years following the date on which it was granted. The remuneration committee may decide from time to time whether options granted under the plan may be exercised in whole or in part.

No option granted under the plan may be exercised until it has vested. The remuneration committee will specify the vesting schedule for each option when it is granted. If no vesting schedule is specified with respect to a particular option, then the vesting schedule set out in the plan will apply so that 33% of the total number of Ordinary Shares granted under the option shall vest on the first anniversary of the date that the option was granted, a further 33% shall vest on the second anniversary and the remaining 34% shall vest on the third anniversary.

The plan provides that the vesting of options shall be accelerated if we undergo a change of control and at the discretion of the remuneration committee. In the event of an offer to acquire all of our issued share capital or the acquisition of all of our issued share capital in other specified circumstances, the option holder may release its option in return for the grant of a new option over shares in the acquiring company.

If a participant’s continuous status as an employee or consultant, as defined under the plan, is terminated for cause then his or her options shall expire immediately. If such status is terminated due to death or permanent disability and if options held by the participant have vested and are exercisable, they shall remain exercisable for twelve months following the date of the participant’s death or disability.

 
39

 


No option award, nor any right under an option award, may be transferred by a participant other than by will or by the laws of descent as specifically set out in the plan. Participants do not have any rights as a shareholder of record in us with respect to the Ordinary Shares issuable on the exercise of their options until a certificate representing such Ordinary Shares registered in the participant’s name has been delivered to the participant.

The plan is governed by the laws of England.

C.  Board Practices

General

No director has a service contract providing for benefits upon the termination of service or employment.

Our articles of association stipulate that the minimum number of directors shall be two and the maximum number shall be fifteen. At December 31, 2007 we had eleven directors. Directors may be elected by the shareholders at a general meeting or appointed by the board of directors. If a director is appointed by the board of directors, that director must stand for election at our subsequent annual general meeting. At each annual general meeting, one-third of our directors must retire and either stand, or not stand, for re-election. In determining which directors shall retire and stand, or not stand, for re-election, first, we include any director who chooses to retire and not face re-election and second, we choose the directors who have served as directors for the longest period of time since their last election.

At the annual general meeting for 2007, Professor Hall and Messrs. Stewart, Cooke and Groom retired by rotation, and were re-elected. Mr. Stewart subsequently resigned as a director on December 19, 2007.  On May 16, 2008, Drs. Doogan, Kukes, Walsh and Lachman, Prof. Hall and Messrs. Cooke and Groom resigned from the board.  On the same date Drs. James Healy, Carl Gordon, Eric Aguiar and Srinivas Akkaraju were appointed to the board, see Item 8B - "Significant Changes" for further details.  The new board appointments are effective upon the closing of the first tranche of the financing. Assuming no further directors choose to retire or resign and not stand for re-election at the annual general meeting in 2008, we would expect Drs. Healy, Gordon, Aguiar, Akkaraju and Climax to retire and stand for re-election at the 2008 annual general meeting. See — “Directors and Senior Management” above for details of when each of our directors joined our board of directors.

Audit Committee

The audit committee of the board of directors generally comprises three of our non-executive directors and meets, as required, to review the scope of the audit and audit procedures, the format and content of the audited financial statements and the accounting principles applied in preparing the financial statements. The audit committee also reviews proposed changes in accounting policies, recommendations from the auditors regarding improving internal controls and the adequacy of resources within the accounting function.

As of December 31, 2007, the audit committee comprised the following directors:

Dr. William Mason (Chairman) (appointed October 22, 2002);

Dr. Simon Kukes (appointed March 20, 2006, resigned May 16, 2008); and

Mr. John Groom (Financial Expert) (appointed October 24, 2003, resigned May 16, 2008).
 
On May 16, 2008, Dr. Simon Kukes and Mr. John Groom resigned as directors of the Company.  Following an equity financing signed on May 13, 2008, certain investors joined Amarin's board of directors (see Item 8B - "Significant Chanages" in this annual report).  The composition of the audit committee will be determined at the earliest opportunity following the appointment of new board members.
 
Remuneration Committee

The remuneration committee of the board of directors comprises three of our non-executive directors. The remuneration committee’s primary responsibility is to approve the level of remuneration for executive directors and key employees. It may also grant options under our share option schemes to employees and executive directors and must approve any service contracts for executive directors and key employees. Non-executive directors’ remuneration is determined by the full board of directors.


 
40

 


As of December 31, 2007, the remuneration committee comprised the following directors:

Mr. Anthony Russell-Roberts (Chairman) (appointed July 19, 2002);

Dr. Michael Walsh (appointed February 28, 2005, resigned May 16, 2008); and

Dr. Prem Lachman (appointed March 20, 2006, resigned May 16, 2008).
 
On May 16, 2008, Drs. Michael Walsh and Prem Lachman resigned as directors of the Company.  Following an equity financing signed on May 13, 2008, certain investors joined Amarin's board of directors (see Item 8B - "Significant Changes" in this annual report).  The composition of the remuneration committee will be determined at the earliest opportunity following the appointment of new board members.

Lead Independent Director

In February 2008, our Board of Directors established the position of Lead Independent Director and appointed current board member, Dr. William Mason, to that role. In his capacity as Lead Independent Director, Dr. Mason will have the authority to convene meetings of the independent directors, and will preside over those meetings, will coordinate the activities of the independent directors, and will act as a liaison between the independent directors, the Board and the Chairman.

D.  Employees

The average numbers of employees employed by us during each of the past two financial years are detailed below:
 
Employment Activity
Number of
Employees
12/31/07
 
Number of
Employees
12/31/06
Marketing and Administration
17
 
12
Research and Development
8
 
6
Total
25
 
18

The average numbers of employees employed by us by geographical region for each of the last two financial years are set forth below:

 
 
Country
 
Number of
Employees
12/31/07
   
Number of
Employees
12/31/06
 
U.K
    11       10  
Ireland
    14       8  
Total
    25       18  

E.  Share Ownership

The beneficial ownership of Ordinary Shares by, and options granted to, our directors or officers, including their spouses and children under eighteen years of age, as of December 31, 2007 are presented in the table below. See also “— Compensation — the Amarin Corporation plc 2002 Stock Option Plan”.

 
 
 
 
 
Director/Officer
 
 
 
 
 
Note
Options/Warrants
Outstanding
to Acquire
Number of
Ordinary
Shares
 
 
 
 
Date of Grant
(dd/mm/yy)
 
 
Exercise
Price per
Ordinary
Share
Ordinary
Shares or
ADS
Equivalents
Beneficially
Owned
 
 
 
Percentage
of Outstanding
Share Capital*
J. Groom                                      
1
15,000
23/01/02
$17.65
417,778
 
1
15,000
06/11/02
$3.10
   
 
1
25,000
21/07/04
$0.84
   
 
7
55,099
21/12/05
$1.43
   
 
1
20,000
11/01/06
$1.35
   
 
1&17
20,000
08/12/06
$0.44
   
T. G. Lynch                                      
2
500,000
25/02/04
$1.90
10,729,060
7.7%
 
8
207,921
21/12/05
$1.43
   
 
11
12,480
01/6/07
$0.72
   
 
12
303,030
06/12/07
$0.48
   
                                      
 
 

 
41

 


 
Director/Officer
Note
Options/Warrants
Outstanding
to Acquire
Number of
Ordinary
Shares
Date of Grant
(dd/mm/yy  
Exercise
Price per
Ordinary
Share
 
Ordinary
Shares or
ADS
Equivalents
Beneficially
Owned
 
Percentage
of Outstanding
Share Capital*
             
W. Mason  
1
15,000
06/11/02
$3.10
 
 
 
1&3
25,000
21/07/04
$0.84
   
 
1&3
20,000
11/01/06
$1.35
   
 
1&17
20,000
08/12/06
$0.44
   
A. Russell-Roberts                                      
4
10,000
07/04/00
$3.00
2,350
 
4
10,000
19/02/01
$6.12
   
 
1
15,000
23/01/02
$17.65
   
 
1
15,000
06/11/02
$3.10
   
 
1
25,000
21/07/04
$0.84
   
 
1
20,000
11/01/06
$1.35
   
 
1&17
20,000
08/12/06
$0.44
   
S. Kukes                                      
7
519,802
21/12/05
$1.43
9,516,081
6.8%
 
1
20,000
11/01/06
$1.35
   
 
1&17
20,000
08/12/06
$0.44
   
 
13
33,278
01/6/07
$0.72
   
 
14
454,545
06/12/07
$0.48
   
M. Walsh                                      
7
38,119
21/12/05
$1.43
530,896
 
1
20,000
11/01/06
$1.35
   
 
1&17
20,000
08/12/06
$0.44
   
 
13
16,639
01/6/07
$0.72
   
 
14
208,333
06/12/07
$0.48
   
A. Cooke                                     
1
375,000
07/07/04
$0.85
270,211
 
6
200,000
10/06/05
$1.30
   
 
7
15,594
21/12/05
$1.43
   
 
1
200,000
16/01/06
$1.95
   
 
1&17
675,000
08/12/06
$0.44
   
P. Lachman                                      
1
20,000
11/01/06
$1.35
234,709
 
1&17
20,000
08/12/06
$0.44
   
 
13
8,320
01/6/07
$0.72
   
 
14
75,756
06/12/07
$0.48
   
J. Climax                                      
9
226,980
21/12/05
$1.43
9,440,160
6.8%
 
1
20,000
27/01/06
$2.72
   
 
1
20,000
20/03/06
$3.26
   
 
1&17
20,000
08/12/06
$0.44
   
 
15
33,278
01/6/07
$0.72
   
 
16
1,363,636
06/12/07
$0.48
   
W. Hall                                      
1&17
75,000
08/03/07
$0.44
T. Maher                                     
1
325,000
02/12/05
$1.16
19,802
 
7
6,931
21/12/05
$1.43
   
 
1&17
350,000
08/12/06
$0.44
   
 
1
150,000
02/08/07
$0.44
   
 
1
150,000
28/08/07
$0.46
   
D. Doogan                                      
1&17
650,000
09/04/07
$0.44
C. Dalton                                      
1
100,000
28/06/05
$1.09
 
1
50,000
12/01/06
$1.53
 
1&17
200,000
08/12/06
$0.44

Notes:

(1)
These options are exercisable as to one third on each of the first, second and third anniversaries of the date of grant and remain exercisable for a period ended on the tenth anniversary of the date of grant.
   
(2)
The Ordinary Shares are held in the form of ADSs by Amarin Investment Holding Limited. The warrants issued to Amarin Investment Holding Limited are exercisable for up to 500,000 Ordinary Shares, on or before February 25, 2009. Amarin Investment Holding Limited is an entity controlled by our Chairman and Chief Executive Officer, Mr. Thomas Lynch.
   
(3)
These options were issued to Vision Resources Limited, a company wholly owned by Dr. Mason.
   
(4)
These options are currently exercisable and remain exercisable until ten years from the date of grant.
   

 
42

 


(5)
When granted 100,000 of these options were to become exercisable at an exercise price of $25.00 in tranches upon the price of our Ordinary Shares achieving certain pre-determined levels. On February 9, 2000, our remuneration committee approved the re-pricing of these 100,000 options to an exercise price of US$5.00 per Ordinary Share, exercisable immediately and the Group entered into an amendment agreement on the same day amending the exercise price from $25.00 to $5.00 and removing the performance criteria attached to such options. These options are currently exercisable and remain exercisable until 1st April 2009.
   
(6)
These options are exercisable as to 50% on the second anniversary of grant, as to 75% of the third anniversary of grant and in full on the fourth anniversary of grant.
   
(7)
These warrants were granted to all investors in the December 2005 private placement including directors and are exercisable at anytime after 180 days from the grant date. If our trading market price is equal to or above $10.20, as adjusted for any stock splits, stock combinations, stock dividends and other similar events, for each of any twenty consecutive trading days, then the Group at any time thereafter shall have the right, but not the obligation, on 20 days’ prior written notice to the holder, to cancel any unexercised portion of this warrant for which a notice of exercise has not yet been delivered prior to the cancellation date.
   
(8)
These warrants were granted to all investors in the December 2005 private placement including directors and are exercisable at anytime after 180 days from the grant date. The warrants were issued to Amarin Investment Holding Limited which is an entity controlled by our Chairman and Chief Executive Officer, Mr. Thomas Lynch. If our trading market price is equal to or above $10.20, as adjusted for any stock splits, stock combinations, stock dividends and other similar events, for each of any twenty consecutive trading days, then the Group at any time thereafter shall have the right, but not the obligation, on 20 days’ prior written notice to the holder, to cancel any unexercised portion of this warrant for which a notice of exercise has not yet been delivered prior to the cancellation date.
   
(9)
The Ordinary Shares are held in the form of ADSs by Sunninghill Limited. The warrants granted to all investors in the December 2005 private placement including directors are exercisable at any time after 180 days from the grant date. These warrants were issued to Sunninghill Limited which is an entity controlled by one of our non-executive directors Dr. John Climax.
   
(10)
These options were granted to Laxdale employees as replacement Laxdale options due to the acquisition of Laxdale by Amarin. These options vested immediately on granting and expire on 31 March 2009.
   
(11)
These warrants were granted to all investors in the June 2007 registered direct offering including directors and are exercisable immediately from the grant date. The warrants were issued to Amarin Investment Holding Limited which is an entity controlled by our Chairman and Chief Executive Officer, Mr. Thomas Lynch.
   
(12)
These warrants were granted to all investors in the December 2007 registered direct offering including directors and are exercisable immediately from the grant date. The warrants were issued to Amarin Investment Holding Limited which is an entity controlled by our Chairman and Chief Executive Officer, Mr. Thomas Lynch.
   
(13)
These warrants were granted to all investors in the June 2007 registered direct offering including directors and are exercisable immediately from the grant date.
   
(14)
These warrants were granted to all investors in the December 2007 registered direct offering including directors and are exercisable immediately from the grant date.
   
(15)
These warrants were granted to all investors in the June 2007 registered direct offering including directors and are exercisable immediately from the grant date.  These warrants were issued to Sunninghill Limited which is an entity controlled by one of our non-executive directors Dr. John Climax.
   
(16)
These warrants were granted to all investors in the December 2007 registered direct offering including directors and are exercisable immediately from the grant date. These warrants were issued to Sunninghill Limited which is an entity controlled by one of our non-executive directors Dr. John Climax.
   
(17)
The exercise price of all options granted between December 8, 2006 and April 11, 2007 were amended to $0.44 – see note 28 to the F-section in this annual report for further details of the options amendment.
   
*
This information is based on 139,057,370 Ordinary Shares outstanding as of December 31, 2007.


 
43

 


Item 7  Major Shareholders and Related Party Transactions

A.  Major Shareholders

The following table sets forth to the best of our knowledge certain information regarding the ownership of our Ordinary Shares at December 31, 2007 by each person who is known to us to be the beneficial owner of more than five percent of our outstanding Ordinary Shares, either directly or by virtue of ownership of ADSs.

 
 
 
Name of Owner(1)
Number of
Ordinary Shares
or ADS Equivalents
Beneficially Owned Capital
 
Percentage of
Outstanding
Share (2)      
Amarin Investment Holding Limited(3)                                                                                                   
11,752,491
 
6.9%
Sunninghill Limited(5)                                                                                                    
11,124,054
 
6.5%
Simon G. Kukes(4)                                                                                                    
10,563,706
 
6.2%
Medica Funds(6)                                                                                                    
10,077,969
 
5.9%
__________
Notes:
 
(1)
Unless otherwise noted, the persons referred to above have sole investment power.
   
(2)
This information is based on 139,057,370 Ordinary Shares outstanding, 20,838,235 warrants granted over Ordinary Shares and 10,804,850 share options granted over Ordinary Shares as of December 31, 2007.
   
(3)
Includes warrants to purchase 500,000 Ordinary Shares, which warrants are exercisable on or before February 25, 2009 and warrants to purchase 523,431 Ordinary Shares, which are currently exercisable. Amarin Investment Holding Limited is an entity controlled by our Chairman and Chief Executive Officer, Mr. Thomas Lynch.
   
(4)
Includes warrants to purchase 1,007,625 Ordinary Shares, which are currently exercisable and options to purchase 40,000 Ordinary Shares of which 13,333 are currently exercisable.
   
(5)
Includes warrants to purchase 1,623,894 Ordinary Shares, which are currently exercisable and share options to purchase 60,000 Ordinary Shares of which 20,000 are currently exercisable. Sunninghill Limited is an entity controlled by one of our non-executive directors, Dr. John Climax.
   
(6)
This information is based on the following holdings:

Name of Fund
Ordinary Shares
Medica II Investments International LP                                                                                                                                            
4,091,635
Medica Investments Israel LP                                                                                                                                            
2,916,808
Medica II Investments Israel LP                                                                                                                                            
1,524,010
Medica II Investments PF Israel LP                                                                                                                                            
785,386
Medica II Management LP                                                                                                                                            
413,666
Medica II Baxter LP                                                                                                                                            
346,464

The following table shows changes over the last two 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)
2007
2006
     
Amarin Investment Holding Limited
7.7
11.0
Simon G. Kukes
6.8
8.3
Medica Funds
7.2
Sunninghill Limited
6.8
7.0
Southpoint
9.9


 
44

 


None of the above shareholders has voting rights that differ from those of our other shareholders. The total number of ADSs outstanding as of December 31, 2007 was approximately 132.7 million. The ADSs represented approximately 95% of the issued and outstanding Ordinary Shares as of such date. As at May 16, 2008, to the best of our knowledge, we estimate that U.S. shareholders constituted approximately 60% of the beneficial holders of both our Ordinary Shares and our ADSs.

B.  Related Party Transactions

During the year ended December 31, 2007, we entered into certain transactions, with related parties. Details of such transactions are given below.

Icon

At December 31, 2007 Sunninghill Limited, a company controlled by Dr. John Climax, held 9.4 million Ordinary Shares and 1.6 million warrants in Amarin (which was approximately 7% of Amarin’s entire issued share capital) and Poplar Limited, a company controlled by Dr. Climax, held approximately 5% of Icon plc. During 2005 the Group entered into an agreement with Icon Clinical Research Limited (a company wholly owned by Icon plc) whereby Icon was appointed as Amarin’s contract research organization to manage and oversee its European Phase II study on AMR101 (Trend 2) and to assist Amarin in conducting its U.S. Phase III on AMR101 (Trend 1). At December 31, 2007, Amarin had incurred costs of $7.0 million ($1.9 million for the 12 months ended December 31, 2007) with respect of direct costs to Icon. At the year end, no amount is included in accruals or accounts payable for direct costs payable to Icon. In addition, the Group also reimbursed Icon for $2.6 million of pass-through costs which Icon settle on behalf of Amarin.

In February 2007, our audit committee reviewed and approved Amarin Neuroscience Limited, a subsidiary of the Group, entering into a supplemental agreement with Icon Clinical Research Limited to amend the number and location of patient activity in the E.U. Phase III clinical trial.

Our Chairman and Chief Executive Officer, Mr. Thomas Lynch, has served as an outside director of Icon since January 1996. He is also a member of Icon’s audit committee, compensation committee and nominations committee. On March 20, 2006, Dr. Climax subsequently became a non-executive director of the Group.

Mr. Richard Stewart

On December 19, 2007, Mr. Stewart resigned as Chief Executive Officer and Executive Director of Amarin. Pursuant to the terms of a compromise agreement between Amarin and Mr. Stewart, Amarin agreed to pay Mr. Stewart £402,500 ($804,000) in respect of a termination payment and bonus, £10,673 ($21,000) in respect of 10 days accrued but untaken holiday entitlement, other expenses of £4,000 ($8,000) and £37,338 ($75,000) in respect of accrued pension entitlement up to the date of termination, December 19, 2007.

As at the December 19, 2007 Mr. Stewart had 1,166,666 vested share options under our 2002 Stock Option Plan. Pursuant to the terms of the compromise agreement, Mr. Stewart’s vested share options will be exercisable for a period of 12 months following December 19, 2007 in accordance with the terms of our 2002 Stock Option Plan and upon the expiration of such 12 month period, Mr. Stewart’s vested options will cease to be exercisable and will expire.

As at December 19, 2007 Mr. Stewart had 883,334 unvested share options under our 2002 Stock Option Plan. Pursuant to the terms of the compromise agreement, it was provided that Mr. Stewart’s share options which were not vested as at December 19, 2007 would not vest and would not become exercisable after December 19, 2007 and accordingly, would expire on December 19, 2007.

The compromise agreement was reviewed and approved by the members of our remuneration committee.

Mr. Thomas Lynch

In March 2007, our remuneration committee reviewed and approved a consultancy agreement between Amarin and Dalriada Limited in relation to the provision by Dalriada Limited to Amarin of corporate consultancy services, including consultancy services relating to financing and other corporate finance matters, investor and media relations and implementation of corporate strategy. Under the Consultancy Agreement, Amarin pay Dalriada Limited a fee of £240,000 per annum for the provision of the consultancy services. An additional amount of £195,000 was also approved by the remuneration committee of which £75,000 was paid during the year ended December 31, 2007 in respect of consultancy services.

Dalriada Limited is owned by a family trust, the beneficiaries of which include Mr. Thomas Lynch, Amarin Chairman and Chief Executive Officer and family members.


 
45

 

Elan

In February 2007, our audit committee reviewed and approved, Amarin Pharmaceuticals Ireland Limited (“APIL”), a subsidiary of the Group, entering into development and license agreement with Elan Pharma International Limited, a subsidiary of Elan Corporation, plc (“Elan”), ultimately signed on March 6, 2007, whereby APIL licensed from Elan rights to develop and market a novel, NanoCrystal® nasal formulation of lorazepam for the out-patient treatment of emergency seizures in epilepsy patients. Mr. Shane Cooke, chief financial officer of Elan is a connected person to Mr. Alan Cooke, our president and chief operating officer, and under Nasdaq rules this transaction was deemed to be a related party transaction. Under the terms of the agreement, we may pay Elan success based development, filing and approval milestones totaling $5.2 million plus royalties on net sales. No payments were made to Elan during the year ended December 31, 2007.

Financings

Registered direct offering

Several of the Company’s directors and officers subscribed for approximately 1.0 million ordinary shares and warrants to subscribe for approximately 0.1 million ordinary shares in June 2007 in a registered direct financing.

Public offerings

Several of the Company’s directors and officers subscribed for approximately 4.4 million ordinary shares and warrants to subscribe for approximately 2.2 million ordinary shares in a public offering in December 2007.

In a second offering in December 2007, Dr. Michael Walsh, a director of the Company, purchased $0.25 million in aggregate principal amount of three-year convertible Debentures and IIU Limited, a company in which Dr. Walsh is a director, purchased $2.5 million in aggregate principal amount of three-year convertible Debentures. These Debentures may be converted into approximately 0.5 million and 5.2 million ordinary shares respectively, commencing four months after the date of closing (December 6, 2007) at a conversion price of $0.48 per ordinary share ($4.80 post share consolidation effective January 18, 2008), which is a 30% premium to the 5-day volume weighted average closing price of our ordinary shares on December 3, 2007. The Debentures will bear interest at a rate of 8% per annum, payable quarterly in arrears. In addition, the Debenture holders will also receive five-year warrants to purchase approximately 0.2 million and 2.1 million ordinary shares  respectively, at an exercise price of $0.48 ($4.80 post share consolidation effective January 18, 2008).   Per the warrant agreement, if at any time prior to December 6, 2009, the Company issues Ordinary Shares, securities convertible into ADSs or Ordinary Shares, warrants to purchase ADSs or Ordinary Shares or options to purchase any of the foregoing to a third party (other than any Exempt Issuance) at a price that is less than, or converts at a price that is less than, $3.66 (such lesser price, the “Down-round Price”), then the Exercise Price shall be adjusted to equal 130% of the Down-round Price.  On May 14, 2008, we announced a private placement of Ordinary Shares for up to $60.0 million. The first tranche from new investors of $28.0 million closed on May 19, 2008 . These warrants have therefore been re-priced to $2.99 per share from their original grant price of $4.80 per share (post share consolidation effective January 18, 2008).  The convertible Debentures will be required to be repaid from the financing outlined above.

C.  Interests of Experts and Counsel

Not applicable.

Item 8  Financial Information

A.  Consolidated Statements and Other Financial Information

See our consolidated financial statements beginning at page F-1.

Legal Proceedings

Permax Litigation

Amarin was responsible for the sales and marketing of Permax from May 2001 until February 2004.  On May 17, 2001, Amarin acquired the U.S. sales and marketing rights to Permax from Elan.  An affiliate of Elan had previously obtained the licensing rights to Permax from Eli Lilly and Company in 1993.  Eli Lilly originally obtained approval for Permax on December 30, 1988, and has been responsible for the manufacture and supply of Permax since that date.  On February 25, 2004, Amarin sold its U.S. subsidiary, Amarin Pharmaceuticals, Inc., including the rights to Permax, to Valeant Pharmaceuticals International.
 
 
46

 

In late 2002, Eli Lilly, as the holder of the NDA for Permax, received a recommendation from the FDA to consider making a change to the package insert for Permax based upon the very rare observation of cardiac valvulopathy in patients taking Permax.  While Permax has not been definitely proven as the cause of this condition, similar reports have been notified in patients taking other ergot- derived pharmaceutical products, of which Permax is an example.  In early 2003, Eli Lilly amended the package insert for Permax to reflect the risk of cardiac valvulopathy in patients taking Permax and also sent a letter to a number of doctors in the United States describing this potential risk.  Causation has not been established, but is thought to be consistent with other fibrotic side effects observed in Permax.

On March 29, 2007, the FDA announced that the manufacturers of pergolide drug products will voluntarily remove these drug products, including Permax, from the market.  Further information about the removal of Permax and other pergolide drug products is available on the FDA’s website.

During 2007, one lawsuit alleging claims related to cardiac valvulopathy and Permax was pending in the United States and currently remains pending.  Eli Lilly, Elan, Valeant, Amarin Pharmaceuticals Inc., Athena Neurosciences, Inc., and Amarin are named as defendants in this lawsuit, and are defending against the claims and allegations.  The case is currently in discovery. In addition, a lawsuit alleging claims related to cardiac valvulopathy and Permax was filed in March 2008 and is currently pending in the United States.  Eli Lilly, Elan, Valeant, and Amarin are named as defendants in this lawsuit.  Amarin has not been formally served with the complaint from this lawsuit.
 
Two other claims related to cardiac valvulopathy and Permax and one claim related to compulsive gambling and Permax are or were being threatened against Eli Lilly, Elan, and/or Valeant, and could possibly implicate Amarin.

We have reviewed the position and having taken external legal advice consider the potential risk of significant liability arising for Amarin from these legal actions to be remote. No provision is booked in the accounts at December 31, 2007.

Other

We are not a party to any other legal or arbitration proceedings that may have, or have had in the recent past, significant effects on our financial position or profitability. No governmental proceedings are pending or, to our knowledge, contemplated against us. We are not a party to any material proceedings in which any director, member of senior management or affiliate of ours is either a party adverse to us or our subsidiaries or has a material interest adverse to us or our subsidiaries.

Policy on Dividend Distributions

We have never paid dividends on Ordinary Shares and do not anticipate paying any cash dividends on the Ordinary Shares in the foreseeable future. Under English law, any payment of dividends would be subject to relevant legislation and our Articles of Association, which requires that all dividends must be approved by our board of directors and, in some cases, our shareholders, and may only be paid from our distributable profits available for the purpose, determined on an unconsolidated basis. See Item 10 “Additional Information — Memorandum and Articles of Association — Description of Ordinary Shares — Dividends.”

B.  Significant Changes
 
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.
 
On May 14, 2008 we announced a private placement of ADSs (each representing one Ordinary Share) with several new institutional and accredited investors and potentially certain current and former directors of the Company, for up to $60.0 million funded under two equal tranches.

        The first first tranche from new investors closed on May 19, 2008 and was settled by the issuance of 12,173,914 Ordinary Shares and 8 new Preference Shares. For further information on Preference Shares, see Item 10B "Memorandum and Articles of Association - The Series A Preference Shares". The investors will have an option to provide up to $28.0 million in a second tranche upon completion of certain business milestones by the Company, potentially over the next 12 months. Certain current and former directors have indicated an interest in investing up to $4.0 million in the placement, also over two tranches bringing the potential total of the placement up to $60.0 million.  For further information regarding the private equity financing please see our Report of Foreign Issuer on Form 6-K filed with the SEC on May 14, 2008. Certain of the investors were entitled to join Amarin’s Board of Directors. On May 16, 2008, Drs. Doogan, Kukes, Walsh and Lachman, Prof. Hall and Messrs. Cooke and Groom resigned from the Board.  On the same date Dr. James Healy, Dr. Carl L. Gordon, Dr. Eric Aguiar and Dr. Srinivas Akkaraju were appointed to the Board. The new board appointments are effective upon the closing of the first tranche of the financing.
 
Jim Healy, M.D., Ph.D. joined Sofinnova Ventures as a General Partner in 2000.  Dr. Healy was a founding investor and board member of Cellective (acquired by MedImmune), CoTherix (acquired by Actelion), Novacea (Nasdaq: NOVC), and Intermune (Nasdaq: ITMN).  He also serves on the boards of directors of several private companies.

In the pharmaceutical industry Dr. Healy held manufacturing positions at Bayer Pharmaceuticals (Miles) and ISTA Pharmaceuticals prior to its initial public offering. He began his private equity career at Sanderling.

Dr. Healy earned B.A.s in Molecular Biology and Scandinavian Studies from the University of California at Berkeley, where he graduated with Distinction in General Scholarship, Honors, and received a Departmental Citation. He received his M.D. from Stanford University’s School of Medicine through the Medical Scientist Training Program, and earned his Ph.D. in Immunology from Stanford University, where he was a Beckman Scholar and received a bursary award from the Novartis Foundation. He teaches a course on entrepreneurship at Stanford University, and is an active member of the BIO-NVCA Working Group.
 
Carl L. Gordon, Ph.D., CFA, is a founding General Partner of OrbiMed and Co-Head of Private Equity. Mr. Gordon is active in both private equity and small-capitalization public equity investments. He was a senior biotechnology analyst at Mehta and Isaly from 1995 to 1997. He was a Fellow at The Rockefeller University from 1993 to 1995. Mr. Gordon received a Ph.D. in Molecular Biology from the Massachusetts Institute of Technology. His doctoral work involved studies of protein folding and assembly. He received a Bachelors degree from Harvard College.

Dr. Eric Aguiar is a Partner at Thomas, McNerney & Partners in Stamford, Ct. He has 16 years of experience in the biopharmaceutical industry. From 2001 to 2007 he was a Managing Director at HealthCare Ventures.  Prior to joining HealthCare Ventures, he was CEO of Genovo, Inc.  Eric was an executive at TheraTech, a drug delivery company that was sold to Watson Pharmaceuticals in 1997. He was a Managing Director and Vice President of Philadelphia Ventures in the mid-90's.  Prior board seats have included Cardiokine, SkinMedica, Vaxinnate, Metaphore Pharmaceuticals, 3-D Pharmaceuticals and ThromboSys. He graduated from Harvard Medical School and Cornell University with honors.
 
Dr. Akkaraju is a founding Managing Director of Panorama Capital and focuses primarily on life sciences investments. Previously, he was with J.P. Morgan Partners, serving as a Principal starting in April 2001 and becoming a Partner in January 2005. From 1998 to 2001, Dr. Akkaraju was in Business and Corporate Development at Genentech, Inc., most recently as Senior Manager responsible for worldwide partnering activities, in-licensing of therapeutics, and out-licensing of development projects. In addition to his business development role, Dr. Akkaraju also served as a Project Team Leader for one of Genentech’s clinical development products. During this time, he also was a founding member of BioStreet, an online marketplace for biotech opportunities. Dr. Akkaraju holds B.A. degrees in both Biochemistry and Computer Science from Rice University and an M.D. and Ph.D. in Immunology from Stanford University School of Medicine. Dr. Akkaraju currently serves on the board of directors of Presidio Pharmaceuticals, Itero Biopharmaceuticals, Barrier Therapeutics, Inc., Phenomix Corporation, Piramed Limited, Seattle Genetics, Inc., and Pharmos, Inc.

 
47

 

 
Item 9  The Offer and Listing

A.  Offer and Listing Details

The following table sets forth the range of high and low closing sale prices for our ADSs for the periods indicated, as reported by the Nasdaq Capital Market. These prices do not include retail mark-ups, markdowns, or commissions but give effect to a change in the number of Ordinary Shares represented by each ADS, implemented in both October 1998 and July 2002. Historical data in the table has been restated to take into account these changes.

 
 
US$
High
US$
Low
Fiscal Year Ended
 December 31, 2003
 
4.81
 
1.39
 December 31, 2004
3.99
0.53
 December 31, 2005
3.40
1.06
 December 31, 2006
3.74
1.27
 December 31, 2007
3.78
0.23
Fiscal Year Ended December 31, 2006
 First Quarter
 
3.74
 
1.27
 Second Quarter
3.10
1.93
 Third Quarter
2.96
2.23
 Fourth Quarter
2.67
1.96
Fiscal Year Ended December 31, 2007
 First Quarter
 
2.62
 
1.74
 Second Quarter
3.78
0.52
 Third Quarter
0.58
0.36
 Fourth Quarter
0.45
0.23
Month Ended
 
 
 November 2007
0.43
0.30
 December 2007
0.40
0.23
 January 2008*
2.90
1.81
 February 2008*
3.59
2.83
 March 2008*
2.95
2.59
 April 2008* 3.07 2.60

Share price information for 2008 has been adjusted for the one-for-ten stock consolidation which became effective on January 18, 2007

On May 15, 2008, the closing price of our ADSs as reported on the Nasdaq Capital Market was U.S. $2.69 per ADS.

B.  Plan of Distribution

Not applicable.

C.  Markets

Our ADSs, which are evidenced by American Depositary Receipts, are traded on the Nasdaq Capital Market, the principal trading market for our securities, under the symbol “AMRN.” Each ADS represents one Ordinary Share. Our Ordinary Shares were admitted to trading on the AIM market of the London Stock Exchange under the symbol, “AMRN” and the IEX market of the Irish Stock Exchange, under the symbol “H2E”, in each case on July 17, 2006.

NASD Rule Election

Pursuant to NASD Rule 4350(a)(1) for Foreign Private Issuers, we have elected to follow the home country practice of the United Kingdom in lieu of the shareholder approval requirements of NASD Rule 4350(i). Under NASD Rule 4350(i), issuers are required to obtain shareholder approval prior to the issuance of securities, interalia ; (A) in connection with the establishment or material amendment of a stock option or purchase plan or other equity compensation arrangement pursuant to which stock may be acquired by officers, directors, employees or consultants of the issuer, subject to certain exceptions; (B) when such issuance or potential issuance will result in a change of control of the issuer; (C) in connection with the acquisition of the stock or assets of another company if (i) any director, officer or substantial shareholder of the issuer has a 5% or greater interest (or such persons collectively have a 10% or greater interest), directly or indirectly, in the company or assets to be acquired or in the consideration to be paid in the transaction or series of related transactions and the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, could result in an increase in outstanding common shares or voting power of 5% or more or (ii) where, due to the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, other than a public offering for cash (a) the common stock has or will have upon issuance voting power equal to or in excess of 20% of the voting power outstanding before the issuance of stock or securities convertible into or exercisable for common stock or (b) the number of shares of

 
48

 

 common stock to be issued is or will be equal to or in excess of 20% of the number of shares or common stock outstanding before the issuance of the stock or securities; or (D) in connection with a transaction other than a public offering involving (i) the sale, issuance or potential issuance of common stock (or securities convertible into or exercisable for common stock) at a price less than the greater of book or market value which together with sales by officers, directors or substantial shareholders of the company equal to 20% or more of the common stock or 20% or more of the voting power outstanding or (ii) the sale, issuance or potential issuance of common stock (or securities convertible into or exercisable for common stock) equal to 20% or more of the common stock or 20% or more of the voting power outstanding before the issuance for less than the greater of book or market value of the stock.  The applicable laws of England and Wales do not prohibit the issuance of securities without shareholder approval in the circumstances described in NASDAQ Rule 4350(i).

D.  Selling Shareholders

Not applicable.

E.  Dilution

Not applicable.

F.  Expenses of the Issue

Not applicable.

Item 10  Additional Information

A.  Share Capital

Not applicable.

B.  Memorandum and Articles of Association

Objects and Purposes

We were formed as a private limited company under the Companies Act 1985 and re-registered as a public limited company on March 19, 1993 under registered number 02353920. Under article 4 of our memorandum of association, our objects are to carry on the business of a holding company and to carry on any other business in connection therewith as determined by the board of directors.

Directors

Directors’ Interests

A director may serve as an officer or director of, or otherwise have an interest in, any company in which we have an interest. A director may not vote (or be counted in the quorum) on any resolution concerning his appointment to any office or any position from which he may profit, either with us or any other company in which we have an interest. A director is not prohibited from entering into transactions with us in which he has an interest, provided that all material facts regarding the interest are disclosed to the board of directors.

A director is not entitled to vote (or be counted in the quorum) on any resolution relating to a transaction in which he has an interest which he knows is material. However, this prohibition does not apply to any of the following matters:

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;

 
49

 


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.

Compensation of Directors

Each director is to be paid a director’s fee at such rate as may from time to time be determined by the board of directors and which shall not exceed £500,000 (approximately USD$999,000 at year end exchange rates) in aggregate to all the directors per annum. Any director who, at our request, goes or resides abroad for any purposes or services which in the opinion of the board of directors go beyond the ordinary duties of a director, may be paid such extra remuneration (whether by way of salary, commission, participation in profits or otherwise) as the board of directors may determine.

Any executive director will receive such remuneration (whether by way of salary, commission, participation in profits or otherwise) as the board of directors or, where there is a committee constituted for the purpose, such committee may determine, and either in addition to or in lieu of his remuneration as a director.

Borrowing Powers of Directors

The board of directors has the authority to exercise all of our powers to borrow money and issue debt securities. If at any time our securities should be listed on the Official List of the London Stock Exchange, our total indebtedness (on a consolidated basis) would be subject to a limitation of three times the total of paid up share capital and consolidated reserves.

Retirement of Directors

At every annual general meeting, one-third of the directors must retire from office. In determining which directors shall retire and stand, or not stand, for re-election, first, we include any director who chooses to retire and not face re-election and, second, we choose the directors who have served as directors for the longest period of time since their last election. A director who has elected to retire is not eligible for re-election. There is no age limit or requirement that directors retire at a specified age. However, if a director proposed for election or re-election has attained the age of 70, this fact must be disclosed in the notice of the meeting. Directors are not required to hold our securities.

Description of Ordinary Shares

Our authorized share capital is £100,000,000 divided into 155,914,406 Ordinary Shares of 50p each (post share consolidation effective January 18, 2008 whereby ten Ordinary Shares of 5p each became one Ordinary Share of 50p each) and 440,855,934 Preference Shares of 5p each. In the following summary, a “shareholder” is the person registered in our register of members as the holder of the relevant securities. For those Ordinary Shares that have been deposited in our American Depositary Receipt facility pursuant to our deposit agreement with Citibank N.A., Citibank or its nominee is deemed the shareholder.

 
50

 



Dividends

Holders of Ordinary Shares are entitled to receive such dividends as may be declared by the board of directors. All dividends are declared and paid according to the amounts paid up on the shares in respect of which the dividend is paid. To date there have been no dividends paid to holders of Ordinary Shares.

Any dividend unclaimed after a period of twelve years from the date of declaration of such dividend shall be forfeited and shall revert to us. In addition, the payment by the board of directors of any unclaimed dividend, interest or other sum payable on or in respect of an Ordinary Share or a Preference Share into a separate account shall not constitute us as a trustee in respect thereof.

Rights in a Liquidation

Holders of Ordinary Shares are entitled to participate in any distribution of assets upon a liquidation, subject to prior satisfaction of the claims of creditors and preferential payments to holders of outstanding Preference Shares.

Voting Rights

Voting at any general meeting of shareholders is by a show of hands, unless a poll is demanded. A poll may be demanded by:

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.

In a vote by a show of hands, every shareholder who is present in person at a general meeting has one vote. In a vote on a poll, every shareholder who is present in person or by proxy shall have one vote for every share of which they are registered as the holder. The quorum for a shareholders’ meeting is a minimum of two persons, present in person or by proxy. To the extent the articles of association provide for a vote by a show of hands in which each shareholder has one vote, this differs from U.S. law, under which each shareholder typically is entitled to one vote per share at all meetings.

Holders of ADSs are also entitled to vote by supplying their voting instructions to Citibank who will vote the Ordinary Shares represented by their ADSs in accordance with their instructions. The ability of Citibank to carry out voting instructions may be limited by practical and legal limitations, the terms of our articles and memorandum of association, and the terms of the Ordinary Shares on deposit. We cannot assure the holders of our ADSs that they will receive voting materials in time to enable them to return voting instructions to Citibank a timely manner.

Unless otherwise required by law or the articles of association, voting in a general meeting is by ordinary resolution. An ordinary resolution is approved by a majority vote of the shareholders present at a meeting at which there is a quorum. Examples of matters that can be approved by an ordinary resolution include:

the election of directors;

the approval of financial statements;

the declaration of final dividends;

the appointment of auditors;

the increase of authorized share capital; or
 
the grant of authority to issue shares.


 
51

 

A special resolution or an extraordinary resolution requires the affirmative vote of not less than three-fourths of the eligible votes. Examples of matters that must be approved by a special resolution include modifications to the rights of any class of shares, certain changes to the memorandum or articles of association, or our winding-up.

Capital Calls

The board of directors has the authority to make calls upon the shareholders in respect of any money unpaid on their shares and each shareholder shall pay to us as required by such notice the amount called on his shares. If a call remains unpaid after it has become due and payable, and the fourteen days notice provided by the board of directors has not been complied with, any share in respect of which such notice was given, may be forfeited by a resolution of the board.

Preference Shares

As of December 31, 2007, we had 440,855,934 Preference Shares of 5p each forming part of our authorized share capital. Pursuant to an authority given by the shareholders at the 2007 Annual General Meeting our board of directors has the authority to issue up to 440,855,934 preference shares of 5p. Pursuant to article 6 of the articles of association, the Preference Shares may be issued in one or more separate series, each of which will constitute a separate class of shares. The board of directors has the authority under article 5 of the articles of association to issue Preference Shares with such rights and subject to such restrictions and limitations as the directors shall determine,  including dividend rights, conversion rights, voting rights, rights and terms of redemption, and liquidation preference, any or all of which may be greater than the rights of the ordinary shares. As of December 31, 2007, our board of directors had not issued any such preference shares.

The issuance of preference shares could adversely affect the voting power of holders of ordinary shares and reduce the likelihood that ordinary shareholders will receive dividend payments and payments upon liquidation. The issuance could have the effect of decreasing the market price of our ordinary shares. The issuance of preference shares also could have the effect of delaying, deterring or preventing a change in control of us.
 
Our articles of association and English Law provide that the holders of preference shares will have the right to vote separately as a class on any proposal involving changes that would adversely affect the powers, preferences, or special rights of holders of that of preference shares.

On May 16, 2008, pursuant to articles 5 and 6 of the articles of association, the board of directors resolved that:
 
●  
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.
 
The Series A Preference Shares
 
Eight Series A Preference Shares have been designated for issuance and were issued to certain investors in the first tranche of a two-tranche private placement in May of 2008.
 
Pursuant to the rights of the Series A Preference Shares, the consent of the holders of at least two-thirds of the Series A Preference Shares is required to increase the number of members on our Board to more than eight (8) or, after the time the additional director described below is required to be added to the Board, to more than nine (9).  Holders of the Series A Preference Shares are entitled to elect four (4) members to our Board (the “Series A Directors”).  In voting for the Series A Directors other than at a general meeting of shareholders, the voting power of the Series A Preference Shares will be determined pro rata among the holders thereof based on each such holder’s ownership of Ordinary Shares as a percentage of all Ordinary Shares owned by the Series A Holders.  In voting for the Series A Directors at a general meeting, each holder of Series A Preference Shares will be entitled to a number of votes equal to (x) five (5) times the number of Ordinary Shares then outstanding times (y) such holder’s percentage ownership of all the Ordinary Shares owned by the Series A Holders.  Except as described herein, the Series A Preference Shares do not entitle holders thereof to vote at general meetings of shareholders.
 
If an additional director who is mutually acceptable to the directors who are not Series A Directors, on the one hand, and the majority of the Series A Directors, on the other hand, is not appointed to the Board by August 22, 2008 or such a mutually acceptable director ceases to serve on the Board and is not replaced within 60 days, then the holders of the Series A Preference Shares will be entitled to elect a fifth Series A Director to serve until replaced by such a mutually acceptable director.
 
The majority of the Series A Directors also have the right to approve the composition of any committee of the Board, so long as such committee has an equal number Series A Directors and directors who are not Series A Directors.  Consent of the majority of the Series A Directors will be required in order to change the quorum necessary for transaction of business by the Board to any number other than six (6), comprising three (3) Series A Directors and three (3) directors who are not Series A Directors.
 
Each holder of Series A Preference Shares has a right of first refusal to purchase its pro rata share of any offering by us of Ordinary Shares or other capital stock, or securities convertible or exchangeable therefor, on the same terms as the other investors participating in such offering, subject to certain exceptions (which include issuances pursuant to approved option plans or, in certain cases, our existing equity line of credit).
 
The Series A Preference Shares will be automatically converted into Ordinary Shares at a rate of one Ordinary Share per Series A Preference Share if the holders of the Series A Preference Shares (including affiliates) cease to hold 33% of the Ordinary Shares purchased by them in the first and second tranches of the private placement or if the second tranche thereof is not funded and, if the second tranche is funded, as to any holder thereof that does not fund its pro rata share of such second tranche.
 
The consent of the holders of at least two-thirds of the Series A Preference Shares is required to issue any additional Series A Preference Shares, amend or alter the rights of the Series A Preference Shares, amend or alter certain of our Articles of Association if the effect thereof would be adverse or inconsistent with the specific rights of the Series A Preference Shares or authorize any additional equity securities which would have the effect of amending, altering or granting rights identical or superior to the specific rights of the Series A Preference Shares.
 
The Series A Preference Shares are not redeemable and rank pari passu with our Ordinary Shares with respect to dividends and rights on a liquidation, winding-up or dissolution.
 
Pre-emptive Rights

English law provides that shareholders have pre-emptive rights to subscribe to any issuances of equity securities that are or will be paid wholly in cash. These rights may be waived by a special resolution of the shareholders, either generally or in specific instances, for a period not exceeding five years. This differs from U.S. law, under which shareholders generally do not have pre-emptive rights unless specifically granted in the certificate of incorporation or otherwise. Pursuant to resolutions passed at our annual general meeting on July 19, 2007, our directors are duly authorized during the period ending on July 19, 2012 to exercise all of our powers to allot our securities and to make any offer or agreement which would or might require such securities to be allotted after that date. The aggregate nominal amount of the relevant securities that may be allotted under the authority cannot exceed £85,147,430 ((equivalent to 126,209,277 Ordinary Shares and 440,855,854 preference shares) post share consolidation effective January 18, 2008 whereby ten Ordinary Shares of 5p each became one Ordinary Share of 50p each). Under these resolutions, subject to the rights of the Series A Holders set out above, we are empowered to allot equity securities as if English statutory pre-emption rights did not apply to such issuance and, therefore, without first offering equity securities to our existing shareholders.

 
52

 
 
Redemption Provisions

Subject to the Companies Acts and with the sanction of a special resolution, shares in us may be issued with terms that provide for mandatory or optional redemption. The terms and manner of redemption would be provided for by the alteration of our articles of association.

Subject to the Companies Acts, we may also purchase in any manner the board of directors considers appropriate any of our own Ordinary Shares, Preference Shares or any other shares of any class (including redeemable shares) at any price.
 
Variation of Rights

If at any time our share capital is divided into different classes of shares, the rights of any class may be varied or abrogated with the written consent of the holders of not less than 75% of the issued shares of the class, or pursuant to an extraordinary resolution passed at a separate meeting of the holders of the shares of that class. At any such separate meeting the quorum shall be a minimum of two persons holding or representing by proxy one-third in nominal amount of the issued shares of the class, unless such separate meeting is adjourned, in which case the quorum at such adjourned meeting or any further adjourned meeting shall be one person. Each holder of shares of that class has one vote per share at such meetings.

Meetings of Shareholders

The board of directors may call general meetings and general meetings may also be called on the requisition of our shareholders representing at least one tenth of the voting rights in general meeting pursuant to section 303 of the Companies Act 2006. Annual general meetings are convened upon advance notice of 21 days. Extraordinary general meetings are convened upon advance notice of 21 days or 14 days depending on the nature of the business to be transacted. Notice to shareholders shall be supplied in electronic form by means of our website to those shareholders who have not opted-out of the electronic communications regime that we implemented by special resolution at our 2007 Annual General Meeting; those shareholders who did opt-out of this regime will receive such notices in hard copy in the usual manner.

Citibank will mail to the holders of ADSs any notice of shareholders’ meeting received from us, together with a statement that holders will be entitled to instruct Citibank to exercise the voting rights of the Ordinary Shares represented by ADSs and information explaining how to give such instructions.

Limitations on Ownership

There are currently no U.K. foreign exchange controls on the payment of dividends on our Ordinary Shares or the conduct of our operations. There are no restrictions under our memorandum and articles of association or under English law that limit the right of non-resident or foreign owners to hold or vote our Ordinary Shares, Preference Shares or ADSs.

Change of Control

Save as expressly permitted by the Companies Acts, we shall not give financial assistance, whether directly or indirectly, for the purposes of the acquisition of any of our shares or for reducing or discharging any liability incurred for the purpose of such acquisition.

Disclosure of Interests

Under English Law, any person who acquires an equity interest above a “notifiable percentage” must disclose certain information to us regarding the person’s shares. The applicable threshold is currently 3%. The disclosure requirement applies to both persons acting alone or, in certain circumstances, with others. After a person’s holdings exceed the “notifiable” level, similar notifications must be made when the ownership percentage figure increases or decreases by a whole number.

In addition, Section 793 of the Companies Act of 2006 gives us the authority to require certain disclosure regarding an equity interest if we know, or have reasonable cause to believe, that the shareholder is interested or has within the previous three years been interested in our share capital. Failure to supply the information required may lead to disenfranchisement under our articles of association of the relevant shares and a prohibition on their transfer and on dividend or other payments. Under the deposit agreement with Citibank pursuant to which the ADRs have been issued, a failure to provide certain information pursuant to a similar request may result in the forfeiture by the holder of the ADRs of rights to direct the voting of the Ordinary Shares underlying the ADSs and to  exercise certain other rights with respect to the Ordinary Shares. The foregoing provisions differ from U.S. law, which typically does not impose disclosure requirements on shareholders.

 
53

 


Directors’ Indemnification

A special resolution was passed at the 2006 Annual General Meeting to adopt new Articles of Association amended to give effect to the U.K. Companies (Audit, Investigations and Community Enterprise) Act 2004 (the “2004 Act”), pursuant to which companies can take advantage of a specific exemption to indemnify directors against liabilities to third parties, and can pay directors’ costs of defence proceedings as they are incurred (subject to an obligation to repay if the defence is not successful). This was to address concerns that directors of companies whose shares are admitted on the securities markets of the United States (including NASDAQ) may face class actions in the United States and to help alleviate (at least in the short term) the cost to directors of court proceedings in the United States pursuant to the 2004 Act.

Companies can obtain liability insurance for directors and can also pay directors’ legal costs if they are successful in defending legal proceedings.

Accordingly, our board of directors has taken a decision that Amarin should so indemnify our directors and officers and Amarin has entered into forms of indemnity with our directors and officers which comply with the 2004 Act. In addition, Amarin carries liability insurance for our directors and officers.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the Group pursuant to the charter provision, by-law, contract, arrangements, statute or otherwise, the Group acknowledges that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable.
 
C.  Material Contracts

We are party to the following material contracts outside of the ordinary course of business. Copies of these agreements are filed or incorporated by reference as exhibits to this annual report.

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.
 
 
54


 
Form of Registration Rights Agreement dated October 7, 2004 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 14 separate Registration Rights Agreements on October 7, 2004 all substantially similar in form and content to this form of Registration Rights Agreement. Pursuant to such Registration Rights Agreements, Amarin Corporation plc agreed to use commercially reasonable efforts to file a registration statement with respect to the securities purchased pursuant to the Subscription Agreements dated October 7, 2004 and to use commercially reasonable efforts to cause the registration statement to be declared effective and to remain effective for a period ending with the first to occur of (i) the sale of all securities covered by the registration statement and (ii) March 30, 2006.

Share Purchase Agreement dated October 8, 2004 between Amarin Corporation plc, Vida Capital Partners Limited and the Vendors named therein relating to the entire issued share capital of Laxdale. The purchase price for the acquisition of Laxdale comprised an initial consideration of 3,500,000 ADSs representing 3,500,000 Ordinary Shares and certain success based milestone payments payable on a pro rata basis to the shareholders of Laxdale.

Clinical Trial Agreement dated March 18, 2005 between Amarin Neuroscience Limited and the University of Rochester. Pursuant to this agreement the University is obliged to carry out or to facilitate the carrying out of a clinical trial research study set forth in a research protocol on AMR101 in patients with Huntington’s disease.

Form of Securities Purchase Agreement dated May, 2005 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 34 separate Securities Purchase Agreements in May, 2005 all substantially similar in form and content to this Securities Purchase Agreement pursuant to which we issued an aggregate of 13,677,110 ordinary shares to such Purchasers, including management. The purchase price was $1.30 per ordinary share.

Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited. Pursuant to this agreement, Amarin Neuroscience Limited appointed Icon Clinical Research Limited as its clinical research organization for the European arm of the Phase III clinical trials relating to the use of AMR101 in Huntington’s disease.

Employment Agreement dated May 12, 2004 and amended September 1, 2005 with Alan Cooke.

Clinical Supply Extension Agreement dated December 13, 2005 between Amarin Pharmaceuticals Ireland Limited and Amarin Neuroscience Limited and Nisshin Flour Milling Co.

Form of Securities Purchase Agreement dated December 16, 2005 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 44 separate Securities Purchase Agreements on December 16, 2005 all substantially similar in form and content to this Securities Purchase Agreement pursuant to which we issued an aggregate of 26,100,098 ordinary shares to such Purchasers, including management. The purchase price was $1.01 per ordinary share.

Form of Securities Purchase Agreement dated January 23, 2006 between Amarin Corporation plc and the Purchasers named therein. The Company entered into 2 separate Securities Purchase Agreements on January 23, 2006 both substantially similar in form and content to this Securities Purchase Agreement pursuant to which we issued an aggregate of 840,000 ordinary shares to such Purchasers. The purchase price was $2.50 per ordinary share.

Assignment Agreement dated May 17, 2006 between Amarin Pharmaceuticals Ireland Limited and Dr Anthony Clarke. Pursuant to this agreement, Amarin Pharmaceuticals Ireland Limited acquired the global rights to a novel oral formulation of Apomorphine for the treatment of “off” episodes in patients with advanced Parkinson’s disease.
 

Amendment (Change Order Number 2), dated June 8, 2006 to Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited.  Pursuant to this agreement, Icon Clinical Research Limited revised the European Project Spceifications and related costs.
 
 
55


 
Lease Agreement dated July 4, 2006 between Amarin Neuroscience Limited and Magdalen Development Company Limited and Prudential Development Management Limited. Pursuant to this agreement, Amarin Neuroscience Limited took a lease of a premises at the South West Wing First Floor Office Suite, The Magdalen Centre North, The Oxford Science Park, Oxford, England.

Form of Securities Purchase Agreement dated October 18, 2006 between Amarin Corporation plc and the Purchasers named therein. The Company entered into 32 separate Securities Purchase Agreements on October 18, 2006 all substantially similar in form and content to this Securities Purchase Agreement pursuant to which we issued an aggregate of 8,965,600 ordinary shares to such Purchasers. The purchase price was $2.09 per ordinary share.

Master Services Agreement dated November 15, 2006 between Amarin Pharmaceuticals Ireland Limited and Icon Clinical Research (U.K.) Limited. Pursuant to this agreement, Icon Clinical Research (U.K.) Limited agreed to provide due diligence services to Amarin Pharmaceuticals Ireland Limited with respect to potential licensing opportunities on an ongoing basis.

Amendment dated December 8, 2006 to Clinical Trial Agreement dated March 18, 2005 between Amarin Neuroscience Limited and the University of Rochester.
 
Agreement dated January 18, 2007 between Neurostat Pharmaceuticals Inc. (“Neurostat”), Amarin Pharmaceuticals Ireland Limited, Amarin Corporation plc and Mr. Tim Lynch whereby the Company agreed to pay Neurostat a finder’s fee relating to a potential licensing transaction and similar payments comprising upfront and contingent milestones totaling $565,000 and warrants to purchase 175,000 ordinary shares with an exercise price of $1.79 per ordinary share.

Lease Agreement dated January 22, 2007 between Amarin Corporation plc, Amarin Pharmaceuticals Ireland Limited and Mr. David Colgan, Mr. Philip Monaghan, Mr. Finian McDonnell and Mr. Patrick Ryan. Pursuant to this agreement, Amarin Pharmaceuticals Ireland Limited took a lease of a premises at The First Floor, Block 3, The Oval, Shelbourne Road, Dublin 4.

Amendment (Change Order Number 4), dated February 15, 2007 to Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited. Pursuant to this agreement, Icon Clinical Research Limited agreed to conduct for Amarin Neuroscience Limited a one year E.U. open label follow-up study to the existing Phase III study in Huntington’s Disease.

Employment Agreement Amendment dated February 21, 2007 with Alan Cooke.

Amendment (Change Order Number 3), dated March 1, 2007 to Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited. Pursuant to this agreement, Icon Clinical Research Limited agreed to increase the patient numbers to 290 patients from 240 patients (pursuant to the original services agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited).

Development and License Agreement dated March 6, 2007 between Amarin Pharmaceuticals Ireland Limited and Elan Pharma International Limited.  Pursuant to this agreement, Amarin Pharmaceuticals Ireland Limited acquired global rights to a novel nasal lorazepam formulation for the treatment of emergency seizures in epilepsy patients.

Consultancy Agreement dated March 9, 2007 between Amarin Corporation plc and Dalriada Limited. Under the Consultancy Agreement, Amarin Corporation plc will pay Dalriada Limited a fee of £240,000 per annum for the provision of the consultancy services. Dalriada Limited is owned by a family trust, the beneficiaries of which include our Chairman and Chief Executive Officer, Mr. Thomas Lynch, and members of his family.
 
 
56


 
Form of Securities Purchase Agreement dated June 1, 2007 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 11 separate Securities Purchase Agreements on June 1, 2007 all substantially similar in form and content to this Securities Purchase Agreement pursuant to which we issued an aggregate of 6,156,406 ordinary shares to such Purchasers, including management. The purchase price was $0.60 per ordinary share.

Equity Credit Agreement dated June 1, 2007 between Amarin Corporation plc and Brittany Capital Management.  Pursuant to this agreement, Amarin has an option to draw up to $15,000,000 of funding at any time over a three year period solely at Amarin Corporation plc’s discretion.

Form of Equity Securities Purchase Agreement dated December 4, 2007 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 19 separate Equity Securities Purchase Agreements on December 4, 2007 all substantially similar in form and content to this Equity Securities Purchase Agreement pursuant to which we issued an aggregate of 16,290,900 ordinary shares to such Purchasers, including management. The purchase price was $0.33 per ordinary share.

Form of Debt Securities Purchase Agreement dated December 4, 2007 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 2 separate Debt Securities Purchase Agreements on December 4, 2007 both substantially similar in form and content to this Debt Securities Purchase Agreement pursuant to which we issued an aggregate of $2,750,000 of 3 year convertible loan notes to such Purchasers including management. The conversion price to convert the loan notes into ordinary shares of Amarin Corporation plc is $0.48 per ordinary share.

Stock Purchase Agreement dated December 5, 2007 between Amarin Corporation plc, the selling shareholders of Ester Neurosciences Limited (“Ester”), Ester, and Medica II Management L.P. pursuant to which Amarin Corporation plc acquired the entire issued share capital of Ester.  Pursuant to this agreement, Amarin Corporation plc paid initial consideration of $15,000,000, of which $5,000,000 was paid in cash and $10,000,000 was paid through the issuance of shares of Amarin Corporation plc.  Additional contingent payments, valued at an aggregate of $17,000,000 are payable in the event that certain development-based milestones are successfully completed.

Letter Agreement dated December 6, 2007 between Amarin Corporation plc and the Seller’s Representatives of the selling shareholders of Ester pursuant to which the definition of “Closing Date Average Buyer Stock Price” in the Stock Purchase Agreement dated December 5, 2007 described above was amended.

Senior Indenture dated December 6, 2007 between Amarin Corporation plc and Wilmington Trust Company.  Under this Indenture, Amarin Corporation plc may issue one or more series of senior debt securities from time to time.

First Supplemental Senior Indenture dated December 6, 2007 between Amarin Corporation plc and Wilmington Trust Company.  Under this Supplemental Indenture, together with the senior debt indenture dated December 6, 2007 described above, Amarin Corporation plc issued its 8% Convertible Debentures due 2010.

Compromise Agreement dated December 19, 2007 between Amarin Corporation plc and Richard Stewart.

Collaboration Agreement dated January 8, 2008 between Amarin Pharmaceuticals Ireland Limited and ProSeed Capital Holdings (“ProSeed”). Pursuant to this agreement, 975,000 ordinary shares in Amarin Corporation plc were issued in the form of ADSs to ProSeed in respect of fees due for investment banking advice provided to Amarin Corporation plc and Amarin Pharmaceuticals Ireland Limited on the acquisition of Ester.
 
Amendment No. 1 to Stock Purchase Agreement dated April 7, 2008 between Amarin Corporation plc and Medica II Management L.P. pursuant to which the definition of “Milestone II Time Limit Date” in the Stock Purchase Agreement dated December 5, 2007 described above was amended.
 
Employment Agreement dated April 28, 2008 with Dr Declan Doogan.
 
Form of Equity Securities Purchase Agreement dated May 13, 2008 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 9 separate Equity Securities Purchase Agreements on May 13, 2008 all substantially similar in form and content to this Securities Purchase Agreement pursuant to which we issued an aggregate of 12,173,914 Ordinary Shares and 8 Preference Shares to such Purchasers. The purchase price was $2.30 per Ordinary Share.

D.  Exchange Controls

There are currently no English exchange controls that may affect the export or import of capital, including the availability of cash and cash equivalents for use by the Group, or that affect the remittance of dividends, interest or other payments to non-U.K. resident holders of Ordinary Shares or ADSs.

E.  Taxation

U.K. Tax Matters – Holders of Ordinary Shares or ADSs

The following statements are intended only as a general guide to the U.K. tax consequences of the acquisition, ownership and disposition of our Ordinary Shares including shares represented by ADSs evidenced by American Depositary Receipts. This summary applies to you only if you are a beneficial owner of Ordinary Shares or ADSs and you are:

an individual citizen or resident of the US;

a corporation organized under the laws of the U.S. or any state thereof or the District of Columbia; or

otherwise subject to U.S. federal income tax on a net income basis in respect of the Ordinary Shares or ADSs.

This summary applies only to holders who will hold our Ordinary Shares or ADSs as capital assets. This summary is based:

upon current U.K. tax law and Revenue and Customs practice and which may be subject to change, perhaps with retroactive effect; and

in part upon representations of Citibank, N.A., as depositary, and assumes that each obligation provided for in or otherwise contemplated by the deposit agreement between us and Citibank and any related agreement will be performed in accordance with its respective terms.

 
57

 


The following summary is of a general nature and does not address all of the tax consequences that may be relevant to you in light of your particular situation. For example, this summary does not apply to US expatriates, insurance companies, investment companies, tax-exempt organizations, financial institutions, dealers in securities, broker-dealers, investors that use a mark-to-market accounting method, holders who hold ADSs or Ordinary Shares as part of hedging, straddle or conversion transactions or holders who own directly, indirectly or by attribution, 10% or more of the voting power of our issued share capital.

In addition, the following summary of U.K. tax considerations does not, except where indicated otherwise, apply to you if:

you are resident or, in the case of an individual, ordinarily resident in the U.K. for U.K. tax purposes;

your holding of ADSs or shares is effectively connected with a permanent establishment in the U.K. through which you carry on business activities or, in the case of an individual who performs independent personal services, with a fixed base situated therein; or
 
you are a corporation which, alone or together with one or more associated corporations, controls, directly or indirectly, 10% or more of our issued voting share capital.

You should consult your own tax advisers as to the particular tax consequences to you under U.K., U.S. federal, state and local and other foreign laws, of the acquisition, ownership and disposition of ADSs or Ordinary Shares.

Taxation of Dividends and Distributions

Under current U.K. taxation legislation, no tax will be withheld by us at source from cash dividend payments. A holder of Ordinary Shares or ADSs should consult his own tax adviser concerning his tax liabilities on dividends received from us.

U.K. Taxation of Capital Gains

You will not ordinarily be liable for U.K. tax on capital gains realized on the disposal of Ordinary Shares or ADSs, unless, at the time of the disposal, you carry on a trade, including a profession or vocation, in the U.K. through a branch or agency and those Ordinary Shares or ADSs are, or have been, held or acquired for the purposes of that trade or branch or agency.

A holder of Ordinary Shares or ADSs who is an individual and who has on or after March 17, 1998 ceased to be resident or ordinarily resident for tax purposes in the U.K., but who again becomes resident or ordinarily resident in the U.K. within a period of less than five years and who disposes of Ordinary Shares or ADSs during that period may also be subject to U.K. tax on capital gains, notwithstanding that he is not resident or ordinarily resident in the U.K. at the time of the disposal.

Certain disposals of assets (which could include our Ordinary Shares and ADSs) will give rise to chargeable gains that are to be included in the computation of the profits of a non-U.K. resident company. The provisions will only apply where the disposal is made while the non-U.K. resident company is carrying on a trade in the U.K. through a “permanent establishment”.

U.K. Inheritance Tax

Ordinary Shares or ADSs beneficially owned by an individual may be subject to U.K. inheritance tax on the death of the individual or, in some circumstances, if the Ordinary Shares or ADSs are the subject of a gift, including a transfer at less than full market value, by that individual (and particular rules apply to gifts where the donor reserves or retains some benefit). Inheritance tax is not generally chargeable on gifts to individuals or on some types of settlement made more than seven years before the death of the donor. Special rules apply to close companies and to trustees of settlement who hold Ordinary Shares or ADSs. Holders of Ordinary Shares or ADSs should consult an appropriate professional adviser if they make a gift of any kind or intend to hold any Ordinary Shares or ADSs through trust arrangements.

U.K. Stamp Duty and Stamp Duty Reserve Tax

U.K. stamp duty will (subject to specific exceptions) be payable at the rate of 1.5% (rounded up to the nearest £5) of the value of shares in registered form on any instrument pursuant to which shares are transferred:
 
to, or to a nominee or agent for, a person whose business is or includes the provision of clearance services; or

to, or to a nominee or agent for, a person whose business is or includes issuing depositary receipts.

 

 
58

 

Stamp duty reserve tax, at the rate of 1.5% of the value of the shares, could also be payable in these circumstances, and on the issue to such a person, but no stamp duty reserve tax will be payable if stamp duty equal to that stamp duty reserve tax liability is paid. In circumstances where stamp duty is not payable on the transfer of shares in registered form at the rate of 1.5%, such as where there is no chargeable instrument, stamp duty reserve tax will be payable to bring the charge up to 1.5% in total. Stamp duty or stamp duty reserve tax, as the case may be, will therefore be payable as a result of the issue of ADSs evidenced by American Depositary Receipts at 1.5% of the value of the Ordinary Shares underlying the ADSs at the time the Ordinary Shares are transferred to the depositary bank or its nominee.

No U.K. stamp duty will be payable on the acquisition of any ADS or on any subsequent transfer of an ADS, provided that the transfer and any subsequent instrument of transfer remains at all times outside the U.K. and that the instrument of transfer is not executed in or brought into the U.K. and the transfer does not relate to any matter or thing to be done in the U.K.  An agreement to transfer an ADS will not give rise to stamp duty reserve tax.

Subject to some exceptions, a transfer or sale of Ordinary Shares in registered form will attract ad valorem U.K. stamp duty at the rate of 0.5% (rounded up to the nearest £5) of the dutiable amount, usually the cash consideration for the transfer. Generally, ad valorem stamp duty applies neither to gifts nor on a transfer from a nominee to the beneficial owner, although in cases of transfers where no ad valorem stamp duty arises, a fixed U.K. stamp duty of £5 may be payable. Stamp duty reserve tax at a rate of 0.5% of the amount or value of the consideration for the transfer may be payable on an unconditional agreement to transfer shares. If, within six years of the date of such agreement, an instrument transferring the shares is executed and stamped, any stamp duty reserve tax paid may be repaid or, if it has not been paid, the liability to pay such tax, but not necessarily interest and penalties, would be cancelled. Stamp duty reserve tax is chargeable whether such agreement is made or effected in the U.K. or elsewhere and whether or not any party is resident or situated in any part of the U.K.

The statements in this paragraph headed “U.K. Stamp Duty and Stamp Duty Reserve Tax” summarize the current position and are intended as a general guide only. Special rules apply to agreements made by, amongst others, intermediaries, market makers, brokers, dealers and persons connected with depositary arrangements and clearance services and certain categories of person may be liable to stamp duty or stamp duty reserve tax at higher rates or may, although not primarily liable for the duty or tax, be required to notify and account for it under the U.K. Stamp Duty Reserve Tax Regulations 1996.

U.K. Tax Matters – Holders of Debentures

The comments below are of a general nature based on current UK law and practice. They do not necessarily apply where the income is deemed for tax purposes to be the income of any other person. They relate only to the position of persons who are the absolute beneficial owners of their Debentures or Ordinary Shares, and hold those Debentures or Ordinary Securities as an investment. The comments below may not apply to certain classes of persons such as dealers. Any holders of Debentures or Ordinary Shares who are in doubt as to their personal tax position should consult their professional advisers.

Payments of Interest.

It is considered that payments of interest on the Debentures will constitute “UK source income” and accordingly may be subject to deduction of UK income tax at source.

As a general matter, debt securities will be exempt from withholding or deduction for on account of UK tax under the provisions of UK tax law if the debt securities are listed on a “recognized stock exchange” within the meaning of section 1005 of the Income Tax Act 2007.

In other cases, and in particular if debt securities, such as the Debentures, are not listed on a “recognized stock exchange”, interest will be paid after deduction of UK income tax at the rate, currently, of 20%. Holders of such debt securities who are not resident for tax purposes in the United Kingdom may be entitled to exemption from (or reduction of) withholding tax if there is an appropriate article in an applicable double tax treaty which provides for an application to be made to HM Revenue & Customs ("HMRC) to make  a direction that interest may be paid without deduction of tax. Holders may also be entitled to recover all or part of the tax that has been deducted from interest payments already made.

Holders of Debentures who are within the charge to UK tax will be subject to UK income tax or corporation tax (as applicable) on interest arising in respect of the Debentures.


 
59

 

E.U. Savings Directive .

Under EC Council Directive 2003/48/EC on the taxation of savings income, each Member State is required to provide to the tax authorities of other Member States details of payments of interest or other similar income paid by a person within its jurisdiction to an individual or certain other residual entities resident in that other Member State; for a transitional period, Austria, Belgium and Luxembourg may instead apply a withholding tax system in relation to such payments, deducting tax at rates rising over time to 35% unless during such period they elect otherwise.

Provision of Information.

Holders of Debentures who are individuals should note that where any interest on Debentures is paid to them (or to any person acting on their behalf) by any person in the UK acting on behalf of the Issuer (a "paying agent"), or is received by any person in the UK acting on behalf of the relevant holder (a "collecting agent"), then the paying agent or the collecting agent (as the case may be) may, in certain cases, be required to supply to HMRC details of the payment and certain details relating to the holder (including the holder's name and address). These provisions will apply whether or not the interest has been paid subject to deduction of income tax at source and whether or not the holder is resident in the UK for UK tax purposes. Where the holder is not so resident, the details provided to HMRC may be passed to the tax authorities of the jurisdiction in which the holder is resident for tax purposes.

Conversion, Redemption and Disposal of Debentures.

Holders of Debentures who are not resident or ordinarily resident for tax purposes in the UK, and who do not carry on a trade, profession or vocation in the UK through a branch or agency (in the case of an individual holder) or a permanent establishment (in the case of a corporate holder) to which the Debentures are attributable, will not be liable to UK taxation in relation to any profits or gains realised on the sale or other disposal or redemption of the Debentures.

The UK tax treatment for holders of Debentures who are within the charge to UK corporation tax will depend on, amongst other things, the accounting treatment of the Debentures in the holder's hands, including whether or not the Debentures are regarded as containing an "embedded derivative" as an accounting matter. The accounting treatment will also affect the tax treatment of a disposal of the Debentures (including a disposal occurring on conversion or redemption). UK-resident corporate holders of Debentures should consult their tax advisers on the tax liabilities that may arise as a result of concerting, redeeming or disposing of Debentures.

Other UK Taxpayers.

A transfer of Debentures by a UK income tax payer may give rise to a charge to UK income tax under the "accrued income scheme" as representing interest accrued on the Debentures at the time of transfer.

If debt securities are treated as "deeply discounted securities" for the purposes of Chapter 8 of Part 4 of the Income Tax (Trading and Other Income) Act 2005, then holders of Debentures who are not within the charge to UK corporation tax and who are resident or ordinarily resident for tax purposes in the UK, or who carry on a trade through a branch or agency to which the Debentures are attributable, may be subject to UK tax on income on a disposal or redemption of the Debentures.

If the Debentures are treated as "deeply discounted securities", then the Debentures will be deemed to be "qualifying corporate bonds" pursuant to section 117(2AA) of the Taxation of Chargeable Gains Act 1992. Consequently, on conversion of the Debentures, such holders of the Debentures will be treated as disposing of the Debentures. The base cost for tax purposes of the Ordinary Shares received on conversion of such Debentures will be the market value of the Debentures as determined immediately before conversion.


 
60

 



Dividends on Ordinary Shares.

Amarin will not be required to withhold any amount for or on account of UK tax at source when paying a dividend in respect of the Ordinary Shares.

An individual holder of Ordinary Shares who is resident in the UK for tax purposes and who receives a dividend from Amarin will be entitled to a tax credit which such shareholder may set off against his or her total income tax liability on the dividend. The tax credit will equate to one-ninth of the dividend received.

Holders of Ordinary Shares within the charge to UK corporation tax will generally not be subject to corporation tax on dividends paid by Amarin.

Holders of Ordinary Shares who are not resident in the UK for tax purposes should consult their tax advisers concerning their tax liabilities on dividends received from Amarin.

Disposals of Ordinary Shares .

A disposal of Ordinary Shares will constitute a disposal for the purposes of UK taxation on chargeable gains, and accordingly may give rise to a liability to taxation for holders who are resident or ordinarily resident in the UK for tax purposes or who carry on a trade, profession or vocation in the UK through a branch or agency (in the case of individual holders) or through a permanent establishment (in the case of holders within the charge to UK corporation tax) to which their Ordinary Shares are attributable.

Stamp Duty and Stamp Duty Reserve Tax .

No UK stamp duty or stamp duty reserve tax should be payable on the issue of the Debentures.

Stamp duty reserve tax, at the rate of 0.5% of the amount or value of the consideration, will be payable on an agreement to transfer Debentures.

No UK stamp duty or stamp duty reserve tax should be payable by holders of Debentures on the issue of Ordinary Shares upon conversion of the Debentures, other than an issue to issuers of depositary receipts or providers of clearance services as indicated below.

The conveyance or transfer on sale of Ordinary Shares will be subject to ad valorem stamp duty, generally at the rate of 0.5% of the amount or value of the consideration for the transfer rounded-up to the nearest £5. The purchaser normally pays the stamp duty.

Issues (including on conversion of the Debentures) or transfers of Ordinary Shares (1) to, or to a nominee or agent for, a person whose business is or includes issuing depositary receipts within section 67 or section 93 of the Finance Act 1986 or (2) to, or to a nominee or agent for, a person providing a clearance service within section 70 or section 96 of the Finance Act 1986, will generally be subject to stamp duty or stamp duty reserve tax at 1.5% of the amount or value of the consideration unless, in the case of an issue or transfer to a clearance service, the clearance service in question has made an election under section 97A of the Finance Act 1986 which applies to the Ordinary Shares. Under section 97A, a clearance service may, provided it meets certain conditions, elect for the 0.5% rate of stamp duty or stamp duty reserve tax to apply to transfers of securities within such service instead of the 1.5% rate applying to an issue or transfer of such securities into such service.

Certain U.S. Federal Income Tax Considerations
 
Subject to the limitations described below, the following generally summarizes certain material U.S. federal income tax consequences to a U.S. Holder (as defined below) of the acquisition, ownership and disposition of Debentures, Warrants and Ordinary Shares.  This discussion assumes that the Debentures, Warrants, or Ordinary Shares are held as capital assets (as defined in Section 1221 of the Code) by the U.S. Holders. The discussion is limited to the U.S. federal income tax consequences to holders acquiring Debentures at original issue for cash at the initial offering price. U.S. Holders of ADSs will be treated for U.S. federal income tax purposes as owners of the Ordinary Shares underlying the ADSs.  Accordingly, except as noted, the U.S. federal income tax consequences discussed below regarding Ordinary Shares apply equally to ADSs.  This discussion is limited to U.S. Holders who are beneficial owners of the Debentures, Warrants or Ordinary Shares, and who hold their Debentures,Warrants or Ordinary Shares as capital assets, within the meaning of the U.S. Internal Revenue Code of 1986, as amended,
 
 
61

 

which we refer to as the “Code.”  For purposes of this summary, a “U.S. Holder” is a beneficial owner of Debentures, Warrants or Ordinary Shares that does not maintain a “permanent establishment” or “fixed base” in the U.K., as such terms are defined in the double taxation convention between the U.S. and U.K. and that is, for U.S. federal income tax purposes,

·  
an individual who is a citizen or resident of the U.S.;

·  
a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized in the U.S. or under the laws of the U.S. or of any state thereof or the District of Columbia;

·  
an estate, the income of which is includible in gross income for U.S. federal income tax purposes regardless of its source; or

·  
a trust (i) if a court within the U.S. is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all substantial decisions of the trust or (ii) if it made a valid election to be treated as a U.S. person.

If a partnership (including for this purpose any entity treated as a partnership for U.S. federal income tax purposes) is a beneficial owner of Debentures, Warrants or Ordinary Shares, the treatment of a partner in the partnership will generally depend upon the status of the partner and the activities of the partnership.  Partnerships and partners in such partnerships should consult their tax advisors about the U.S. federal income tax consequences of owning and disposing of Debentures, Warrants or Ordinary Shares.

This summary is for general information purposes only.  It does not purport to be a comprehensive description of all the U.S. federal income tax considerations that may be relevant to each U.S. Holder’s decision in regard to the Debentures, Warrants and Ordinary Shares.  This discussion also does not address any aspect of U.S. federal gift or estate tax, or any state, local or non-U.S. tax laws.  Prospective owners of Debentures, Warrants or Ordinary Shares who are U.S. Holders are advised to consult their own tax advisors with respect to the U.S. federal, state and local tax consequences, as well as the non-U.S. tax consequences, of the acquisition, ownership and disposition of Debentures, Warrants and Ordinary Shares applicable to their particular tax situations.

This discussion is based on current provisions of the Code, current and proposed U.S. Treasury regulations promulgated thereunder, the double taxation convention between the U.S. and U.K. entered into force on March 31, 2003, and administrative and judicial decisions, each as of the date hereof, all of which are subject to change or differing interpretation, possibly on a retroactive basis.  The new convention replaces the double taxation convention between the U.S. and the U.K. entered into force on April 24, 1980.  The new convention is effective, in respect of taxes withheld at source, for amounts paid or credited on or after May 1, 2003.  Other provisions of the new convention will take effect on certain other dates.  A U.S. Holder would, however, be entitled to elect to have the old convention apply in its entirety for a period of twelve months after the effective dates of the new convention.  The following discussion assumes that U.S. Holders are residents of the U.S. for purposes of both the old convention and the new convention, and are entitled to the benefits of those conventions.

This discussion does not address all aspects of U.S. federal income taxation that may be relevant to a particular U.S. Holder based on such holder’s individual circumstances.  In particular, this discussion does not address the potential application of the alternative minimum tax nor does it address the tax treatment of shareholders, partners or beneficiaries of a holder of Debentures, Warrants or Ordinary Shares.  In addition, this discussion does not address the U.S. federal income tax consequences to U.S. Holders that are subject to special treatment, including broker-dealers, including dealers in securities or currencies; insurance companies; taxpayers that have elected mark-to-market accounting; tax-exempt organizations; financial institutions or “financial services entities”; taxpayers who hold Debentures, Warrants or Ordinary Shares as part of a straddle, hedge or conversion transaction; U.S. Holders owning directly, indirectly or by attribution at least 10% of our voting power; U.S. Holders whose functional currency is not the U.S. Dollar; certain expatriates or former long-term residents of the U.S.; and taxpayers who acquired their Debentures, Warrants or Ordinary Shares as compensation. There can be no assurances that the IRS will not challenge one or more of the tax consequences described herein, and we have not obtained, nor do we intend to obtain, a ruling from the IRS with respect to the U.S. federal income tax consequences of purchasing, owning or disposing of the Debentures, Warrants, or Ordinary Shares.

 
62

 



You should consult your own tax advisors about the particular tax consequences to you under U.K., U.S. federal, state and local and other foreign laws, of the acquisition, ownership and disposition of Debentures, Warrants, ADSs or Ordinary Shares.

Units

Allocation of Purchase Price

A U.S. Holder’s acquisition of a Unit will be treated as the acquisition of a Unit consisting of a Debenture and a Warrant.  The purchase price of each Unit will be allocated between the Debentures and Warrants based upon their relative fair market values on the Issue Date. This allocation will establish the U.S. Holder’s initial tax basis in its Debenture and Warrant and the issue price of the Debentures.  We expect to treat the fair market value of each Debenture as $752 and the fair market value of each Warrant as $248.  This allocation will be binding on each U.S. Holder (but not on the IRS) unless it discloses otherwise in a timely filed U.S. federal income tax return of the U.S. Holder for the taxable year in which it acquires the Units.  The remainder of this discussion assumes that this allocation will be respected for U.S. federal income tax purposes.

Sale or Exchange of Units

Subject to the PFIC rules discussed below, the sale of a Unit will result in the recognition of capital gain or loss to a U.S. Holder in a manner similar to that described below under “Ordinary Shares—Sale or Exchange of Ordinary Shares.”

Debentures

Payment of Interest

Payment of stated interest on a Debenture will be taxable as ordinary interest income at the time it is received or accrued, depending upon the method of accounting applicable to the U.S. Holder of the Debenture.

Original Issue Discount

Because a portion of the issue price of each Unit will be allocable to the Warrants, the Debentures will be issued with OID in an amount equal to the excess of the “stated redemption price at maturity” of the Debentures over their “issue price.”  For purposes of the foregoing, the general rule is that the stated redemption price at maturity of a debt instrument is the sum of all payments provided by the debt instrument other than payments of “qualified stated interest” (generally interest that is unconditionally payable no less frequently than annually at a single fixed rate).  A U.S. Holder generally must include OID in gross income as it accrues over the term of the Debentures using the “constant yield method” without regard to its regular method of accounting for U.S. federal income tax purposes, and in advance of the receipt of cash payments attributable to that income.

The amount of OID includible in income for a taxable year by a U.S. Holder will generally equal the sum of the “daily portions” of the total OID on the Debenture for each day during the taxable year (or portion thereof) on which such holder held the Debenture.  Generally, the daily portion of the OID is determined by allocating to each day during an accrual period (generally each semi-annual period during the term of the Debentures) a ratable portion of the OID on such Debenture which is allocable to the accrual period in which such day is included.  The amount of OID allocable to each accrual period will generally be an amount equal to the product of the “adjusted issue price” of a Debenture at the beginning of such accrual period and its “yield to maturity.”  The “adjusted issue price” of a Debenture at the beginning of any accrual period will equal the issue price increased by the total OID accrued for each prior accrual period, less any payments made on such Debenture (other than any payments of qualified stated interest) on or before the first day of the accrual period.  The “yield to maturity” of a Debenture will be computed on the basis of a constant annual interest rate compounded at the end of each accrual period.

Interest income (including OID) on a Debenture generally will be foreign source “passive category income” or, in the case of certain U.S. Holders, “general category income” for purposes of computing the foreign tax credit allowable to U.S. Holders under U.S. federal income tax laws.


