o |
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE
ACT OF 1934
|
x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 FOR THE FISCAL YEAR ENDED DECEMBER 31,
2008
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 FOR THE TRANSITION PERIOD FROM
TO
|
o
|
SHELL
COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 DATE OF EVENT REQUIRING THIS SHELL COMPANY
REPORT
|
Title
of Each
Class
|
Name
of Each Exchange
on
Which Registered
|
None
|
None
|
4.11
|
Stock
Purchase Agreement, dated November 30, 2001, by and among Abriway
International S.A., Beta Pharmaceuticals Corporation and the
Group(7)
|
4.12
|
Novation
Agreement, dated November 30, 2001, by and among Beta Pharmaceuticals
Corporation, Amarin Technologies S.A. and the Group(7)
|
4.13
|
Loan
Agreement, dated September 28, 2001, between Elan Pharma International
Limited and the Group(8)
|
4.14
|
Deed
of Variation, dated July 19, 2003, amending certain provisions of the Loan
Agreement between the Group and Elan Pharma International
Limited(10)
|
4.15
|
Deed
of Variation No. 2, dated December 23, 2002, between The Group and Elan
Pharma International Limited(10)
|
4.16
|
Deed
of Variation No. 3, dated January 27, 2003, between the Group and Elan
Pharma International Limited(10)
|
4.17
|
The
Group 2002 Stock Option Plan(17)
|
4.18
|
Agreement
Letter, dated October 21, 2002, between the Group and Security Research
Associates, Inc.(10)
|
4.19
|
Agreement,
dated January 27, 2003, among the Group, Elan International Services, Ltd.
and Monksland Holdings B.V.(10)
|
4.20
|
Master
Agreement, dated January 27, 2003, between Elan Corporation, plc., Elan
Pharma International Limited, Elan International Services, Ltd., Elan
Pharmaceuticals, Inc., Monksland Holdings B.V. and the
Group(10)
|
4.21
|
Form
of Warrant Agreement, dated March 19, 2003, between the Group and
individuals designated by Security Research Associates, Inc.(10) (The
Group entered into seven separate Warrant Agreements on March 19, 2003 all
substantially similar in form and content to this form of Warrant
Agreement).
|
4.22
|
Sale
and Purchase Agreement, dated March 14, 2003, between F. Hoffmann — La
Roche Ltd., Hoffmann — La Roche Inc, and the Group(10)†
|
4.23
|
Share
Subscription and Purchase Agreement dated October 28, 2003 among the
Group, Amarin Pharmaceuticals Company Limited, Watson Pharmaceuticals,
Inc. and Lagrummet December NR 911 AB (under name change to WP Holdings
AB)(12)
|
4.24
|
Asset
Purchase Agreement dated February 11, 2004 between the Group, Amarin
Pharmaceuticals Company Limited and Valeant Pharmaceuticals
International(12)†
|
4.25
|
Amendment
No. 1 to Asset Purchase Agreement dated February 25, 2004 between the
Group, Amarin Pharmaceuticals Company Limited and Valeant Pharmaceuticals
International(12)
|
4.26
|
Development
Agreement dated February 25, 2004 between the Group and Valeant
Pharmaceuticals International(12)
|
4.27
|
Settlement
Agreement dated February 25, 2004 among Elan Corporation plc, Elan Pharma
International Limited, Elan International Services, Ltd, Elan
Pharmaceuticals, Inc., Monksland Holdings BV and the
Group(12)
|
4.28
|
Debenture
dated August 4, 2003 made by the Group in favor of Elan Corporation plc as
Trustee(12)
|
4.29
|
Debenture
Amendment Agreement dated December 23, 2003 between the Group and Elan
Corporation plc as Trustee(12)
|
4.30
|
Debenture
Amendment Agreement No. 2 dated February 24, 2004 between the Group and
Elan Corporation plc as Trustee(12)
|
4.31
|
Loan
Instrument dated February 25, 2004 executed by Amarin in favor of Elan
Pharma International Limited(12)
|
4.32
|
Amended
and Restated Master Agreement dated August 4, 2003 among Elan Corporation
plc, Elan Pharma International Limited, Elan International Services, Ltd,
Elan Pharmaceuticals, Inc., Monksland Holdings BV and the Group
(11)(12)
|
4.33
|
Amended
and Restated Option Agreement dated August 4, 2003 between the Group and
Elan Pharma International Limited (11)(12)
|
4.34
|
Deed
of Variation No. 2, dated August 4, 2003, to the Amended and Restated