 
63

 



Conversion of the Debentures

A U.S. Holder will generally not recognize income, gain or loss upon conversion of a Debenture into Ordinary Shares except with respect to cash received in lieu of a fractional Ordinary Share.  A U.S. Holder's tax basis in the Ordinary Shares received upon conversion will be the same as the U.S. Holder's tax basis in the Debenture at the time of conversion reduced by any basis allocable to a fractional Ordinary Share, and the holding period for the Ordinary Shares received upon conversion will include the holding period of the Debenture converted.

Cash received in lieu of a fractional Ordinary Share upon conversion will be treated as a payment in exchange for the fractional Ordinary Share.  Accordingly, the receipt of cash in lieu of a fractional Ordinary Share generally will result in capital gain or loss (measured by the difference between the cash received for the fractional share and the U.S. Holder’s adjusted tax basis in the fractional share).

C o nstructive Distributions

The terms of the Debentures allow for changes in the conversion rate of the Debentures under certain circumstances.  A change in conversion rate that allows U.S. Holders to receive more Ordinary Shares on conversion may increase the U.S. Holders’ proportionate interests in our earnings and profits or assets. In that case, the U.S. Holders may be treated as though they received a taxable distribution in the form of our Ordinary Shares.  A taxable constructive stock distribution would result, for example, if the conversion rate is adjusted to compensate U.S. Holders for distributions of cash or property to our stockholders.  Not all changes in the conversion rate that result in U.S. Holders’ receiving more Ordinary Shares on conversion, however, increase the U.S. Holders’ proportionate interests in us.  For instance, a change in conversion rate could simply prevent the dilution of the U.S. Holders’ interests upon a stock split or other change in capital structure. Changes of this type, if made pursuant to a bona fide reasonable adjustment formula, are not treated as constructive stock distributions.  Conversely, if an event occurs that dilutes the U.S. Holders’ interests and the conversion rate is not adjusted, the resulting increase in the proportionate interests of other stockholders may be treated as a taxable stock distribution to the stockholders.

Any such constructive distributions would be treated as a taxable dividend for U.S. federal income tax purposes to the extent of our current or accumulated earnings and profits (with the U.S. Holder’s tax basis in its Debenture or Ordinary Shares (as the case may be) being increased by the amount of such dividend).  The passive foreign investment company rules discussed below may apply to such constructive distribution.  U.S. Holders should consult their own tax advisors regarding whether any taxable constructive stock dividend would be eligible for the reduced rate of tax generally applicable to certain dividends paid to non-corporate U.S. Holders.

Sale or Exchange of the Debentures

Subject to the passive foreign investment company rules discussed below, upon a taxable sale or exchange (including a redemption or retirement) of a Debenture, a U.S. Holder will recognize gain or loss equal to the difference between the sum of all cash plus the fair market value of all property received on such sale or exchange (less any portion allocable to accrued but unpaid interest, which will be treated as a payment of interest for U.S. federal income tax purposes) and the U.S. Holder’s adjusted tax basis in the Debenture.  A U.S. Holder’s adjusted tax basis in a Debenture generally will be the U.S. Holder’s cost therefor, increased by the amount of OID previously included in income by the holder up through the date of the sale or exchange and decreased by the amount of any payments on the Debenture other than any payments of qualified stated interest.

Gain or loss recognized by a U.S. Holder on the sale or exchange of a Debenture will be capital gain or loss, and will be long-term capital gain or loss if the Debenture has been held by the U.S. Holder for more than one year at the time of the disposition.  In the case of a non-corporate U.S. Holder, long-term capital gain is currently subject to a maximum U.S. federal tax rate of 15%.  The deductibility of capital losses by U.S. Holders is subject to certain limitations.

Warrants

Exercise of Warrants

The exercise of a Warrant will not be a taxable event for a U.S. Holder.  Subject to the passive foreign investment company rules discussed below, a U.S. Holder will generally have a holding period in the Ordinary Shares acquired upon exercise of a Warrant that begins on the day after the date of exercise of the Warrant.  The cost basis of the Ordinary Shares acquired upon such exercise will equal the sum of the U.S. Holder’s cost basis in the Warrant and the Exercise Price paid upon the exercise of the Warrant.  As further described below, gain or loss will be recognized upon the subsequent sale or exchange of the Ordinary Shares acquired by the exercise of the Warrant, measured by the difference between the amount realized upon the sale or exchange and the cost basis of the Ordinary Shares so acquired.

 
64

 


Lapse of Warrants

If a Warrant is allowed to lapse unexercised, a U.S. Holder would realize a capital loss equal to such holder’s tax basis in the Warrant.  A U.S. Holder’s tax basis in a Warrant will equal the portion of the Unit Purchase Price allocable to the Warrant, as described above under “Units — Allocation of Purchase Price.”

Sale or Exchange of Warrants

Subject to the PFIC rules discussed below, the sale of a Warrant will result in the recognition of capital gain or loss to a U.S. Holder in a manner similar to that described below under “—Sale or Exchange of Ordinary Shares.”

Constructive Distributions

An adjustment to the Exercise Price of the Warrants, or the failure to make such adjustments, may in certain circumstances result in constructive distributions to U.S. Holders that could be taxable as dividends for U.S. federal income tax purposes in the manner described above under “Debentures—Constructive Distributions.”

Ordinary Shares

Distributions

Subject to the PFIC rules discussed below, the amount of any distributions (including, provided certain elections are made, as discussed in “—U.K. Withholding Tax/Foreign Tax Credits” below, the full tax credit amount deemed received) paid out of current and/or accumulated earnings and profits, as determined under U.S. tax principles, will be included in the gross income of a U.S. Holder on the day such distributions are actually or constructively received, and will be characterized as ordinary income for U.S. federal income tax purposes.  Dividends paid to noncorporate holders in taxable years beginning before January 1, 2011 are subject to taxation at a reduced rate of 15% provided that the holder has held the shares for more than 60 days during the 120-day period beginning 60 days before the ex-dividend date, the issuer is a “qualified foreign corporation,” and certain other conditions are met.  A company is a “qualified foreign corporation” if the shares on which the dividend is paid (or ADRs in respect of such shares) are listed on certain securities markets, including the Nasdaq Stock Market, or if the corporation is eligible for the benefits of a tax treaty determined to be satisfactory by the U.S. Secretary of the Treasury.  The income tax treaty between the U.S. and the U.K. has been designated as satisfactory for such purpose.

To the extent that a distribution on Ordinary Shares exceeds our current and accumulated earnings and profits, it will be treated as a non-taxable return of capital to the extent of a U.S. Holder’s adjusted basis in the Ordinary Shares, and thereafter as capital gain.  We do not currently maintain calculations of our earnings and profits under U.S. tax principles.  Dividends paid by us to corporate U.S. Holders will not be eligible for the dividends-received deduction that might otherwise be available if such dividends were paid by a U.S. corporation.

Foreign Currency Considerations

Distributions paid by us in pounds sterling will be included in a U.S. Holder’s income when the distribution is actually or constructively received by the U.S. Holder.  The amount of a dividend distribution includible in the income of a U.S. Holder will be the U.S. Dollar value of the pounds sterling, determined by the spot rate of exchange on the date when the distribution is actually or constructively received by the U.S. Holder, regardless of whether the pounds sterling are actually converted into U.S. Dollars at such time.  If the pounds sterling received as a dividend distribution are not converted into U.S. Dollars on the date of receipt, a U.S. Holder may realize exchange gain or loss on a subsequent conversion of such pounds sterling into U.S. Dollars.  The amount of any gain or loss realized in connection with a subsequent conversion will be treated as ordinary income or loss, and generally will be treated as U.S. source income or loss for foreign tax credit purposes.

 
65

 


U.K. Withholding Tax/Foreign Tax Credits

A U.S. Holder that elects to receive benefits under the old convention is, in principle, entitled to claim a refund from the Revenue and Customs for (i) the amount of the tax credit that a U.K. resident individual would be entitled to receive with respect to a dividend payment, which we refer to as the “Tax Credit Amount,” reduced by (ii) the amount of U.K. withholding tax, which we refer to as “U.K. Notional Withholding Tax,” imposed on such dividend payment under the old convention.  The Tax Credit Amount will equal that amount of U.K. Notional Withholding Tax imposed on dividends paid by us.  As a result, no such refund is available. However, a U.S. Holder may be entitled to claim a foreign tax credit for the amount of U.K. Notional Withholding Tax associated with a dividend paid by us by filing a Form 8833 in accordance with U.S. Revenue Procedure 2000-13. U.S. Holders that file Form 8833 will be treated as receiving an additional dividend from us equal to the Tax Credit Amount (unreduced by the U.K. Notional Withholding Tax).  Such additional dividend must be included in the U.S. Holder’s gross income, and the U.S. Holder will be treated as having paid the applicable U.K. Notional Withholding Tax due under the old convention.  For purposes of calculating the foreign tax credit, dividends paid on the Ordinary Shares will be treated as non-U.S. source income, and generally will constitute “passive category income” or, in the case of certain U.S. Holders, “general category income.”  In lieu of claiming a foreign tax credit, a U.S. Holder may be eligible to claim a deduction for foreign taxes paid in a taxable year.  However, a deduction generally does not reduce a U.S. Holder’s U.S. federal income tax liability on a dollar-for-dollar basis as does a tax credit.

Under the new convention, the Tax Credit Amount and U.K. Notional Withholding Tax described above will no longer apply to U.S. Holders.  The U.K. does not currently apply a withholding tax on dividends under its internal tax laws.  Were such withholding imposed in the U.K., as permitted under the new convention, the U.K. generally will be entitled to impose a withholding tax at a rate of 15% on dividends paid to U.S. Holders.  A U.S. Holder who is subject to such withholding should be entitled to a credit for such withholding, subject to applicable limitations, against such U.S. Holder’s U.S. federal income tax liability.

The rules relating to foreign tax credits are complex.  U.S. Holders are urged to consult their tax advisors to determine whether and to what extent a foreign tax credit might be available in connection with dividends paid on the Ordinary Shares.
 
Sale or Exchange of Ordinary Shares

Subject to the PFIC rules described below, a U.S. Holder generally will recognize capital gain or loss on the sale or exchange of Ordinary Shares in an amount equal to the difference between the amount realized in such sale or exchange and the U.S. Holder’s adjusted tax basis in such Ordinary Shares.  Such capital gain or loss will be long-term capital gain or loss if a U.S. Holder has held the Ordinary Shares for more than one year, and generally will be U.S. source income for foreign tax credit purposes.  Long-term capital gains realized by an individual U.S. Holder on a sale or exchange of Ordinary Shares are generally subject to reduced rates of taxation.  The deductibility of capital losses is subject to limitations.

A U.S. Holder that receives foreign currency upon the sale or exchange of Ordinary Shares generally will realize an amount equal to the U.S. Dollar value of the foreign currency on the date of sale (or, if Ordinary Shares are traded on an established securities market, in the case of cash basis tax payers and electing accrual basis tax payers, the settlement date).  A U.S. Holder will have a tax basis in the foreign currency received equal to the U.S. Dollar amount realized.  Any gain or loss realized by a U.S. Holder on a subsequent conversion or other disposition of foreign currency will be ordinary income or loss, and will generally be U.S. source income for foreign tax credit purposes.

Surrender of ADSs for Ordinary Shares

The surrender of ADSs for the underlying Ordinary Shares will not be a taxable event for U.S. federal income tax purposes, and U.S. Holders will not recognize any gain or loss upon such an exchange.

PFIC Rules

Certain adverse U.S. tax consequences apply to a U.S. shareholder in a company that is classified as a passive foreign investment company, which is referred to herein as a PFIC.  We will be classified as a PFIC in a particular taxable year if either (i) 75% or more of our gross income is passive income; or (ii) the average percentage of the value of our assets that produce or are held for the production of passive income is at least 50%.  Cash balances, even if held as working capital, are considered to be passive.

Because we will receive interest income and may receive royalties, we may be classified as a PFIC under the income test described above.  In addition, as a result of our cash position and our ownership of patents, we may be classified as a PFIC under the asset test.

 
66

 


If we were a PFIC in any year during which a U.S. Holder owned Ordinary Shares, the U.S. Holder would generally be subject to special rules (regardless of whether we continued to be a PFIC) with respect to (i) any “excess distribution” (generally, distributions received by the U.S. Holder in a taxable year in excess of 125% of the average annual distributions received by such holder in the three preceding taxable years, or, if shorter, such holder’s holding period) and (ii) any gain realized on the sale or other disposition of the Ordinary Shares.  Under these rules:

·  
the excess distribution or gain would be allocated ratably over the U.S. Holder’s holding period, including the holding period that the U.S. Holder owned the Debentures or Warrants;
·  
the amount allocated to the current taxable year and any taxable year prior to the first taxable year in which we are a PFIC would be taxed as ordinary income; and
·  
the amount allocated to each of the prior taxable years would be subject to tax at the highest rate of tax in effect for the taxpayer for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable to each such prior taxable year.

Although not free from doubt, it is likely that proposed Treasury regulations would apply the rules described above to gain on the disposition of Debentures or Warrants.  The proposed Treasury regulations regarding PFIC rules also provide that the holding period of PIFC stock acquires upon the exercise of an option (including conversion of a Debenture and the exercise of a Warrant) would include the period the option (including the Debenture or Warrant) was held.

U.S. Holders who own ADSs (but not Ordinary Shares) generally should be able to avoid the interest charge described above by making a mark-to-market election with respect to such ADSs, provided that the ADSs are “marketable.”  The ADSs are marketable if they are regularly traded on certain U.S. stock exchanges, or on a foreign stock exchange if:

·  
the foreign exchange is regulated or supervised by a governmental authority of the country in which the exchange is located;
·  
the foreign exchange has trading volume, listing, financial disclosure, and other requirements designed to prevent fraudulent and manipulative acts and practices, remove impediments to, and perfect the mechanism of, a free and open market, and to protect investors;
·  
the laws of the country in which the exchange is located and the rules of the exchange ensure that these requirements are actually enforced; and
·  
the rules of the exchange effectively promote active trading of listed stocks.

For purposes of these regulations, the ADSs will be considered regularly traded during any calendar year during which they are traded, other than in de minimis quantities, on at least fifteen days during each calendar quarter.  Any trades that have as their principal purpose meeting this requirement will be disregarded.  If a U.S. Holder makes a mark-to-market election, it will be required to include as ordinary income the excess of the fair market value of such ADSs at year-end over its basis in those ADSs.  In addition, any gain that the U.S. Holder recognizes upon the sale of such ADSs will be taxed as ordinary income in the year of sale.  A U.S. Holder of Debentures or Warrants may not make a mark-to-market election with respect to the Debentures or Warrants it holds.  U.S. Holders should consult their tax advisors regarding the availability of the mark-to-market election.

A U.S. Holder of an interest in a PFIC can sometimes avoid the interest charge described above by making a “qualified electing fund” or “QEF” election to be taxed currently on its share of the PFIC’s undistributed ordinary income.  Such election must be based on information concerning the PFIC’s earnings provided by the relevant PFIC to investors on an annual basis. We will make such information available to U.S. Holders upon request, and consequently U.S. Holders will be able to make a QEF election.  A U.S. Holder may not make a QEF election with respect to Debentures or Warrants.  As a result, if a U.S. Holder sells Debentures or Warrants, any gain may be subject to the special tax and interest charge rules treating the gain as an excess distribution, as described above, if the company is a PFIC at any time during the period the U.S. Holder holds the Debentures or Warrants.  If a U.S. Holder that converts Debentures or exercises Warrants properly makes a QEF election with respect to the newly acquired Ordinary Shares, the adverse tax consequences under PFIC rules will continue to apply with respect to the pre-QEF election period.

The application of the PFIC and QEF rules to Debentures, Warrants, Ordinary Shares and ADSs acquired upon conversion of the Debentures or exercise of Warrants is subject to significant uncertainties.  Accordingly, each U.S. Holder should consult such holder’s tax advisor concerning the PFIC consequences of holding Debentures, Warrants or Ordinary Shares acquired through the conversion of Debentures or exercise of the Warrants.  In addition, U.S. Holders who hold ADSs or Ordinary Shares other than through exercise  of Warrants should consult their tax advisors regarding the U.S. federal income tax considerations discussed above and the desirability of making a QEF election.

 
67

 


CFC Rules

 
We expect that we will be classified as a CFC for the taxable year 2008 and we may be classified as a CFC in future taxable years.  We will be a CFC for any year in which more than 50% of either the total combined voting power of our outstanding shares entitled to vote or the total value of all of our outstanding shares were owned, directly, indirectly or constructively, by citizens or residents of the United States, U.S. partnerships or corporations, or U.S. estates or trusts (as defined for U.S. federal income tax purposes), each of which owned, directly, indirectly or constructively, 10% or more of the total combined voting power of our outstanding shares entitled to vote.
 
The classification as a CFC has many complex results, one of which is that if you are a 10% U.S. Holder, you may be subject to current U.S. income taxation at ordinary income tax rates on all or a portion of the Company’s undistributed earnings and profits attributable to “subpart F income.”  Your adjusted tax basis in your shares would be increased to reflect any taxed but undistributed earnings and profits. Any distribution of earnings and profits that previously had been taxed would result in a corresponding reduction in your adjusted tax basis in your shares and would not be taxed again when you receive such distribution.  You may also be taxable at ordinary income tax rates on any gain realized on a sale of Ordinary Shares or ADSs to the extent of the Company’s current and accumulated earnings and profits attributable to such shares.  In addition, special foreign tax credit rules would apply.  For any year in which we are both a PFIC and a CFC, if you are a 10% U.S. Holder, you would be subject to the CFC rules and not the PFIC rules with respect to your investment in shares.
 
Each U.S. Holder should consult their own tax adviser to determine whether their ownership interest in the Company would cause them or any affiliated person to become a 10% shareholder, and to determine the potential gross income inclusions and other tax consequences of that status.
 
U.S. Backup Withholding and Information Reporting Requirements

Interest paid on Debentures, dividends paid on the Ordinary Shares, and proceeds received in connection with the sale or exchange of Debentures, Ordinary Shares or Warrants may be subject to information reporting to the Internal Revenue Service (the “IRS”) and backup withholding (currently imposed at a rate of 28%).  Backup withholding will not apply, however, if a U.S. Holder (i) is a corporation or comes within certain other exempt categories and, when required, demonstrates such fact, or (ii) provides a taxpayer identification number, certifies as to no loss of exemption from backup withholding and otherwise complies with applicable backup withholding rules.  Persons required to establish their exempt status generally must provide certification on IRS Form W-9 or Form W-8BEN (as applicable).  Amounts withheld as backup withholding may be credited against a holder’s U.S. federal income tax liability.  A holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the IRS and timely furnishing any required information.

F.  Dividends and Paying Agents

Not applicable.

G.  Statement of Experts

Not applicable.

H.  Documents on Display

We file reports, including this annual report on Form 20-F, and other information with the SEC pursuant to the rules and regulations of the SEC that apply to foreign private issuers. Any materials filed with the SEC may be inspected without charge and copied at prescribed rates at its Public Reference Room at 100 F Street, N.E. Washington, D.C. 20549. Information on the operation of the Public Reference Room may be obtained by calling the SEC at 1-800-SEC-0330. This annual report and subsequent public filings with the SEC will also be available on the website maintained by the SEC at http://www.sec.gov.

We provide Citibank N.A., as depositary under the deposit agreement between us, the depositary and registered holders of the American Depositary Receipts evidencing ADSs, with annual reports, including a review of operations, and annual audited consolidated financial statements prepared in conformity with IFRS. Upon receipt of these reports, the depositary is obligated to promptly mail them to all record holders of ADSs. We also furnish to the depositary all notices of meetings of holders of Ordinary Shares and other reports and communications that are made generally available to holders of Ordinary Shares. The depositary undertakes to mail to all holders of ADSs a notice containing the information contained in any notice of a shareholders’ meeting received by the depositary, or a summary of such information. The depositary also undertakes to make available to all holders of ADSs such notices and all other reports and communications received by the depositary in the same manner as we make them available to holders of Ordinary Shares.

Item 11  Quantitative and Qualitative Disclosures About Market Risk

General

Historically, our global operations and our existing liabilities were exposed to various market risks (i.e. the risk of loss arising from adverse changes in market rates or prices). Our principal market risks were:

foreign exchange rates — generating translation and transaction gains and losses; and

interest rate risks related to financial and other liabilities.

We have not entered into any market risk sensitive instruments for trading purposes. We have not entered into any hedging or derivative instruments in respect of these exposures.

 
68

 


Foreign Exchange Rate Risks

We record our transactions and prepare our financial statements in U.S. Dollars. Since our strategy involves the development of products for the U.S. market, a significant part of our clinical trial expenditures are denominated in U.S. Dollars and we anticipate that the majority of our future revenues will be denominated in U.S. Dollars. However, a significant portion of our costs are denominated in pounds sterling, euro and shekel as a result of our conducting activities in the United Kingdom, the European Union and Israel. As a consequence, the results reported in our financial statements are potentially subject to the impact of currency fluctuations between the U.S. Dollar, pounds sterling, euro and shekel. We are focused on development activities and do not anticipate generating on-going revenues in the short-term. Accordingly, we do not engage in significant currency hedging activities in order to restrict the risk of exchange rate fluctuations. However, if we should commence commercializing any products in the U.S., changes in the relation of the U.S. Dollar to the pound sterling, the euro and/or the shekel may affect our revenues and operating margins. In general, we could incur losses if the U.S. Dollar should become devalued relative to the pound sterling, the euro and/or the shekel. We manage foreign exchange risk by holding our cash in the currencies in which we expect to incur future cash outflows.

Interest Rate Risk

At December 31, 2007, we had fixed rate convertible Debentures outstanding and are therefore not subject to interest rate risk. Accordingly, we do not hedge any of our interest rate risks.

Item 12  Description of Securities Other than Equity Securities

Not applicable.

PART II

Item 13  Defaults, Dividend Arrearages and Delinquencies

None.

Item 14  Material Modifications to the Rights of Security Holders and Use of Proceeds

None.

Item 15  Controls and Procedures

A.  Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, we have evaluated the effectiveness of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b) as of the end of the period covered by this report. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that these disclosure controls and procedures are effective. There were no changes in our internal control over financial reporting during the year ended December 31, 2007 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

B.  Management’s Annual Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting for the company. Internal control over financial reporting is a process to provide reasonable assurance regarding the reliability of our financial reporting for external purposes in accordance with IFRS. Internal control over financial reporting includes maintaining records that in reasonable detail accurately and fairly reflect our transactions; providing reasonable assurance that transactions are recorded as necessary for preparation of our financial statements; providing reasonable assurance that receipts and expenditures of company assets are made in accordance with management authorization; and providing reasonable assurance that unauthorized acquisition, use or disposition of company assets that could have a material effect on our financial statements would be prevented or detected on a timely basis. Because of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement of our financial statements would be prevented or detected.

 
69

 
 

The audited consolidated financial statements of the Group include the results of an acquisition completed during the year ended December 31, 2007. As permitted by the SEC’s June 23, 2004 implementation guidance to issuers relating to the SEC’s final rules on internal control over financial reporting, management’s assessment does not include an assessment of the internal control over financial reporting of this acquisition. The total assets of this acquisition represent less than 1% of the related consolidated financial statements as of and for the year ended December 31, 2007. The acquisition was not individually significant to the Group’s financial position, results of operations or cash flows.
 
Management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, management concluded that the company’s internal control over financial reporting was effective as of December 31, 2007.

This annual report does not include an attestation report of the company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the company’s registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the company to provide only management’s report in this annual report.

Item 16  [Reserved]

Item 16A  Audit Committee Financial Expert

Our Board of Directors has determined that John Groom, a member of our audit committee, is the audit committee financial expert and an independent director as defined in the Nasdaq Marketplace Rules.
 
Item 16B  Code of Ethics

We have adopted a written Code of Ethics that applies to all employees and executive officers, including our Chief Executive Officer and Chief Financial Officer. A copy of our Code of Ethics has been filed as Exhibit 11.1 to our 2006 annual report on Form 20-F.

Item 16C  Principal Accountant Fees and Services

PricewaterhouseCoopers has served as our independent public auditor for each of the fiscal years ended December 31, 2006 and 2007.

The following table sets forth the aggregate fees billed by PricewaterhouseCoopers for professional services in each of the last two fiscal years:

 
2007
 
2006
 
($’000)
 
($’000)
Audit fees
516
 
357
Audit-related fees
153
 
150
Tax fees
43
 
18
All other fees
88
 
105
Total
800
 
630

Audit fees comprise the work undertaken in auditing the Group and issuing an audit opinion on our U.K., Irish and Israeli statutory accounts and work on the Group’s quarterly earnings. Audit related fees comprise work associated with SEC regulatory compliance and work on the Group’s conversion to International Financial Reporting Standards. Tax fees comprise work relating to tax filing compliance. Other fees comprise work relating to tax advisory services.

All services provided by our auditor and companies affiliated with our auditor must be pre-approved by the audit committee. The annual contract relating to the audit of the financial statements of the Group must be approved by the audit committee. Contracts for other non-audit services must also be approved by the audit committee.

Any requests for services to be provided by the auditor or an affiliate must be made through our Chief Financial Officer, who will discuss and seek approval from the audit committee. The Chief Financial Officer also notifies the audit committee of the services  provided, monitors the costs incurred and notifies the chairman of the audit committee if the costs are likely to materially exceed the estimated amount.

In accordance with Regulation S-X, Rule 2-01, paragraph (c)(7)(i) no fees for services were approved pursuant to any waivers of the pre-approval requirement.

 
70

 


Item 16D  Exemptions from the Listing Standards for Audit Committees

Not Applicable.

Item 16E  Purchases of Equity Securities by the Issuer and Affiliated Purchasers

No purchase of equity securities as registered by the Group pursuant to section 12 of the Exchange Act were made by or on behalf of the Group.
 
PART III

Item 17  Financial Statements

We are furnishing financial statements pursuant to the instructions of Item 18 of Form 20-F.

Item 18  Financial Statements

See our consolidated financial statements beginning at page F-1.
 
Item 19 Exhibits

 
Exhibits filed as part of this annual report:

 
1.1
Memorandum of Association of the Group(16)
1.2
Articles of Association of the Group(17)
2.1
Form of Deposit Agreement, dated as of March 29, 1993, among the Group,Citibank, N.A., as Depositary, and all holders from time to time of American Depositary Receipts issued thereunder(1)
2.2
Amendment No. 1 to Deposit Agreement, dated as of October 8, 1998, among the Group, Citibank, N.A., as Depositary, and all holders from time to time of the American Depositary Receipts issued thereunder(2)
2.3
Amendment No. 2 to Deposit Agreement, dated as of September 25,2002 among the Group, Citibank N.A., as depositary, and all holders from time to time of the American Depositary Receipts issued thereunder(3)
2.4
Form of Ordinary Share certificate(10)
2.5
Form of American Depositary Receipt evidencing ADSs (included in Exhibit 2.3)(3)
2.6
Registration Rights Agreement, dated as of October 21, 1998, by and among Ethical Holdings plc and Monksland Holdings B.V.(10)
2.7
Amendment No. 1 to Registration Rights Agreement and Waiver, dated January 27, 2003, by and among the Group, Elan International Services, Ltd. and Monksland Holdings B.V.(10)
2.8
Second Subscription Agreement, dated as of November 1999, among Ethical Holdings PLC, Monksland Holdings B.V. and Elan Corporation PLC(4)
2.9
Purchase Agreement, dated as of June 16, 2000, by and among the Group and the Purchasers named therein(4)
2.10
Registration Rights Agreement, dated as of November 24, 2000, by and between the Group and Laxdale Limited(5)
2.11
Form of Subscription Agreement, dated as of January 27, 2003 by and among the Group and the Purchasers named therein(10) (The Group entered into twenty separate Subscription Agreements on January 27, 2003 all substantially similar in form and content to this form of Subscription Agreement.).
2.12
Form of Registration Rights Agreement, dated as of January 27, 2003 between the Group and the Purchasers named therein (10) (The Group entered into twenty separate Registration Rights Agreements on January 27, 2003 all substantially similar in form and content to this form of Registration Rights Agreement.).
2.13
Securities Purchase Agreement dated as of December 16, 2005 by and among the Group and the purchasers named therein(16)
4.1
Amended and Restated Asset Purchase Agreement dated September 29, 1999 between Elan Pharmaceuticals Inc. and the Group(10)

 
71

 


4.2
Variation Agreement, undated, between Elan Pharmaceuticals Inc. and the Group(10)
4.3
License Agreement, dated November 24, 2000, between the Group and Laxdale Limited(6)
4.4
Option Agreement, dated as of June 18, 2001, between Elan Pharma International Limited and the Group(7)
4.5
Deed of Variation, dated January 27, 2003, between Elan Pharma International Limited and the Group(10)
4.6
Lease, dated August 6, 2001, between the Group and LB Strawberry LLC(7)
4.7
Amended and Restated Distribution Marketing and Option Agreement, dated September 28, 2001, between Elan Pharmaceuticals, Inc. and the Group(8)
4.8
Amended and Restated License and Supply Agreement, dated March 29, 2002, between Eli Lilly and Group and the Group(10)†
4.9
Deed of Variation, dated January 27, 2003, between Elan Pharmaceuticals Inc. and the Group(10)
4.10
Stock and Intellectual Property Right Purchase Agreement, dated November 30, 2001, by and among Abriway International S.A., Sergio Lucero, Francisco Stefano, Amarin Technologies S.A., Amarin Pharmaceuticals Company Limited and the Group(7)
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, 2002, 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 favour 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)

 
72

 


4.36
Amendment Agreement No. 1, dated August 4, 2003, to Amended and Restated Asset Purchase Agreement among Elan International Services, Ltd., Elan Pharmaceuticals, Inc. and theGroup(11)(12)
4.37
Warrant dated February 25, 2004 issued by the Group in favor of the Warrant Holders named therein(12)
4.38
Amendment Agreement dated December 23, 2003, between Elan Corporation plc, Elan Pharma International Limited, Elan Pharmaceuticals, Inc., Monksland Holdings BV and the Group(11)(12)
4.39
Bridging Loan Agreement dated December 23, 2003 between the Group and Elan Pharmaceuticals, Inc.(11)(12)
4.40
Agreement dated December 23, 2003 between the Group and Elan Pharma International Limited, amending the Amended and Restated Option Agreement dated August 4, 2003(11)(12)
4.41
Form of Subscription Agreement, dated as of October 7, 2004 by and among the Group and the Purchasers named therein(13) (The Group entered into 14 separate Subscription Agreements on October 7, 2004 all substantially similar in form and content to this form of Subscription Agreement.)
4.42
Form of Registration Rights Agreement, dated as of October 7, 2004 between the Group and the Purchasers named therein(13) (The Group entered into 14 separate Registration Rights Agreements on October 7, 2004 all substantially similar in form and content to this form of Registration Rights Agreement.)
4.43
Share Purchase Agreement dated October 8, 2004 between the Group,Vida Capital Partners Limited and theVendors named therein relating to the entire issued share capital of Laxdale Limited(13)
4.44
Escrow Agreement dated October 8, 2004 among the Group, Belsay Limited and Simcocks Trust Limited as escrow agent(13)
4.45
Loan Note Redemption Agreement dated October 14, 2004 between Amarin Investment Holding Limited and the Group(13)
4.46
Settlement agreement dated 27 September 2004 between the Group and Valeant Pharmaceuticals International(14)†
4.47
Exclusive License Agreement dated October 8, 2004 between Laxdale and Scarista Limited pursuant to which Scarista has the exclusive right to use certain of Laxdale’s intellectual property(14)†
4.48
Clinical Supply Agreement between Laxdale and Nisshin Flour Milling Co.,Limited dated 27th October 1999(14)†
4.49
Clinical Trial Agreement dated March 18, 2005 between Amarin Neuroscience Limited and the University of Rochester. Pursuant to this agreement the University is obliged to carry out or to facilitate the carrying out of a clinical trial research study set forth in a research protocol on AMR 101 in patients with Huntington’s disease(14)†
4.50
Loan Note Redemption Agreement dated May, 2005 between Amarin Investment Holding Limited and the Group.(14)
   4.51
Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited.(15)
   4.52
Employment Agreement with Alan Cooke, dated May 12, 2004 and amended September 1, 2005.(16)
   4.53
Clinical Supply Extension Agreement dated December 13, 2005 to Agreement between Amarin Pharmaceuticals Ireland Limited and Amarin Neuroscience Limited and Nisshin Flour Milling Co.†(17)
   4.54
Securities Purchase Agreement dated May 20, 2005 between the Company and the purchasers named therein. The Company entered into 34 separate Securities Purchase Agreements on May 18, 2005 and in total issued 13,677,110 ordinary shares to management, institutional and accredited investors. The purchase price was $1.30 per ordinary share.(17)
   4.55
Securities Purchase Agreement dated January 23, 2006 between the Company and the purchasers named therein. The Company entered into 2 separate Securities Purchase Agreements on January 23, 2006 and in total issued 840,000 ordinary shares to accredited investors. The purchase price was $2.50 per ordinary share.(17)

 
73

 


4.56
Assignment Agreement dated May 17, 2006 between Amarin Pharmaceuticals Ireland Limited and Dr Anthony Clarke, pursuant to which, Amarin Pharmaceuticals Ireland Limited acquired the global rights to a novel oral formulation of Apomorphine for the treatment of “off” episodes in patients with advanced Parkinson’s disease.(17)
      4.57 Amendment (Change Order Numer 2), dated June 8, 2006 to Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited.*
4.58
Lease Agreement dated July 4, 2006 between Amarin Neuroscience Limited and Magdalen Development Company Limited and Prudential Development Management Limited. Pursuant to this agreement, Amarin Neuroscience Limited took a lease of a premises at the South West Wing First Floor Office Suite, The Magdalen Centre North, The Oxford Science Park, Oxford, England.(17)
4.59
Securities Purchase Agreement dated October 18, 2006 between the Company and the purchasers named therein. The Company entered into 32 separate Securities Purchase Agreements on October 18, 2006 and in total issued 8,965,600 ordinary shares to institutional and accredited investors. The purchase price was $2.09 per ordinary share(17)
4.60
Master Services Agreement dated November 15, 2006 between Amarin Pharmaceuticals Ireland Limited and Icon Clinical Research (U.K.) Limited. Pursuant to this agreement, Icon Clinical Research (U.K.) Limited agreed to provide due diligence services to Amarin Pharmaceuticals Ireland Limited on ongoing licensing opportunities on an ongoing basis.(17)
4.61
Amendment dated December 8, 2006 to Clinical Trial Agreement dated March 18, 2005 between Amarin Neuroscience Limited and the University of Rochester.†(17)
     4.62 Agreement dated January 18, 2007 between Neurostat Pharmaceuticals Inc. ("Neurostat"), Amarin Pharmaceuticals Ireland Limited, Amarin Corporation plc and Mr. Tim Lynch whereby the Company agreed to pay Neurostat a finder's fee relating to a potential licensing transaction and similar payments comprising upfront and contingent milestones totaling $565,000 and warrants to purchase 175,000 ordinary shares with an exercise price of $1.79 per ordinary share.* 
4.63
Lease Agreement dated January 22, 2007 between the Company, Amarin Pharmaceuticals Ireland Limited and Mr. David Colgan, Mr. Philip Monaghan, Mr. Finian McDonnell and Mr. Patrick Ryan. Pursuant to this agreement, Amarin Pharmaceuticals Ireland Limited took a lease of a premises at The First Floor, Block 3, The Oval, Shelbourne Road, Dublin 4, Ireland.(17)
4.64
Amendment (Change Order Number 4), dated February 15, 2007 to Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited. (17)
4.65
Employment Agreement Amendment with Alan Cooke, dated February 21, 2007.(17)
4.66
Amendment (Change Order Number 3), dated March 1, 2007 to Services Agreement dated June 16, 2005 between Icon Clinical Research Limited and Amarin Neuroscience Limited.(17)
4.67
Development and License Agreement dated March 6, 2007 between Amarin Pharmaceuticals Ireland Limited and Elan Pharma International Limited.  Pursuant to this agreement, Amarin Pharmaceuticals Ireland Limited acquired global rights to a novel nasal lorazepam formulation for the treatment of emergency seizures in epilepsy patients.*
4.68
Consultancy Agreement dated March 9, 2007 between Amarin Corporation plc and Dalriada Limited. Under the Consultancy Agreement, Amarin Corporation plc will pay Dalriada Limited a fee of £240,000 per annum for the provision of the consultancy services. Dalriada Limited is owned by a family trust, the beneficiaries of which include our Chairman and Chief Executive Officer, Mr. Thomas Lynch, and members of his family.*
4.69
Form of Securities Purchase Agreement dated June 1, 2007 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 11 separate Securities Purchase Agreements on June 1, 2007 all substantially similar in form and content to this Securities Purchase Agreement pursuant to which we issued an aggregate of 6,156,406 ordinary shares to such Purchasers, including management. The purchase price was $0.60 per ordinary share.*
4.70
Equity Credit Agreement dated June 1, 2007 between Amarin Corporation plc and Brittany Capital Management.  Pursuant to this agreement, Amarin has an option to draw up to $15,000,000 of funding at any time over a three year period solely at Amarin Corporation plc’s discretion.(18)
4.71
Form of Equity Securities Purchase Agreement dated December 4, 2007 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 19 separate Equity Securities Purchase Agreements on December 4, 2007 all substantially similar in form and content to this Equity Securities Purchase Agreement pursuant to which we issued an aggregate of 16,290,900 ordinary shares to such Purchasers, including management. The purchase price was $0.33 per ordinary share.(19)
 

 
74

 


4.72
Form of Debt Securities Purchase Agreement dated December 4, 2007 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 2 separate Debt Securities Purchase Agreements on December 4, 2007 both substantially similar in form and content to this Debt Securities Purchase Agreement pursuant to which we issued an aggregate of $2,750,000 of 3 year convertible loan notes to such Purchasers including management. The conversion price to convert the loan notes into ordinary shares of Amarin Corporation plc is $0.48 per ordinary share.(19)
4.73
Stock Purchase Agreement dated December 5, 2007 between Amarin Corporation plc, the selling shareholders of Ester Neurosciences Limited (“Ester”), Ester, and Medica II Management L.P. pursuant to which Amarin Corporation plc acquired the entire issued share capital of Ester.  Pursuant to this agreement, Amarin Corporation plc paid initial consideration of $15,000,000, of which $5,000,000 was paid in cash and $10,000,000 was paid through the issuance of shares of Amarin Corporation plc.  Additional contingent payments, valued at an aggregate of $17,000,000 are payable in the event that certain development-based milestones are successfully completed.(21)
4.74
Letter Agreement dated December 6, 2007 between Amarin Corporation plc and the Seller’s Representatives of the selling shareholders of Ester pursuant to which the definition of “Closing Date Average Buyer Stock Price” in the Stock Purchase Agreement dated December 5, 2007 described above was amended.(22)
4.75
Senior Indenture dated December 6, 2007 between Amarin Corporation plc and Wilmington Trust Company.  Under this Indenture, Amarin Corporation plc may issue one or more series of senior debt securities from time to time.(19)
4.76
First Supplemental Senior Indenture dated December 6, 2007 between Amarin Corporation plc and Wilmington Trust Company.  Under this Supplemental Indenture, together with the senior debt indenture dated December 6, 2007 described above, Amarin Corporation plc issued its 8% Convertible Debentures due 2010.(19)
4.77
Compromise Agreement dated December 19, 2007 between Amarin Corporation plc and Richard Stewart.(20)
4.78
Collaboration Agreement dated January 8, 2008 between Amarin Pharmaceuticals Ireland Limited and ProSeed Capital Holdings (“ProSeed”). Pursuant to this agreement, 975,000 ordinary shares in Amarin Corporation plc were issued in the form of ADSs to ProSeed in respect of fees due for investment banking advice provided to Amarin Corporation plc and Amarin Pharmaceuticals Ireland Limited on the acquisition of Ester.*
4.79
Amendment No. 1 to Stock Purchase Agreement dated April 7, 2008 between Amarin Corporation plc and Medica II Management L.P. pursuant to which the definition of “Milestone II Time Limit Date” in the Stock Purchase Agreement dated December 5, 2007 described above was amended.*
4.80
Employment Agreement dated April 28, 2008 with Dr Declan Doogan.*
4.81
Form of Equity Securities Purchase Agreement dated May 13, 2008 between Amarin Corporation plc and the Purchasers named therein. Amarin Corporation plc entered into 9 separate Equity Securities Purchase Agreements on May 13, 2008 all substantially similar in form and content to this Securities Purchase Agreement pursuant to which we issued an aggregate of 12,173,914 Ordinary Shares and 8 Preference Shares to such Purchasers. The purchase price was $2.30 per Ordinary Share.*
8.1
Subsidiaries of the Group*
11.1
Code of Ethics(17)
12.1
Certification of Thomas G. Lynch required by Rl 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
12.2
Certification of Alan Cooke required by Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
13.1
Certification of Thomas G. Lynch required by Section 1350 of Chapter 63 of Title 18 of the United States Code, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
13.2
Certification of Alan Cooke required by Section 1350 of Chapter 63 of Title 18 of the United States Code, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
14.1
Consent of PricewaterhouseCoopers *

 

Filed herewith
   
Confidential treatment requested (the confidential portions of such exhibits have been omitted and filed separately with the Securities and Exchange Commission)
   
(1)
Incorporated herein by reference to certain exhibits to the Group’s Registration Statement on Form F-1, File No. 33-58160, filed with the Securities and Exchange Commission on February 11, 1993.
   
(2)
Incorporated herein by reference to Exhibit (a)(i) to the Group’s Registration Statement on Post-Effective Amendment No. 1 to Form F-6, File No. 333-5946, filed with the Securities and Exchange Commission on October 8, 1998.

 
75

 


   
(3)
Incorporated herein by reference to Exhibit (a)(ii) to the Group’s Registration Statement on Post-Effective Amendment No. 2 to Form F-6, File No. 333-5946, filed with the Securities and Exchange Commission on September 26, 2002.
   
(4)
Incorporated herein by reference to certain exhibits to the Group’s Annual Report on Form 20-F for the year ended December 31, 1999, filed with the Securities and Exchange Commission on June 30, 2000.
   
(5)
Incorporated herein by reference to certain exhibits to the Group’s Registration Statement on Form F-3, File No. 333-13200, filed with the Securities and Exchange Commission on February 22, 2001.
   
(6)
Incorporated herein by reference to certain exhibits to the Group’s Annual Report on Form 20-F for the year ended December 31, 2000, filed with the Securities and Exchange Commission on July 2, 2001.
   
(7)
Incorporated herein by reference to certain exhibits to the Group’s Annual Report on Form 20-F for the year ended December 31, 2001, filed with the Securities and Exchange Commission on May 9, 2002.
   
(8)
Incorporated herein by reference to certain exhibits to the Group’s Registration Statement on Pre-Effective Amendment No. 2 to Form F-3, File No. 333-13200, filed with the Securities and Exchange Commission on November 19, 2001.
   
(9)
Incorporated herein by reference to certain exhibits to the Group’s Registration Statement on Form S-8, File No. 333-101775, filed with the Securities and Exchange Commission on December 11, 2002.
   
(10)
Incorporated herein by reference to certain exhibits to the Group’s Annual Report on Form 20-F for the year ended December 31, 2002, filed with the Securities and Exchange Commission on April 24, 2003.
   
(11)
These agreements are no longer in effect as a result of superseding agreements entered into by the Group.
   
(12)
Incorporated herein by reference to certain exhibits to the Group’s Annual Report on Form 20-F for the year ended December 31, 2003, filed with the Securities and Exchange Commission on March 31, 2004.
   
(13)
Incorporated herein by reference to certain exhibits to the Group’s Registration Statement on Form F-3, File No. 333-121431, filed with the Securities and Exchange Commission on December 20, 2004.
   
(14)
Incorporated herein by reference to certain exhibits to the Group’s Annual Report on Form 20-F for the year ended December 31, 2004, filed with the Securities and Exchange Commission on April 1, 2005.
   
(15)
Incorporated herein by reference to certain exhibits to the Group’s Registration Statement on Form F-3, File No. 333- 131479 , filed with the Securities and Exchange Commission on February 2, 2006.
   
(16)
Incorporated by reference herein to certain exhibits in the Group’s Annual Report on Form 20-F for the year ended December 31, 2005, filed with the Securities and Exchange Commission on March 30, 2006 as amended on Form 20-F/A filed October 13, 2006.
   
 (17) Incorporated by reference herein to certain exhibits in the Group's Annual Report on Form 20-F for the year ended December 31, 2006, filed with the Securities and Exchange Commission on March 5, 2007.
   
 (18) Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on June 1, 2007.
   
 (19) Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on December 17, 2007.
   
 (20) Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on December 19, 2007.
   
 (21) Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on January 28, 2008.
   
 (22) Incorporated by reference herein to certain exhibits in the Group's Report of Foreign Private Issuer filed on Form 6-K with the Securities and Exchange Commission on February 1, 2008.

 
76

 


SIGNATURES

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.

AMARIN CORPORATION PLC

 
By: /s/  THOMAS G. LYNCH

__________

Thomas G. Lynch

Chairman and Chief Executive Officer

        Date: May 19, 2008
 
 
 
 
 
 
 
 
 
 

 
 
 
77

 

 

 
Report of Independent Registered Public Accounting Firm
 

To the Board of Directors and Shareholders of Amarin Corporation plc:

In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of income, shareholders’ equity, and cash flows present fairly, in all material respects, the financial position of Amarin Corporation plc and its subsidiaries   at December 31, 2007 and 2006, and the results of their operations and their cash flows for each of the two years in the period ended December 31, 2007   in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board and in conformity with International Financial Reporting Standards as adopted by the European Union.  These financial statements are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these financial statements based on our audits.  We conducted our audits of these statements in accordance with the standards of the Public Company Accounting Oversight Board (United States) and International Standards on Auditing (UK and Ireland).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation.  We believe that our audits provide a reasonable basis for our opinion.



PricewaterhouseCoopers
Dublin, Ireland
May 19, 2008


 
F-1

 



Amarin Corporation plc

Consolidated Income Statement for year ended December 31, 2007

         
Total
   
Total
 
                   
   
Note
   
2007
   
2006
 
           
$’000
     
$’000
 
Revenue                                                                                         
    4             500  
                         
Gross profit                                                                                         
                  500  
Research and development expenses                                                                                         
    6       (12,108 )     (15,106 )
Selling, general and administrative expenses                                                                                         
    6       (19,841 )     (13,462 )
Impairment of intangible assets                                                                                         
    5, 6       (8,784 )      
Total operating expenses                                                                                         
            (40,733 )     (28,568 )
Operating loss                                                                                         
            (40,733 )     (28,068 )
                         
Finance income                                                                                         
    9       1,882       3,344  
Finance costs                                                                                         
    10       (183 )     (2,826 )
                         
Loss before taxation                                                                                          
            (39,034 )     (27,550 )
Tax credit                                                                                         
    12       837       799  
                         
Loss attributable to equity holders of the parent                                                                                         
            (38,197 )     (26,751 )
                         
           
U.S. Cents
   
U.S. Cents
 
Basic loss per ordinary share*                                                                                          
    14       (3.90 )     (3.25 )
Diluted loss per ordinary share*                                                                                          
    14       (3.90 )     (3.25 )

The accompanying notes on pages F-7 to F-60 are an integral part of the financial statements.

* Basic and diluted loss per share information is adjusted for our one-for-ten share consolidation which is effective January 18, 2008. See note 14 for further information.
 
F-2


Amarin Corporation plc

Balance Sheets at December 31, 2007

         
Group
   
Company
 
   
Note
   
2007
   
2006
   
2007
   
2006
 
           
$’000
     
$’000
     
$’000
     
$’000
 
Non-current assets
Property, plant and equipment 
   
16
      595       314       19       25  
Intangible assets 
   
15
      19,916       9,636       19,916       3,765  
Investments in subsidiaries 
   
17
                  60,136       22,715  
Available for sale investments 
   
20
      15       18       15       18  
Total non-current assets 
            20,526       9,968       80,086       26,523  
                                         
Current assets
Inventory
   
18
                         
Current tax recoverable
    19       1,704       1,617              
Other current assets
    19       1,721       1,172       1,059       770  
Cash and cash equivalents
            18,303       36,802       17,298       34,719  
Total current assets
            21,728       39,591       18,357       35,489  
                                         
Total assets                                                                                             
            42,254       49,559       98,443       62,012  
                                         
Non-current liabilities
Borrowings                                                                                             
    21       2,051             2,051        
Provisions                                                                                             
    24       606       110       606       110  
Other liabilities                                                                                             
    23       36                    
Total non-current liabilities
            2,693       110       2,657       110  
                                         
Current liabilities
                                       
Trade payables                                                                                             
            3,462       2,096       841       396  
Accrued expenses and other liabilities
    22       6,733       8,625       3,430       1,814  
Provisions                                                                                             
    24       5,217       160       5,217       160  
Total current liabilities                                                                                             
            15,412       10,881       9,488       2,370  
                                         
Total liabilities                                                                                             
            18,105       10,991       12,145       2,480  
                                         
Equity
Capital and reserves attributable to equity holders of the Company
Share capital                                                                                             
   
26
        12,942         7,990         12,942         7,990  
Share premium                                                                                             
            147,171       139,313       147,171       136,587  
Share based payment reserve
    28       10,175       4,824       10,175       4,824  
Warrant reserve                                                                                             
            13,328       10,009       13,328       10,009  
Equity component of 8% convertible debt
            145             145        
Capital redemption reserve                                                                                             
            27,633       27,633       27,633       27,633  
Treasury shares                                                                                             
            (217 )     (217 )            
Foreign currency translation reserve
            (1,836 )     (1,261 )     832       683  
Retained earnings                                                                                             
            (185,192 )     (149,723 )     (125,928 )     (128,194 )
Total shareholders’ equity                                                                                             
            24,149       38,568       86,298       59,532  
                                         
Total shareholders’ equity and liabilities
            42,254       49,559       98,443       62,012  

The accompanying notes on pages F-7 to F-60 are an integral part of the financial statements.


 
F-3

 




Amarin Corporation plc

Consolidated Statement of Changes in Equity for the year ended December 31, 2007

   
 
 
Share capital
   
 
 
Share premium
   
Share based payment reserve
   
 
 
Warrant reserve
   
Equity component of 8% convertible debt
   
 
Capital redemption reserve
   
 
 
Treasury shares
   
Foreign currency translation reserve
   
 
 
Retained earnings
   
 
 
 
Total
 
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
 
                                                             
At January 1, 2006
    6,778       113,239       2,623       9,620             27,633       (217 )     697       (122,972 )     37,401  
Share issuances
    1,212       25,212                                                 26,424  
Share issuance costs
          (2,450 )                                               (2,450 )
Share based compensation
                2,201                                           2,201  
Fair value of future investment right
          3,701                                                 3,701  
Warrant issue/exercise
          (389 )           389                                      
Recognized income and expense:
                                                                               
Foreign currency translation adjustment
                                              (1,958 )           (1,958 )
Net loss recognized directly in equity
                                              (1,958 )           (1,958 )
Loss for the year
                                                    (26,751 )     (26,751 )
Total recognized income and expense
                                              (1,958 )     (26,751 )     (28,709 )
At December 31, 2006 and
January 1, 2007
    7,990       139,313       4,824       10,009             27,633       (217 )     (1,261 )     (149,723 )     38,568  
Share issuances
    4,952       14,032                                                 18,984  
Share issuance costs
          (948 )                                               (948 )
Share based compensation
                5,351                                           5,351  
Warrant issue/exercise
          (2,498 )           3,319                                     821  
Strike off of subsidiary
          (2,728 )                                         2,728        
Fair value of equity on 8%
convertible debt
                            145                               145  
Recognized income and expense:
                                                                               
Foreign currency translation
adjustment
                                              (575 )           (575 )
Net loss recognized directly in equity
                                              (575 )           (575 )
Loss for the year
                                                    (38,197 )     (38,197 )
Total recognized income and expense
                                                            (575 )     (38,197 )     (38,772 )
At December 31, 2007
    12,942       147,171       10,175       13,328       145       27,633       (217 )     (1,836 )     (185,192 )     24,149  


The accompanying notes on pages F-7 to F-60 are an integral part of the financial statements.

 
F-4

 

Amarin Corporation plc

Company Statement of Changes in Equity for the year ended December 31, 2007

 
 
 
 
Share capital
 
 
 
 
Share
premium
 
 
Share based payment
reserve
 
 
 
 
Warrant
reserve
 
Equity
component of
8%
convertible
debt
 
 
 
Capital redemption reserve
 
 
Foreign
currency translation reserve
   
 
 
 
Retained
earnings
   
 
 
 
 
Total
 
 
US$’000
 
US$’000
 
US$’000
 
US$’000
 
US$’000
 
US$’000
 
US$’000
   
US$’000
   
US$’000
 
                                         
At January 1, 2006
  6,778     110,513     2,623     9,620         27,633     (235 )     (120,842 )     36,090  
Share issuances
  1,212     25,212                                 26,424  
Share issuance costs
      (2,450)                                 (2,450 )
Share based ompensation
          2,201                             2,201  
Fair value of future investment right
      3,701                                 3,701  
Warrant issue/exercise
      (389)         389                          
Recognized income and expense:
                                                         
Foreign currency translation adjustment
                          918             918  
Net loss recognized directly in equity
                          918             918  
Loss for the year
                                (7,352 )     (7,352 )
Total recognized income and expense
                          918       (7,352 )     (6,434 )
At December 31, 2006 and
January 1, 2007
  7,990     136,587     4,824     10,009         27,633     683       (128,194 )     59,532  
Share issuances
  4,952     14,032                                 18,984  
Share issuance costs
      (950)                                 (950 )
Share based compensation
          5,351                             5,351  
Warrant issue/exercise
      (2,498)         3,319                         821  
Adjustment on asset acquisition
                                (371 )     (371 )
Fair value of equity on 8%
convertible debt
                  145                     145  
Recognized income and expense:
                                                         
Foreign currency translation djustment
                          149             149  
Net loss recognized directly in equity
                          149             149  
Profit for the year
                                2,637       2,637  
Total recognized income and expense
                          149       2,637       2,786  
At December 31, 2007
  12,942     147,171     10,175     13,328     145     27,633     832       (125,928 )     86,298  



The accompanying notes on pages F-7 to F-60 are an integral part of the financial statements.



 
 
F-5

 


Amarin Corporation plc
Cash Flow Statements for the year ended December 31, 2007

         
Group
   
Company
 
   
Note
   
2007
   
2006
   
2007
   
2006
 
            $’000       $’000       $’000       $’000  
Cash flows from operating activities
                                     
(Loss)/Profit after tax
          (38,197 )     (26,751 )     2,637       (7,352 )
Adjustments:
Depreciation of property, plant and equipment
   
16
      217       121       20       31  
Amortization of intangible assets
   
15
      169       674       58       232  
Impairment of investment in subsidiary
   
17
                  4,593        
Impairment of intangible assets
   
15
      8,784             3,707        
Impairment of property, plant and equipment
                  235             151  
Impairment of available for sale investment
   
20
      3             3        
Share based compensation
   
28, 17
      5,001       2,201       (640 )     2,201  
Share based compensation - warrants
   
28
      275             275        
Effect of exchange rate changes on assets/liabilities and other items*
            (560 )     (2,020 )     (858 )     1,867  
Interest received
   
9
      (1,252 )     (1,344 )     (1,197 )     (1,299 )
Interest expense
   
10
      176             176        
Interest paid on finance leases
            4       (2 )            
(Increase)/decrease in other current assets
            (250 )     282       10       (75 )
(Decrease)/increase in current liabilities
            (1,359 )     2,690       1,238       (2,408 )
(Decrease) in other liabilities
                  (49 )            
Gain on strike off of subsidiaries
   
17
                  (14,085 )      
Increase/(decrease) in provisions
            797       104       797       (35 )
R&D tax credit
   
12
      (837 )     (799 )            
Cash expended on operating activities
            (27,029 )     (24,658 )     (3,266 )     (6,687 )
Tax refund
            750       505              
Net cash outflow from operating activities
            (26,279 )     (24,153 )     (3,266 )     (6,687 )
                                         
Cash flows from investing activities
Purchase intangible assets
            (5,810 )           (5,810 )      
Interest received
   
9
      1,252       1,344       1,197       1,299  
Investment in subsidiaries
   
17
                  (22,288 )     (19,524 )
Purchases of property, plant and equipment
            (415 )     (245 )     (14 )     (13 )
Net cash (outflow)/inflow from investing activities
            (4,973 )     1,099       (26,915 )     (18,238 )
                                         
Cash flows from financing activities
Proceeds from issue of share capital
   
26
      9,685       26,424       9,685       26,424  
Proceeds on the issue of convertible debentures
   
21
      2,750             2,750        
Expenses on issue of share capital
            (285 )     (2,450 )     (285 )     (2,450 )
Expenses on issue of convertible debentures
            (20 )           (20 )      
Repayment of finance lease
            (7 )     (25 )            
Net cash inflow from financing activities
            12,123       23,949       12,130       23,974  
                                         
Net (decrease)/increase in cash and cash equivalents
            (19,129 )     895       (18,051 )     (951 )
Cash and cash equivalents at the beginning of the year
            36,802       33,907       34,719       33,691  
Exchange rate gains on cash and cash equivalents
            630       2,000       630       1,979  
                                         
Cash and cash equivalents at end of year
            18,303       36,802       17,298       34,719  

*
Included in the 2006 comparative figure is an amount of $2,818,000 reflecting the loss arising from the movement in the fair value between January 1, 2006 and the date of settlement, March 15, 2006 of the Future Investment Right negotiated as part of the May 2005 financing.

 
The accompanying notes on pages F-7 to F-60 are an integral part of the financial statements.
 

 
F-6

 



Amarin Corporation plc
Notes to the financial statements
for the year ended December 31, 2007

1.  Going concern and basis of preparation

Going concern and liquidity
 
At December 31, 2007, Amarin had a cash balance of $18.3 million.   On May 14, 2008, we announced a private placement of Ordinary Shares for up to $60.0 million. The first tranche from new investors of $28.0 million closed on May 19, 2008 , see note 33 “Post balance sheet events”. Based upon current business activities, the directors forecast Amarin having sufficient cash to fund operations for at least the next 12 months from May 19, 2008. The directors therefore believe that it is appropriate that these financial statements are prepared on a going concern basis. This basis of preparation assumes that the Group will continue in operational existence for the foreseeable future.
 
Basis of preparation

These Consolidated Financial Statements have been prepared in accordance with International Financial Reporting Standards as adopted by the European Union (“E.U.”) and International Financial Reporting Standards issued by the International Accounting Standards Board (“IASB”). All International Financial Reporting Standards issued by the IASB and effective at the time of preparing these consolidated financial statements have been adopted by the E.U. through the endorsement procedure established by the European Commission, with the exception of the International Accounting Standard IAS 39 "Financial Instruments: Recognition and Measurement" related to the hedging portfolio.   Since the company is not materially affected by the provisions regarding portfolio hedging that are not required by the E.U.-endorsed version of IAS 39, the accompanying financial statements comply with both International Financial Reporting Standards as adopted by the European Union and International Financial Reporting Standards issued by the IASB.

These are our first Consolidated Financial Statements prepared in accordance with IFRS, and comparative information, which was previously presented in accordance with United Kingdom (“U.K.”) generally accepted accounting principles (“U.K. GAAP”) for the year ended December 31, 2006 has been restated under IFRS as adopted by the E.U. and as issued by the IASB. As these are our first Consolidated Financial Statements prepared in accordance with IFRS as adopted by the E.U. and issued by the IASB we have availed of the option to disclose two years of financial information. Previously three years financial information was disclosed.

In December 2007 the Securities and Exchange Commission (“SEC”) adopted rules to allow foreign private issuers to file financial statements prepared in accordance with IFRS as issued by the IASB without reconciliation to United States generally accepted accounting principles (“U.S. GAAP”), effective March 4, 2008. Therefore, we have not prepared reconciliations from IFRS to U.S. GAAP.

An explanation of the effect of the transition to IFRS is provided in Note 35 to the Consolidated Financial Statements.

The Consolidated and Parent Company Financial Statements are presented in U.S. Dollars rounded to the nearest thousand, being the functional and presentation currency of the Parent Company. They are prepared on the historical cost basis of accounting as modified by the revaluation of available-for-sale financial assets and financial liabilities (including the future investment right) at fair value through profit or loss.

The preparation of financial statements in conformity with IFRS as adopted by the E.U. and as issued by the IASB requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Group’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the Consolidated Financial Statements are disclosed in note 2.

Statement of compliance

The Consolidated and Parent Company Financial Statements have been prepared in accordance with IFRS as adopted by the E.U. and as issued by the IASB that are effective at December 31, 2007. These are our first Consolidated Financial Statements prepared in accordance with IFRS, and therefore, IFRS 1, “First-time Adoption of International Financial Reporting Standards,” (“IFRS 1”), has been applied. For additional information on the transition to IFRS, please refer to Note 35 to the Consolidated Financial Statements.

 
F-7

 


Adoption of new and revised standards

Standards, amendments and interpretations effective in 2007

In the current year, the Group has adopted IFRS 7 “Financial Instruments: Disclosures” (“IFRS 7”) which is effective for annual reporting periods beginning on or after January 1, 2007, and the complementary amendments to IAS 1 “Presentation of Financial Statements” (“IAS 1”). The impact of the adoption of IFRS 7 and the changes to IAS 1 has been to expand the disclosures provided in these financial statements regarding the Group’s financial instruments and management of capital (see note 25).

Four interpretations issued by the IFRIC are effective for the current period. These are: IFRIC 7, “Applying the Restatement Approach under IAS 29, Financial Reporting in Hyperinflationary Economies”; IFRIC 8 “Scope of IFRS 2”, IFRIC 9 “Reassessment of Embedded Derivatives” and IFRIC 10 “Interim financial reporting and impairment”. The adoption of these interpretations has not led to any changes in the Group’s accounting policies.
 
Standards and interpretations in issue not yet adopted

At the date of authorization of these financial statements, other than the Interpretation adopted by the Group in advance of the effective date the following new standards and amendments relevant to the Group were in issue but not yet effective:

 
·  
IFRS 2 “Vesting conditions and cancellations - Amendment to IFRS 2 Share-based Payment”, (effective for accounting periods beginning on or after January 1, 2009).   The amendment addresses two matters.  It clarifies that vesting conditions are service conditions and performance conditions only.  Other features of a share-based payment are not vesting conditions.  It also specifies that all cancellations, whether by the entity or by other parties, should receive the same accounting treatment.  The Group will apply this revised standard from the effective date and is currently assessing the impact on the Group’s financial statements;
·  
IAS 23, (Amendment), “Borrowing Costs” (effective for accounting periods beginning on or after January 1, 2009). The amendment to the standard requires an entity to capitalize borrowing costs directly attributable to the acquisition, construction or production of a qualifying asset (one that takes a substantial period of time to get ready for use or sale) as part of the cost of that asset. The option of immediately expensing those borrowing costs will be removed. The Group will apply IAS 23 (Amended) from January 1, 2009 but is currently not applicable to the Group as there are no qualifying assets;
·  
IAS 32 and IAS 1 (Amendment) “Puttable financial instruments and obligations arising on liquidation”, (effective for annual periods beginning on or after 1 January 2009). The amendments require some puttable financial instruments and some financial instruments that impose on the entity an obligation to deliver to another party a pro rata share of net assets of the entity only on liquidation to be classified as equity;
·  
IFRS 8, “Operating Segments” (effective for accounting periods beginning on or after January 1, 2009). This standard will replace IAS 14 “Segment Reporting”, and will require additional disclosures relating to operating segments than those currently required;
·  
IFRS 3 (Revised), “Business combinations”, (effective for accounting periods beginning on or after 1 July 2009).  The standard continues to apply the acquisition method to business combinations, with some significant changes.  These changes include a requirement that all payments to purchase a business are to be recorded at fair value at the acquisition date, with some contingent payments subsequently re-measured through income.  Goodwill may be calculated based on the parent’s share of net assets or it may include goodwill related to minority interest.  All transactions costs will be expensed;
·  
 IAS 27 (Revised), ‘Consolidated and separate financial statements’, (effective for annual periods beginning on or after 1 July 2009).  IAS 27 (revised) requires the effect of all transactions with non-controlling interests to be recorded in equity if there is no change in control.  They will no longer result in goodwill or gains and losses.  The standard also specifies the accounting when control is lost.  Any remaining interest in the entity is re-measured to fair value and a gain or loss is recognized in profit or loss.

 
 
F-8

 

The Group is currently assessing the impact of the adoption of these new standards and amendments and currently believe they will have no material impact on the Consolidated Financial Statements of the Group in the period of initial application.
 
Interpretations not yet effective
 
IFRIC 11, “IFRS 2: Group and Treasury Share Transactions”, provides guidance on whether share-based transactions involving treasury shares or involving group entities should be accounted for as equity-settled or cash-settled share-based payment transactions in the stand-alone accounts of the parent and group companies.

2.  Summary of significant accounting policies

The financial statements have been prepared in accordance with U.K. Companies Acts and applicable international financial reporting standards. The significant accounting policies adopted by Amarin Corporation plc (“the Group”), are as follows:

Basis of consolidation

The Consolidated Financial Statements include the parent and all its subsidiary undertakings. Subsidiaries are entities controlled by the Company. Control exists when the Company has the power, directly or indirectly, to govern the financial and operating policies of an entity so as to obtain benefits from the entity’s activities. Control generally accompanies a shareholding of more than one half of the voting rights. The financial statements of subsidiary companies are included in the Consolidated Financial Statements from the date of acquisition.

All inter-company account balances, transactions, and any unrealized gains and losses or income and expenses arising from inter- company transactions have been eliminated in preparing the Consolidated Financial Statements. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group.

The purchase method of accounting is used in accounting for the acquisition of subsidiaries by the Group. The cost of an acquisition is measured as the fair value of the assets given, equity instruments issued and liabilities incurred at the date of exchange, plus costs directly attributable to the acquisition. On the acquisition of a business, fair values are attributed to the identifiable assets, liabilities and contingent liabilities acquired.  Goodwill arises when the fair value of the consideration given for a business exceeds the fair value of such assets, liabilities and contingent liabilities acquired.  Goodwill arising on acquisitions is capitalized and subject to an impairment review, both annually and when there is an indication that the carrying value may not be recoverable.

Contingent consideration is recognized as an additional cost of an acquisition when it can be measured reliably and it is probable that an outflow of economic benefit will be required. The fair value of the contingent component is determined through discounting the amounts payable to their present value using the binomial model.

Intangible assets and research and development expenditure

In-process research and development

Acquired in-process research and development (“IPR&D”) is stated at cost less accumulated amortization and impairments. Acquired IPR&D arising on acquisitions is capitalized and amortized on a straight-line basis over its estimated useful economic life. The useful economic life commences upon generation of economic benefits relating to the acquired IPR&D.

Capitalization policy

Costs incurred on development projects (relating to the design and testing of new or improved products) are recognized as intangible assets when the following criteria are fulfilled: completing the asset so it will be available for use or sale is technically feasible; management intends to complete the intangible asset and use or sell it; an ability to use or sell the intangible asset; it can be demonstrated how the intangible asset will generate probable future economic benefits; adequate technical; financial and other resources to complete the development and to use or sell the intangible asset are available; and the expenditure attributable to the intangible asset during its development can be reliably measured. To date, development expenditures have not met the criteria for recognition of an internally generated intangible asset.

 
F-9

 


Intangible assets not yet available for use are not subject to amortization but are tested for impairment at least annually. An impairment loss is recognized if the carrying amount of an asset exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. Value in use is calculated by discounting the expected future cash flows obtainable as a result of the asset’s continued use

Research and development expenditure

On an ongoing basis the Group undertakes research and development, including clinical trials to establish and provide evidence of product efficacy. Clinical trial costs are expensed to the income statement on a systematic basis over the estimated life of trials to ensure the costs charged reflect the research and development activity performed. To date, all research and development costs have been written off as incurred and are included within operating expenses, as disclosed in Note 6. Research and development costs include staff costs, professional and contractor fees, inventory, and external services.

Foreign currency

Functional and presentation currencies

Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The Consolidated Financial Statements are presented in U.S. Dollars, which is the Company’s functional and presentation currency.

Transactions and balances

Transactions in foreign currencies are recorded at the exchange rate prevailing at the date of the transaction.  The resulting monetary assets and liabilities are translated into the appropriate functional currency at exchange rates prevailing at the balance sheet date and the resulting gains and losses are recognized in the income statement. Foreign exchange gains and losses resulting from the settlement of such transactions are recognized in the income statement.

Group companies

The results and financial position of all the Group entities (none of which has the currency of a hyper-inflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:

(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.

Monetary items that are receivable or payable to a foreign operation are treated as a net investment in the foreign operation by the Company as settlement is neither planned nor likely to occur in the foreseeable future. On consolidation, exchange differences arising from the translation of the net investment in foreign operations, and of borrowings and other currency instruments designated as hedges of such investments, are taken to shareholders’ equity. When a foreign operation is partially disposed or sold, exchange differences that were recorded in equity are recognized in the income statement as part of the gain or loss on sale.

Goodwill and fair value adjustments arising on the acquisition of a foreign entity are treated as assets and liabilities of the foreign entity and translated at the closing rate.

Revenue

Revenue from the sale of goods is measured at the fair value of the consideration received or receivable, net of returns and allowances, trade discounts and volume rebates.  Revenue is recognized when the significant risks and rewards of ownership have been transferred to the buyer, recovery of the consideration is probable, the associated costs and possible return of goods can be estimated reliably, and there is no continuing management involvement with the goods.


 
F-10

 

Revenue from technology licensing to third parties is recognized when earned and non-refundable, through the achievement of specific milestones set forth in the applicable contract, when there is no future obligation with respect to the revenue and receipt of the consideration is probable, in accordance with the terms prescribed in the applicable contract.

Royalty income is recognized when earned, based on related sales of products under agreements providing for royalties.

Property, plant and equipment

Property, plant and equipment are stated at cost of acquisition less accumulated depreciation and impairment losses.  Cost includes expenditures that are directly attributable to the acquisition of the asset. Land is not depreciated. The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date.

Subsequent costs are included in the assets carrying amount or recognized as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the item can be measured reliably. The carrying amount of the replaced part is derecognized. All other repair and maintenance costs are charged to the income statement during the financial period in which they are incurred.

An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount.

Depreciation is calculated using the straight line method to write down the value of assets to their residual value over their estimated useful lives as follows:

Plant and equipment
5-10 years
Short leasehold                                                                                                                                                 
5-10 years
Fixtures and fittings                                                                                                                                                 
5 years
Computer equipment                                                                                                                                                 
3 years

Evaluation of assets for impairment

Intangible assets are subject to impairment testing at each balance sheet date.  All intangible assets are tested for impairment whenever events or changes in circumstances indicate that the carrying value may not be recoverable.

Goodwill, intangible assets with an indefinite life and intangible assets not yet available for use are not subject to amortization but are tested for impairment at least annually. Additionally, non-current assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. Value in use is calculated by discounting the expected future cash flows obtainable as a result of the asset’s continued use. For the purposes of impairment, assets are grouped into cash-generating units and an impairment charge is recognized whenever the carrying amount of an asset or its cash-generating unit exceeds its recoverable amount.

A cash-generating unit is the smallest identifiable asset group that generates cash flows that largely are independent from other assets and groups.  Impairment losses are recognized in the income statement.  Impairment losses recognized in respect of cash-generating units are allocated first to reduce the carrying amount of any goodwill allocated to the units and then to reduce the carrying amount of the other assets in the unit (group of units) on a pro-rata basis.

Impairment losses in respect of goodwill are not reversed. For other assets, an impairment loss may be reversed to the extent that the asset’s original carrying amount does not exceed the carrying amount that would have been determined, net of depreciation or amortization, if no impairment loss had been recognized. Non-financial assets other than goodwill that suffer an impairment are reviewed for possible reversal of the impairment at each reporting date.


 
F-11

 


Investments in subsidiary undertakings
 
Investments in subsidiary undertakings are shown at cost less any provision for impairment. Cost includes loans advanced to/received from subsidiary undertakings that are considered to form part of the net investment in the subsidiary undertakings.  Investments in subsidiaries also include the cost of recharges to subsidiary undertakings for share based payment expense incurred by Amarin Corporation plc.
 
Pre-launch costs

Prior to launch of a new pharmaceutical product, the Group may incur significant pre-launch marketing costs. Such costs are expensed as incurred.

Advertising costs

Advertising costs are expensed as incurred.

Inventories

Inventories are stated at the lower of cost and net realizable value.  Cost is calculated on a first-in, first-out basis and includes expenditure incurred in acquiring the inventories and bringing them to their existing location and condition (e.g. the purchase price, including import duties, transport and handling costs and any other directly attributable costs, less trade discount).  Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and selling expenses. Inventory held for research and development is written off when acquired unless capitalized as part an internally generated intangible asset in accordance with our capitalization policy.

Leases

Property, plant and equipment acquired under a lease that transfers substantially all of the risks and rewards of ownership to the Group (finance lease), are capitalized.  Upon initial recognition, a finance lease is capitalized at an amount equal to the lower of its fair value and the present value of the minimum lease payments at inception of the lease.  The discount rate to be used in calculating the present value of the minimum lease payments is the interest rate implicit in the lease. Subsequent to initial recognition the property, plant and equipment acquired under the finance lease is accounted for in accordance with the accounting policy applicable to the asset.

Each lease payment is allocated between the liability and finance charges so as to achieve a constant rate on the finance balance outstanding. Finance charges on finance leases are expensed over the term of the lease to give a constant periodic rate of interest charge in proportion to the capital balances outstanding.

All other leases which are not finance leases are considered operating leases.  Rental payments on operating leases are expensed on a straight-line basis over the term of the lease.

Financial assets

Available for sale financial assets are non-derivative assets that are either designated in this category or not classified in any other category. Equity securities are classified as available for sale. They are measured on initial recognition and subsequently at fair value within non-current assets. Fair value gains or losses are recognized directly in shareholders’ equity.  A significant or prolonged decline in the fair value of the investment below its cost is considered as an indicator that the investment is impaired. If any such evidence exists, the accumulated fair value adjustments recognized in equity are included in the income statement as gains or losses from investments.  Impairment losses recognized in the income statement on available for sale securities are not reversed through the income statement if there is a subsequent increase in value. Available for sale financial assets are classified in non-current assets as management does not intend to dispose of the assets during the next 12 months.

Current and deferred taxation

Current tax is the expected tax payable on the taxable income for the year using tax rates enacted or substantively enacted at the balance sheet date, and any adjustment to tax payable in respect of previous years.

 
F-12

 



Deferred tax is calculated using the liability method, based on temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the tax bases. However, the deferred tax is not accounted for as it arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit or loss. The amount of deferred tax provided is based on the expected manner of realisation or settlement of the carrying amount of assets and liabilities at rates expected to apply in the period when the temporary differences reverse based on the laws that have been enacted or substantively enacted by the reporting date.

A deferred tax asset is recognized only to the extent that it is probable that future taxable profits will be available against which the temporary differences can be utilized.

No deferred tax asset or liability is recognized in respect of temporary differences associated with investments in subsidiaries where the Group is able to control the timing of reversals of the temporary differences and it is probable that the temporary differences will not reverse in the foreseeable future.

Borrowings

Convertible debentures

The fair value of the liability portion of a convertible debenture is determined using a market interest rate for an equivalent non-convertible debenture. This amount is recorded as a liability on an amortized cost basis until extinguished on conversion, redemption or maturity of the debentures. The remainder of the proceeds is allocated to the conversion option. This is recognized and included in shareholders’ equity, net of income tax effects.

Derivative financial instruments

 Financial assets and liabilities are recorded at their fair value at each reportable period end, with any gains and losses recorded in the income statement.

Employee benefits

Pension obligations and vacation pay

The Group accounts for pensions and other employee benefits under IAS 19 “Employee benefits”.  Short-term employee benefits including vacation pay are accrued for in the period in which the related employee service is rendered.

The Group operates a defined contribution benefit plan. For defined contribution plans, the Group pays contributions to publicly or privately administered pension insurance plans on a mandatory, contractual or voluntary basis. The Group has no further payment obligations once the contributions have been paid. The contributions are recognized as employee benefit expense when they are due. Prepaid contributions are recognized as an asset to the extent that a cash refund or a reduction in the future payments is available. The Group provides no other post retirement benefits to its employees.

Share based compensation

The Group operates an equity-settled, share based compensation plan. The fair value of the employee services received in exchange for the grant of the options is recognized as an expense. The total amount to be expensed over the vesting period is determined by reference to the fair value of the options granted, excluding the impact of any non-market vesting conditions. Non-market vesting conditions are included in assumptions about the number of options that are expected to vest. At each balance sheet date, the entity revises its estimates of the number of options that are expected to vest.  It recognizes the impact of the revision to original estimates, if any, in the income statement, with a corresponding adjustment to equity.

When the Group modifies share options and the fair value of the options granted increases, the incremental fair value granted is recognized over the remaining vesting period.  The incremental fair value is calculated as the difference between the fair value of the modified option and that of the original option, both estimated at the date of the modification.

 
F-13

 



The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the options are exercised.

The grant by the Company of options over its equity instruments to the employees of subsidiary undertakings is treated as a capital contribution in the books of the subsidiary. The fair value of employee services received by the subsidiary, measured by reference to the grant date fair value, is recognized over the vesting period as an increase to investment in subsidiary undertakings, with a corresponding credit to equity.

Provision is made for employer’s National Insurance and similar taxes that arise on the exercise of certain share options, calculated using the market price at the balance sheet date.
 
In transactions where the Group receive goods and services from non-employees in exchange for its equity instruments, the corresponding increase in equity is measured at the fair value of the goods and services received.
 
Termination benefits

Termination benefits are payable when employment is terminated by the Group before the normal retirement date, or whenever an employee accepts voluntary redundancy in exchange for these benefits. The Group recognizes termination benefits when it is demonstrably committed to either: terminating the employment of current employees according to a detailed formal plan without possibility of withdrawal: or providing termination benefits as a result of an offer made to encourage voluntary redundancy. Benefits falling due more than 12 months after the balance sheet date are discounted to their present value.

Cash and cash equivalents

Cash and cash equivalents include cash in hand, deposits held at call with banks, other short term highly liquid investments with original maturities of three months or less and for the purposes of the cashflow statement, bank overdrafts are included within cash and cash equivalents. Bank overdrafts are shown within borrowings in current liabilities on the balance sheet.

Provisions and contingencies

A provision is recognised in the balance sheet when there is a present legal or constructive obligation as a result of a past event, it is probable that an outflow of economic benefit will be required to settle the obligation and it is reliably measured.  Provisions are determined by discounting the expected future cash flows at a pre-tax rate that reflects current market assessments of the time value of money and the risks specific to the liability.

A contingent liability is disclosed where the existence of the obligation is considered more than remote.

Contingent consideration payable under collaborative agreements is recognized when it is probable that any cash flow of economic benefit will be required and can be measured reliably. Payments relating to the funding of research are expensed and payments relating to the acquisition of an asset are capitalized. Provisions are re-measured at each balance sheet date based on the best estimate of the settlement amount.

Finance income and costs

Finance income comprises interest income on cash and cash equivalents, gains on the disposal of available for sale financial assets and foreign currency gains on financing activities. Interest income is recognized on a time proportion basis using the effective interest method.

Finance costs comprise foreign currency losses incurred on financing activity, impairment losses on financial assets and borrowing costs. Borrowing costs are allocated to financial reporting periods over the effective life of the related borrowings using the effective interest method.

 
F-14

 




Share capital

(a) Ordinary shares
Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new ordinary shares, options or warrants are recognized as a deduction from share premium account in equity.

(b)Treasury shares
When share capital recognized as equity is repurchased, it is classified as treasury shares, with the amount of the consideration paid, including directly attributable costs, being recognized as a reduction from equity. When such shares are subsequently re-issued, any consideration received, net of any directly attributable incremental transaction costs, is included in equity.

(c) Warrants and options granted in connection with ordinary share issuances
Where at the time of an ordinary share issuance the Group grants shareholders warrants or options to acquire additional shares, the total consideration received is apportioned on a fair value basis between that relating to the issued shares, which is recorded in share capital and share premium account, and the warrants or options.
 
Where the options or warrants give rise to an obligation for the Group to issue, if called to do so, a fixed number of shares for a fixed amount of money in functional currency terms then the options or warrants are classified into a separate component in equity.

Where the options and warrants give rise to obligations to issue ordinary shares other than on the above basis they are classified as financial liabilities on the balance sheet.  Where these instruments meet the definition of derivatives they are included at fair value on the balance sheet at each reporting year end, with the resulting unrealised gains or losses being recorded in the income statement.

In both situations, at settlement date the carrying value of the options and warrants are transferred to retained earnings.  The cash proceeds received from shareholders for additional shares are recorded in the share capital and share premium account.

Earnings per share

The Group presents basic and diluted earnings per share (“EPS”) data for its own ordinary shares. Basic EPS is calculated by dividing the profit or loss attributable to ordinary shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. Diluted EPS is determined by adjusting the profit or loss attributable to ordinary shareholders and the weighted average number of ordinary shares outstanding for the effects of all dilutive potential ordinary shares, which comprise convertible debentures, share options and warrants granted. If the number of ordinary or potential ordinary shares outstanding increases as a result of a capitalisation, bonus issue or share split, or decreases as a result of a reverse share split, the calculation of basic and diluted earnings per share for all periods presented shall be adjusted retrospectively. If these changes occur after the balance sheet date but before the financial statements are authorised for issue, the per share calculations for those and any prior period financial statements presented shall be based on the new number of shares.

Segment reporting

A segment is a distinguishable component of the Group that is engaged in either providing related products or services (business segment), or in providing products or services within a particular economic environment (geographical segment), which is subject to risks and rewards that are different from those of other segments.  The Group’s primary format for segment reporting is currently based on geographic location.

Capital redemption reserve

The capital redemption reserve is comprised of deferred shares previously in issue, which were cancelled.


 
F-15

 



Risks and uncertainties

Intellectual Property

The value of the Group’s patent and proprietary rights will be affected by its ability to obtain and preserve patent protection for its products and trade secrets, and by the emergence of competing technologies over time. In particular, the value of the intangible assets described in Note 3 could be severely affected by changes in the status of the Group’s patent and proprietary rights.

Foreign Exchange Rate Risks

We record our transactions and prepare our financial statements in U.S. Dollars. Since our strategy involves the development of products for the U.S. market, a significant part of our clinical trial expenditures are denominated in U.S. Dollars and we anticipate that the majority of our future revenues will be denominated in U.S. Dollars. However, a significant portion of our costs are denominated in pounds sterling, euro and shekel as a result of our conducting activities in the United Kingdom, the European Union and Israel. As a consequence, the results reported in our financial statements are potentially subject to the impact of currency fluctuations between the U.S. Dollar, pounds sterling, euro and shekel. We are focused on development activities and do not anticipate generating on-going revenues in the short-term. Accordingly, we do not engage in significant currency hedging activities in order to restrict the risk of exchange rate fluctuations. However, if we should commence commercializing any products in the U.S., changes in the relation of the U.S. Dollar to the pound sterling, the euro and/or the shekel may affect our revenues and operating margins. In general, we could incur losses if the U.S. Dollar should become devalued relative to the pound sterling, the euro and/or the shekel. We manage foreign exchange risk by holding our cash in the currencies in which we expect to incur future cash outflows.

Interest Rate Risk

At December 31, 2007 we had fixed rate convertible debentures and are therefore not subject to interest rate risk. Accordingly, we do not hedge any of our interest rate risks.

Patent costs

The Group undertakes to protect its intellectual property using patent applications. Costs associated with such applications are written off as incurred where they relate to ongoing development expenditure that is also not capitalized.

Acquired patent costs arising on acquisitions are capitalized and amortized on a straight-line basis over its estimated useful economic life. The useful economic life commences upon generation of economic benefits relating to the acquired patent.

Critical accounting estimates and assumptions

The Group makes estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.

Fair value of intangible assets

Intangible assets relate to the asset acquisition of Ester Neurosciences Limited on December 5, 2007. The carrying value of the intangible asset comprises Amarin Common Stock issued, cash paid and Amarin Common Stock to be issued under the achievement of certain milestones. The Group used certain judgments when determining the probability and timing of contingent consideration payable.

The Group reviews intangible assets not yet available for use for impairment at least annually. An impairment loss is recognized if the carrying amount of an asset exceeds its recoverable amount. The recoverable amount of an intangible asset is determined by discounting the expected future cash flows. The Group uses significant assumptions and estimates in determining an intangible assets recoverable amount.
 
Carrying value of investment in subsidiaries

The carrying value of the Company's investment in subsidiaries is tested at least annually for impairment. The Company uses the present value of future cash flows of their products to determine whether an impairment provision is required. These cash flows assume the Company's products will be approved by the FDA and will be capable of generating revenues.  Management judgment is required in forecasting the cash flows of each product and these cash flows are adjusted for industry probability factors and the Group discount rate.  During 2007, the Company provided for $4,593,000 for impairment on AMR101 for HD related investments.
 

 
F-16

 




3.  Asset acquisitions

On December 5, 2007, Amarin Corporation plc, declared its offer for the shares of Ester Neurosciences Limited (“Ester”) wholly unconditional and on that date acquired 100% of the outstanding Ester shares (the “Acquisition”). Ester’s principal assets include rights to intellectual property relating to the treatment Myasthenia Gravis (“MG”). Ester has been accounted for as an asset acquisition and as a result Ester’s net assets are included within the consolidated balance sheet at December 31, 2007. The results of Ester from the date of acquisition are included in the income statement for the Company which has been consolidated into the Group income statement.

Ester’s core assets include (i) a platform messenger RNA (mRNA) silencing technology which targets the cholinergic pathway; (ii) EN101, a Phase II compound with promising efficacy data for the treatment of MG utilizing this technology; and (iii) a preclinical program in neurodegenerative and inflammatory diseases.  

The purchase price for the acquisition of Ester comprises both upfront and contingent consideration in the form of both cash and share payments.  Share payments will be in the form of ADSs with each ADS representing one Ordinary Shares of £0.05 each in the capital of Amarin (one Ordinary Share of £0.50 post share consolidation effective January 18, 2008 whereby ten Ordinary Share of £0.05 each became one Ordinary Share of £0.50 each) and certain success based milestone payments as follows:
 
.   
Initial consideration of approximately $15 million on closing comprising $5.191 million in cash and $10 million in Amarin shares (subject to a maximum of 25 million Ordinary Shares).

.   
$5 million, payable, at Amarin’s option in either, (i) Amarin shares at the volume weighted average closing price for the 10-day trading period ending the day before the Acquisition Agreement is signed (“First Share Amount”), subject to the adjustment described below or (ii) cash, upon achievement of Milestone Ia – Monarsen Phase II in MG study meeting its study objectives: Efficacy – having a QMG score of one or more of the three doses being superior to Mestinon as compared to the baseline by at least 10%; Safety – no major adverse drug related side effects.  If the weighted average closing price for the 10-day trading period commencing immediately after the date of announcement of the achievement of Milestone Ia (“Milestone Ia Price”) exceeds twice the Closing Price by any amount (“First Excess”), the First Share Amount will be reduced by a percentage calculated by dividing 2/3rds of the First Excess by the Milestone Ia Price provided that if the Milestone Ia Price exceeds $50 per Amarin Share ($5 per Amarin Share pre one-for-ten share consolidation which became effective on January 18, 2008), such excess shall be disregarded and the Milestone Ia Price shall be deemed to be $50 per Amarin Share ($5 per Amarin Share pre one-for-ten share consolidation which became effective on January 18, 2008).  If the Milestone Ia Price is less than the Closing Price no adjustment will be made to the First Share Amount.

.   
$6 million, payable, at Amarin’s option in either, (i) Amarin shares at the Closing Price (“Second Share Amount”), subject to the adjustment described below or (ii) cash, upon achievement of Milestone Ib – 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.  If the volume weighted average closing price for the 10-day trading period commencing immediately after the date of announcement of the achievement of Milestone Ib (“Milestone Ib Price”) exceeds twice the Closing Price by any amount (“Second Excess”), the Second Share Amount will be reduced by a percentage calculated by dividing 2/3rds of the Second Excess by the Milestone Ib Price provided that if the Milestone Ib Price exceeds $50 per Buyer Ordinary Share ($5 per Buyer Ordinary Share pre one-for-ten share consolidation which became effective on January 18, 2008), such excess shall be disregarded and the Milestone Ib Price shall be deemed to be $50 per Amarin Share ($5 per Amarin Share pre one-for-ten share consolidation which became effective on January 18, 2008).  If the Milestone Ib Price is less than the Closing Price no adjustment will be made to the Second Share Amount.

.  
$6 million in cash on the achievement of Milestone II – successful completion of the US Phase III clinical trial program (to include successful completion of long term studies) enabling NDA filing for Monarsen for MG in the US.  If Milestone Ia is successfully achieved, a time limit date is triggered for Milestone II being the date which falls two years following the achievement of Milestone Ib (“Time Limit Date”).  If on the Time Limit Date, Milestone II has not yet been achieved (other than by reason of failure to meet primary endpoints in any Phase III Clinical Study or a delay in completing the U.S. Phase III Clinical Study caused by certain Monarsen-related factors), Amarin will pay the Sellers $3 million in cash with the remaining $3 million being payable whenever Milestone II is achieved.  In addition, if the Milestone Ib Price is greater than or equal to $10 ($1 pre one-for-ten share consolidation which became effective on January 18, 2008), no Time Limit Date will apply.

 
F-17

 


Amarin also incurred approximately $1.3 million in transaction fees, including legal, due diligence and accounting fees. The transaction has been accounted for as an asset acquisition as it does not constitute a business under IFRS 3.

Preliminary purchase price

The preliminary purchase price of an upfront payment of $5.191 million in cash and $10 million in common stock and contingent common stock payment of $5 million (which is considered probable) for 100% of the outstanding shares of Ester. The fair value of the Amarin common stock issued was $9 million. This was based on the issue of 25 million shares and the closing price of Amarin common stock of $0.36, on December 5, 2007, the date of the acquisition. The achievement of Milestone Ia is considered to be probable and therefore has been recognized as a cost of investment.  The fair value of Milestone Ia (using a Monte Carlo model) has been valued at $4.8 million.  As at December 31, 2007, Milestone Ia has not been paid, therefore a provision has been established for $4.8 million.

The total purchase price for the acquisition of 100% of the outstanding shares of Ester is as follows:

 
$’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

The final purchase price is dependent on the actual number of shares of Amarin common stock issued and actual direct acquisition costs, together with contingent consideration which may become payable, in the future, on the achievement of certain Milestones (as outlined above). Such additional consideration may be paid in cash or shares at the sole option of Amarin (with the exception of Milestone II which is payable in cash) and would increase the carrying value of the intangible fixed assets and result in an increased amortization charge over the remaining useful economic life of these assets. Under the asset acquisition method of accounting, the total estimated purchase price is allocated to Ester's net tangible and intangible assets based on their relative fair value as of the date of completion of the acquisition.





 


 
F-18

 




Allocation of the costs of investment to the net assets
   
Ester
   
Adjustments
   
Acquisition
accounting
 
   
$'000
   
$'000
   
$'000
 
                   
Intangible assets
    -       19,916       19,916  
Property, plant and equipment
    7       -       7  
Net current assets
    364       -       364  
                         
Net assets acquired
    371       19,916       20,287  
                         
Consideration
                       
   
No. of Shares ('000)
      $      
$'000
 
Fair value of Amarin common stock issued
    25,000       0.36       9,000  
Cash payment
                    5,191  
Fair value of Amarin common stock to be issued under Milestone Ia
                    4,756  
Direct acquisition costs
                    1,340  
Cost of investment
                    20,287  

Adjustments to allocate the cost of investment based on the relative fair values of the net assets acquired have been considered for all assets/liabilities present on Ester’s balance sheet at the date of acquisition (December 5, 2007). For all asset classes other than intangible assets, no adjustment is required due to the nature of the assets and liabilities acquired and the proximity to settlement for the other current assets and liabilities. The most significant adjustment is the recognition of the intangible asset based on its fair value, representing intellectual property rights.

The intangible asset is required to be adjusted for any contingent consideration as soon as payment becomes probable and the amount can be measured reliably. A description of the contingent consideration is described in detail above (see preliminary purchase price).

4.  Analysis by segment

For management purposes the Group is organized into two principal operating divisions based on the geographic operations of the Group: U.K. and Ireland, and Rest of World. The information in the tables below is based on the origin of each segment’s activities and the location of their respective assets and liabilities.

   
2007
   
2006
 
   
UK & Ireland
   
Rest of world
   
Total
   
UK & Ireland
   
Rest of world
   
Total
 
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
 
                                     
Revenue
                      500             500  
Operating expenses
    (40,571 )     (162 )     (40,733 )     (28,568 )           (28,568 )
Operating loss
    (40,571 )     (162 )     (40,733 )     (28,068 )           (28,068 )
Finance income
    1,882             1,882       3,344             3,344  
Finance costs
    (183 )           (183 )     (2,826 )           (2,826 )
Loss before taxation
    (38,872 )     (162 )     (39,034 )     (27,550 )           (27,550 )
Tax credit
    837             837       799             799  
Loss for the year
    (38,035 )     (162 )     (38,197 )     (26,751 )           (26,751 )
                                                 
Other segment items:
                                               
Impairment of intangible assets
    (8,784 )           (8,784 )                  
Impairment of property, plant and equipment
                      (235 )           (235 )

Revenue in 2006 originated in the U.K. and Ireland and related to one customer in the U.S.

 
F-19

 


Assets and liabilities
   
2007
   
2006
 
   
UK & Ireland
   
Rest of world
   
Total
   
UK & Ireland
   
Rest of world
   
Total
 
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
   
US$’000
 
                                     
Segment assets
    41,996       258       42,254       49,559             49,559  
Segment liabilities
    (17,876 )     (49 )     (17,925 )     (10,838 )           (10,838 )
Unallocated liabilities:Income tax liabilities
    (180 )           (180 )     (153 )           (153 )
Net assets
    23,940       209       24,149       38,568             38,568  
                                                 
Other segment items:
                                               
Capital expenditure on property, plant and equipment
    444             444       245             245  
Capital expenditure on intangible assets
    20,287             20,287                    
Depreciation
    217             217       121             121  

The Group operates as one business segment, research and development.

5.  Exceptional operating expenses

 
2007
2006
 
$’000
$’000
Impairment of intangible assets
8,784
Redundancy
277
Property
19
Impairment of property, plant and equipment
235
Total
      8,784
      531

On April 24, 2007, we announced top-line results from Amarin’s two Phase III trials of AMR 101 to treat HD. Study data showed no statistically significant difference in either study between AMR 101 and placebo with regard to the primary and secondary endpoints.

While AMR 101 may have potential value in HD, central nervous system disorders and other therapeutic indications, due to the results of the Phase III trials, it was deemed appropriate to write off the AMR 101 intangible asset.

During 2006, the Group recorded reorganization charges to align the business for maximum efficiency. Amarin’s reorganization plan, now completed, has resulted in a reduction in headcount, the relocation of the research and development function to Oxford, England and the consolidation of administrative functions in Dublin, Ireland. In determining the charges to record, the directors made certain estimates and judgments surrounding the amounts ultimately to be paid for the actions the Group has taken or is committed to taking. As at December 31, 2007, all payments in respect of exceptional operating expenses have been made and there are no provisions in respect of exceptional operating expenses.










 
F-20

 





6.  Operating expenses

   
Note
   
2007
   
2006
 
            $’000       $’000  
Selling, general and administrative expenses
                     
Administrative and general expenses*
          9,794       6,306  
Employee benefit expenses
          4,736       3,535  
Depreciation of property, plant and equipment
          217       121  
Operating lease expenses
          1,260       820  
Amortization of intangible assets
          169       674  
Restructuring costs
   
5
            531  
Share based compensation
   
28
      3,665       1,475  
     
 
      19,841       13,462  
Impairment of intangible assets    
      8,784        
Total selling, general and administrative expenses
            28,625       13,462  
                       
Research and development expenses
                       
General research and development expenses
            8,563       12,831  
Employee benefit expenses
            2,209       1,549  
Share based compensation
   
28
      1,336       726  
Total research and development expenses
            12,108       15,106  
                         
Total operating expenses
            40,733       28,568  

Research and development costs include professional and contractor fees, materials and external services.

* Included in administrative and general expenses is a termination payment to a former director and chief executive officer, Mr. Richard Stewart and a provision relating to the lease of offices at Curzon Street, London, from which Amarin has planned to vacate.

7.  Directors’ emoluments

 
2007
2006
 
$’000
$’000
Aggregate emoluments
3,688
2,097
Group pension contributions to money purchase schemes
90
294
 
3,778
2,391

The Group paid or accrued pension contributions to money purchase pension schemes on behalf of three directors for December 31, 2007 (year to December 31, 2006: two directors).

Mr. Groom waived emoluments in respect of the year ended December 31, 2007 amounting to $50,000 (year to December 31, 2006; $46,000).

Total remuneration of directors (including benefits in kind) includes amounts paid to:

Highest paid director

 
2007
2006
 
$’000
$’000
Aggregate emoluments*                                                                                                                                       
1,517
815
Group pension contributions to money purchase schemes                                                                                                                                       
60
169
 
1,577
984

*Included in aggregate emoluments in 2007, is a termination payment of $908,000.

During each of the years ended December 31, 2007 and 2006 no director exercised options.
 
Directors emoluments and interests are presented in further detail in “Item 6 — Directors, Senior Management and Employees” in the front section of this document.

 
F-21

 



8.  Employee information

The average monthly number of persons (including executive directors) employed by the Group during the year was:

 
2007
Number
2006
Number
Marketing and administration                                                                                                                                   
17
12
Research and development                                                                                                                                   
8
6
 
25
18

 
2007
2006
 
$’000
$’000
Staff costs (for the above persons):
   
Wages and salaries                                                                                                                                    
6,075
4,228
Social security costs                                                                                                                                    
566
453
Other pension costs                                                                                                                                    
304
403
 
6,945
5,084

Share based payment information is disclosed in note 28.
 
At the end of 2007, the Group employed 28 people.

The average monthly number of persons (including executive directors) employed by the Company during the year was:

 
2007
Number
2006
Number
Marketing and administration
 2
 3

 
2007
2006
 
$’000
$’000
Staff costs (for the above persons):
   
Wages and salaries
677
1,032
Social security costs
121
87
Other pension costs
68
181
 
866
1,300

At the end of 2007, the Company employed 1 person.

9.  Finance income

 
   2007  
2006  
 
$’000
$’000
Interest income on short term bank deposits                                                                                                                               
1,252
1,344
Foreign exchange gains                                                                                                                               
       630
     2,000
 
    1,882
     3,344

For the years ended December 31, 2007 and 2006 the foreign exchange gain resulted primarily from the weakening of the U.S. Dollar against sterling.


 
F-22

 



10.  Finance costs

 
2007
2006
 
$’000
$’000
On future investment right
2,818
On finance leases
4
2
On 8% convertible debentures
176
Impairment on available for sale investments
          3
           6
 
       183
2,826

On December 4, 2007 we entered into an agreement to issue three year 8% convertible debentures. Interest is payable quarterly in arrears. See note 21 for further information.

On March 15, 2006 the future investment right which was granted under the May 2005 financing was settled.   A charge of $2,818,000 was recorded in 2006, being the movement in the fair value of the future investment right from January 1, 2006 to March 15, 2006.

11.  Loss before taxation

 
2007
2006
 
$’000
$’000
Loss before taxation is stated after charging/(crediting):
   
Depreciation/amortization charge for the period:
   
 Intangible assets                                                                                                                                          
169
674
 Owned property, plant and equipment                                                                                                                                          
207
111
 Property, plant and equipment held under  finance leases                                                                                                                                          
10
10
Auditors remuneration:
   
  Auditor’s remuneration for audit of Company and consolidated statutory accounts*
444
408
  Auditor’s remuneration for audit of subsidiaries’ statutory accounts*                                                                                                                                          
72
69
  Auditor’s service for Sarbanes Oxley                                                                                                                                          
101
 
  Other advisory services                                                                                                                                          
52
4
  Taxation Compliance services                                                                                                                                          
43
19
  Taxation Advisory services                                                                                                                                          
88
85
Operating lease charges:                                                                                                                                          
   
 Plant and machinery                                                                                                                                          
10
21
 Other operating lease charges                                                                                                                                          
1,250
799
Foreign exchange difference                                                                                                                                          
(630)
(2,000)

 * Professional fees of $312,000 were paid to PricewaterhouseCoopers in respect to the acquisition of shares in Ester Neurosciences Limited.  These fees were directly attributable to the transaction and have been capitalized.

In order to maintain the independence of the external auditors, the Board has determined policies as to what non-audit services can be provided by the Group’s external auditors and the approval processes related to them.

12.  Taxation

 
2007
2006
 
$’000
$’000
Tax on loss before taxation:
   
 United Kingdom corporation tax at 30%:
   
  current year                                                                                                                                          
(837)
(799)
 
 
 
Total current tax credit                                                                                                                                          
(837)
(799)
 
 
 
Total tax credit                                                                                                                                          
(837)
(799)


 
F-23

 


The following items represent the principal reasons for the differences between corporate income taxes computed at the U.K. statutory tax rate and the total tax charge for the year.

 
2007
2006
 
$’000
$’000
Loss before taxation                                                                                                                                       
(39,034)
(27,550 )
Loss on ordinary activities multiplied by standard rate of corporate tax in the U.K. of 30%
(11,710)
(8,265)
Overseas tax and adjustments in respect of foreign tax rates                                                                                                                                       
521
238
Unrecognized accelerated capital allowances and other timing differences                                                                                                                                       
4,516
7,320
Research and development tax credit relief (rate differences)                                                                                                                                      
734
1,079
Expenses not deductible for tax purposes                                                                                                                                       
5,102
1,171
Total tax credit                                                                                                                                       
(837)
(799)

In the U.K., the applicable statutory rate for corporate income tax was 30% for the years ended December 31, 2007 and 2006.

The corporate tax rate in Ireland is 12.5% for profits on trading activities and 25% for non-trading activities. The corporate tax rate in Israel is 27%.

Tax losses carried forward in Amarin Corporation plc at December 31, 2007 were $43,866,000 (December 31, 2006: $41,697,000) subject to confirmation by U.K. tax authorities. Tax losses carried forward in Amarin Neuroscience Limited at December 31, 2007 were $43,364,000 (December 31, 2006: $42,501,000) subject to confirmation by U.K. tax authorities.

Tax losses carried forward in Amarin Pharmaceuticals Ireland Limited at December 31, 2007 were $13,778,000 (December 31, 2006: $5,440,000) subject to confirmation by Irish tax authorities.

Tax losses carried forward in Ester Neurosciences Limited at December 31, 2007 were $9,189,000 subject to confirmation by Israeli tax authorities.

Deferred tax (Group)

The Group has unrecognized deferred tax asset as follows:
 
2007
2006
 
$’000
$’000
Accelerated capital allowances
(19,409)
(19,380)
Short term timing differences
(3,446)
(1,143)
Losses
(32,499)
(26,772)
 
(55,354)
(47,295)

In 2007 and 2006 high levels of corporate tax losses carried forward and insufficient certainty of future profitability resulted in unrecognized deferred tax assets of $55,354,000 and $47,295,000 respectively. The deferred tax asset of $32,499,000 in respect of losses includes $153,000 of capital loss that can only be utilized against future capital gains.

During the years ended December 31, 2007 and 2006 the reconciling items in arriving at the current tax charge related to accelerated capital allowances, other short term timing differences, tax losses carried forward and expenses not deductible for tax purposes. The main timing difference related to tax losses that were carried forward for set off against future profits of the same trade.
 
The tax residency of Amarin Corporation plc migrated to Ireland in early 2008. Trading losses not utilized at the date of migration may no longer be available for offset against taxable profits.

13.  Profit/(Loss) for the financial period

As permitted by section 230 of the Companies Acts, the Company’s Income Statement has not been included in these financial statements. Of the consolidated loss attributable to the shareholders of Amarin Corporation plc, a profit of $2,637,000 (December 31, 2006: loss of $7,352,000) has been dealt with in the financial statements of the Company.


 
F-24

 



14.  Loss per ordinary share

The loss per ordinary share is as follows:
   
2007
   
2006
 
      $’000       $’000  
Loss for the financial year attributable to ordinary shareholders
    (38,197 )     (26,751 )

   
U.S. cents
   
U.S. cents
 
 
Basic loss per ordinary share                                                                                                                                    
    (3.90 )     (3.25 )
Diluted loss per ordinary share                                                                                                                                    
    (3.90 )     (3.25 )

   
Number
   
Number
 
Weighted average number of ordinary shares in issue
    9,783,595       8,233,705  
Dilutive impact of convertible debentures
           
Dilutive impact of share options and warrants outstanding
           
Diluted average number of ordinary shares in issue
    9,783,595       8,233,705  

Basic

Basic loss per share is calculated by dividing the loss attributable to equity holders by the weighted average number of ordinary shares in issue in the year. In 2007, 20,079 (2006: 20,079) shares have been deducted in arriving at the weighted average number of ordinary shares in issue, being the weighted average number of treasury shares for the year.

Diluted

Diluted loss per share is calculated by dividing the loss for the year by the weighted average number of ordinary shares outstanding and, when dilutive, adjusted for the effect of all potentially dilutive shares, including share options, warrants and convertible debt on an as-if-converted basis. The Group reported a net loss from continuing operations in 2007 and 2006. As a result the loss per share is not reduced by dilution. As at December 31, 2007, there were share options and warrants outstanding of 3.2 million shares (2006: 1.9 million shares) which could potentially have a dilutive impact in the future, but which were anti-dilutive in 2007 and 2006. On December 6, 2007 we issued convertible debentures which may be converted into 0.6 million ADSs commencing four months after the date of closing. At December 31, 2007 the convertible debentures had no dilutive effect, however they could potentially have a dilutive impact in the future.

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. The shares and share information above has been adjusted to reflect this share consolidation.




 



 
F-25

 


15.  Intangible assets

   
IPR&D
 
      $’000  
Group
Cost
At January 1, 2006                                                                                                                                                
      12,753  
Foreign currency adjustment                                                                                                                                                
    1,343  
At December 31, 2006 and at January 1, 2007                                                                                                                                                
    14,096  
Acquisitions                                                                                                                                                
    19,916  
Impairments                                                                                                                                                
    (14,096 )
At December 31, 2007                                                                                                                                                
    19,916  
Amortization
At January 1, 2006                                                                                                                                            
    3,361  
Charge for the year                                                                                                                                            
    674  
Foreign currency adjustment                                                                                                                                            
    425  
At December 31, 2006 and at January 1, 2007                                                                                                                                            
    4,460  
Charge for the year                                                                                                                                            
    169  
Eliminated on impairments                                                                                                                                                
    (4,629 )
At December 31, 2007                                                                                                                                            
     
Net book value at December 31, 2007                                                                                                                                             
    19,916  
Net book value at December 31, 2006                                                                                                                                            
    9,636  
Net book value at January 1, 2006                                                                                                                                            
    9,392  

Company
   
IPR&D
 
      $’000  
Cost
At January 1, 2006                                                                                                                                                
    5,895  
Foreign currency adjustment                                                                                                                                                
    1,343  
At December 31, 2006 and at January 1, 2007                                                                                                                                                
    7,238  
Acquisitions                                                                                                                                                
    19,916  
Impairments                                                                                                                                                
    (7,238 )
At December 31, 2007                                                                                                                                                
    19,916  
Amortization
At January 1, 2006                                                                                                                                                
    2,816  
Charge for the year                                                                                                                                                
    232  
Foreign currency adjustment                                                                                                                                                
    425  
At December 31, 2006 and at January 1, 2007                                                                                                                                                
    3,473  
Charge for the year                                                                                                                                                
    58  
Eliminated on impairments                                                                                                                                                
    (3,531 )
At December 31, 2007                                                                                                                                                
     
Net book value at December 31, 2007                                                                                                                                                
    19,916  
Net book value at December 31, 2006                                                                                                                                                
    3,765  
Net book value at January 1, 2006                                                                                                                                                
    3,079  

On December 5, 2007, Amarin Corporation plc, declared its offer for the shares of Ester wholly unconditional and on that date acquired 100% of the outstanding Ester shares (the “Acquisition”). The acquisition was accounted for as an asset acquisition, see note 3 for further information. The carrying value of the Ester intangible asset (“EN101”) at December 5, 2007 was supported by a discounted future cash flow model using a discount factor of 15%. EN101 is protected by a granted composition of matter patent in the U.S. which extends to 2022. We reviewed the carrying value of the Ester intangible asset at December 31, 2007 for impairment and no adjustments are required.

Intangible assets not yet available for use (Ester IPR&D) are not subject to amortization but are tested for impairment at least annually. An impairment loss is recognized if the carrying amount of the asset exceeds its recoverable amount. The recoverable amount is determined using a value in use methodology which is arrived at by discounting the expected future cash flows of the intangible asset.

 
F-26

 


On April 24, 2007, we announced top-line results from Amarin’s two Phase III trials of AMR 101 to treat HD. Study data showed no statistically significant difference in either study between AMR 101 and placebo with regard to the primary and secondary endpoints. While AMR 101 may have potential value in HD, central nervous system disorders and other therapeutic indications, due to the results of the Phase III trials, it was deemed appropriate to write off the AMR 101 intangible asset. See note 5 for further information.

Of the impairment of $9,467,000 above, $8,784,000 was recognized in the income statement and $683,000 was recognized in the foreign currency translation reserve.

16.  Property, plant and equipment

Group

 
Cost
 
Short
leasehold
   
Plant and
equipment
   
Fixtures
and fittings
   
Computer
equipment
   
Total
 
      $’000       $’000       $’000       $’000       $’000  
At January 1, 2006                                                                         
    409       37       192       341       979  
Additions                                                                         
    102       11       21       111       245  
Impairments                                                                         
    (408 )           (95 )           (503 )
Disposals                                                                         
          (33 )     (90 )           (123 )
Foreign exchange adjustments                                                                         
    6       1       1       24       32  
At December 31, 2006 and at 1 January 2007
    109       16       29       476       630  
Additions                                                                         
    152       76       8       232       468  
Disposals                                                                         
                             
Foreign exchange adjustments                                                                         
    3       3       5       19       30  
At December 31, 2007                                                                         
    264       95       42       727       1,128  
Accumulated depreciation                                                                         
                                       
At January 1, 2006                                                                         
    165       8       111       235       519  
Charge for the year                                                                         
    17       13       21       70       121  
Eliminated on disposals                                                                         
          (18 )     (38 )           (56 )
Eliminated on impairments                                                                         
    (178 )           (90 )           (268 )
At December 31, 2006 and January 1, 2007
    4       3       4       305       316  
Charge for the year                                                                         
    40       17       12       148       217  
Eliminated on disposals                                                                         
                             
At December 31, 2007                                                                         
    44       20       16       453       533  
Net book value At December 31, 2007
    220       75       26       274       595  
                                         
At December 31, 2006                                                                         
    105       13       25       171       314  
                                         
At January 1, 2006                                                                         
    244       29       81       106       460  

Plant and equipment includes assets held under finance leases and purchase contracts as follows:
 
Cost
      $’000  
At January 1, 2006                                                                                                                                                   
    33  
Disposals                                                                                                                                                   
    (33 )
At December 31, 2006 and January 1, 2007                                                                                                                                                   
     
Additions                                                                                                                                                   
    53  
At December 31, 2007                                                                                                                                                   
    53  
Accumulated depreciation
At January 1, 2006                                                                                                                                                   
    8  
Charge for the year                                                                                                                                                   
    10  
Disposals                                                                                                                                                   
    (18 )
At December 31, 2006 and January 1, 2007                                                                                                                                                   
     
Charge for the year                                                                                                                                                   
    10  
Disposals                                                                                                                                                   
     
At December 31, 2007                                                                                                                                                   
    10  
Net book value At December 31, 2007                                                                                                                                                   
    43  
At December 31, 2006                                                                                                                                                   
     
 
During 2006, the Group recorded reorganization charges to align the business for maximum efficiency. Amarin’s reorganization plan, now completed, involved the relocation of the research and development function from Stirling, Scotland to Oxford, England. Property, plant and equipment with a net book value of $235,000 was impaired as a result of the relocation of offices to Oxford.
 

 
 
F-27

 

 

Company
 
Cost
 
Short
leasehold
   
Fixtures
and fittings
   
Computer
equipment
   
Total
 
      $’000       $’000       $’000       $’000  
At January 1, 2006
    293       95       246       634  
Additions
                13       13  
Impairments
    (293 )     (95 )           (388 )
At December 31, 2006 and at January 1, 2007
                259       259  
Additions
          8       6       14  
At December 31, 2007
          8       265       273  
Accumulated depreciation
At January 1, 2006
    140       85       215       440  
Charge for the year
    7       5       19       31  
Eliminated on impairments
    (147 )     (90 )           (237 )
At December 31, 2006 and at January 1, 2007
                234       234  
Charge for the year
          1       19       20  
At December 31, 2007                                                                                       
          1       253       254  
Net book value
At December 31, 2007
          7       12       19  
At December 31, 2006
                25       25  

The Company had no property, plant or equipment under finance leases at December 31, 2007 or 2006.

17.  Investments in subsidiaries

Company
   
 
 
Cost
At January 1, 2006
    $'000
3,191
 
Inter company movements during the year
    19,524  
At December 31, 2006 and January 1, 2007
    22,715  
Gain on strike off of Amarin Pharmaceuticals Company Limited
    15,745  
Loss on strike off of Ethical Pharmaceuticals (U.K.) Limited
    (1,660 )
Loss on impairment of investment in subsidiary
    (4,593 )
IFRS 2 re-charges to subsidiaries during the period
    5,641  
Other inter company movements during the year
    22,288  
At December 31, 2007
    60,136  




 


 
F-28

 



Interest in group undertakings at December 31, 2007
       
Proportion of nominal
 
       
value of issued share
 
 
Country of
   
capital held by the
 
 
incorporation
       
Name of Undertaking
or registration
Description of shares held
 
Group
   
Company
 
       
%
   
%
 
Amarin Neuroscience Limited                                                                
Scotland
4,000,000 £1 ordinary shares
   
100
     
100
 
Amarin Pharmaceuticals Ireland Limited   
Ireland
100 €1 ordinary shares
   
100
     
100
 
Amarin Finance Limited                                                                
Bermuda
11,991 $1 ordinary shares
   
100
     
100
 
Ester Neurosciences Limited                                                                
Israel
1,320,264 NIS 0.01 ordinary shares
   
100
 
   
100
 
   
440,526 NIS 0.01 “A” redeemable convertible preference shares
   
100
     
100
 
   
1,121,145 NIS 0.01 “B” redeemable convertible preference shares
   
100
     
100
 

Ester Neurosciences Limited was acquired on December 5, 2007 and was accounted for as an asset acquisition (see note 3).

Amarin Finance Limited was incorporated on June 23, 2006 as a fully owned subsidiary of Amarin Corporation plc.

Group undertakings during the year had the following nature of business:

Research and development companies

Amarin Neuroscience Limited.
Amarin Pharmaceuticals Ireland Limited.
Ester Neurosciences Limited.

Non trading companies

Amarin Finance Limited.
Ethical Pharmaceuticals (U.K.) Limited. This company was struck off in March 2007.

Intermediate holding company

Amarin Pharmaceuticals Company Limited. This company was struck off in March 2007.

As a result of the strike off of Amarin Pharmaceuticals Company and Ethical Pharmaceuticals (U.K.) Limited, the Company recognized a net gain of $14,085,000 due to the cancellation of inter company loans.

18.  Inventory

   
Group
   
Company
 
   
2007
   
2006
   
2007
   
2006
 
      $’000       $’000       $’000       $’000  
Raw materials and consumables                                                                                              
    982       414              
Provision                                                                                              
    (982 )     (414 )            
Net realizable value                                                                                              
                       
 

At December 31, 2007 full provision was made against raw materials and consumables which comprise AMR 101 for commercial use. An amount of $568,000 was expensed to the income statement in 2007 relating to the provision against AMR 101 raw materials and consumables.


 
F-29

 


19.  Other current assets

   
Group
   
Company
 
   
2007
   
2006
   
2007
   
2006
 
      $’000       $’000       $’000       $’000  
                                 
Corporation tax receivable
    1,704       1,617              
                                 
Other current assets
                               
Other debtors
    840       456       625       271  
Prepayments and accrued income
    881       716       434       499  
      1,721       1,172       1,059       770  

Corporation tax receivable relates to tax credits for research and development held within Amarin Neuroscience Limited.

No provision or charge against bad or doubtful debts has been made during 2007 or 2006. Included in prepayments at December 31, 2007 is an amount of $19,973 for director’s fees paid in advance to one of our non-executive directors, Dr. William Mason.

20.  Available for sale investments

 
$’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

The Group holds an investment in Antares Pharma Inc. (“Antares”) (formerly Medi-Ject Corporation), which is listed on the American Stock Exchange (AMEX) in the United States. At December 31, 2007, the market value of this investment was $15,000 (December 31, 2006: $18,000).

21.  Borrowings

On December 4, 2007, the company entered into an agreement to issue $2.75 million 8% convertible debentures. Net proceeds amounted to approximately $2.6 million after deducting transaction costs. The holders of the debentures have the option to convert their debentures into American Depository Shares (“ADSs”) at any time on or after April 6, 2008 and up to December 6, 2010 at $0.48 per ADS ($4.80 post share consolidation effective January 18, 2008), a conversion rate of 2083.33 ADSs for every $1,000 principal amount of the debentures. The 8% debentures may be redeemed at par at the company’s option at any time before April 6, 2008. Mandatory redemption will occur if a financing takes place or there is a change of control of the Company. If the debentures have not been converted, they will be redeemed on December 6, 2010. Interest of 8% is paid quarterly up until that settlement date. In addition, the debenture holders received warrants to purchase 2.3 million ADSs at an exercise price of $0.48 per ADS ($4.80 post share consolidation effective January 18, 2008). Notwithstanding any redemption of the debentures, the warrants will remain outstanding.
 
The fair value of the liability component was calculated using a market interest rate for an equivalent non-convertible debenture. The fair value of the Company's redemption option was determined using a Monte Carlo model and was nil at December 4, 2007 and December 31, 2007.

Gross proceeds received from the issue of the convertible debentures have been split between the liability element and an equity component, representing the fair value of the embedded option to convert the liability into equity as follows:



 
F-30

 



Group and Company
   
 
2007
2006
 
$’000
$’000
Gross proceeds of convertible debentures issued
2,750
Liability component at the date of issue
(2,055)
Equity and warrants component
695
 
     
Attributable to:
   
Fair value of warrants component                                                                                                                                    
550
Fair value of equity component                                                                                                                                    
145
Liability component at the date of issue                                                                                                                                    
695

The difference between the carrying amount of the liability component at the date of issue and the amount reported in the balance sheet at December 31, 2007 represents the change in amortized cost under the effective interest rate method. The fair value of the liability component was calculated using three years based on the terms of the contract. The expected life is four months from the date of issue as management expect a financing to be completed by the end of this period. Transaction costs of $217,000 have been allocated to the liability and equity component based on the relative fair values of these components on the date of issue.

22.  Accrued and other liabilities

   
Group
   
Company
 
   
2007
   
2006
   
2007
   
2006
 
      $’000       $’000       $’000       $’000  
                                 
Trade creditors
    3,462       2,096       841       396  
                                 
Current liabilities
                               
Obligations under finance leases
    10                    
Corporation tax payable
          94             94  
Other taxation and social security payable
    180       153       60       45  
Other creditors
    206       162       86       129  
Accruals and deferred income
    6,337       8,216       3,284       1,546  
      6,733       8,625       3,430       1,814  

Included in accruals and deferred income is an amount for $941,000 which relates to a termination payment to a former director and chief executive officer, Mr. Richard Stewart.

23.  Other liabilities

   
 Group
   
 Company
   
      2007       2006        2006        2007   
      $’000       $’000       $’000       $’000  
Obligations under finance leases                                                                                                                 
    36                    

Analysis of repayments

The future minimum lease payments to which the Group and the Company are committed under finance leases are as follows:

 
Group
Company
 
2007
2006
2007
2006
 
$’000
$’000
$’000
$’000
Not later than one year
13
Later than one year and not later than five years
40
Less: future finance charges on finance leases
(7)
 
46
Less: current maturities
(10)
Long-term maturity
36


Finance lease liabilities are in respect of office equipment with lease terms of five years. Finance lease liabilities are effectively secured obligations, as the rights to the leased asset revert to the lessor in the event of default. The fair value of the finance lease liabilities is not materially different to their carrying value.

 
 
F-31

 


24.  Provisions

Group and Company
   
Ester milestone
   
Onerous lease
   
National
insurance
   
Total
 
      $’000       $’000       $’000       $’000  
At January 1, 2006                                                                                                                   
          220       15       235  
Charged to the income statement                                                                                                                   
                218       218  
Released to the income statement                                                                                                                   
          (69 )     (114 )     (183 )
At December 31, 2006                                                                                                                   
          151       119       270  
Capitalized to intangible assets                                                                                                                   
    4,756                   4,756  
Charged to the income statement                                                                                                                   
          957             957  
Released to the income statementts
          (41 )     (119 )     (160 )
At December 31, 2007                                                                                                                   
    4,756       1,067             5,823  

At December 31, 2007 provisions due within one year was $5,217,000 (December 31, 2006: $160,000). Provisions greater than one year was $606,000 (December 31, 2006: $110,000). The provision for the Ester milestone of $4,756,000 at December 31, 2007 relates to the fair value of the contingent consideration payable to former Ester shareholders on the achievement of a certain milestone as a result of the acquisition of Ester Neurosciences Limited on December 5, 2007. The achievement of this milestone is considered to be probable and is recognized as a liability. See note 3 for further information.

At December 31, 2007 it was decided to vacate our premises at Curzon Street, London. We are obliged to pay rent, service charges and rates to the end of the lease which expires on March 20, 2010. We have fully provided for these costs.

In December 2005 we had a lease at a premises in Ely, Cambridgeshire which became onerous. We are obliged to pay rent, service charges and rates to the end of the lease which expires in November 2014. We have fully provided for these costs.

The provision for employer’s National Insurance contributions relates to amounts due on the exercise of certain share options held by employees which will accumulate over the vesting period of the relevant options. Due to the decline in the share price during the year, there is no provision for National Insurance at December 31, 2007.

25.  Financial risk management

The Group and Company’s activities expose it to a variety of financial risks: market risk (including currency risk and interest rate risk), liquidity and credit risk. There is no material price risk for the Group and Company. Details of the Group’s financial instruments with regard to liquidity risk, interest rate risk and foreign currency risk are disclosed in the following sections to this note. It has been, and continues to be, the policy of the Board to minimize the exposure of the Group to these risks.

The Group and Company use certain derivative instruments to hedge exposures from time to time.

The Group has available financial instruments including borrowings, finance leases, cash and other liquid resources, and various items, such as receivables, trade payables, that arise directly from its operations.

The balance sheet positions at December 31, 2007 and 2006 is representative of the position throughout the period as cash and short-term investments, loans and shares fluctuate considerably depending on when fund-raising activities have occurred.

Liquidity risk

The Group has historically financed its operations through a number of equity finances. The Group has, where possible, entered into long term borrowing facilities in order to protect short term liquidity. More recently, Amarin has raised finance by offerings of ordinary shares and convertible debentures and intends to obtain additional funding through earning license fees from existing and new partners for its drug development pipeline, the receipt of proceeds from the exercise of outstanding warrants and options and/or completing further equity-based financings.

 
F-32

 


 
The table below analyses the Group and Company’s financial liabilities into relevant maturity groupings based on the remaining period at the balance sheet date to the contractual maturity date. With the exception of borrowings, all the amounts disclosed in the table are equal to their carrying balances as the impact of discounting is not significant. The amounts disclosed for borrowings are the contractual undiscounted cash flows and hence will not agree to the amount disclosed on the balance sheet.

Group
 
At December 31 2007
Less than
Between 1
Between 2
Over 5
 
1 year
and 2 years
and 5 years
years
 
$’000
$’000
$’000
$’000
Borrowings
    220
   220
2,970
   —
Trade and other payables
10,187
   —
   —
   —
Finance Leases
    13
     13
     27
   —
         
         
At December 31 2006
Less than
Between 1
Between 2
Over 5
 
1 year
and 2 years
and 5 years
years
 
$’000
$’000
$’000
$’000
Borrowings
    —
    —
    —
   —
Trade and other payables
10,627
    —
    —
   —
 
 
   
 
Company
       
         
At December 31 2007
Less than
Between 1
Between 2
Over 5
 
1 year
and 2 years
and 5 years
years
 
$’000
$’000
$’000
$’000
Borrowings
   220
    220
2,970
   —
Trade and other payables
4,271
    —
    —
   —
   
 
   
         
At December 31 2006
Less than
Between 1
Between 2
Over 5
 
1 year
and 2 years
and 5 years
years
 
$’000
$’000
$’000
$’000
Borrowings
    —
    —
    —
   —
Trade and other payables
2,115
    —
    —
   —
 

Credit risk

The Group and Company is exposed to credit-related losses in the event of non-performance by third parties to financial instruments. Credit risk arises predominantly from cash and cash equivalents. For banks and institutions, only independently rated parties with a minimum rating of ‘A’ are accepted. All banks used by the Group and Company are ‘AA’ rated.

Creditor payment policy

It is Amarin’s normal procedure to agree terms of transactions, including payment terms, with suppliers in advance. Payment terms vary, reflecting local practice throughout the world. It is Amarin’s policy that payment is made on time, provided suppliers perform in accordance with the agreed terms.

 
F-33

 


Amarin’s policy follows the DTI’s Better Payment Policy, copies of which can be obtained from the Better Payments Group’s website.

Interest rate risk profile of financial liabilities

The Group’s financial liabilities comprised trade and other payables, borrowings and finance leases.

   
2007
   
2006
 
   
Floating
Rate
   
Fixed
Rate
   
No
Interest
   
Total
   
Floating
Rate
   
Fixed
Rate
   
No
Interest
   
Total
 
      $000       $000       $000       $000       $000       $000       $000       $000  
Sterling                                                                         
          46       5,144       5,190                   6,795       6,795  
Euro                                                                         
                2,290       2,290                   1,300       1,300  
U.S. Dollar                                                                         
          2,750       2,704       5,454                   2,532       2,532  
NIS                                                                         
                49       49                          
Total                                                                         
          2,796       10,187       12,983                   10,627       10,627  

The Company’s financial liabilities comprised trade and other payables, borrowings and finance leases.

   
2007
   
2006
 
   
Floating
Rate
   
Fixed
Rate
   
No
Interest
   
Total
   
Floating
Rate
   
Fixed
Rate
   
No
Interest
   
Total
 
      $000       $000       $000       $000       $000       $000       $000       $000  
Sterling                                                                         
                1,972       1,972                   1,833       1,833  
Euro                                                                         
                813       813                   130       130  
U.S. Dollar                                                                         
          2,750       1,486       4,236                   152       152  
Total                                                                         
          2,750       4,271       7,021                   2,115       2,115  

Interest rate risk profile of financial assets

The Group’s financial assets comprise cash, other receivables, short-term deposits and available for sale investments.

   
2007
   
2006
 
   
Floating
Rate
   
Fixed
Rate
   
No
Interest
   
Total
   
Floating
Rate
   
Fixed
Rate
   
No
Interest
   
Total
 
      $000       $000       $000       $000       $000       $000       $000       $000  
Sterling                                                                 
    9,046             343       9,389       23,773             288       24,061  
Euro                                                                 
    606             46       652       5,102             50       5,152  
U.S. Dollar                                                                 
    8,666             79       8,745       7,945             115       8,060  
NIS                                                                 
                57       57                          
Total                                                                 
    18,318             525       18,843       36,820             453       37,273  

The Company’s financial assets comprise cash, other receivables, short-term deposits and available for sale investments.

   
2007
   
2006
 
   
Floating
Rate
   
Fixed
Rate
   
No
Interest
   
Total
   
Floating
Rate
   
Fixed
Rate
   
No
Interest
   
Total
 
      $000       $000       $000       $000       $000       $000       $000       $000  
Sterling                                                                 
    8,950             176       9,126       22,635             133       22,768  
Euro                                                                 
    173             1       174       4,638             14       4,652  
U.S. Dollar                                                                 
    8,189             79       8,268       7,464             115       7,579  
Total                                                                 
    17,312             256       17,568       34,737             262       34,999  

The floating rate financial assets comprise cash balances. The majority of cash is generally held in floating rate accounts earning interest based on relevant national LIBID equivalents.



 
F-34

 



Interest sensitivity analysis

If interest rates had been 50 base points higher/lower and all other variables were constant, loss for the year ended December 31, 2007 would decrease/increase by $119,000 (2006: decrease/increase by $166,000). This is attributable to the Group and Company’s exposure to interest rates on its cash balances.

Foreign currency risk profile

The Group and Company undertakes certain transactions denominated in foreign currencies. Hence, exposures to exchange rate fluctuations arise.

The carrying amounts of the group’s foreign currency denominated monetary assets and liabilities at year ended December 31, 2007 are as follows:
 
 
   
Financial Assets
   
Financial Liabilities
 
      $’000       $’000  
Sterling                                                                                                                             
    9,389       5,190  
Euro                                                                                                                              
    652       2,290  
NIS                                                                                                                              
    57       49  
      10,098       7,529  

The carrying amounts of the group’s foreign currency denominated monetary assets and liabilities at year ended December 31, 2006 are as follows:

   
Financial Assets
   
Financial Liabilities
 
      $’000       $’000  
Sterling                                                                                                                             
    24,061       6,795  
Euro                                                                                                                              
    5,152       1,300  
NIS                                                                                                                             
           
      29,213       8,095  

The carrying amounts of the Company’s foreign currency denominated monetary assets and liabilities at year ended December 31, 2007 are as follows:

   
Financial Assets
   
Financial Liabilities
 
      $’000       $’000  
Sterling                                                                                                                             
    9,126       1,972  
Euro                                                                                                                              
    174       813  
      9,300       2,785  

The carrying amounts of the Company’s foreign currency denominated monetary assets and liabilities at year ended December 31, 2006 are as follows:

   
Financial Assets
   
Financial Liabilities
 
      $’000       $’000  
Sterling                                                                                                                             
    22,768       1,833  
Euro                                                                                                                              
    4,652       130  
      27,420       1,963  

 

 
F-35

 



Foreign currency sensitivity analysis

The Group and Company are mainly exposed to euro and sterling. The following table details the group’s sensitivity to a ten per cent increase and decrease in the unit of currency.
 
Impact on Profit or Loss
 of the Group
 
      2007 *     2006 *
      $’000       $’000  
Sterling                                                                                                                             
    420       1727  
Euro                                                                                                                              
    164       385  
NIS                                                                                                                             
    1        
                 
   
Impact on Profit or Loss
of the Company
 
      2007 *     2006 *
      $’000       $’000  
Sterling                                                                                                                             
    715       2,094  
Euro                                                                                                                             
    64       452  

* This is mainly attributable to the exposure outstanding on sterling and euro.

The Group and Company expect the primary currency to continue to be U.S. Dollars as the level of U.S. Dollar denominated financial assets and liabilities, including cash balances, increases as a result of future equity financings and/or license fees from partnering its drug development pipeline. We hold, and will continue to hold funds in currencies other than the U.S. Dollar, principally pounds sterling, euro and shekel to meet future expenditure requirements.

Capital risk management

The Group and Company’s objective when managing capital are to safeguard the Group and Company’s ability to continue as a going concern in order to provide returns for shareholders and benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital.
 
The Group and Company is primarily funded through equity and debt financing. Management believe that this method is sufficient to manage our capital requirements.

Fair values of financial assets and liabilities

The fair values of financial assets and liabilities have been established using the market rate where available. For those instruments without a market value a discounted cash flow approach has been used based on a cost of capital of 15%. There is no significant difference between the fair value and the carrying value of the Group's financial assets and liabilities as at December 31, 2007.

At December 31, 2007 and 2006, the Group had no overdraft facilities. The Group has no undrawn committed borrowing facilities as at December 31, 2007.

26.  Called-up share capital

   
2007
   
2006
 
      $’000       $’000  
Authorized
1,559,144,066 ordinary shares of £0.05 each (1,559,144,066 ordinary shares of £0.05 each for December 31, 2006)
      125,319         125,319  
440,855,934 preference shares of £0.05 (December 31, 2006: 440,855,434)
    40,566       40,566  
      165,885       165,885  
Allotted, called up and fully paid
               
139,057,370 ordinary shares of £0.05 each (December 31, 2006: 90,684,230)
    12,942       7,990  


 
F-36

 


On January 18, 2008 our Ordinary Shares were consolidated on a one-for-ten basis whereby ten Ordinary Shares of £0.05 each became one Ordinary Share of £0.50. The shares and share related information above and below has not been adjusted to give effect to this one-for-ten Ordinary Share consolidation.

Issue of share capital

In April 2007, the Company issued 420,000 shares due to the exercise of warrants of nominal value $42,000 in aggregate for the total consideration of $600,600. These warrants were issued as part of the financing completed in December 2005.

On June 1, 2007, the Company issued a total of 6,156,406 ordinary £0.05 shares in consideration for $3,700,000 (nominal value $610,000) and warrants to purchase 615,643 shares with an exercise price of $0.72 per share in a registered direct offering, the proceeds of which will be used to fund the combined operations of the Amarin group.

On June 1, 2007, the Company and an affiliate of a former shareholder, Southridge Capital entered into an equity line of credit agreement. A one time fee of $300,000 was paid to Southridge in connection with the agreement through the issuance of 499,168 ordinary shares (nominal value $49,000). The agreement provides Amarin with the option to draw down up to a total of $15.0 million of additional equity funding from time to time over a three year period. The amounts to be drawn down under the equity line of credit agreement are influenced by the average share price and traded share volumes in the valuation period. As of December 31, 2007, no amounts have been drawn down on this facility.

On December 5, 2007, the Company issued a total of 16,290,900 ordinary £0.05 shares in consideration for $5,376,000 (nominal value $1,677,000) and warrants to purchase 10,437,112 shares with an exercise price of $0.48 per share in a registered direct offering, the proceeds of which will be used to fund the combined operations of the Amarin Group.

On December 4, 2007, the Company issued a total of 25,000,000 ordinary £0.05 shares in consideration for the acquisition of Ester Neurosciences Limited (nominal value $2,574,000). See note 3 for further information.

In the twelve months to December 31, 2007, the Company issued 6,666 shares due to the exercise of share options of nominal value $600 in aggregate for a total consideration of $8,000.

On January 23, 2006, the Group issued a total of 840,000 ordinary £0.05 shares in consideration for $2,100,000 (nominal value of $75,000) in a private equity placement, the proceeds of which were used to fund the combined operations of the Amarin Group.

On March 31, 2006 the Group issued 2,383,293 ordinary £0.05 shares in consideration for $4,171,000 (nominal value $207,000) raised in a registered direct financing which was completed pursuant to pre-existing contractual commitments arising from a previously completed financing in May 2005, the proceeds of which were used to fund the combined operations of the Amarin Group.

On October 23, 2006 the Group issued 8,965,600 ordinary £0.05 shares in consideration for $18,738,000 (nominal value $845,000) raised in a private offering of equity, the proceeds of which were be used to fund the combined operations of the Amarin Group.

In the twelve months to December 31, 2006, the Group issued 694,693 shares due to the exercise of share options of nominal value $62,000 in aggregate for a total consideration of $1,037,000.

In the twelve months to December 31, 2006, the Group issued 251,788 shares due to the exercise of warrants of nominal value $23,000 in aggregate for a total consideration of $360,000. These warrants were issued as part of the financing completed in December 2005.

As at December 31, 2007, Amarin had 440,855,934 Preference Shares of £0.05 each forming part of its authorized share capital. Pursuant to an authority given by the shareholders at the 2007 Annual General Meeting Amarin’s board of directors has the authority to issue up to 440,855,934 preference shares of £0.05. Pursuant to article 6 of the articles of association, the Preference Shares may be issued in one or more separate series, each of which will constitute a separate class of shares. The board of directors has the authority under article 5 of the articles of association to issue Preference Shares with such rights and subject to such restrictions and limitations as the directors shall determine  including dividend rights, conversion rights, voting rights, rights and terms of redemption, and liquidation preference, any or all of which may be greater than the rights of the ordinary shares. As at December 31, 2007, Amarin’s board of directors had not issued any such preference shares.
 
The issuance of preference shares could adversely affect the voting power of holders of ordinary shares and reduce the likelihood that ordinary shareholders will receive dividend payments and payments upon liquidation. The issuance could have the effect of decreasing the market price of our ordinary shares. The issuance of preference shares also could have the effect of delaying, deterring or preventing a change in control of the Group.
 
The Group’s articles of association and English Law provide that the holders of preference shares will have the right to vote separately as a class on any proposal involving changes that would adversely affect the powers, preferences, or special rights of holders of that preference share.
 
On May 16, 2008, pursuant to articles 5 and 6 of the articles of association, the board of directors resolved that:
 
●  
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.
 
The Series A Preference Shares
 
Eight Series A Preference Shares have been designated for issuance and were issued to certain investors in the first tranche of a two-tranche private placement in May of 2008.
 
Pursuant to the rights of the Series A Preference Shares, the consent of the holders of at least two-thirds of the Series A Preference Shares is required to increase the number of members on our Board to more than eight (8) or, after the time the additional director described below is required to be added to the Board, to more than nine (9).  Holders of the Series A Preference Shares are entitled to elect four (4) members to our Board (the “Series A Directors”).  In voting for the Series A Directors other than at a general meeting of shareholders, the voting power of the Series A Preference Shares will be determined pro rata among the holders thereof based on each such holder’s ownership of Ordinary Shares as a percentage of all Ordinary Shares owned by the Series A Holders.  In voting for the Series A Directors at a general meeting, each holder of Series A Preference Shares will be entitled to a number of votes equal to (x) five (5) times the number of Ordinary Shares then outstanding times (y) such holder’s percentage ownership of all the Ordinary Shares owned by the Series A Holders.  Except as described herein, the Series A Preference Shares do not entitle holders thereof to vote at general meetings of shareholders.
 
If an additional director who is mutually acceptable to the directors who are not Series A Directors, on the one hand, and the majority of the Series A Directors, on the other hand, is not appointed to the Board by August 22, 2008 or such a mutually acceptable director ceases to serve on the Board and is not replaced within 60 days, then the holders of the Series A Preference Shares will be entitled to elect a fifth Series A Director to serve until replaced by such a mutually acceptable director.
 

 
F-37

 
 
 
The majority of the Series A Directors also have the right to approve the composition of any committee of the Board, so long as such committee has an equal number Series A Directors and directors who are not Series A Directors.  Consent of the majority of the Series A Directors will be required in order to change the quorum necessary for transaction of business by the Board to any number other than six (6), comprising three (3) Series A Directors and three (3) directors who are not Series A Directors.
 
Each holder of Series A Preference Shares has a right of first refusal to purchase its pro rata share of any offering by us of Ordinary Shares or other capital stock, or securities convertible or exchangeable therefor, on the same terms as the other investors participating in such offering, subject to certain exceptions (which include issuances pursuant to approved option plans or, in certain cases, our existing equity line of credit).
 
The Series A Preference Shares will be automatically converted into Ordinary Shares at a rate of one Ordinary Share per Series A Preference Share if the holders of the Series A Preference Shares (including affiliates) cease to hold 33% of the Ordinary Shares purchased by them in the first and second tranches of the private placement or if the second tranche thereof is not funded and, if the second tranche is funded, as to any holder thereof that does not fund its pro rata share of such second tranche.
 
The consent of the holders of at least two-thirds of the Series A Preference Shares is required to issue any additional Series A Preference Shares, amend or alter the rights of the Series A Preference Shares, amend or alter certain of our Articles of Association if the effect thereof would be adverse or inconsistent with the specific rights of the Series A Preference Shares or authorize any additional equity securities which would have the effect of amending, altering or granting rights identical or superior to the specific rights of the Series A Preference Shares.
 
The Series A Preference Shares are not redeemable and rank pari passu with our Ordinary Shares with respect to dividends and rights on a liquidation, winding-up or dissolution.
 
27.  Options and warrants over shares of Amarin Corporation plc
 

Number of share
options outstanding
over £0.05 Ordinary
Shares*
   
Note
 
Date Option
Granted
 
Exercise price per
Ordinary Share*
   
Number of share
options repriced
at US$5.00 per
Ordinary Share
   
Number of share
options repriced
at US$0.44 per
Ordinary Share
 
               
US$
   
(Note 1)
   
(Note 20)
 
  100,000      
1
   
23 November 1998
    25.00       100,000        
  250,000       2    
23 November 1998
    5.00              
  5,000       3    
2 March 1999
    7.22              
  5,500       4    
7 September 1999
    3.00              
  37,500       4    
1 April 2000
    3.00              
  10,000       3    
7 April 2000
    3.00              
  5,000       4    
23 May 2000
    3.00              
  3,293       4    
26 September 2000
    3.00              
  10,000       3    
19 February 2001
    6.13              
  45,000       6    
4 June 2001
    8.65              
  15,000       6    
2 July 2001
    10.00              
  6,000       6    
27 July 2001
    12.88              
  186,500       6,7    
23 January 2002
    17.65              
  80,000       8    
18 February 2002
    13.26              
  20,000       7    
1 May 2002
    19.70              
  15,000       7    
1 May 2002
    21.30              
  5,000       7    
19 July 2002
    8.81              
  15,000       7    
5 September 2002
    3.33              
  60,000       7    
6 November 2002
    3.46              
  221,667       9    
6 November 2002
    3.10              
  105,933       10    
24 February 2003
    3.17              
  40,000       6    
29 April 2003
    2.82              
  10,000       7    
2 July 2003
    3.37              
  70,000       6    
21 November 2003
    2.38              
  375,000       6    
7 July 2004
    0.85              
  170,000       11    
21 July 2004
    0.84              
  210,000       12    
8 October 2004
    1.25              
  19,125       13    
8 October 2004
    1.25              
  20,000       6    
29 November 2004
    2.40              
  100,000       14    
28 February 2005
    3.04              
  100,000       14    
28 February 2005
    3.04              
  350,000       15    
28 February 2005
    3.04              
  10,000       6    
28 March 2005
    2.43              
  150,000       21    
10 June 2005
    1.30              
  200,000       16    
10 June 2005
    1.30              
  200,000       17    
28 June 2005
    1.09              
  160,000       6    
28 June 2005
    1.09              
 
 

 
F-38

Number of share options outstanding over £0.05 Ordinary Shares*  
   
  Note  
   
Date Option
Granted
   
Exercise price per
Ordinary Share*
    Number of share options repriced
at US$5.00 per Ordinary Share  
    Number of share options repriced
at US$0.44 per Ordinary Share  
 
                             
(Note 1)
     
(Note 20)
 
  20,000       6    
13 July 2005
    1.37              
  20,000       6    
1 September 2005
    1.44              
  10,000       6    
9 September 2005
    1.42              
  20,000       6    
20 September 2005
    1.49              
  100,000       6    
27 September 2005
    1.50              
  10,000       18    
28 October 2005
    1.38              
  325,000       19    
2 December 2005
    1.16              
  10,000       6    
12 December 2005
    1.18              
  120,000       6    
11 January 2006
    1.35              
  431,000       6    
12 January 2006
    1.53              
  100,000       21    
16 January 2006
    1.95              
  200,000       6    
16 January 2006
    1.95              
  80,000       6    
27 January 2006
    2.72              
  100,000       6    
3 February 2006
    3.46              
  20,000       6    
20 March 2006
    3.26              
  30,000       5    
7 April 2006
    2.86              
  40,000       6    
5 May 2006
    2.95              
  20,000       6    
6 June 2006
    2.38              
  10,000       6    
10 July 2006
    2.40              
  10,000       6    
28 July 2006
    2.45              
  10,000       6    
20 September 2006
    2.65              
  10,000       6    
25 October 2006
    2.23              
  2,721,666       6,20    
8 December 2006
    2.30             2,721,666  
  266,666       20,21    
8 December 2006
    2.30             266,666  
  20,000       6,20    
8 January 2007
    2.27             20,000  
  20,000       6,20    
12 February 2007
    1.87             20,000  
  20,000       6,20    
19 February 2007
    1.83             20,000  
  20,000       6,20    
21 February 2007
    1.87             20,000  
  175,000       6,20    
23 February 2007
    1.80             175,000  
  75,000       6,20    
8 March 2007
    1.82             75,000  
  75,000       6,20    
15 March 2007
    2.49             75,000  
  600,000       6,20    
2 April 2007
    2.30             600,000  
  650,000       6,20    
9 April 2007
    2.49             650,000  
  350,000       6,20    
11 April 2007
    3.00             350,000  
  50,000       6    
4 June 2007
    0.60              
  450,000       6    
2 August 2007
    0.44              
  150,000       6    
28 August 2007
    0.46              
  30,000       6    
11 September 2007
    0.52              
  50,000       6    
12 September 2007
    0.54              
  10,804,850                           100,000       4,993,332  
 
Notes:

*
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.

A fresh issue of one ordinary £0.05 share was made for a consideration of £1. These proceeds were used by the Group to purchase the deferred shares in issue. The deferred shares were then cancelled by the Group and accordingly a transfer was made for the amount of $27,633,000 to the Capital Redemption Reserve. These changes do not affect the exercise prices of options.

During 2002, the nominal value of ordinary shares was converted from 10p to £1 each, resulting in the number of shares reducing by a factor of 10 and increasing the exercise price by a factor of 10.

 
1.
When granted these options were to become exercisable in tranches upon the Group’s share price achieving certain pre-determined levels. On February 9, 2000, the Group’s remuneration committee approved the re-pricing of these 100,000 options to an exercise price of US$0.50 per share (US$5.00 per share following the conversion of the nominal value of

 
F-39

 

 
ordinary shares from 10p to £1 in 2002; the 2004 conversion discussed above has no effect on the exercise price), and the Group entered into an amendment agreement on the same day amending the exercise price and also removing the performance criteria attached to such options. These options are currently exercisable and remain exercisable until November 23, 2008.

 
2.
Of these options 80% became exercisable immediately and 20% after six months from date of grant and are exercisable until ten years from date of grant.

 
3.
These options are exercisable now and remain exercisable until November 30, 2008.

 
4.
These options were granted to a former employee of Amarin Corporation plc, are now exercisable and expire on November 30, 2008.

 
5.
These options were granted to a former employee of Amarin Corporation plc. These options became exercisable on the date of grant and expire on May 31, 2009.

 
6.
These options become exercisable in tranches of 33% over three years on the first, second and third anniversary of the date of grant and expire 10 years from the date of the grant.

 
7.
These options become exercisable in tranches of 33% over three years on the first, second and third anniversary of the date employment commences. The options expire 10 years from the date of the grant.

 
8.
These options became exercisable in October 2005 and expire on March 31, 2009.

 
9.
These options become exercisable in tranches of 33% over three years on the first, second and third anniversary of the date of grant and expire 10 years from the date of the grant. Of these options 26,667 were immediately vested in October 2005 and expiry dated March 31, 2009.

 
10.
These options become exercisable in tranches of 33% over three years on the first, second and third anniversary of the date of grant and expire 10 years from the date of the grant. Of these options 65,933 were immediately vested in October 2005 and expiry dated March 31, 2009.

 
11.
These options become exercisable in tranches of 33% over three years on the first, second and third anniversary of the date of grant and expire 10 years from the date of the grant. Of these options 125,000 were immediately vested in October 2005 and expiry dated March 31, 2009.

 
12.
Of these options, 40,000 were issued to a consultant and 170,000 were issued to employees of Amarin Neuroscience Limited (formerly Laxdale Limited) on the date of acquisition by the Group and become exercisable in tranches of 33% over three years on the first, second and third anniversary of the date of grant and expire 10 years from the date of the grant. Of these options, 5,125 were immediately vested in June 2005 with expiry dated January 31, 2007.

 
13.
These options were issued to employees of Amarin Neuroscience Limited (formerly Laxdale Limited) on the date of acquisition by the Group in consideration of the cancellation of a comparable number of stock options (in value terms) previously held by these employees in Amarin Neuroscience Limited. All these options are fully vested.

 
14.
These options became exercisable on the date of grant and expire 10 years from the date of the grant.

 
15.
These options become exercisable, subject to performance criteria, in tranches of 33% over three years on the first, second and third anniversary of the date of grant and expire 10 years from the date of the grant.

 
16.
These options become exercisable in tranches of 50% on the second anniversary, 25% on the third anniversary and 25% on the fourth anniversary of the date of grant and expire 10 years from the date of the grant.

 
17.
These options became exercisable on the date of grant and expire 4 years from the date of grant.

 
F-40

 
 
 
 
 
18.
These options became exercisable on the date of grant and expire 5 years from the date of grant.

 
19.
These options were granted prior to commencement of employment and become exercisable in tranches of 33% over three years on the first, second and third anniversary of the date of grant and expire 10 years from the date of the grant.
 
20.      
Following the significant decline in the Company's stock price as a result of the disappointing outcome of the two Phase III studies of AMR 101 conducted by the Company in Huntington’s Disease, the Remuneration Committee (the “Committee”) reviewed the effect of that decline on certain awards of stock options previously made to Directors, employees and the Board's Scientific Advisor under the Company's 2002 Stock Option Plan and has determined that, in order to incentivise Directors, employees and the Board's Scientific Advisor in relation to future performance and to re-align their interests with those of the Company's shareholders, the option exercise price stated in all Award Agreements relating to stock options granted in the period from December 8, 2006 to April 11, 2007 should be amended so that it will be equal to the sale price of the Company's American Depositary Receipts at market close on NASDAQ on the last trading day preceding a meeting of the Committee to be convened as soon as practicable following the AGM. The Committee was conscious that shareholders may potentially be sensitive to the making of such amendments to the Award Agreements and considers it appropriate that the shareholders approve the Committee’s action in making such amendments.  At the Annual General Meeting held on July 19, 2007, a resolution to the above affect was approved by the shareholders. On August 2, 2007 the Remuneration Committee approved the amendment. The new strike price for these stock options was set at $0.44.

21.     
On December 19, 2007 (“Termination Date”), Rick Stewart, Amarin’s Chief Executive Officer resigned. Mr Stewart’s vested options became exercisable for a period of 12 months following the Termination Date in accordance with the terms of the 2002 Stock Option Plan and upon the expiration of such 12 month period, Mr. Stewart’s vested options shall cease to be exercisable and shall expire. Mr Stewart’s options which had not vested as at the Termination Date expired and accordingly are no longer exercisable after the Termination Date and accordingly, expired on the Termination Date.

Warrants in shares of Amarin Corporation plc

At December 31, 2007, warrants have been granted over ordinary shares as follows:

 
Number of warrants
outstanding
 
Note
 
Date warrant granted
Exercise price per
ordinary share
Share price at date
of issue
Fair value per warrant
at date of issue
313,234
1
27 January 2003
US$3.48
US$2.84
US$2.13
500,000
2
25 February 2004
US$1.90
US$1.68
US$1.28
8,463,246
3
21 December 2005
US$1.43
US$1.19
US$0.91
294,000
4
26 January 2006
US$3.06
US$2.72
US$2.10
175,000
5
27 April 2007
US$1.79
US$1.82
US$1.49
615,643
6
1 June 2007
US$0.72
US$0.60
US$0.49
30,000
7
21 June 2007
US$0.60
US$0.54
US$0.37
10,000
8
29 November 2007
US$0.34
US$0.36
US$0.30
10,437,112
9
4 December 2007
US$0.48
US$0.36
US$0.24
20,838,235
         

(1)
During January 2003, 313,234 warrants were issued to Security Research Associates Inc. and may be exercised between 27 January 2004 and 26 January 2008.
   
(2)
In February 2004, all debt obligations due to Elan were settled by a cash payment of $17,195,000 (part of which represented the cost of acquiring Zelapar that was concurrently sold to Valeant) and the issuance of a loan note for $5,000,000 and 500,000 warrants granted to Elan at a price of $1.90 and exercisable from 25 February 2004 to 25 February 2009. During September 2004, Elan sold its remaining interests in Amarin to Amarin Investment Holding Limited, an entity controlled by Amarin’s Chairman and Chief Executive Officer, Mr. Thomas Lynch. These interests included Elan’s equity interest, the $5,000,000 loan note and the 500,000 warrants.
   
(3)
During December 2005, 9,135,034 warrants were issued to those investors at a rate of approximately 35% of shares acquired. These warrants were granted at a price of $1.43 and are exercisable from 19 June 2006 to 21 December 2010. If our trading market price is equal to or above $4.76, as adjusted for any stock splits, stock combinations, stock dividends and other similar events, for each of any twenty consecutive trading days, then the Group at any time thereafter shall have the right, but not the obligation, on 20 days’ prior written notice to the holder, to cancel any unexercised portion of this warrant for which a notice of exercise has not yet been delivered prior to the cancellation date.

 
F-41

 


   
(4)
During January 2006, via the private placement referred to in note 26, 240,000 warrants were issued to those investors at a rate of approximately 35% of shares acquired. These warrants were granted at a price of $3.06 and are exercisable from 25 July 2006 to 26 January 2011. If our trading market price is equal to or above $10.20, as adjusted for any stock splits, stock combinations, stock dividends and other similar events, for each of any twenty consecutive trading days, then the Group at any time thereafter shall have the right, but not the obligation, on 20 days’ prior written notice to the holder, to cancel any unexercised portion of this warrant for which a notice of exercise has not yet been delivered prior to the cancellation date.
   
(5)
In April 2007, 175,000 warrants were issued in consideration for termination and release of certain contractual obligations and a license of certain intellectual property rights pursuant to an agreement between NeuroStat, Amarin Pharmaceuticals Ireland Limited, Amarin Corporation plc and Tim Lynch. These warrants were granted at a price of $1.79 and are exercisable from April 27, 2007 to January 17, 2014. The fair value of these warrants were expensed to the income statement in accordance with IFRS 2.
   
(6)
During June 2007, via the registered direct offering referred to in note 26, 615,643 warrants were issued to those investors at a rate of approximately 10% of shares acquired.  These warrants were granted at a price of $0.72 and are exercisable from June 1, 2007 to May 31, 2012. If our trading market price is equal to or above $1.80, as adjusted for any stock splits, stock combinations, stock dividends and other similar events, for each of any twenty consecutive trading days, then the Group at any time thereafter shall have the right, but not the obligation, on 20 days’ prior written notice to the holder, to cancel any unexercised portion of this warrant for which a notice of exercise has not yet been delivered prior to the cancellation date.
   
(7)
During June 2007, 30,000 warrants were issued in consideration for advisory services performed by ProSeed pursuant to an advisory services agreement between ProSeed and Amarin Corporation plc.  These warrants were granted at a price of $0.60 and are exercisable from June 21, 2007 to June 20, 2010. The fair value of these warrants were expensed to the income statement in accordance with IFRS 2. If our trading market price is equal to or above $1.80, as adjusted for any stock splits, stock combinations, stock dividends and other similar events, for each of any twenty consecutive trading days, then the Group at any time thereafter shall have the right, but not the obligation, on 20 days’ prior written notice to the holder, to cancel any unexercised portion of this warrant for which a notice of exercise has not yet been delivered prior to the cancellation date.
   
(8)
During November 2007, 10,000 warrants were issued in consideration for consulting services performed by Strategic Pharmaceuticals Solutions, Inc., pursuant to the Consulting Agreement, dated as of July 31, 2007, by and among Amarin Pharmaceuticals Ireland Limited, a wholly owned subsidiary of the Company, and the Strategic Pharmaceuticals Solutions, Inc. The fair value of these warrants were expensed to the income statement in accordance with IFRS 2. These warrants were granted at a price of $0.34 and are exercisable from November 29, 2007 to November 28, 2012.
   
(9)
During December 2007, via the registered direct offering referred to in note 26, 8,145,446 warrants were issued to those equity investors at a rate of approximately 50% of shares acquired and 2,291,666 warrants were issued to those convertible debt investors at a rate of approximately 40% of debt acquired.  These warrants were granted at a price of $0.48 and are exercisable from December 4, 2007 to December 3, 2012. If our trading market price is equal to or above $0.915, as adjusted for any stock splits, stock combinations, stock dividends and other similar events, for each of any twenty consecutive trading days, then the Group at any time thereafter shall have the right, but not the obligation, on 20 days’ prior written notice to the holder, to cancel any unexercised portion of this warrant for which a notice of exercise has not yet been delivered prior to the cancellation date.  Per the warrant agreement, if at any time prior to December 6, 2009, the Company issues Ordinary Shares, securities convertible into ADSs or Ordinary Shares, warrants to purchase ADSs or Ordinary Shares or options to purchase any of the foregoing to a third party (other than any Exempt Issuance) at a price that is less than, or converts at a price that is less than, $3.66 (such lesser price, the “Down-round Price”), then the Exercise Price shall be adjusted to equal 130% of the Down-round Price.  On May 14, 2008, we announced a private placement of Ordinary Shares for up to $60.0 million. The first tranche from new investors of $28.0 million closed on May 19, 2008 (see note 33  for further details). These warrants have therefore been re-priced to $2.99 per share from their original grant price of $4.80 per share  ( post share consolidation effective January 18, 2008).


 
 
F-42

 



28. Share-based compensation

The Amarin Corporation plc 2002 Stock Option Plan came into effect on January 1, 2002. The term of the plan is ten years, and no award shall be granted under the plan after January 1, 2012.

The plan is administered by the remuneration committee of our board of directors. A maximum of 8,000,000 Ordinary Shares may be issued under the plan. This limit was increased to 8,986,439 Ordinary Shares by the Remuneration Committee of the Group on December 6, 2006, pursuant to section 4(c) of the Plan to prevent dilution of the potential benefits available under the Plan as a result of certain discounted share issues. This limit was further increased to 12,000,000 Ordinary Shares at an Extraordinary General Meeting held on January 25, 2007. This limit was further increased to 18,000,000 Ordinary Shares at an Annual General Meeting held on July 19, 2007. Directors, employees, officers, consultants and independent contractors are eligible persons under the plan.

Effective January 1, 2006, IFRS 2 was adopted and the comparative amounts were restated where applicable. The operating loss includes a non cash charge of $5.0 million for the year ended December 31, 2007 in respect of share-based compensation. The charge for the year is spilt $3.7 million and $1.3 million between selling, general and administration and research and development respectively. The corresponding figure the year ended December 31, 2006 is $2.2 million (spilt $1.5 million and $0.7 million between selling, general and administration and research and development respectively). The adoption of IFRS 2 has no impact on the net assets of the Group.

Following the significant decline in the Company's stock price as a result of the disappointing outcome of the two Phase III studies of AMR 101 conducted by the Company in Huntington’s disease, the Remuneration Committee (“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 would 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 2007 Annual General Meeting (“2007 AGM”). The Committee was conscious that shareholders might potentially be sensitive to the making of such amendments to the Award Agreements and considered it appropriate that the shareholders approve the Committee’s action in making such amendments.  At the 2007 AGM held on July 19, 2007, a resolution to the above affect was approved by the shareholders. On August 2, 2007, the Committee approved the amendment of the exercise price of 5,526,666 stock options held by employees to $0.44 from original exercise prices ranging between $1.80 and $3.00 per share. The incremental fair value was the fair value of the options at the date of the amendment of the exercise price, based on the new exercise price less the fair value of the options at the date of the amendment of the exercise price, based on the original exercise price. This incremental fair value was then expensed over the remaining vesting period of the options, in addition to the expense originally recognized.   As a result of the amendment, under IFRS 2, the company has recognized incremental compensation expense related to the increase in fair value due to the modification of $143,000 in the twelve months to December 31, 2007. The total incremental compensation expense at the date of modification was $368,000.

In December 2007, we entered in to a Collaboration Agreement with ProSeed Capital Holdings CVA (“Proseed”).  Pursuant to this agreement we agreed to pay Proseed 975,000 ordinary shares in consideration for advisory services performed by Proseed in respect of the acquisition of Ester (see note 3).  The fair value of these shares is $350,000 which corresponds to 975,000 ordinary shares at $0.36 per share determined with reference to the price of our ADSs on the Nasdaq Capital Market on December 4, 2007, the date prior to the closing of the Ester acquisition.






 
F-43

 




A summary of activity under the 2002 Stock Option Plan for the years ended December 31, 2007 and December 31, 2006 is as follows:

 
 
 
 
2007
Options
2007
Weighted
average
exercise
price
 
 
 
2006
Options
2006
Weighted
average
exercise
price *
   
$
 
$
Outstanding at January 1,                                                                         
8,964,975
1.99
4,821,952
3.55
Granted                                                                         
2,735,000
0.45
4,907,666
0.88
Exercised                                                                         
(6,666)
1.25
(694,643)
1.49
Lapsed                                                                         
(888,459 )
0.93
(70,000 )
8.79
Outstanding at December 31,                                                                         
10,804,850
1.69
8,964,975
1.99
Exercisable at December 31,                                                                         
5,113,073
2.75
2,677,308
4.28

* Comparative information for December 31, 2006 has been updated to reflect the option exercise price amendment described above.

During the 12 months ended December 31, 2007 and December 31, 2006 all options were granted at the market price. Options outstanding and exercisable at the 12 months ended December 31, 2007 and December 31, 2006 had the following attributes:

   
2007
options
   
2007
Weighted
average
exercise
price
   
2006
options
   
2006
Weighted
average
exercise
price *
 
         
 $
             
$
 
Outstanding at December 31,
Options granted at market price                                                                                  
    9,759,390       1.11       7,919,515       1.32  
Options granted at a discount to the market price                                                                                  
    697,793       8.01       697,793       8.01  
Options granted at a premium to the market price                                                                                  
    347,667       5.25       347,667       5.25  
Exercisable at December 31,
Options granted at market price                                                                                  
    4,067,613       1.64       1,631,848       2.47  
Options granted at a discount to the market price                                                                                  
    697,793       8.01       697,793       8.01  
Options granted at a premium to the market price                                                                                  
    347,667       5.25       347,667       5.25  

* Comparative information for December 31, 2006 has been updated to reflect the option exercise price amendment described above.

The weighted average fair value of the stock options granted during the year ended December 31, 2007 was $1.37 (December 31, 2006: $1.58).

For the 12 months ended December 31, 2007, we received $8,000 from the exercise of share options. During the 12 months ended December 31, 2007, 888,459 options forfeited.

On December 19, 2007, Richard Stewart, Amarin’s Chief Executive Officer resigned. Mr. Stewart’s vested options became exercisable for a period of 12 months following December 19, 2007 in accordance with the terms of the 2002 Stock Option Plan and upon the expiration of such 12 month period, Mr. Stewart’s vested options shall cease to be exercisable and shall be forfeited. Mr. Stewart’s options which had not vested as at December 19, 2007 have forfeited and accordingly are no longer exercisable.




 
F-44

 





The following assumptions were used to estimate the fair values of options granted:

 
Year ended
December 31
2007
Year ended
December 31
2006
Risk free interest rate (percentage)                                                                                                                                
4.58
4.47
Volatility (percentage)                                                                                                                                
100%
98%
Expected forfeiture rate (percentage)                                                                                                                                
5%
5%
Dividend yield                                                                                                                                
Expected option life                                                                                                                                
4
4
Forced exercise rate (percentage)                                                                                                                                
10%
10%
Minimum gain for voluntary exercise rate (percentage)                                                                                                                                
33%
33%
Voluntary early exercise at a minimum gain rate (percentage)                                                                                                                                
50%
50%

Employee stock options generally vest over a three-year service period. Employee Stock Options are equity settled. Compensation expense recognized for all option grants is net of estimated forfeitures and is recognized over the awards’ respective requisite service periods. The fair values relating to all options granted were estimated on the date of grant using the Binomial Lattice option pricing model. Expected volatilities are based on historical volatility of our stock and other factors, such as implied market volatility. This is based on analysis of daily price changes over a four year measurement period from the period end, December 31, 2007. We used historical exercise data based on the age at the grant of the option holder to estimate the option’s expected term, which represents the period of time that the options granted are expected to be outstanding. The risk free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. We recognize compensation expense for the fair values of those awards which have graded vesting on an accelerated recognition basis.

In 2007, the Group did not accelerate the vesting of any options. In 2006, the Group accelerated the vesting of 118,750 options held by terminated employees. The Group recorded an expense of $84,000 in 2006 for options with accelerated vesting terms. The unvested component of these options has been expensed in the period in which the employees were terminated.

Exercise
price ($)
 Date of
 Expiry
Number
Outstanding at
December 31, 2007
Number
Exercisable at
December 31, 2007
Number
Outstanding at
December 31, 2006
Number
Exercisable at
December 31, 2006
       0.54
12-Sep-17
                 50,000
-
-
-
       0.52
11-Sep-17
                 30,000
-
-
-
       0.46
28-Aug-17
               150,000
-
-
-
       0.44
2-Aug-17
               300,000
-
-
-
       0.44
2-Aug-17
               150,000
-
-
-
       0.60
4-Jun-17
               50,000
-
-
-
       0.44
11-Apr-17
               350,000
-
-
-
       0.44
9-Apr-17
               650,000
-
-
-
       0.44
2-Apr-17
               600,000
-
-
-
       0.44
15-Mar-17
                 75,000
-
-
-
       0.44
8-Mar-17
                 75,000
-
-
-
       0.44
23-Feb-17
               175,000
-
-
-
       0.44
21-Feb-17
                 20,000
-
-
-
       0.44
19-Feb-17
                 20,000
-
-
-
       0.44
12-Feb-17
                 20,000
-
-
-
       0.44
8-Jan-17
                 20,000
-
-
-
       0.44
7-Dec-16
             2,721,666
907,222
             3,521,666
-
       2.23
24-Oct-16
                 10,000
3,333
                 10,000
-

 
F-45

 


Exercise
price ($)
 Date of
 Expiry
Number
Outstanding at
December 31, 2007
Number
Exercisable at
December 31, 2007
Number
Outstanding at
December 31, 2006
Number
Exercisable at
December 31, 2006
       2.65
19-Sep-16
                 10,000
3,333
                 10,000
-
       2.45
27-Jul-16
                 10,000
3,333
                 10,000
-
       2.40
9-Jul-16
                 10,000
3,333
                 10,000
-
       2.38
5-Jun-16
                 20,000
6,667
                 20,000
-
       2.95
4-May-16
                 40,000
13,333
                 40,000
-
       2.86
6-Apr-16
                 30,000
30,000
                 30,000
-
       3.26
19-Mar-16
                 20,000
6,667
                 20,000
-
       3.46
3-Feb-16
               100,000
33,333
               100,000
-
       2.72
27-Jan-16
                 80,000
26,667
                 80,000
-
       1.95
16-Jan-16
               200,000
66,667
               500,000
-
       1.53
12-Jan-16
               431,000
143,667
               431,000
-
       1.35
11-Jan-16
               120,000
40,000
               120,000
-
       1.18
12-Dec-15
10,000
6,667
10,000
3,333
       1.16
2-Dec-15
325,000
216,667
325,000
108,333
       1.50
27-Sep-15
100,000
66,667
100,000
33,333
       1.49
20-Sep-15
20,000
13,333
20,000
6,667
       1.42
9-Sep-15
10,000
6,667
10,000
3,333
       1.44
1-Sep-15
20,000
13,333
20,000
6,667
       1.37
13-Jul-15
20,000
13,333
20,000
6,667
       1.09
28-Jun-15
200,000
200,000
200,000
200,000
       1.09
28-Jun-15
160,000
106,667
160,000
53,333
       1.30
10-Jun-15
200,000
100,000
500,000
-
       2.43
28-Mar-15
10,000
6,667
10,000
3,333
       3.04
28-Feb-15
550,000
433,333
550,000
316,667
       2.40
28-Nov-14
20,000
20,000
20,000
13,333
       1.25
7-Oct-14
40,000
40,000
40,000
26,667
       0.84
20-Jul-14
170,000
170,000
170,000
113,333
       0.85
6-Jul-14
375,000
375,000
375,000
250,000
       2.38
21-Nov-13
70,000
70,000
70,000
70,000
       3.37
22-Jul-13
10,000
10,000
10,000
10,000
       2.82
28-Apr-13
40,000
40,000
40,000
40,000
       3.17
23-Feb-13
40,000
40,000
40,000
40,000
       6.13
18-Feb-13
10,000
10,000
10,000
10,000
       3.10
5-Nov-12
45,000
45,000
45,000
45,000
       3.33
16-Aug-12
15,000
15,000
15,000
15,000
       3.46
18-Jul-12
60,000
60,000
60,000
60,000
       8.81
15-May-12
5,000
5,000
5,000
5,000
      13.26
3-Mar-12
80,000
80,000
80,000
80,000
      19.70
10-Feb-12
20,000
20,000
20,000
20,000
      17.65
22-Jan-12
36,500
36,500
36,500
36,500
      21.30
30-Sep-11
15,000
15,000
15,000
15,000
      12.88
26-Jul-11
6,000
6,000
6,000
6,000
      10.00
1-Jul-11
15,000
15,000
15,000
15,000
       8.65
3-Jun-11
45,000
45,000
45,000
45,000
       1.38
28-Oct-10
10,000
10,000
10,000
10,000
       1.25
31-Mar-09
189,125
189,125
195,791
195,791
       3.17
31-Mar-09
65,933
65,933
65,933
65,933
       3.10
31-Mar-09
26,667
26,667
26,667
26,667
       0.44
19-Dec-08
               266,666
266,666
-
-

 
F-46

 


Exercise
price ($)
Date of
 Expiry
Number
Outstanding at
December 31, 2007 
Number
Exercisable at
December 31, 2007 
Number
Outstanding at
December 31, 2006 
Number
Exercisable at
December 31, 2006 
       1.95
19-Dec-08
               100,000
100,000
-
-
       1.30
19-Dec-08
150,000
150,000
-
-
       3.10
19-Dec-08
150,000
150,000
150,000
150,000
      17.65
19-Dec-08
150,000
150,000
150,000
150,000
       7.22
30-Nov-08
5,000
5,000
5,000
5,000
       3.00
30-Nov-08
51,293
51,293
51,293
51,293
       3.00
30-Nov-08
10,000
10,000
10,000
10,000
       5.00
23-Nov-08
250,000
250,000
250,000
250,000
       5.00
23-Nov-08
100,000
100,000
100,000
100,000
       1.25
31-Jan-07
-
-
5,125
5,125
           
   
10,804,850
5,113,073
8,964,975
2,677,308

29.  Capital commitments

Capital expenditure that has been contracted for but has not been provided for in the financial statements amounted to $nil at December 31, 2007 (December 31, 2006: $nil).

30.  Financial commitments

The Group and Company had future minimum payments under non-cancellable operating leases as follows:

   
2007
Land and buildings
   
2006
Land and buildings
 
   
Group
   
Company
   
Group
   
Company
 
      $’000       $’000       $’000       $’000  
Not later than one year                                                                                                        
    1,278       715       1,235       687  
Later than one year and not later than five years
    2,755       1,714       3,637       2,096  
Later then five years                                                                                                        
    496       496       741       741  
      4,529       2,925       5,613       3,524  

The Group and Company’s minimum sublease payments receivable under non-cancellable operating subleases are as follows:

   
2007
Land and buildings
   
2006
Land and buildings
 
   
Group
   
Company
   
Group
   
Company
 
      $’000       $’000       $’000       $’000  
Not later than one year                                                                                                        
    265       265       260       260  
Later than one year and not later than five years
    562       562       812       812  
Later then five years                                                                                                        
                       
      827       827       1,072       1,072  

On April 27, 2001 the Group acquired a nine year lease for premises in London, U.K. In prior years the rental was £105,500 per annum (approximately $182,000). In November 2005, the rental on these premises was subject to review and was increased to £112,000 per annum (approximately $193,000). There was no increase during the financial year ended December 31, 2007.

The Group has annual commitments under non-cancellable operating leases relating to plant and machinery which expire between two and five years. The annual amount payable, per annum for rent is £1,782 (approximately $3,600).

On July 4, 2006 Amarin Neuroscience Limited entered into an operating lease relating to land and buildings which expires on July 3, 2009. The annual amount payable is £130,500 (approximately $256,000) with an annual increase of 2% thereafter.

On January 22, 2007 Amarin Pharmaceuticals Ireland Limited entered into a twenty year operating lease relating to land and buildings which can be cancelled after 5 years. The annual rent payable is £114,000 (approximately ($229,000).

 
F-47

 



Amarin Neuroscience Limited has annual commitments under non-cancelable operating leases relating to plant and machinery which will expire within one year. The annual amount payable, per annum is £1,489 (approximately $3,000). This lease expired on February 28, 2008.

Following the acquisition of Laxdale Limited on October 8, 2004, further consideration may become payable upon marketing approval being obtained for approval of products (covered by Laxdale’s intellectual property) by the U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMEA”) approval. The first approval obtained in the U.S. and Europe would result in additional consideration of £7,500,000 payable (approximately $14,980,000 at 2007 year end exchange rates) for each approval to the vendors of Laxdale Limited. The second approval obtained in the U.S. and Europe would result in additional consideration of £5,000,000 payable (approximately $9,987,000 at 2007 year end exchange rates) for each approval, to the vendors of Laxdale Limited. Such additional consideration may be paid in cash or shares at the sole option of each of the vendors.

In November 2005 we entered into a supplemental manufacturing and supply agreement with Nisshin Pharma Inc. for the production of materials required for our products. The remaining purchase obligations at December 31, 2007 under this agreement, was $674,000.

In May 2006, we signed an agreement with Dr. Anthony Clarke (a related party – see note 34) in respect of certain patents and other intellectual property rights relating to a formulation of the compound, Apomorphine. Under the assignment agreement a total of £742,000 ($1,482,000) is payable on the achievement of certain milestones.

In March 2007, we acquired a global license to develop and market a novel, nasal lorazepam formulation for the out-patient treatment of emergency seizures in epilepsy patients. This formulation utilizes the patent protected NanoCrystal® Technology from Elan Corporation, plc ((“Elan”) a related party – see note 34). Under the terms of the agreement, the Company will pay Elan success based development, filing and approval milestones totaling $5.2 million plus royalties on net sales.

Following the acquisition of Ester Neurosciences Limited on December 5, 2007 further consideration may become payable if the following milestones are achieved:

·  
$5 million, payable, at Amarin’s option, in cash or shares upon achievement of Milestone Ia – Monarsen Phase II in MG study meeting its study objectives: Efficacy – having a QMG score of one or more of the three doses being superior to Mestinon as compared to the baseline by at least 10%; Safety – no major adverse drug related side effects. The fair value of this milestone payment is included in accrued expenses and other liabilities as it is probable that this milestone will be achieved.

·  
$6 million payable, at Amarin’s option, in cash or shares upon successful completion of Monarsen Phase II MG study program with adequate efficacy and safety data that fully supports the commencement of a Phase III program in the U.S.

·  
$6 million payable, in cash, upon successful completion of the U.S. Phase III clinical trial program (to include successful completion of long term studies) enabling NDA filing for Monarsen for MG in the U.S, Milestone II.

If Milestone Ia is successfully achieved, a time limit date is triggered for Milestone II being the date which falls two years following the achievement of Milestone Ib (“Time Limit Date”).  If on the Time Limit Date, Milestone II has not yet been achieved (other than by reason of failure to meet primary endpoints in any Phase III Clinical Study or a delay in completing the U.S. Phase III Clinical Study caused by certain Monarsen-related factors), Amarin will pay the Sellers $3 million in cash with the remaining $3 million being payable whenever Milestone II is achieved.  In addition, if the Milestone Ib Price is greater than or equal to $1 ($10 post share consolidation effective January 18, 2008), no Time Limit Date will apply.

The Company sublet properties under operating lease agreements which terminate in 2011. There are no contingent based rents included in the income statement.

31.  Contingent liabilities

The Group is not presently subject to any litigation where the potential risk of significant liability arising from such litigation is considered to be more than remote.

 
F-48

 

32.  Pensions

The Group operates a number of defined contribution money purchase pension schemes for certain eligible employees. The assets of the schemes are held separately from those of the Group in independently administered funds. The pension cost charge represents contributions paid and payable by the Group to the fund and amounted to $304,000 for the year ended December 31, 2007 (year to December 31, 2006: $403,000). At the year end there was a liability of $nil (December 31, 2006: liability of $nil).

33.  Post balance sheet events

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.

On March 3, 2008 we signed an exclusive license with Scarista Limited (“Scarista”) for the development and commercialization rights to a broad intellectual property portfolio in the field of lipid science. The transaction consideration comprises an upfront fee to Scarista of $0.5 million and royalties upon commercialization.
 
On May 14, 2008 we announced a private placement of ADSs (each representing one Ordinary Share) with several new institutional and accredited investors and potentially certain current and former directors of the Company, for up to $60.0 million funded under two equal tranches. The first tranche from new investors of $28.0 million closed on May 19, 2008 and was settled by the issuance of 12,173,914 Ordinary Shares and 8 new Preference Shares. See Note 26 for further details on Preference Shares.

       The investors will have an option to provide up to $28.0 million in a second tranche upon completion of certain business milestones by the Company, potentially over the next 12 months. Certain current and former directors have indicated an interest in investing up to $4.0 million in the placement, also over two tranches bringing the potential total of the placement up to $60.0 million.
 
Certain of the investors were entitled to join Amarin's board of directors.  On May 16, 2008, Drs. Doogan, Kukes, Walsh and Lachman, Prof. Hall and Messrs. Cooke and Groom resigned from the board. On the same date Drs. James Healy, Carl Gordon, Srinivas Akkaraju and Eric Aguiar were appointed to the board. The new board appointments are effective upon the closing of the first tranche of the financing.

34.  Related party transactions

We have a related party relationship with our subsidiaries (see note 17), directors and executive officers and certain parties outlined below. All transactions with subsidiaries eliminate on consolidation and are not disclosed.

All of the below transactions were approved in accordance with our policy for related party transactions. Our policy in 2007 and 2006 was to require Audit Committee review and approval of all transactions involving a potential conflict of interest, followed by the approval of the Audit Committee or of a majority of the board of directors who do not have a material interest in the transaction.

All of the related part transactions below are in respect of the Group and the Company with the exception of (A) Elan and (D) Apomorphine which are in respect of the Group only.

A.  Elan

In February 2007, our audit committee reviewed and approved, Amarin Pharmaceuticals Ireland Limited (“APIL”), a subsidiary of the Group, entering into development and license agreement with Elan Pharma International Limited, a subsidiary of Elan Corporation, plc (“Elan”), ultimately signed on March 6, 2007, whereby APIL licensed from Elan rights to develop and market a novel, NanoCrystal® nasal formulation of lorazepam for the out-patient treatment of emergency seizures in epilepsy patients. Mr. Shane Cooke, chief financial officer of Elan is a connected person to Mr. Alan Cooke, our president and chief operating officer, and under Nasdaq rules this transaction was deemed to be a related party transaction. Under the terms of the agreement, we may pay Elan success based development, filing and approval milestones totaling $5.2 million plus royalties on net sales. No payments were made to Elan during the year ended December 31, 2007.

B.  Financings

Future investment right

Several of the Group’s directors and officers subscribed for approximately 0.7 million ordinary shares in March 2006 in a registered direct financing. The offer was completed pursuant to certain pre-existing contractual commitments of the Group to investors that participated in a previously completed financing in May 2005.

Registered direct offering

Several of the Company’s directors and officers subscribed for approximately 1.0 million ordinary shares and warrants to subscribe for approximately 0.1 million ordinary shares in June 2007 in a registered direct financing.


 
F-49

 



Public offerings

Several of the Company’s directors and officers subscribed for approximately 4.4 million ordinary shares and warrants to subscribe for approximately 2.2 million ordinary shares in a public offering in December 2007.

In a second offering in December 2007, Dr. Michael Walsh, a director of the Company, purchased $0.25 million in aggregate principal amount of three-year convertible Debentures and IIU Limited, a company in which Dr. Walsh is a director, purchased $2.5 million in aggregate principal amount of three-year convertible Debentures. These Debentures may be converted into approximately 0.5 million and 5.2 million ordinary shares respectively, commencing four months after the date of closing (December 6, 2007) at a conversion price of $0.48 per ordinary share, ($4.80 post share consolidation effective Janaury 18, 2008) which is a 30% premium to the 5-day volume weighted average closing price of our ordinary shares on December 3, 2007. The Debentures will bear interest at a rate of 8% per annum, payable quarterly in arrears. In addition, the Debenture holders will also receive five-year warrants to purchase approximately 0.2 million and 2.1 million ordinary shares respectively at an exercise price of $0.48 ($4.80 post share consolidation effective Janaury 18, 2008).  Per the warrant agreement, if at any time prior to December 6, 2009, the Company issues Ordinary Shares, securities convertible into ADSs or Ordinary Shares, warrants to purchase ADSs or Ordinary Shares or options to purchase any of the foregoing to a third party (other than any Exempt Issuance) at a price that is less than, or converts at a price that is less than, $3.66 (such lesser price, the “Down-round Price”), then the Exercise Price shall be adjusted to equal 130% of the Down-round Price.  On May 14, 2008, we announced a private placement of Ordinary Shares for up to $60.0 million. The first tranche from new investors of $28.0 million closed on May 19, 2008 ( see note 33 for further details). These warrants have therefore been re-priced to $2.99 per share from their original grant price of $4.80 per share ( post share consolidation effective January 18, 2008).  The convertible Debentures will be required to be repaid from the financing outlinded above.

C.  Icon

At December 31, 2007 Sunninghill Limited, a company controlled by Dr. John Climax, held 9.4 million shares and 1.6 million warrants in Amarin (which was approximately 7% of Amarin’s entire issued share capital) and Poplar Limited, a company controlled by Dr. Climax, held approximately 5% of Icon plc. During 2005 the Group entered into an agreement with Icon Clinical Research Limited (a company wholly owned by Icon Plc) whereby Icon were appointed as Amarin’s contract research organization to manage and oversee its European Phase II study on AMR 101 (Trend 2) and to assist Amarin in conducting its U.S. Phase III on AMR 101 (Trend 1). At December 31, 2007 Amarin had incurred costs of $7.0 million ($1.9 million for the 12 months ended December 31, 2007) with respect of direct costs to Icon. At the year end, no amount is included in accruals or accounts payable for direct costs payable to Icon. In addition the Group also reimbursed Icon for $2.6 million of pass-through costs which Icon settle on behalf of Amarin.

Our Chairman and Chief Executive Officer, Mr. Thomas Lynch has served as an outside director of Icon since January 1996. He is also a member of Icon’s audit committee, compensation committee and nominations committee. On March 20, 2006 Dr. Climax subsequently became a non-executive director of Amarin.

In November 2006, our audit committee reviewed and approved APIL, a subsidiary of the Group entering into a Master Services Agreement with Icon Clinical Research (U.K.) Limited whereby Icon Clinical Research (U.K.) would provide due diligence services to Amarin Pharmaceuticals Ireland Limited on ongoing licensing opportunities on an ongoing basis.

In December 2006, our audit committee reviewed and approved Amarin Neuroscience Limited, entering into a supplemental agreement with Icon Clinical Research Limited whereby Icon Clinical Research Limited would conduct a one year E.U. open label follow-up study to the Phase III study in Huntington’s disease.

In February 2007, our audit committee reviewed and approved Amarin Neuroscience Limited, a subsidiary of the Group, entering into a supplemental agreement with Icon Clinical Research Limited to amend the number and location of patient activity in the E.U. Phase III clinical trial.

D.  Apomorphine

In May 2006, our audit committee reviewed and approved an assignment agreement between APIL and Dr. Anthony Clarke in respect of certain patents and other intellectual property rights relating to a formulation of the compound, Apomorphine. Dr. Clarke, who was our Vice President of Clinical Development, was the developer of this target product opportunity independently of the Group. Under the assignment agreement APIL agreed to pay Dr. Clarke initial consideration of £42,000 ($84,000) and a further £742,000 ($1,484,000) in milestone payments on the achievement of certain milestones. The assignment agreement also provided for APIL to pay Dr. Clarke royalties as a percentage of net sales if we were to sell or license the product. The royalty percentages applicable are dependant on the level of net sales achieved.


 
F-50

 


E.  Transactions with Directors and Executive Officers

The total compensation of our key management, defined as directors and executive officers was as follows:

 
2007
US$’000
2006
US$’000
Short-term employee benefits
4,569
3,361
Post-employment benefits
Share-based compensation
2,300
1,045
Total
6,869
4,406
     

There are no service contracts greater than one year in existence between any of the directors and executive officers of Amarin.

Mr. Thomas Lynch

In March 2007, Amarin’s remuneration committee reviewed and approved a consultancy agreement between the Company and Dalriada Limited in relation to the provision by Dalriada Limited to the Company of corporate consultancy services, including consultancy services relating to financing and other corporate finance matters, investor and media relations and implementation of corporate strategy. Under the Consultancy Agreement, the Company pays Dalriada Limited a fee of £240,000 per annum for the provision of the consultancy services. An additional amount of £195,000 was also approved by the remuneration committee of which £75,000 was paid during the year ended December 31, 2007 in respect of consultancy services.

Dalriada Limited is owned by a family trust, the beneficiaries of which include Mr. Thomas Lynch, Amarin Chairman and Chief Executive Officer, and family members.

Arrangements with Former Directors

Mr. Richard Stewart

On December 19, 2007, Mr. Stewart resigned as Chief Executive Officer and Executive Director of Amarin. Pursuant to the terms of a compromise agreement between Amarin and Mr. Stewart, Amarin agreed to pay Mr. Stewart £402,500 ($804,000) in respect of a termination payment and bonus, £10,673 ($21,000) in respect of 10 days accrued but untaken holiday entitlement, other expenses of £4,000 ($8,000) and £37,338 ($75,000) in respect of accrued pension entitlement up to the date of termination, December 19, 2007.

As at the December 19, 2007 Mr. Stewart had 1,166,666 vested share options under our 2002 Stock Option Plan. Pursuant to the terms of the compromise agreement, Mr. Stewart’s vested share options will be exercisable for a period of 12 months following December 19, 2007 in accordance with the terms of our 2002 Stock Option Plan and upon the expiration of such 12 month period, Mr. Stewart’s vested options will cease to be exercisable and will expire.

As at December 19, 2007 Mr. Stewart had 883,334 unvested share options under our 2002 Stock Option Plan. Pursuant to the terms of the compromise agreement, it was provided that Mr. Stewart’s share options which were not vested as at December 19, 2007 would not vest and would not become exercisable after December 19, 2007 and accordingly, would expire on December 19, 2007.

The compromise agreement was reviewed and approved by the members of our remuneration committee.

Other than the transactions listed above, there are no other related party transactions with our Directors and Executive Officers or Former Directors.




 
F-51

 


35.  Reconciliations on transition to IFRS

As stated in Note 1, this is our first full set of consolidated and parent company financial statements prepared in accordance with the recognition and measurement principles of IFRS as adopted by the E.U. and as issued by the IASB. The accounting policies set out in Note 2 have been applied in preparing the consolidated financial statements for the years ended December 31, 2007 and 2006, and in the preparation of an opening balance sheet at January 1, 2006, our date of transition.
 
The transition date to IFRS for the Group is 1 January 2006 ("the Transition Date"), being the start of the period of comparative information. IFRS 1 requires the Group to determine its IFRS accounting policies and apply these retrospectively to determine the opening balance sheet position at the date of transition to IFRS. Details of the IFRS 1 exemptions being adopted are as follows:
 
IFRS 3 “Business Combination”
 
The Group has elected not to apply IFRS 3 “Business Combinations” to combinations which took place prior to the Transition Date.
 
IFRS 2 “Share-Based Payments”
 
IFRS 1 provides an exemption which allows entities to only apply IFRS 2 “Share Based Payments” to share based payment awards granted after November 7, 2002 and which had not vested as at January 1, 2005. The Group has elected to apply this exemption.
 
IFRS 5 “Asset available for sale”
 
IFRS 5 provides for an exemption which allows entities to apply the standard prospectively. The Group has elected not to apply IFRS 5 retrospectively.
 
IAS 39 “Fair Value Measurement of Financial Assets and Liabilities”
 
IFRS 1 provides an exemption which allows the fair values of financial assets and liabilities to be measured at time of initial recognition with no restatement. The Group elected to apply this exemption.
 
The following reconciliations provide a quantification of the effect of the transition to IFRS from previously reported U.K. GAAP on:

(i)   Consolidated balance sheet at January 1, 2006
(ii)   Consolidated income statement for the year ended December 31, 2006
(iii)   Consolidated balance sheet at December 31, 2006
(iv)   Parent company balance sheet at January 1, 2006
(v)   Parent company balance sheet at December 31, 2006
(vi)   Explanatory notes


 
F-52

 

(i) Reconciliation of impact of IFRS on the Consolidated Balance Sheet as at January 1, 2006 (opening balance sheet at date of transition to IFRS)
 
                                                 
   
Previously reported under UK GAAP
 
IAS 19 Employee Benefits
   
IAS 21 Foreign Currency
   
IAS 32/39 Financial Instruments
   
IAS 39 Financial Instruments
   
IAS 32/39 Financial Instruments
   
Cumulative effect of Transition to IFRS at Jan 1, 2006
   
As stated under IFRS
 
   
US$'000
 
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
 
BALANCE SHEET
       
Note 1
   
Note 2
   
Note 3
   
Note 4
   
Note 5
             
ASSETS
                                               
Non-current assets
                                               
Property, plant and equipment
    460       -       (7 )     -       -       -       (7 )     453  
Intangible assets
    9,627       -       (235 )     -       -       -       (235 )     9,392  
Available for sale investment
    -       -       -       -       24       -       24       24  
Total non-current assets
    10,087       -       (242 )     -       24       -       (218 )     9,869  
                                                                 
Current assets
                                                               
Current tax recoverable
    1,312       -       -       -       -       -       -       1,312  
Other current assets
    1,454       -       -       -       -       -       -       1,454  
Cash and cash equivalents
    33,907       -       -       -       -       -       -       33,907  
Total current assets
    36,673       -       -       -       -       -       -       36,673  
                                                                 
Total assets
    46,760       -       (242 )     -       24       -       (218 )     46,542  
                                                                 
LIABILITIES
                                                               
Non-current liabilities
                                                               
Provisions
    15       -       -       -       -       -       -       15  
Other liabilities
    165       -       -       -       -       -       -       165  
Total non-current liabilities
    180       -       -       -       -       -       -       180  
                                                                 
Current liabilities
                                                               
Trade payables
    779       -       -       -       -       -       -       779  
Derivative liability
    -       -       -       883       -       -       883       883  
Accrued expenses and other liabilities
    7,221       78       -       -       -       -       78       7,299  
Total current liabilities
    8,000       78       -       883       -       -       961       8,961  
Total liabilities
    8,180       78       -       883       -       -       961       9,141  
                                                                 
EQUITY
                                                               
Capital and reserves attributable to
equity holders of the Company
                                 
Share capital
    6,778       -               -       -       -       -       6,778  
Share premium
    124,097       -       -       (1,238 )     -       (9,620 )     (10,858 )     113,239  
Share based payments reserve
    2,623       -       -       -       -       -       -       2,623  
Warrant reserve
    -       -       -       -       -       9,620       9,620       9,620  
Capital redemption reserve
    27,633       -       -       -       -       -       -       27,633  
Treasury shares
    (217 )     -       -       -       -       -       -       (217 )
Foreign currency translation reserve
    -       -       697       -       -       -       697       697  
Retained earnings
    (122,334 )     (78 )     (939 )     355       24       -       (638 )     (122,972 )
Total shareholders' equity
    38,580       (78 )     (242 )     (883 )     24       -       (1,179 )     37,401  
                                                                 
Total shareholders' equity and liabilities
    46,760       -       (242 )     -       24       -       (218 )     46,542  
                                                                 
 





 
F-53

 

 
(ii) Reconciliation of impact of IFRS on the Consolidated Income Statement for the year ended December 31, 2006
 
                                           
   
Previously reported under UK GAAP
   
IAS 19 Employee Benefits
   
IAS 21 Foreign Currency
   
IAS 32/39 Financial Instruments
   
IAS 39 Financial Instruments
   
Cumulative effect of Transition to IFRS in the year
   
As stated under IFRS
 
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
 
         
Note 1
   
Note 2
   
Note 3
   
Note 4
             
                                           
Revenue
    500       -       -       -       -       -       500  
Research & development
    (17,186 )     73       2,007       -       -       2,080       (15,106 )
Selling, general & administrative expenses
    (14,475 )     5       1,008       -       -       1,013       (13,462 )
Operating loss
    (31,161 )     78       3,015       -       -       3,093       (28,068 )
                                                         
Finance income
    3,444       -       (100 )     -       -       (100 )     3,344  
Finance costs
    (2 )     -       -       (2,818 )     (6 )     (2,824 )     (2,826 )
                                                         
Loss before taxation
    (27,719 )     78       2,915       (2,818 )     (6 )     169       (27,550 )
Tax credit
    799                                       -       799  
                                                         
Lossattributable to equity holders of the parent
    (26,920 )     78       2,915       (2,818 )     (6 )     169       (26,751 )
                                                         
                                                         
                                                         
Loss per Ordinary Share (pre-share consolidation)*
    (0.33 )                                             (0.32 )
Loss per Ordinary Share (post-share consolidation)*
    (3.27 )                                             (3.25 )
                                                         
Diluted loss per Ordinary Share (pre-share consolidation)*
    (0.33 )                                             (0.32 )
Diluted loss per Ordinary Share (post-share consolidation)*
    (3.27 )                                             (3.25 )
                                                         
*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.
 
The shares and share information above has been adjusted to reflect this share consolidation.
                 
                                                         

 
F-54

 


(iii) Reconciliation of impact of IFRS on the Consolidated Balance Sheet at December 31, 2006
 
                                                       
   
Previously reported under UK GAAP
 
Total opening adjustment at Jan 1, 2006
   
IAS 19 Employee Benefits
   
IAS 21 Foreign Currency
   
IAS 32/39 Financial Instruments
   
IAS 39 Financial Instruments
   
IAS 32/39 Financial Instruments
   
Cumulative effect of Transition to IFRS at Dec 31, 2006
   
As stated under IFRS
 
   
US$'000
 
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
 
BALANCE SHEET
             
Note 1
   
Note 2
   
Note 3
   
Note 4
   
Note 5
             
ASSETS
                                                     
Non-current assets
                                                     
Property, plant and equipment
    282       (7 )     -       39       -       -       -       32       314  
Intangible assets
    8,953       (235 )     -       918       -       -       -       683       9,636  
Available for sale investment
    -       24       -       -       -       (6 )     -       18       18  
Total non-current assets
    9,235       (218 )     -       957       -       (6 )     -       733       9,968  
                                                                         
Current assets
                                                                       
Current tax recoverable
    1,617       -       -       -       -       -       -       -       1,617  
Other current assets
    1,172       -       -       -       -       -       -       -       1,172  
Cash and cash equivalents
    36,802       -       -       -       -       -       -       -       36,802  
Total current assets
    39,591       -       -       -       -       -       -       -       39,591  
                                                                         
Total assets
    48,826       (218 )     -       957       -       (6 )     -       733       49,559  
                                                                         
LIABILITIES
                                                                       
Non-current liabilities
                                                                       
Provisions
    110       -       -       -       -       -       -       -       110  
Total non-current liabilities
    110       -       -       -       -       -       -       -       110  
                                                                         
Current liabilities
                                                                       
Trade payables
    2,096       -       -       -       -       -       -       -       2,096  
Derivative liability
    -       883       -       -       (883 )     -       -       -       -  
Accrued expenses and other liabilities
    8,625       78       (78 )     -       -       -       -       -       8,625  
Provisions
    160       -       -       -       -       -       -       -       160  
Total current liabilities
    10,881       961       (78 )     -       (883 )     -       -       -       10,881  
                                                                         
Total liabilities
    10,991       961       (78 )     -       (883 )     -       -       -       10,991  
                                                                         
EQUITY
                                                                       
Capital and reserves
attributable to equity
holders of the Company
                                 
Share capital
    7,990       -       -       -       -       -       -       -       7,990  
Share premium
    146,859       (10,858 )     -       -       3,701       -       (389 )     (7,546 )     139,313  
Share based payment reserve
    4,824       -       -       -       -       -       -       -       4,824  
Warrant reserve
    -       9,620       -       -       -       -       389       10,009       10,009  
Capital redemption reserve
    27,633       -       -       -       -       -       -       -       27,633  
Treasury shares
    (217 )     -       -       -       -       -       -       -       (217 )
Foreign currency translation reserve
    -       697       -       (1,958 )     -       -       -       (1,261 )     (1,261 )
Retained earnings
    (149,254 )     (638 )     78       2,915       (2,818 )     (6 )     -       (469 )     (149,723 )
Total shareholders' equity
    37,835       (1,179 )     78       957       883       (6 )     -       733       38,568  
                                                                         
Total shareholders' equity and liabilities
    48,826       (218 )     -       957       -       (6 )     -       733       49,559  
                                                                         

 
F-55

 


(iv) Reconciliation of impact of IFRS on the parent company balance sheet at January 1, 2006 (opening balance sheet at date of transition to IFRS)
       
                                           
   
Previously reported under UK GAAP
   
IAS 21 Foreign Currency
   
IAS 39 Financial Instruments
   
IAS 32/39 Financial Instruments
   
IAS 32/39 Financial Instruments
   
Cumulative effect of Transition to IFRS at Jan 1, 2006
   
As stated under IFRS
 
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
 
         
Note 2
   
Note 4
   
Note 3
   
Note 5
             
                                           
BALANCE SHEET
                                         
ASSETS
                                         
Non-current assets
                                         
Property, plant and equipment
    194       -       -       -       -       -       194  
Intangible assets
    3,314       (235 )     -       -       -       (235 )     3,079  
Investment in subsidiaries
    3,191       -       -       -       -       -       3,191  
Available for sale investments
    -       -       24       -       -       24       24  
Total non-current assets
    6,699       (235 )     24       -       -       (211 )     6,488  
                                                         
Current assets
                                                       
Other current assets
    695       -       -       -       -       -       695  
Cash and cash equivalents
    33,691       -       -       -       -       -       33,691  
Total current assets
    34,386       -       -       -       -       -       34,386  
                                                         
Total assets
    41,085       (235 )     24       -       -       (211 )     40,874  
                                                         
LIABILITIES
                                                       
Non-current liabilities
                                                       
Provisions
    15       -       -       -       -       -       15  
Other liabilities
    151       -       -       -       -       -       151  
Total non-current liabilities
    166       -       -       -       -       -       166  
                                                         
Current liabilities
                                                       
Trade payables
    309       -       -       -       -       -       309  
Accrued expenses and other liabilities
    3,426       -       -       883       -       883       4,309  
Total current liabilities
    3,735       -       -       883       -       883       4,618  
Total liabilities
    3,901       -       -       883       -       883       4,784  
                                                         
EQUITY
                                                       
Capital and reserves attributable to equity holders of the Company
                                                       
Share capital
    6,778       -       -       -       -       -       6,778  
Share premium
    121,371       -       -       (1,238 )     (9,620 )     (10,858 )     110,513  
Share based payment reserve
    2,623       -       -       -       -       -       2,623  
Foreign currency translation reserve
    -       (235 )     -       -       -       (235 )     (235 )
Warrants reserve
    -       -       -       -       9,620       9,620       9,620  
Treasury shares
    27,633       -       -       -       -       -       27,633  
Retained earnings
    (121,221 )     -       24       355               379       (120,842 )
Total shareholders' equity
    37,184       (235 )     24       (883 )     -       (1,094 )     36,090  
                                                         
Total shareholders' equity and liabilities
    41,085       (235 )     24       -       -       (211 )     40,874  
                                                         
 
 


 
F-56

 

(v) Reconciliation of impact of IFRS on the parent company balance sheet at December 31, 2006
             
                                                 
                                                 
   
Previously reported under UK GAAP
   
Total opening adjustment at Jan 1, 2006
   
IAS 21 Foreign Currency
   
IAS 39 Financial Instruments
   
IAS 39 Financial Instruments
   
IAS 39 Financial Instruments
   
Cumulative effect of Transition to IFRS at Dec 31, 2006
   
As stated under IFRS
 
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
   
US$'000
 
               
Note 2
   
Note 3
   
Note 4
   
Note 5
             
BALANCE SHEET
                                               
ASSETS
                                               
Non-current assets
                                               
Property, plant and equipment
    25       -       -       -       -       -       -       25  
Intangible assets
    3,082       (235 )     918       -       -       -       683       3,765  
Investment in subsidiaries
    22,715       -       -       -       -       -       -       22,715  
Available for sale investments
    -       24       -               (6 )     -       18       18  
Total non-current assets
    25,822       (211 )     918       -       (6 )     -       701       26,523  
                                                                 
Current assets
                                                               
Other current assets
    770       -       -       -       -       -       -       770  
Cash and cash equivalents
    34,719       -       -       -       -       -       -       34,719  
Total current assets
    35,489       -       -       -       -       -       -       35,489  
                                                                 
Total assets
    61,311       (211 )     918       -       (6 )     -       701       62,012  
                                                                 
LIABILITIES
                                                               
Non-current liabilities
                                                               
Other liabilities
    110       -       -       -       -       -       -       110  
Total non-current liabilities
    110       -       -       -       -       -       -       110  
                                                                 
Current liabilities
                                                               
Trade payables
    396       -       -       -       -       -       -       396  
Accrued expenses and other liabilities
    1,814       883       -       (883 )     -       -       -       1,814  
Provisions
    160       -       -       -       -       -       -       160  
Total Current Liabilities
    2,370       883       -       (883 )     -       -       -       2,370  
                                                                 
Total liabilities
    2,480       883       -       (883 )     -       -       -       2,480  
                                                                 
EQUITY
                                                               
Capital and reserves attributable to
equity holders of the Company
                                                 
Share capital
    7,990       -       -       -       -       -       -       7,990  
Share premium
    144,133       (10,858 )     -       3,701       -       (389 )     (7,546 )     136,587  
Share based payment reserve
    4,824       -       -       -       -               -       4,824  
Foreign currency translation reserve
    -       (235 )     918       -       -               683       683  
Warrants reserve
    -       9,620       -       -       -       389       10,009       10,009  
Treasury shares
    27,633       -       -       -       -       -       -       27,633  
Retained earnings
    (125,749 )     379       -       (2,818 )     (6 )             (2,445 )     (128,194 )
Total shareholders' equity
    58,831       (1,094 )     918       883       (6 )     -       701       59,532  
                                                                 
Total shareholders' equity and liabilities
    61,311       (211 )     918       -       (6 )     -       701       62,012  
                                                                 
 

 

 
F-57

 


(vi) Explanatory notes

Note 1: IAS 19 Employee Benefits

IAS 19 requires companies to accrue for paid vacation leave in the period in which the employees render the related employee service.

Typically companies operating in a U.K. GAAP environment recorded holiday pay on an incurred basis and did not establish accruals for the potential liability.  However, Amarin commenced accruing for vacation leave entitlements in its U.K. GAAP financial statements in 2006.  This accrual comprised a catch-up for all unutilised leave entitlements.  Under IFRS, a vacation leave accrual is required in each reportable period presented.  Consequently, Amarin will be required to accrue for paid vacation leave at January 1, 2006 (date of transition to IFRS) and at each reportable period thereafter.

The operating loss impact in 2006 of applying IAS 19 is a credit of US$78,000, being the portion of the accrual recognized during the year ended December 31, 2006 under U.K. GAAP which relates to pre January 1, 2006 unutilized leave entitlements.  Therefore, an accrual of US$78,000 is recorded at January 1, 2006 with a corresponding reduction in opening retained earnings upon adoption of IAS 19.

Note 2: IAS 21 Effects of Changes in Foreign Exchange Rates

Part A: Determination of functional currency

Under U.K. GAAP, Amarin adopted the temporal method set out in SSAP 20 “Foreign Currency Translation” to translate the results and the financial position of foreign operations.  This resulted in the operations of the Group’s subsidiaries being deemed to be an extension of the parent company’s operations and therefore the financial transactions of the subsidiary were recorded as if they had been entered into by the parent.  As the parent company’s operational currency is the US Dollar this was also deemed to be the operational currency of its subsidiary undertakings.

IAS 21 defines the functional currency of a company as the currency of the primary economic environment in which the entity operates, and requires that a determination of the appropriate functional currency of each Group company should be made for at each reportable period.

IAS 21 prescribes a hierarchy of factors to consider when determining the functional currency of a company.  Having considered these factors, the functional currencies of each Group company under IFRS are determined to be as follows:

·  
Amarin Corporation plc: US$ (no change)
·  
Amarin Neuroscience Limited: Stg£ (previously US$ under U.K. GAAP)
·  
Amarin Pharmaceuticals Ireland Limited: € (previously US$ under U.K. GAAP)

Part B: Translation from functional currency to presentation currency

Amarin presents its annual report in US Dollars.  IAS 21 prescribes the manner in which the results of foreign subsidiaries are translated from their functional currency into the presentation currency of the consolidated financial statements, as follows:

Assets and liabilities for each balance sheet presented shall be translated at the closing rate at the date of that balance sheet
Income and expenses for each income statement shall be translated at exchange rates at the dates of the transactions
All resulting exchange differences shall be recognized as a separate component of equity

Applying these rules gives rise to a reduction in the amount of US$2,915,000 of operating loss for the year ended December 31, 2006, being the quantum of net foreign currency unrealized gains and losses previously recorded in the subsidiary income statements under U.K. GAAP which is now recognized in a separate component of equity.  In addition, a foreign currency reserve is established of US$697,000 representing the opening foreign currency reserve of subsidiary entities translated into dollars at the closing exchange rates.

 
F-58

 


In addition, as noted above, IAS 21 requires all assets and liabilities of each subsidiary to be translated at the closing rate for the purpose of consolidation in the Group accounts.  Under the U.K. GAAP temporal method, non-monetary items (such as property, plant and equipment) were translated using the exchange rate at the date of transaction (i.e. historical cost).  This gives rise to an increase of US$39,000 to property plant and equipment and an increase to intangible assets of US$918,000 at December 31, 2006.
 
Similarly, opening retained earnings at January 1, 2006 are increased in the amount of US$939,000 and the carrying value of property, plant and equipment and intangible assets are reduced by US$7,000 and US$235,000 respectively.

Note 3: IAS 32/39 Financial Instruments

In May 2005, Amarin raised US$17.8 million by way of a share offering.  In addition, investors in the share offering were given a future investment right, which, subject to certain conditions, would allow the investors subscribe for additional shares at March 15, 2006 with a value up to a maximum of US$7.22 million.

In accordance with IAS 32, the definition of a financial liability includes:

·  
A contract that will or may be settled in the entity’s own equity instruments and is:
·  
A non-derivative for which the entity is or may be obliged to deliver a variable number of the entity’s own equity instruments; or
·  
A derivative that will or may be settled other than by the exchange of a fixed amount of cash or another financial asset for a fixed number of the entity’s own equity instruments.

The future investment right meets the definition of a derivative as:

·  
There is little or no upfront investment
·  
The value of the right moves in relation to the movement in the underlying share price of the Company subject to a cap
·  
It is settled at a future date; under IFRS, expiry at maturity date is a form of settlement.

The terms of the future investment right specified a share price for this offering equal to the lower of (a) $1.75 or (b) 84% of the volume weighted average of closing prices of the ADRs on the Nasdaq Stock Market over the thirty trading days ending March 16, 2006.  However, neither the number of shares nor the expected proceeds to be raised in March 2006 were fixed in the agreement and therefore this right meets the definition of a financial liability set out above.

In accordance with IAS 39, the financial liability is initially recorded at its fair value in May 2005, with a corresponding entry to reduce share premium.  The financial liability is recorded at its fair value at each subsequent reportable period end, with any gains and losses recorded in the income statement.  On settlement of the future investment right in March 2006, the financial liability is derecognised and share capital and share premium are adjusted according to the actual number of shares subscribed for.

Consequently, the opening IFRS balance sheet at January 1, 2006 has been adjusted to record the fair value of the financial liability at that date which amounted to US$883,000, a reduction of US$1,238,000 in share premium being the fair value of the financial liability in May 2005, and a gain of US$355,000 credited to retained earnings.

An additional loss of US$2,818,000 is recorded in the IFRS income statement for the year ended December 31, 2006, being the movement in the fair value of the financial liability from January 1, 2006 to the settlement date in March 2006.  On settlement of the future investment right in March 2006, the financial liability amounting to US$3,701,000 is derecognized with a corresponding entry to share capital and share premium.

Note 4: IAS 39 Financial Instruments

Amarin holds an equity investment in Antares Pharma Inc which is listed on AMEX in the United States.  In 2002, the directors decided to write off the value of this investment, which at the time amounted to US$66,000, to nil.

IAS 39 defines available for sale financial assets as those non-derivative financial assets that are designated as available for sale or are not classified into one of the other available categories.

 
F-59

 


In accordance with IAS 39, the investment in this company is classified as available for sale and held at fair value, with changes in the fair value at each reportable period recognised directly in equity unless the asset is impaired (if the new fair value of the asset is less than its initial cost) in which case the loss is reported in the income statement.

Consequently, the opening IFRS balance sheet at January 1, 2006 has been adjusted to record the fair value of this investment at that date of US$24,000 with a corresponding entry to retained earnings. An additional impairment charge of US$6,000 is recorded in the IFRS income statement for the year ended December 31, 2006.

Note 5: IAS 32/39 Financial Instruments

Amarin has issued warrants which enable the holders to convert to ordinary shares at pre-determined prices within specified periods of time.

IAS 39 provides examples of equity instruments which include “non-puttable ordinary shares, some types of preference shares and warrants or written call options that allow the holder to subscribe for or purchase a fixed number of non-puttable ordinary shares in the issuing entity in exchange for a fixed amount of cash or another asset. An entity's obligation to issue or purchase a fixed number of its own equity instruments in exchange for a fixed amount of cash or another financial asset is an equity instrument of the entity.”

In accordance with IAS 39, the fair value of the warrants on issue are recorded in a warrant reserve with a corresponding entry to share premium account. On settlement, the warrant reserve is derecognized with a corresponding entry to share premium and share capital account.

Consequently, the opening IFRS balance sheet at January 1, 2006 has been adjusted to record the fair value of the equity instruments at that date which amounted to US$9,620,000 in the warrant reserve, with a corresponding entry to the share premium account.

An additional amount of US$389,000 for the fair value of warrants issued in 2006 was recorded in the warrant reserve with a corresponding amount in the share premium account.

36.  Approval of financial statements

The Consolidated Financial Statements were approved on May 19, 2008.
 
 
 
 
 
 
 
F-60
 
 

Exhibit 4.57
 
 
 Amarin 694/005    
     
 Protocol AN01.01.0012  
 Change Order no. 2, 8th June 2006
 
 

Change Order
 
DATED
the 8th day of June 2006.
 
BETWEEN
Amarin Neuroscience Limited of King’s Park House, Laurelhill Business Park, Stirling, UK FK7 9PQ (‘Amarin’)
 
AND
ICON Clinical Research Limited of South County Business Park, Leopardstown, Dublin 18 (‘ICON’)
 
 
WHEREAS :
 
A.
The parties entered into an Agreement for Services on 30th June 2005, concerning Study known as Protocol AN01.01.0012A Multi-centre, double-blind, randomized, parallel group, placebo-controlled trial of ethylepa (Ethyl-Icosapent) in patients with Huntington’s Disease.  This is a Europe only study.
 
B.
The main changes to the project specifications are to the study timelines, the site and patient distribution and the CRF page numbers.  The revised specifications are detailed in Appendix 1 attached.
 
 
IT IS AGREED BY THE PARTIES AS FOLLOWS:
 
 
1.
The parties agree to amend the Agreement to reflect changes set out in the ‘European Revised Project Specifications and Cost Document’ which is attached hereto and incorporated hereby.
 
 
2.
Save as otherwise provided in this Change Order, all the terms and conditions of the Agreement dated the 30th June 2005 shall remain in full force and effect.
 
 
3.
The value of this Change Order shall be £382,057 in direct fees and £1,385,655 in pass through costs.  The direct fees shall be paid in an initial fee of 10% at signature of this agreement and monthly fees thereafter as outlined below:
 
Change Order Direct Fee Value: £382,057 
Initial Payment 10% on siqnature of Change Order (June 06)
  £38,205
Monthly Payments x 12 months (June’06 to May’07)
£28,654.33


 
 

 
 
 
 
 Amarin 694/005    
     
 Protocol AN01.01.0012  
 Change Order no. 2, 8th June 2006
 

IN WITNESS WHEREOF , the parties hereto have executed this Change Order by their duly authorised representatives on the date(s) written below.
 
Amarin Neuroscience Limited
ICON Clinical Research Limited
King’s Park House
South County Business Park
Laurelhill Business Park
Leopardstown
UKFK7 9PQ
Dublin 18
United Kingdom
Ireland


 
 30 June 2006    29 September 2006
DATE
 
DATE
     
 /s/ Anthony Clarke    /s/ Sean Leech
SIGNED
 
SIGNED
     
 A. CLARKE    SEAN LEECH
NAME
 
NAME
     
 
 V.P. CLINICAL DEVELOPMENT
   EXEC. VP COMMERCIAL AND ORGANISATIONAL DEVELOPMENT
TITLE
 
TITLE
 
 


 
 

 

 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

 
 
Appendix 1
 
 
Change Order No. 2
 
Europe Revised Project Specifications and Cost
 
Document
 
Version 4, Submitted 7th June 2006
 
A MULTICENTRE, MULTINATIONAL, DOUBLE-BLIND, RANDOMISED,
PARALLEL GROUP, PLACEBO CONTROLLED TRIAL OF ETHYL-EPA
(ETHYL-ICOSAPENT) IN PATIENTS WITH HUNTINGTON’S DISEASE
 
Protocol Number: AN01.01.0012
 

 
Page 1 of 18

 

 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

 
 
1.  Introduction

This document includes revised specifications to the Clinical Research Proposal Version 5 Submitted 17 May 2005 and the Change Order #1 document (Version 2, Dated 15 Nov 2005) and associated costs for the clinical conduct of study AN01.01.0012 in Europe.  The main changes to the project specifications are to the study timelines, the site and patient distribution and the CRF page numbers.  For Biometrics, we have removed the costs for the US study and the synergies for managing both studies in parallel.
 
The study set-up was delayed primarily due to the late delivery of the final signed protocol to ICON on the 9th of August.  Study set-up was also delayed due to the delay in providing details of the required number of pre-selected sites.  Details of the final 5 sites were provided to ICON on the 14 th of September 2005.
 
Consequently the selection of study sites was delayed as well as EC and regulatory submissions.  The other study timelines will also be affected accordingly.
 
It is now planned to conduct this study in 6 countries.  Austria, Italy and Portugal have been added to the countries originally selected (other countries previously agreed are:  Germany, Spain, UK and Netherlands, however Netherlands has now been excluded).
 
Allowing for staggered site initiations, we estimate that the total number of monitoring visits for each site will vary from 7 to 9 visits.  We propose that the monitoring frequency from April to August 2006 be every 5 weeks.  This will have an impact on CRA and CPM allocation and these allocations have been increased accordingly (CPM = 0.8 FTE, CRA = 4.6 FTE).  The increase in CRA allocation has also been due to an increase in the number of CRF pages from 60 pages to 96 pages.  We have been able to reduce the planned number of CRAb allocated after study set-up from a total of 3 FTEs to 2.8 FTEs (January 2006 to March 2006).
 
In order to effectively manage the study we have extended the Project Manager to 0.8 FTEs from the original 1-month after the planned FPI (1st September 2005) until 15 days after, the revised planned FPI (15th December 2005).
 
Following the meeting with Amarin on 7th November 2005, it was agreed that as the clinical resource required will be heavily dependent on enrolment and site activity, and as the CRF has increased to a 96-page CRF (from 60 pages) ICON will actively evaluate the clinical resource on an ongoing basis and provide 3-monthly reports to Amarin of the same.  Where required, ICON will adjust the clinical resource, following written approval from Amarin.
 
During a subsequent meeting with Amarin on 16th February 2006 it was agreed that additional changes in specifications would be included in Change Order No: 1.
 
 


 
Page 2 of 18

 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 
2.  Revised Clinical project Specifications

(1)           Project Timelines:
 
The table below summarizes the original and revised projected timelines for the conduct of this study.
 
Milestone
Original Date
Revised Date
ICON involvement begins
1st April 2005
1st   April 2005
Final Protocol Available*
1st June 2005
9th August 2005
First patient in
1st September 2005
15th December 2005
Last patient screened
Not specified
June 2006
Last patient in
1st March 2006
July 2006

The proposed revised dates for LPO, Database lock and ICON end will be according to previously agreed intervals.
 
The revised timelines include the following revisions:
 
·  
A delay of 2.5 months to study set-up.
 
·  
The inclusion of the 1-month follow-up period (i.e. patients will be in the study for 6 months plus 1 month follow-up)
 
·  
The inclusion of an additional 2 weeks period (It was planned to screen the first patient in December 2005; in the project meeting in November it was decided that the last patient in date would be June 2006, in total 6.5 months).
 
·  
Last patient in date means date last patient randomised to medication
 
·  
Last patient out date is 1 month/35 days after last patient off treatment.
 
 
(2)           Site and Patient Distribution
 
Approximately 37 sites will be contacted and surveyed to establish their interest and suitability for participating in this study (originally 38 planned).  It is planned to conduct a total of 37 pre-study visits (originally 33 planned) and to initiate 30 sites (originally 30 planned).
 

 
Page 3 of 18

 
 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

The tables below show the site and patient distribution per the original contract as well as the current site and patient distribution.
 
Original Site and Patient Distribution
 
Country
Number of
screened
sites
Number of
initiated sites
Number of
randomized
patients
Germany
14
12
96
Netherlands
UK
24
18
144
Spain
TOTAL
38
30
240

 
Revised Site and Patient Distribution
 
Country
Number of
screened
sites
Number of
initiated sites
Number of
randomized
patients
Austria
2
2
24
Germany
9
9
80
Italy
4
4
30
Netherlands
1
0
0
Portugal
3
2
8
Spain
5
4
28
Switerland
1
0
0
UK
12
9
70
TOTAL
37
30
240


 
Page 4 of 18

 
 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

 
(3)           Staff Allocation
 
Based on the revised study timelines and the current site and patient distribution the clinical study team allocation has been revised as follows:
 
FTE
Staff
Time Allocation
0.4
Project Manager
Allocated in April 2005
0.8
Project Manager
Allocated from 1st   of May 2005 through 31st of December 2005
0.6
Project Manager
Allocated from 1st of January 2006 through 31st of March 2006
0.8
Project Manager
Allocated from 1st of April 2006 through 31st of August 2006
0.6
Project Manager
Allocated from 1st of September 2006 through 31st of January 2007
0.8
Project Manager
Allocated from 1 st of February 2007 through 31st of May 2007
1.5
Clinical Research Associate(s)
Allocated in April 2005
3.0
Clinical Research Associate(s)
Allocated from 1st of May 2005 through 31st of December 2005
2.8
Clinical Research Associate(s)
Allocated from 1st of January 2006 through 31st of March 2006
4.6
Clinical Research Associate(s)
Allocated from 1st of April 2006 through 31st of August 2006
3.4
Clinical Research Associate(s)
Allocated from 1st of September 2006 through 31st of May 2007
0.7
Clinical Research Assistant(s)
Allocated in April 2005
1.4
Clinical Research Assistant(s)
Allocated from 1st of May 2005 through 31st of December 2005
1.2
Clinical Research Assistant(s)
Allocated from 1st of January 2006 through 31st of March 2006
1.4
Clinical Research Assistant(s)
Allocation from 1st of April 2006 through 31st of August 2006
1.2
Clinical Research Assistant(s)
Allocation from 1st of September 2006 through 31st of May 2007
 
Therapeutic Director
Allocated for 5 days for study duration
 
Clinical Regulatory Compliance Associate
Allocated for 17 days for study duration
 
Accounting
Administrator
Allocated for 69 days for study duration



 
Page 5 of 18

 

 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

The above allocations are also based on the participation of 30 sites in the project, 96 CRF pages per patient and on a 5- weekly monitoring visit frequency from April 2006 to August 2006 and 7- weekly thereafter (previously 6 weekly) for a total of 7-9 visits per site (previously 8).  Based on the recruitment rates expected at EU sites, on-site monitoring activities and the revised number of CRF pages will take approximately 10 hours to perform.
 
ICON will actively evaluate the clinical resource on an ongoing basis and provide 3-monthly reports to Amarin of the same.  Where required, ICON will adjust the clinical resource, following written approval from Amarin.
 
 
(4)           Clinical Documentation
 
The following changes in project specifications have been made in respect to study documentation:
 
·  
ICON will write the Austrian Protocol Amendment required for EC and regulatory submissions.
 
·  
ICON will organise for the translation of medication instructions through a third party vendor.
 
·  
ICON will organise for the translation of the study protocol into Spanish through a third party vendor.
 
·  
ICON will organise for the translation of regulatory documentation through a third party vendor.
 
 
(5)           Clinical Activities
 
 
(a)           Administration of Investigator Payments
 
ICON will be responsible for the administration of investigator payments and hospital and pharmacy fees, where necessary.  Payments will be made by ICON on a 3-monthly basis.  All payments, which will be agreed in advance, will be charged to Amarin as “pass-through”.  In addition Amarin will provide ICON with a float of 30% of the total budget of investigator fees for the payment of investigator fees to support the agreed up front payments to sites.
 
 
(b)           Regulatory Submissions
 
ICON will be responsible for any follow-up or re-submission of regulatory clinical trial submissions to the relevant authorities in Germany, Spain and the UK.  Any future request will be documented in a change notification before documented in a change order.  (Amarin has requested ICON to be responsible for any new submission or follow-up).
 
ICON will complete the AMG form for the German submission and will make the local regulatory notifications.  ICON has also provided advice to Alison Bannon (Sub-contractor of Amarin) regarding regulatory submissions for a total of 8 hours.
 

 
Page 6 of 18

 

 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 
 
ICON will be responsible for making regulatory clinical trial submissions to the relevant authorities in Austria, Italy (including the Osservatorio web site) and Portugal.  Amarin will provide draft documentation for the Austrian and Portuguese submissions.
 
ICON will be responsible for any additional notification or submission.
 
Amarin will be responsible for responding in a timely way to questions from regulatory agencies to affect a final outcome.  ICON will assist, as appropriate
 
 
(c)           Ethics Committee Submissions
 
ICON will be responsible for preparing 27 local and 6 central ethics committee submissions in Austria, Germany, Italy, Portugal, Spain and in the UK.  Both Amarin and ICON will be responsible for responding in a timely manner to questions raised by ethics committees to affect a final outcome.
 

 
Page 7 of 18

 
 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

 
3.  Revised Biometrics Project Specifications

The following changes have been made to the Biometrics costs and specifications:
 
Data Management
Contract
CO#1
Comments
US Study and Synergies:
-
-
Both the costs for the US study and the synergies (for managing both studies in parallel) have been removed.
Timelines (EU study):
21
28
The original contract specifications were based on 21 months (from 1 Apr 05 to 1 Jan 07).  The date for database lock has been moved so the timelines have been extended by 5 months thus increasing the costs for the following activities:  Project Management, teleconferences and the review of monthly central laboratory and ECG transfers.  The date for Database lock is estimated to be 4-6 weeks post Last Patient Last Visit (LPLV) date.  ICON will make all possible efforts to achieve Database Lock as early as possible.
Status Reports (EU study):
21
76
The original contract specifications were based on monthly status reports over 21 months.  From April 2006 status reports will be provided on a weekly basis, thus the number of reports has increased to 76.
Face-to-face Meetings (EU study):
2
6
The original contract specifications were based on attendance at two face-to-face meetings.  Four additional meetings have been included (including travel costs) as the Data Management group has already attended two meetings to date and it is expected that there will be quarterly meetings on an ongoing basis.
Pages (EU Study):
13,680
21,816
The original contract specifications were based on 13,680 (24 drop-outs x 30 pages plus 216 completers x 60 pages) pages.  The number of CRF pages has now increased to 21,816 pages (24 drop-outs x 45 pages plus 216 completers x 96 pages), thus increasing the costs for data and query processing (10%).
CRF Design (EU study):
60
96
The original contract was based on 30 unique/30 replicate CRF pages.  This has now increased to 30 unique/66 replicate pages thus increasing the costs for CRF design.

 
Note :   No changes have been applied to the Biostatistics costs and specifications as the Statistical Analysis Plan(s) has yet to be finalised.
 

 
Page 8 of 18

 
 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

4.  Revised Pass-through Costs

The following changes have been made to the cost estimates of pass-through costs.
 
Activity
Description
Travel Costs
Cost estimates for site visits have been increased from an average of £210 to £300 due to the revised site allocation.  It is estimated that there will be an additional 26 visits conducted.
Translations
Translation costs for the following have been included in the budget:
 
Translation of patient cards into 7 languages.
 
Translation of medication instructions into 7 languages.
 
Translation of the study protocol into Spanish.
 
Translation of the study synopsis into 3 additional languages.
 
Translation of the informed consent form into 4 additional languages.
 
Translation of additional EC documentation for 6 additional submissions.
 
Translation of regulatory documents from three languages into English.
 
Translation of investigator contracts.
Regulatory Agency Fees
Regulatory fees for 3 clinical trial submissions have been included in the revised pass-through budget.
Ethics Committee Fees
EC fees for one less EC submission have been deduced from the revised pass-through budget.
Investigator Fees
Cost estimates for investigators fees including hospital overheads and pharmacy fees have been included in the revised past-through budget.


 
Page 9 of 18

 
 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

5.  Revised Cost Estimates (Clinical)5.  Revised Cost Estimates (Clinical)

Cost estimates for ICON services and associated “pass-through” costs are presented in this section.  These cost estimates reflect the changes in cost associated with the revised project specifications presented in sections 1-3.  Should these or other project specifications change the cost estimate provided herein may require modification.
 
Clinical Research Management
Units
Number of
Units
Price per unit*
Revised Cost
(STG£)
Contract
(STG£)
Change Order (STG£)
Therapeutic Director
Days
5
1,330
6,651
6,651
0
Project Manager
Days
357
922
329,143
252,780
76,363
Clinical Research Associate
Days
1663
497
827,105
580,952
246,153
Clinical Research Assistant
Days
633
390
246,579
197,766
48,813
Clinical Regulatory Compliance
Days
17
511
8,692
6,977
1,715
Account Administrator
Days
69
494
34,076
34,076
0
CLINICAL RESEARCH MANAGEMENT SUB-TOTAL
£1,452,246
£1,079,202
£373,044

*Figures in the “Price per unit” column have been rounded, figures in the “Total” column are correct.
 

 
Page 10 of 18

 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 


Support Services
Units
Number of
Units
Price per
unit*
Revised Cost
(STG£)
Contract
(STG£)
Change Order (STG£)
Local Ethics Committee Submissions
Sites
27
552
14,905
16,562
-1,657
Central Ethics Committee Submission
Sites
6
828
4,968
3,312
1,656
Regulatory Submission
Submission
3
3,005
9,015
0
9,015
ICOTrack Set-up
System Set-
1
2,795
2,795
2,795
0
ICOTrackMaintenance
Months
26
177
4,612
4,612
0
SUPPORT SERVICES SUB-TOTAL
£36,295
£27,281
£9,013

 
*Figures in the “Price per unit” column have been rounded, figures in the “Total” column are correct.
 
ICON CLINICAL RESEARCH
     
£1,488,541
£1,106,484
£382,057

 

 
Page 11 of 18

 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

Estimated pass-through costs
Units
Number of
Units
Price per unit
Revised Cost (STG£)
Contract (STG£)
Change Order
(STGE)
Travel
           
Site Visit Adjustment
Visits
333
300
99,900
69,810
30,090
Additional Site visits
Visit
26
300
7,800
0
7,800
Team Meetings
Meetings
7
629
4,402
4,402
0
Sponsor Meetings
Meetings
7
1,118
7,827
7,827
0
Investigator Fees
           
Investigator Fees
Patient
240
4,900
1,176,000
0
1,176,000
Pharmacy Fees
site
30
340
10,200
0
10,200
Hospital Overheads
10% per
240
490
117,600
0
117,600
Investigator Meetings
           
Travel
Attendees
69
1,747
120,543
120,543
0
Administrative Fee - 10%
     
12,054
12,054
0
Translations
           
Protocol synopsis (1,000 words)
Language
6
391
2,348
1,174
1,174
Protocol
Language
1
3,000
3,000
0
3,000
Informed consent document
Language
7
783
5,479
2,348
3,131
EC documents
Submission
33
433
14,297
11,265
3,033
Medication Instructions
Language
7
120
840
0
840
Regulatory documents
Submission
3
866
2,598
0
2,598
Patient Cards
Language
7
53
371
0
371
Investigator Contracts
Site
23
800
18,400
0
18,400
Other
           
Teleconferencing (3 lines)
Meetings
65
84
5,451
5,451
0
Ethics Committee Fees
Sites
33
559
18,448
19,007
-559
Regulatory Fees
Submission
3
800
2,400
0
2,400
Courier
per site/month
120
71
33,258
24,710
8,548
Mobile phones
per CRA per
25
42
3,675
2,646
1,029
       
£1,666,891
£281,237
£1,385,655
             
CLINICAL RESEARCH TOTAL
£1,488,541
£1,106,484
£382,057
ESTIMATED PASS THROUGH COSTS
£1,666,891
£281,237
£1,385,655
OVERALL TOTAL
£3,155,432
£1,387,720
£1,763,512

 

 
Page 12 of 18

 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

Revised cost Estimates (Biometrics)
 

Data Management
Contract Costs
Removal of US
Study Costs and
Synergies
EU Study Cost
(No Synergy)
New Costs
(CO#1)
Change in
Specifications
Cost Reduction
1. Project Management
£30,677
£17,367
£13,310
£29,951
£16,641
-£726
Planning
£9,409
£6,914
£2,495
£3,327
£832
-£6,082
Communications
£9,409
£6,914
£2,495
£3,327
£832
-£6,082
Set-up of Status Reports
£992
£22
£969
£969
£0
-£22
Ongoing Status Reports
£1,884
£637
£1,248
£4,515
£3,267
£2,631
2. Meetings
           
Teleconference with Sponsor
£7,651
£3,612
£4,039
£5,385
£1,346
-£2,265
Kick-off Meeting
£3,328
£75
£3,253
£3,253
£0
-£75
Face-to-face Meetings
£3,948
£1,997
£1,952
£16,263
£14,312
£12,315
3. Project Set-up
           
Data Management Plan
£4,225
£1,492
£2,733
£2,733
£0
-£1,492
Study Specific Procedures
£5,147
£1,104
£4,042
£4,042
£0
-£1,104

 
Page 13 of 18

 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

 
Data Management
 
Contract Costs
Removal of US
Study Costs and
Synergies
 
EU Study Cost
(No Synergy)
 
New Costs
(CO#1)
 
Change in
Specifications
 
Cost Reduction
Edit Check Document
£6,659
£1,906
£4,753
£4,753
£0
-£1,906
Data Management Report
£3,026
£649
£2,376
£2,376
£0
-£649
Database Setup
£14,839
£1,628
£13,211
£13,211
£0
-£1,628
Edit Programming
£28,107
£8,046
£20,061
£20,061
£0
-£8,046
Data Listings - Programming
£3,026
£649
£2,376
£2,376
£0
-£649
Central Laboratory - Programming
£4,886
£1,678
£3,208
£3,208
£0
-£1,678
ECG - Programming
£6,491
£3,282
£3,208
£3,208
£0
-£3,282
4. Review External Data
           
Central Laboratory - Data
Reconciliation
£11,745
£7,067
£4,679
£6,238
£1,560
-£5,507
ECG - data Reconciliation
£5,873
£3,533
£2,339
£3,119
£780
-£2,754
5. Data Processing
           
CRF Scanning
£20,269
£11,264
£9,005
£13,772
£4,766
-£6,498
Data Entry
£58,239
£32,685
£25,555
£40,753
£15,198
-£17,486
Obvious Corrections
£42,736
£23,984
£18,752
£29,905
£11,153
-£12,831
Data Listings - Review
£5,001
£2,807
£2,194
£3,499
£1,305
-£1,502
Validation
£60,777
£34,109
£26,668
£42,529
£15,861
-£18,248

 
Page 14 of 18

 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 

 
Data Management
 
Contract Costs
Removal of US
Study Costs and
Synergies
 
EU Study Cost
(No Synergy)
 
New Costs
(CO#1)
 
Change in
Specifications
 
Cost Reduction
6. Coding
           
Data Coding (60% autoencode)
£9,228
£5,179
£4,049
£4,049
£0
-£5,179
7. Query Processing
           
Query Resolution
£28,864
£16,199
£12,665
£20,198
£7,532
-£8,666
8. Data Transfers to Sponsor
           
Test Transfer
£2,449
£1,176
£1,274
£1,274
£0
-£1,176
Final Database Transfer
£12,625
£5,981
£6,644
£6,644
£0
-£5,981
9. Closeout Activities
           
CRF Quality Control Reviews (SQRT n+1) Enrolled Patients
£1,483
£791
£692
£692
£0
-£791
Critical Item Reviews 100% Enrolled Patients
£12,796
£8,411
£4,384
£4,384
£0
-£8,411
Closeout & Archive
£4,893
£2,648
£2,246
£2,246
£0
-£2,648
10. SAE Reconciliation
           
SAE Reconciliation
£5,741
£3,313
£2,428
£2,428
£0
-£3,313
DATA MANAGEMENT*
£426,423
£217,119
£209,304
£304,688
£95,384
-£121,734
 
* NOTE :   No costs have been included for the merging of data between the EU and US studies, which, if requested, may incur an additional cost.

 
CFR DESIGN
£16,393
£3,279
£13,114
£15,906
£2,791
-£487
 

BIOSTATISTICS
£163,451
-
-
£163,451
-
-
 

PASS-THROUGH COSTS
£50,742
£26,972
£23,770
£34,019
£10,249
£16,723

 


 
Page 15 of 18

 
 
 
 Amarin Neuroscience  
 CONFIDENTIAL
 
 Change Order No. 2
 
     
 Version 4, 7th of June 2006
 
The table below summarizes the revised, original and change order cost.
 
Overall costs
Revised Cost

(STG£)
Contract Costs

 (STG£)
Change Order

(STG£)
CLINICAL RESEARCH TOTAL
1,488,541
1,106,484
382,057
ESTIMATED PASS THROUGH COSTS
1,666,891
281,237
1,385,655
OVERALL CLINICAL TOTAL
£3,155,432
£1,387,720
£1,763,512
       
DATA MANAGEMENT
304,688
426,423
-121,734
CRF DESIGN
15,906
16,393
-487
BIOSTATISTICS
163,451
163,451
0
DM and BIOSTAT PASS-THROUGH Costs
34,019
50,742
-16,723
OVERALL DM and BIOSTAT TOTAL
£518,064
£657,009
-£138,944
       
OVERALL TOTAL
£3,673,496
£2,044,729
£1,624,568


 

 
Page 16 of 18

 
 
 
 Amarin 694/005  
 
 
 
         
 Protocol AN01.01.0012      
  Change Order No. 2   Version 4, 7th of June 2006
 
     
Payment Schedule
 
 
Payment Schedule
 
Summary of Costs (CO#2)

Change Order Direct Fee Value:  £382,057
Initial Payment 10% on signature of Change Order (June 06)
£38,205
Monthly Payments x 12 months (June ’06 to May ’07)
£28,654.33 per month
£343,852

Change Order Direct Fee Value:  -£122,221
Initial Payment 10% on signature of Change Order (June 06)
-£12,222
Monthly Payments x 12 months (June ’06 to May ’07) -
£1,018.51 per month
£109,999

SUMMARY:  Change Order 2 Payment Schedule
Change Order Direct Fee Value:  Clinical
£382,057
Change Order Direct Fee Value:  Data Management
-£122,221
 
£259,836

 
Summary of Costs (CO#2)

10% upon signature
£25,984
Monthly Payments x 12 months (June ’06 to May ’07)
£19,487.70 per month
£233,852
 
£259,836

REVISED ICON EU PAYMENT SCHEDULED (CHANGE ORDER #2)U PAYMENT SCHEDULED (CHANGE ORDER #2)
   
Milestone Payments
 
Task Completed
Contract Value
Contract Signed
342,550
All sites initiated
192,684
50% of patients enrolled
192,684
Initial Payment 10% on signature of C/O#2
25,984
100% of patients enrolled
192,684
Mid-point of treatment phase
192,684
All patients completed and data at DM
192,684
All sites closed
38,537
Final Tables & Listings
25,691

Total Milestones payments
£1,396,185
Monthly Payments contract
April ’05 - June ‘07
22
15,570
342,550
Monthly Payments change order #2*
Jun ’06 - May ‘07
12
19,488
233,852

Total Monthly payments
£576,403
   
Total payments
£1,972,587

*Change Order #2:  monthly payment have been adjusted to include the increase of the clinical direct cost and decrease the data management cost
 

 
Page 17 of 18

 
 
 
 Amarin 694/005  
 
 
 
         
 Protocol AN01.01.0012      
  Change Order No. 2   Version 4, 7th of June 2006
 
     
Payment Schedule
 

IN WITNESS WHEREOF , the parties hereto have executed this Change Order by their duly authorised representatives on the date(s) written below.
 

Amarin Neuroscience Limited
ICON Clinical Research Limited
King’s Park House
South County Business Park
Laurelhill Business Park
Leopardstown
UKFK7 9PQ
Dublin 18
United Kingdom
Ireland


 
 16 October 2006    29 September 2006
DATE
 
DATE
     
 /s/ Anthony Clarke    /s/ Sean Leech
SIGNED
 
SIGNED
     
 A. CLARKE    SEAN LEECH
NAME
 
NAME
     
 
VP CLINICAL DEVELOPMENT
   EXEC. VP COMMERCIAL AND ORGANISATIONAL DEVELOPMENT
TITLE
 
TITLE
 
 
 
 
Page 18 of 18
Exhibit 4.62
 
 

Dated 18 January 2007
______________________________________





(1) NEUROSTAT PHARMACEUTICALS INC.

and

(2) AMARIN PHARMACEUTICALS IRELAND LIMITED

and

(3) AMARIN CORPORATION PLC

and

(4) TIM LYNCH




________________________________________

AGREEMENT
for termination and release of
certain confidentiality obligations
________________________________________





Reed Smith Rambaud Charot LLP
Minerva House
5 Montague Close
London SE1 9BB
United Kingdom

Tel:  +44 20 7403 2900
Fax:  +44 20 7403 4221
www.reedsmith.com
Ref:   JNW/GP


 
 

 

THIS AGREEMENT IS MADE ON 18 JANUARY 2007

PARTIES

(1)
NEUROSTAT PHARMACEUTICALS INC . a company organised under the laws of the state of Delaware, with a principal place of business at 1422 NW First Street, Bend, OR 97701, United States of America ( NeuroStat ); and

(2)
AMARIN PHARMACEUTICALS IRELAND LIMITED a company incorporated in Ireland under registration number 408912, with a registered office is at 50 Pembroke Road, Ballsbridge, Dublin 4, Republic of Ireland ( Amarin Pharma ); and

(3)
AMARIN CORPORATION PLC a company registered in England with registered number 02353920 and a registered office at 110 Cannon Street, London EC4N 6AR, United Kingdom ( Amarin Corp ); and

(4)
TIM LYNCH of 1422 NW First Street, Bend, OR 97701, United States of America ( Mr Lynch ).

BACKGROUND

(A)
Amarin Pharma is a neuroscience company focused on the research, development and commercialisation of novel drugs for the treatment of central nervous system disorders.  Amarin Pharma is a wholly-owned subsidiary of Amarin Corp.

(B)
NeuroStat and Amarin Corp entered into an Mutual Confidentiality Agreement dated 2 November 2006 (the Confidentiality Agreement ).  NeuroStat has valuable, confidential information relating to various forms of Lorazepam (as defined below) including a compound known as nano-Lorazepam under development by Elan Corporation plc of Treasury Building, Lower Grand Canal Street, Dublin 2, Republic of Ireland and its Affiliates (as defined below) (together referred to as Elan ; and specifically including Elan Pharma International Limited, a limited liability company incorporated under the laws of Ireland).

(C)
Under the Confidentiality Agreement, due to the sensitivity of the Confidential Information held by NeuroStat, Amarin Corp agreed, among other things, not to pursue the license or development of a Lorazepam product with Elan or any of its affiliates.  NeuroStat and Amarin Corp have agreed to terminate the Confidentiality Agreement on the following terms and conditions.

NOW, THEREFORE, in consideration of the mutual promises and covenants contained in this Agreement and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

 
 

 

AGREEMENT

1.            Definitions and Interpretation

1.1
In this Agreement and in the Schedules to this Agreement the following words and phrases shall have the following meanings unless the context requires otherwise:

Affiliate means, with respect to a particular Party, a person, corporation, partnership or other entity, that from to time Controls, is Controlled by, or is under common Control with such a Party;

Agreement means this agreement and any and all schedules, appendices and other addenda to it as may be varied from time to time in accordance with the provisions of this agreement;

Business Day means a day other than a Saturday, Sunday, bank or other public holiday in England, the Republic of Ireland or the state of Oregon;

Commencement Date means the date set out at the beginning of Agreement;

Confidential Information means any proprietary information which is not in the public domain, whether or not such information is identified as confidential, including, without limitation, information relating to products, processes, services, businesses, personnel, research, commercial activities, formulas, materials, compounds, substances, programmes, devices, concepts, inventions, patents, designs, methods, techniques, intellectual property, marketing and commercial strategies, data, trade secrets, know-how, plans, operations, tests, studies, manuals, market reports, customers, contracts, financial status, cash flow projections and the like or any other matter connected with the business of a Party or any of its, suppliers, partners or customers related to a Party or its business;

Control means:

 
(a)
with respect to any legal entity, the direct or indirect ownership or possession of (i) the power to direct or cause the direction of the management and policies of a company or entity whether by contract or otherwise; (ii) at least 50% (in the aggregate) of the voting power of all outstanding shares entitled to vote at a general election of directors of a company or entity; or (iii) at least 50% of the assets of a company or entity;

 
(b)
with respect to any material, item of information, or intellectual property right, the possession, whether by ownership or licence, of the right to grant a licence or sub-licence with respect thereto, without breaching any prior written obligation to any Third Party,

and Controlled shall be construed accordingly;

 
 

 


Elan Lorazepam Agreement has the meaning given such term in Clause 4.1(b)(i).
Licensed Know How means all the Confidential Information Controlled by NeuroStat at or at any time after the Commencement Date relating to Products and/or their development and/or commercialisation, which, for the avoidance of doubt shall not include any Confidential Information of Elan;

Lorazepam means the active drug substance Lorazepam the chemical structure and formula for which are set forth in Exhibit A, together with and including all salts, esters, complexes, chelates, isomers (including stereoisomers), crystalline forms, amorphous forms, prodrugs (including all compounds that are metabolized or dissolve into the same active moiety in the body), solvates (including hydrates), metabolites/metabolic precursors, and pegylated forms thereof.

Parties means Mr Lynch, NeuroStat, Amarin Corp and Amarin Pharma, and Party shall mean either of them;

Product means any product in any formulation containing any form of Lorazepam, including any nasally administered nanocrystal formulation of Lorazepam; any injectible (including via intravenous, intramuscular and or-subcutaneous injection), buccal, sublingual, rectal or inhalation nanocrystal formulation of Lorazepam; and/or any other nanocrystal formulation of Lorazepam;

Third Party means any entity or person other than the Parties and their Affiliates.

1.2
In this Agreement:

 
(a)
unless the context otherwise requires, all references to a particular clause or schedule shall be a reference to that clause or schedule in or to this Agreement as it may be amended from time to time pursuant to this Agreement;

 
(b)
the headings are inserted for convenience only and shall be ignored in construing this Agreement;

 
(c)
unless the contrary intention appears, words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa;

 
(d)
any reference to persons includes natural persons, firms, partnerships, limited liability partnerships, companies, corporations, unincorporated associations, local authorities, governments, states, foundations and trusts (in each case whether or not having separate legal personality) and any agency of any of the above;

 
 

 


 
(e)
any phrase introduced by the terms “including”, “include”, “in particular” or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms;

 
(f)
any reference to a statute, statutory provision or subordinate legislation (legislation) (except where the context otherwise requires) (i) shall be deemed to include any bye-laws, licences, statutory instruments, rules, regulations, orders, notices, directions, consents or permissions made under that legislation and (ii) shall be construed as referring to any legislation which replaces, re-enacts, amends or consolidates such legislation (with or without modification) at any time; and

 
(g)
any reference to a Party includes a reference to their respective successors-in-title and permitted assignees.

2.            Release and Termination

2.1
Subject to the terms and conditions of this Agreement, NeuroStat and Amarin Corp hereby agree to terminate the Confidentiality Agreement and release each other from further compliance with the Confidentiality Agreement with effect from the Commencement Date.

2.2
Subject to Amarin Corp’s satisfaction of its obligations under this Agreement, NeuroStat hereby releases, waives and discharges Amarin Corp and its Affiliates, successors, directors, agents, servants, officers, shareholders, employees and representatives of and from all claims, debts, demands, rights and causes of action, arising out of the transactions, events and occurrences, or any other claims NeuroStat presently may have against Amarin Corp, relating to the Confidentiality Agreement.

2.3
Amarin Corp hereby releases, waives and forever discharges NeuroStat and its Affiliates, successors, directors, agents, servants, officers, shareholders, employees and representatives of and from all claims, debts, demands, rights and causes of action, arising out of the transactions, events and occurrences, or any other claims Amarin Corp presently may have against NeuroStat, relating to the Confidentiality Agreement.

3.            Technical Assistance

3.1
NeuroStat shall, forthwith following the Commencement Date and free of charge to Amarin Pharma, disclose and supply to Amarin Pharma any and all Licensed Know How to the extent not already disclosed to Amarin Corp or Amarin Pharma.  To avoid any doubt, NeuroStat has no obligation to disclose any information with respect to which it or Tim Lynch has any obligation of confidentiality or non-use to Elan.

3.2
Mr Lynch shall enter into a consultancy agreement on mutually acceptable terms pursuant to which, during a period of six months following the Commencement Date, Mr Lynch shall render such assistance as Amarin Pharma may request in negotiations with Elan relating to the in-licensing of rights to Products and in initiating development of Products.  Mr Lynch shall be remunerated on a daily rate basis and the rate payable shall be US$2,000.  NeuroStat hereby irrevocably consents to such an arrangement.

 
 

 


4.            Consideration

4.1
In consideration of the terms and conditions of this Agreement, including the license of the Licensed Know How pursuant to Clause 6 and the release and termination pursuant to Clause 2, and conditional upon Amarin Pharma or an Affiliate of Amarin Pharma entering into an Elan Lorazepam Agreement (as defined below):

 
(a)
In exchange for the property rights set forth above, Amarin Corp shall issue to NeuroStat, within 10 days of Amarin Pharma or an Affiliate of Amarin Pharma entering into an Elan Lorazepam Agreement, immediately exercisable warrants to purchase 175,000 ordinary shares of Amarin Corp of five pence par value at the exercise price per share set forth below in the form of ADSs, exercisable no later than the seventh anniversary of the Commencement Date on 10 days’ written notice to Amarin Corp (the Warrants ).  The Warrants and the underlying ADSs shall be issued to NeuroStat pursuant to a prospectus supplement to Amarin Corp’s shelf registration statement filed with the Securities Exchange Commission which became effective on 2 August 2006.

 
NeuroStat may exercise the Warrants in respect of amounts of not less than 25,000 ordinary shares on each occasion of exercise.

 
The exercise price of the Warrants shall be the NASDAQ closing price on the Business Day before the date upon which Amarin Pharma or an Affiliate of Amarin Pharma enters into Elan Lorazepam Agreement.

 
(b)
Amarin Pharma shall make the following payments to NeuroStat:

 
(i)
a non-refundable, non-creditable sum of US$165,000 within 10 days after the date upon which Amarin Pharma or any Affiliate of Amarin Pharma executes a legally-binding agreement with Elan (or any one of the companies that is defined as being part of Elan) pursuant to which Amarin Pharma or any Affiliate of Amarin Pharma obtains any right with respect to or in connection with any Product, including any license, any option, any covenant not to sue, any supply commitment, any right to distribute, and/or any other right with respect to or in connection with any Product (each, an Elan Lorazepam Agreement ;  Elan Lorazepam Agreements exclude, however, any confidential disclosure or similar agreement in both cases pursuant to which Amarin Pharma or any Affiliate of Amarin Pharma obtains solely the right to use confidential information relating to Lorazepam or Products in order to evaluate whether to enter into an Elan Lorazepam Agreement but does not receive any other rights with respect

 
 

 

to or in connection with any Product (including the kinds enumerated above);  to avoid any doubt the mere presence of confidentiality provisions within a license agreement or other agreement granting Product rights (confidentiality provisions would, by way of background, ordinarily be expected to be included in any such agreement) shall not qualify the agreement as the kind of confidentiality agreement that is excluded from the Elan Lorazepam Agreements); and

 
(ii)
non-refundable, non-creditable milestone payments within 10 days after the relevant milestone event as follows:

 
(A)
US$200,000 on the first administration to a human subject of a Product covered by an Elan Lorazepam Agreement (defined in Clause 4.1(b)(i)); and

 
(B)
US$200,000 on the first administration to a human subject of a Product covered by an Elan Lorazepam Agreement (defined in Clause 4.1(b)(i)) in the first clinical study that is designed to assess the efficacy of such a Product, however such clinical trial is denominated (with respect to phase of trial) and whether or not such first clinical study is in a limited patient group.  Clinical studies in any patient population (or patient populations) are considered “designed to assess the efficacy of such a Product” for this purpose.

(the payments of (A) and (B) in this Clause 4.1(b)(ii) are together referred to as the Milestone Payments ) provided that Amarin Corp may elect to discharge fully Amarin Pharma’s obligation to make the Milestones Payments by issuing to NeuroStat ordinary shares of five pence par value in the capital of Amarin Corp to the value of the Milestone Payment at the NASDAQ closing price on the day before the relevant milestone event occurs.  Such shares will be represented by ADSs issued to NeuroStat pursuant to a prospectus supplement to Amarin Corp’s shelf registration statement filed with the Securities Exchange Commission which became effective on 2 August 2006.

It is acknowledged for the avoidance of doubt that (A) and (B) each apply when the events described therein occur, and whether they are achieved by or on behalf of any of Amarin Pharma, an Amarin Affiliate, a sublicensee of Amarin Pharma or an Amarin Affiliate, or another entity contracted with or engaged by any of them.

Amarin Pharma shall notify NeuroStat and Mr. Lynch in writing within three (3) days after the occurrence of each of the events referred to in this Clause 4.1 (including the signing of an Elan Lorazepam Agreement and each of Milestone events (A) and (B)).

 
 

 



4.2
Within five days from the Commencement Date or, if later, receipt by Amarin Pharma of the relevant copy invoices, Amarin Pharma shall reimburse NeuroStat’s and Mr Lynch’s reasonable and documented attorneys’ fees and expenses in connection with the negotiation and documentation of this Agreement and to the extent such fees and expenses do not exceed in total US$15,000.

5.            Non-Compete

5.1
NeuroStat and Mr Lynch hereby jointly undertake that neither shall, and each of NeuroStat and Mr Lynch shall procure that none of NeuroStat’s Affiliates shall, whether alone or in conjunction with an Affiliate or Third Party:

 
(a)
Prior to the expiration or termination of this Agreement, enter into or continue any discussions or negotiations relating to the grant by Elan of any rights in any Product to NeuroStat, any Affiliate of NeuroStat or Mr Lynch or any entity Controlled by Mr Lynch; or

 
(b)
Prior to the expiration or termination of this Agreement, research, develop, use, keep, make, have made, import, offer for sale, sell or otherwise dispose of Products anywhere in the world or grant or receive any licence to do any of the foregoing.

The Parties acknowledge that the foregoing restriction is reasonable, valid and necessary for the protection of Amarin’s business with respect to Products to which it may obtain rights pursuant to an Elan Lorazepam Agreement and that Amarin Pharma would not have entered into this Agreement without the foregoing protection.

Furthermore each of the undertakings contained in each of Clauses 5.1(a) and (b) shall be, and is, a separate undertaking by each of NeuroStat and Mr Lynch and shall be enforceable by Amarin Pharma separately and independently of the right of the Amarin Pharma to enforce any one or more of the other covenants contained in Clause 5 and in the event that any of such undertakings shall be found to be void but would be valid if some part thereof were deleted then such undertaking shall apply with such deletion as may be necessary to make it valid and effective.

6.            Grant of Licence

6.1
Subject to the terms and conditions of this Agreement, NeuroStat hereby grants to Amarin Pharma and its Affiliates an exclusive, worldwide right and license to use the Licensed Know-How to (a) seek to enter into an Elan Lorazepam Agreement, and (b) to research, develop, use, make, have made, import, offer for sale, sell and otherwise dispose of Products with respect to which Amarin Pharma or an Amarin Pharma Affiliate has obtained rights pursuant to an Elan Lorazepam Agreement.  Such license to Amarin Pharma and its Affiliates shall include the right to grant sub-licenses within the scope of

 
 

 

activities described in clause (b) of the foregoing sentence (including the right to grant sub-licensees the right to grant further sub-licensable sub-licences); provided that the activities of the sub-licensees (including all further sub-licensees, direct and indirect) shall be deemed to be activities of Amarin Pharma for purposes of the payment obligations under this Agreement.  Such license to Amarin Pharma and its Affiliates shall be royalty-bearing in the sense that payments to NeuroStat are required under this Agreement, partially in consideration of such license; but other than the payments explicitly called for under this Agreement, such license to Amarin Pharma and its Affiliates shall be royalty-free.

7.            Payment Terms

7.1
All payments due to NeuroStat under this Agreement shall be made in US dollars and by electronic bank transfer to an account specified by NeuroStat.

7.2
Without prejudice to NeuroStat’s right to receive payment on the due date, where NeuroStat does not receive payment of any sums due to it pursuant to this Clause 4 within the time specified, interest shall accrue on the sum due and owing to NeuroStat at the rate equivalent to an annual rate the greater of (i) 1% over the then current base rate of National Westminster Bank plc, for the United Kingdom, calculated on a daily basis, and (ii) 10% and such interest shall run from the date on which payment is due to the date on which payment is made by Amarin Pharma, which the Parties acknowledge to be a substantial remedy for failure to pay the sums due within the time specified.  If Amarin is late in tendering any payment that it is otherwise permitted to tender in warrants or equity (e.g., if it does not tender payment in warrants or equity within the 10-day period for payment after achievement of the event triggering payment under Clause 4.1), then NeuroStat shall be entitled by written notice to Amarin to require the payment to be made by wire transfer of immediately available funds instead;   provided that if Amarin timely notified NeuroStat in writing of the payment-triggering event for the particular payment as required under Clause 4.1 by a notice that is in accordance with Clause 14, then Amarin will have 3 business days from receiving NeuroStat's written notice that payment is due to make the payment of warrants, equity or cash.

7.3
All payments to NeuroStat under this Agreement are expressed to be exclusive of goods, sales, valued added or any similar such tax (Value Added Tax) howsoever arising, and Amarin Corp or Amarin Pharma (as the case may be) shall pay to NeuroStat in addition to those payments or if earlier on receipt of a tax invoice or invoices from NeuroStat, all Value Added Tax for which NeuroStat is liable to account to any competent authority in relation to any supply made or deemed to be made for Value Added Tax purposes pursuant to this Agreement.

7.4
NeuroStat shall be entitled to request to audit and shall be given access to appropriate records to confirm the timing payments are due hereunder (and in the case of payments made in warrants or equity the appropriate calculation of the number of warrants or shares in accordance with this Agreement).

 
 

 


8.            Warranties and Liability

8.1
Each Party represents and warrants to the other Parties that:

 
(a)
it has legal power, authority and right to enter into this Agreement and to perform its respective obligations hereunder;

 
(b)
it is not at the Commencement Date a party to any agreement, arrangement or understanding with any Third Party which conflicts with this Agreement;

 
(c)
this Agreement has been duly authorised, executed, and delivered by that Party and is a valid, binding, and legally enforceable obligation of that Party; and

 
(d)
no consent, approval, authorisation, or order of any court or governmental agency or body is required for the consummation of the transactions contemplated by this Agreement.

8.2
NeuroStat gives no warranty of any nature as to the completeness, accuracy or otherwise of the Licensed Know How and accepts no liability howsoever arising from Amarin Pharma’s use of the Licensed Know How.

8.3
Subject to Clause 8.4, neither Party shall be liable to the other or any of the other Party’s Affiliates or any sub-licensees for any of the following types of loss, damage, cost or expense arising (whether in contract, tort, negligence, breach of statutory duty or otherwise) under or in relation to this Agreement or the subject-matter of this Agreement:

 
(a)
any loss of profits, business, contracts, anticipated savings, goodwill, or revenue; or

 
(b)
any indirect or consequential loss or damage whatsoever, even if that party was advised in advance of the possibility of such loss or damage; or

 
(c)
any punitive, exemplary or similar damages.

8.4
Nothing in Clause 8.2 shall prohibit or hinder the exercise of another Party’s rights in respect of any liability for fraud or fraudulent misrepresentation, notwithstanding that any loss or damage that Party may be seeking to recover is of the type referred to in Clause 8.2.

8.5
The rights, powers and remedies provided in this Agreement are (except as expressly provided) cumulative and not exclusive of any rights, powers and remedies provided by law, or otherwise.

9.            Confidentiality

 
 

 


9.1
A confidential relationship with respect to such Confidential Information shall be established as of the Commencement Date between the Parties.

9.2
Each Party to whom Confidential Information is disclosed (a Recipient ) by another Party (a Disclosing Party ) shall use all necessary care to prevent disclosure or release of Confidential Information of a Disclosing Party to any third party, except with the Disclosing Party’s prior written consent.  Each Recipient shall limit dissemination of Confidential Information of a Disclosing Party to those officers and employees of Recipient who reasonably require access to Confidential Information of a Disclosing Party  for the purposes of this Agreement and who have been made aware that Confidential Information is confidential, are bound by written obligations of confidentiality to the Recipient to treat information such as the Confidential Information of a Disclosing Party  in the strictest confidence.

9.3
Each Recipient shall only use the Confidential Information of a Disclosing Party  for the purposes of this Agreement including in the case of Amarin Pharma as permitted by Clause 6.

9.4
Recipient undertakes to maintain in confidence the fact that discussions are or will be taking place, the nature of the discussions envisaged by this Agreement and the fact that the parties have entered into this Agreement.

9.5
All Confidential Information given or transmitted under the terms of this Agreement will be subject to the terms of this Agreement, except for Confidential Information that a Recipient can establish:

 
(a)
came lawfully into Recipient’s possession prior to the date of disclosure;

 
(b)
is or becomes public knowledge through no fault or omission of Recipient;

 
(c)
is required to be disclosed by law, in which case Recipient shall give the Disclosing Party as much advance notice of the proposed disclosure as is practical (including a copy of any written request or order), and shall cooperate with the Disclosing Party in any effort to limit or restrict such disclosure, via a protective order or otherwise;

 
(d)
is furnished or made known to the Recipient by a third party otherwise than in breach of any obligation of confidentiality to the Disclosing Party; or

 
(e)
is independently developed by the Recipient or one of its Affiliates, without access to the Confidential Information disclosed by the Disclosing Party.

9.6
The terms of this Agreement and negotiations leading to the execution of this Agreement shall be considered to be Confidential Information of both parties.

 
 

 


9.7
The obligations of confidence referred to in this Clause 9 shall furthermore not extend to any Confidential Information which:

 
(a)
being Licensed Know How, Amarin Pharma considers reasonably considers should be disclosed to sub-licensees, agents, consultants, Affiliates and/or other Third Parties for the research and development, manufacturing and/or marketing of Products (or for such Third Parties to determine their interest in performing such activities) on the condition that such Third Parties agree to be bound by confidentiality obligations no less onerous than those contained in this Agreement; and

 
(b)
Amarin Pharma reasonably wishes to disclose to consultants, agents or other Third Parties solely to the extent required in connection with the purposes of this Agreement or in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents or for the purposes of such financing (and, for the avoidance of doubt to potential sub-licensees or other strategic partners) on the condition that such Third Parties agree to be bound by confidentiality obligations no less onerous than those contained in this Agreement.

9.8
It is acknowledged for the avoidance of doubt that Confidential Information disclosed pursuant to the Confidentiality Agreement shall be considered to have been disclosed pursuant to, and subject to the provision of, this Agreement.

9.9
The Parties recognise and agree that remedies at law for breach of the provisions of this Clause 9 are likely to be inadequate and that the disclosing Party shall, in addition to any other rights it may have, be entitled to seek injunctive relief.

9.10
The obligations of each Party under this Clause 9 shall survive until five years after the expiry or termination for whatever reason of this Agreement.

10.            Term and Termination

10.1
This Agreement shall come into effect on the Commencement Date and, subject to earlier termination in accordance with this Clause 10, will expire on the first anniversary of the Commencement Date provided that in the event that Amarin Pharma or an Affiliate of Amarin Pharma enters into an agreement with Elan for the development of Products prior to the first anniversary of the Commencement Date and prior to earlier termination under this Clause 10, Amarin Pharma shall on written notice be entitled to extend the term of this Agreement until the second anniversary of the date on which such agreement with Elan enters effect.

10.2
Each of NeuroStat and Amarin Pharma shall have the right to terminate this Agreement effective at any time on or after 1 June 2007 on 30 days’ written notice to Amarin Pharma and NeuroStat respectively.  This right to terminate can only take effect if

 
 

 

Amarin Pharma or an Affiliate has not entered into an Elan Lorazepam Agreement at the date of termination.

10.3
Amarin Pharma on the one hand or NeuroStat on the other hand (the Terminating Party ) shall have the right to terminate this Agreement in its entirety forthwith upon giving written notice of termination to NeuroStat and Mr Lynch on the one hand or Amarin Corp and Amarin Pharma on the other hand (the Defaulting Party ), upon the occurrence of any of the following events at any time during this Agreement:

 
(a)
the Defaulting Party commits a material breach of an obligation set out in this Agreement which is not capable of remedy; or

 
(b)
the Defaulting Party commits a material breach of an obligation set out in this Agreement which is capable of remedy but has not been remedied within 30 days of the receipt by it of a notice identifying the breach and requiring its remedy.

11.            Consequences of Termination

11.1
In the event of expiry of this Agreement or termination of this Agreement pursuant to Clause 10.2 and 10.3: (a) subject to Clause 11.2, all rights and licences granted to Amarin under this Agreement shall terminate; and (b) each Party shall return all data, files, records and other materials in its possession or control containing or comprising the other Party’s Confidential Information to which such first Party does not retain rights hereunder (except one copy of which may be retained by the returning Party’s legal department solely for archival purposes).

11.2
Following the expiry of this Agreement after the extended term set out in the proviso to Clause 10.1 (but not otherwise), the exclusive license granted pursuant to Clause 6.1 shall -- subject to Amarin and its Affiliates' continued compliance with this Agreement, including payment obligations, and in particular (but without limitation) the next sentence -- become irrevocable, perpetual, fully paid-up and royalty-free (subject to the next sentence), but shall otherwise continue in full force and effect.   Notwithstanding the foregoing, if all consideration provided to be payable or potentially payable under Clause 4 have not as of the time of such expiration been paid, then the obligations to provide the remaining-unpaid consideration shall survive and in this sense the license shall remain royalty-bearing until all such consideration has been paid.

11.3
Following the expiry or termination of this Agreement, Amarin Corp, Amarin Pharma and the Affiliates of each of them shall not pursue the license or development of a Lorazepam Product with Elan (or any of the companies defined as being part of Elan), and shall not enter into any Elan Lorazepam Agreement, unless Amarin Pharma or an Affiliate has previously entered into an Elan Lorazepam Agreement prior to the expiry or termination of this Agreement.  Without limiting or implying any exception to the foregoing, if Amarin Pharma, Amarin Corp, or the Affiliate of either of them enters into any Elan Lorazepam Agreement or develops a Lorazepam Product with or under license with (or other right from) Elan (or any of the companies defined as being part of Elan)

 
 

 

following the expiration or termination of this Agreement, then the Parties agree that the damages to NeuroStat and Mr. Lynch shall be no less than the total consideration provided for in Clause 4, calculated as if all contingencies have been achieved (whether or not actually achieved), payable by wire transfer of immediately available funds (and specifically not payable in equity).  Amarin Corp shall pay such amount to NeuroStat within three (3) Business Days after receiving written notice from NeuroStat that NeuroStat requires such payment to be made.  The Parties hereby explicitly instruct any judge, jury, arbitrator or other arbiter of any dispute relating to a breach of this Clause 11.3 to award NeuroStat at least such amount, plus any additional damages that may be available at law or in equity in relation to such a breach, but excluding punitive, exemplary and similar damages.  This Clause 11.3 shall survive any expiration or termination of this Agreement.

11.4
Termination or expiry of this Agreement for whatever reason shall not affect the accrued rights of the Parties arising in any way out of this Agreement as at the date of termination or expiry and in particular but without limitation the right to recover damages and interest, and the provisions of Clauses 9, 10 and 11 shall remain in full force and effect.  NeuroStat’s and Mr. Lynch’s rights under Clause 4 shall be considered accrued rights as of the Effective Date for this purpose, however, the payments under Clause 4 shall not actually be due until the times provided for in Clause 4 (i.e., each payment remains contingent on achievement of the corresponding Milestone or other event specified in Clause 4, but such contingency need not be achieved prior to the expiration or termination of this Agreement).

12.
Waiver

12.1
No Party shall be deemed to have waived any of its rights or remedies conferred by this Agreement unless the waiver is made in writing and signed by a duly authorised representative of that Party.  In particular, no delay or failure of any Party in exercising or enforcing any of its rights or remedies conferred by this Agreement shall operate as a waiver of those rights or remedies or so as to preclude or impair the exercise or enforcement of those rights or remedies nor shall any partial exercise or enforcement of any right or remedy by any Party preclude or impair any other exercise or enforcement of that right or remedy by that Party.

13.            Entire Agreement/Variations

13.1
This Agreement constitutes the entire agreement and understanding between the Parties and supersedes all prior oral or written understandings, arrangements, representations or agreements between them relating to the subject matter of this Agreement (including the Confidentiality Agreement).

13.2
No variation, amendments, modification or supplement to this Agreement shall be valid unless made in writing in the English language and signed by a duly authorised representative of each Party.

 
 

 


14.            Notices

14.1
Any notice to be given pursuant to this Agreement shall be in writing in the English language and shall be delivered by hand, sent by registered or recorded delivery airmail post or sent by facsimile confirmed by registered or recorded delivery post to the address or facsimile number of the recipient set out at the start of this Agreement or such other address or facsimile number as a Party may from time to time designate by written notice to the other Party.

14.2
Any notice given pursuant to this Clause 14 shall be deemed to have been received:

 
(a)
in the case of delivery by hand, when delivered; or

 
(b)
in the case of sending by post:

 
(i)
where posted in the country of the addressee, on the third Business Day following the day of posting; and

 
(ii)
where posted in any other country, on the seventh Business Day following the day of posting; or

 
(c)
in the case of facsimile, on acknowledgement by the recipient facsimile receiving equipment on a Business Day if the acknowledgement occurs before 1700 hours local time of the recipient and in any other case on the following Business Day.

14.3
All notices to NeuroStat and all notices to Mr. Lynch must also be faxed to +1 415 268 7522, attention Laura Spiegelman, and +1 650 494 0792, attention Chip Lion to be considered effectively given under this agreement.  For the avoidance of doubt, the absence of Ms. Spiegelman or Mr. Lion from these fax numbers, law firm or locations will not adversely affect whether or not the required copy notice has been given.

15.            Assignment

15.1
Neither Party may assign its rights or delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed, except that Amarin Corp and Amarin Pharma shall always have the right, without such consent: (a) to perform any or all of their obligations and exercise any or all of their rights under this Agreement through any of their Affiliates or sub-licensees; and (b) assign any or all of their rights and delegate any or all of its obligations hereunder to any of their Affiliates or to any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of the business to which this Agreement relates (which shall include any sub-licensee under any rights granted to Amarin Pharma or an Affiliate pursuant to an agreement with Elan for the development of Products),

 
 

 

provided that Amarin Corp or Amarin Pharma (as the case may be) shall provide written notice to NeuroStat within 30 days after such assignment or delegation.

15.2
Any permitted successor of a Party or any permitted assignee of all of a Party’s rights under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party to this Agreement and shall cease to have any rights or obligations under this Agreement.

15.3
All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party.  Any attempted assignment or delegation in violation of this Clause 15 shall be void.

16.            Force Majeure

16.1
No Party shall be liable to another Party for failure or delay of any of its obligations under this Agreement, for the time and to the extent such failure or delay is caused by riots, civil commotions, wars, hostilities between nations, embargoes, acts of God, storms, fires, accidents, labour disputes or strikes, sabotage, explosions or other similar or different contingencies which affect its performance or are beyond its reasonable control. If the performance of any obligation under this Agreement is delayed owing to force majeure for any continuous period of more than six months, the Parties shall consult with respect to an equitable solution, including the possible termination of this Agreement.

17.            Severance of Terms

17.1
If the whole or any part of this Agreement is or becomes or is declared illegal, invalid or unenforceable in any jurisdiction for any reason (including both by reason of the provisions of any legislation and also by reason of any court or competent authority which either has jurisdiction over this Agreement or has jurisdiction over any of the Parties):

 
(a)
in the case of the illegality, invalidity or un-enforceability of the whole of this Agreement it shall terminate only in relation to the jurisdiction in question; or

 
(b)
in the case of the illegality, invalidity or un-enforceability of part of this Agreement that part shall be severed from this Agreement in the jurisdiction in question and that illegality, invalidity or un-enforceability shall not in any way whatsoever prejudice or affect the remaining parts of this Agreement which shall continue in full force and effect.

17.2
If in the reasonable opinion of any Party any severance under this Clause 17 materially affects the commercial basis of this Agreement, the Parties shall discuss, in good faith, ways to eliminate the material effect.

 
 

 



18.            This Agreement not to Constitute a Partnership

18.1
None of the provisions of this Agreement shall be deemed to constitute a partnership between the Parties and neither Party shall have any authority to bind the other in any way except as provided in this Agreement.

19.            Public Statements

19.1
Except as provided in Clause 19.2, neither Party shall, without the prior written consent of the other Party:

 
(a)
release any information about this Agreement, or any information or results of work undertaken by either Party pursuant to this Agreement; or

 
(b)
use in advertising, publicly or otherwise, any trade-name, personal name, trade mark, trade device, service mark, symbol, or any abbreviation, contraction or simulation thereof, owned by the other Party; or

 
(c)
represent, either directly or indirectly, that any product or service of the other Party is a product or service of the representing Party or that it is made in accordance with or utilises the information or documents of the other Party.

19.2
The restrictions in Clause 19.1 shall not apply to the following:

 
(a)
use as required by any applicable law or governmental regulation; or

 
(b)
any disclosures as a Party determines, based on the advice of counsel, are required to comply with law or applicable rule or regulation of any nationally recognised securities exchange (such exchange to include the London Stock Exchange, Euronext and NASDAQ), provided the same is accurate.

20.            Costs and Execution

20.1
Save as provided in Clause 4.2, each Party shall bear its own legal costs, legal fees and other expenses incurred in the preparation and execution of this Agreement.

20.2
This Agreement may be entered into by the parties in any number of counterparts.  Each counterpart shall, when executed and delivered, be regarded as an original, and all the counterparts shall together constitute one and the same instrument.  This Agreement shall not take effect until it has been executed by all the parties.  This Agreement may be validly exchanged and delivered by fax.

21.            Third Party Rights

 
 

 


21.1
It is hereby agreed that this Agreement is not intended by the Parties to create rights or benefits in favour of any person not party to this Agreement or make any rights or benefits enforceable by or on behalf of such third parties and for the avoidance of doubt all laws providing to the contrary in any country including the provisions of the Contracts (Rights of Third Parties) Act 1999 in the United Kingdom are hereby excluded to the fullest extent permitted.

22.            Governing Law and Jurisdiction

22.1
This Agreement shall be governed by the laws of the State of New York, USA.

22.2
Any question, difference or dispute which may arise concerning the construction meaning or effect of this Agreement or concerning the rights and liabilities of the parties hereunder shall be subject to the exclusive jurisdiction of the federal and state courts in New York, New York.

23.
Attorneys’ Fees

23.1
In the event that any suit or action is instituted to enforce any of the terms of this Agreement, the prevailing party in such dispute shall be entitled to all fees, costs and expenses of enforcing any right of such prevailing party under or with respect to this Agreement (including reasonable attorneys’ fees), in addition to any other relief to which such party is entitled.

[REMAINDER OF PAGE INTENTIONALLY BLANK]

 
 

 


This Agreement shall come into force on the date given at the beginning of this Agreement.



Signed by                      /s/ Timothy P. Lynch
Full name (capitals):    TIMOTHY P. LYNCH
Position:CEO
FOR AND ON BEHALF OF NEUROSTAT PHARMACEUTICALS INC.



Signed by                      /s/ Timothy P. Lynch
TIM LYNCH



Signed by                      /s/ Alan Cooke
Full name (capitals):    ALAN COOKE
Position: CFO, DIRECTOR
FOR AND ON BEHALF OF AMARIN CORPORATION PLC



Signed by                      /s/ Alan Cooke
Full name (capitals):    ALAN COOKE
Position:                      CFO, DIRECTOR
FOR AND ON BEHALF OF AMARIN PHARMACEUTICALS IRELAND LIMITED



 
 

 


EXHIBIT A
LORAZEPAM COMPOUND STRUCTURE AND FORMULA
(including certain synonyms)

•            Structure and primary formula :


•            Systematic IUPAC Name :

9-chloro-6-(2-chlorophenyl)-4-hydroxy-2,5-diazabicyclo[5.4.0]undeca-5,8,10,12-tetraen-3-one

•            Other formulae and chemical names for this compound (excludes brand names) :

2H-1,4-Benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-
2H-1,4-Benzodiazepin-2-one, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-
7-Chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
7-Chloro-5-(2-chlorophenyl)-3-hydroxy-1H-1,4-benzodiazepin-2(3H)-one
2H,1,4-Benzodiazepin-2-one, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-
2H-1, 4-Benzodiazepin-2-one, 7-chloro-5- (o-chlorophenyl)-1, 3-dihydro-3-hydroxy-
2H-1,4-Benzodiazepin-2-one, 7-chloro-5- (2-chlorophenyl)-1,3-dihydro-3-hydroxy-
7-Chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one



Exhibit 4.67
 

 
Certain portions of this Exhibit have been omitted pursuant to a request for “Confidential Treatment” under Rule 24b-2 of the Securities and Exchange Commission.  Such portions have been redacted and bracketed in the request and appear as [*] in the text of this Exhibit.  The omitted confidential information has been filed with the Securities and Exchange Commission.

 
 
Execution Copy
 
 

 
 

 
 
ELAN PHARMA INTERNATIONAL LIMITED
 
AND
 
AMARIN PHARMACEUTICALS IRELAND LIMITED
 
 
 
 
 
 
 
DEVELOPMENT AND LICENSE AGREEMENT
 
 
 

 
 
 

 


 
INDEX
 
 
1.
Definitions and Interpretation
2
2.
The License
13
3.
Intellectual Property
15
4.
Non-Competition
21
5.
Development of the Product Intermediate
23
6.
Project Team and Project Management
24
7.
Regulatory Matters
25
8.
Clinical Develpmt, Registration, Marketing and the Promotion of the Product
27
9.
Commercial Manufacture
30
10.
Financial Provisions
31
11.
Payments, Reports and Audits
35
12.
Duration and Termination
37
13.
Consequences of Termination
39
14.
Warranties, Indemnification and Liability
41
15.
Confidentiality
44
16.
Miscellaneous Provisions
46
Schedule 1
Elan Patents
51
Schedule 2
R&D Program
52
Schedule 3
Technological Competitors of Elan
54
Schedule 4
Manufacturing Costs
55
Schedule 5
Amarin Stage I Activities
56


 

 


 
THIS AGREEMENT is dated March 6, 2007
 
 
PARTIES:
 
 
(1)
ELAN PHARMA INTERNATIONAL LIMITED , a limited liability company incorporated under the laws of Ireland, having its registered office at Monksland, Athlone, Co. Westmeath, Ireland (“ Elan ”); and
 
 
(2)
AMARIN PHARMACEUTICALS IRELAND LIMTED , a limited liability company incorporated under the laws of Ireland, having its principal place of business at First Floor, Block 3, the Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland (“ Amarin ”).
 
 
BACKGROUND:
 
 
(A)  
Elan possesses certain proprietary small particle technology as well as proprietary know-how and confidential information used or useful in the manufacture and use of products containing nanoparticles.
 
 
(B)  
Amarin has certain expertise relating to the Compound (as defined below).
 
 
(C)  
Amarin wishes to enter into this Agreement to obtain the right to utilize the Elan Intellectual Property (as defined below) to import, use, offer for sale and sell the Product in the Field in the Territory, and to have Elan develop the Product Intermediate for Amarin, in accordance with the terms and conditions set out below.
 
 
TERMS:
 
 
The parties agree as follows:
 
 
1.  
DEFINITIONS AND INTERPRETATION
 
 
1.1.  
Definitions .  In this Agreement:
 

 
 

 

 

 
 
Affiliate ” means any corporation or entity controlling, controlled or under common control with Elan or Amarin, as the case may be.  For the purposes of this Agreement, “control” means 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.
 
 
Agreement ” means this development and license agreement (which expression shall be deemed to include its Recitals and Schedules).
 
 
Amarin Compound Data ” means data relating to the Compound, Product Intermediate or Product generated pursuant to this Agreement as follows: (i) all data from any Phase I, Phase II, Phase III and/or Phase IV study conducted by Amarin in relation to the Compound, Product Intermediate or Product during the Term; (ii) all data from any pre-clinical study conducted by Amarin in relation to the Compound, Product Intermediate or Product during the Term; and (iii) all data generated by Amarin arising out of the incorporation of the Product Intermediate into the Product.  For the avoidance of doubt, Amarin Compound Data does not include any data generated from formulation development activities related to the Compound, Product Intermediate or Product using Elan Intellectual Property.
 
 
Amarin Improvements ” means (i) any and all rights in respect of improvements or inventions pertaining to the Compound, of which, as of the Effective Date, there are none, that may be conceived, created, developed and/or otherwise invented solely by Amarin outside the R&D Program pursuant to this Agreement; (ii) any and all rights in respect of improvements or inventions pertaining to a Device and which, as of the Effective Date, there are none, that may be conceived, created, developed and/or otherwise solely invented by Amarin or on behalf of Amarin and (iii) Amarin’s interest in the [*].
 
 
Amarin Intellectual Property ” means the Amarin Know-How, Amarin Improvements and the Amarin Patents, of which, as of the Effective Date, there are none.
 
 
Amarin Know-How ” means any and all rights, of which, as of the Effective Date, there is none, which Amarin may own, license or control (otherwise than pursuant to this Agreement) to any scientific, pharmaceutical or technical information, data, discovery, invention (whether patentable or not), know-how, substances, techniques, processes, systems, formulations and designs and expertise relating to the Compound or Device used to administer the Product which is not generally known to the public.
 

 
2

 

 

 
 
 “ Amarin Patents ” means any and all Patent Rights, of which, as of the Effective Date, there are none, which Amarin may hereafter file or acquire or license relating to the Compound, the Device used to administer the Product or the Product (other than the Elan Patents or Elan Improvements licensed under this Agreement or any patents arising out of [*]).
 
 
Amarin Trademark ” means Amarin’s rights to use such trademark(s) as Amarin may from time to time reasonably specify.
 
 
Buccal Formulation ” means formulations of Product Intermediate for administration by placing in the mouth for absorption through the cheek, the gum or the upper or lower inside lip without swallowing, achieved by means of a muco adhesive, including but not limited to any specific formulation that may be selected for commercialization.
 
 
Business Days ” means Monday to Friday inclusive, excluding any days on which the clearing banks are generally closed in Dublin and/or New York.
 
 
cGMP ”, “ cGLP ” and “ cGCP   respectively mean current Good Manufacturing Practice, current Good Laboratory Practice and current Good Clinical Practice, as defined in the US Federal Food, Drug and Cosmetic Act of 1934, and the regulations promulgated thereunder, as may be amended from time to time, and, where applicable, the equivalent regulations and requirements imposed by other Governmental Authorities in the Territory.
 
 
Claims ” means all and any claims (whether successful or otherwise), loss, liability, damages and expenses, including reasonable attorneys’ fees and expenses and legal costs.
 
 
CMC Section ” means the chemistry, manufacturing, and controls section of the Regulatory Application in the United States as defined in 21 Code of Federal Regulations Section 314.50 (1), as may be amended from time to time, and/or its equivalent in other Regulatory Applications.
 
 
Compound ” means the active drug substance lorazepam (7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-2 H -1,4-benzodiazepin-2-one) including all salts, esters, complexes, chelates, hydrates, isomers, stereoisomers, crystalline forms, amorphous forms, prodrugs (including all compounds that are metabolized or dissolve into the same active moiety in the body), solvates, metabolites/metabolic precursors, and pegylated form thereof.
 
 
 “ Device ” shall mean any instrument, apparatus, appliance, material or other article (including software) that will be used to administer or that otherwise utilizes or applies the Product, Product Intermediate or a derivative thereof.
 
 
DMF ” means the Drug Master File, as defined in the United States in 21 Code of Federal Regulations, Section 314.420   and/or its equivalent in the other countries of the Territory, which Elan may file in respect of the Elan Technology and (at Elan’s sole option) the application of the Elan Technology as regards the Product.
 
 
EEA ” means the Member States of the European Economic Area, as same may change from time to time in terms of Member States.
 
 
Effective Date ” means the date of this Agreement.
 
 
Elan Compound Data ” means data relating to the Compound, Product Intermediate, or Product generated by Elan pursuant to this Agreement (which includes but is not limited to the R&D Program) or the Manufacturing Agreement, including but not limited to data relating to chemistry, manufacturing and controls in support of any Compound formulation(s) generated during the R&D Program, including the Product Intermediate, but excluding the Amarin Compound Data.
 
 
Elan’s Facility” shall mean Elan facility for manufacture of commercial supplies of Product Intermediate, as such will be defined in the Manufacturing Agreement.
 
 
Elan Improvements ” means (i) the Product Patents and any and all improvements to the Elan Patents, the Elan Know-How and/or the Elan Technology and/or the Product and/or the Product Intermediate that have been conceived, created, developed and/or otherwise invented by Elan and/or Amarin under the R&D Program, or otherwise pursuant to this Agreement, (ii) any and all rights in respect of improvements or inventions pertaining to the Device and which, as of the Effective Date, there are none, that may be conceived, created, developed and/or otherwise solely invented by Elan pursuant this Agreement and (iii) any and all rights in respect of improvements or inventions pertaining to the Compound conceived, created, developed and/or otherwise invented solely by Elan under the R&D Program (excluding [*]) or otherwise.
 
 
Elan Intellectual Property ” means the Elan Know-How, the Elan Patents, the Elan Improvements and Elan’s interest in the [*].
 
 
Elan Know-How ” means any and all rights owned by Elan as of the Effective Date to any scientific, pharmaceutical or technical information, data, discovery, invention (whether patentable or not), know-how, substances, techniques, processes, systems, formulations, designs and expertise relating to the Elan Technology which is not generally known to the public.
 

 
3

 

 

 
 
Elan Patents ” means any and all Patent Rights, now existing, currently pending or hereafter filed by Elan relating to the Elan Technology and the Product Intermediate (other than [*]), as set forth in Schedule 1, together with any other patents that may be filed by Elan in relation to the Product Intermediate (other than [*]) and any additional Elan Patents that may need to be licensed to Amarin in the event that Amarin exercises the option set out in Clause 2.4.
 
 
Elan Technology ” means Elan’s proprietary technology directed to nanoparticulate dispersions of compounds stabilized against agglomeration of the nanoparticles and methods and equipment used for making such dispersions and characterizing such dispersions, as more fully described in the Elan Patents and applied in the Elan Know-How.
 
 
Elan Trademark ” means Elan’s trademark “NanoCrystal®”, or such other trade marks as Elan may from time to time reasonably specify.
 
 
EU ” means the Member States of the European Union, as same may change from time to time in terms of Member States.
 
 
EU Major Markets ” means the United Kingdom, France, Germany, Italy and Spain, and an “ EU Major Market ” means any of them.
 
 
EXW ” (ex works) has the same meaning as in the ICC Incoterms 2000, International Rules for the Interpretation of Trade terms, ICC Publication No. 560.
 
 
Ex-US Net Revenues ” means:
 
 
(i) all royalties received by Amarin or an Affiliate of Amarin pursuant to a Sub-License Agreement in respect of sales of the Product by a sub-licensee made outside the United States;
 
 
(ii) all upfront payments and milestone payments received by Amarin or an Affiliate of Amarin in respect of the Product pursuant to a Sub-License Agreement which upfront payments and milestone payments relate to countries or territories outside the United States.
 
 
(iii) any other consideration received by Amarin and/or any Amarin Affiliate in respect of the Product arising from a Sub-License Agreement that applies outside the United States, provided that this shall not include any bona fide consideration which Amarin or an Amarin Affiliate receives for any pre-clinical, clinical or regulatory work undertaken by Amarin for the purpose of regulatory approval or marketing purposes in the country/countries to which the Sub-License Agreement applies.
 

 
4

 

 

 
 
FDA ” means the United States Food and Drug Administration or any other successor agency whose approval is necessary to market the Product in the United States.
 
 
Field ” means the use as a prescription or over-the-counter pharmaceutical product in humans, specifically excluding diagnostic use.
 
 
Force Majeure ” means any cause or condition beyond the reasonable control of the party obliged to perform, including acts of God, acts of government (in particular with respect to the refusal to issue necessary import or export licenses), fire, flood, earthquake, war, riots or embargoes or strikes affecting a party, or the failure of the Compound, other materials or Product Intermediate to meet applicable specifications for reasons that cannot be determined or rectified and that are not attributable to the negligent acts or omissions of the party obliged to perform under this Agreement or to a breach of an obligation by the performing party under this Agreement.
 
 
Generic Competition ” means the commercial sale by a third party of a product which is AB-Rateable to the Product in the applicable country.
 
 
Governmental Authority ” means all governmental and regulatory bodies, agencies, departments or entities, whether or not located in the Territory, which regulate, direct or control commercial and other related activities in or with the Territory.
 
 
IND ” means Investigational New Drug Application in the United States as set forth in the 21 Code of Federal Regulations Section 312 and/or its equivalent in the other countries of the Territory.
 
 
Infringement Claim Fees ” means the following court ordered costs or court ordered settlements incurred in defending or otherwise managing an Infringement Claim:  (i) a party’s reasonable costs and expenses (including attorneys’ fees), (ii) damages or costs awarded against either party, and (iii) other payments that a party may be ordered to pay a third party in order to secure the right to continue the commercialization of the Product.
 
 
In Market ” means the sale of the Product in the Territory by Amarin, or where applicable, by an Amarin Affiliate, a permitted sub-licensee or a distributor, to an unaffiliated third party, such as a wholesaler, managed care organisation, hospital or pharmacy which effects the final commercial sale to the end user of the Product and shall exclude the transfer pricing of the Product by one Amarin Affiliate to another Amarin Affiliate, a permitted sub-licensee or a distributor.
 
 
“[ *] ” means [*]
 

 
5

 

 

 
 
Manufacturing Agreement ” means the future agreement referred to in Clause 9 .
 
 
Manufacturing Cost ” shall mean the costs described in Schedule 4.
 
 
Manufacturing Royalty ” shall mean a royalty of 8% of Worldwide Net Sales, which shall be payable by Amarin to Elan under Clause 10.4 during any period when Elan manufactures the Product Intermediate under the terms of this Agreement.
 
 
NDA ” means a New Drug Application filed with the FDA, including any supplements or amendments thereto which may be filed.
 
 
Net Sales ” shall, subject to the provisions of Clause 10.6, mean in the case of Product sold by Amarin, an Affiliate of Amarin, a permitted sub-licensee or a distributor in the circumstances set out in Clauses 10.4.1 and 10.4.2 only, the aggregate gross In Market sales proceeds billed for the Product by Amarin, an Affiliate of Amarin, a permitted sub-licensee or a distributor in the circumstances set forth in Clauses 10.4.1 and 10.4.2 only, in accordance with generally accepted accounting principles as adopted by Amarin, less the following deductions:
 
 
(i)  
trade, cash or quantity discounts, allowances, adjustments and rejections;
 
 
(ii)  
rebates, recalls (other than where the Product is replaced without charge) and returns;
 
 
(iii)  
price reductions or rebates imposed by Governmental Authorities;
 
 
(iv)  
sales, excise, turnover, inventory, value-added and similar taxes assessed on the royalty-bearing sale of such Product, but not including any taxes on income paid by or assessed against Amarin or a permitted sub-licensee;
 
 
(v)  
transportation, importation, shipping, insurance and other handling expenses directly chargeable to the royalty-bearing sale of the Product, but only to the extent that such expenses are separately delineated in the applicable invoices; and
 
 
(vi)  
credits, chargebacks, prime vendor rebates, reimbursements and similar payments granted to drug wholesalers or their customers in cases where there are not direct shipments to such customers by Amarin or its permitted sublicense.
 
 
Any discretionary rebates, discounts or adjustments shall be commercially reasonable and consistent with standard industry practices.
 

 
6

 

 

 
 
Notional NSP ” shall mean the estimated NSP of Product at the applicable time, which shall on a country by country basis be provided by Amarin to Elan within ninety (90) days prior to commencement of each calendar year (or, for the launch year in any country, within ninety (90) days prior to the estimated date of first commercial sale in such country); provided that:
 
 
(a)  
for (i) the launch year and (ii) if no Statement is due to be produced prior to ninety (90) days of the estimated first commercial sale in such country, the Notional NSP shall be estimated in good faith; and
 
 
(b)  
in each subsequent year, Notional NSP shall be calculated by reference to the average NSP in that country as evidenced by the last four Statements (or such lesser number of Statements as have actually been produced in relation to that country);
 
 
NSP ” shall mean the Worldwide Net Sales divided the number of units of Product sold for the given period.
 
 
Other Compound ” means diazepam (7-chloro-1-methyl-5-phenyl-1,3-dihydro-2 H -1,4-benzodiazepin-2-one). including all salts, esters, complexes, chelates, hydrates, isomers, stereoisomers, crystalline forms, amorphous forms, prodrugs (including all compounds that are metabolized or dissolve into the same active moiety in the body), solvates, metabolites/metabolic precursors, and pegylated form thereof.
 
 
Patent Rights ” means any and all rights under any and all patent applications and/or issued or granted patents, now existing, currently pending or hereafter filed, including, but not limited to, provisional applications, substitutions, divisionals, continuations, continuations-in-part, renewals and any foreign counterparts thereof or equivalents thereto, including the right to claim priority from any of the foregoing under the Paris Convention, and all patents issuing or granted on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof, or any other government-issued rights substantially equivalent to the foregoing.
 
 
Phase I ” means a human clinical trial of a Product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, including the trials referred to in 21 Code of Federal Regulations. §312.21(a), as amended.
 
 
Phase II ” means a human clinical trial of a Product, the principal purpose of which is a determination of safety and efficacy in the target patient population or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 Code of Federal Regulations §312.21(b), as amended.
 

 
7

 

 

 
 
Phase III Studies ” means a human clinical trial of the Product that is designed to establish that such Product is safe and efficacious for its intended use, and which trial is intended to support marketing approval of such Product in any country or countries, and “ Phase III Study ” means any one such study.
 
 
Phase IV ” means a human clinical trial of a Product that is not included in the original NDA submission for such Product, but is required to obtain or maintain the approval by the FDA of the NDA for such Product, including studies conducted to fulfill commitments made as a condition of NDA approval or any subsequent human clinical trials requested or required by the FDA as a condition of maintaining such approval or which are desirable for the purposes of marketing or otherwise.
 
 
Primary Territory ” means the United States, Canada, Mexico, Japan, the countries of the European Union, Australia and New Zealand.
 
 
Product ” means, subject to Clause 2.4, the nasal formulation of Product Intermediate incorporated or filled into a Device.
 
 
Product Intermediate ” shall mean non-sterile formulations of the Compound (or Other Compound, if applicable and subject to Clause 2.4) as the sole active ingredient that incorporates Elan Technology, including but not limited to the specific formulation that is selected for use in the Product.
 
 
Product Patents ” means any and all Patent Rights relating to any formulation of the Compound (or Other Compound, if applicable and subject to Clause 2.4) incorporating the Elan Technology, including the composition of any formulations and methods of formulating the Compound using the Elan Technology.
 
 
Prosecute ” means in relation to a class of intellectual property:
 
 
(a)  
to secure the grant of any patent application within such class;
 
 
(b)  
to file and prosecute patent applications on patentable inventions and discoveries relating to that class;
 
 
(c)  
to defend all such applications against third party oppositions; and
 
 
(d)  
to maintain in force any issued letters patent relating to the same
 
 
and “ Prosecution ” has a corresponding meaning.
 

 
8

 

 

 
 
R&D Program ” means the research and development program set forth in Schedule 2, as it may be amended by agreement of the parties from time to time, including but not limited to any work agreed by the parties under the R&D Program pursuant to a workplan.
 
 
Regulatory Application ” means any regulatory application or any other application for marketing approval for the Product, which Amarin will file in the Territory hereunder, including any supplements or amendments thereto which Amarin may file.
 
 
Regulatory Approval ” means the final approval to market the Product hereunder in any country of the Territory, including pricing and reimbursement approval and any other approval which is required to launch the Product in the normal course of business.
 
 
Secondary Territory ” means the Territory other than the Primary Territory.
 
 
Sub-License Agreement ” means any sub-license agreement or distribution agreement entered into by Amarin with a third party sub-licensee or distributor in reference to this Agreement whereby the third party is granted the right to offer for sale and sell the Product in the Territory.
 
 
Sublingual Formulation ” means formulations of Product Intermediate for administration by placing in the mouth under the tongue without swallowing, including but not limited to any specific formulation that may be selected for commercialization.
 
 
Technological Competitor ” means a person or entity listed in Schedule 3, and divisions, subsidiaries and successors thereof, or any additional broad-based technological competitor of Elan added to such Schedule from time to time by Elan.
 
 
PROVIDED THAT Elan may only add to Schedule 3 companies that are “competitors” to Elan and Elan shall remove from such list companies which cease to be competitors.  For this definition “competitors” shall mean companies who have or use, other than through a license from Elan, technology that is directed to and / or suitable for providing substantially similar or comparable enhancements to the solubility characteristics of active pharmaceutical ingredients as those provided by the Elan Technology, via any particle size reduction technology approaches, as opposed to chemical solubilization or other approaches.  In so far as a third party company is a licensee of Elan Technology they shall only cease to be a Technology Competitor to the extent of the licence.  In particular, holding a licence to Elan Technology shall not preclude a company from being a Technological Competitor where that company has or uses other technology that is directed to and / or suitable for providing substantially similar or comparable enhancements to the solubility characteristics of active pharmaceutical ingredients as those provided by the Elan Technology, via any particle size reduction technology approaches, as opposed to chemical solubilization or other approaches.
 

 
9

 

 

 
 
Term ” means the Initial Term and any continuations under Clause 12.2.
 
 
Territory ” means all of the countries of the world.
 
 
Third Party Royalties ” means license fees, milestone payments and royalties paid to a Third Party arising from an Infringement Claim that relates to the use of the Elan Patents, Elan Know-How or the Elan Improvements in the Product and Product Intermediate.
 
 
Valid Patent Claim ” means any claim of an issued (or granted) and unexpired patent included within the Elan Intellectual Property, which has not been held permanently revoked, unenforceable, unpatentable or invalid by a decision of a court or government agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal, and which has not been abandoned, disclaimed, denied or expressly admitted by the holder of the patent or supplementary protection certificate to any person to be invalid or unenforceable through reissue or disclaimer or otherwise.
 
 
Worldwide Net Sales ” shall, subject to the provisions of Clause 10.6, mean in the case of Product sold by Amarin, an Affiliate of Amarin, any permitted sub-licensee or any distributor, the aggregate gross In Market sales proceeds billed for the Product by Amarin, an Affiliate of Amarin, a permitted sub-licensee or a distributor, in accordance with generally accepted accounting principles as adopted by Amarin, less the following deductions:
 
 
(vii)  
trade, cash or quantity discounts, allowances, adjustments and rejections;
 
 
(viii)  
rebates, recalls (other than where the Product is replaced without charge) and returns;
 
 
(ix)  
price reductions or rebates imposed by Governmental Authorities;
 
 
(x)  
sales, excise, turnover, inventory, value-added and similar taxes assessed on the royalty-bearing sale of such Product, but not including any taxes on income paid by or assessed against Amarin or a permitted sub-licensee;
 
 
(xi)  
transportation, importation, shipping, insurance and other handling expenses directly chargeable to the royalty-bearing sale of the Product, but only to the extent that such expenses are separately delineated in the applicable invoices; and
 

 
10

 

 
(xii)  
 
 
 
(xiii)  
credits, chargebacks, prime vendor rebates, reimbursements and similar payments granted to drug wholesalers or their customers in cases where there are not direct shipments to such customers by Amarin or its permitted sublicense.
 
 
Any discretionary rebates, discounts or adjustments shall be commercially reasonable and consistent with standard industry practices.
 
 
$ ” and “ US$ ” mean United States Dollars.
 
 
1.2.  
Further Definitions .  In addition, the following definitions have the meanings in the Clauses corresponding thereto, as set forth below:
 

Definition
Clause
“Acquiring/Successor Entity”
15.15
“Confidential Information”
15.1
“Combination Formulation”
2.4
“Disclosing Party”
15.12
“Due Date”
11.9
“Elan License”
2.1
“Expanded Formulation”
2.4.1
“Infringement Claim”
3.4.1
“Initial Term”
12.1
“License Milestone Payments”
10.1
“Notice”
16.11.1
“Project Team”
6.1
“Relevant Marks”
3.7.4
“Statement”
11.1
“Third Party Site”
9.6
“Trademark Owner”
3.7.4
“Trademark User”
3.7.4

 
1.3.  
Interpretation .  In this Agreement:
 

 
11

 

 

 
 
1.3.1  
the singular includes the plural and vice versa, and unless the context or subject otherwise requires, references to words in one gender include references to the other genders;
 
 
1.3.2  
unless the context otherwise requires, reference to a recital, article, paragraph, provision, clause or schedule is to a recital, article, paragraph, provision, clause or schedule of or to this Agreement;
 
 
1.3.3  
the headings in this Agreement are inserted for convenience only and do not affect its construction; and
 
 
1.3.4  
the expressions “include”, “includes”, “including”, “in particular” and similar expressions shall be construed without limitation.
 
 
2.  
THE LICENSE
 
 
2.1.  
Elan License to Amarin .  Subject to the terms of this Agreement, Elan hereby grants to Amarin for the Term an exclusive license (the “ Elan License ”) to the Elan Intellectual Property to import, export, use (other than for formulation development activities), offer for sale and sell the Product in the Field in the Territory.  For the avoidance of doubt, nothing in this license grant permits Amarin to make or have made Product Intermediate or to carry out, directly or indirectly (other than through Elan which retains these rights), any formulation development activities with regard to the Compound using the Elan Intellectual Property.
 
 
2.2.  
Elan acknowledges that Amarin may contract with a third party (who is not a Technological Competitor) to further carry out any activities required to fill the Product Intermediate into a Device.  Elan agrees to provide such third party with a royalty-free, non-exclusive license to any Elan Intellectual Property limited to the extent necessary for the third party to conduct such activities, subject to the formulation development restrictions set out in Clause 2.1.
 
 
2.3.  
Sub-licensing .  Amarin shall be entitled, subject to [*] to grant sub-licenses in respect of the Elan Intellectual Property to import, export, have imported, have exported, use (other than formulation development activities), offer for sale and sell the Product in the Field in one or more countries of the Territory.  Any grant of sub-license shall also be subject to the following conditions:
 
 
2.3.1  
Amarin shall grant one sub-license only per country except as required by law;
 

 
12

 

 

 
 
2.3.2  
Amarin shall not grant a sub-license to a Technological Competitor, nor in circumstances which cause a material adverse tax consequence to Elan which is not fully compensated for by Amarin;
 
 
2.3.3  
Amarin shall remain responsible for all payments due to Elan under this Agreement;
 
 
2.3.4  
Any sub-license granted shall be in the same terms as the terms of this Agreement insofar as they are applicable, mutatis mutandis, but excluding the right to grant a sub-license; provided that the sub-licence need not contain obligations with respect to diligence in marketing and promotion efforts, provided further that nothing herein shall prejudice Amarin’s obligations in respect thereof (including in that part of the territory sub-licensed);
 
 
2.3.5  
Amarin shall use reasonable efforts to obtain for Elan the same rights of audit and inspection vis-à-vis a sub-licensee as Elan has vis-à-vis Amarin pursuant to this Agreement; provided, however, if Amarin does not obtain such rights for Elan with respect to a sub-licensee, Amarin shall obtain such rights for itself with respect to such sub-licensee and shall promptly exercise such rights upon written request of Elan.
 
 
2.3.6  
Amarin shall be liable to Elan for all acts and omissions of any sub-licensee as though such acts and omissions were by Amarin.
 
 
2.3.7  
Amarin shall undertake to protect the confidentiality of Elan’s formulation, engineering and manufacturing processes for the Product Intermediate and the Product in its dealings with permitted sub-licensees and shall not disclose any information from the CMC Section to any third party, including a permitted sub-licensee, without the prior written consent of Elan.
 
 
2.4.  
Option .  In the event that, within 3 (three) years of the commencement of the R&D Program, it is determined by the parties that the Product is not feasible, then Amarin shall have an option, which shall become effective on the date that the parties agree that the Product is not feasible and shall expire sixty (60) days thereafter if the option is not exercised in writing by Amarin before that time, to expand the Elan License to include (i) a Buccal Formulation or a Sublingual Formulation of the Compound in combination with the Elan Technology or, alternatively, (ii)  one of any of a nasal formulation or a Buccal Formulation or a Sublingual Formulation of the Other Compound, by written notice to Elan.  Upon exercise of such option:
 
 
2.4.1  
Amarin shall promptly articulate the precise option it wishes to exercise, namely the exact compound and the route of delivery that is to be developed (“ Expanded Formulation ”);
 

 
13

 

 

 
 
2.4.2  
this Agreement shall expand and apply as necessary (including but not limited to the expansion of the terms “Compound”, “Product Intermediate” and “Product” throughout this Agreement) to include the exact compound and the exact route of delivery of the Expanded Formulation;
 
 
2.4.3  
subject to the provisions of Clause 10.1, the provisions of this Agreement regarding milestones and royalties shall additionally apply to such Expanded Formulation;
 
 
2.4.4  
a new Expanded Formulation R&D Program will be determined by the parties through good faith negotiations within 90 days from the date that Amarin notifies Elan that it intends to exercise the option granted under this Clause 2.4;
 
 
2.4.5  
pricing for development services and for commercial supply of such Expanded Formulation will be determined by the parties through good faith negotiations;
 
 
2.4.6  
such other changes as shall be agreed by the parties in good faith.  For the avoidance of doubt, the parties acknowledge and agree that Elan shall not be required under any circumstances to fund any further aspect of the R&D Program unless it so agrees; and
 
 
2.4.7  
the parties shall be released from of any further obligation to pursue the development and marketing of a Product Intermediate or Product for nasal use containing the Compound.
 
 
Amarin shall also be entitled to service notice on Elan at any time after the Effective Date and prior to the end of the three (3) year option period that it wishes to terminate its option right hereunder.  Said notice, once served, shall automatically terminate all parties’ rights and obligations in reference to the option set out in this Clause 2.4.
 
 
2.5.  
Secondary Territory .  Prior to marketing the Product in any country of the Secondary Territory, Amarin shall notify Elan of its intention to do so, and thereafter Elan may if it considers it necessary to protect its Confidential Information, remove such country from the Territory and the Secondary Territory.
 
 
3.  
INTELLECTUAL PROPERTY
 
 
3.1.  
Ownership of Intellectual Property .
 

 
14

 

 

 
 
3.1.1  
Elan shall remain the owner of the Elan Intellectual Property.
 
 
3.1.2  
Amarin shall remain the owner of the Amarin Intellectual Property.
 
 
3.1.3  
Elan and Amarin shall jointly own the [*] and each party shall have an undivided interest in such [*] and may exercise its interests in such [*] (including, subject to Clause 2.1, the right to grant licences) without accounting to the other party except as otherwise specifically provided for herein.  To the extent either party or its Affiliates would be deemed to be the sole owner of such [*] under the intellectual property laws of any jurisdiction, such party hereby irrevocably assigns, and shall cause such Affiliate to assign, to the other party an equal undivided interest in such [*].
 
 
3.1.4  
Elan owns Elan Compound Data.
 
 
3.1.5  
Amarin owns Amarin Compound Data.
 
 
3.1.6  
Amarin grants Elan the right to use Amarin Compound Data to Prosecute Elan Patents or Elan Improvements and/or [*].
 
 
3.2.  
Patent Prosecution and Maintenance .
 
 
3.2.1  
Elan, at its sole discretion and expense, may Prosecute the Elan Intellectual Property in the Territory.  Elan and Amarin shall discuss any filing strategy in the Territory for any proposed patent applications (s) relating to the Product, the Product Intermediate and/or [*]. Elan shall inform Amarin of any patent applications relating to the Product, the Product Intermediate and/or [*] filed in the Territory.  Elan shall have the first right to Prosecute Product Patents and [*].  Elan shall keep Amarin reasonably informed regarding the prosecution of Product Patents and [*].  Amarin shall treat such information as Confidential Information.  Where Elan chooses not to Prosecute any Product Patents or [*] Patent Rights, Elan shall provide written notice to this effect to Amarin.  Upon receipt of such notice, Amarin shall have the right at its sole expense to Prosecute the Product Patents or [*] referred to in this notice.
 
 
3.2.2  
Amarin, at its sole discretion and expense, may Prosecute the Amarin Intellectual Property in the Territory.
 
 
3.2.3  
Elan shall promptly notify Amarin of any developments that fall within the Amarin Intellectual Property.  Amarin shall promptly notify Elan of any developments that fall within the Elan Intellectual Property.
 

 
15

 

 

 
 
3.2.4  
Each party shall provide the other with reasonable support in the Prosecution of the Elan Intellectual Property and the Amarin Intellectual Property in respect of any inventions that were developed under this Agreement and shall provide all information and/or data in its possession that is necessary to support any relevant patent application in the Territory.
 
 
3.2.5  
Amarin and Elan shall discuss the filing strategy for any proposed patent application(s) in the Territory and shall co-ordinate the filing of such patent application(s) between the two parties in order to protect the intellectual property rights of both parties in the Territory.
 
 

 
 

 
 
3.3.  
Enforcement .
 
 
With respect to any unauthorized use of the Elan Intellectual Property or the Amarin Intellectual Property by a third party, including but not limited to any permitted sub-licensee, as such relates to the Product and Product Intermediate the parties agree as follows:
 
 
3.3.1  
Elan and Amarin shall promptly inform each other in writing of any actual or alleged unauthorized use of the Elan Intellectual Property or the Amarin Intellectual Property by a third party of which it becomes aware and provide the other party with any available evidence of such unauthorized use.
 
 
3.3.2  
Elan shall have the right to enforce for Elan’s own benefit (including by agreement or by litigation) Elan Intellectual Property at its own instigation and expense.  Amarin shall reasonably cooperate with Elan to enforce such rights, provided that Amarin is indemnified for any out-of-pocket expenses incurred in providing such cooperation.  Amarin shall be kept advised at all times of such suit or proceedings brought by Elan.
 
 
3.3.3  
In the event that Elan does not wish to enforce its rights in respect of Product Patents within sixty (60) days of notification under Clause 3.3.1, then insofar as the alleged infringement occurred after the Effective Date, Amarin may instead at its own instigation and expense enforce for its own benefit (including by agreement or by litigation) such Product Patents, subject to the following provisions:
 

 
16

 

 

 
 
3.3.3.1  
Elan shall reasonably cooperate with Amarin to enforce such rights, provided that Elan is indemnified for out-of-pocket expenses incurred in providing such cooperation;
 
 
3.3.3.2  
Such proceedings shall be conducted at Amarin’s expense;
 
 
3.3.3.3  
Elan shall be kept advised at all times of such suit or proceedings brought by Amarin;
 
 
3.3.3.4  
Elan shall have the right to review and comment on settlement agreement proposals and any pleadings or other documents to be filed with the court in any such litigation and shall do so promptly.  Amarin shall consider such comments and take them into account as is necessary and reasonable;
 
 
3.3.3.5  
Without prejudice to Clause 12.6.1.1 , prior to knowingly making any statements, that would render any Product Patents unenforceable, invalid or unpatentable, Amarin shall notify Elan of such statement and discuss reasonable alternatives with Elan (except as prohibited by applicable law); however in no circumstances shall Amarin make any such statement without the prior written consent of Elan, except to the extent required by applicable law; and
 
 
3.3.3.6  
Under no circumstances shall Amarin, without Elan’s prior written consent, purport to grant, or otherwise suggest or offer the grant of, any license to Product Patents as a part of any settlement proposal .
 
 
3.3.4  
Amarin shall have the right to enforce for Amarin’s own benefit (including by agreement or through litigation) Amarin Intellectual Property at its own instigation and expense.  Elan shall reasonably cooperate with Amarin to enforce such rights, provided that Elan is indemnified for out-of-pocket expenses incurred in providing such cooperation.  Elan shall be kept advised at all times of such suit or proceedings brought by Amarin.
 
 
3.4.  
Defense of and Liability for Infringement Claims .
 
 
3.4.1  
Each of the parties shall promptly notify the other party in writing of any Claim made or brought against either of them alleging infringement or other unauthorised use of the proprietary rights of a third party arising from the manufacture, importation, use, offer for sale, sale or other commercialization of the Product or Product Intermediate in the Territory (“ Infringement Claim ”).
 

 
17

 

 

 
 
3.4.2  
Notwithstanding any term or provision to the contrary contained in this Agreement, Amarin shall indemnify and hold harmless Elan against all Infringement Claims arising from the use or sale of Product or Product Intermediate by Amarin, its Affiliates, permitted sub-licensees, distributors or other Amarin subcontractors except to the extent such claims arise from a breach by Elan of its representations and warranties set forth in Clause 14.1 herein or except as provided in Clause 3.4.3.  Amarin shall indemnify and hold harmless Elan against all Infringement Claims arising from but not limited to:
 
 
3.4.2.1  
the handling or storage of the Product Intermediate or Product by or on behalf of Amarin, its Affiliates, permitted sub-licensees, distributors or other Amarin subcontractors;
 
 
3.4.2.2  
the further processing of the Product Intermediate by or on behalf of Amarin, its Affiliates, permitted sub-licensees, distributors or other Amarin subcontractors;
 
 
3.4.2.3  
the handling or use of any Device in relation to the Product by or on behalf of Amarin, its Affiliates, permitted sub-licensees, distributors or other Amarin subcontractors, including any use of a Device to administer the Product; or
 
 
3.4.2.4  
the method by which the Product is administered to any patient as directed by or on behalf of Amarin, its Affiliates, permitted sub-licensees, distributors or other Amarin subcontractors.
 
 
3.4.3  
Elan will provide reasonable assistance to Amarin in its defence of Infringement Claims.  In respect of those Infringement Claims related to the Elan Patents, Elan Know-How or the Elan Improvements, the Infringement Claim Fees and/or Third Party Royalties arising from the use or sale of Product or Product Intermediate by Amarin, its Affiliates, permitted sub-licensees, distributors or other Amarin subcontractors shall be apportioned as follows subject to the terms and conditions as set forth in Clause 3.5 herein:
 
 
3.4.3.1  
Elan shall be responsible for [*] of Infringement Claim Fees arising from any Infringement Claims related to Elan Patents, Elan Know-How or Elan Improvements and/or Third Party Royalties payable  up to [*] of the royalties otherwise payable to Elan under this Agreement;
 
 
3.4.3.2  
Amarin shall be responsible for any excess Infringement Claim Fees and/or Third Party Royalties over and above the amount as set forth in Clause 3.4.3.1;
 

 
18

 

 

 
 
3.4.3.3  
Amarin will be entitled to recover Infringement Claim Fees and/or Third Party Royalties due by Elan as set forth in Clause 3.4.3.1 as a credit against up to [*] of the royalties otherwise payable to Elan under this Agreement in a calendar quarter, subject to Clause 3.5 below;
 
 
3.4.3.4  
Any deficit remaining in Amarin’s recovery of amounts due by Elan to Amarin under Clause 3.4.3.1 may be carried over to subsequent calendar quarters until exhausted.  Such carry-over shall remain subject to the limit of up to [*] of the royalties otherwise payable to Elan under this Agreement in such calendar quarter (subject to Clause 3.5).
 
 
3.4.4  
In its defence of Infringement Claims, Amarin shall:
 
 
3.4.4.1  
keep Elan informed with respect to any developments in such proceedings that are reasonably likely to have a material adverse effect on sales of the Product;
 
 
3.4.4.2  
provide Elan with the right to review and comment, as practical, on any pleadings or other documents to be filed with the court in any such litigation (including at the option of Elan through separately appointed counsel); and
 
 
3.4.4.3  
except to the extent required by applicable law, not make any reference to Elan Intellectual Property in any proceedings, without the prior written consent of Elan, such consent not to be unreasonably withheld, conditioned or delayed.
 
 
3.4.5  
Save as specifically provided otherwise in this Clause 3.4, the provisions of Clause 14.6 shall apply as regards the conduct of any Infringement Claim.
 
 
3.5.  
For the avoidance of doubt, Elan's maximum aggregate liability for all Third Party Royalties and all Infringement Claim Fees under Clause 3.4.3.1 in any calendar quarter shall be limited to up to [*] of the royalties otherwise payable to Elan under Clause 10.4 in that calendar quarter, provided that any sums paid by Amarin to Elan pursuant to  Clauses 9 and 10 or under the Manufacturing Agreement for the supply of Product Intermediate shall not be treated as royalty payments for the purposes of this Clause 3.5.
 
 
3.6.  
With reference to the provisions of this Clause 3, Elan and Amarin shall consult as regards any actions Elan or Amarin proposes to take in order to mitigate any loss or liability in respect of any Infringement Claim, such as for example Amarin ceasing to sell the Product, the parties agreeing to modify the Product, or either or both of the parties entering into a licensing or settlement negotiation with the third party.  In the event that the parties
 

 
19

 

 
are unable to agree on such action, Elan shall be entitled to take and direct such action as it may reasonably consider expedient, including requiring the withdrawal of the Product within a reasonable time frame.  In the event that Amarin fails to promptly take such action, Amarin shall indemnify and hold Elan harmless against all Infringement Claims to the extent that they relate to the period after the date by which Amarin was required to take  such action.
 
 

 
 
3.7.  
Trademarks .
 
 
3.7.1  
Amarin shall market the Product in the Territory under the Amarin Trademark.
 
 
3.7.2  
Amarin shall prominently display the Elan Trademark on the packaging of the Product and on all promotional materials in relation to the Product to acknowledge that the Elan Technology has been applied in developing and manufacturing the Product.
 
 
3.7.3  
For this purpose:
 
 
3.7.3.1  
Amarin grants to Elan and its Affiliates for the Term a royalty free, worldwide, non-exclusive license to the Amarin Trademark and, if different, trademarks showing Amarin’s corporate logo, solely for the purpose of Elan’s promotion of its activities in relation to this Agreement and of the Elan Technology in relation to this Agreement; and
 
 
3.7.3.2  
Elan grants to Amarin for the Term a paid-up, worldwide, non-exclusive license to the Elan Trademark, solely for the purpose of fulfilling Amarin’s obligations in relation to this Agreement, and for the purpose of Amarin’s promotion of its activities in relation to this Agreement.
 
 
3.7.4  
The following provisions shall apply to the use by one party (“ Trademark User ”) of the trademark(s) (“ Relevant Marks ”) of the other (“ Trademark Owner ”):
 
 
3.7.4.1  
Trademark User shall ensure that each reference to and use of the Relevant Marks by Trademark User is in a manner from time to time approved by Trademark Owner and accompanied by an acknowledgement, in a form approved by Trademark Owner, that the same is a trademark (or registered trademark) of Trademark Owner.
 

 
20

 

 

 
 
3.7.4.2  
Trademark User shall not use the Relevant Mark in any way which might materially prejudice its distinctiveness or validity or the goodwill of Trademark Owner therein.
 
 
3.7.4.3  
Trademark User shall not use in the Territory any trademarks or trade names so resembling the Relevant Marks or any of them as to be likely to cause confusion or deception.
 
 
3.7.4.4  
Trademark Owner shall, at its sole discretion and expense, file and prosecute applications to register and maintain registrations of Relevant Marks in the Territory.
 
 
3.7.4.5  
Trademark Owner will be entitled to conduct all enforcement proceedings relating to the Relevant Marks and shall at its sole discretion decide what action, if any, to take in respect of any infringement or alleged infringement of the Relevant Marks or passing-off or any other claim or counter-claim brought or threatened in respect of the use or registration of the Relevant Marks.  Any such proceedings shall be conducted at Trademark Owner’s expense and for its own benefit.
 
 
4.  
NON-COMPETITION
 
 
4.1.  
Product and Product Intermediate .  During the Term, Amarin shall not, and shall procure that its Affiliates do not, either directly or indirectly:
 
 
4.1.1  
market, sell or distribute the Product or Product Intermediate in a country outside the EEA (other than in those countries outside the EEA which are part of the Territory), or sell the Product to any person who it believes or ought reasonably to know intends to sell the Product in such a country; or
 
 
4.1.2  
actively sell the Product or Product Intermediate into a territory in the EEA reserved on an exclusive basis to Elan or a territory allocated by Elan on an exclusive basis to its other licensees and/or distributors.  For this purpose, the parties acknowledge that each territory which is not exclusively allocated by Elan to other licensees and/or distributors and in respect of which this Agreement has been terminated is reserved to Elan.
 
 
4.2.  
Competing Products (Amarin) .  Amarin shall not, and shall procure that its Affiliates do not market or sell:
 

 
21

 

 

 
 
4.2.1  
any nasal formulation containing the Compound (but not including the Other Compound in any circumstances as formulations of Other Compound are regulated by Clause 4.2.2)  as its sole active ingredient, other than the Product: (i) in the EEA for a period of five years beginning on the date of the first In Market sale of the Product in the EEA, or (ii) elsewhere in the Territory during the Initial Term;
 
 
4.2.2  
any formulation containing the Compound as its sole active ingredient for use in buccal or sublingual administration or any formulation containing the Other Compound as its sole active ingredient for use in nasal, buccal or sublingual administration, as from the Effective Date until the soonest of:
 
 
(a)  
the end of the Initial Term; or
 
 
(b)  
where Amarin exercises its option under Clause 2.4, the restriction imposed by this Clause 4.2 shall immediately terminate in relation to any option formulation that Amarin does not chose to be the Expanded Formulation; or
 
 
(c)  
service of notice by Amarin on Elan that it wishes to terminate its option rights under Clause 2.4 prior to the expiry of the time period referred to in Clause 2.4; or
 
 
(d)  
expiry of the period referred to in Clause 2.4 without the exercise of an option in respect of an Expanded Formulation.
 
 
For the avoidance of doubt, in the event that the Elan License is extended to include an Expanded Formulation, then Amarin shall not market or sell any formulation containing the same compound (Compound or Other Compound, as applicable) as its sole active ingredient in the Expanded Formulation and using the same route of administration as the Expanded Formulation, other than the Product: (i) in the EEA for a period of five years beginning on the date of the first In Market sale of the Expanded Formulation in the EEA or (ii) elsewhere in the Territory during the Initial Term.
 
 
4.3.  
Competing Products (Elan) .  Elan shall not, and shall procure that its Affiliates do not, use or license the Elan Technology to market or sell:
 
 
4.3.1  
any nasal formulation containing the Compound (not including the Other Compound in any circumstances as formulations of Other Compound are regulated by Clause 4.3.2) as its sole active ingredient, other than the Product in circumstances and in countries where Elan is entitled under this Agreement to market Product: (i) in the EEA for a period of five years beginning on the date of the first In Market sale of the Product in the EEA or (ii) elsewhere in the Territory during the Initial Term;
 

 
22

 

 

 
 
4.3.2  
any formulation containing the Compound as its sole active ingredient for use in buccal or sublingual administration or any formulation containing the Other Compound as its sole active ingredient for use in nasal, buccal, or sublingual administration  as from the Effective Date until the soonest of:
 
 
(a)  
the end of the Initial Term; or
 
 
(b)  
where Amarin exercises its option under Clause 2.4, the restriction imposed by this Clause 4.3 shall immediately terminate in relation to any option formulation that Amarin does not chose to be the Expanded Formulation; or
 
 
(c)  
service of notice by Amarin on Elan that it wishes to terminate its option to expand the license under Clause 2.4 prior to the expiry of the time period referred to in Clause 2.4; or
 
 
(d)  
expiry of the period referred to in Clause 2.4 without the exercise of an  option having been made under Clause 2.4 in respect of an Extended Formulation.
 
 
4.4
Competing Combination Products .  Clauses 4.2 and 4.3 shall apply mutatis mutandis to such formulations in which the Compound is an active ingredient but not the sole active ingredient (“ Combination Formulation ”), provided that such Combination Formulation does not require human clinical trials comparing the efficacy of such Combination Formulation to both the Compound and the other active ingredient individually.
 
 
5.  
DEVELOPMENT OF THE PRODUCT INTERMEDIATE
 
 
5.1.  
Development .  Elan shall use commercially reasonable efforts to develop the Product Intermediate in accordance with the R&D Program:
 
 
5.1.1  
in particular, Elan agrees that it shall:
 
 
5.1.1.1  
be responsible for obtaining and maintaining the necessary licenses and permits for the development, manufacturing, testing and storage of the Product Intermediate by Elan as may be required under the R&D Program.
 
 
5.1.1.2  
provide Product Intermediate as agreed in the R&D Program and shall manufacture such Product Intermediate in accordance with prevailing cGLP, cGCP and cGMP and, in all material respects, in accordance with all applicable Governmental Authority
 

 
23

 

 
standards and guidelines, as appropriate for the phase or stage under which such Product Intermediate is produced during the R&D Program.
 
 
5.2.  
Compound Supply .  Elan shall supply Compound for its activities under the R&D Program up until the completion of the initial animal pharmacokinetic.  Thereafter, Amarin shall re-imburse Elan for any Compound purchased by Elan for use in the R&D Program.
 
 
5.3.  
Other Materials, Third Party Costs and Services .  Following the completion of the initial animal pharmacokinetic study, Amarin shall reimburse Elan for all materials (including but not limited to the Compound as set out in Clause 5.2), other out-of-pocket expenses, third party costs and development services provided by Elan under the R&D Program in accordance with Clause 10.3.  
 
 
5.4.  
Changes and Additional Work .  Any changes to the R&D Program shall be agreed in advance with Elan, and Amarin shall bear the cost of any resulting additional work.  The Parties also agreed that additional work will be conducted under additional workplans, which if agreed and undertaken, will be appended and controlled by the terms of this Agreement.
 
 
6.  
PROJECT TEAM AND PROJECT MANAGEMENT
 
 
6.1.  
Establishment .  Within sixty (60) days of the Effective Date, the parties will establish a project team (“ Project Team ”), which shall consist of development personnel from each party who are appropriately skilled and knowledgeable in relation to the R&D Program and who are deemed necessary to accomplish the work of the R&D Program.
 
 
The Project Team shall have an equal number of members from each of the parties and the total size of the Project Team shall not exceed six (6) people.
 
 
6.2.  
Conduct .  Unless otherwise agreed by the parties:
 
 
6.2.1  
the Project Team shall meet at least once each calendar quarter, such meetings to continue until the time of launch or such later time as may be agreed, alternatively at the offices of Elan and Amarin;
 
 
6.2.2  
meetings shall be chaired by an Elan representative;
 
 
6.2.3  
each party shall be responsible for its own costs in respect of travel and accommodation expenses in attending meetings of the Project Team;
 

 
24

 

 

 
 
6.2.4  
at and between meetings of the Project Team, each party shall keep the other fully and regularly informed as to its progress with its respective tasks and obligations under the R&D Program;
 
 
6.2.5  
the Project Team shall also monitor the progress of the R&D Program against the timeframe set for it and shall report on delays in the conduct of the R&D Program which would materially affect Elan’s ability to successfully complete the R&D Program within the timeframe set out for it and recommend whether corrective action is required under the provisions of Clause 6.3.
 
 
6.3.  
Co-operation .  Elan and Amarin shall undertake their respective obligations under the R&D Program on a collaborative basis.  Accordingly, the parties shall co-operate in good faith particularly with respect to unknown problems or contingencies and shall perform their respective obligations in a commercially reasonable, diligent and workmanlike manner.
 
 
6.4.  
The parties hereby confirm that the parties first and primary objective (under the R&D Program and under this Agreement generally) is to generate an NDA and to secure an NDA Approval for the Product in the United States.  While it is the parties desire and expectation that where possible the body of data generated by them for NDA filing and NDA Approval may also be used to support other regulatory filings and approvals, the parties’ initial focus and efforts during the development program will be intended to generate an NDA and secure NDA Approval.
 
 
7.  
REGULATORY MATTERS
 
 
7.1.  
Elan .  Elan shall own, and shall be responsible for, filing for and maintaining:
 
 
7.1.1  
regulatory approvals in respect of the Elan Technology;
 
 
7.1.2  
the DMF and any equivalent; and
 
 
7.1.3  
all necessary manufacturing approvals for the manufacture of the Product Intermediate.
 
 
Amarin shall reimburse Elan forthwith for any filing fees incurred by Elan in connection therewith.  Amarin shall additionally reimburse Elan at Elan’s then-current full time equivalent rate, currently [*] per person-hour, for all services provided by Elan and for any out-of-pocket expenses and any Third Party costs associated with preparing, filing, obtaining and maintaining Regulatory Approvals for the Product.
 

 
25

 

 

 
 
7.2.  
Amarin .  Except as provided in Clause 7.1 , Amarin shall own and shall be responsible for filing for and maintaining the Amarin Compound Data and all necessary Regulatory Approvals, including any necessary export or import licenses in relation to the Compound (where applicable), Product Intermediate and/or the Product.  For the avoidance of doubt, all of the data, filings and other information provided by Elan to Amarin or any such Affiliate to support Amarin regulatory filings shall be treated as Confidential Information belonging to Elan and its Affiliates in accordance with the provisions of Clause 15.
 
 
7.3.  
Disclosure .  Without prejudice to any other right of Elan under this Agreement, Amarin shall pursue a strategy of minimum disclosure of information relating to the manufacturing process of the Product.  The parties shall discuss the implementation of this strategy in good faith on a case by case basis.
 
 
7.4.  
Review .  Elan shall be given a reasonable opportunity to review and comment upon all regulatory submissions prior to their submission.
 
 
7.5.  
Co-operation .  Elan and Amarin will provide all reasonable co-operation with respect to the other’s regulatory filings.
 
 
7.6.  
Keep Advised .  Amarin shall keep Elan promptly and fully advised of all Amarin’s regulatory activities in respect of the Product and the Compound.  Without prejudice to the generality of the foregoing, Amarin shall:
 
 
7.6.1  
notify Elan upon the date of submission of any Regulatory Application in the Territory;
 
 
7.6.2  
notify Elan upon the date of issue of a Regulatory Approval or related regulatory action letters; and
 
 
7.6.3  
submit to Elan a quarterly report, for every calendar quarter prior to the marketing of the Product within 14 days of the end of the relevant quarter fully outlining the regulatory status of the Product throughout the Territory.
 
 
7.7.  
Right of Reference to DMF .  Elan will authorise Amarin to reference Elan’s DMF with the Governmental Authorities to the extent necessary to enable Amarin to file Regulatory Applications and to maintain Regulatory Approvals in connection with the Product.  In the event that a Governmental Authority raises any queries in relation to Elan’s DMF which can only be resolved by Elan (and not by Amarin), Elan shall use commercially reasonable efforts to resolve any such queries with said Governmental Authority in an expeditious manner.
 

 
26

 

 

 
 
7.8.  
Retention of Samples .  Unless the parties agree otherwise, Elan will maintain raw material, clinical supply and analytical samples in storage for a time period based upon Elan’s sample retention policy, or such longer period of time as Amarin may reasonably request. Elan agrees to maintain Product Intermediate batch production and control records and associated test results until the marketing application is approved by the FDA or until Amarin notifies FDA of discontinuation of the IND.
 
 
7.9.  
Access .  Upon Elan’s prior written notice, Amarin shall permit Elan to have access to the Regulatory Applications and Regulatory Approvals and to take photocopies of same, as required by Elan to fulfil reporting requirements or as otherwise may reasonably be required by Elan in connection with this Agreement.
 
 
7.10.  
Governmental Inspection .  Each party shall notify the other as soon as possible of any notification received by that party from a Governmental Authority to conduct an inspection of its manufacturing or other facilities specific to the development, manufacturing, packaging, storage or handling of the Compound, Product Intermediate and/or the Product.  Copies of all correspondence with the Governmental Authority solely related to the Compound, Product Intermediate or the Product and material to that party’s activities under this Agreement will be provided to that other party.
 
 
7.11.  
Right to Inspect .  Each party shall make that portion of its facility where the Compound, Product Intermediate or the Product is manufactured, tested or stored, including all record and reference samples, available for inspection upon reasonable notice and not more than once per annum:
 
 
7.11.1  
by the other party’s duly qualified employee or, with the consent of the party being inspected, by the other party’s duly qualified agent or contractor; or
 
 
7.11.2  
by the relevant Governmental Authority.
 
 
An inspection under this Clause 7.11 shall be limited to determining whether there is compliance with cGMP and other requirements of applicable law.
 
 
Any consent required under this Clause 7.11 shall not be unreasonably withheld or delayed.
 

 
27

 

 

 
 
8.  
CLINICAL DEVELOPMENT, REGISTRATION, MARKETING AND THE PROMOTION OF THE PRODUCT
 
 
8.1.  
Diligent Efforts .  Amarin shall be responsible for (at its own cost) and shall use commercially reasonable efforts to (i) conduct all stage I activities set out in Schedule 5; (ii) conduct any further development activities and any further clinical trials with respect to the Product Intermediate, the Product or any relevant Device to commercialize Product in the Primary Territory and (iii) register, market and promote the Product in the Primary Territory:  
 
 
8.1.1  
in particular in respect of the Primary Territory, Amarin agrees that it, its Affiliates and permitted sub-licensees shall:
 
 
8.1.1.1  
conduct in an expeditious manner all necessary pre-clinical and clinical studies in respect of the Product Intermediate, the Product and any Device that may be used to administer the Product or Product Intermediate and to conduct such activities in accordance with prevailing cGLP, cGCP and cGMP and, in all material respects, in accordance with all applicable Governmental Authority standards and guidelines;
 
 
8.1.1.2  
obtain Regulatory Approvals for the Product and all necessary governmental approvals that may need to be obtained for the Device in order to market the Product in the Primary Territory;
 
 
8.1.1.3  
promote the Product as the flagship brand under Amarin’s prevailing trademark(s) for use in an outpatient setting in repetitive epileptic seizures and for any other indications in a country for which the Product is approved for use in that country and to otherwise use the same level of effort as used by Amarin with other similar products of similar sales potential;
 
 
8.1.1.4  
market and promote the Product with a view to achieving maximum market impact and concentration throughout the Primary Territory and at least the same level of effort as with other similar products of similar sales potential which it markets; and in the event that Amarin elects to market the Product in any part of the Secondary Territory, the same obligation shall apply to such territory; and
 
 
8.1.1.5  
comply with all applicable rules and regulations, in all material respects,  in regard to the storage, handling, development and commercialization of Product and Product Intermediate and otherwise conduct all storage, handling, development and commercialization activities relating to the Product and Product Intermediate with due care in accordance with normal standards in the pharmaceutical industry.
 

 
28

 

 

 
 
8.2.  
Promotional Campaign .  Amarin shall:
 
 
8.2.1  
control and be responsible for the content and format of each promotional campaign to be submitted to the relevant Governmental Authority, but shall inform Elan thereof and, upon reasonable request by Elan, provide to Elan a copy of such submissions;
 
 
8.2.2  
within ninety (90) days after the filing of the first Regulatory Application in the Territory, if requested in writing by Elan, outline to Elan the structure of the promotional activities to be carried out by Amarin for the period up to the first launch of the Product and for a period of 1 year thereafter; and
 
 
8.2.3  
both prior to and subsequent to the launch of the Product, communicate with Elan regarding its objectives for and performance of the Product in the Territory.
 
 
8.3.  
Packaging and Labels .  Amarin shall submit to Elan for Elan’s information copies of all trade packaging and labels and other printed materials which Amarin proposes at any time to use in relation to the sale of the Product.  For the avoidance of doubt, nothing in this Clause 8.3 affects any other obligation of Amarin, and Amarin shall indemnify and hold harmless Elan against all Claims which may arise relating to the activities described in this Clause 8 .
 
 
8.4.  
Changes .  Amarin shall be entitled to change such trade packaging and labels and other printed materials only as often as is commercially reasonable and in compliance with applicable laws and regulations.  Such changes shall be at Amarin’s sole expense and for the avoidance of doubt shall not constitute allowable deductions from Net Sales.
 
 
8.5.  
Required Markings .  All trade packaging and marketing materials shall:
 
 
8.5.1  
to the extent permitted by law, include due acknowledgement that the Product Intermediate is developed and manufactured by Elan; and
 
 
8.5.2  
have marked representative patent number(s) including that of the formulation patent in respect of the Elan Patents on all Product, or otherwise reasonably communicate to the trade the existence of any Elan Patents for the countries within the Territory in such a manner as to ensure compliance with, and enforceability under, applicable laws.
 
 
8.6.  
Launch .  Amarin shall effect the first full scale national commercial launch of the Product:
 

 
29

 

 

 
 
8.6.1  
in the United States within 180 days of the Regulatory Approval in the United States, provided that Amarin shall have received the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders under this Agreement at least 60 days in advance of the launch date; and
 
 
8.6.2  
in each of the other countries of the Territory, within 270 days after the relevant Regulatory Approval.
 
 
8.7.  
Reporting .  Following first Regulatory Approval of the Product, the parties shall meet as often as reasonably requested by the other (not more than once per calendar quarter).  At such meetings, Amarin shall report on the ongoing sales performance of the Product in each country of the Territory, including marketing approaches, promotional and educational campaigns, performance against competitors, its ongoing objectives for the Product and its plans for promotion of the Product for the next quarterly period.  Such meetings may be held by telephone.  If held in person, each party shall be responsible for its own costs in respect of travel and accommodation expenses in attending such meetings.
 
 
9.  
COMMERCIAL MANUFACTURE
 
 
The parties shall negotiate in good faith a manufacturing agreement relating to the commercial supply of Product Intermediate (“ Manufacturing Agreement ”) containing the following terms, and such other terms as may be agreed:
 
 
9.1.  
Elan shall maintain the exclusive right and obligation to manufacture or have manufactured and to supply or have supplied Amarin’s entire requirement of commercial supplies of Product Intermediate in the Field in the Territory, subject to Clause 9.6 and 9.7.  Elan shall be entitled to subcontract or delegate these obligations (subject to Amarin’s prior written consent which shall not be unreasonably withheld, conditioned or delayed), but shall remain liable to Amarin for all acts or omissions of any Affiliate or subcontractor under the Manufacturing Agreement as though such acts or omissions were by Elan.
 
 
9.2.  
Elan shall be responsible for the cost and sourcing of the Compound for the commercial supply of Product Intermediate referred to in Clause 9.1.
 
 
9.3.  
The Product Intermediate supplied shall be manufactured in accordance with cGMP and all applicable laws and regulations.  The manner in which Amarin shall notify Elan of any failure by Elan to supply Product Intermediate to Amarin that conforms to such requirements and the methods by which Elan may rectify such problems and other consequences for failing to provide Product Intermediate in accordance with these requirements shall be negotiated in good faith and set out in the Manufacturing Agreement.
 

 
30

 

 

 
 
9.4.  
The price of Product Intermediate manufactured by Elan under the Manufacturing Agreement shall be equivalent to [*] of Notional NSP (the “ Supply Price ”) and upon delivery Elan will render to Amarin an invoice for Product Intermediate supplied EXW Elan’s Facility packaged and labelled in a form to be agreed between the parties.
 
 
9.5.  
For the avoidance of doubt the parties agree that if for whatever reason the Product Intermediate supplied by Elan to Amarin, which meets agreed Product Intermediate specifications and applicable law and regulatory requirements, is not sold by Amarin, payment for such Product Intermediate shall nonetheless be effected and the price of the  Product Intermediate shall be the Supply Price.
 
 
9.6.  
In the event that either party is of the opinion that [*] of Manufacturing Cost for one unit of Product Intermediate would exceed the Supply Price, then it shall promptly notify the other in writing. In such event the parties shall meet within thirty (30) days of such notification to discuss, inter alia , the manner in which Manufacturing Cost is calculated by Elan and also Amarin’s commercialisation plans. Thereafter, the parties shall  re-negotiate in good faith (i) the Supply Price or, alternatively, (ii) whether Elan shall use commercially reasonable efforts to locate a third party site (“ Third Party Site ”) of Elan’s choosing (but subject to Amarin’s prior written consent which shall not be unreasonably withheld, conditioned or delayed)  to supply the Product Intermediate and to arrange for a technology transfer between Elan and that third party at Elan’s cost.  The parties further agree that during the course of such good faith discussions and during any period prior to the time at which the Third Party Site is ready to commence manufacture of the Product  Intermediate, Elan shall continue to supply Product Intermediate to Amarin at a price of not less than [*] of Manufacturing Cost.
 
 
9.7.  
In the event that the parties cannot agree on a Supply Price or on the technology transfer as provided in Clause 9.6, then Elan shall continue to supply the Product Intermediate to Amarin but at a price not less than [*] of Manufacturing Cost.
 
 
9.8.  
Forecasting and ordering provisions will be agreed in good faith, taking into account the practical requirements involved in manufacturing the Product Intermediate including, inter alia, the fact that the Compound is a controlled substance;
 
 
9.9.  
Amarin will be responsible for the purchase of (and shall own) any capital equipment specifically required for the manufacture of the Product Intermediate which is unique and/or dedicated to the manufacture of Product Intermediate.  Elan will be responsible for all other capital equipment used in manufacture;
 

 
31

 

 

 
 
9.10.  
In circumstances where the gross sales of the Product exceed US$50,000,000, Elan shall establish a second site of manufacture.  In such circumstance, Amarin shall bear its own and all third-party costs related to any regulatory filing fees and any regulatory maintenance fees or any license fees related to the registration of such second site, to the extent related to the manufacture of Product Intermediate.
 
 
10.  
FINANCIAL PROVISIONS
 
 
10.1.  
Milestone Payments .  In consideration of the grant of the Elan License, Amarin shall pay to Elan the following non-refundable amounts:
 
 
10.1.1  
A milestone of [*] upon the  earlier of: (i) the commencement of Stage 1 of the R&D Program or (ii) the commencement of the second animal pharmacokinetic study that may be conducted on Product Intermediate;
 
 
10.1.2  
a milestone payment of [*] upon the commencement of the first Phase III Study of the Product;
 
 
10.1.3  
a milestone payment of [*] upon the filing of the first Regulatory Application in the United States or in any other country in the Primary Territory;
 
 
10.1.4  
a milestone payment of [*] upon Regulatory Approval in the United States;
 
 
10.1.5  
a milestone payment of [*] upon first Regulatory Approval in any country other than the United States in the Primary Territory.
 
 
the payments described in Clauses 10.1.1 to 10.1.5 being “ License Milestone Payments ”, and for the avoidance of doubt each being payable once only, save where Amarin exercises its option under Clause 2.4 to develop an Expanded Formulation that includes Other Compound, in which case the milestones described in Clause 10.1.2 to 10.1.5 (but excluding the milestone described in Clause 10.1.1) shall be payable more than once.
 
 
If an event in respect of which a License Milestone Payment would be payable does not occur, but another such event occurs which would ordinarily occur only after the first such event, then the amount of the first relevant License Milestone Payment shall be added to the second.
 
 
10.2.  
Not Subject to Future Performance Obligations .  The License Milestone Payments shall not be subject to future performance obligations of Elan to Amarin and shall not be applicable against future services provided by Elan to Amarin.
 

 
32

 

 

 
 
The terms of Clause 10.1 relating to the License Milestone Payments are independent and distinct from the other terms of this Agreement.
 
 
10.3.  
Development Fees .  Following the completion of the initial animal pharmacokinetic study that is conducted on the Product or Product Intermediate in accordance with the R&D Program, Amarin shall reimburse Elan for all materials (including the Compound), other reasonable out-of-pocket expenses and third party costs incurred by Elan during the R&D Program. Amarin shall also reimburse Elan for all services provided by Elan after the completion of the initial animal pharmacokinetic study that is conducted on the Product or Product Intermediate during the R&D Program at Elan’s prevailing full time equivalent rate (“FTE”), currently US$250/hour.
 
 
10.4.  
Royalties .  In consideration of the grant of the Elan License, Amarin shall pay to Elan non-refundable royalties as follows:
 
 
10.4.1  
If Amarin or an Amarin Affiliate sells the Product In Market in any country in the Territory, then subject to Clause 10.5, a non-refundable royalty, calculated by reference to the table set out below, being the sum of the royalties payable to Elan within the bands of Net Sales generated by Amarin or an Amarin Affiliate in the Territory at the corresponding royalty percentage below:
 
 

 
Annual Worldwide Net Sales Bands
 
Applicable Royalty Rate
First[*] of Worldwide Net Sales
[*] of Net Sales generated by Amarin or an Amarin Affiliate in the Territory
Increments above [*] of Worldwide Net Sales
[*] of Net Sales generated by Amarin or an Amarin Affiliate in the Territory.
 

 

 
33

 

 

 
 
The above royalty includes the Manufacturing Royalty which shall be payable by Amarin to Elan for the commercial manufacture and supply by Elan of the Product Intermediate to Amarin.
 
 
10.4.2  
If Amarin enters into a Sub-License Agreement or other agreement whereby a third party is granted rights to sell the Product in the United States, then subject to Clause 10.5, a non-refundable royalty calculated by reference to the table set out below, being the sum of royalties payable to Elan with the bands of Net Sales generated by the third party sub-licensee at the corresponding royalty percentage below:
 
 

 
Annual Worldwide Net Sales Bands
 
Applicable Royalty Rate
First [*] of Worldwide Net Sales
[*] of Net Sales generated in the US.
Increments above [*] of Worldwide Net Sales
[*] of Net Sales generated in the US.
 

 
 
The above royalty includes the Manufacturing Royalty which shall be payable by Amarin to Elan for the commercial manufacture and supply of the Product Intermediate by Elan to Amarin for Product that is sold by third parties in the United States.
 
 
10.4.3  
If Amarin enters into a Sub-License Agreement or other agreement whereby a third party is granted rights to sell the Product outside the United States, then subject to Clause 10.5:
 
 
10.4.3.1  
a non-refundable royalty of [*] of the Ex-US Net Revenues; and
 

 
34

 

 

 
 
10.4.3.2  
the Manufacturing Royalty, which shall be payable by Amarin to Elan for the commercial manufacture and supply of the Product Intermediate by Elan to Amarin for Product that is sold by a third party outside the United States.
 
 
The parties also agree that upon provision of any Statement, Amarin will pay Elan the difference between the sums previously paid to Elan for the supply of Product Intermediate for the quarter in question pursuant to Clause 9 and the royalty sums due hereunder by reference to the Statement for that quarter.
 
 
10.5.  
Generic Competition .  In the event of Generic Competition in a given country, the parties agree that Elan shall at all times continue to receive the Manufacturing Royalty for all Product Intermediate supplied by or on behalf of Elan pursuant to this Agreement and the Manufacturing Agreement but that the remaining royalties due to Elan pursuant to Clause 10.4 shall be [*] as from the date of commencement of such Generic Competition in that country.
 
 
10.6.  
Bundling .  In the event that Amarin, an Amarin Affiliate, permitted sub-licensee and a third party distributor  or any permitted sub-licensee shall sell the Product together with other products of Amarin, an Amarin Affiliate, a permitted sub-licensee and third party distributor to third parties (by the method commonly known in the pharmaceutical industry as “bundling”) and the price attributable to the Product is less than the average price of “arms length” sales to similar customers for the reporting period in which sales occur (such sales to be excluded from the calculation of the average price of “arms length” sales), Net Sales for any such sales shall be the average price of “arms length” sales by Amarin or sub permitted sub-licensee to similar customers in the country where such bundling occurs during the reporting period in which such sales occur.
 
 
10.7.  
Method of calculation of fees .  The parties acknowledge and agree that the methods for calculating the royalties and fees under this Agreement are for the purposes of the convenience of the parties, are freely chosen and not coerced.
 
 
11.  
PAYMENTS, REPORTS AND AUDITS
 
 
11.1.  
Records .  Amarin shall keep true and accurate records of gross sales of the Product, the items deducted from the gross amount in calculating the Net Sales, the Net Sales and the royalties payable to Elan under Clause 10.4 .  Amarin shall deliver to Elan a written statement (the “ Statement ”) thereof within 45 days following the end of each calendar quarter, (or any part thereof in the first or last calendar quarter of this Agreement) for such calendar quarter.  The Statement shall outline on a country-by-country basis, the calculation of the Net Sales from gross revenues during that calendar quarter, the applicable percentage rate, and a computation of the sums due to Elan.  The parties’ financial officers shall agree upon the precise format of the Statement.
 

 
35

 

 

 
 
11.2.  
Foreign Currency .  Payments due on Net Sales of the Product based on sales amounts in a currency other than US$ shall first be calculated in the foreign currency and then converted to US$ on the basis of the exchange rate in effect for the purchase of US$ with such foreign currency quoted in the Wall Street Journal (or comparable publication if not quoted in the Wall Street Journal) on the last day of the relevant calendar quarter.
 
 
11.3.  
VAT .  All payments to Elan are exclusive of any applicable value added or any other sales tax, for which Amarin will be additionally liable if applicable.
 
 
11.4.  
Taxes .  If Amarin is required by law to pay or withhold any income or other taxes on behalf of Elan with respect to any monies payable to Elan under this Agreement:
 
 
11.4.1  
Amarin shall deduct them from the amount of such monies due;
 
 
11.4.2  
any such tax required to be paid or withheld shall be an expense of and borne solely by Elan;
 
 
11.4.3  
Amarin shall promptly provide Elan with a certificate or other documentary evidence to enable Elan to support a claim for a refund or a foreign tax credit.
 
 
11.5.  
Withholding Notice . In the event that Amarin is required by law to withhold any income or other taxes on behalf of Elan from any payment to Elan under the terms of this Agreement, Amarin shall use commercially reasonable efforts to notify Elan at least thirty (30) days in advance of making any such payment.
 
 
11.6.  
Double Tax Co-operation .  Elan and Amarin agree to co-operate in all respects necessary to take advantage of any double taxation agreements or similar agreements as may, from time to time, be available in order to enable Amarin to make such payments to Elan without any deduction or withholding.
 
 
11.7.  
Timing .  Payments to Elan shall be made as follows:
 
 
11.7.1  
each of the License Milestone Payments shall be paid within 45 days of the achievement of the relevant event to which they relate;
 
 
11.7.2  
payment for all Product supplied shall be made within 30 days of receipt of the relevant invoice; and
 

 
36

 

 

 
 
11.7.3  
payment of royalties shall be made upon provision of the Statement.
 
 
11.8.  
Manner of Payment .  All payments due hereunder shall be made in US$ to the designated bank account of Elan in accordance with such timely written instructions as Elan shall from time to time provide.
 
 
11.9.  
Interest .  Without prejudice to Elan’s other remedies hereunder, Amarin shall pay interest to Elan on sums not paid to Elan on the date on which payment should have been made pursuant to the applicable provisions of this Agreement (“ Due Date ”) over the period from the Due Date until the date of actual payment (both before and after judgement) at the Prime Rate publicly announced by Morgan Guaranty Trust Company of New York at its principal office on the Due Date (or next to occur business day, if such date is not a business day) plus [*], such interest to payable on demand from time to time and compounded monthly.  Interest shall be payable both before and after judgment.
 
 
11.10.  
Audit .  For the 180 day period following the close of each calendar year of the Agreement, Elan and Amarin will, in the event that the other party reasonably requests such access, provide each other’s independent certified accountants (reasonably acceptable to the other party) with access, during regular business hours and subject to the confidentiality provisions as contained in this Agreement, to such party’s books and records relating to the Product, solely for the purpose of verifying the accuracy and reasonable composition of the calculations under this Agreement for the calendar year then ended.
 
 
11.11.  
Correction of Discrepancies .  In the event of a discovery of a discrepancy, a correcting payment shall be made forthwith by Amarin to Elan or Elan to Amarin, as the case may be, together with interest at the rate specified in Clause 11.9 .  If the discrepancy exceeds 5% of the amount due or charged by a party for any period and provided that the amount of the discrepancy exceeds US$5,000, then additionally the cost of such accountants shall be borne by the audited party.
 
 
12.  
DURATION AND TERMINATION
 
 
12.1.  
Initial Term .  This Agreement shall be deemed to have come into force on the Effective Date and, subject to the rights of termination outlined in this Clause 12 and the provisions of applicable laws, will expire on a country by country basis:-
 
 
12.1.1  
on the 15th anniversary of the date of the first In Market sale of the Product in the country concerned; or
 
 
12.1.2  
in any country upon expiry of the last Valid Patent Claim  –
 

 
37

 

 

 
 
whichever date is later to occur (the “ Initial Term ”).
 
 
12.2.  
Continuation .  At the end of the Initial Term, the Agreement shall continue automatically for rolling 3 year periods thereafter, unless the Agreement has been terminated by either of the parties by serving 2 years’ written notice on the other party immediately prior to the end of the Initial Term or any such additional 3 year period.
 
 
12.3.  
Breach / Insolvency .  In addition to the rights of termination provided for elsewhere in this Agreement, either party will be entitled forthwith to terminate this Agreement by written notice to the other party if:
 
 
12.3.1  
that other party commits a material breach of any of the provisions of this Agreement or the Manufacturing Agreement, and fails to cure the same within 60 days after receipt of a written notice from another party hereto giving full particulars of the breach and requiring it to be remedied; provided, that if the breaching party has proposed a course of action to cure the breach and is acting in good faith to cure same but has not cured the breach by the 60th day, such period shall be extended by such period as is reasonably necessary to permit the breach to be cured, provided that such period shall not be extended by more than 90 days, unless otherwise agreed in writing by the parties;
 
 
12.3.2  
that other party goes into liquidation under the laws of any applicable jurisdiction (except for the purposes of amalgamation or reconstruction and in such manner that the company resulting therefrom effectively agrees to be bound by or assume the obligations imposed on that other party under this Agreement);
 
 
12.3.3  
a receiver, administrator, examiner, trustee or similar officer is appointed over all or substantially all of assets of that other party under the laws of any applicable jurisdiction; or
 
 
12.3.4  
any proceedings are filed or commenced by that other party under bankruptcy, insolvency or debtor relief laws, or anything analogous to any of the foregoing under the laws of any applicable jurisdiction occurs in relation to that other party.
 
 
12.4.  
Free Termination by Amarin .  Amarin may terminate this Agreement upon thirty (30) days’ written notice to Elan:
 
 
12.4.1  
at any time up to the initiation of a Phase III Study of the Product; or
 
 
12.4.2  
at any time following the failure of a Phase III Study; or
 

 
38

 

 

 
 
12.4.3  
at any time after the fifth anniversary of the first In Market sale of the Product; or
 
 
12.4.4  
if Elan is in breach of Clause 4.3, provided that if such breach results solely from the acquisition of Elan by a third party, Amarin shall not terminate this Agreement if the acquirer completes the divestiture of the competing products or the Product Intermediate  within six (6) months.  Save with respect to the provision in the previous sentence, this Clause shall not prejudice any other remedy Amarin may have in respect of such breach.
 
 
12.5.  
Other Termination by Amarin .  Amarin may terminate this Agreement on a country-by-country basis at any time upon thirty (30) days’ written notice to Elan where:
 
 
12.5.1  
the sale of the Product becomes prohibited by a Governmental Authority in that country; or
 
 
12.5.2  
despite having used commercially reasonable efforts, Amarin is unable to obtain Regulatory Approval for the Product in such country so as to permit a reasonable commercial return for Amarin.
 
 
12.6.  
Additional Elan Termination Rights .  In further addition to the rights and termination provided for elsewhere in this Agreement, Elan shall be entitled to terminate this Agreement upon thirty (30) days written notice to Amarin:
 
 
12.6.1  
in its entirety in the event that:
 
 
12.6.1.1  
Amarin, its Affiliates or a permitted sub-licensee knowingly challenges the validity and/or ownership of any of the Elan Patents and/or the scope of any claims therein in a formal proceeding, mediation or binding arbitration; or
 
 
12.6.1.2  
Amarin is in breach of Clause 4.2 , provided that if such breach results solely from the acquisition of Amarin by a third party, Elan shall not terminate this Agreement if the acquiror completes the divestiture of the competing product(s) or the Product (without prejudice to any right of Elan to withhold consent to such divestiture) within six (6) months.  Save with respect to the proviso in the previous sentence, this Clause shall not prejudice any other remedy Elan may have in respect of such breach.
 
 
12.6.2  
for any country or countries of the Territory in the event   that Amarin fails to file a Regulatory Application:
 

 
39

 

 

 
 
12.6.2.1  
in the United States within [*] after the completion of first human pharmacokenetics study that enables entry into efficacy studies (“ PK Date ”);
 
 
12.6.2.2  
in an EU Major Market (through either a local or EU procedure which would result in the immediate approval of the Product in a EU Major Market) [*] from the PK Date; or
 
 
12.6.2.3  
in Japan [*] from the PK Date.
 
 
Recognizing that Amarin’s ability to move forward relies on Elan’s (and its Affiliates’) performance, the dates listed above shall be extended to take account of any unreasonable delay or failure on Elan’s part to perform, and any evaluation of Amarin’s diligence must take account of these delays and failures.  Similarly, Elan’s unreasonable delays (including unreasonable delay in supplying required clinical supplies) will extend the 7, 8 and 9 year deadlines.
 
 
13.  
CONSEQUENCES OF TERMINATION
 
 
13.1.  
General Consequence .  Upon exercise of those rights of termination specified in Clause 12 or elsewhere in this Agreement, this Agreement shall, subject to Clauses 13.2 and 13.3 , automatically terminate forthwith and be of no further legal force or effect.
 
 
13.2.  
Specific Consequences .  Upon termination of the Agreement, or upon termination of a license for a particular country under Clause 12.6 , the following shall be the consequences relating to the Territory or the particular country, as applicable:
 
 
13.2.1  
any sums that were due from Amarin to Elan under the provisions of this Agreement prior to its termination or expiry shall be paid in full within 30 days of termination of this Agreement and Elan shall not be liable to repay to Amarin any amount of money paid or payable by Amarin to Elan up to the date of the termination of this Agreement;
 
 
13.2.2  
the provisions of this Agreement regarding with respect to confidentiality and non-use of Confidential Information shall remain in effect for a further period of 7 (seven) years.
 
 
13.2.3  
Clauses 1, 3.1, 3.4, 3.5, 3.6, 11, 13 (in accordance with its terms), 14.1 through 14.10, 14.11 (in accordance with its terms), and 16 shall survive termination;
 

 
40

 

 

 
 
13.2.4  
any sub-license granted under Clause 2.3 shall automatically terminate, although Elan agrees that it will negotiate in good faith with sub-licensees to renew such sub-license agreements after the date of such termination provided that Elan is satisfied that renewing said agreements will produce a reasonable economic return for Elan and the sub-licensee is not a Technological Competitor.  In the event that such negotiations do not result in the renewal of the relevant license rights, the sub-licensee shall be provided with a certain period of time in which to deplete stock and to return or destroy all Elan Confidential Information in its possession;
 
 
13.2.5  
where Elan terminates under Clause 12.3, 12.6 or where Amarin terminates this License on a country-by-country basis or for reasons other than a breach of this Agreement by Elan, [Elan shall be entitled to research, develop and commercialise the Product for its own benefit in the Territory or in the relevant country or countries of the Territory] in accordance with the provisions of Clause 13.3 ;
 
 
13.2.6  
where Elan terminates under Clause 12.3, 12.6 or where Amarin terminates this License on a country-by-country basis or for reasons other than a breach of this Agreement by Elan, [*];
 
 
13.2.7  
for the avoidance of doubt, the parties further agree that the termination of this Agreement for any reason shall not relieve the parties of any obligation accruing prior thereto and shall be without prejudice to the rights and remedies of either party with respect to any antecedent breach of the provisions of this Agreement.
 
 
13.2.8  
If following the date of termination of this Agreement Amarin is required to indemnify Elan under the provisions of [*].
 
 
13.3.  
Ancillary Rights.  [*]
 
 
14.  
WARRANTIES, INDEMNIFICATION AND LIABILITY
 
 
14.1.  
Elan Warranties .  Elan represents and warrants to Amarin as of the Effective Date, as follows:
 
 
14.1.1  
Elan owns, beneficially or otherwise, the Elan Patents has the right to enter into this Agreement and grant the Elan License.
 
 
14.1.2  
There are no agreements between Elan and any third party that conflict with this Agreement.
 

 
41

 

 

 
 
14.1.3  
Except for the oppositions in the European Patent Office of EP-B-499299 and EP-1185371, Elan has not been notified of and, to the best of Elan’s knowledge, information and belief with no special search (i) there are no infringement proceedings, actions, suits or complaints pending against nor any outstanding injunctions, judgments, orders, decrees, rulings or other charges against Elan or any Affiliate of Elan in connection with the Elan Patents or the Elan Know How in the Territory that may affect the making, using, or selling of the Product, (ii) there are no claims or litigation brought or threatened by any third party alleging that the Elan Patents are invalid or unenforceable, in whole or in part and (iii) Elan or any Affiliate has not received notice from a third party indicating that the use of the Elan Patents or Elan Know-How infringes any third party patent rights which would adversely affect the commercialization of the Product in the Territory.
 
 
14.1.4  
Elan has not been notified and to the best of its knowledge without any special search no allegation has been made that the application of the Elan Technology ot the Product Intermediate infringes the patent rights of any third party.
 
 
14.2.  
Amarin Warranties .  Amarin represents and warrants to Elan as of the Effective Date, as follows:
 
 
14.2.1  
Amarin has the right to enter into this Agreement.
 
 
14.2.2  
There are no agreements between Amarin and any third party that conflict with this Agreement.
 
 
14.2.3  
As of the Effective Date of this Agreement, there is no Amarin Intellectual Property in existence.
 
 
14.2.4  
Amarin has not been notified and has no actual knowledge that application of the Elan Technology to the Product Intermediate infringes the patent rights of any third party.
 
 
14.3.  
Mutual Indemnification .  Each of the parties (“Indemnifying Party”) shall indemnify and hold harmless the other party (“Indemnified Party”) against all Claims insofar as they arise out of any breach by the Indemnifying Party of any of its obligations or warranties under this Agreement or from the Indemnifying Party’s fraud or wilful misconduct.
 
 
14.4.  
Infringement Claims .  The parties acknowledge that Clause 3.4 contains the parties’ full agreement as regards liability for Infringement Claims, save to the extent that Clause 3.4 incorporates other provisions of this Agreement by specific cross-reference.
 

 
42

 

 

 
 
14.5.  
Indemnification (Medical Claims) .  Except to the relative extent that Elan is obliged to indemnify Amarin under this Agreement, Amarin shall indemnify Elan against all any Claims made or brought against Elan seeking damages for personal injury (including death) and/or for the cost of medical treatment, caused by or attributed to the Product Intermediate or Product.
 
 
For the avoidance of doubt, this Clause shall require Amarin to indemnify Elan for any Claim arising out of or in connection with Amarin’s, it’s Affiliates’, permitted sub-licensees or third party subcontractors’ obligations and activities under this Agreement or otherwise, including but not limited to:
 
 
14.5.1  
the use, sale, promotion, distribution, storage of Product or Product Intermediate in the Territory;
 
 
14.5.2  
the application and use of any Device with the Product or Product Intermediate
 
 
14.5.3  
the storage of and any further processing, packaging or other activities performed by, or on behalf of Amarin, its Affiliates, its permitted sub-licensees or its permitted subcontractors of the Product Intermediate;
 
 
14.5.4  
any clinical trial programs conducted by, on behalf of, or at the request of Amarin, its Affiliates, its permitted sub-licensees or permitted third party subcontractors with respect to the development of the Product and Product Intermediate and in respect of all regulatory activities conducted in connection with the Product or Product Intermediate.
 
 
14.6.  
Conduct of Claims .  The party seeking an indemnity shall:
 
 
14.6.1  
fully and promptly notify the other party of any claim or proceedings, or threatened claim or proceedings;
 
 
14.6.2  
permit the indemnifying party to take full control of such claim or proceedings, with counsel of the indemnifying party’s choice, provided that the indemnifying party shall reasonably and regularly consult with the indemnified party in relation to the progress and status of such claim or proceedings;
 
 
14.6.3  
co-operate in the investigation and defense of such claim or proceedings; and
 
 
14.6.4  
take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceedings.
 

 
43

 

 

 
 
The indemnifying party may settle a Claim on terms which provide only for monetary relief and do not include any admission of liability.  Save as aforesaid, neither the indemnifying party nor Indemnified Party shall acknowledge the validity of, compromise or otherwise settle any Claim without the prior written consent of the other, which shall not be unreasonably withheld.
 
 
14.7.  
Exclusion of Implied Warranties .  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, AMARIN ACKNOWLEDGES THAT THE ELAN LICENSE IS GRANTED AND THE PRODUCT INTERMEDIATE SUPPLIED ON AN “AS IS” BASIS, WITHOUT REPRESENTATION OR WARRANTY WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAWS.
 
 
14.8.  
Exclusion of Consequential Loss .  WITHOUT PREJUDICE TO THE OBLIGATION OF EITHER PARTY TO INDEMNIFY THE OTHER IN RESPECT OF CLAIMS BY A THIRD PARTY, NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND AMARIN SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL, INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE.
 
 
14.9.  
Extension of Indemnification .  Where this Agreement provides for the indemnification of a party to this Agreement or for the limitation of a party’s liability, such indemnification and/or limitation (as the case may be) shall also apply for the benefit of such party’s Affiliates and the employees, officers, directors and agents of any of them, acting in such capacity.
 
 
14.10.  
Inherent Risk .  It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products and such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration outlined in this Agreement.  Accordingly, Amarin shall have no liability to Elan as a result of the failure of the Product to obtain Regulatory Approval in one or more countries in the Territory provided that Amarin has satisfied its diligence efforts under Clause 8.1 to conduct pre-clinical and clinical studies in respect of the Product Intermediate and Product  and Elan will have no liability to Amarin as a result of any failure or delay of the Product Intermediate to achieve the Product Intermediate Specifications or one or more of the milestones set out in the R&D Program and/or to obtain the Regulatory Approval in one or more of the countries of the Territory provided that Elan uses commercially reasonable efforts under Clause 5.1 to develop the Product Intermediate in accordance with the R&D Program.
 

 
44

 

 

 
 
14.11.  
Insurance .  Amarin shall maintain clinical trial insurance and comprehensive general liability insurance including product liability insurance on the Product, the Product Intermediate and Compound in such prudent amount as the parties may agree for the duration of this Agreement and for such period thereafter as necessary to cover the insured risks.
 
 
Amarin shall provide Elan with a certificate from the insurance company verifying the above and shall notify Elan in writing at least 30 days prior to the expiration or termination of such coverage.
 
 
15.  
CONFIDENTIALITY
 
 
15.1.  
Confidential Information :  The parties agree that it will be necessary, from time to time, to disclose to each other confidential and proprietary materials and information, including without limitation, inventions, trade secrets, specifications, designs, data, know-how and other proprietary information relating to the Product, processes, services and business of the disclosing party.
 
 
The foregoing shall be referred to collectively as “ Confidential Information ”.
 
 
15.2.  
Exclusion .  Confidential Information shall be deemed not to include:
 
 
15.2.1  
information which is in the public domain;
 
 
15.2.2  
information which is made public through no breach of this Agreement;
 
 
15.2.3  
information which is independently developed by a party, as evidenced by such party’s records; or
 
 
15.2.4  
information that becomes available to a receiving party on a non-confidential basis, whether directly or indirectly, from a source other than the other party hereto, which source did not acquire this information on a confidential basis.
 
 
15.3.  
Use of Confidential Information .  Any Confidential Information disclosed by the disclosing party shall be used by the receiving party exclusively for the purposes of fulfilling the receiving party’s obligations under this Agreement and for no other purpose.
 

 
45

 

 

 
 
15.4.  
Non-Disclosure .  Except as otherwise specifically provided in this Agreement, each party shall disclose Confidential Information of the other party only to those employees, representatives and agents requiring knowledge thereof in connection with fulfilling the party’s obligations under this Agreement, and not to any other third party.
 
 
15.5.  
Obligation to Inform .  Each party further agrees to inform all such employees, representatives and agents of the terms and provisions of this Agreement relating to Confidential Information and to obtain their agreement hereto as a condition of receiving Confidential Information.
 
 
15.6.  
Care .  Each party shall exercise the same standard of care as it would itself exercise in relation to its own confidential information (but in no event less than a reasonable standard of care) to protect and preserve the proprietary and confidential nature of the Confidential Information disclosed to it by the other party.
 
 
15.7.  
Return of Information .  Upon termination or expiration of this Agreement, each party shall promptly, upon request of the other party, return all documents and any copies thereof containing Confidential Information belonging to, or disclosed by, such other party, save that it may retain one copy of the same solely for the purposes of ensuring compliance with this Clause 15 .
 
 
15.8.  
Attribution .  Any breach of this Clause 15 by any person informed by one of the parties is considered a breach by the party itself.
 
 
15.9.  
Acknowledgment .  The parties agree that the obligations of this Clause 15 are necessary and reasonable in order to protect the parties’ respective businesses.  The parties further agree that monetary damages may be inadequate to compensate a party for any breach by the other party of its covenants and agreements with respect to confidentiality, and that each party shall be entitled to seek injunctive or other equitable relief against the threatened or continued breach of those provisions, in addition to with any other remedy which may be available.
 
 
15.10.  
Compound Data .  For the purpose of demonstrating to third parties the benefits of the Elan Technology, Elan shall be entitled, with the prior written consent of Amarin, to disclose to third parties the numerical values underlying the Amarin Compound Data provided that Elan does not disclose Amarin’s name or the name of the Compound.
 
 
15.11.  
Announcements .  No announcement or public statement concerning the existence, subject matter or any term of this Agreement, or its performance, shall be made by or on behalf of any party without the prior written approval of the other, such approval not to be unreasonably withheld or delayed.  Any such statement by Amarin shall contain suitable reference to the fact that the Product is developed using the Elan Technology, and that Elan is the owner of such technology.
 

 
46

 

 

 
 
15.12.  
Required Disclosure s .  A party (the “ Disclosing Party ”) will be entitled to make an announcement or public statement concerning the existence, subject matter or any term of this Agreement, or to disclose Confidential Information that the Disclosing Party is required to make or disclose pursuant to:
 
 
15.12.1  
a valid order of a court or Governmental Authority; or
 
 
15.12.2  
any other requirement of law or any securities or stock exchange;
 
 
provided that if the Disclosing Party becomes legally required to make such announcement, public statement or disclosure hereunder, the Disclosing Party shall give the other party prompt notice of such fact to enable the other party to seek a protective order or other appropriate remedy concerning any such announcement, public statement or disclosure, including confidential treatment and/or appropriate redactions.
 
 
The Disclosing Party shall fully co-operate with the other party in connection with that other party’s efforts to obtain any such order or other remedy.  If any such order or other remedy does not fully preclude announcement, public statement or disclosure, the Disclosing Party shall make such announcement, public statement or disclosure only to the extent that the same is legally required.
 
 
15.13.  
Disclosures to Regulatory Authorities .  Notwithstanding Clause 15.12 , Amarin (and its distributors and permitted sub-licensees) shall not be permitted to include Elan’s Confidential Information in any Regulatory Application or other regulatory filings, without Elan’s prior written consent.  For the avoidance of doubt, such consent shall not be taken to permit Amarin, its distributors and/or permitted sub-licensees to claim ownership rights to the information provided and/or to use the information for any purpose other than the specific use and in such manner as that for which consent was obtained.
 
 
15.14.  
Other Disclosures .  Each of the parties shall be entitled to provide a redacted copy of this Agreement, to be agreed by the parties, to any potential  distributor or sub-licensees without the prior written consent of the other party on the condition that such potential sub-licensees agree to be bound by confidentiality obligations no less onerous than those contained in this Agreement.
 
 
15.15.  
Technological Competitors . [*]
 

 
47

 

 

 
 
16.  
MISCELLANEOUS PROVISIONS
 
 
16.1.  
Force Majeure .  Neither party shall be liable for failure or delay in the performance of any of its obligations under this Agreement if such failure or delay results from Force Majeure, but any such failure or delay shall be remedied by such party as soon as practicable.
 
 
16.2.  
Assignment .
 
 
16.2.1  
Each party be entitled without the consent of the other:
 
 
16.2.1.1  
to subcontract or delegate the whole or any part of its duties hereunder to its Affiliate(s); and/or
 
 
16.2.1.2  
to assign this Agreement to its Affiliate, provided that such assignment has no material adverse tax implications for the other party.
 
 
16.2.2  
Amarin may assign this Agreement to any person to whom it would be permitted to grant a sub-license under the Elan License, subject to any conditions which would attach thereto.  For the avoidance of doubt, Amarin shall under no circumstances assign this Agreement to a Technological Competitor.
 
 
16.2.3  
Each party shall be entitled to assign this Agreement to any acquiror of all or substantially all of its assets related to this Agreement, regardless of the form of such transaction provided that Amarin shall under no circumstances assign this Agreement to a Technological Competitor and shall make Elan whole for any tax consequence.
 
 
16.2.4  
Except as provided for in Clauses 16.2.1 to 16.2.3 inclusive, this Agreement may not be assigned by a party nor any duties hereunder subcontracted or delegated by a party without the prior written consent of the other, which shall not be unreasonably withheld or delayed.
 
 
16.2.5  
In the event that an Affiliate of Amarin to whom this Agreement has been assigned ceases to be an Affiliate of Amarin, this Agreement shall be deemed automatically reassigned to Amarin (or such Affiliate as it may specify, subject to the condition set out in Clause 16.2.1.2 ).
 
 
16.2.6  
Any assignee shall assume the obligations of the assignor under this Agreement.
 

 
48

 

 
16.2.7  
 
 
 
16.2.8  
Each party is entering into this Agreement on its own behalf and not on behalf of any other person or entity.
 
 
16.3.  
Parties Bound .  This Agreement shall be binding upon and run for the benefit of the parties, their successors and permitted assigns.
 
 
16.4.  
Relationship of the Parties .  In this Agreement, nothing shall be deemed to constitute a partnership between the parties or make either party an agent for the other, for any purpose whatsoever.
 
 
16.5.  
Entire Agreement .  This Agreement constitutes the entire agreement and understanding between the parties with respect to its subject matter, and except as expressly provided, supersedes all prior representations, writings, negotiations or understandings with respect to that subject matter.
 
 
Nothing in this Clause 16.5 shall exclude any liability which any party would otherwise have to the other party or any right which either of them may have to rescind this Agreement in respect of any statements made fraudulently by the other prior to the execution of this Agreement or any rights which either of them may have in respect of fraudulent concealment by the other.
 
 
16.6.  
Severability .  If any provision in this Agreement is deemed to be, or becomes invalid, illegal, void or unenforceable under applicable laws, such provision will be deemed amended to conform to applicable laws so as to be valid and enforceable, or if it cannot be so amended without materially altering the intention of the parties, it will be deleted, but the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
 
 
16.7.  
Further Assurance .  Each party shall do and execute, or arrange for the doing and executing of, each necessary act, document and thing reasonably within its power to implement this Agreement.
 
 
16.8.  
Counterparts .  This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and all of which when taken together shall constitute this Agreement.
 
 
16.9.  
Waivers .  A failure to exercise or delay in exercising a right or remedy provided by this Agreement or by law does not constitute a waiver of the right or remedy or a waiver of other rights or remedies.  No single or partial exercise of a right or remedy provided by this Agreement or by law prevents further exercise of the right or remedy or the exercise of another right or remedy.
 
 
16.10.  
Variations .  No variation of this Agreement shall be effective unless it is made in writing and signed by each of the parties.
 

 
49

 

 

 
 
16.11.  
Notices .
 
 
16.11.1  
A notice under or in connection with this Agreement (a “ Notice ”):
 
 
16.11.1.1  
shall be in writing; and
 
 
16.11.1.2  
may be delivered personally or sent by first class post (and air mail if overseas) or by fax to the party due to receive the Notice at its address set out below:
 
 
16.11.2  
The address referred to in Clause 16.11.1.2 is:
 
 
(a)        in the case of Elan:
 

Address:
Elan Pharma International Limited
Monksland
 
Athlone
Co. Westmeath
Ireland
   
Attention:
Vice President & Legal Counsel
Fax:
+ 353 9064 95402


 
50

 


 
(b)        in the case of Amarin:
 
Address:
Amarin Pharmaceuticals Ireland Limited
First Floor
Block 3
The Oval
Shelbourne Road
Ballsbridge
Dublin 4
Ireland
Fax:
+353 1 669 9028
Marked for the attention of :  General Counsel
 
 
16.11.3  
Notice is deemed given:
 
 
16.11.3.1  
if delivered personally, when the person delivering the notice obtains the signature of a person at the address referred to in Clause 16.11.1.2 ;
 
 
16.11.3.2  
if sent by post, except air mail, two Business Days after posting it;
 
 
16.11.3.3  
if sent by air mail, six Business Days after posting it;
 
 
16.11.3.4  
if sent by fax, when confirmation of its transmission has been recorded by the sender's fax machine.
 
 
16.12.  
Set-off .  Each of the parties will be entitled but not obliged to set-off against any amount of money payable to it by the other party under this Agreement, any amount of money payable by it to the other party under this Agreement.
 
 
16.13.  
Disputes .  Any disputes between the parties which cannot be amicably resolved shall first be referred to the Chief Operations Officer of Elan Drug Technologies and the Chief Executive Office of Amarin, who shall attempt to resolve the matter in good faith.
 
 
16.14.  
Governing Law and Jurisdiction :  This Agreement shall be governed by and construed in accordance with the laws of Ireland, without regard to its conflict of laws rules, and shall be subject to the exclusive jurisdiction of Irish Courts.
 
***

 
51

 



 
SCHEDULE 1 ELAN PATENTS
 


 

 

[ * ]

 

 

 
52

 

 
SCHEDULE 2 R&D PROGRAM
 

[*]

 
53

 


 
SCHEDULE 3 TECHNOLOGICAL COMPETITORS OF ELAN
 
 

 

[*]


 
54

 

 
SCHEDULE 4 MANUFACTURING COSTS
 
 

 
 
“Manufacturing Cost” means the fully absorbed cost of manufacture which shall be determined on the basis of the following elements:
 
 
(a)           Direct material, labour and overhead cost; and
 
 
(b)
Such indirect labour, factory, laboratory and other overhead costs properly allocable.  Overhead allocations shall include expenses of plant maintenance and engineering, plant management, receiving and warehousing, disposal and treatment of waste, building occupancy, quality control, costs of services provided to manufacturing, insurance provided to manufacturing, and depreciation/amortisation of applicable capital.
 
 
Such allocations shall be in a manner consistent with US generally accepted accounting principles from time to time and in a manner consistent with expenses and overhead allocated to other products manufactured by Elan or its Affiliates.
 
 
Where some parts of the manufacture are conducted by unaffiliated third party(ies), Product Manufacturing Cost shall be the amount paid to such third party(ies) plus any of the aforementioned costs incurred by Elan or its Affiliates in completing the manufacture, or delivery of the Product Intermediate.
 
 

 

 
55

 

 
SCHEDULE 5 AMARIN STAGE I ACTIVITIES
 

·  
[* ]
 

 
 

 

 
56

 



SIGNED
 
 
 
_________________________________
Duly authorised for and on behalf of:
ELAN PHARMA INTERNATIONAL LIMITED
 
 
 
 
SIGNED
 
 
 
_________________________________
Duly authorised for and on behalf of:
AMARIN PHARMACEUTICALS IRELAND LIMITED

 
 
 
 
 
 
 
 
 
57
 
Exhibit 4.68
 

DATED 9 DAY OF MARCH 2007
 
(1) AMARIN CORPORATION PLC
 

 
and
 

 
(2) DALRIADA LIMITED
 
____________________________________________

CORPORATE CONSULTANCY AGREEMENT
____________________________________________


 
 

 

INDEX
 
1
DEFINITIONS AND INTERPRETATION
1
     
2
CONSULTANCY SERVICES
2
     
3
DURATION
2
     
4
CONSULTANT'S OBLIGATIONS
2
     
5
FEE / EXPENSES
2
     
6
TERMINATION
2
     
7
USE OF CONFIDENTIAL INFORMATION
2
     
8
STATUS AND INDEMNITY
3
     
9
INTELLECTUAL PROPERTY RIGHTS
3
     
10
SEVERABILITY
3
     
11
BINDING ON SUCCESSORS AND ASSIGNMENTS
3
     
12
VARIATION
4
     
13
WHOLE AGREEMENT
4
     
14
WAIVER, RELEASE AND REMEDIES
4
     
15
NOTICES
4
     
16
GOVERNING LAW AND JURISDICTION
4


 
-i- 

 

THIS AGREEMENT , is made on 9 March 2007 BETWEEN
 
(1)
Amarin Corporation plc, a company incorporated under the laws of United Kingdom having its registered office at 7 Curzon Street, London, W1J 5HG (the "Company")
 
AND
 
(2)
Dalriada Limited, a Bermuda exempted company limited by shares and having its registered office at Clarendon House, 2 Church Street, Hamilton HM 11, Bermuda (the "Consultant").
 
WHEREAS
 
A.
The Consultant has certain skills and abilities and provides consultancy/advisory/management consultancy services which the Company wishes to avail of on a non-exclusive "as required" basis.
 
B.
The Consultant as an independent contractor is willing and hereby agrees to provide services to the Company as set out herein.
 
NOW IT IS HEREBY AGREED as follows:
 
1  
DEFINITIONS AND INTERPRETATION
 
Definitions
 
In this Agreement unless the context otherwise requires or unless otherwise specified:
 
" Associated Undertaking " means any undertaking which from time to time is a subsidiary undertaking of the Company or is the parent undertaking of the Company or a subsidiary undertaking of any such parent undertaking and for the purposes of this definition "subsidiary undertaking " and "parent undertaking" shall have the meanings respectively given to them by Regulations 3 and 4 of the European Communities (Companies: Group Accounts) Regulations, 1992.
 
" Confidential Information " means any proprietary information of the Company or the Group, including without prejudice to the generality of the foregoing, information which concerns the business, finance, strategy, organisation, suppliers or customers or research programs or Intellectual Property of the Company or the Group, which shall have come to the Consultant's knowledge during the course of this Agreement.
 
" Effective Date " means March 9, 2007.
 
" Group " means the Company and all Associated Undertakings.
 
" Intellectual Property " means discoveries, concepts, ideas and improvements to existing technology whether or not written down or otherwise converted to tangible form, patents, designs, trade marks, trade names, goodwill, copyrights, all rights in inventions, designs, processes, formulae, notations, improvements, know-how, goodwill, reputation, moulds, get-up, computer programmes and analogous property, plans, models, literary, dramatic, musical and artistic works and all other forms of industrial or intellectual property (in each case in any part of the world and whether or not registered or registerable and to the fullest extent thereof and for the full period thereof and all extensions and renewals thereof) and all applications for registration thereof and all rights and interests, present and future, thereto and therein.
 
" UK " means the United Kingdom.
 
" £ " means UK Pounds.
 
" Services " means the consultancy services provided by the Consultant, including but not limited to consultancy services relating to financing and other corporate finance matters, investor and media relations and implementation of corporate strategy.
 

 
 

 


 
2  
CONSULTANCY SERVICES
 
The Company engages the Consultant to provide the Services and the Consultant agrees to provide the Services upon the terms and conditions set out herein.
 
3  
DURATION
 
3.1  
This Agreement shall be deemed to have commenced on the Effective Date and shall be for an initial period of 1 year from the Effective Date and shall renew thereafter automatically for rolling periods of 1 year, unless at any time the Agreement is terminated by either party in accordance with clause 6.
 
4  
CONSULTANT'S OBLIGATIONS
 
4.1  
For the purpose of this Agreement and the provision of the Services, the Consultant shall procure and make available to the Company the services, skills and expertise of Mr. Thomas G. Lynch and any additional or substitute persons as may be agreed between the parties hereto ("the Consultant's Representative").
 
4.2  
The Consultant is retained on a non-exclusive "as required" basis to provide the Services to the Company.
 
5  
FEE / EXPENSES
 
5.1  
The Company will pay to the Consultant a fee of £240,000 per annum for the provision of the Services, which will be paid to the Consultant quarterly in arrears.  This fee will be reviewed by the Company and the Consultant on an annual basis in advance of renewal in accordance with clause 3.1.  The Company may also determine to pay the Consultant performance-related payments from time to time.
 
5.2  
The Company shall reimburse the Consultant in respect of all expenses reasonably incurred in the proper performance of the Services, subject to the Consultant providing such receipts or other evidence as the Company may require.
 
6  
TERMINATION
 
6.1  
This Agreement may be terminated by either party giving to the other not less than three months prior notice in writing.
 
6.2  
Each of the parties shall be entitled to forthwith terminate this Agreement if the other party:
 
6.2.1  
shall be in breach of any of the terms of this Agreement; or
 
6.2.2  
goes into liquidation, receivership or Court protection or enters into an arrangement with its creditors.
 
7  
USE OF CONFIDENTIAL INFORMATION
 
7.1  
The Consultant acknowledges:
 
7.1.1  
that the Company possesses a valuable body of Confidential Information; and
 
7.1.2  
that the Company will give the Consultant access to Confidential Information in order to facilitate the proper provision of the Services.
 
7.2  
The Consultant shall and shall procure that its servants or agents (including the Consultant's Representative) shall keep secret and shall not at any time either during the term of this Agreement, or after its termination for whatever reason, use, communicate, reveal, or cause any unauthorised disclosure to any person any of the Confidential Information.
 

 
-2-

 


 
7.3  
The restrictions contained in this clause shall not apply to any disclosure required in the ordinary and proper course of the provision of the Services under this Agreement or as required by the order of a court of competent jurisdiction or an appropriate regulatory authority or any information which the Consultant can demonstrate was known to the Consultant prior to the commencement of this Agreement or is in the public domain otherwise than as a result of a breach of this clause.
 
8  
STATUS AND INDEMNITY
 
8.1  
It is hereby declared that the Consultant's Representative is not and will not become an employee of the Company and it is agreed that the Consultant shall be responsible for all payments to the Consultant's Representative for his services to the Consultant for the purposes of this Agreement and will be responsible for, if applicable, the deduction of income tax liabilities and pay related social insurance or similar contributions in respect of any payments to the Consultant's Representative.  The Consultant hereby agrees to indemnify and hold harmless the Company against any claims or demands that may be made by the relevant authorities in respect of income tax, pay related social insurance, penalties or interest relating to payments to the Consultant's Representative in respect of his services to the Consultant for the purposes of this Agreement.
 
In his capacity as the Consultant's Representative hereunder, the Consultant's Representative shall not be entitled to any fee, salary, pension, bonus, or other fringe benefits from the Company.
 
8.2  
It is further declared that this Agreement shall not constitute or create a partnership between the parties or between either party.
 
8.3  
It is acknowledged by the Company that the Consultant will be free to undertake activities and offer the same or other services (including the services of the Consultant's Representative) at the same time.
 
8.4  
The indemnity contained in this clause 8 shall remain in full force and effect notwithstanding termination by either party in any manner whatsoever.
 
9  
INTELLECTUAL PROPERTY RIGHTS
 
9.1  
This clause 9 applies to any Intellectual Property produced invented or discovered by the Consultant, its servants or agents, including the Consultant's Representative, whether alone or with any other person at any time during the term of this Agreement which relates directly to the business of the Group.
 
9.2  
All Intellectual Property to which this clause 9 applies shall to the fullest extent permitted by law belong to, vest in and be the absolute and sole property of the Company.
 
9.3  
The Consultant hereby undertakes In relation to any Intellectual Property to which this clause 9 applies:
 
9.3.1  
to hold on trust for the benefit of the Company any such Intellectual Property to the extent that the same may not be, and until the same is, vested absolutely in the Company;
 
9.3.2  
at the expense of the Company, to execute all such documents, make such applications, give such assistance and do such acts and things as may be necessary or desirable to vest in and register or obtain letters patent in the name of the Company and otherwise to protect and maintain such Intellectual Property.
 
10  
SEVERABILITY
 
In the event that any of these terms, conditions or provisions, or any part thereof, should be determined to be invalid, unlawful or unenforceable, such term, condition or provision, or any part thereof, shall be severed from the remaining terms, conditions and provisions which will continue to be valid to the fullest extent permitted by law.
 

 
-3-

 


 
11  
BINDING ON SUCCESSORS AND ASSIGNMENTS
 
11.1  
This Agreement shall enure for the benefit of and be binding upon the respective parties hereto and their respective successors and assigns.
 
11.2  
Neither party may assign or transfer this Agreement or any of the rights arising hereunder without the prior written consent of the other party.
 
12  
VARIATION
 
No variation of this Agreement shall be valid unless it is in writing and signed by or on behalf of each of the parties hereto.
 
13  
WHOLE AGREEMENT
 
This Agreement contains the whole agreement between the parties hereto relating to the transactions provided for in this Agreement and supersedes all previous agreements (if any) between such parties in respect of such matters and each of the parties to this Agreement acknowledges that in agreeing to enter into this Agreement, it has not relied on any representations or warranties except for those contained in this Agreement.
 
14  
WAIVER, RELEASE AND REMEDIES
 
14.1  
A waiver by either party of any breach of any of the terms, provisions or conditions of this Agreement shall not constitute a general waiver of such term, provision or condition or to any subsequent act contrary thereto.
 
14.2  
Any remedy or right conferred upon either party for breach of this Agreement shall be in addition to and without prejudice to all other rights and remedies available to it whether pursuant to this Agreement or otherwise provided for by law.
 
15  
NOTICES
 
Any notice or other communication whether required or permitted to be given hereunder shall be given in writing and shall be deemed to have been duly given if delivered by hand against receipt of the addressee or if transmitted by fax or sent by prepaid registered post addressed to the party to whom such notice is to be given.
 
Any such notice shall be deemed to have been duly given if delivered at the time of delivery, if transmitted by fax at the time of termination of the transmission, and if sent by prepaid registered post as aforesaid forty eight hours after the same shall have been posted.
 
16  
GOVERNING LAW AND JURISDICTION
 
This Agreement shall be governed by and construed in accordance with the laws of UK and the courts of UK shall have non-exclusive jurisdiction to deal with all disputes arising from this Agreement.
 
IN WITNESS whereof this Agreement has been duly executed on the date shown at the beginning of this Agreement.
 

 
-4-

 

SIGNED by and on behalf
 
of the Company by:
 
SIGNED:
 
/s/ Alan Cooke
Alan Cooke
Director, Amarin Corporation, plc
 
SIGNED by and on behalf
 
of the Consultant by:
 
SIGNED:
 
/s/ Thomas G. Lynch

 
Exhibit 4.69
 


 
PURCHASE AGREEMENT
 

Amarin Corporation plc
7 Curzon Street
London W1J 5HG, England

Ladies and Gentlemen:

The undersigned, ______________ (the “Investor”), hereby confirms its agreement with you as follows:
 

1.   This Purchase Agreement (the “Agreement”) is made as of June 1, 2007 between Amarin Corporation plc, a public limited company registered in England and Wales (the “Company”), and the Investor.
 

2.   Pursuant to the terms of the offer contained in the prospectus included in the Registration Statement on Form F-3, File No. 333-135718 (the “Registration Statement”), which registration statement was filed with the Securities and Exchange Commission (the “Commission”) on July 12, 2006 and was declared effective by the Commission on August 2, 2006, and is effective on the date hereof and the prospectus supplement appended to such prospectus (such documents, together with the documents incorporated by reference in such prospectus and prospectus supplement, being referred to collectively herein as the “Prospectus”), the Investor hereby tenders to the Company this subscription for, and agrees to purchase __________ ordinary shares, ₤0.05 par value per share, of the Company (each, an “Ordinary Share”), each Ordinary Share represented by one American Depositary Share (an “ADS”), evidence by one American Depositary Receipt (an “ADR”) (collectively, the “Shares”) and a warrant (substantially in the form attached as Exhibit A hereto, the “Warrant” and, together with the Shares, the “Securities”) to purchase _____ Ordinary Shares (the “Warrant Shares”) at an exercise price per Warrant Share equal to $0.72.  The purchase price for the Securities shall be $________ (the “Purchase Price”).
 
The Company has not received notice that the Commission has issued or intends to issue a stop order suspending the effectiveness of the Registration Statement or that the Commission otherwise has suspended or withdrawn the effectiveness of the Registration Statement, either temporarily or permanently.  On the date hereof, the Registration Statement (including the information and documents incorporated therein by reference), as amended by any amendment or post-effective amendment thereto on or prior to the date hereof, did not include any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading.  The Company hereby agrees to file with the Commission, as required, no later than two business days after the date hereof, a prospectus supplement in accordance with Rule 424(b)(2) of the Securities Act of 1933, as amended.  The Registration Statement registers the issuance of the Shares and the Warrant Shares to the Investor and, when issued to the Investor, the Shares and the Warrant Shares will be freely transferable by
 

 
-1-

 

the Investor.  The Shares and the Warrant Shares have been approved for listing on the Nasdaq Stock Market.
 

3.   The Investor directs the Company to issue the Ordinary Shares issued and sold hereunder, at the Closing (as defined below), in the name of National City Nominees Limited of Citigroup Centre, Canada Square, Canary Wharf, London, E14 5LB, being the nominee of Citibank, N.A., the Company’s depositary for its ADR program (the “ADR Depositary”), against the issuance by the ADR Depositary of ADRs in the name of, or as otherwise instructed below by, the Investor.
 

4.   The completion of the purchase and sale of the Securities (the “Closing”) shall occur at the office of Cahill Gordon & Reindel llp, 80 Pine Street, New York, NY 10005, at 10:00 a.m., Eastern Daylight time, on June 1, 2007 (the “Closing Date”).  At the Closing, subject to receipt of the Purchase Price, the Company shall (a) cause the CREST account of the nominee of the ADR Depositary to be credited with the Ordinary Shares issued and sold hereunder, (b) instruct the ADR Depositary to issue ADRs in the amount to be registered to a nominated Depository Trust Company (“DTC”) account designated by the Investor in writing, in each case, as indicated below and (c) issue to the Investor the Warrant.  At the Closing, the Investor shall, against delivery of the Securities, deliver to the Company the Purchase Price by wire transfer in immediately available funds to the Company’s account as follows:
 
Bank:
Wachovia Bank, NY, USA
ABA No:
026–005–092
For the account of:
Lloyds TSB plc
Swift Code:
PNBPUS3NNYC
   
For further credit to:
 
Lloyds TSB,
 
Minster Place
 
Ely, Cambridge
 
CB7 4EN
 
U.K.
 
   
Account Name:
Amarin Corporation plc
Account No:
11427458
Sort Code:
30 – 93 – 05
Swift Code:
LOYDGB21265
IBAN No:
GB82 LOYD 3093 0511 4274 58

5.   The Investor has received and carefully reviewed the Prospectus.  The Investor is also aware of and acknowledges that:
 

 
-2-

 


 
(a)   no Federal or state agency has made any finding or determination regarding the fairness of this subscription for investment, or any recommendation or endorsement of the Securities;
 
(b)   none of the officers, directors, agents, affiliates or employees of the Company, nor any other person, has, expressly or by implication, made any representation or warranty concerning the Company other than as set forth in the Prospectus; and
 
(c)   that the past performance or experience of the Company, the Company’s officers, directors, agents, or employees, will not in any way indicate or predict the results of the ownership of Securities or of the Company’s activities or performance.
 
6.   This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of New York, without giving effect to the principles of conflicts of law.
 
7.   The Company has no liability or obligation to pay any fees or commissions to any broker, finder or agent with respect to the issuance and sale of the Warrant or the Shares for which the Investor could become liable or obligated.
 
8.   This Agreement may be executed in two or more counterparts, including by facsimile transmission, each of which shall constitute an original, but all of which, when taken together, shall constitute but one instrument, and shall become effective when one or more counterparts have been signed by each party hereto and delivered to the other parties.
 

 
-3-

 

Please confirm that the foregoing correctly sets forth the agreement between us by signing in the space provided below for that purpose.
 


Investor Name:

___________________________________

Address:

___________________________________

___________________________________

___________________________________

Telephone:

___________________________________

Facsimile:

___________________________________

Email:

___________________________________

Social Security Number or
Tax Identification
Number:

___________________________________













 
-4-

 



  DTC Account Details:
Name of DTC Participant:

__________________________________
(your broker or custodian bank)


Address of DTC Participant:

___________________________________
(address of your broker
or custodian bank)

___________________________________

___________________________________


DTC Participant Account Number:

___________________________________


Client Account (“Account Holder”)
number at DTC Participant:

___________________________________


Address of Account Holder:

___________________________________

___________________________________

___________________________________

 
-5-

 

____________________________________
INVESTOR NAME

By:  _________________________________
     Name:
     Title:


AGREED AND ACCEPTED:
 
Amarin Corporation plc,
a public limited company registered in England and Wales

By:  ________________________________________
     Name:  Thomas G. Lynch
     Title:  Chairman
 



 
-6-

 

EXHIBIT A
 

 
WARRANT
 
AMARIN CORPORATION PLC
 
WARRANT TO PURCHASE ORDINARY SHARES
 
No. W-[    ]   
June 1, 2007 
 
                                    
Void After May 31, 2012
 
THIS CERTIFIES THAT, for value received, ______________, with its principal office at ______________, or assigns (the “ Holder ”), is entitled to subscribe for and purchase at the Exercise Price (defined below) from Amarin Corporation plc, a public limited company organized under the laws of England and Wales, with its principal office at 7 Curzon Street, London, W1J 5HG, United Kingdom (the “ Company ”), up to ______________ ordinary shares, par value £0.05 per share, of the Company (the “ Ordinary Shares ”), each Ordinary Share represented by one American Depositary Share (an “ ADS ”), evidenced by one American Depositary Receipt (an “ ADR ”), of the Company, subject to adjustment as provided herein.  This warrant (the “ Warrant ”) is being issued pursuant to the terms of the Purchase Agreement, dated as of June 1, 2007, by and between the Holder and the Company (the “ Purchase Agreement ”).  Capitalized terms not otherwise defined herein shall have the respective meanings ascribed to such terms in the Purchase Agreement.
 
1.            DEFINITIONS .  As used herein, the following terms shall have the following respective meanings:
 
(a)           “ Exercise Period ” shall mean the period commencing on the date hereof and ending on May 31, 2012, unless sooner terminated as provided below.
 
(b)           “ Exercise Price ” shall mean U.S.$0.72 per Ordinary Share, subject to adjustment as provided in Section 4 below.
 
(c)           “ Exercise Shares ” shall mean the Ordinary Shares, each Ordinary Share represented by one ADS, evidenced by one ADR, of the Company, issued upon exercise of this Warrant, subject to adjustment and limitation pursuant to the terms herein, including but not limited to Sections 4 and 5 below.
 
(d)           “ VWAP ” shall mean, for any date, the price determined by the first of the following clauses that applies:  (i) if the Ordinary Shares in the form of ADSs are then listed on The Nasdaq Stock Market or another national securities exchange (a “ Trading Market ”), the daily volume weighted average price of the ADSs for such date (or the
 

 
-7-

 

nearest preceding trading date) on the Trading Market on which the ADSs are then listed, as reported by Bloomberg Financial LP; (b) if the ADSs are not then listed on a Trading Market and if prices for the ADSs are then quoted on the OTC Bulletin Board, the volume weighted average price of the ADSs for such date (or the nearest preceding trading date) on the OTC Bulletin Board; and (c) if the ADSs are not then listed on the OTC Bulletin Board and if prices for the ADSs are then reported on the “Pink Sheets” published by the Pink Sheets LLC (or similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the ADSs so reported; or (d) in all other cases, the fair market value of an ADS as determined by an independent appraiser selected in good faith by the Company.
 
2.            EXERCISE OF WARRANT .
 
2.1            Method of Exercise .  The rights represented by this Warrant may be exercised in whole or, subject to Section 2.2 hereof, in part at any time during the Exercise Period, by delivery at least ten (10) days prior to the date of exercise of the following to the Company at its address set forth above (or at such other address as it may designate by notice in writing to the Holder):
 
(a)           An executed Notice of Exercise in the form attached hereto;
 
(b)           Payment of the Exercise Price by wire transfer of immediately available funds; and
 
(c)           This Warrant (together with each duly completed Assignment Form in respect of each assignment of this Warrant, if any, subsequent to the date hereof).
 
Upon the exercise of the rights represented by this Warrant, ADRs shall be issued for the Exercise Shares so purchased, and shall be registered in the name of the Holder or persons affiliated with the Holder, if the Holder so designates, reasonably promptly after the rights represented by this Warrant shall have been so exercised and shall be issued and delivered to the Holder through the book-entry facilities of The Depository Trust Company, unless the Holder specifies otherwise.  The issuance of Exercise Shares upon exercise of this Warrant shall be made without charge to the Holder for any stamp duty or stamp duty reserve tax with respect thereto or any other cost incurred by the Company in connection with the exercise of this Warrant and the related issuance of Exercise Shares.
 
2.2            Partial Exercise .  This Warrant may be exercised in part; provided that no exercise of this Warrant may be in respect of less than 10,000 Exercise Shares; provided , however , that if this Warrant is, upon issuance, exercisable for less than 10,000 Exercise Shares, this Warrant may be exercised in whole but not in part.  If this Warrant is exercised in part only, the Company shall, upon surrender of this Warrant, execute and deliver, within 10 days after the date of exercise, a new Warrant evidencing the rights of the Holder, or such other person as shall be designated in the Notice of Exercise, to purchase the balance of the Exercise Shares purchasable hereunder.  In no event shall this Warrant be exercised in part if, after giving effect to such exercise, the remaining number of Exercise Shares in respect of such new Warrant would be less than 10,000.  In no event shall this Warrant be exercised for a fractional Exercise Share, and the
 

 
-8-

 

Company shall not distribute a Warrant exercisable for a fractional Exercise Share.  Fractional Exercise Shares shall be treated as provided in Section 5 hereof.
 
2.3            Call Right .
 
(a)           Subject to the provisions of this Section 2.3, if at any time the VWAP of the ADSs on the Company’s Trading Market is equal to or above U.S.$1.80, as adjusted for any stock splits, stock combinations, stock dividends and other similar events (the “ Threshold Price ”), for each of any twenty consecutive Trading Day period, then the Company at any time thereafter shall have the right, but not the obligation (the “ Call Right ”), on 20 days’ prior written notice to the Holder, to cancel all, but not less than all, of the unexercised portion of this Warrant for which a Notice of Exercise has not yet been delivered prior to the Cancellation Date (as defined below).
 
(b)           To exercise the Call Right, the Company shall deliver to the Holder an irrevocable written notice thereof (a “ Call Notice ”).  The date that the Company delivers the Call Notice to the Holder shall be referred to as the “ Call Date ”.  Within 20 days after receipt of the Call Notice, the Holder may exercise this Warrant in whole or in part, subject to the terms hereof, as set forth in herein.  Any portion of this Warrant that is not exercised by 5:30 p.m. (New York City time) on the 20th day following the date of receipt of the Call Notice (the “ Ca n cell a tion Date ”) shall be cancelled.
 
(c)           Notwithstanding anything to the contrary set forth in this Warrant, unless waived in writing by the Holder, the Company may not deliver a Call Notice or require the cancellation of any unexercised portion of this Warrant (and any Call Notice will be void) unless from the Call Date through the Cancellation Date (the “ Call Period ”) the Registration Statement shall be effective as to the issuance of all of the Exercise Shares to be issued to the Holder upon exercise of the Warrant.
 
3.            COVENANTS OF THE COMPANY .
 
3.1            Covenants as to Exercise Shares .  The Company covenants and agrees that all Exercise Shares that may be issued upon the exercise of the rights represented by this Warrant will, upon issuance, be duly authorized, validly issued, fully paid, non-assessable and free from all preemptive or similar rights, taxes, liens and charges with respect to the issuance thereof.  The Company further covenants and agrees that the Company will at all times during the Exercise Period, have sufficient authorized share capital to provide for the exercise of the rights represented by this Warrant.  If at any time during the Exercise Period the authorized share capital shall not be sufficient to permit exercise of this Warrant, the Company will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued share capital (or other securities as provided herein) to such amount as shall be sufficient for such purposes.
 
3.2            No Impairment .  Except and to the extent as waived or consented to by the Holder in writing or otherwise in accordance with Section 11 hereof, the Company will not, by amendment of its Memorandum and Articles of Association (as such may be amended from time to time), or through any means, avoid or seek to avoid the observance or performance of
 

 
-9-

 

any of the terms to be observed or performed hereunder by the Company, but will at all times in good faith assist in the carrying out of all the provisions of this Warrant and in the taking of all commercially reasonable actions as may be necessary in order to protect the exercise rights of the Holder against impairment.
 
3.3            Notices of Record Date .  In the event of any taking by the Company of a record of the holders of any class of securities for the purpose of determining the holders thereof who are entitled to receive any dividend or other distribution, the Company shall mail to the Holder, where practicable, at least ten (10) days prior to the date specified therein, a notice specifying the date on which any such record is to be taken for the purpose of such dividend or distribution; provided that the failure to mail such notice or any defect therein or in the mailing thereof shall not adversely affect the validity of the dividend or distribution required to be specified in such notice.
 
4.            ADJUSTMENT OF EXERCISE PRICE .  In the event of changes in the outstanding Ordinary Shares of the Company, on or after the date hereof, by reason of a stock dividend, subdivision, split-up, or combination of shares, the number of shares purchasable under the Warrant in the aggregate and the Exercise Price shall be correspondingly adjusted to give the Holder of the Warrant, on exercise for the same aggregate Exercise Price, the total number of shares as the Holder would have owned had the Warrant been exercised prior to the event requiring adjustment and had the Holder continued to hold such shares until after such event.  The form of this Warrant need not be changed because of any adjustment in the Exercise Price and/or number of shares subject to this Warrant.  The Company shall promptly provide a certificate from the Company notifying the Holder in writing of any adjustment in the Exercise Price and/or the total number of shares issuable upon exercise of this Warrant, which certificate shall describe the event giving rise to the adjustment and specify the Exercise Price and number of shares purchasable under this Warrant after giving effect to such adjustment.
 
If, for any reason, prior to the exercise of the Warrant in full, the Company spins off or otherwise divests itself of a part of its business or operations or disposes all or a part of its assets (the “Spin Off”), in each case in a transaction in which the Company does not receive compensation for such business, operations or assets, but causes securities of another entity (the “Spin Off Securities”) to be issued to security holders of the Company, then the Exercise Price of the Outstanding Warrant shall be adjusted immediately after consummation of the Spin Off by multiplying the Exercise Price in effect immediately prior to the Spin Off by a fraction (if, but only if, such fraction is less than 1.0), the numerator of which is the average closing bid price of the ADSs for the five trading days immediately following the fifth trading day after the record date (the “Record Date”) for determining the amount and number of Spin Off Securities to be issued to security holders of the Company, and the denominator of which is the average closing bid price of the ADSs for the five trading days immediately preceding the Record Date; and such adjusted Exercise Price shall be deemed to be the Exercise Price with respect to the Outstanding Warrant after the consummation of the Spin Off.
 
5.            FRACTIONAL SHARES .  No fractional shares shall be issued upon the exercise of this Warrant as a consequence of any adjustment pursuant hereto.  All Exercise Shares (including fractions) issuable upon exercise of this Warrant may be aggregated for purposes of determining whether the exercise would result in the issuance of any fractional share.
 

 
-10-

 

If, after aggregation, the exercise would result in the issuance of a fractional share, the Company shall, in lieu of issuance of any fractional share, pay the Holder otherwise entitled to such fraction a sum in cash equal to the product resulting from multiplying the then current fair market value of an Exercise Share by such fraction.
 
6.            CERTAIN EVENTS .  In the event of, at any time during the Exercise Period, any capital reorganization, or any reclassification of the capital stock of the Company (other than a change in par value or from par value to no par value or no par value to par value or as a result of a stock dividend, subdivision, split-up or combination of shares), or the consolidation or merger of the Company with or into another corporation (other than a merger solely to effect a reincorporation of the Company into another state), in each case, in which the shareholders of the Company immediately prior to such capital reorganization, reclassification, consolidation or merger, will hold less than a majority of the outstanding shares of the Company or resulting corporation immediately after such capital reorganization, reclassification, consolidation or merger, or the sale or other disposition of all or substantially all of the properties and assets of the Company and its Subsidiaries, taken as a whole, in its entirety to any other person, other than sales or other dispositions that do not require shareholder approval (each, an “ Event ”), the Company shall provide to the Holder ten (10) days' advance written notice of the Event, and the Holder shall have the option, in its sole discretion, to allow any unexercised portion of the Warrant to be deemed automatically exercised.  This Warrant will be binding upon the successors and assigns of the Company upon an Event.
 
7.            NO SHAREHOLDER RIGHTS .  This Warrant in and of itself shall not entitle the Holder to any voting rights or other rights as a shareholder of the Company.
 
8.            TRANSFER OF WARRANT .  This Warrant and all rights hereunder are transferable by the Holder in person or by duly authorized attorney, upon delivery of this Warrant and the duly completed Assignment Form attached hereto to any authorized transferee designated by the Holder with a copy to the Company.
 
9.            LOST, STOLEN, MUTILATED OR DESTROYED WARRANT .  If this Warrant is lost, stolen, mutilated or destroyed, the Company may, on such terms as to indemnity or otherwise as it may reasonably impose (which shall, in the case of a mutilated Warrant, include the surrender thereof), issue a new Warrant of like denomination and tenor as the Warrant so lost, stolen, mutilated or destroyed.  Any such new Warrant shall constitute an original contractual obligation of the Company, whether or not the allegedly lost, stolen, mutilated or destroyed Warrant shall be at any time enforceable by anyone.
 
10.            MODIFICATION OR WAIVER .  Unless otherwise provided herein, this Warrant and any provision hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the Company and the Holder.
 
11.            NOTICES, ETC.   All notices required or permitted hereunder shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed facsimile if sent during normal business hours of the recipient, if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) business day after deposit
 

 
-11-

 

with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt.  All communications shall be sent to the Company at the address listed on the signature page and to the Holders at the addresses on the Company records, or at such other address as the Company or Holder may designate by ten days’ advance written notice to the other party hereto.
 
12.            ACCEPTANCE .  Receipt of this Warrant by the Holder shall constitute acceptance of and agreement to all of the terms and conditions contained herein and in the Purchase Agreement.
 
13.            GOVERNING LAW .  This Warrant and all rights, obligations and liabilities hereunder shall be governed by the laws of England and Wales without regard to the principles of conflict of laws.
 
14.            DESCRIPTIVE HEADINGS .  The descriptive headings of the several paragraphs of this Warrant are inserted for convenience only and do not constitute a part of this Warrant. The language in this Warrant shall be construed as to its fair meaning without regard to which party drafted this Warrant.
 
15.            SEVERABILITY .  The invalidity or unenforceability of any provision of this Warrant in any jurisdiction shall not affect the validity or enforceability of such provision in any other jurisdiction, or affect any other provision of this Warrant, which shall remain in full force and effect.
 
16.            ENTIRE AGREEMENT .  This Warrant constitutes the entire agreement between the parties pertaining to the subject matter contained in it and supersedes all prior and contemporaneous agreements, representations, and undertakings of the parties, whether oral or written, with respect to such subject matter.
 
[Signature Page Follows]

 
-12-

 

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its duly authorized officer as of June1, 2007.
 
AMARIN CORPORATION PLC
By:_____________________________
Name:  Thomas G. Lynch
Title:  Chairman
 
 
 
Address:  7 Curzon Street
                  London, Greater LondonW1J 5HG
                  United Kingdom
                  Attention:  Chief Financial Officer
                  Facsimile: 44 20 7499 9004

 
-13-

 

NOTICE OF EXERCISE
 
TO:           AMARIN CORPORATION PLC
 
(1)           The undersigned hereby elects to purchase ________ ordinary shares (“ Ordinary Shares ”) of Amarin Corporation plc (the “ Company ”) in the form of American Depositary Shares (“ ADSs ”) pursuant to the terms of the attached warrant (the “ Warrant ”), and tenders herewith payment of the exercise price in full for such ADSs, together with all applicable transfer taxes, if any.
 
(2)           Please issue ADRs evidencing ADSs representing said Ordinary Shares in the name of the undersigned or in such other name as is specified below:
 

                                ____________________________________________________
(Name)
 
                                ____________________________________________________
 
 
                                ____________________________________________________
(Address)
 
 
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:
 

 

 
-14-

 

____________________
(Date)
 

 
(Signature)
 

 
(Holder’s Name)
 

 

(Authorized Signature)
 

 

(Title)
____________________________________
(Tax ID Number)
____________________________________
(Telephone)
 
 
NOTE:  SIGNATURE MUST CONFORM IN ALL RESPECTS TO THE NAME OF HOLDER AS SPECIFIED ON THE FACE OF THE WARRANT.

 
 
-15-

 


 
ASSIGNMENT FORM
 
(To assign the foregoing Warrant, subject to compliance with the terms of the Warrant, execute this form and supply required information.  Do not use this form to exercise the Warrant.)
 
FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to
 
 
 
Name:_______________________________________
 
 
(Please Print)
 
 
Address:____________________________________
 
                ____________________________________
 
 
(Please Print)
 
and _______________________________________ is hereby appointed attorney to transfer said rights on the books of Amarin Corporation plc, with full power of substitution in the premises.
 
Dated:  __________, 20__
 

 
Holder’s Name:___________________________
 
 
Title:___________________________________
 
 
Holder’s Address:_________________________
 
 
Holder’s Telephone:_______________________
 
 
Facsimile:_______________________________
 
 
Assignee Tax ID No.:_______________________
 
 
Assignee Telephone: _______________________
 
 
Assignee Facsimile: ________________________
 
 
Signature Guaranteed:_______________________

 
NOTE:  The signature to this Assignment Form must correspond with the name as it appears on the face of the Warrant, without alteration or enlargement or any change whatever and must be guaranteed by a bank or trust company.  Officers of corporations and those acting in a fiduciary or other representative capacity should file proper evidence of authority to assign the foregoing Warrant.
 
 
Exhibit 4.78
 

 
Certain portions of this Exhibit have been omitted pursuant to a request for “Confidential Treatment” under Rule 24b-2 of the Securities and Exchange Commission. Such portions have been redacted and bracketed in the request and appear as [*] in the text of this Exhibit. The omitted confidential information has been filed with the Securities and Exchange Commission.
 
 
 
 
EXECUTION COPY






COLLABORATION AGREEMENT







Between ProSeed Capital and Amarin Pharmaceuticals Ireland Limited













 

 

 
 

 

GENERAL:
 
This Agreement is made and entered into as of the date of last signature of this Agreement.

Parties:
 
AMARIN PHARMACEUTICALS IRELAND LIMITED an Irish company whose address is First Floor, Block 3, The Oval, Ballsbridge, Dublin 4, Ireland, and legally affiliated entities (the “ Company ”)
 
and,
 
Proseed Capital Holdings CVA, a Belgian company whose registered office is at 162 Avenue de Broqueville, 1200 Brussels, Belgium, and its legally affiliated entities, hereinafter referred to as “ ProSeed
 
Purpose
 
The purpose of this Agreement is to set forth the terms and conditions of the Collaboration between the Company and ProSeed.
 
THE COLLABORATION:
 
On the terms and subject to the conditions of this Agreement, ProSeed will provide the Company with such business advice and assistance detailed below as may be appropriate and mutually agreed upon by the Company and ProSeed (the “ Collaboration ”).

Background & Objectives:

The Company is a CNS therapeutics biopharmaceutical organization with pre-clinical and clinical stage products.  The key objective of the Collaboration between the Company and ProSeed is a Corporate Transaction , as described further below, other than a pure financing (pure financing is covered by separate agreements between the Parties).

Throughout the Term (as defined below) ProSeed shall at all times liaise with the Company and obtain the Company’s written consent before making contact with any third party with regard to a potential Corporate Transaction (upon consent being given to such contact such a party shall be deemed a “Covered Party”) and ProSeed shall use its best efforts to identify and/or locate for the Company prospective Corporate Transaction

 
2

 

candidates. Notwithstanding the above, prior to the Commencement Date (as defined below in Section 2), the Company had given consent to ProSeed to contact a number of companies which are also deemed to be Covered Parties and which are listed in full in Schedule A. Additional names may be added to Schedule A provided pre-approved by the Company.

As part of the process ProSeed shall in such manner as is pre-agreed by the Company on a case by case basis for each Covered Party:

(i)  
provide the Company with corporate contacts to access key decision-makers  and influencers within Covered Parties;
(ii)  
help facilitate the business process;
(iii)  
help recruit internal champions within Covered Parties and  present, and follow-up with each key corporate contact;
 
           (iv)
participate in face to face meetings and in conference call sessions with Covered Parties;
             (v)
assist the Company where required throughout the negotiation in order to complete successful agreements;
            (vi)
involve the Company in all aspect of the process including in major presentations, conference calls and face to face meetings; and
           (vii)
provide such other services as may be reasonably requested by the Company and mutually agreed upon by ProSeed and the Company.

TERMS AND CONDITIONS
 
1.    PROFESSIONAL FEES:

ProSeed’s compensation shall be as follows:
 
 
1.1   Success Fee -

1.1.1(a)                      Subject to Section 1.1.1(b) and Section 1.1.2(b), in the event that the Company enters into a Corporate Transaction, as hereinafter defined, with a Covered Party, then the Company agrees to pay to ProSeed or its designees [*] of all Consideration in the Corporate Transaction (the “ Success Fee ”).

1.1.1(b)                      In the event that the Company enters into a Corporate Transaction with a Covered Party relating to the acquisition of the entire issued outstanding share capital of the Company or the acquisition of all or substantially all of the assets of the Company, then the Company agrees to pay to ProSeed or its designees a fee calculated by reference to the table set out below, being the sum of the amount payable within the bands set out

 
3

 

below of the Consideration in the Corporate Transaction at the corresponding percentage rate:

Amount of Consideration
Percentage Payable to ProSeed
First $[*]
[*]
Next $[*]
[*]
Increments above $[*]
[*]

PROVIDED THAT the total aggregate amount payable by the Company to ProSeed under this Section 1.1.1(b) shall be $[*] (the “Acquisition of Amarin Success Fee Cap”) .

1.1.1(c)                      Subject to Section 1.1.2(b), the form of fee paid to ProSeed in any Corporate Transaction (i.e. cash and/or cash worth) shall be dictated by the actual form of Consideration in the relevant transaction.

1.1.1(d)                      For the avoidance of doubt, no sum shall be payable to ProSeed whether hereunder or otherwise in respect of any transaction which is not a Corporate Transaction or in respect of any transaction with a party which is not a Covered Party. The parties shall keep a list of Covered Parties which shall be amended upon each occasion the Company agrees to further additions to such list.

1.1.2   (a)           The Success Fee shall be calculated on all cash and non-cash consideration in the Corporate Transaction paid to the Company (e.g., in the case of out-licensing, acquisition of the Company or its assets, etc.) or by the Company (e.g., in the case of in-licensing, acquisitions by the Company, etc.), as the case may be in the relevant Corporate Transaction, during the Eligibility Period  (individually and collectively referred to as the “ Consideration ”) and shall apply during such Eligibility Period to all Corporate Transactions between the Company and a Covered Party (or any company within the same group of companies as such Covered Party) where the Corporate Transaction occurs during the Term or within [*] (the “ Tail ”) from the termination or expiration of this Agreement. The “Eligibility Period” shall mean the period starting on the closing date of a Corporate Transaction and ending [*] from such closing.

(b)           In the case of a Corporate Transaction which involves the Company paying out Consideration (in-licensing or acquisition by the Company), then (i) the Success Fee payable by the Company to ProSeed on that portion of Consideration which is immediately payable upon closing of the Corporate Transaction (the “Upfront Success Fee” ) will be capped at $[*] (the “ Upfront Success Fee Cap ”) PROVIDED THAT the first $[*] of the Upfront Success Fee shall be payable in cash and the remainder of the Upfront Success Fee shall, at the Company’s sole discretion and subject to the Upfront Success Fee Cap, be payable in cash and/or non-cash consideration; and (ii) the remaining Success Fee payable after closing of that Corporate Transaction shall not be

 
4

 

subject to the Upfront Success Fee Cap.  For the avoidance of any doubt, the Upfront Success Fee Cap shall apply only to in-licensing or acquisitions by the Company and does not apply in any way whatsoever to any other Corporate Transaction.

1.1.3                      As used herein, a “Corporate Transaction” shall mean any form of agreement with a Covered Party including without limitation any form of in-licensing or out-licensing, collaborative joint venture, distribution, asset purchase, asset sale, asset exchange, M&A, research and development agreement, etc..

1.1.4                      The Success Fee shall be paid and issued respectively, within 30 days of the actual receipt of, or payment by, the Company of the relevant Consideration.


2.           TERM AND TERMINATION:

The parties agree that the Agreement will be deemed to have commenced on 2 October 2007 (the “Commencement Date” ) and shall continue until terminated in accordance with the provisions of this Agreement (the “Term” ).

The Company and ProSeed will have the right to terminate the Agreement with 30 days written notice at any time on or after 12 months from the Commencement Date; except that ProSeed shall be entitled to the fees payable pursuant to Section 1 hereof and except that approved expenses incurred by ProSeed as a result of services rendered prior to the date of the termination shall become immediately payable in full.

3.           EXPENSES:

Subject to pre-approval by the Company, the Company will reimburse ProSeed monthly for expenses to include travel expenses including the participation in all face to face meetings with target entities, regulatory experts and external consultants, video and phone conference calls, access to paid databases or any other pre-approved expenses.

4.           RELATIONSHIP:

Nothing in this Agreement shall make or be deemed to make ProSeed an agent, employee or partner of the Company and Proseed shall not without the Company’s prior written consent incur any liability or obligation in the name of and/or on behalf of the Company or otherwise commit or bind the Company in any way. ProSeed understands that it does not have the right to commit or bind the Company to any third party agreement.  The Company shall have sole and absolute right to accept or reject any proposed transaction resulting from ProSeed’s efforts and the Success Fee shall be payable by Company to ProSeed in the manner set out above only if and when a Corporate Transaction is finally executed, exchanged and closed by the Company and the counterparty or counterparties and all pre-conditions to closing are satisfied in full.

 
5

 



For the avoidance of doubt, it is hereby clarified, that by entering into this Agreement the Company does not grant ProSeed the exclusive right to provide the Company with the services and support described herein, and the Company shall be entitled and shall have the full right according to its sole discretion to establish any connection with any person or corporation, either by itself or by others on its behalf.

5.           USE OF INFORMATION:

The Company acknowledges that all opinions and advice (oral or written) given by ProSeed to the Company and/or its officers, directors, employees or others in connection with ProSeed's engagement hereunder, are intended solely for the benefit of the Company and may be used by the Company in considering the matters to which they relate. The Company agrees that no such opinion or advice may be used by any other person, firm or entity or otherwise reproduced, disseminated, quoted or referred to at any time, in any manner or be made available by the Company (or such persons), without ProSeed's express written consent.

6.             LIABILITY OF PROSEED:

In furnishing the Company with management advice and other services, ProSeed or any of their officers, directors, consultants, advisors, partners, agents or affiliates shall not be liable to the Company or its creditors for errors of judgment or for any other act except breach of the terms of this Agreement, willful misconduct or bad faith in the performance of ProSeed’s duties. ProSeed understands that it is not being asked to render a fairness opinion with respect to any proposed transaction.

It is further understood and agreed that ProSeed is relying upon information furnished to it, which it reasonably believes to be accurate and reliable, and that, except as herein provided, Proseed shall not be accountable for any loss suffered by the Company by reason of the Company action or inaction on the basis of any recommendation, advice or approval of Proseed, its partners, employees, or agents.

7.             OWNERSHIP AND RIGHTS:

All the Company information and all title, patents, patent rights, and other intellectual property owned by the Company (collectively “Rights”) in connection therewith shall remain the sole property of the Company.

8.           CONFIDENTIALITY:

For the purposes of this Agreement, the term “ Confidential Information ” shall mean this Agreement, and any information, either in oral or written form, owned by either the

 
6

 

Company or ProSeed and communicated to the other and so identified as Confidential Information including all Proseed reports and progress reports, planning documents, ideas, techniques, proprietary know-how, formulations, market data, financial plans, members of ProSeed’s network and customer lists, activities, products and services of the Company and/or of companies and/or entities in which the Company has an interest including by way of holdings and/or investing therein, or products and services, business and marketing plans, customers, prospective developments and plans, etc. Further, the Company agrees that all information regarding ProSeed, its directors, advisors, consultants and network members, this Agreement’s terms and any proposals and written reports provided by ProSeed shall be considered Confidential Information.

During the Term and for a period of five (5) years following the expiration and/or termination hereof, each party (except as is explicitly otherwise provided hereby) shall keep confidential, shall not use for itself or for the benefit of others and shall not copy or allow to be copied in whole or in part any Confidential Information disclosed to such party by the other.

The obligations of confidentiality imposed upon the parties hereto shall not apply with respect to Confidential information which:

A.
Is known to the recipient thereof prior to receipt thereof from the other party hereto, in a manner which did not result in the breach of any confidentiality obligation between disclosing party and any other party;
B.
Is disclosed to said recipient after the date hereof by a third party who has the right to make such disclosure;
C.
Is or becomes a part of the public domain through no fault of the said recipient; or
D.
Is required to be disclosed by applicable law, regulation or court proceeding in which case the recipient shall give the disclosing party as much advance notice of the proposed disclosure as is practical (including a copy of any written request or order), and shall cooperate with the disclosing party in any effort to limit or restrict such disclosure, via a protective order or otherwise.

9.             LIMITATION ON BUSINESS ACTIVITY:

During the Term of this Agreement and until 12 months from its expiration or termination neither party shall solicit or request any of the other’s employees, directors, advisors, consultants as a paid or unpaid consultant, advisor, employee or board member, without prior written approval (such approval not to be unreasonably withheld, conditioned  or delayed).

10.           TRACKING OF PAYMENTS:

The Company shall notify ProSeed promptly on any Corporate Transaction or other events that makes ProSeed eligible to Success Fees (the “ Event ”) according to the agreed

 
7

 

terms herein. Proseed shall receive a copy of any agreement between the Company and the relevant counterparty or counterparties.  The Company shall keep adequate records to accurately determine the payments due under this Agreement and shall upon written request from ProSeed provide ProSeed such records on an annual basis until such date when the Company meets all its payment obligations under this Agreement.

11.           RIGHT TO REVIEW RECORDS

ProSeed shall have the right to use one of the top five accounting firms (or other accounting firm, if acceptable both to the Company and Proseed) to audit the relevant records of the Company and verify the reports and payments required to be made hereunder any one time in any year. A reasonable notice of at least twenty one (21) business days shall be provided to the Company prior to such audit.

12.           SURVIVAL OF COMMITMENTS

All clauses, commitments and obligations of the Company and ProSeed described in this Agreement shall survive the termination or expiration of the Agreement for any reason, and shall bind any successor and assigns of any substantial portion of the Company and shall survive the Company’s acquisition by, or merger with a third party entity.

13.           ANNOUNCEMENT:

Following the closing and public announcement of any Corporate Transaction, ProSeed may, at its own expense, place customary tombstone announcements or advertisements in financial newspapers and journals describing its services hereunder provided that any such announcement or advertisement is pre-approved by the Company.

14.           GOVERNING LAW:

Interpretation of this Agreement, as well as resolution of all disputes arising out of or related to this Agreement or the validity, performance, enforcement, breach or termination of this Agreement and any remedies relating thereto, shall be governed by and construed under the laws of England.

15.            DISPUTE RESOLUTION:

Any dispute, controversy or claim initiated by either party arising out of, resulting from or relating to this Agreement, or the performance by either party of its obligations under this Agreement whether before or after termination of this Agreement, shall be submitted to a single arbitrator to be agreed by the parties.  In the event that the parties are unable to select an arbitrator acceptable to both parties within 20 days of the date one party has notified the other party of its request for arbitration, the dispute shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more

 
8

 

arbitrators appointed in accordance with the said Rules. The cost of arbitration shall be borne by the party whose contention was not upheld by the arbitration proceedings, unless otherwise provided in the arbitration award.

16.             MISCELLANEOUS:

This Agreement sets forth the entire agreement and understanding between the parties and supersedes all prior agreements and understandings relating to the subject matter hereof.  If any provision of this Agreement is determined to be invalid or unenforceable in any respect, such determination will not affect such provision in any other respect or any other provision of this Agreement, which will remain in full force and effect.  This Agreement may not be amended or otherwise modified or waived except by an instrument in writing signed by both Proseed and the Company.  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same agreement.

IN WITNESS WHEREOF, the parties have caused this Agreement to be signed by their respective officers and/or representatives duly authorized under seal, the day and year first above written.

The Company
 
PROSEED
     
By:   /s/ Tom Maher            
 
By:   /s/ Benjamin Van Oudenhove
     
     
Name: Tom Maher
 
Name: Benjamin Van Oudenhove
     
     
Title: Company Secretary
 
Title: Chairman
     
Date:  January 8, 2008
 
Date: ______________________


 
9

 

Schedule A Covered Parties as at Commencement Date

Samaritan
NeuroDerm Ltd
Esther Neurosciences Ltd
D-Pharm Ltd
Xytis
 
 
 
 
10
 
Exhibit 4.79
 

AMENDMENT NO. 1 TO STOCK PURCHASE AGREEMENT
 
THIS AMENDMENT NO. 1 TO STOCK PURCHASE AGREEMENT, dated as of April 7, 2008 (this “ Agreement ”), by and among Amarin Corporation plc, a public limited liability company incorporated under the laws of England and Wales (the “ Buyer ”) and Medica II Management L.P., a Cayman Islands limited partnership (the “ Sellers’ Representative ”), in its capacity as the Sellers’ Representative appointed pursuant to Section 13 of that certain Stock Purchase Agreement dated 5 December 2007 between Buyer, the Security Holders of Ester Neuroscience Ltd (the “ Company ”), the Company, and the Sellers’ Representative (the “ SPA ”; all capitalized terms used herein and not otherwise defined herein shall have the meanings ascribed to them in the SPA).
 
Whereas, the Buyer, the Security Holders of the Company, the Company and the Sellers’ Representative have entered into the SPA, and now the Buyer and the Sellers’ Representative, in accordance with Section 14.5 of the SPA, wish to amend the SPA, as set forth herein;
 
NOW, THEREFORE, in consideration of the premises and the mutual representations, warranties, covenants and agreements herein contained and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto, intending to be legally bound, agree that, notwithstanding anything to the contrary in the SPA:
 
1.           The definition of “Milestone II Time Limit Date” in Section 1.1 of the SPA shall be amended to read as follows:  “ Milestone II Time Limit Date ” means the date that is two years from the Milestone Ib Date.”
 
2.           Other than as specifically stated herein, the SPA shall remain in fall force and effect without any change.
 
IN WITNESS WHEREOF, the parties hereto have caused this Agreement, to be signed the day and year first above written.
 
MEDICA II MANAGEMENT L.P.
 
 
By:  /s/ Ehud Geller
        Name:
        Title:
 
 
AMARIN CORPORATION PLC
 
 
By:  /s/ Alan Cooke
        Name:
        Title:


 
Exhibit 4.80
 

1.  
Employer

Amarin Corporation plc (the “Company”)

2.  
Employee (the “Executive”)

Declan Doogan
15 Main Street
Stonington
Connecticut, 06378

3.  
Commencement Date and Role Title

You will be employed as President – Research & Development and Chief Medical Officer, the main duties of which are detailed in your job description.

You will also be appointed to the Board of Amarin Corporation plc and the Company may at any time require that you serve any other group company or companies and to carry out for such group company or companies such duties and responsibilities as may be assigned by the Board, but otherwise on the same terms and conditions as herein provided.

These duties may change to meet the business needs or you may be required to work in other equivalent roles, as the Company may reasonably require.

Your employment commenced on 9 April 2007.

4.  
Place of Work

You will initially be based in the USA for the first 12 months of your employment and will work from home or other such location, to be mutually agreed.  You may be required to work at your normal place of work or to change to other locations as reasonably required by the Company.

It may also be necessary from time to time for you to work overseas or to be located in another of the Company’s offices.

5.  
Reporting Line

You will report to the Chief Executive Officer, but your reporting line may change in the future due to any restructure.

6.  
Working hours

Your normal hours of work are 3 days per week, 21 hours per week, with a lunch break of one hour.

Please note that you are expected to work additional hours to meet the needs of the business.



 
1

 


7.  
Duties

During your employment you shall:

Perform such duties as the Company may reasonably require and well and faithfully serve the Company to the best of your ability devoting your whole time and attention during working hours and use your best endeavours to promote the interests of the Company at all times.

Comply with all reasonable and lawful management instructions given to you by the Company and all applicable rules, regulations, policies and working practices as laid down by the Company for employees.

Fulfil your job description duties.

8.  
Remuneration

Your salary will be $350,000 per annum pro rated by 3/5 th to reflect your part time hours of working and is payable monthly in arrears by BACS (or other such means in the U.S. to be mutually agreed) on or around the last Friday of each calendar month.  Your salary is inclusive of any fees payable to you as director of the Company and/or any group company.

At the Company’s discretion your salary will be reviewed annually on the 1 st January and any increases will be notified to you in writing.

Bonus eligibility – There shall be no contractual right to a bonus, and the quantum of any bonus awarded shall remain in the absolute discretion of the Company at all times and accordingly the Company or any Group Company reserves the right to make no payment of a bonus.

9.  
Car Allowance

You will receive a car allowance of $1400 per month paid along with your monthly salary.

10.  
Deductions from pay

By signing these terms and conditions of employment you consent to any deduction from any sum otherwise payable to you, the value of any claim the Company may have against you including but not limited to:-

·  
Overpayment of salary or bonus.
·  
Sums representing holiday taken in excess of entitlement.
·  
Overpayment of expenses.
·  
Motoring fines incurred by you for a Company vehicle.
·  
Loans made to you by the Company.
·  
Personal expenditure incurred on Company credit cards.
·  
Where the Company has sustained loss in relation to monies of the Company caused through your negligence, recklessness, dishonesty or through breach of the Company rules the Company requires the employee to repay any proven loss.
·  
Where you leave the Company the balance of any training assistance given under a study loan agreement.

 
2

 



11.  
Expenses

The company will reimburse to you all business expenses reasonably incurred by you in the proper performance of your duties, provided that you provide vat receipts and claim the expenses on the correct form.


12.  
Pension

The Company will contribute 6% of your annual salary into an equivalent Scheme in the U.S. or you will receive an equivalent amount as a salary allowance.

13.  
Insurance Benefits

You will receive a salary allowance to compensate you for insurance benefits as the Company is unable currently to provide you with the following benefits in the U.S.:

·  
Permanent Health Insurance (PHI)
·  
Life Assurance (4 x salary)
·  
Private Medical Insurance (PMI)

14.  
Stock Options

You will be granted 650,000 stock options in accordance with the Amarin Corporation plc 2002 Stock Option Plan.  The option price will be the price quoted for Amarin shares at the date your participation is approved by the Chief Executive Officer.

15.  
Holidays

You will receive 14.5 days paid holiday during each complete year of service plus public holidays on days that you would normally work.  Your entitlement in the first year of service will be confirmed to you following confirmation of your start date.  You will receive an additional day’s holiday for every completed year of service up to a maximum of 5 additional days (pro rated for the part time working hours).

The holiday year runs from 1 st January to 31 st December.  Holiday must be taken and unused holiday entitlement cannot be carried forward to the following year.  Holiday must be taken at a time convenient to the Company.  No more than 10 working days may be taken at any one time.

16.  
Sickness

If you are ill and unfit for work, you must personally contact your manager as early as possible on the first day and comply with the absence policy as detailed in the handbook.

If you are ill for less than 7 consecutive days (including weekends) you must complete a self certification form.  For longer periods of illness a Doctor’s certificate must be supplied and additional ones sent to cover the whole period of sickness.

 
3

 



Statutory Sick Pay is paid to employees in accordance with the Statutory Sick Pay Regulations and Company Sick pay will include any Statutory Sick Pay due.

After the Probationary period and subject to the correct notification , Company Sick Pay may be paid at the Company’s absolute discretion as follows in a rolling 12 month period:

Length of continuous employment on commencement of absence
Period for which full pay is normally payable in a twelve month period
Up to 1 year
4 weeks
Over 1 year and up to 3 years
8 weeks
Over 3 years and up to 5 years
13 weeks
Over 5 years
26 weeks

The Company may at any time require you to have a medical examination at the Company’s expense.

Should you have, or develop a condition that could be described as a disability you have a duty to inform us so that any reasonable adjustment may be made to your work or working environment.  This disclosure would be treated in strictest confidence and you would not be discriminated in any way.

17.  
Confidential Information and Company Documents

The Executive shall neither during the Employment (except in the proper performance of his duties) nor at any time after the termination of the employment, divulge or communicate to any person, company, business entity or other organisation;

use for his own purposes or for any other purposes that those of the Company or Group Company; or

through any failure to exercise due care and diligence, permit or cause any unauthorised disclosure of any Confidential Information.  These restrictions shall cease to apply to any information which shall become available to the public generally otherwise than through any default of the Executive.

All books, notes, memoranda, records, lists of customers and suppliers and employees, correspondence, documents, computer and other discs, tapes and other data storage, date listings, codes, designs, and drawings and other documents and material whatsoever (whether made or created by the executive or otherwise) relating to the business of the company or any Group Company (and copies of the same); shall be and remain the property of the Company or to the relevant Group Company; and shall be handed over by the executive to the Company or to the relevant Group Company on demand and in any event on the termination of Employment.

18.  
Intellectual Property Rights

It shall be part of the contractual duties of the Executive (whether alone or with any other employee of the Company or any Group Company) at

 
4

 

all times to further the interests of the Company and its Group Companies and, without prejudice to the generality of the foregoing and to the extent as is consistent with the Executive’s role within the Company;

a)  
to make, discover and conceive inventions, processes, techniques, designs, improvements or developments relating to or capable of use or adaptation for use in connection with the business or any Group Company (“an Invention”)

b)  
to consider in what manner and by what new methods or devices the products, services, processes, equipment or systems of the Company or any Group Company with which the Executive is concerned or for which the Executive is responsible, might be improved (“a Development”);

c)  
promptly to give to the Company or any Group Company full details of any such Invention or Development which the Executive may from time to time make or discover in the course of their Employment; and

d)  
to further the interests of the Company’s or any Group Company’s undertaking with regard thereto

and the Company or any Group Company shall be entitled to the exclusive ownership of any such Invention or Development and to the exclusive use thereof, provided that this clause shall take effect subject to any statutory rights of the Executive.

The Executive shall immediately give full information to the Board as to such Invention or Development and the exact mode of working, producing, using and exploiting the same and shall also give all such explanations and instructions to the Board as may be necessary or useful to enable the Company or any Group Company to obtain full benefit of them and will at the expense of the Company or any Group Company furnish it with all necessary plans, drawings, formulae and models applicable to the same and shall at the cost and expense of the Company or any Group Company execute all documents and do all acts and things necessary to enable the Company or any Group Company (or its or their nominees) to apply for and obtain protection for such Inventions and Developments throughout the world and for vesting the ownership of them in the Company or any Group Company (or its or their nominees).

The Executive shall not knowingly do anything to imperil the validity of any patent or protection related to the business of any Company or any Group Company or any application therefore but shall at the cost to the Company or any Group Company render all possible assistance to the Company or any Group Company, both in obtaining and in maintaining such patents or other protection.

The Executive shall not either during Employment or any time after the Employment exploit or assist others to exploit any Invention or Development which the Executive may from time to time make to discover in the course of the Employment or (unless the same shall have become public knowledge otherwise than by breach by the Executive of

 
5

 

the terms of the Appointment) make public or disclose any such Invention or Development or improvement or given any information in respect of the same except to the Company or any Group Company or as it may direct.

The Executive hereby irrevocably appoints the Company or any Group Company to be the Executive’s attorney in the Executive’s name and on the Executive’s behalf to execute all documents and do all things necessary and generally to use the Executive’s name for the purpose of giving the Company or any Group Company (or its or their nominees) the full benefit of the provisions of this clause and in favour of any third party a certificate in writing signed by any director or the secretary of the Company or any Group Company that any instrument or act which falls within the authority conferred by this clause which shall be conclusive evidence that such is the case.

Copyright and unregistered design rights in all works created by the Executive in the course of the Employment will, in accordance with the Copyright Designs and Patent Act 1988, vest in the Company or any Group Company.  Rights in any design registerable pursuant to the Registered Designs Act 1949, (as amended) created by the Executive in the course of his Employment shall, in accordance with the Act, vest in the Company or any Group Company.

This intellectual property rights clause shall not apply to any Inventions or Developments made by the Executive when serving from time to time and continuing to serve on the Boards of and hold any other offices or positions in companies or organisations as previously notified to the Board.

19.  
Restrictions during Employment

During the course of Employment the Executive shall not:

a)  
be directly or indirectly employed, engaged, concerned or interested in any other business or undertaking; or

b)  
engage in any activity which the Board reasonably considers may be, or become harmful to the interests of Company or any Group Company or which might reasonably be considered to interfere with the performance of the Executive’s duties under this Agreement.

 
The above Clause shall not apply:

a)  
to the Executive holding (directly or through nominees) of investments listed on the London Stock Exchange or in respect of which dealing takes place in the Unlisted Securities Market on the London Stock Exchange or any recognised stock exchange as long as he does not hold more than 5% of the issued shares or other securities of any class of any one Company; or

b)  
to any act undertaken by the Executive after prior notification to the Board; or

 
6

 



c)  
to any interest, notified in advance to the Board, for the Executive to serve from time to time and continue to serve on the Boards of and hold any other offices or positions in companies or organisations which will not present any conflict of interest with Company or any Group Company and provided that such activities do not materially detract from the performance of the Executive’s duties.
 

20.  
Share Dealings
 
The Executive shall comply fully with Amarin’s Share Dealing Code.

21.  
Notice
 
You are entitled to give and receive from the Company 3 month’s notice of the termination of your employment.  If written notice is given by you or by the Company to terminate your employment, the Company may, notwithstanding any other terms of these terms and conditions and in its absolute discretion, require you to;

Continue to perform such duties as the Company may direct or to perform no duties during the period of your notice provided always that it shall continue to pay you your salary and provide all contractual benefits to which you are entitled during such notice period.

Accept a payment of salary in lieu of notice and your employment shall terminate immediately but without prejudice to any other claim the Company or you may have against the other.

22.  
Termination of Employment
 
The Company shall be entitle to terminate the Employment at any time by giving written notice of immediate termination to the Executive in any of the following circumstances:

·  
if the Executive commits a criminal offence or is found guilty of serious misconduct or wilful neglect whether during the performance of his duties or otherwise which in the opinion of the Company renders the executive unfit to continue his Employment with the Company or which would be likely to adversely prejudice the reputation or interests of the Company or any group company;

·  
if the Executive seriously or persistently breaches any provision in this Agreement or is , in the opinion of the Board, incompetent in the performance of his duties;

·  
if the Director is unable to perform his duties as result of illness or injury for a period or periods aggregating at least 90 working days in any period of 12 consecutive calendar months;

·  
if the Executive becomes insolvent or bankrupt or enters into any composition or arrangement with or for the benefit of his creditors;

 
7

 



·  
if the Executive becomes of unsound mind;

·  
if the Director becomes prohibited by law from being a director.

The Executive shall not be entitled to make a claim against the Company for damages for loss of Employment where the Employment was validly terminated under this Clause 22.

Upon termination of the Employment the Executive shall deliver up to the Company all notes, memoranda and other correspondence, documents, papers and property belonging to the Company or any group company which may have been prepared by him or have come into his possession and shall not retain any copies thereof and not permit the same to be used by any party.

23.  
Restrictions after Termination
 
The Director shall not after termination of the Employment represent himself as being in any way connected with the Company or any group company.

Since the Executive is likely to obtain knowledge of Confidential Information in the course of his Employment and the trust and personal knowledge of customers, suppliers and other contacts of the Company or any group company the Executive hereby agrees that in addition to the other terms of this Agreement he will be bound by the following restrictions.

The Executive shall not for a period of 3 months from the date of termination of Employment (“the restricted period”), directly or indirectly carry on or be engaged or concerned in (whether as director, manager, partner, consultant, agent, employee or otherwise) any business which is directly competitive to the compound areas with which the Executive was materially involved during the period of six months immediately prior to the termination of his employment other than to the extent that the Director is already engaged in activities with third parties in this field;

The Executive shall not during the restricted period directly or indirectly by any means whatsoever, whether for himself or for any third party, canvass or solicit the customer of any person, firm company or otherwise who was a customer of, or who dealt with the Company or any group company and with whom the Executive had material dealings within the period of six months immediately prior to the termination of his employment at any time during the 6 months period preceding the date of termination of Employment;

The Executive shall not during the restricted period directly or indirectly by any means whatsoever, whether for himself or for any third party, solicit or endeavour to entice away from the Company or any group company any person who is at the date of termination of Employment a director or consultant of the Company or any group company and with whom the Executive had material contact during the period of six months immediately prior to the termination of his employment;

 
8

 



The Executive shall not following termination of the Employment disclose any confidential information relating to the business of the Company or any group company to any party whatsoever, unless ordered to do so by a court of competent jurisdiction.

Nothing in this restrictions after termination shall prevent the Executive from continuing to undertake any duties, notified in advance to the Board, for the Executive to serve from time to time and continue to serve on the Boards of and hold any other offices or positions in companies or organisations which will not present any conflict of interest with Company or any Group Company and provided that such activities do not materially detract from the performance of the Executive’s duties.

24.  
Resolving Problems
 
The Company want to resolve issues speedily ensuring fair and consistent treatment for all employees.  The Disciplinary and Grievance Procedure is attached in the Amarin Employee Handbook.

 
25.  
Reconstruction and Amalgamations
    
If before the expiration or determination of this Agreement the Employment shall be terminated by reasons of the liquidation of the Company for the purpose of reconstruction or amalgamation and the director shall be offered employment with any concern or undertaking resulting from such reconstruction or amalgamation on terms which are substantially the same as the terms of this Agreement then he shall have no claim against the Company in respect of the termination of the Employment.

26.  
Health and Safety
 
The health, safety and well being of all Company employees is paramount.  As an employee you should note that it is your individual responsibility to take reasonable care of yourself and others who may be affected by your actions whilst at work.

The company operates a no smoking policy.

27.  
Security

Your appointment requires your consent to the company checking, recording and reviewing telephone calls, computer files, records and e-mail and any other compliance, security or risk analysis checks the Company considers reasonably necessary.

The Company reserves the right to search any employee, including any property in their possession, whilst they are on Company premises.

You are responsible for the integrity and security of all work-related data, materials and equipment in your charge and for taking all the necessary anti-virus measures and strictly following the IT Security policy.  Failure to do so may be treated as disciplinary matter.

 
9

 



28.  
Data Protection
 
In order to keep and maintain records relating to your employment it will
be necessary for the Company to record, keep and process personal data relating to you.  This data may be recorded, kept and processed on computer or in a hard copy form. The Company may on occasion have need to disclose this data to others, including other employees in the Company, the Company’s professional advisors, the Inland Revenue and other authorities.

By accepting these Terms and Conditions you are consenting to the recording, processing, use and disclosure of records as detailed above.  This does not affect your rights as a data subject or the Company’s obligations under the Data Protection Act.

29.  
Retirement
 
The Company’s normal retirement age is 65yrs.

30.  
Company Property

On termination of your employment you must deliver up to the Company all property, documentation, records, client lists, work in progress, discs, tapes, or other software media belonging to the Company which may be in your possession.  You shall not   without the express written consent of the Company, retain any copies.  If so required by the CEO, you will sign a statement confirming that you have complied with the requirement.

31.  
Variation of Contract and handbook
 
The Company reserves the right to make reasonable changes to these and other agreed terms and conditions of employment.  Minor changes of detail may be made form time to time and will be effected by a general notice to employees.  You will be given not less than one month’s written notice before significant changes are made.  Such changes will be deemed to have been accepted unless the Company receives from you an objection in writing before the expiry of the notice period.

32.  
The Agreement
 
These terms and conditions set out together with the staff handbook the entire agreement and understanding between many in connection with the terms and conditions of your employment and supersede any prior agreement or arrangement.  There are no collective agreements applicable t your employment.

This offer is subject to:

·  
Receipt of two references in terms acceptable to the Company.
·  
You being contractually free to join the Company on the day of commencement.
·  
That you are not subject to any contractual term that would be breached by you commencing work with us.

 
10

 



33.  
Whole Agreement

This agreement sets out the entire agreement between the parties and supersedes all prior discussions, agreements, statements, representations, terms and conditions, communications and understandings whether oral in writing.


34.  
Applicable Law

This Agreement shall be governed and construed in accordance with English law and the parties agree to submit to the exclusive jurisdiction of the English courts and tribunals as regards my claim or matters arising in respect of this Agreement.
 

Signed /s/ Thomas Lynch

 
Thomas Lynch
Chief Executive Officer

Dated April 27, 2008

 

I acknowledge receipt of this Contract of employment and agree to the terms and conditions as set out above.


Signed /s/ Declan Doogan

 
Dated  April 28, 2008


 
 
11
Exhibit 4.81
 
 

FORM OF SECURITIES PURCHASE AGREEMENT
 
This SECURITIES PURCHASE AGREEMENT (this “ Agreement ”), dated as of May 13, 2008, is made by and among Amarin Corporation plc, a company incorporated under the laws of England and Wales (the “ Company ”), and the purchasers listed on Exhibit A   hereto, together with their permitted transferees (each, a “ Purchaser ” and collectively, the “ Purchasers ”).
 
RECITALS:
 
A.           The Company and the Purchasers are executing and delivering this Agreement in reliance upon the exemption from the registration requirements of the Securities Act afforded by Section 4(2) thereof and/or Regulation D thereunder.
 
B.           The Purchasers desire to purchase and the Company desires to sell, upon the terms and conditions stated in this Agreement, Shares and Preference Shares in an aggregate amount of $56,000,000, with $28,000,000 (the “ First Closing Amount ”) to be funded at the first closing (the “ First Closing ”) and $28,000,000 (the “ Second Closing Amount ”) to be funded at the second closing (the “ Second Closing ”) if the Second Closing occurs.
 
C.           The capitalized terms used herein and not otherwise defined have the meanings given them in Article 8.
 
AGREEMENT
 
In consideration of the premises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Purchasers (severally and not jointly) hereby agree as follows:
 
ARTICLE 1
 
PURCHASE AND SALE OF SECURITIES
 
SECTION 1.1.  
Purchase and Sale of Securities .
 
(a)   At the First Closing, the Company will allot, issue and sell to each Purchaser, and each Purchaser will subscribe for from the Company, the number of Preference Shares, if any, (the “ Preference Shares ”) and the number of Ordinary Shares (the “ First Closing Ordinary Shares ” and together with the Preference Shares, the “ First Closing Securities ”), each Ordinary Share represented by one American Depositary Share (each, an “ ADS ” and collectively, “ ADSs ”), in each case as set forth opposite such Purchaser’s name on Exhibit A hereto.  The purchase or subscription price for each unit of the First Closing Securities shall be US$2.30 (the “ Per Share First Closing Purchase Price ”) of which the dollar amount equivalent to ₤0.50 per Preference Share on the First Closing Date shall be paid in respect of each Preference Share purchased, if any.
 
(b)   The Purchasers will have the option to invest the Second Closing Amount as provided herein.  If the Purchasers, in accordance with Section 1.1(c), elect to invest the Second
 
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS
.
 

 
 

 

Closing Amount, then at the Second Closing, the Company will allot, issue and sell to each Purchaser, and each Purchaser will subscribe for from the Company the number of Ordinary Shares (the “ Second Closing Securities ” and, together with the First Closing Securities, the “ Securities ”), each Ordinary Share represented by one ADS, that is equal to the quotient obtained by dividing (A) the product of (x) the Second Closing Amount and (y) such Purchaser’s “Pro Rata Percentage” as set forth opposite such Purchaser’s name on Exhibit A hereto, by (B) the Per Share Second Closing Purchase Price (as defined below).
 
The “ Per Share Second Closing Purchase Price ” shall mean the purchase or subscription price for each Second Closing Security equal to the lesser of (i) $2.60 and (ii) the product of (x) the average of the volume weighted average prices as published on the HP screen on Bloomberg of the ADSs as reported on Nasdaq (symbol “AMRN”) for each of the thirty (30) trading days immediately prior to the Second Closing Date and (y) 1.13.
 
(c)   Not later than the tenth (10th) Business Day following the date on which the Company notifies the Purchasers in writing (the “ Notice ”) of its good faith determination, which shall have been confirmed by the affirmative vote of at least a majority of all the members of the Board of Directors plus one additional Director (the “ Supermajority Directors ”), that either (i) it believes the Milestone has been achieved (in which case the Company shall provide the Purchasers with supporting documentation) or (ii) it has permanently ceased to pursue achievement of the Milestone, the Purchasers will vote on whether to exercise their option to fund the Second Closing Amount.  If a Majority of the Preference Share Purchasers vote in favor of such exercise, then each Purchaser shall be required to fund in full its Pro Rata Percentage of the Second Closing Amount at the Second Closing; provided , that if, after such vote, any Purchaser funds less than such Purchaser’s full Pro Rata Percentage of the Second Closing Amount (such unfunded amount shall be referred to herein as a “ Shortfall Amount ”), then, (A) upon consummation of the Second Closing, all Preference Shares held by such Purchaser shall immediately convert into Ordinary Shares in accordance with their terms, and (B) the Purchasers that fund their full Pro Rata Percentages of the Second Closing Amount at the Second Closing shall have the right, but not the obligation, to fund any Shortfall Amount (in such proportions as such participating Purchasers shall determine in their sole discretion) and acquire the Second Closing Securities in respect of the amount funded.  If, at the time of such vote, a Majority of the Preference Share Purchasers do not vote in favor of such exercise, then the Purchasers’ option to fund the Second Closing Amount will expire and be of no further force or effect.  Notwithstanding any provision hereof to the contrary, a Majority of the Preference Share Purchasers may elect by written notice to the Company to waive the Notice and consummate the Second Closing at any time prior to delivery to the Purchasers of the Notice.
 
(d)   The Per Share Second Closing Purchase Price and/or the number of Second Closing Securities issuable upon funding of the Second Closing Amount will be subject to adjustment in the event of (i) stock splits, stock dividends and similar events, and (ii) issuances of Ordinary Shares (including as ADSs), securities convertible into Ordinary Shares or ADSs, warrants to subscribe for Ordinary Shares or ADSs, or options to purchase any of the foregoing, exclusive however of Exempt Securities (“ Additional Stock ”), at a price per share that is less than, or with a conversion or exercise price that is less than, the Per Share Second Closing Purchase Price.  In the case of clause (i), in the event of changes in the outstanding Ordinary Shares, on or after the First Closing Date, by reason of a stock split, reverse stock split, stock dividend, subdivision, split-up, combination of shares, consolidation or other transaction having similar effect, the number of Second Closing Securities purchasable under this Agreement in the aggregate and the Per Share Second Closing Purchase Price shall be correspondingly adjusted to give each
 

 
-2-

 

Purchaser, on exercise of the option related to the Second Closing for the same aggregate Second Closing Purchase Price, the total number of Second Closing Securities as such Purchaser would have owned had the Second Closing been consummated prior to the event requiring adjustment and had such Purchaser continued to hold such Securities until after such event.  In the case of clause (ii), the provisions of Exhibit B hereto shall apply.
 
SECTION 1.2.   Payment .  At or prior to the First Closing, each Purchaser will pay the aggregate First Closing Purchase Price for the First Closing Securities as set forth opposite such Purchaser’s name on Exhibit A hereto (the “ First Closing Purchase Price ”) by wire transfer of immediately available funds to the Company in accordance with wire instructions provided by the Company to the Purchasers prior to the First Closing.  Upon such wire transfer the Company will instruct its depositary to deliver to each Purchaser, on an expedited basis, a statement of account in the name of such Purchaser reflecting the number of First Closing Ordinary Shares set forth on Exhibit A and will deliver certificates evidencing the Preference Shares set forth on Exhibit A .  In the event of the Second Closing, in accordance with and subject to Section 1.1(b) hereof, substantially identical payment and delivery procedures will apply with respect to the aggregate price payable hereunder by each Purchaser for the Second Closing Securities (the “ Second Closing Purchase Price ”).  The First Closing Purchase Price and the Second Closing Purchase Price include costs of issuance, such as any stamp duty or stamp duty reserve tax with respect thereto or any other cost incurred by the Company in connection with the issuance of the Securities.
 
SECTION 1.3.   Closing Date .  The First Closing will take place on May 16, 2008, or on such other date as shall be agreed upon by the Company and a Majority of the Preference Share Purchasers (the date upon which the First Closing occurs shall be referred to herein as the “ First Closing Date ”).  The First Closing will be held at the offices of Cahill Gordon & Reindel llp, 80 Pine Street, New York, New York 10005 or at such other place as shall be agreed upon by the Company and a Majority of the Preference Share Purchasers.  If a Majority of the Preference Share Purchasers vote in favor of the Second Closing pursuant to Section 1.1(c), then the Second Closing will take place no more than fifteen (15) Business Days following such affirmative vote (the “ Second Closing Date ”).  The Second Closing, if applicable, will be held at the offices of Cahill Gordon & Reindel llp, 80 Pine Street, New York, New York 10005 or at such other time and place as shall be agreed upon by the Company and a Majority of the Preference Share Purchasers.
 
SECTION 1.4.   Redemption of Convertible Debentures .  Pursuant to the Company’s Convertible Debentures due 2010 (the “ Debentures ”), within fifteen (15) days following the First Closing Date the Company will apply proceeds from the First Closing Amount to, among other things, redeem for cash all outstanding Debentures at a redemption price equal to 100% of the principal amount thereof, plus any accrued and unpaid interest thereon up to and including the date upon which the Debentures are redeemed.  The principal amount of the Debentures, as of the date hereof, is $2,750,000.
 
ARTICLE 2
 
REPRESENTATIONS AND WARRANTIES OF THE COMPANY
 
Except as specifically contemplated by this Agreement or as set forth in the SEC Documents, the Draft Annual Report or the Disclosure Schedules, which Disclosure Schedules are attached hereto and shall be deemed a part hereof, the Company hereby represents and warrants to each of the Purchasers and the Placement Agent as follows:
 

 
-3-

 


 
SECTION 2.1.   Organization and Qualification .  All of the direct and indirect Subsidiaries of the Company are as disclosed in the Draft Annual Report.  The Company owns, directly or indirectly, all of the capital stock or other equity interests of each Subsidiary free and clear of any Liens, and all the issued and outstanding shares of capital stock of each Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar rights to subscribe for or purchase securities.  The Company is duly incorporated and validly existing under the laws of England and Wales, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted.  Neither the Company nor any Subsidiary is in violation or default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents.  The Company is duly qualified to conduct business as a foreign corporation in each United States jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not reasonably be expected to have (i) a material adverse effect on the legality, validity or enforceability of this Agreement and the transactions contemplated hereby, (ii) a material adverse effect on the results of operations, assets, business, or financial condition of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under this Agreement and the transactions contemplated hereby (any of (i), (ii) or (iii), a “ Material Adverse Effect ”), and no Proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.  Each Subsidiary is duly incorporated or otherwise organized and validly existing under the laws of the jurisdiction of its incorporation or organization (as applicable), with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted.  Each Subsidiary is duly qualified to conduct business as a foreign corporation or other entity in each United States jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not reasonably be expected to have a Material Adverse Effect.
 
SECTION 2.2.   Authorization; Enforcement .  The Company has the requisite corporate power and authority to enter into and to consummate this Agreement and the transactions contemplated hereby and otherwise to carry out its obligations hereunder and thereunder.  The execution and delivery of this Agreement by the Company and the consummation by it of the transactions contemplated hereby have been duly authorized by all necessary action on the part of the Company and no further action is required by the Company, its Board of Directors or its shareholders in connection therewith other than in connection with the Required Approvals.  This Agreement has been (or upon delivery will have been) duly executed by the Company and, when delivered in accordance with the terms hereof, will constitute the valid and binding obligation of the Company, enforceable against the Company in accordance with its terms except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii) rights to indemnity and contribution may be limited by applicable law or public policy.
 
SECTION 2.3.   Capitalization .  The capitalization of the Company is as set forth in Schedule 2.3 of the Disclosure Schedules.  All of the issued shares of capital stock of the Company are validly issued and fully paid.  Except as a result of the purchase and sale of the Securities and as set forth in the SEC Documents, the Draft Annual Report and Schedule 2.3, there are no outstanding options, warrants, rights to subscribe for, or securities, rights or obligations convertible into, or giving
 

 
-4-

 

any person any right to subscribe for or acquire, any Ordinary Shares or any options, warrants, rights or other instruments convertible into or exchangeable for Ordinary Shares.  The Company’s Memorandum of Association and Articles of Association (the “ Memorandum and Articles of Association ”), as in effect on the date hereof, have previously been provided to the Purchasers.  There are no shareholders agreements, voting agreements or other similar agreements with respect to the Company’s capital stock to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s shareholders.  Schedule 2.3 of the Disclosure Schedules contains a true, correct and complete copy of the Company’s 2002 Stock Option Plan, as amended by that certain Amendment to 2002 Stock Option Plan dated May 9, 2008 (collectively, the “ Amended Plan ”), which Amended Plan is in full force and effect.  No option or award issued under or pursuant to the Amended Plan will vest, and the vesting schedule of any outstanding option or award will not accelerate, as a result of the transactions contemplated hereby.  The Company has not back-dated any of its options or awards issued under or pursuant to the Amended Plan, or otherwise.
 
SECTION 2.4.   Issuance of Securities .  The Securities (in connection with both the First Closing and the Second Closing) are within the authorized share capital of the Company and, upon issuance in accordance with the terms of this Agreement, will be validly issued and fully paid and, except for antidilution adjustments described in Schedule 2.4 of the Disclosure Schedules, will not be subject to preemptive rights or other similar rights of shareholders of the Company.
 
SECTION 2.5.   No Conflicts; Government Consents and Permits .
 
(a)   The execution, delivery and performance of this Agreement by the Company and the consummation by the Company of the transactions contemplated hereby (including the issuance of the Securities) will not (i) conflict with or result in a violation of any provision of its Memorandum and Articles of Association, (ii) violate or conflict with, result in a material breach of any provision of, constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien upon any of the properties or assets of the Company or any Subsidiary, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, indenture or instrument to which the Company or any of its Subsidiaries is a party, or (iii) subject to receipt of Required Approvals, result in a violation of any applicable law, rule, regulation, order, judgment or decree (including United States federal and state securities laws and regulations and regulations of any self-regulatory organizations to which the Company or its securities are subject) applicable to the Company or any of its Subsidiaries, except in the case of clauses (ii) and (iii) only, for such conflicts, breaches, defaults, and violations as would not reasonably be expected to have a Material Adverse Effect.
 
(b)   Assuming the accuracy of each of the Purchasers’ representations and warranties in Article 3 hereof, the Company is not required to obtain any consent, authorization or order of, or make any filing or registration with, any Governmental Authority or other Person in order for it to execute, deliver or perform any of its obligations under this Agreement in accordance with the terms hereof, or to issue and sell the Securities in accordance with the terms hereof, other than such as have been made or obtained, and except for (i) the registration of the Securities under the Securities Act pursuant to Article 6 hereof, (ii) such filings required to be made under English law or U.S. federal or state or foreign securities laws as set forth on Schedule 2.5 of the Disclosure Schedules, and (iii) such required filings or notifications regarding the issuance or listing of additional shares with Nasdaq as set forth on Schedule 2.5 (collectively, the “ Required Approvals ”).
 

 
-5-

 


 
(c)   The Company and each Subsidiary has all certificates, authorizations, permits, licenses and any similar authority necessary for the conduct of its business as now being conducted by it as described in the Draft Annual Report, except for such certificates, authorizations, permits, licenses or similar authority, the lack of which would not reasonably be expected to have a Material Adverse Effect (“ Material Permits ”).  Neither the Company nor any of its Subsidiaries has received any actual notice of any proceeding relating to revocation or modification of any Material Permit.
 
SECTION 2.6.   SEC Documents; Financial Statements .  The Company has complied in all material respects with requirements to file all reports required to be filed by it under the Exchange Act for the preceding two years (all of the foregoing and all exhibits included therein and financial statements and schedules thereto and documents (other than exhibits) incorporated by reference therein being hereinafter referred to as the “ SEC Documents ”) on a timely basis or has received a valid extension of such time of filing and has filed any such SEC Document prior to the expiration of any such extension.  At the time of filing, the SEC Documents complied in all material respects with the applicable requirements of the Exchange Act.  At the time of filing, the Financial Statements and the related notes complied as to form in all material respects with applicable accounting requirements and the published rules and regulations of the SEC with respect thereto.  Such Financial Statements have been prepared in accordance with United States generally accepted accounting principles (“ GAAP ”) applied on a consistent basis during the periods involved (the Financial Statements are prepared under U.K. GAAP and reconciled to U.S. GAAP), except as may be otherwise specified in such Financial Statements or the notes thereto and except that unaudited financial statements may not be reconciled to U.S. GAAP or contain all footnotes required by GAAP, and fairly present in all material respects the financial position of the Company and its consolidated Subsidiaries as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments.
 
SECTION 2.7.   Annual Report for 2007 .  The Company has previously made available to the Purchasers a draft, which was delivered to the Purchasers by the Placement Agent on April 18, 2008, of the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2007 (the “ Draft Annual Report ”), which has been prepared assuming the First Closing occurs subsequent to the period covered thereby but before the filing thereof with the SEC.  At the time of filing, the Draft Annual Report will comply in all material respects with the applicable requirements of the Exchange Act.  The Financial Statements contained in the Draft Annual Report and the related notes comply as to form in all material respects with applicable accounting requirements and the published rules and regulations of the SEC with respect thereto.  Such Financial Statements have been prepared in accordance with International Financial Reporting Standards applied on a consistent basis during the periods involved, except as may be otherwise specified in such Financial Statements or the notes thereto and fairly present in all material respects the financial position of the Company and its consolidated Subsidiaries as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments.  As of the date hereof, the Draft Annual Report does not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.
 

 
-6-

 


 
SECTION 2.8.   Absence of Litigation .  Except as described or referred to in the SEC Documents, the Draft Annual Report or Schedule 2.8 of the Disclosure Schedules, there is no Proceeding pending or, to the knowledge of the Company, threatened against or affecting the Company, any Subsidiary or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign) which (i) adversely affects or challenges the legality, validity or enforceability of any of the Securities, this Agreement or the transactions contemplated hereby or (ii) could, if there were an unfavorable decision, reasonably be expected to result in a Material Adverse Effect.  Except as described or referred to in the SEC Documents, the Draft Annual Report or Schedule 2.8 of the Disclosure Schedules, there has not been, and to the knowledge of the Company, there is not pending or contemplated, any investigation by any Governmental Authority involving the Company or any Subsidiary regarding the business, operations, activities or securities of the Company.  The SEC has not issued any stop order or other order suspending the effectiveness of any registration statement filed by the Company or any Subsidiary under the Exchange Act or the Securities Act.
 
SECTION 2.9.   Intellectual Property Rights .  The Company and each Subsidiary owns, or has sufficient rights worldwide to use, all patents and patent applications (including reissues, divisions, continuations, continuations-in-part, extensions, reexaminations and foreign counterparts thereof), trademarks, trademark applications, service marks, trade names, copyrights, trade secrets and know-how, including unpatented inventions, licenses for any of the foregoing and other intellectual property rights listed on Schedule 2.9 of the Disclosure Schedule (collectively, the “ Intellectual Property Rights ”).  To the Company’s best knowledge (after diligent inquiry), there are no other intellectual property rights used in or necessary or material for use in connection with the Company’s and its Subsidiaries’ respective businesses as currently being conducted as described in the SEC Documents and the Draft Annual Report.  Except as set forth in Schedule 2.9, all of the Intellectual Property Rights owned by the Company or any Subsidiary are exclusively owned by the Company or a Subsidiary and are free and clear of all Liens.  Schedule 2.9 (a) of the Disclosure Schedule sets forth a complete and accurate list of all patents, registered trademarks and registered copyrights owned by the Company or any Subsidiary, in any jurisdiction throughout the world, and all applications for the foregoing; and Schedule 2.9 (b) sets forth a list of all agreements under which the Company or any Subsidiary receives from or grants to any Person any Intellectual Property Rights, other than off-the-shelf, shrink-wrap or click-wrap software licenses.  There are no Proceedings, including without limitation any interference, reissue, reexamination, opposition, cancellation or similar proceedings, which adversely affect or challenge the legality, validity, use or enforceability of any of the Intellectual Property Rights.  Neither the Company nor any Subsidiary has received any written notice, including any offers to license the intellectual property of any Person, or opinion of counsel that, and the Company has no knowledge of any facts or circumstances or any other reason to believe that, the use of the Intellectual Property Rights by the Company or any Subsidiary violates or infringes or is alleged to violate or infringe upon the rights of any Person.  None of the Intellectual Property Rights have been judged invalid or unenforceable in whole or in part by any jurisdiction throughout the world and except as set forth in the Draft Annual Report, to the knowledge of the Company, all of the Intellectual Property Rights are valid and enforceable.  All of the registrations and pending applications for Intellectual Property Rights have been timely and duly filed and prosecuted, all maintenance and related fees have been paid, and the Company or its Subsidiaries have taken all other actions required to maintain the validity and effectiveness of such registrations and applications.  To the knowledge of the Company, there has been no infringement or misappropriation by another Person of any of the Intellectual Property Rights.  The Company has taken reasonable measures consistent with industry standards to protect and
 

 
-7-

 

maintain the confidentiality of its trade secrets and other confidential Intellectual Property Rights.  Each present or past employee, officer, consultant or any other Person who developed, in whole or in part, any Intellectual Property Rights owned or purported to be owned by the Company or any of its Subsidiaries has executed a valid and enforceable assignment to the Company of all right, title and interest in such Intellectual Property Rights.
 
SECTION 2.10.   Certain Fees .  Except for fees payable by the Company pursuant to the Company’s engagement letter with the Placement Agent, no brokerage or finder’s fees or commissions are or will be payable by the Company to any broker, financial advisor or consultant, finder, placement agent, investment banker, bank or other Person with respect to the transactions contemplated by this Agreement.  The Purchasers shall have no obligation with respect to any fees or with respect to any claims made by or on behalf of other Persons for fees of a type contemplated in this Section that may be due in connection with the transactions contemplated by this Agreement.
 
SECTION 2.11.   Investment Company .  The Company is not and, after giving effect to the offering and sale of the Securities, will not be an “investment company” as such term is defined in the Investment Company Act of 1940, as amended (the “ Investment Company Act ”).  The Company shall conduct its business in a manner so that it will not become subject to the Investment Company Act.
 
SECTION 2.12.   No Material Adverse Effect .  Since September 30, 2007, except as described or referred to in the Draft Annual Report and except for cash expenditures in the ordinary course of business consistent with past practice, there has not been any change in the assets, business, properties, financial condition or results of operations of the Company that would reasonably be expected to have a Material Adverse Effect.  Since September 30, 2007, except as described or referred to in the Draft Annual Report, (i) there has not been any dividend or distribution of any kind declared, set aside for payment, paid or made by the Company on any class of capital stock, (ii) the Company has not sustained any material loss or interference with the Company’s business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor disturbance or dispute or any action, order or decree of any court or arbitrator or governmental or regulatory authority, and (iii) the Company has not incurred any material liabilities except in the ordinary course of business consistent with past practice.
 
SECTION 2.13.   Nasdaq Capital Market .  The ADSs are listed on the Nasdaq Capital Market and, to the Company’s knowledge, there are no proceedings to revoke or suspend such listing.  The Company is, and after giving effect to the transactions contemplated hereby will be, in compliance with the requirements of Nasdaq Capital Market and the Company has not been notified by its depositary bank of, nor is it aware of, any breach of the terms of its ADS depositary agreement in the last two (2) years.
 
SECTION 2.14.   Acknowledgment Regarding Purchasers’ Purchase of Securities . The Company acknowledges and agrees that each Purchaser is acting solely in the capacity of an arm’s-length purchaser with respect to this Agreement and the transactions contemplated hereby.  The Company further acknowledges that no Purchaser is acting as a financial advisor or fiduciary of the Company (or in any similar capacity with respect to the Company) with respect to this Agreement and the transactions contemplated hereby and any advice given by any Purchaser or any of its respective representatives or agents to the Company in connection with this Agreement and the transactions contemplated hereby is merely incidental to such Purchaser’s purchase of the Securities.  The Company further represents to each Purchaser that the Company’s decision to enter into this
 

 
-8-

 

Agreement has been based on the independent evaluation of the transactions contemplated hereby by the Company and its representatives.
 
SECTION 2.15.   Accountants .  The Company’s accountants are Pricewaterhouse-Coopers LLP.  To the knowledge of the Company, such accountants, who the Company expects will express their opinion with respect to the financial statements to be included in the Draft Annual Report as finalized and filed with the SEC promptly following the First Closing, are a registered public accounting firm as required by the Securities Act.
 
SECTION 2.16.   Insurance .  The Company and each Subsidiary are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as the Company believes are prudent and customary for a company (i) in the business (currently limited to the clinical trial stage) and locations in which the Company and each Subsidiary are engaged and (ii) with the resources of the Company and each Subsidiary, including, but not limited to, directors and officers insurance coverage.  The Company has not received any written notice that the Company or any Subsidiary will not be able to renew its existing insurance coverage as and when such coverage expires.
 
SECTION 2.17.   Foreign Corrupt Practices .  Since January 1, 2004, neither the Company nor, to the Company’s knowledge, any director, officer, agent, employee or other person acting on behalf of the Company has, in the course of its actions for, or on behalf of, the Company, (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of in any material respect any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended; or (iv) made any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any foreign or domestic government official or employee.
 
SECTION 2.18.   No Registration Rights .  No Person has the right to (i) prohibit the Company from filing the Registration Statement or (ii) except as described or referred to in the Draft Annual Report or Schedule 2.18 of the Disclosure Schedules, require the Company to register any securities for sale under the Securities Act by reason of the filing of the Registration Statement or otherwise.  The granting and performance of the registration rights under this Agreement will not violate or conflict with, or result in a breach of any provision of, or constitute a default under, any agreement, indenture or instrument to which the Company or any Subsidiary is a party.
 
SECTION 2.19.   Taxes .  The Company has filed (or has obtained an extension of time within which to file) all necessary federal, state and foreign income and franchise tax returns and has paid all taxes that are due and payable, except where the failure to so file or the failure to so pay would not reasonably be expected to have a Material Adverse Effect.
 
SECTION 2.20.   Real and Personal Property .  Except as referred to or described in the Draft Annual Report, the Company and each Subsidiary have good and marketable title to, or have valid rights to lease or otherwise use, all items of real and personal property that are material to the business of the Company and its Subsidiaries, free and clear of all Liens, except those that (i) do not materially interfere with the use of such property by the Company and its Subsidiaries or (ii) would not reasonably be expected to have a Material Adverse Effect.
 
SECTION 2.21.   Application of Takeover Protections .  The Company and its Board of Directors have taken all necessary action, if any, in order to render inapplicable any control
 

 
-9-

 

share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Company’s Memorandum and Articles of Association or the laws of England and Wales that is or could become applicable as a result of the Purchasers and the Company fulfilling their obligations or exercising their rights under this Agreement and the transactions contemplated hereby, including without limitation as a result of the Company’s issuance of the Securities and the Purchasers’ ownership of the Securities.  Without in any way limiting the foregoing, the Company and the transactions to be effected at the First Closing and the Second Closing are not subject to the UK Takeover Code and neither the Company nor any Purchaser is required to obtain any consent, authorization or order of, or make any filing or registration pursuant to the UK Takeover Code in order for it to execute, deliver or perform any of its obligations under this Agreement in accordance with the terms hereof, or to allot, issue and sell the Securities in accordance with the terms hereof.
 
SECTION 2.22.   No Manipulation of Stock .  The Company has not taken, nor will it take, directly or indirectly, any action designed to stabilize or manipulate the price of the ADSs or any security of the Company to facilitate the sale or resale of any of the Securities.
 
SECTION 2.23.   Related Party Transactions .  Except as set forth in the Draft Annual Report or Section 2.23 of the Disclosure Schedules, neither the Company nor any Subsidiary is presently a party to any transaction with any officer or director of the Company, any member of such officer’s or director’s family or any entity in which such officer, director or family member has a 5% or greater   interest or is an officer, director, trustee or partner,   including any contract, agreement or other arrangement providing for the furnishing of services, providing for rental of real or personal property, or otherwise requiring payments, other than (i) for payment of salary or consulting fees for services rendered to the Company or a Subsidiary, (ii) reimbursement for expenses incurred on behalf of the Company or a Subsidiary and (iii) other employee benefits, including stock option agreements under any stock option plan of the Company or a Subsidiary.
 
SECTION 2.24.   Sarbanes-Oxley .  To the Company’s knowledge, the Company is in material compliance with all provisions of the Sarbanes-Oxley Act of 2002 which are applicable to it or the transactions contemplated herein.
 
SECTION 2.25.   Solvency .  Based on the financial condition of the Company as of the First Closing Date after giving effect to the receipt by the Company of the proceeds from the sale of the First Closing Securities hereunder, (i) the Company’s fair saleable value of its assets exceeds the amount that will be required to be paid on or in respect of the Company’s existing debts and other liabilities (including known contingent liabilities but excluding contingent liabilities relating to completed acquisitions, including the acquisition of Laxdale Limited, Ester Neurosciences Limited, the rights to an oral formulation of apomorphine and the rights to a nanocrystal nasal formulation of lorazepam as described in Schedule 2.25 of the Disclosure Schedules) as they mature and (ii) the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses of the cash, would be sufficient to pay all amounts on or in respect of its debt when such amounts are required to be paid.
 
SECTION 2.26.   Obligations on Pipeline Candidates.   Schedule 2.26 of the Disclosure Schedules contains a true, correct and complete schedule of all licenses, collaboration agreements and other binding agreements of any kind with third parties that require the Company or any Subsidiary to (i) make any milestone, royalty and other similar payments in excess of $100,000 in the aggregate for each such agreement (each, a “ Payment Obligations ”) or (ii) perform any product development work (pre-clinical or clinical) or undertake any manufacturing (pilot or commercial)
 

 
-10-

 

requiring expenditures in excess of $100,000 in the aggregate for each such agreement (each, a “ Work Obligation ”), with respect to any development/pipeline product, development/pipeline compound or development/pipeline candidate (each, a “ Product ”) owned or licensed by or to the Company or any of its Subsidiaries, including on such schedule (a) the names of the Products, (b) the agreements or other documents that are the source of the Payment Obligations and/or Work Obligations, naming the parties thereto, (c) a description of the Work Obligations, the diligence standards for performing the Work Obligations, and whether each such agreement may be terminated at the Company’s option without liability and if not, the measure of such liability if specified, (d) the milestones, developments, or events that give rise to the Payment Obligations and Work Obligations, and (e) the amounts of the Payment Obligations and whether such Payment Obligations may be settled other than by the payment of cash.
 
ARTICLE 3
 
PURCHASERS’ REPRESENTATIONS AND WARRANTIES
 
Each Purchaser represents and warrants to the Company, severally and not jointly, with respect to itself and its purchase hereunder, that:
 
SECTION 3.1.   Investment Purpose .  The Purchaser is purchasing the Securities for its own account for investment and not with a present view toward the public sale or distribution thereof and has no intention of selling or distributing any of such Securities or any arrangement or understanding with any other Persons regarding the sale or distribution of such Securities except in accordance with the provisions of Article 6 or otherwise as would not result in a violation of the Securities Act.  The Purchaser will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) any of the Securities except in accordance with the provisions of Article 6 or otherwise pursuant to and in accordance with the Securities Act.
 
SECTION 3.2.   Purchaser Status .  At the time the Purchaser was offered the Securities, it was, and at the date hereof it is, either (i) a “qualified institutional buyer” as defined in Rule 144A(a) under the Securities Act, (ii) an institutional “accredited investor” as defined in Rule 501(a)(1), (2) or (3) under the Securities Act or (iii) a person who is not a “U.S. Person” (as defined in Rule 902(k) under the Securities Act) (a “ Non-US Person ”).
 
SECTION 3.3.   Reliance on Exemptions .  The Purchaser understands that the Securities are being offered and sold to it in reliance upon specific exemptions from or non-application of the registration requirements of United States federal and state securities laws and that the Company is relying upon the truth and accuracy of, and the Purchaser’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of the Purchaser set forth herein in order to determine the availability of such exemptions and the eligibility of the Purchaser to acquire the Securities.
 
SECTION 3.4.   Information .  The Purchaser acknowledges that it has been afforded (i) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions of the offering of the Securities and the merits and risks of investing in the Securities; (ii) access to such information about the Company and its financial condition, results of operations, businesses, properties, management and prospects as it believes to be sufficient to enable it to evaluate its investment, including, without limitation, the Company’s SEC Documents, the Draft Annual Report and the
 

 
-11-

 

Disclosure Schedules; (iii) the opportunity to review the SEC Documents, the Draft Annual Report and the Disclosure Schedules; and (iv) the opportunity to obtain such additional information that the Purchaser has requested and the Company has provided.  The foregoing acknowledgment of opportunity and access shall not be deemed in any way to limit the representations and warranties of the Company set forth in Article 2 above or the ability of the Purchasers to rely thereupon.
 
SECTION 3.5.   Acknowledgement of Risk .
 
(a)   The Purchaser acknowledges and understands that its investment in the Securities involves a significant degree of risk, including, without limitation, (i) the Company has a history of operating losses and requires substantial funds in addition to the proceeds from the sale of the Securities; (ii) an investment in the Company is speculative, and only purchasers who can afford the loss of their entire investment should consider investing in the Company and the Securities; (iii) the Purchaser may not be able to liquidate its investment; (iv) transferability of the Securities is limited; (v) in the event of a disposition of the Securities, the Purchaser could sustain the loss of its entire investment; and (vi) the Company has not paid any dividends on its Ordinary Shares since inception and does not anticipate the payment of dividends in the foreseeable future.  Such risks are more fully set forth in the SEC Documents, the Draft Annual Report and the Disclosure Schedules.
 
(b)   The Purchaser is able to bear the economic risk of holding the Securities for an indefinite period, and has knowledge and experience in financial and business matters such that it is capable of evaluating the risks of the investment in the Securities.
 
(c)   The Purchaser has with respect to all legal matters relating to this Agreement and the offer and sale of the Securities relied solely upon the advice of such Purchaser’s own counsel and has not relied upon or consulted any counsel to the Placement Agent or counsel to the Company.
 
(d)   The Purchasers acknowledge that the only representations or warranties the Company is making in connection with the transaction contemplated hereby are those set forth in Article 2, as modified by the SEC Documents, the Draft Annual Report and the Disclosure Schedules.
 
SECTION 3.6.   Governmental Review .  The Purchaser understands that no United States federal or state or foreign Governmental Authority has passed upon or made any recommendation or endorsement of the Securities or an investment therein.
 
SECTION 3.7.   Transfer or Resale; Legends .
 
(a)   The Purchaser understands that:
 
(i)   the Securities have not been and will not be registered under the Securities Act (other than as contemplated in Article 6) or any applicable state securities laws and, consequently, the Purchaser may have to bear the risk of owning the Securities for an indefinite period of time because the Securities may not be transferred unless (A) the resale of the Securities is registered pursuant to an effective registration statement under the Securities Act, as contemplated in Article 6; or (B) the Securities to be sold or transferred are sold or transferred pursuant to an exemption from such registration and, if requested by the Company, or required by the
 

 
-12-

 

depositary, the Purchaser has delivered to the Company an opinion of counsel to the Purchaser (in form, substance and scope reasonably acceptable to the Company) to such effect;
 
(ii)   except as set forth in Article 6 and Article 4, neither the Company nor any other Person is under any obligation to register the resale of the Securities under the Securities Act or any state or foreign securities laws or to comply with the terms and conditions of any exemption thereunder;
 
(iii)   the First Closing Ordinary Shares and the Second Closing Securities will be delivered to the Purchaser in the form of uncertificated restricted ADSs in the depositary’s direct registration system and will be held as restricted securities until they are resold pursuant to an effective registration statement under the Securities Act (or an available exemption therefrom), or otherwise cease to be restricted securities under the Securities Act; and
 
(iv)   the restricted ADSs will be subject to the transfer restrictions contained in the legend set forth below:
 
THE RESTRICTED AMERICAN DEPOSITARY SHARES (“ RESTRICTED ADSs ”) CREDITED TO YOUR ACCOUNT AND THE UNDERLYING RESTRICTED SHARES (“ RESTRICTED SHARES ”) OF THE COMPANY ARE SUBJECT TO THE TERMS OF THE SUPPLEMENTAL LETTER AGREEMENT, DATED AS OF MAY 16, 2008 (THE “ SUPPLEMENTAL LETTER AGREEMENT ”), AND THE DEPOSIT AGREEMENT, DATED AS OF MARCH 29, 1993, AS AMENDED AND SUPPLEMENTED (AS SO AMENDED AND SUPPLEMENTED, THE “ DEPOSIT AGREEMENT ”).  ALL TERMS USED BUT NOT OTHERWISE DEFINED HEREIN SHALL, UNLESS OTHERWISE SPECIFICALLY DESIGNATED HEREIN, HAVE THE MEANING GIVEN TO SUCH TERMS IN THE SUPPLEMENTAL LETTER AGREEMENT, OR IF NOT DEFINED THEREIN, IN THE DEPOSIT AGREEMENT.
 
HOLDERS AND BENEFICIAL OWNERS OF THE RESTRICTED ADSs BY ACCEPTING AND HOLDING THE RESTRICTED ADSs, AND ANY INTEREST THEREIN, SHALL BE BOUND BY THE TERMS OF THE DEPOSIT AGREEMENT AND THE SUPPLEMENTAL LETTER AGREEMENT.  AT THE TIME OF ISSUANCE, THE RESTRICTED ADSs HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS 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
 

 
-13-

 

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.
 
PRIOR TO THE TRANSFER OF THE RESTRICTED ADSs, A HOLDER OF RESTRICTED ADSs WILL BE REQUIRED TO PROVIDE TO THE DEPOSITARY AND TO THE COMPANY A CERTIFICATION IN THE FORM ATTACHED TO THE SUPPLEMENTAL LETTER AGREEMENT.  PRIOR TO THE WITHDRAWAL OF THE RESTRICTED SHARES, A HOLDER OF RESTRICTED ADSs WILL BE REQUIRED TO PROVIDE TO THE DEPOSITARY AND TO THE COMPANY A WITHDRAWAL CERTIFICATION IN THE FORM ATTACHED TO THIS LETTER.  THE TRANSFER AND OTHER RESTRICTIONS SET FORTH HEREIN AND IN THE SUPPLEMENTAL LETTER AGREEMENT SHALL REMAIN APPLICABLE WITH RESPECT TO THE RESTRICTED ADSs AND THE RESTRICTED SHARES UNTIL SUCH TIME AS THE PROCEDURES SET FORTH IN THE SUPPLEMENTAL LETTER AGREEMENT FOR REMOVAL OF RESTRICTIONS ARE SATISFIED.  NEITHER THE COMPANY NOR THE DEPOSITARY MAKES ANY REPRESENTATION AS TO THE AVAILABILITY OF THE EXEMPTION PROVIDED BY RULE 144 UNDER THE SECURITIES ACT FOR RESALE OF THE RESTRICTED SHARES OR THE RESTRICTED ADSs.  A COPY OF THE DEPOSIT AGREEMENT AND OF THE SUPPLEMENTAL LETTER AGREEMENT MAY BE OBTAINED FROM THE DEPOSITARY OR THE COMPANY UPON REQUEST.
 
(b)   A Purchaser may request, and the Company agrees to authorize, that its Securities be withdrawn from the depositary’s direct registration system at any time and reissued in certificated form to the Purchaser or any transferee from the Purchaser pursuant to a transfer complying with this Section 3.7, provided that all such certificates shall bear the legend provided in Section 3.7(a)(iv) unless (i) the sale of the Securities was made pursuant to an effective Registration Statement or (ii)  such Securities in the hands of the transferee are eligible for sale under Rule 144 under the Securities Act without restriction as to current public information, volume or the manner of sale.
 
Notwithstanding the provisions of subsections (a) and (b) above, no such registration statement or opinion of counsel shall be necessary for a transfer by a Purchaser (i) that is a partnership to an affiliate, a partner or limited partner of such partnership or a retired partner of such partnership who retires after the date hereof, or to the estate of any such partner, limited partner or retired partner or the transfer by gift, will or intestate succession of any partner to his or her spouse or to the siblings, lineal descendants or ancestors of such partner or his or her spouse; (ii) that is a corporation to its stockholders in accordance with their interest in the corporation; (iii) that is a limited liability company to its members or former members in accordance with their interest in the limited liability company; or (iv) to the Purchaser’s family member or trust for the benefit of the individual Purchaser, if the transferee agrees in writing to be subject to the terms hereof to the same extent as if he or she were an original Purchaser hereunder.
 
SECTION 3.8.   Authorization; Enforcement .  The Purchaser has the requisite power and authority to enter into this Agreement and to consummate the transactions contemplated hereby and thereby.  The Purchaser has taken all necessary action to authorize the execution, delivery
 

 
-14-

 

and performance of this Agreement.  Upon the execution and delivery of this Agreement, this Agreement shall constitute a valid and binding obligation of the Purchaser enforceable in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ and contracting parties’ rights generally and except as enforceability may be subject to general principles of equity and except as rights to indemnity and contribution may be limited by applicable securities laws or public policy underlying such laws.
 
SECTION 3.9.   Residency .   The Purchaser is organized under the laws and the jurisdiction set forth immediately below such Purchaser’s name on the signature pages hereto.
 
SECTION 3.10.   No Short Sales .  During the period commencing at the time the Purchaser was first contacted with reference to the transactions contemplated hereunder, neither the Purchaser nor, to the Purchaser’s knowledge, any Affiliate of the Purchaser, foreign or domestic, has, directly or indirectly, effected or agreed to effect any “short sale” (as defined in Rule 200 under Regulation SHO), whether or not against the box, established any “put equivalent position” (as defined in Rule 16a-1(h) under the Exchange Act) with respect to the Ordinary Shares, borrowed or pre-borrowed any Ordinary Shares, or granted any other right (including, without limitation, any put or call option) with respect to the Ordinary Shares or with respect to any security that includes, relates to or derived any significant part of its value from the Ordinary Shares or otherwise sought to hedge its position in the Securities (each, a “ Prohibited Transaction ”).  Prior to the earliest to occur of (i) the termination of this Agreement, (ii) the date that the First Registration Statement becomes effective or (iii) the First Required Effectiveness Date, such Purchaser shall not engage, directly or indirectly, in a Prohibited Transaction.  Additionally, in the event that the Second Closing occurs, beginning on the date the Purchasers receive Notice from the Company and prior to the earliest to occur of (i) the date that the Second Registration Statement becomes effective or (ii) the Second Required Effectiveness Date, such Purchasers shall not engage, directly or indirectly, in a Prohibited Transaction.  Each Purchaser acknowledges that the representations, warranties and covenants contained in this Section 3.10 are being made for the benefit of the Purchasers as well as the Company and that each Purchaser shall have an independent right to assert any claims against any other Purchaser arising out of any breach or violation of the provisions of this Section 3.10.
 
SECTION 3.11.   Acknowledgments Regarding Placement Agent; Solicitation .  The Purchaser acknowledges that the Placement Agent is acting as the lead North American placement agent on a “best efforts” basis for the Securities being purchased hereunder and will be compensated by the Company for acting in such capacity.  The Purchaser represents that (i) the Purchaser was contacted regarding the sale of the Securities by the Placement Agent (or an authorized agent or representative thereof), with whom the Purchaser entered into a confidentiality agreement and (ii) the Purchaser did not become aware that the Securities were being offered for sale by means of any form of general solicitation or general advertising.
 
ARTICLE 4
 
COVENANTS
 
SECTION 4.1.   Conduct of Business .  During the period from the date of this Agreement until the First Closing, except as expressly set forth in this Agreement, the Company agrees that, without the prior written consent of a Majority of the Preference Share Purchasers (the parties hereto agree that, for purposes of this Section 4.1 and Section 4.2, references to the Company shall include each Subsidiary of the Company, such that each Subsidiary of the Company shall be
 

 
-15-

 

subject to, and bound by, the obligations and requirements contained in this Section 4.1 and Section 4.2, and the Company agrees to take such action as may be required to cause each such Subsidiary to comply with and be bound by this Section 4.1 and Section 4.2):
 
(a)   The Company’s business shall be conducted only in the ordinary course, in a manner consistent with past practice, and in compliance in all material respects with all applicable law;
 
(b)   The Company shall not (i) make or assist in making any change in, or amendment to, the governance or organizational documents of the Company or any material contract of the Company listed in Schedule 4.1(b) of the Disclosure Schedules (the “ Material Contracts ”); (ii) breach any Material Contract; or (iii) enter into any contract that requires the Company to pay, or entitles the Company to receive, in excess of $100,000 in any twelve month period;
 
(c)   The Company shall not (i) create, incur, assume, or guarantee any liability or Indebtedness, except trade payables incurred in the ordinary course of business, consistent with past practice; or (ii) loan or advance any funds;
 
(d)   Other than in the ordinary course of business, consistent with past practice, the Company shall not (i) acquire any property or asset; (ii) make any capital expenditure; (iii) sell, transfer, lease, assign, or dispose of, or agree to sell, transfer, lease, assign, or dispose of, any property or asset; or (iv) enter into any transaction or transactions;
 
(e)   The Company shall not make any distribution or pay any dividend in respect of its capital stock;
 
(f)   The Company shall not subject to any Lien, or permit any Lien to exist on, the leased real property or any other property or asset of the Company (other than Liens in existence as of the date hereof);
 
(g)   The Company shall not issue any (i) securities; (ii) options, warrants, puts, calls, commitments, agreements, contracts, preemptive, rights of first refusal, or other rights to purchase, issue, or otherwise acquire any securities of the Company; or (iii) obligations or securities convertible into or exchangeable for securities of the Company;
 
(h)   The Company shall maintain each of its insurance policies in existence as of the date hereof;
 
(i)   The Company shall not (i) enter into any employment or consulting agreement or arrangement; (ii) amend or modify any existing employment or consulting agreement or arrangement, or adopt, amend, modify, or terminate any employee benefit plan (except as provided in Section 5.2(o)); (iii) other than in the ordinary course of practice, consistent with past practice, terminate or modify the terms of employment of, any of the Company’s employees; or (iv) make any change in the rate of compensation, commission, bonus, benefits, or other direct or indirect remuneration payable to or in respect of any of the Company’s employees or consultants;
 
(j)   The Company shall not (i) release any claims, or waive any rights; or (ii) settle or compromise any litigation, action, proceeding, or claim involving any liability for
 

 
-16-

 

money damages or any restrictions upon any of its operations or that may be precedential with respect to other litigations, actions, proceedings, or claims that may involve such damages or restrictions;
 
(k)   The Company shall not change accounting principles, policies, practices, or related methodologies, or change any of its methods of reporting income and deductions for income tax purposes, except as required by changes in applicable law;
 
(l)   The Company shall not close any offices at which the Company’s business is conducted or open any new offices; and
 
(m)   The Company shall not make or change any tax election, change an annual accounting period, adopt or change any accounting method with respect to taxes, file any amended tax return, enter into any closing agreement, settle or compromise any proceeding with respect to any tax claim or assessment relating to the Company, surrender any right to claim a refund of taxes, consent to any extension or waiver of the limitation period applicable to any tax claim or assessment relating to the Company, or take any other similar action relating to the filing of any tax return or the payment of any tax.
 
SECTION 4.2.   Preservation of Business and Assets .  During the period from the date of this Agreement until the First Closing, the Company (a) shall use its commercially reasonable efforts to preserve the current business and goodwill of the Company, and (b) shall not change the fundamental nature or characteristics of its business from the business conducted as of the date hereof.
 
SECTION 4.3.   Notification .  During the period from the date of this Agreement until the First Closing, the Company shall promptly notify each Purchaser in writing of any fact, condition, event, or occurrence that (a) causes or constitutes a breach of any of the Company’s representations or warranties made as of the date of this Agreement or that would cause or constitute such a breach had such representation or warranty been made as of the time of occurrence or discovery of such fact, condition, event, or occurrence; (b) causes or constitutes a breach of any covenant of the Company under this Agreement or that may make satisfaction of any of the conditions in Section 5.2 impossible or unlikely; or (c) has or could reasonably be expected to have a Material Adverse Effect.  No such notification shall be deemed to modify the representations, warranties, or covenants of the Company contained in this Agreement for any purpose.
 
SECTION 4.4.   Access and Information .  During the period from the date of this Agreement until the First Closing, the Company shall give each Purchaser and its Affiliates and their respective accountants, counsel, and other representatives reasonable access during normal business hours to the Company’s offices, properties, books, contracts, commitments, reports, records, and personnel, and give them, or give them access to, the documents, financial data, records, and information with respect to the Company and its business as any Purchaser from time to time reasonably requests.
 
SECTION 4.5.   Further Actions .  Each party hereto shall, as promptly as practicable, use all commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary, proper, or advisable to fulfill its obligations under this Agreement and to consummate and make effective the transactions contemplated hereby.
 

 
-17-

 


 
SECTION 4.6.   Reporting Status .  The ADSs and the Ordinary Shares are registered under Section 12 of the Exchange Act.  During the Registration Period, the Company agrees to use commercially reasonable efforts to timely file all documents with the SEC, and the Company will not terminate its status as an issuer required to file reports under the Exchange Act even if the Exchange Act or the rules and regulations thereunder would permit such termination.
 
SECTION 4.7.   Financial Information .  The financial statements of the Company to be included in any documents to be filed with the SEC will be prepared in accordance with accounting standards permitted by the Exchange Act (including on the date hereof, International Financial Reporting Standards as adopted by the European Union), consistently applied (except as may be otherwise indicated in such financial statements or the notes thereto) and will fairly present in all material respects the consolidated financial position of the Company and consolidated results of its operations and cash flows as of, and for the periods covered by, such financial statements (subject, in the case of unaudited statements, to normal year-end audit adjustments).
 
SECTION 4.8.   Securities Laws Disclosure; Publicity .  On May 14, 2008, the Company shall issue a press release (subject to prior review and approval, not to be unreasonably withheld, by the Purchasers) announcing the signing of this Agreement and describing the terms of the transactions contemplated by this Agreement.  On or before May 16, 2008, the Company shall submit a Current Report on Form 6-K (subject to prior review and approval, not to be unreasonably withheld, by the Purchasers) to the SEC describing the terms of the transactions contemplated by this Agreement and including as an exhibit to such Current Report on Form 6-K, this Agreement in the form required by the Exchange Act.  The Company shall not otherwise publicly disclose the name of any Purchaser, or include the name of any Purchaser in any filing with the SEC (other than the Registration Statement and any exhibits to filings made in respect of this transaction in accordance with periodic filing requirements under the Exchange Act) or any regulatory agency, without the prior written consent of such Purchaser, except to the extent such disclosure is required by law or regulations.
 
SECTION 4.9.   Sales by the Purchasers .  Each Purchaser agrees that it will comply with the prospectus delivery requirements of the Securities Act as applicable to it in connection with the sales of Registrable Securities pursuant to a Registration Statement or otherwise comply with the requirements for an exemption from registration under the Securities Act and the rules and regulations promulgated thereunder.  No Purchaser will make any sale, transfer, pledge or other disposition of the Securities in violation of U.S. federal or state or foreign securities laws or the terms of this Agreement.  Without limiting the foregoing, the Purchasers acknowledge that, as a result of their representation on the Company’s Board of Directors or otherwise, they may from time to time come into possession of confidential information regarding the Company that may constitute “material non-public information” under the U.S. securities laws and agree not to trade in any securities of the Company while in possession of such information in a manner that would violate the U.S. securities laws or be inconsistent with the Company’s share dealing code.
 
SECTION 4.10.   Reservation of Ordinary Shares .  As of the date hereof, the Company has sufficient authorized and unissued share capital, and the Company shall continue to have sufficient authorized and unissued share capital for the purpose of enabling the Company to issue Securities pursuant to this Agreement, and including, if applicable, in connection with the Second Closing.
 

 
-18-

 


 
SECTION 4.11.   Preemptive Rights .
 
(a)   Each Purchaser shall have a right of first refusal to purchase up to such Purchaser’s pro rata share (as defined below) of any offering by the Company of Ordinary Shares or any other class or series of its capital stock, or any other securities convertible into or exchangeable for Ordinary Shares or any other class or series of capital stock (including convertible stock, redeemable stock and debt with warrants, but excluding any Exempt Securities, any issuances pursuant to the Company’s equity credit agreement with Brittany Capital Management Ltd. dated as of June 1, 2007 provided such issuance shall have been approved by the Supermajority Directors, and any issuances pursuant to the Additional Financing in accordance with Section 4.14 below), in each case on the same terms as the other investors participating in such offering.  Each Purchaser’s pro rata share shall be equal to the percentage of the Company’s outstanding Ordinary Shares that are owned by such Purchaser at the time of each such offering.
 
(b)   The Company shall provide written notice to each Purchaser that the Company is considering any proposed future financing subject to this Section 4.11(b), providing a general outline of the proposed structure and anticipated terms thereof, not less than 15 days prior to completion thereof (the “ Completion Date ”).  The Company shall also provide written notice to each such Purchaser describing in reasonable detail the terms of any such proposed future financing (the “ Detailed Notice ”) within a reasonable period of time (but not less than ten (10) days prior to the Completion Date).  Unless a Purchaser provides the Company notice in writing within five (5) days of its receipt of the Detailed Notice that it wishes to participate in such financing, such Purchaser’s right with respect to such proposed future financing shall be deemed waived.  Anything herein to the contrary notwithstanding, if required to accumulate from its investors the funds necessary to participate in any such financing, each Purchaser who has delivered timely notice of its intent to participate in such financing shall have up to fifteen (15) Business Days from the date it sent such notice of its intent to participate to fund its purchase even if any such period extends beyond the Completion Date.
 
(c)   The rights and obligations established pursuant to this Section 4.11 shall terminate if (i) a Special Rights Termination Event shall have occurred or (ii) the Purchasers cease to own in the aggregate at least 33% of the number of Securities purchased by them in the First Closing and Second Closing.
 
SECTION 4.12.   Private Foreign Investment Company; Controlled Foreign Corporation .
 
(a)   Upon request, the Company will provide each Purchaser all information needed to make a “Qualified Electing Fund” election pursuant to Section 1295 of the U.S. Internal Revenue Code of 1986, as amended (or any successor thereto) (the “ Code ”) and will provide each Purchaser a completed “PFIC Annual Information Statement” as required by Treasury Regulation Section 1.1295-1(g)(1) within sixty (60) days after the end of the Company’s taxable year.
 
(b)   The Company shall make due inquiry with its tax advisors on at least an annual basis regarding the Company’s status as a “Controlled Foreign Corporation” as defined in the Code (“ CFC ”) and regarding whether any portion of the Company’s income is “Subpart F Income” (as defined in Section 952 of the Code) (“ Subpart F Income ”).  Each Purchaser shall reasonably cooperate with the Company to provide information about such Purchaser and such
 

 
-19-

 

Purchaser’s Partners (as defined below) in order to enable the Company’s tax advisor’s to determine the status of such Purchaser and/or any of such Purchaser’s Partners as a “United States Shareholder” within the meaning of Section 951(b) of the Code.  No later than sixty (60) days following the end of each Company taxable year, the Company shall provide the following information to the Purchasers: (i) the Company’s capitalization table as of the end of the last day of such taxable year and (ii) a report regarding the Company’s status as a CFC.  In addition, the Company shall provide the Purchasers with access to such other Company information as may be necessary for the Purchasers to determine the Company’s status as a CFC and to determine whether Purchaser or any of Purchaser’s Partners is required to report its pro rata portion of the Company’s Subpart F Income on its United States federal income tax return, or to allow such Purchaser or such Purchaser’s Partners to otherwise comply with applicable United States federal income tax laws.   
 

 
-20-

 

For purposes of this provision, (A) the term “ Purchaser’s Partners ” means each of the Purchaser’s partners and any direct or indirect equity owners of such partners and (B) the “ Company ” means the Company and any of its Subsidiaries.
 
SECTION 4.13.   Additional Covenants .
 
(a)   Other than pursuant to an Additional Financing in accordance with Section 4.14 below, the Company shall not issue any Ordinary Shares or other securities in connection with the raising of additional financing or capital until all of the Securities issued in the First Closing have been registered for resale as provided in Article 6.
 
(b)   ********** Approximately 11 lines omitted **********
 
(c)   ********** Approximately 7 lines omitted **********
 
(d)   In advance of the Company’s next Annual General Meeting, the Board will propose such amendments to its Memorandum and Articles of Association as are necessary to (i) ensure to the maximum extent permitted by English law that the Preference Shares held by the Purchasers will entitle them to vote as a separate class without the vote of the holders of Ordinary Shares in all general, extraordinary, annual, or special meetings of the shareholders of the Company, and whether or not adjourned or postponed, for the election of the four (4) or five (5) (as the case may be) Directors as they will be entitled to elect pursuant to the provisions of the Preference Shares attached as Exhibit D hereto, and (ii) generally to bring the Memorandum and Articles of Association current with the 2006 amendments to the Companies Act.
 
(e)   At the first meeting of the Board of Directors following the First Closing, the committees of the Board will be re-constituted to consist of four (4) members each, with the members of each committee being appointed as provided in the provisions of the Preference Shares.
 
SECTION 4.14.   Additional Financing .  The Company shall have the right, but not the obligation, to issue and sell Ordinary Shares to certain of its directors (the “ Additional Financing Purchasers ”) in an additional financing (the “ Additional Financing ”); provided that all documentation for the Additional Financing (the “ Additional Financing Documentation ”) shall be in substantially the form most recently provided to the Purchasers prior to their execution of this Agreement; and provided , further , that:
 
(a)   the aggregate amount raised in the Additional Financing shall not exceed $4,000,000;
 
(b)   the Additional Financing shall be at the same price and on the same economic terms as those contemplated hereby;
 
(c)   the Additional Financing shall be funded in two (2) tranches, (A) the first of which shall equal 50% of the total Additional Financing and (B) the second of which shall
 
 
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS
.
 
 

 
-21-

 

equal 50% of the total Additional Financing (the “ Additional Financing Second Closing Amount ”); and
 
(d)   the proceeds received by the Company in the Additional Financing shall be applied in accordance with Section 4.13(b) above.
 
If any Additional Financing Purchaser funds less than such Additional Financing Purchaser’s full pro rata share of the Additional Financing Second Closing Amount (such unfunded amount shall be referred to herein as an “ Additional Financing Shortfall Amount ”), then upon consummation of the Second Closing the Additional Financing Purchasers that fund their full pro rata shares of the Additional Financing Second Closing Amount at the Second Closing shall have the right, but not the obligation, to fund any Additional Financing Shortfall Amount (in such proportions as such participating Additional Financing Purchasers shall determine in their sole discretion).
 
ARTICLE 5
 
CONDITIONS TO CLOSING
 
SECTION 5.1.   Conditions to the Company’s Obligations at the First Closing .  The Company’s obligation to complete the purchase and sale of the First Closing Securities in respect of each Purchaser in connection with the First Closing is subject to the fulfillment or waiver as of the First Closing Date of the following conditions in respect of such Purchaser:
 
(a)   Receipt of Funds .  The Company shall have received immediately available funds, in US dollars, in the full amount of the First Closing Purchase Price as set forth opposite such Purchaser’s name on Exhibit A hereto.
 
(b)   Representations and Warranties .  The representations and warranties made by such Purchaser in Article 3 shall be true and correct in all material respects as of the date such representation and warranty was made and as of the First Closing Date.
 
(c)   Covenants .  All covenants, agreements and conditions contained in this Agreement to be performed by such Purchaser on or prior to the First Closing Date shall have been performed or complied with in all material respects.
 
(d)   Absence of Litigation .  No proceeding challenging this Agreement or the transactions contemplated hereby, or seeking to prohibit, alter, prevent or materially delay the First Closing, shall have been instituted, threatened or be pending before any court, arbitrator, official or Governmental Authority.
 
(e)   No Governmental Prohibition .  The sale of the First Closing Securities by the Company to such Purchaser shall not be prohibited by any law or governmental order or regulation.
 
(f)   Full Funding .  Each of the other Purchasers shall have paid in full the aggregate First Closing Purchase Price as set forth opposite each such Purchaser’s name on Exhibit A .
 

 
-22-

 


 
SECTION 5.2.   Conditions to Each Purchaser’s Obligations at the First Closing .  Each Purchaser’s obligation to complete the purchase and sale of the First Closing Securities is subject to the fulfillment or waiver as of the First Closing Date of the following conditions:
 
(a)   Representations and Warranties .  The representations and warranties made by the Company in Article 2, if made without reference to materiality or a Material Adverse Effect shall be true and correct in all material respects and if made subject to materiality or with reference to a Material Adverse Effect shall be true and correct as written, in each case as of the date such representation and warranty was made and as of the First Closing Date.
 
(b)   Covenants .  All covenants, agreements and conditions contained in this Agreement to be performed by the Company on or prior to the First Closing Date shall have been performed or complied with in all material respects.
 
(c)   Material Adverse Effect .  There shall have been no Material Adverse Effect with respect to the Company since September 30, 2007.
 
(d)   Other Documentation .  The Company shall have delivered such other certificates, instruments, opinions and other documents as the Purchasers may reasonably request, and the Purchasers shall have received such documents and certificates of officers of the Company to verify the satisfaction of the conditions set forth in Sections 5.2(a) and (b), and the form and substance of all certificates, instruments, opinions and other documents delivered to the Purchasers under this Agreement shall be satisfactory in all reasonable respects to the Purchasers
 
(e)   Legal Opinions .
 
(i)   The Company shall have delivered to the Purchasers an opinion, dated as of the First Closing Date, from each of (x) KL Gates LLP, UK counsel to the Company, in form and substance reasonably acceptable to the Purchasers, and (y) Cahill Gordon & Reindel llp , US counsel to the Company, in substantially the form attached hereto as Exhibit C ; and
 
(ii)   Each Purchaser whose fund documents so require shall have received an opinion, dated as of the First Closing Date, from counsel in the Republic of Ireland and the United Kingdom regarding the continued limited liability of such Purchaser’s limited partners and the tax effects on such limited partners of the transactions contemplated by this Agreement, in each case reasonably acceptable to such Purchaser.
 
(f)   Depositary Account Statements .  The Company shall have delivered to its ADS depositary, with a copy to each Purchaser, irrevocable instructions to issue to such Purchaser, on an expedited basis, one or more account statements in the name of such Purchaser reflecting the number of First Closing Ordinary Shares set forth opposite such Purchaser’s name on Exhibit A hereto.
 
(g)   Absence of Litigation .  No proceeding challenging this Agreement or the transactions contemplated hereby, or seeking to prohibit, alter, prevent or materially delay the
 

 
-23-

 

First Closing, shall have been instituted, threatened or be pending before any court, arbitrator, official or Governmental Authority.
 
(h)   Full Funding .  Each of the other Purchasers shall have paid in full the Aggregate First Closing Purchase Price as set forth opposite each such Purchaser’s name on Exhibit A .
 
(i)   No Governmental Prohibition .  The sale of the First Closing Securities by the Company to such Purchaser shall not be prohibited by any law or governmental order or regulation.
 
(j)   Governmental Approvals .  All actions and approvals, consents, or waivers by or in respect of, or filings with, any Governmental Authority required to be taken, obtained, or made in connection with, or to permit, the consummation of the transactions contemplated by this Agreement shall have been taken, obtained, or made, including, without limitation, all such actions, approvals, consents, waivers, or filings that may be required by the anti-competition laws of the European Union.
 
(k)   Preference Shares .  The Company shall have delivered to each Purchaser, one or more certificates in the name of the Purchaser evidencing the number of Preference Shares set forth opposite such Purchaser’s name on Exhibit A .
 
(l)   Board Resolutions .  The Company shall have delivered to the Purchasers a certified copy of the resolutions of its Board of Directors (i) approving the creation of the Preference Shares, including the rights, preferences and designations thereto, this Agreement and the transactions contemplated hereby, and (ii) establishing that the quorum necessary for the transaction of the business of the Company’s Board of Directors shall be six (6) directors, comprising three (3) Directors who shall have been elected or appointed to the Board pursuant to the provisions of the Preference Shares and any three (3) directors other than directors who have been elected or appointed to the Board of Directors pursuant to the provisions of the Preference Shares, in each case, in form and substance reasonably acceptable to the Purchasers.
 
(m)   Board of Directors .
 
(i)   The Company’s Board of Directors shall consist of not more than eight directors, four (4) of whom shall be the following designees of the Purchasers: James I. Healy, Carl L. Gordon, Srinivas Akkaraju, and Eric Aguiar.
 
(ii)   The Company shall have delivered to the Purchasers copies of the resignations of the directors that were required to be received to produce the result set forth in Section 5.2(m)(i) abo ve.
 
(iii)   Lars Ekman shall have been appointed as an observer to the Board of Directors and as a member of the Company’s Scientific Advisory Board.
 
(iv)   The Company and the Purchasers shall have entered into a letter agreement, in form and substance reasonably acceptable to the Company and a Majority of the Preference Share Purchasers, with respect to the operations and structure of the Board of Directors.
 

 
-24-

 


 
(n)   Additional Financing Documentation .  In accordance with Section 4.14 hereof, the Company shall have delivered to the Purchasers fully executed copies of the Additional Financing Documentation.
 
(o)   Amendments to Employment Agreements .
 
(i)   The employment agreement of Alan Cooke shall have been amended (in form and substance reasonably acceptable to the Purchaser) so as to delete from such employment agreement the Company’s obligation to appoint Alan Cooke to the Company’s Board of Directors.
 
(ii)   ********** Approximately 5 lines omitted ********** *
 
(p)   Voting Agreement .  Tom Lynch (and/or Amarin Investment Holding Limited, as applicable), IIU Nominees Ltd., Michael Walsh, Simon Kukes and Sunninghill Limited (each, a “ Shareholder ”) will have entered into voting agreements reasonably satisfactory to the Purchasers whereby each Shareholder severally and not jointly, and solely with respect to the ADSs and Ordinary Shares held of record by such Shareholder, will agree that (i) at any meeting (whether general, extraordinary, annual or special and whether or not an adjourned or postponed meeting) of the holders of Ordinary Shares, however called, or in connection with any written consent of the holders of Ordinary Shares, such Shareholder shall vote (or cause to be voted) all of the ADSs and Ordinary Shares held of record by such Shareholder in favor of (A) amendments to the Memorandum and Articles of Association as are necessary to ensure to the maximum extent permitted by English law that the Preference Shares held by the Purchasers will entitle them to vote as a separate class without the vote of the holders of Ordinary Shares for the election of the four (4) or five (5) (as the case may be) Directors as they will be entitled to elect pursuant to the provisions of the Preference Shares attached as Exhibit D to this Agreement, (B) the Second Closing, ratifying the execution, delivery and performance of this Agreement and the approval and adoption of the terms hereof and each of the other actions contemplated herein and (C) such amendments to the Memorandum and Articles of Association as are determined by the Board to be necessary generally to bring the Memorandum and Articles of Association current with the 2006 amendments to the Companies Act and (ii) such Shareholder shall not enter into any agreement or understanding with any Person the effect of which would be inconsistent with or violative of such voting agreements.
 
SECTION 5.3.   Conditions to the Company’s Obligations at the Second Closing .  The Company’s obligation to complete the purchase and sale of the Second Closing Securities in respect of each Purchaser contemplated by the Second Closing is subject to the fulfillment or waiver as of the Second Closing Date of the following conditions in respect of such Purchaser:
 

 
 
  CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
  WITH THE SECURITIES AND EXCHANGE COMMISSION.
  ASTERISKS (*) DENOTE SUCH OMISSIONS.
 

 
-25-

 


 
(a)   Receipt of Funds .  The Company shall have received immediately available funds, in US dollars, in an amount equal to at least 75% of the Second Closing Amount.
 
(b)   Representations and Warranties .  The representations and warranties made by such Purchaser in Article 3 (other than the representations and warranties made in Sections 3.4, 3.9 and 3.11), shall be true and correct in all material respects as of the date such representation and warranty was made and as of the Second Closing Date.
 
(c)   Covenants .  All covenants, agreements and conditions contained in this Agreement to be performed by such Purchaser on or prior to the Second Closing Date shall have been performed or complied with in all material respects.
 
(d)   Absence of Litigation .  No proceeding challenging this Agreement or the transactions contemplated hereby, or seeking to prohibit, alter, prevent or materially delay the Second Closing, shall have been instituted, threatened or be pending before any court, arbitrator, official or Governmental Authority.
 
(e)   No Governmental Prohibition .  The sale of the Second Closing Securities by the Company shall not be prohibited by any law or governmental order or regulation.
 
SECTION 5.4.   Conditions to Each Purchaser’s Obligations at the Second Closing .  Each Purchaser’s obligation to complete the purchase and sale of the Second Closing Securities contemplated by the Second Closing is subject to the fulfillment or waiver as of the Second Closing Date of the following conditions:
 
(a)   Representations and Warranties .  The representations and warranties made by the Company in Article 2 (other than the representations and warranties made in Sections 2.7, 2.15, 2.25 and 2.26), if made not subject to materiality or without reference to a Material Adverse Effect shall be true and correct in all material respects and if made subject to materiality or with references to a Material Adverse Effect shall be true and correct as written, in each case as of the date such representation and warranty was made, as of the First Closing Date and as of the Second Closing Date; provided that any reference in Article 2 to the Draft Annual Report shall be deemed to refer to the SEC Documents; and provided further that the representation in Section 2.4 may be updated to reflect the First Closing, the issuance of Exempt Securities (if any), and any issuance of securities pursuant to the Additional Financing, without such changes constituting non-fulfillment of this condition.
 
(b)   Covenants .  All covenants, agreements and conditions contained in this Agreement to be performed by the Company on or prior to the Second Closing Date shall have been performed or complied with in all material respects.
 
(c)   Legal Opinions .
 
(i)   The Company shall have delivered to the Purchasers an opinion, dated as of the Second Closing Date, from each of (x) KL Gates LLP, UK counsel to the Company, in substantially the form delivered at the First Closing but relating only to the Second Closing Securities and (y) Cahill Gordon & Reindel llp , US counsel to
 

 
-26-

 

the Company, in substantially the form attached hereto as Exhibit C , but relating only to the Second Closing Securities; and
 
(ii)   Each Purchaser whose fund documents so require shall have received an opinion, dated as of the First Closing Date, from counsel in the Republic of Ireland and the United Kingdom regarding the continued limited liability of such Purchaser’s limited partners and the tax effects on such limited partners of the transactions contemplated by this Agreement, in each case in substantially the form delivered at the First Closing pursuant to Section 5.2(e)(i) but relating only to the Second Closing Securities.
 
(d)   Depositary Account Statements .  The Company shall have delivered to its ADS depositary, with a copy to the Purchaser, irrevocable instructions to issue to such Purchaser, on an expedited basis, one or more account statements in the name of such Purchaser reflecting the number of Second Closing Securities to be purchased by such Purchaser as determined in accordance with Section 1.1(b).
 
(e)   Absence of Litigation .  No proceeding challenging this Agreement or the transactions contemplated hereby, or seeking to prohibit, alter, prevent or materially delay the Second Closing, shall have been instituted, threatened or be pending before any court, arbitrator, official or Governmental Authority.
 
(f)   No Governmental Prohibition .  The sale of the Second Closing Securities by the Company to such Purchaser shall not be prohibited by any law or governmental order or regulation.
 
(g)   Receipt of Funds .  Other Purchasers shall have paid, in the aggregate, not less than that portion of the aggregate Second Closing Purchase Price which, when added to the Second Closing Purchase Price to be paid by such Purchaser, equals at least 75% of the Second Closing Amount.
 
(h)   Governmental Approvals .  All actions and approvals, consents, or waivers by or in respect of, or filings with, any Governmental Authority required to be taken, obtained, or made in connection with, or to permit, the consummation of the transactions contemplated by this Agreement shall have been taken, obtained, or made, including, without limitation, all such actions, approvals, consents, waivers, or filings that may be required by the anti-competition laws of the European Union.
 
(i)   Other Documentation .  The Company shall have delivered such other certificates, instruments, opinions and other documents as the Purchasers may reasonably request, and the Purchasers shall have received such documents and certificates of officers of the Company to verify the satisfaction of the conditions set forth in Sections 5.4(a) and (b), and the form and substance of all certificates, instruments, opinions and other documents delivered to the Purchasers under this Agreement shall be satisfactory in all reasonable respects to the Purchasers.
 

 
-27-

 


 
ARTICLE 6
 
REGISTRATION RIGHTS
 
SECTION 6.1.   Registration Statements .
 
(a)   As soon as reasonably practicable, but in no event later than sixty (60) days after the First Closing Date (the “ First Filing Date ”), the Company shall prepare and file a registration statement (the “ First Registration Statement ”) covering the resale on a continuous or delayed basis by the Holders of all of the Registrable Securities issued in connection with the First Closing with the SEC pursuant to Rule 415 and shall use its commercially reasonable efforts to cause the First Registration Statement to become effective under the Securities Act not later than the later of (i) ninety (90) days after the initial filing of such First Registration Statement or (ii) one hundred fifty (150) days after the Closing Date or, in the event of a “review” by the SEC, not later than the later of (i) one hundred twenty (120) days after the initial filing of such First Registration Statement or (ii) one hundred eighty (180) days after the First Closing Date (the “ First Required Effectiveness Date ”).
 
(b)   If the Second Closing occurs, then as soon as reasonably practicable, but in no event later than sixty (60) days after the Second Closing Date (the “ Second Filing Date ”), the Company shall prepare and file a registration statement (the “ Second Registration Statement ” and, together with the First Registration Statement, the “ Registration Statements ”) covering the resale on a continuous or delayed basis by the Holders of all of the Registrable Securities issued in connection with the Second Closing with the SEC pursuant to Rule 415 and shall use its commercially reasonable efforts to cause the Second Registration Statement to become effective under the Securities Act not later than the later of (i) ninety (90) days after the initial filing of such Second Registration Statement or (ii) one hundred fifty (150) days after the Closing Date or, in the event of a “review” by the SEC, not later than the later of (i) one hundred twenty (120) days after the initial filing of such Second Registration Statement or (ii) one hundred eighty (180) days after the Second Closing Date (the “ Second Required Effectiveness Date ”).
 
(c)   The Company’s shareholders (other than the Holders and the Additional Financing Purchasers) shall not have the right to include any of the Company’s securities in the Registration Statements.
 
(d)   The Company agrees that it shall cause each Registration Statement and the related prospectus and any amendment or supplement thereto, as of the effective date of the Registration Statement or such amendment or supplement, (i) to comply in all material respects with the applicable requirements of the Securities Act, and (ii) not to contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein (in the case of the prospectus, in the light of the circumstances under which they were made) not misleading, and the Company agrees to furnish to the Holders copies of any supplement or amendment upon the request of such Holder prior to its being used or promptly following its filing with the SEC; provided, however , that the Company shall have no obligation to deliver to the Holders copies of any amendment consisting exclusively of an Exchange Act report or other Exchange Act filing otherwise publicly available on the Company’s website.
 

 
-28-

 


 
SECTION 6.2.   Registration Expenses .  All Registration Expenses shall be borne by the Company.  All Selling Expenses relating to the sale of securities registered by or on behalf of Holders shall be borne by such Holders pro rata on the basis of the number of securities so registered.
 
SECTION 6.3.   Registration Default .  The Company further agrees that, in the event that (a) the First or Second Registration Statements (i) have not been filed with the SEC within 60 days after the First or Second Closing Date, respectively, (ii) have not been declared effective by the SEC by the First or Second Required Effectiveness Dates, respectively, or (iii) after either of the First or Second Registration Statements are declared effective by the SEC, either or both are suspended by the Company or cease to remain continuously effective at all times during the Registration Period as to all applicable Registrable Securities for which such Registration Statement is required to be effective, other than, in each case, within the time period(s) permitted by Section 6.7(b), or (b) the Company has failed to perform its obligations set forth in Section 6.4 within the time periods required therein (each such event referred to in clauses (a)(i), (ii) and (iii) and clause (b), a “ Registration Default ”), for all or part of one or more thirty-day periods (each a “ Penalty Period ”) during which the Registration Default remains uncured, the Company shall pay to each Purchaser 1% of such Purchaser’s aggregate purchase price of its Securities for each Penalty Period (or partial Penalty Period) during which the Registration Default remains uncured; provided , however , that if the primary cause of a Registration Default is a Purchaser’s failure to provide the Company with any information that is required to be provided in the applicable Registration Statement with respect to such Purchaser as set forth herein, then the commencement of the Penalty Period described above shall be extended until two Business Days following the date of receipt by the Company of such required information; and provided , further , that in no event shall the Company be required hereunder to pay to any Purchaser pursuant to this Agreement an aggregate amount that exceeds 10% of the aggregate First Closing Purchase Price and, if applicable, Second Closing Purchase Price paid by such Purchaser for such Purchaser’s Securities.  The Company shall deliver said cash payment to the Purchaser by the fifth Business Day after the end of each such Penalty Period.  If the Company fails to pay said cash payment to the Purchasers in full by the fifth Business Day after the end of such Penalty Period, the Company will pay interest thereon at a rate of 12% per annum (or such lesser maximum amount that is permitted to be paid by applicable law) to the Purchasers, accruing daily from the date such liquidated damages are due until such amounts, plus all such interest thereon, are paid in full.  The cash payments provided by this Section 6.3 shall be in addition to, and not in lieu of, such other damages as each Purchaser may establish in connection with each Registration Default.
 
SECTION 6.4.   Registration Procedures. At its expense the Company shall:
 
(a)   (i)  prepare and file with the SEC, in accordance with this Article 6, Registration Statements with respect to the registrations of the Registrable Securities on any forms which may be utilized by the Company and which shall permit the disposition of the Registrable Securities in accordance with the intended method or methods thereof, as specified in writing by the Holders, and, except for such times as the Company is permitted hereunder to suspend the use of the prospectus forming part of the Registration Statements as provided in Section 6.7(b), use its commercially reasonable efforts to keep such Registration Statements continuously effective with respect to a Holder and to keep such Registration Statements free of any material misstatements or omissions, until the earlier of (A) the date all Registrable Securities have been sold pursuant to effective Registration Statements and (B) the date that all Registrable Securities can be sold by all Holders publicly under Rule 144 under the Securities Act without restriction as to current public information, volume, manner of sale, or
 

 
-29-

 

otherwise.  The period of time during which the Company is required hereunder to keep the Registration Statements effective, as provided in the immediately preceding sentence, is referred to herein as the “ Registration Period ”; and (ii) use its commercially reasonable efforts to prepare and file with the SEC such amendments and post-effective amendments to the Registration Statements and file with the SEC any other required document as may be necessary to keep such Registration Statements continuously effective until the expiration of the Registration Period; cause the related prospectus to be supplemented by any required prospectus supplement, and as so supplemented to be filed pursuant to Rule 424 (or any similar provisions then in force) under the Securities Act; and comply with the provisions of the Securities Act applicable to it with respect to the disposition of all Registrable Securities covered by such Registration Statements during the Registration Period in accordance with the intended methods of disposition by the sellers thereof set forth in such Registration Statements as so amended or such prospectus as so supplemented;
 
(b)   advise the Holders within five Business Days:
 
(i)   when the Registration Statements or any amendment thereto have been filed with the SEC and when the Registration Statements or any post-effective amendments thereto has become effective;
 
(ii)   of any request by the SEC for amendments or supplements to the Registration Statements or the prospectus included therein or for additional information;
 
(iii)   of the issuance by the SEC of any stop order suspending the effectiveness of the Registration Statements or the initiation of any proceedings for such purpose;
 
(iv)   of the receipt by the Company of any notification with respect to the suspension of the qualification of the Registrable Securities included therein for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; and
 
(v)   of the occurrence of any event that requires the making of any changes in the Registration Statements or the prospectus so that, as of such date, the statements therein are not misleading and do not omit to state a material fact required to be stated therein or necessary to make the statements therein (in the case of the prospectus, in the light of the circumstances under which they were made) not misleading;
 
(c)   use its commercially reasonable efforts to prevent the issuance of and obtain the withdrawal of any order suspending the effectiveness of any Registration Statement as soon as reasonably practicable;
 
(d)   if a Holder so requests in writing, promptly furnish to each such Holder, without charge, at least one copy of such Registration Statement(s) and any post-effective amendment thereto, including financial statements and schedules and, if explicitly requested, all exhibits in the form filed with the SEC;
 

 
-30-

 


 
(e)   during the Registration Period, promptly deliver to each such Holder, without charge, as many copies of the prospectus included in such Registration Statements and any amendments or supplements thereto as such Holder may reasonably request in writing; and the Company consents to the use, consistent with the provisions hereof, of the prospectus or any amendment or supplement thereto by each of the selling Holders of Registrable Securities in connection with the offering and sale of the Registrable Securities covered by the prospectus or any amendment or supplement thereto;
 
(f)   during the Registration Period, if a Holder so requests in writing, promptly deliver to each such Holder, without charge one copy of the following documents, other than those documents available via EDGAR:  (i) its annual report to its shareholders, if any (which annual report shall contain financial statements audited in accordance with GAAP in the United States of America by a firm of certified public accountants of recognized standing), (ii) if not included in substance in its annual report to shareholders, its annual report on Form 20-F (or similar form), (iii) its definitive proxy statement with respect to its annual meeting of shareholders, (iv) each of its interim reports to its shareholders and, if not included in substance in its interim reports to shareholders, its interim report on Form 6-K (or similar form);
 
(g)   prior to any public offering of Registrable Securities pursuant to either Registration Statement, promptly take such actions as may be necessary to register or qualify or obtain an exemption for the offer and sale under the securities or blue sky laws of such United States jurisdictions as any such Holders reasonably request in writing, provided that the Company shall not for any such purpose be required to qualify generally to transact business as a foreign corporation in any jurisdiction where it is not so qualified or to consent to general service of process in any such jurisdiction, and do any and all other acts or things reasonably necessary or advisable to enable the offer and sale in such jurisdictions of the Registrable Securities covered by such Registration Statement;
 
(h)   upon the occurrence of any event contemplated by Section 6.4(b)(v) above, except for such times as the Company is permitted hereunder to suspend the use of the prospectus forming part of the Registration Statements, use its commercially reasonable efforts to prepare as soon as reasonably practicable a post-effective amendment to the Registration Statements or a supplement to the related prospectus, or file any other required document so that, as thereafter delivered to purchasers of the Registrable Securities included therein, the prospectus will not include any untrue statement of a material fact or omit to state any material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading;
 
(i)   otherwise use its commercially reasonable efforts to comply in all material respects with all applicable rules and regulations of the SEC which could affect the sale of the Registrable Securities;
 
(j)   use its commercially reasonable efforts to cause all Registrable Securities to be listed on Nasdaq;
 

 
-31-

 


 
(k)   use its commercially reasonable efforts to take all other steps necessary to effect the registration of the Registrable Securities contemplated hereby and to enable the Holders to sell Registrable Securities under Rule 144;
 
(l)   provide to each Purchaser and its representatives, if requested, the opportunity to conduct a reasonable inquiry of the Company’s financial and other records during normal business hours and make available its officers, directors and employees for questions regarding information which such Purchaser may reasonably request in order to conduct any due diligence obligation on its part; and
 
(m)   permit a single counsel for the Purchasers to review the Registration Statements and all amendments and supplements thereto, within two Business Days prior to the filing thereof with the SEC;
 
provided that, in the case of clauses (l) and (m) above, the Company shall not be required (A) to delay the filing of the Registration Statements or any amendment or supplement thereto as a result of any ongoing diligence inquiry by or on behalf of a Holder or to incorporate any comments to the Registration Statements or any amendment or supplement thereto by or on behalf of a Holder if such inquiry or comments would require a delay in the filing of such Registration Statements, amendments or supplements, as the case may be, or (B) to provide, and shall not provide, any Purchaser or its representatives with material, non-public information unless such Purchaser agrees to receive such information and enters into a written confidentiality agreement with the Company in a form reasonably acceptable to the Company.
 
SECTION 6.5.   Limitations on Restraining Registration .  Neither the Company nor any Holder shall have any right to take any action to restrain, enjoin or otherwise delay any registration pursuant to Section 6.1 hereof as a result of any controversy that may arise with respect to the interpretation or implementation of this Agreement.
 
SECTION 6.6.   Indemnification .
 
(a)   Indemnification by the Company .   To the extent permitted by law, the Company shall indemnify each Holder, each of such Holder’s officers and directors, and each Person controlling such Holder within the meaning of Section 15 of the Securities Act, with respect to any registration that has been effected pursuant to this Agreement, against all claims, losses, damages and liabilities (and all Proceedings in respect thereof), including any of the foregoing incurred in settlement of any Proceeding, commenced or threatened (subject to Section 6.6(c) below), arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in the Registration Statements, prospectuses, any amendments or supplements thereof, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances in which they were made, not misleading, and will reimburse each Holder and each Person controlling such Holder for reasonable legal and other out-of-pocket expenses reasonably incurred in connection with investigating or defending any such claim, loss, damage, liability or Proceeding, as such expenses are incurred; provided that the Company will not be liable in any such case to the extent that any untrue statement or omission or allegation thereof is made in reliance upon and in conformity with written information furnished to the Company by or on behalf of such Holder for use in preparation of such Registration Statements, prospectuses, amendments or supplements; and
 

 
-32-

 

provided, further, that the Company will not be liable in any such case where the claim, loss, damage or liability arises out of or is related to the failure of such Holder to comply with the covenants and agreements of such Holder contained in this Agreement respecting sales of Registrable Securities, and except that the foregoing indemnity agreement is subject to the condition that, insofar as it relates to any such untrue statement or alleged untrue statement or omission or alleged omission made in the preliminary prospectuses but eliminated or remedied in the amended prospectuses on file with the SEC at the time the Registration Statements become effective or in the amended prospectuses filed with the SEC pursuant to Rule 424(b) or in the prospectuses subject to completion under Rule 434 of the Securities Act, which together meet the requirements of Section 10(a) of the Securities Act (the “ Final Prospectuses ”), such indemnity shall not inure to the benefit of any such Holder or any controlling Person of such Holder, if a copy of the Final Prospectuses furnished by the Company to the Holder for delivery was required to be but was not furnished to the Person or entity asserting the loss, liability, claim or damage at or prior to the time such furnishing is required by the Securities Act and the Final Prospectuses would have cured the defect giving rise to such loss, liability, claim or damage.
 
(b)   Indemnification by the Holder .   To the extent permitted by law, each Holder will severally, and not jointly, indemnify the Company, each of its directors and officers, and each Person who controls the Company within the meaning of Section 15 of the Securities Act, against all claims, losses, damages and liabilities (and all Proceedings in respect thereof), including any of the foregoing incurred in settlement of any Proceeding, commenced or threatened (subject to Section 6.6(c) below), arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in the Registration Statements, prospectuses, or any amendments or supplements thereof, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in the light of the circumstances in which they were made, and will reimburse the Company, such directors and officers, and each Person controlling the Company for reasonable legal and any other expenses reasonably incurred in connection with investigating or defending any such claim, loss, damage, liability or Proceeding, as such expenses are incurred, in each case to the extent, but only to the extent, that such untrue statement or omission or allegation thereof is made in reliance upon and in conformity with written information furnished to the Company by or on behalf of the Holder for use in preparation of the Registration Statements, prospectuses, amendments or supplements; provided that the indemnity shall not apply to the extent that such claim, loss, damage or liability results from the fact that a current copy of the prospectuses was not made available to the person or entity asserting the loss, liability, claim or damage at or prior to the time such furnishing is required by the Securities Act and the Final Prospectuses would have cured the defect giving rise to such loss, claim, damage or liability.  Notwithstanding the foregoing, a Holder’s aggregate liability pursuant to this subsection (b) and subsection (d) shall be limited to the net amount received by the Holder from the sale of the Registrable Securities.
 
(c)   Conduct of Indemnification Proceedings .   Each party entitled to indemnification under this Section 6.6 (for purposes of this Section 6.6, the “ Indemnified Party ”) shall give notice to the party required to provide indemnification (for purposes of this Section 6.6, the “ Indemnifying Party ”) promptly after such Indemnified Party has actual knowledge of any claim as to which indemnity may be sought, and shall permit the Indemnifying Party (at its expense) to assume the defense of any such claim or any Proceeding resulting therefrom, provided that counsel for the Indemnifying Party, who shall conduct the defense of such claim or Proceeding, shall be approved by the Indemnified Party (whose approval shall not unreasonably be withheld), and the Indemnified Party may participate in such defense at such Indemnified Party’s expense, and provided further that the failure of any Indemnified Party to give notice as provided
 

 
-33-

 

herein shall not relieve the Indemnifying Party of its obligations under this Agreement, unless such failure is materially prejudicial to the Indemnifying Party in defending such claim or litigation.  An Indemnifying Party shall not be liable for any settlement of an action or claim effected without its written consent (which consent will not be unreasonably withheld).  No Indemnifying Party, in its defense of any such claim or litigation, shall, except with the consent of each Indemnified Party, consent to entry of any judgment or enter into any settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party and Indemnifying Party of a release from all liability in respect to such claim or litigation or which admits liability or fault on the part of the Indemnified Party.
 
(d)   Contribution .  If the indemnification provided for in this Section 6.6 is held by a court of competent jurisdiction to be unavailable to an Indemnified Party with respect to any loss, liability, claim, damage or expense referred to therein, then the Indemnifying Party, in lieu of indemnifying such Indemnified Party thereunder, shall contribute to the amount paid or payable by such Indemnified Party as a result of such loss, liability, claim, damage or expense in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party on the one hand and of the Indemnified Party on the other in connection with the statements or omissions which resulted in such loss, liability, claim, damage or expense as well as any other relevant equitable considerations.  The relative fault of the Indemnifying Party and of the Indemnified Party shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission to state a material fact relates to information supplied by the Indemnifying Party or by the Indemnified Party and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.
 
(e)   Survival .  The provisions of this Section 6.6 shall remain in full force and effect, and shall survive the sale by a Holder of Registrable Securities covered by the Registration Statements.
 
SECTION 6.7.   Dispositions .
 
(a)   Each Holder agrees that, upon receipt of any notice from the Company of the happening of any event requiring the preparation of a supplement or amendment to a prospectus relating to Registrable Securities so that, as thereafter delivered to the Holders, such prospectus shall not contain an untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading, each Holder will forthwith discontinue disposition of Registrable Securities pursuant to the Registration Statements and prospectuses contemplated by Section 6.1 until its receipt of copies of the supplemented or amended prospectus from the Company and, if so directed by the Company, each Holder shall deliver to the Company all copies, other than permanent file copies then in such Holder’s possession, of the prospectus covering such Registrable Securities current at the time of receipt of such notice.
 
(b)   Each Holder shall suspend, upon request of the Company, any disposition of Registrable Securities pursuant to the Registration Statements and prospectuses contemplated by Section 6.1 during no more than two periods of no more than 60 calendar days each during any 12-month period to the extent that the Company’s Board of Directors determines in good faith that the sale of Registrable Securities under the Registration Statements would be reasonably likely to cause a violation of the Securities Act or Exchange Act.
 

 
-34-

 


 
(c)   As a condition to the inclusion of its Registrable Securities in the Registration Statements, each Holder shall timely furnish to the Company such information regarding such Holder and the distribution proposed by such Holder as the Company may reasonably request in writing, including completing a Registration Questionnaire in the form provided by the Company, or as shall be required in connection with any registration referred to in this Article 6.
 
(d)   Each Holder hereby covenants with the Company not to make any sale of the Registrable Securities under the Registration Statements without effectively causing the prospectus delivery requirements under the Securities Act to be satisfied.
 
(e)   Each Holder acknowledges and agrees that the Registrable Securities sold pursuant to the Registration Statements are not transferable on the books of the depositary in the form of ADSs except in accordance with the Depositary Letter.  Each Holder further acknowledges and agrees that the only public market in the Registrable Securities in the U.S. is in the form of ADSs and that no Registrable Securities may be deposited into the Company’s ADS facility other than in compliance with the legend described in Section 3.8(a) hereof.
 
(f)   Each Holder agrees not to take any action with respect to any distribution deemed to be made pursuant to such Registration Statements that would constitute a violation of Regulation M under the Exchange Act or any other applicable rule, regulation or law.
 
(g)   Following termination of the Registration Period, the Holders shall discontinue sales of Ordinary Shares and/or ADSs pursuant to the Registration Statements upon receipt of notice from the Company of its intention to remove from registration the Ordinary Shares and/or ADSs covered by such Registration Statements that remain unsold, and such Holders shall notify the Company of the number of Ordinary Shares and/or ADSs registered that remain unsold promptly following receipt of such notice from the Company.
 
SECTION 6.8.   Registration Exemptions .  With a view to making available to the Holders the benefits of certain rules and regulations of the SEC which at any time permit the sale of the Registrable Securities to the public without registration, so long as any Holder still owns Registrable Securities, the Company shall use its commercially reasonable efforts to:
 
(a)   make and keep public information available, as those terms are understood and defined in Rule 144, at all times;
 
(b)   file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act; and
 
(c)   so long as a Holder owns any Registrable Securities, furnish to such Holder, upon any reasonable request, a written statement by the Company as to its compliance with clauses (a) and (b) of this Section 6.8, a copy of the most recent annual report of the Company, and such other reports and documents of the Company as such Holder may reasonably request in availing itself of any rule or regulation of the SEC allowing a Holder to sell any such securities without registration.
 

 
-35-

 


 
SECTION 6.9.   Assignment .  The rights to cause the Company to register Registrable Securities granted to the Holders by the Company under Section 6.1 may be assigned by a Holder in connection with a transfer by such Holder of all or a portion of its Registrable Securities; provided , that (i) such transfer must be effected in accordance with applicable securities laws; (ii) such transferee must agree to comply with the terms and provisions of this Agreement, and (iii) such transfer must be otherwise in compliance with this Agreement.  Except as specifically permitted by this Section 6.9, the rights of a Holder with respect to Registrable Securities as set out herein shall not be transferable to any other Person.
 
SECTION 6.10.   Waiver/Amendment .  The rights of any Holder under any provision of this Article 6 may be waived (either generally or in a particular instance, either retroactively or prospectively and either for a specified period of time or indefinitely) or amended by an instrument in writing signed by such Holder.
 
SECTION 6.11.   Piggy-Back Registrations .  If at any time prior to the end of the Registration Period (including during periods when the Company is permitted to suspend the use of the prospectus forming part of the Registration Statements) there is not an effective Registration Statement covering all of the Registrable Securities, the Company shall determine to prepare and file with the SEC a registration statement relating to an offering for its own account or the account of others under the Securities Act of any of its equity securities, other than on Form S-4 or Form S-8 (each as promulgated under the Securities Act) or their then equivalents relating to equity securities to be issued solely in connection with any acquisition of any entity or business or equity securities issuable in connection with stock option or other employee benefit plans, then the Company shall send to each Holder written notice of such determination and if, within twenty days after receipt of such notice, any such Holder shall so request in writing, the Company shall include in such registration statement all or any part of such Registrable Securities such Holder requests to be registered.  Notwithstanding the foregoing, in the event that, in connection with any underwritten public offering, the managing underwriter(s) thereof shall impose a limitation on the number of Ordinary Shares which may be included in the registration statement because, in such underwriter(s)’ judgment, marketing or other factors dictate such limitation is necessary to facilitate public distribution, then the Company shall be obligated to include in such registration statement only such limited portion of the Registrable Securities with respect to which such Holder has requested inclusion hereunder as the underwriter shall permit; provided , however , that (i) except in accordance with the underwriter cutbacks described in Schedule 2.18 of the Disclosure Schedules, the Company shall not exclude any Registrable Securities unless the Company has first excluded all outstanding securities which are not Registrable Securities and (ii) after giving effect to the immediately preceding proviso, any such exclusion of Registrable Securities shall be made pro rata among the Holders seeking to include Registrable Securities and the holders of other securities having the contractual right to inclusion of their securities in such registration statement by reason of demand registration rights, in proportion to the number of Registrable Securities or other securities, as applicable, sought to be included by each such Holder or other holder.  If an offering in connection with which a Holder is entitled to registration under this Section 6.11 is an underwritten offering, then each Holder whose Registrable Securities are included in such registration statement shall, unless otherwise agreed by the Company, offer and sell such Registrable Securities using the same underwriter or underwriters and, subject to the provisions of this Agreement, on the same terms and conditions as other securities of the Company included in such underwritten offering and shall enter into an underwriting agreement in a form and substance reasonably satisfactory to the Company and the underwriter or underwriters.  Upon the effectiveness of the registration statement for which piggy-back registration has been provided in this Section 6.11,
 

 
-36-

 

any payments that after such effectiveness date would otherwise become payable pursuant to Section 6.3 to a Purchaser whose Securities are included in such registration statement shall not become payable so long as such piggy-back registration statement remains effective.
 
ARTICLE 7
 
GENERAL INDEMNIFICATION
 
SECTION 7.1.   Indemnification by the Company .  The Company shall indemnify each Purchaser and each of such Purchaser’s officers, directors, partners and members against all claims, losses, damages and liabilities incurred as a result of or in settlement of any Proceeding, commenced or threatened (subject to Section 7.3 below), to the extent related to or arising out of any breach of any representation or warranty made by the Company in this Agreement or any failure to perform or breach by the Company of any covenant, obligation, or undertaking made by the Company in this Agreement,   it being understood that   such losses and damages may, if proven, include, without limitation, any diminution in value of the Securities to the extent related to or arising out of any such breach or failure to perform, and will reimburse each such indemnified party for all reasonable legal and other out-of-pocket expenses reasonably incurred by such indemnified party in connection with investigating or defending any such claim, loss, damage, liability or Proceeding, as such expenses are incurred.
 
SECTION 7.2.   Indemnification by Each Purchaser .  Each Purchaser will severally, and not jointly, indemnify the Company and each of its directors and officers against all claims, losses, damages and liabilities, including any of the foregoing incurred as a result of or in settlement of any Proceeding, commenced or threatened (subject to Section 7.3 below), to the extent related to or arising directly or indirectly out of any breach of any representation or warranty made by such Purchaser in this Agreement or any failure to perform or breach by such Purchaser of any covenant, obligation, or undertaking made by such Purchaser in this Agreement and will reimburse such indemnified party for all reasonable legal and other out-of-pocket expenses reasonably incurred by such indemnified party in connection with investigating or defending any such claim, loss, damage, liability or Proceeding, as such expenses are incurred.
 
SECTION 7.3.   Conduct of Indemnification Proceedings .  Each party entitled to indemnification under this Article 7 (for purposes of this Section 7.3, the “ Indemnified Party ”) shall give notice to the party required to provide indemnification (for purposes of this Section 7.3, the “ Indemnifying Party ”)  promptly after such Indemnified Party has actual knowledge of any claim as to which indemnity may be sought, and shall permit the Indemnifying Party (at its expense) to assume the defense of any such claim or any Proceeding resulting therefrom, provided that counsel for the Indemnifying Party, who shall conduct the defense of such claim or Proceeding, shall be approved by the Indemnified Party (whose approval shall not be unreasonably withheld or delayed), and the Indemnified Party may participate in such defense at such Indemnified Party’s expense, and provided further that the failure of any Indemnified Party to give notice as provided herein shall not relieve the Indemnifying Party of its obligations under this Article 7, unless such failure is materially prejudicial to the Indemnifying Party in defending such claim or litigation.  An Indemnifying Party shall not be liable for any settlement of an action or claim affected without its written consent (which consent will not be unreasonably withheld).  No Indemnifying Party, in its defense of any such claim or litigation, shall, except with the consent of each Indemnified Party, consent to entry of any judgment or enter into any settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party and Indemnifying Party of a release from all liability in respect to such claim or litigation or which admits liability or fault on the part of the Indemnified Party.
 

 
-37-

 


 
ARTICLE 8
 
DEFINITIONS
 
ADS ” and “ ADSs ” have the respective meanings set forth in Section 1.1(a).
 
Affiliate ” means, with respect to any Person, any other Person controlling, controlled by or under direct or indirect common control with such Person (for the purposes of this definition “ control ,” when used with respect to any specified Person, shall mean the power to direct the management and policies of such Person, directly or indirectly, whether through ownership of voting securities, by contract or otherwise; and the terms “ controlling ” and “ controlled ” shall have meanings correlative to the foregoing).
 
Business Day ” means a day Monday through Friday on which banks are generally open for business in New York City and London, England.
 
Company ” means Amarin Corporation plc, a company incorporated under the laws of England and Wales.
 
Debentures ” has the meaning set forth in Section 1.4.
 
Depositary Letter ” means the letter agreement between the Company and Citibank, N.A. dated as of the First Closing Date.
 
Disclosure Schedules ” means the Disclosure Schedules of the Company attached hereto.
 
Draft Annual Report ” has the meaning set forth in Section 2.7.
 
Exchange Act ” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
 
Exempt Securities ” means (i) options granted, and shares issued upon exercise thereof, to employees, directors or consultants under the Company’s stock option plans in amounts approved by the Company’s Board of Directors upon the recommendation of its remuneration committee (as appropriately adjusted for stock splits, stock dividends, and the like), (ii) securities offered under a registration statement on Form F-4 (or any applicable successor form), (iii) the conversion or exercise of convertible debt or exercisable securities outstanding on the date hereof as set forth in Schedule 2.27 of the Disclosure Schedules (iv) the issuance of Ordinary Shares to pay milestones which may become payable in relation to the acquisitions by the Company of Laxdale Limited and Ester Neurosciences Ltd. as set forth on Schedule 2.26 of the Disclosure Schedules, (v) the issuance of shares in connection with bank financing or similar transactions that are primarily of a non-equity financing nature and approved by the Company’s Board of Directors, and (vi) securities issued pursuant to acquisitions or strategic transactions approved by the Supermajority Directors.
 
Final Prospectus ” has the meaning set forth in Section 6.6(a).
 

 
-38-

 


 
Financial Statements ” means the financial statements of the Company included in the SEC Documents and the Draft Annual Report.
 
First Closing ” has the meaning set forth in the Recitals.
 
First Closing Amount ” has the meaning set forth in the Recitals.
 
First Closing Date ” has the meaning set forth in Section 1.3.
 
First Closing Purchase Price ” has the meaning set forth in Section 1.2.
 
First Closing Securities ” has the meaning set forth in Section 1.1(a).
 
First Filing Date ” has the meaning set forth in Section 6.1(a).
 
Governmental Authority ” means any governmental body or regulatory authority of the United States or any other country or any political subdivision of any thereof.
 
Holders ” means any Person holding Registrable Securities or any Person to whom the rights under Article 6 have been transferred in accordance with Section 6.9 hereof.
 
Indebtedness ” means, as applied to any Person, all indebtedness of such Person for borrowed money, whether current or funded, or secured or unsecured, excluding current trade payables incurred in the ordinary course of business consistent with past practice, but including, (i) all obligations of that Person evidenced by bonds, debentures, notes, or other similar instruments or debt securities, (ii) all indebtedness of that Person secured by a purchase money mortgage or other Lien to secure all or part of the purchase price of the property subject to such Lien, (iii) all obligations under leases that shall have been or must be recorded as capital leases in respect of which such Person is liable as lessee, (iv) any liability of that Person in respect of banker’s acceptances or letters of credit, and (v) all indebtedness referred to above which is directly or indirectly guaranteed by that Person or
 

 
-39-

 

which that Person has agreed (contingently or otherwise) to purchase or otherwise acquire or in respect of which it has otherwise assured a creditor against loss.
 
Indemnified Party ” has the meaning set forth in Section 6.6(c).
 
Indemnifying Party ” has the meaning set forth in Section 6.6(c).
 
Intellectual Property Rights ” has the meaning set forth in Section 2.9.
 
Investment Company Act ” has the meaning set forth in Section 2.11.
 
Liens ” means a lien, charge, security interest, encumbrance, right of first refusal, preemptive right, claim, defect or imperfection of title or similar restriction.
 
Majority of the Preference Share Purchasers ” means (i) prior to the First Closing, two-thirds (2/3) of the Purchasers purchasing Preference Shares (based on the aggregate “Pro Rata Percentages” of the Purchasers as set forth on Exhibit A hereto) and (ii) from and after the First Closing, the Purchasers who purchased Preference Shares holding two-thirds (2/3) of the Securities sold hereunder.
 
Material Adverse Effect ” has the meaning set forth in Section 2.1.
 
Material Contracts ” has the meaning set forth in Section 4.1(b).
 
Material Permits ” has the meaning set forth in Section 2.5(c).
 
Memorandum and Articles of Association ” has the meaning set forth in Section 2.3.
 
(a)   Milestone ” means that the Company has ********** Approximately 2 lines omitted **********.
 
Nasdaq ” means The Nasdaq Capital Market.
 
Net Proceeds ” has the meaning set forth in Section 4.13(b).
 
Non-US Person ” has the meaning set forth in Section 3.2.
 
Notice ” has the meaning set forth in Section 1.1(c).
 
Ordinary Shares ” means the ordinary shares, par value ₤0.50 per share, of the Company.
 
Per Share First Closing Purchase Price ” has the meaning set forth in Section 1.1(a).
 
 
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS
.
 

 
-40-

 


 
Per Share Second Closing Purchase Price ” has the meaning set forth in Section 1.1(b).
 
Person ” means any person, individual, corporation, limited liability company, partnership, trust or other nongovernmental entity or any governmental agency, court, authority or other body (whether foreign, federal, state, local or otherwise).
 
Placement Agent ” means, collectively, Cowen and Company LLC and Rodman and Renshaw LLC.
 
Preference Shares ” means the Preference Shares to be issued to the Purchasers at the First Closing having the rights, preferences and other characteristics set forth on Exhibit D .
 
Proceeding ” means any action, claim, suit, inquiry, notice of violation, investigation or proceeding (including, without limitation, an investigation or partial proceeding, such as a deposition), whether commenced or threatened.
 
Purchasers ” mean the Purchasers whose names are set forth on the signature pages of this Agreement and are listed on Exhibit A hereto, and their permitted transferees.
 
Unless the context requires otherwise, the terms “ register ,” “ registered ” and “ registration ” refer to the registration of securities of the Company effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of the effectiveness of such registration statement.
 
Registrable Securities ” means the First Closing Ordinary Shares and the Second Closing Securities; provided , however , that securities shall only be treated as Registrable Securities if and only for so long as they (A) have not been disposed of pursuant to a registration statement declared effective by the SEC, (B) have not been sold in a transaction exempt from the registration and prospectus delivery requirements of the Securities Act so that all transfer restrictions and restrictive legends with respect thereto are removed upon the consummation of such sale or (C) are held by a Holder or a permitted transferee pursuant to Section 6.9.
 
Registration Expenses ” means all expenses incurred by the Company in complying with Section 6.1 hereof, including, without limitation, all registration, qualification and filing fees, printing expenses, escrow fees, fees and expenses of counsel for the Company, blue sky fees and expenses and the expense of any special audits incident to or required by any such registration (but excluding the fees of legal counsel for any Holder).
 
Registration Period ” has the meaning set forth in Section 6.4(a).
 
Registration Statement ” has the meaning set forth in Section 6.1(b).
 
Required Approvals ” has the meaning set forth in Section 2.5(b).
 
Rule 144 ” means Rule 144 promulgated under the Securities Act.
 
SEC ” means the United States Securities and Exchange Commission.
 

 
-41-

 


 
SEC Documents ” has the meaning set forth in Section 2.6.
 
Second Closing ” has the meaning set forth in the Recitals.
 
Second Closing Amount ” has the meaning set forth in the Recitals.
 
Second Closing Date ” has the meaning set forth in Section 1.3.
 
Second Closing Purchase Price ” has the meaning set forth in Section 1.2.
 
Second Closing Securities ” has the meaning set forth in Section 1.1(b).
 
 “ Second Filing Date ” has the meaning set forth in Section 6.1(b).
 
Securities ” has the meaning set forth in Section 1.1(b).
 
Securities Act ” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
 
Selling Expenses ” means all selling commissions applicable to the sale of Registrable Securities and all fees and expenses of legal counsel for any Holder other than as set forth in the definition of “Registration Expenses.”
 
Shortfall Amount ” has the meaning set forth in Section 1.1(c).
 
Special Rights Termination Event ” shall mean either (i) the failure of the Purchasers to timely exercise their option to fund the Second Closing Amount pursuant to Section 1.1(c) or (ii) the timely exercise of such option by the Purchasers followed by the failure of the Second Closing to occur due to the failure of the Purchasers to satisfy any of the conditions provided in Sections 5.3(a)-(c).
 
Subsidiary ” of any Person shall mean any corporation, partnership, limited liability company, joint venture or other legal entity of which such Person (either alone or through or together with any other subsidiary) owns, directly or indirectly, more than 50% of the stock or other equity interests the holders of which are generally entitled to vote for the election of the board of directors or other governing body of such corporation or other legal entity.
 
Termination Date ” has the meaning set forth in Section 9.1(b).
 
ARTICLE 9
 
TERMINATION
 
SECTION 9.1.   Termination .  This Agreement may be terminated:
 
(a)   by the mutual written consent of the Company and a Majority of the Preference Share Preference Share Purchasers;
 

 
-42-

 


 
(b)   by either the Company or a Majority of the Preference Share Purchasers, if the First Closing has not been consummated by May 31, 2008 (the “ Termination Date ”); provided , however , that the right to terminate this Agreement pursuant to this Section 9.1(b) shall not be available to any party(ies) who is in material breach of this Agreement, or whose failure to fulfill any of its obligations under this Agreement results in such failure to close;
 
(c)   by either the Company or a Majority of the Preference Share Purchasers, if any applicable law makes consummation of the transactions contemplated hereby illegal, or if any judgment, injunction, order, or decree enjoining any party hereto from consummating the transactions contemplated hereby is entered and that judgment, injunction, order, or decree becomes final and nonappealable; provided , however , that the party(ies) seeking to terminate this Agreement pursuant to this subsection 9.1(c) shall have used all reasonable efforts to remove such judgment, injunction, order or decree;
 
(d)   by the Company, if the Company is not in material breach of this Agreement, in the event of a material breach by any Purchaser of any representation, warranty, or agreement contained herein; or
 
(e)   by a Majority of the Preference Share Purchasers, if a Majority of the Preference Share Purchasers are not in material breach of this Agreement, in the event of a material breach by the Company of any representation, warranty, or agreement contained herein.
 
SECTION 9.2.   Effect of Termination .  If this Agreement is validly terminated pursuant to Section 9.1, it shall become null and void immediately and there shall be no liability or obligation to any Person in respect of the Agreement or of the transactions contemplated hereby on the part of any party, or a party’s directors, officers, employees, agents, representatives, advisers, stockholders, members, partners, or Affiliates, except that the provisions of this Section 9.2 and Article 10 shall remain in full force and effect and shall survive any termination of this Agreement and except that each party shall remain liable for any breach of this Agreement prior to its termination.
 
ARTICLE 10
 
GOVERNING LAW; MISCELLANEOUS
 
SECTION 10.1.   Governing Law; Jurisdiction; Waiver of Jury Trial .
 
(a)   This Agreement will be governed by and interpreted in accordance with the laws of the State of New York without regard to the principles of conflict of laws that would yield a contrary result.
 
(b)   Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Agreement (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York.  Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or therewith or with any transaction contemplated hereby or
 

 
-43-

 

thereby, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, or that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding.  Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof.  Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law.
 
(c)   In any action, suit or proceeding in any jurisdiction brought by any party against any other party under this Agreement, the parties each knowingly and intentionally, to the greatest extent permitted by applicable law, hereby waive all rights to trial by jury.
 
(d)   If any action, suit or proceeding is instituted to enforce any provision in this Agreement, the prevailing party in such dispute shall, to the extent permitted by New York law, be entitled to recover from the losing party all fees, costs and expenses of enforcing any right of such prevailing party under or with respect to this Agreement, including, without limitation, such reasonable fees and expenses of attorneys and accountants, which shall include, without limitation, all fees, costs and expenses of appeals.
 
SECTION 10.2.   Counterparts; Signatures .  This Agreement may be executed in two or more counterparts, all of which are considered one and the same agreement and will become effective when counterparts have been signed by each party and delivered to the other parties.  In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.
 
SECTION 10.3.   Headings .  The headings of this Agreement are for convenience of reference only, are not part of this Agreement and do not affect its interpretation.
 
SECTION 10.4.   Severability .  If any provision of this Agreement is invalid or unenforceable under any applicable statute or rule of law, then such provision will be deemed modified in order to conform with such statute or rule of law.  Any provision hereof that may prove invalid or unenforceable under any law will not affect the validity or enforceability of any other provision hereof.
 
SECTION 10.5.   Entire Agreement; Amendments .  This Agreement (including all schedules and exhibits hereto) constitutes the entire agreement among the parties hereto with respect to the subject matter hereof.  There are no restrictions, promises, warranties or undertakings, other than those set forth or referred to herein.  This Agreement supersedes all prior agreements and understandings among the parties hereto with respect to the subject matter hereof.  No provision of this Agreement may be amended or waived other than by an instrument in writing signed by the Company and Purchasers holding at least two-thirds (2/3) of the then outstanding Securities or, in the case of Article 6, the Holders of at least two-thirds (2/3) of the outstanding Registrable Securities, or in the case of a waiver, by the party against whom enforcement of such waiver is sought.  Any amendment effected in accordance with this Section 10.5 shall be binding upon the Company and the Purchasers or, in the case of Article 6, the Holders.
 

 
-44-

 


 
SECTION 10.6.   Notices .  All notices required or permitted hereunder shall be in writing and shall be deemed effectively given:  (a) upon personal delivery to the party to be notified, (b) when sent by confirmed facsimile if sent during normal business hours of the recipient, and if not, then on the next business day, (c) five days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one Business Day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt.  The addresses for such communications are:
 
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

 
If to a Purchaser:  To the address set forth immediately below such Purchaser’s name on the signature pages hereto.  Each party will provide ten (10) days’ advance written notice to the other parties of any change in its address.
 
SECTION 10.7.   Successors and Assigns .  This Agreement is binding upon and inures to the benefit of the parties and their successors and assigns.  The Company or its successors will not assign this Agreement or any rights or obligations hereunder without the prior written consent of the Purchasers, and no Purchaser may assign this Agreement or any rights or obligations hereunder (including the option to fund the Second Closing Amount and the Preference Shares) without the prior written consent of the Company, except that, as permitted in accordance with Section 3.7 and Section 6.9 hereof and subject to applicable securities laws, the Purchasers shall be entitled to assign and transfer, without any other person’s or the Company’s consent and without restriction, all or any portion of the Securities (exclusive of the Preference Shares).
 
SECTION 10.8.   Third Party Beneficiaries .  This Agreement is intended for the benefit of the parties hereto, their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.
 
SECTION 10.9.   Further Assurances .  Each party will do and perform, or cause to be done and performed, all such further acts and things, and will execute and deliver all other
 

 
-45-

 

agreements, certificates, instruments and documents, as may be necessary in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.
 
SECTION 10.10.   No Strict Construction .  The language used in this Agreement is deemed to be the language chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against any party.
 
SECTION 10.11.   Equitable Relief .  The Company recognizes that, if it fails to perform or discharge any of its obligations under this Agreement, any remedy at law may prove to be inadequate relief to the Purchasers.  The Company therefore agrees that the Purchasers are entitled to seek temporary and permanent injunctive relief in any such case.  Each Purchaser also recognizes that, if it fails to perform or discharge any of its obligations under this Agreement, any remedy at law may prove to be inadequate relief to the Company.  Each Purchaser therefore agrees that the Company is entitled to seek temporary and permanent injunctive relief in any such case.
 
SECTION 10.12.   Survival of Representations and Warranties .  All representations and warranties made by the Company and the Purchasers herein shall survive the First Closing and the Second Closing.
 
SECTION 10.13.   Fractional Securities .  No fractional Securities shall be issued at the Second Closing.  The Company shall, in lieu of issuing any fractional Securities, pay the Purchaser otherwise entitled to such fraction a sum in cash equal to the product resulting from multiplying the Per Share Second Closing Purchase Price by such fraction.
 
SECTION 10.14.   Independent Nature of Purchasers’ Obligations and Rights .  The obligations of each Purchaser under this Agreement are several and not joint with the obligations of any other Purchaser, and no Purchaser shall be responsible in any way for the performance of the obligations of any other Purchaser under this Agreement.  Nothing contained herein and no action taken by any Purchaser pursuant thereto shall be deemed to constitute the Purchasers as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Purchasers are in any way acting in concert or as a group, or are deemed affiliates (as such term is defined under the Exchange Act) with respect to such obligations or the transactions contemplated by this Agreement.  Each Purchaser shall be entitled to independently protect and enforce its rights, including without limitation the rights arising out of this Agreement, and it shall not be necessary for any other Purchaser to be joined as an additional party in any proceeding for such purpose.
 
SECTION 10.15.   Notice to Purchasers Not Receiving Preference Shares .  Notwithstanding any other provision of this Agreement, upon any vote or action by Purchasers with respect to which Fountain Healthcare Partners Fund 1, L.P. does not have a right to participate, including, without limitation a vote or action of the Majority of the Preference Share Purchasers, the Company shall deliver notice of the outcome of such vote or action promptly upon it becoming aware of the outcome of such vote or action to Fountain Healthcare Partners Fund 1, L.P.
 
[Signature Pages Follow]


 
-46-

 

IN WITNESS WHEREOF, the undersigned Purchasers and the Company have caused this Agreement to be duly executed as of the date first above written.
 
AMARIN CORPORATION PLC
 
 
By:
Name:
Title:

 
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK
SIGNATURE PAGE FOR PURCHASER FOLLOWS]

 
 

 

[PURCHASER SIGNATURE PAGES TO AMARIN SECURITIES PURCHASE AGREEMENT]
 
IN WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
 
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:
 
 
EIN Number:   [PROVIDE THIS UNDER SEPARATE COVER]

 

 


 
 

 

EXHIBIT A
 
SCHEDULE OF PURCHASERS
 
 
Purchaser
 
Pro Rata Percentage
 
First Closing Committed Amount
 
First Closing Ordinary Shares
Preference Shares
Aggregate First Closing Purchase Price
           
           
           
           
           
           
           
           
           
           
 
Total:
 
100.00%
 
$28,000,000.00
 
12,173,914
 
8
 
$28,000,002.20

 


 
 

 

EXHIBIT B
 
Issuance of Additional Stock for Consideration Below the Per Share Second Closing Purchase Price .
 
If the Company, at any time and from time to time, shall issue, after the date hereof and prior to the Second Closing, any Additional Stock (as defined in Section 1.1(d)(ii)) without consideration or for a consideration per share (or with a conversion or exercise price per share) less than the Per Share Second Closing Purchase Price in effect immediately prior to the issuance of such Additional Stock, then and in each such event the Per Share Second Closing Purchase Price in effect immediately prior to each such issuance shall forthwith (except as otherwise provided in this Exhibit B) be adjusted to a price determined by multiplying such Per Share Second Closing Purchase Price by a fraction, the numerator of which shall be the number of Ordinary Shares outstanding immediately prior to such issuance plus the number of Ordinary Shares that the aggregate consideration received by the Company for such issuance would purchase at such Per Share Second Closing Purchase Price; and the denominator of which shall be the number of Ordinary Shares outstanding immediately prior to such issuance plus the number of shares of such Additional Stock.
 
For all purposes of this Exhibit B, “ Ordinary Shares ” shall mean Ordinary Shares as such are represented by ADSs.
 
(a)           No adjustment of the Per Share Second Closing Purchase Price shall be made in an amount less than one cent per share, provided that any adjustments that are not required to be made by reason of this sentence shall be carried forward and shall be taken into account at the earlier of the Second Closing Date and the date of any subsequent adjustment made pursuant to this Exhibit B.  No adjustment made pursuant to this Exhibit B shall have the effect of increasing the Per Share Second Closing Purchase Price above the Per Share Second Closing Purchase Price in effect immediately prior to such adjustment.
 
(b)           In the case of the issuance of Ordinary Shares for cash, the consideration shall be deemed to be the amount of cash paid therefor excluding amounts paid or payable for accrued interest or accrued dividends.
 
(c)           In the case of the issuance of Ordinary Shares for a consideration in whole or in part other than cash, the consideration other than cash shall be deemed to be the fair value thereof as determined in good faith by a committee of the independent directors of the Company irrespective of any accounting treatment.
 
(d)           In the case of the issuance of Additional Stock consisting of options to purchase or rights to subscribe for Ordinary Shares, securities by their terms convertible into or exchangeable for Ordinary Shares or options to purchase or rights to subscribe for such convertible or exchangeable securities, the following provisions shall apply for all purposes of this Exhibit B:
 
(i)           The aggregate maximum number of Ordinary Shares deliverable upon exercise (assuming the satisfaction of any conditions to exercisability, including without limitation, the passage of time, but without taking into account potential antidilution adjustments) of such options to purchase or rights to subscribe for Ordinary Shares shall be deemed to have been issued at the time such options or rights were issued and for a consideration equal to the consideration (determined in the manner provided in subsections (b) and (c) of this Exhibit B), if any, received by the Company upon the issuance of such options or rights plus the minimum exercise price provided in such options or rights (without taking into account potential antidilution adjustments) for the Ordinary Shares covered thereby.
 

 
 

 


 
(ii)           The aggregate maximum number of Ordinary Shares deliverable upon conversion of or in exchange (assuming the satisfaction of any conditions to convertibility or exchangeability, including, without limitation, the passage of time, but without taking into account potential antidilution adjustments) for any such convertible or exchangeable securities or upon the exercise of options to purchase or rights to subscribe for such convertible or exchangeable securities and subsequent conversion or exchange thereof shall be deemed to have been issued at the time such securities were issued or such options or rights were issued and for a consideration equal to the consideration, if any, received by the Company for any such securities and related options or rights (excluding any cash received on account of accrued interest or accrued dividends), plus the minimum additional consideration, if any, to be received by the Company (without taking into account potential antidilution adjustments) upon the conversion or exchange of such securities or the exercise of any related options or rights (the consideration in each case to be determined in the manner provided in subsections (b) and (c) of this Exhibit B).
 
(iii)           In the event of any change in the number of Ordinary Shares deliverable or in the consideration payable to the Company upon exercise of such options or rights or upon conversion of or in exchange for such convertible or exchangeable securities, including, but not limited to, a change resulting from the antidilution provisions thereof, the Per Share Second Closing Purchase Price, to the extent in any way affected by or computed using such options, rights or securities, shall be recomputed to reflect such change, but no further adjustment shall be made for the actual issuance of Ordinary Shares or any payment of such consideration upon the exercise of any such options or rights or the conversion or exchange of such securities.
 
(iv)           Upon the expiration of any such options or rights, the termination of any such rights to convert or exchange or the expiration of any options or rights related to such convertible or exchangeable securities, the Per Share Second Closing Purchase Price, to the extent in any way affected by or computed using such options, rights or securities or options or rights related to such securities, shall be recomputed to reflect the issuance of only the number of Ordinary Shares (and convertible or exchangeable securities that remain in effect) actually issued upon the exercise of such options or rights, upon the conversion or exchange of such securities or upon the exercise of the options or rights related to such securities.
 
(v)           The number of Ordinary Shares deemed issued and the consideration deemed paid therefor pursuant to subsections (d)(i) and (ii) above shall be appropriately adjusted to reflect any change, termination or expiration of the type described in either subsection (d)(iii) or (iv).
 
(e)           Upon each adjustment of the Per Share Second Closing Purchase Price pursuant to the provisions of this Exhibit B, the number of Ordinary Shares issuable at the Second Closing shall be adjusted by (A) multiplying the Per Share Second Closing Purchase Price in effect immediately prior to such adjustment by the number of Ordinary Shares issuable at the Second Closing immediately prior to such adjustment and (B) dividing the product so obtained by the adjusted Per Share Second Closing Purchase Price.
 

 
-2- 

 

EXHIBIT C
 
Form of Opinion of Cahill Gordon & Reindel llp
 
 
May [  ], 2008
 
To the Parties Listed on Schedule A hereto
 
and
 
Cowen and Company, LLC
1221 Avenue of the Americas
New York, NY 10020
United States of America
 
 
 
Re:
Amarin Corporation plc
 
Ladies and Gentlemen:
 
This opinion is being furnished to you pursuant to Section 5.2(e) of the Securities Purchase Agreement, dated May 13, 2008 (the “ Purchase Agreement ”), between Amarin Corporation plc, a public limited company organized under the laws of England and Wales (the “ Company ”), and the various persons listed on Schedule A thereto (each, a “ Purchaser ” and collectively, the “ Purchasers ”), relating to the issuance and sale to the Purchasers by the Company of ordinary shares of ₤0.05 each in the capital of the Company (“ Ordinary Shares ”) and to certain Purchasers, series a preference shares of ₤0.50 each in the capital of the Company (“ Preference Shares ” and together with the Ordinary Shares, the “ Securities ”).  Capitalized terms used herein and not otherwise defined herein shall have the meanings ascribed thereto in the Purchase Agreement.
 
In rendering the opinions set forth herein, we have examined originals, photocopies or conformed copies certified to our satisfaction of all such company or corporate records, agreements, instruments and documents of the Company and its subsidiaries, certificates of public officials and other certificates and opinions, and have made such other investigations, as we have deemed necessary in connection with the opinions set forth herein.  In such examination, we have assumed the genuineness of all signatures, the authenticity of all documents submitted to us as originals, the conformity to original documents of all documents submitted to us as certified or photocopies or conformed copies and the authenticity of originals of such documents.  We have relied, to the extent we deem such reliance proper, on certificates of officers of the Company and its subsidiaries as to factual matters.
 
Based upon the foregoing, it is our opinion that:
 

 
 

 


 
1.           no filing with, or authorization, approval, consent, order, registration, qualification or decree of, any United States federal or New York state court or governmental authority or agency is required in connection with the execution, delivery or performance by the Company of the Purchase Agreement or the offering, issuance or sale of the Securities except (a) such as have already been obtained and are in full force and effect, (b) any filings under U.S. federal or state securities or Blue Sky laws in connection with the sale of the Securities and (c) for such filings, authorizations, approvals, consents, orders, registrations, qualifications or decrees the failure so to obtain would not, individually or in the aggregate, have a Material Adverse Effect and would not materially and adversely affect the consummation of the transactions contemplated by the Purchase Agreement;
 
2.           the execution, delivery and performance of the Purchase Agreement by the Company, the issuance and sale of the Securities by the Company and the consummation by the Company of the transactions contemplated by the Purchase Agreement do not and will not result in any violation of any United States federal or New York State statute or any rule or regulation issued pursuant to any United States federal or New York State court of governmental agency or body (other than U.S. federal and state securities or Blue Sky laws and regulations relating to FINRA), except for violations that would not, individually or in the aggregate, have a Material Adverse Effect; and
 
3.           assuming (i) the accuracy of the representations and warranties of the Company contained in the Purchase Agreement, (ii) the accuracy of the representations and warranties of each Purchaser in the Purchase Agreement and (iii) the Placement Agent has not engaged in any activity with respect to the Securities that would constitute a public offering within the meaning of Section 4(2) of the Securities Act, it is not necessary in connection with the issuance and sale of the Securities to the Purchasers under the circumstances contemplated by the Purchase Agreement to register the sale of the Securities to the Purchasers under the Securities Act of 1933, as amended, it being understood that no opinion is being expressed as to any subsequent resale of the Securities; and
 
4.           the Purchase Agreement constitutes a valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to applicable bankruptcy, insolvency or similar laws affecting creditors’ rights generally and general principles of equity and except that (a) rights to indemnification may be limited under applicable law or public policy and (b) the enforceability of provisions imposing liquidated damages or penalties upon the occurrence of certain events may be limited in certain circumstances.
 
We are members of the Bar of the State of New York and do not purport to be experts in, or to express any opinion concerning, the laws of any jurisdictions other than the laws of the State of New York and the federal laws of the United States of America.
 
This opinion is solely for your benefit as Purchasers of the Securities and as the Placement Agent and neither this opinion nor any part hereof may be delivered to or used or relied upon by any person other than you without our prior written consent.
 
 
Very truly yours,
 

 
-2- 

 

SCHEDULE A

List of Recipients

·  
Caduceus Private Investments III, LP
 
·  
Orbimed Associates III, LP
 
·  
Sofinnova Venture Partners VII, L.P.

·  
Panorama Capital, L.P.

·  
Thomas, McNerney & Partners II, L.P.

·  
TMP Nominee II, LLC

·  
TMP Associates II, L.P.

·  
Longitude Venture Partners, L.P.

·  
Fountain Healthcare Partners Fund 1, L.P.
 


 
 

 

EXHIBIT D
 
SERIES A PREFERENCE SHARES
 
1.1.  
CONSOLIDATION OF PREFERENCE SHARES
 
(a)   It was noted that the Company’s authorised share capital currently comprised 155,914,406 Ordinary Shares with a nominal value of 50 pence each and 440,855,934 Preference Shares with a nominal value of 5 pence each.
 
(b)   The Chairman explained that, in connection with the transactions contemplated by the Securities Purchase Agreement, dated as of May 13, 2008, by and among Sofinnova Venture Partners VII, L.P., Caduceus Private Investments III, LP and Orbimed Associates III, LP and their affiliated entities, Panorama Capital, L.P., Thomas, McNerney & Partners II, L.P., TMP Nominees II, LLC, TMP Associates II, L.P., and Longitude Venture Partners, L.P. (collectively, the “ Purchasers ”), and the Company (the “ Purchase Agreement ”), it was proposed to issue to the Purchasers Preference Shares with a nominal value of 50 pence each with certain rights attached.
 
(c)   In addition, it was proposed that such Preference Shares would automatically convert into Ordinary Shares on a one-for-one basis upon the occurrence of certain events, as described below.
 
(d)   On that basis, the Chairman explained that it would be necessary to consolidate certain of the Company’s Preference Shares with a nominal value of 5 pence each (the “ 5 pence Preference Shares ”) on a ten-for-one basis into Preference Shares with a nominal value of 50 pence each in order to allow for conversion of such Preference Shares into Ordinary Shares on a one-for-one basis without any unlawful issue of shares at a discount.
 
(e)   It was noted that, in passing the resolution to adopt article 5 of the Company’s Articles, the Company’s shareholders had granted to the Directors authority, inter alia , to consolidate the 5 pence Preference Shares.
 
(f)   Pursuant to such authority IT WAS RESOLVED that 50 of the 5 pence Preference Shares be and they are hereby consolidated and divided into 5 Preference Shares with a nominal value of 50 pence each.
 
1.2.  
RIGHTS ATTACHING TO SERIES A PREFERENCE SHARES
 
(a)   It was noted that article 5 of the Articles empowers the Directors to issue Preference Shares with such rights and subject to such restrictions and limitations as the Directors shall determine in the resolution of the Directors approving the issue of such shares.  It was further noted that article 6 of the Articles provides that Preference Shares may be issued in one or more separate series, each of which will constitute a separate class of shares.
 
(b)   IT WAS RESOLVED that the Preference Shares with a nominal value of 50 pence each to be issued and allotted pursuant to paragraph ___ below shall be known as “ Series A Preference Shares, ” shall not be redeemable, and shall be issued with the other rights, and subject to the restrictions and limitations, set out in this paragraph 1.2(b):
 

 
 

 


 
(i)   Board Size
 
 
(A)
Prior to August 22, 2008, the written consent of the holders (the “ Series A Holders ”) of at least two-thirds (2/3s) of the issued and outstanding Series A Preference Shares (a “ Majority of the Series A Holders ”) shall be required prior to any appointment by the Company’s Board of Directors (the “ Board ”) or election by the Company’s shareholders of a Director of the Company which would increase the total number of Directors of the Company then in office to more than 8.
 
 
(B)
From and after August 22, 2008, the written consent of a Majority of the Series A Holders shall be required prior to any appointment by the Board or election by the Company’s shareholders of a Director of the Company which would increase the total number of Directors of the Company then in office to more than 9 (inclusive of the Director appointed pursuant to paragraph 1.2(b)(ii)(D) below).
 
(ii)   Appointment of Directors; Voting
 
 
(A)
Subject to paragraph 1.2(b)(ii)(D) below, the Series A Holders shall be entitled (x) to elect four (4) members (each such member and any additional director elected by the Series A Holders under paragraph 1.2(b)(ii)(D) below to be known as a “ Series A Director ”) to the Board, (y) to remove from office any Series A Director, with or without cause, and (z) to fill any vacancy caused by the resignation, death, or removal of a Series A Director.
 
 
(B)
Subject to paragraph 1.2(b)(ii)(E) below, the election of each Series A Director by the Series A Directors (including to fill any vacancy caused by the resignation, death, or removal of a Series A Director) shall be by a vote, in person or by written consent, of a Majority of the Series A Holders.
 
 
(C)
Subject to paragraph 1.2(b)(ii)(E) below, in each election of a Series A Director (other than where such election takes place at a general meeting of the Company) and all other matters referred to in this paragraph 1.2(b) upon which the holders of Series A Preference Shares shall be entitled to vote, each Series A Preference Share shall entitle the Series A Holder thereof to the number of votes equal to the product of (i) 1,000 and (ii) the quotient obtained by dividing the number of the Company’s Ordinary Shares at the time owned by such Series A Holder, directly or through American Depositary Shares, by the number of the Company’s Ordinary Shares at the time so owned by all the Series A Holders.
 
 
(D)
If (x) on or before August 22, 2008, an individual who is mutually acceptable (each such mutually acceptable individual, the “ Mutually Selected Director ”) to the Directors of the Company who are not Series A Directors, on the one hand, and a majority of the Series A Directors (a “ Majority of the Series A Directors ”), on the other hand, shall not have
 

 
-2- 

 

been appointed to the Board as the ninth (9th) Director of the Company, or (y) an appointed Mutually Selected Director at any time has ceased to serve as a Director and a new Mutually Selected Director shall not have been appointed by the Directors within sixty (60) days thereafter, then, in each such instance, the Series A Holders shall be entitled to elect a fifth (5th) member to the Board (which shall then consist of a total of nine (9) Directors) who shall continue in office until replaced by a new Mutually Selected Director, which the Directors shall in good faith endeavor to appoint, or failing such new appointment, by another Person elected by a Majority of the Series A Holders.
 
 
(E)
In the case of any resolution proposed on a poll at a general meeting of the Company to appoint any person as a Director of the Company who has previously been appointed as a Series A Director (whether by written notice, by the Board or otherwise) or any person nominated by a Majority of the Series A Holders pursuant to Article 113, the holders of the Series A Preference Shares shall be entitled to vote, and each Series A Preference Share held by a Series A Holder shall entitle such Series A Holder to cast in respect of such resolution such number of votes as is equal to the product obtained by multiplying (i) the product of the total number of the Company’s Ordinary Shares then outstanding times five (5) by (ii) the quotient obtained by dividing the number of the Ordinary Shares at the time owned by such Series A Holder, directly or through American Depositary Shares, by the number of the Company’s Ordinary Shares at the time so owned by all the Series A Holders (for each Series A Holder, its “ Number of Supermajority Votes ”). In the case of any resolution proposed on a poll at a general meeting of the Company to remove any Series A Director or to elect any person(s) whose election would cause the total number of Series A Directors following such general meeting to be less than four (4), the holders of the Series A Preference Shares shall be entitled to vote, and each Series A Preference Share held by a Series A Holder shall entitle such Series A Holder to cast in respect of such resolution such number of votes as is equal to its Number of Supermajority Votes.
 
(iii)   Committees
 
From and after the date hereof, a Majority of the Series A Directors shall have the right to approve the composition of any committee of the Board, provided that any such committee shall have an equal number of Series A Directors and Directors other than Series A Directors.
 
(iv)   Quorum of the Board
 
Any resolution of the Board to set the quorum necessary for the transaction of the business of the Board (the “ Quorum ”) at any number other than six (6), comprising three (3) Series A Directors and any three (3) Directors other than Series A Directors   shall require the written consent of a Majority of the Series A Directors.
 
(v)   Preemptive Rights
 

 
-3- 

 


 
 
(A)
Each Series A Holder shall have a right of first refusal to purchase up to such Series A Holder’s pro rata share (as described below) of any offering by the Company of Ordinary Shares or any other class or series of its capital stock, or any other securities convertible into or exchangeable for Ordinary Shares or any other class or series of capital stock (including convertible stock, redeemable stock and debt with warrants, but excluding any Exempt Securities (as defined below), any issuances pursuant to the Company’s equity credit agreement with Brittany Capital Management Ltd. dated as of 1 June 2007, provided such issuance shall have been approved by the affirmative vote of at least a majority of all the members of the Board plus one additional Director (the “ Supermajority Directors ”), and any issuances pursuant to that certain Securities Purchase Agreement, dated May 13, 2008, by and among the Company and the purchasers named therein related to an additional financing), in each case, on the same terms as the other investors participating in such offering.  Each Series A Holder’s pro rata share shall be equal to the percentage of the Company’s outstanding Ordinary Shares that are owned by such Series A Holder at the time of each such offering.
 
 
(B)
The Company shall provide written notice to each Series A Holder that the Company is considering any proposed future financing subject to such preemptive rights, providing a general outline of the proposed structure and anticipated terms thereof, not less than 15 days prior to completion thereof (the “ Completion Date ”).  The Company shall also provide written notice to each such Series A Holder describing in reasonable detail the terms of any such proposed future financing (the “ Detailed Notice ”) within a reasonable period of time (but not less than ten (10) days prior to the Completion Date).  Unless a Series A Holder provides the Company notice in writing within five (5) days of its receipt of the Detailed Notice that it wishes to participate in such financing, such Series A Holder’s right with respect to such proposed future financing shall be deemed waived.  Anything herein to the contrary notwithstanding, if required to accumulate from its investors the funds necessary to participate in any such financing, each Series A Holder who has delivered timely notice of its intent to participate in such financing shall have up to fifteen (15) Business Days from the date it sent such notice of its intent to participate to fund its purchase even if any such period extends beyond the Completion Date.
 
 
(C)
The rights and obligations established pursuant to this paragraph 1.2(b)(v) shall terminate if (x) a Special Rights Termination Event (as defined below) shall have occurred, or (y) the Series A Holders (and/or their Affiliates (as defined below)) cease to own in the aggregate at least 33% of the number of Shares (as defined in the Purchase Agreement) purchased by them in the First Closing (as defined in the Purchase Agreement) and the Second Closing (as defined in the Purchase Agreement).
 

 
-4- 

 


 
 
(D)
For purposes herein:
 
 
(x)
Exempt Securities   means (i) options granted, and shares issued upon exercise thereof, to employees, Directors or consultants under the Company’s stock option plans in amounts approved by the Company’s Board of Directors upon the recommendation of its remuneration committee (as appropriately adjusted for stock splits, stock dividends, and the like), (ii) securities offered under a registration statement on Form F-4 (or any applicable successor form), (iii) the conversion or exercise of convertible debt or exercisable securities outstanding on the date hereof as set forth on Schedule 2.27 of the Disclosure Schedule to the Purchase Agreement, (iv) the issuance of Ordinary Shares to pay milestones which may become payable in relation to the acquisitions by the Company of Laxdale Limited and Ester Neurosciences Ltd. as set forth on Schedule 2.26 of the Disclosure Schedule to the Purchase Agreement, (v) the issuance of shares in connection with bank financing or similar transactions that are primarily of a non-equity financing nature and approved by the Board, and (vi) securities issued pursuant to acquisitions or strategic transactions approved by the Supermajority Directors.
 
 
(y)
Special Rights Termination Event ” shall mean either (1) the failure of the Series A Holders to timely exercise their option to fund the Second Closing Amount (as defined in the Purchase Agreement) pursuant to Section 1.1(c) of the Purchase Agreement, or (2) the timely exercise of such option by the Series A Holders followed by the failure of the Second Closing to occur due to the failure of the Series A Holders to satisfy any of the conditions provided in Sections 5.3(a)-(c) of the Purchase Agreement.

(vi)   Conversion and Termination
 
 
(A)
If (x) the Second Closing occurs, and (y) at the Second Closing, any Series A Holder funds less than such Series A Holder’s full Pro Rata Percentage (as set forth opposite such Series A Holder’s name on Exhibit A to the Purchase Agreement) of the Second Closing Amount, then each Series A Preference Share held by such Series A Holder shall automatically convert into one (1) Ordinary Share.
 
 
(B)
Each Series A Preference Share held by all the Series A Holders shall automatically convert into one Ordinary Share, and the rights and obligations of the Series A Preference Shares shall terminate, if, at any time after the Second Closing, (x) a Special Rights Termination Event shall have occurred, or (y) the Series A Holders (and/or their Affiliates)
 

 
-5- 

 

 
cease to own in the aggregate at least 33% of the number of Shares purchased by them in the First Closing and the Second Closing.
 
 
(C)
For purposes herein, “ Affiliates ” shall mean with respect to any Person, any other Person controlling, controlled by or under direct or indirect common control with such Person (for the purposes of this definition “ control ,” when used with respect to any specified Person, shall mean the power to direct the management and policies of such Person, directly or indirectly, whether through ownership of voting securities, by contract or otherwise; and the terms “ controlling ” and “ controlled ” shall have meanings correlative to the foregoing).

(vii)   Required Votes
 
The written consent of a Majority of the Series A Purchasers shall be required for the Company to effect or validate the following actions:
 
 
(A)
Any amendment, alteration or repeal of any provision contained in this paragraph 1.2(b);
 
 
(B)
Any amendment, alteration or repeal of any provision contained in Articles 5 to 30 inclusive of the Company’s Articles of Association, in force as at May 13, 2008, if such amendment, alteration or repeal of any such provision would be adverse or inconsistent with the specific rights attaching to the Series A Preference Shares as expressly set forth in this paragraph 1.2(b) (the “ Specific Series A Rights ”);
 
 
(C)
Any issuance of any additional Series A Preference Shares; or
 
 
(D)
Any authorization, creation or designation, whether by reclassification or otherwise, of any new class or series of capital stock or any other securities convertible into equity securities of the Company which would amend alter or repeal any of the Specific Series A Rights, or grant any rights which are identical or superior to any of the Specific Series A Rights.
 
(viii)   Voting Rights at General Meeting
 
Except as provided in this paragraph 1.2(b), the Series A Preference Shares shall not entitle the Series A Holders to vote at general meetings of the Company.
 
(ix)   Other Rights
 
Save as expressly provided in this paragraph 1.2(b), each Series A Preference Share shall rank pari passu in all respects with the Ordinary Shares.
 

 
 
-6-
 
 

Exhibit 8.1


SUBSIDIARIES OF AMARIN CORPORATION PLC

 
 
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%


 
 

Exhibit 12.1
 
CERTIFICATIONS
 
I, Thomas G. Lynch, certify that:

1.  
I have reviewed this annual report on Form 20-F of Amarin Corporation plc;

2.  
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.  
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

4.  
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
 
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
        (b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;  

(c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
 
(d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
 
5.  
The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent function):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
 
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
 

/s/  THOMAS G. LYNCH
________________________________________
Thomas G. Lynch
Chairman and Chief Executive Officer

Date:           May 19, 2008

 

 

Exhibit 12.2
 
CERTIFICATIONS
 
I, Alan Cooke, certify that:

1.  
I have reviewed this annual report on Form 20-F of Amarin Corporation plc;

2.  
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.  
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

4.  
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
 
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
        (b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;  

(c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
 
(d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
 
5.  
The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent function):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
 
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
 

/s/  ALAN COOKE
________________________________________
Alan Cooke
President, Chief Operating Officer and Chief Financial Officer

Date:           May 19, 2008

 

 

Exhibit 13.1
 

AMARIN CORPORATION PLC
 
CERTIFICATION OF THOMAS G. LYNCH, CHAIRMAN AND CHIEF EXECUTIVE OFFICER
OF AMARIN CORPORATION PLC, PURSUANT TO SECTION 18 U.S.C. SECTION 1350, AS
ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 
In connection with the Annual Report of Amarin Corporation plc (the “Company”) on Form 20-F for the period ending December 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certifies that to the best of his knowledge:

1.  
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2.  
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


/s/ THOMAS G. LYNCH
___________________________________
Name: Thomas G. Lynch

Title:   Chairman and Chief Executive Officer
Date:           May 19, 2008





 

Exhibit 13.2
 

AMARIN CORPORATION PLC
 
CERTIFICATION OF ALAN COOKE, PRESIDENT, CHIEF OPERATING OFFICER AND
CHIEF FINANCIAL OFFICER OF AMARIN CORPORATION PLC, PURSUANT TO
SECTION 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE
SARBANES-OXLEY ACT OF 2002

 
In connection with the Annual Report of Amarin Corporation plc (the “Company”) on Form 20-F for the period ending December 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certifies that to the best of his knowledge:

1.  
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2.  
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


/s/  ALAN COOKE
___________________________________
Name: Alan Cooke

Title:   President, Chief Operating Officer and Chief Financial Officer
Date:           May 19, 2008





 
 
 


Exhibit 14.1
 




Consent of Independent Registered Public Accounting Firm

 
We hereby consent to the incorporation by reference in the Registration Statements on Form F-3 (Registration Nos. 333-104748, 333-13200, 333-12642, 333-121431, 333-121760, 333-135718 and 333-131479 ) of Amarin Corporation plc of our report dated May 19, 2008 relating to the financial statements of Amarin Corporation plc which appears in this Form 20-F. We also consent to the references to us under the heading “Experts” in such Registration Statements.  

 
PricewaterhouseCoopers  

Dublin, Ireland
May 19, 2008