Distribution, Marketing and Option Agreement between Elan Pharmaceuticals,
Inc. and the Group(11)(12)
|
4.35
|
Deed
of Variation No. 4, dated August 4, 2003, to Loan Agreement between the
Group and Elan Pharma International Limited (11)(12)
|
4.36
|
Amendment
Agreement No. 1, dated August 4, 2003, to Amended and Restated Asset
Purchase Agreement Among Elan International Services, Ltd., Elan
Pharmaceuticals, Inc. and the
Group(11)(12)
|
4.37
|
Warrant
dated February 25, 2004 issued by the Group in favor of the Warrant
Holders named therein(12)
|
4.38
|
Amendment
Agreement dated December 23, 2003, between Elan Corporation plc, Elan
Pharma International Limited, Elan Pharmaceuticals, Inc., Monksland
Holdings BV and the Group(11)(12)
|
4.39
|
Bridging
Loan Agreement dated December 23, 2003 between the Group and Elan
Pharmaceuticals, Inc.(11)(12)
|
4.40
|
Agreement
dated December 23, 2003 between the Group and Elan Pharma International
Limited, amending the Amended and Rested Option Agreement dated August 4,
2003(11)(12)
|
4.41
|
Form
of Subscription Agreement, dated as of October 7, 2004 by and among the
Group and the Purchasers named therein(13) (The Group entered into 14
separate Subscription Agreements on October 7, 2004 all substantially
similar in form and content to this form of Subscription
Agreement.)
|
4.42
|
Form
of Registration Rights Agreement, dated as of October 7, 2004 between the
Group and the Purchasers named therein(13) (The Group entered into 14
separate Registration Rights Agreements on October 7, 2004 all
substantially similar in form and content to this form of Registration
Rights Agreement.)
|
4.43
|
Share
Purchase Agreement dated October 8, 2004 between the Group,Vida Capital
Partners Limited and the Vendors named therein relating to the entire
issued share capital of Laxdale Limited(13)
|
4.44
|
Escrow
Agreement dated October 8, 2004 among the Group, Belsay Limited and
Simcocks Trust Limited as escrow agent(13)
|
4.45
|
Loan
Note Redemption Agreement dated October 14, 2004 between Amarin Investment
Holding Limited and the Group(13)
|
4.46
|
Settlement
agreement dated 27 September 2004 between the Group and Valeant
Pharmaceuticals International(14)†
|
4.47
|
Exclusive
License Agreement dated October 8, 2004 between Laxdale and Scarista
Limited pursuant to which Scarista has the exclusive right to use certain
of Laxdale’s intellectual property(14)†
|
4.48
|
Clinical
Supply Agreement between Laxdale and Nisshin Flour Milling Co., Limited
dated 27th October 1999(14)†
|
4.49
|
Loan
Note Redemption Agreement dated May, 2005 between Amarin Investment
Holding Limited and the Group.(14)
|
4.50
|
Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited and
Amarin Neuroscience Limited.(15)
|
4.51
|
Employment
Agreement with Alan Cooke, dated May 12, 2004 and amended September 1,
2005.(16)
|
4.52
|
Clinical
Supply Extension Agreement dated December 13, 2005 to Agreement between
Amarin Pharmaceuticals Ireland Limited and Amarin Neuroscience Limited and
Nisshin Flour Milling Co.†(17)
|
4.53
|
Securities
Purchase Agreement dated May 20, 2005 between the Company and the
purchasers named therein. The Company entered into 34 separate Securities
Purchase Agreements on May 18, 2005 and in total issued 13,677,110
ordinary shares to management, institutional and accredited investors. The
purchase price was $1.30 per ordinary share.(17)
|
4.54
|
Securities
Purchase Agreement dated January 23, 2006 between the Company and the
purchasers named therein. The Company entered into 2 separate
Securities Purchase Agreements on January 23, 2006 and in total issued
840,000 ordinary shares to accredited investors. The purchase price was
$2.50 per ordinary share.(17)
|
4.55
|
Assignment
Agreement dated May 17, 2006 between Amarin Pharmaceuticals Ireland
Limited and Dr Anthony Clarke, pursuant to which, Amarin Pharmaceuticals
Ireland Limited acquired the global rights to a novel oral formulation of
Apomorphine for the treatment of “off” episodes in patients with advanced
Parkinson’s disease.(17)
|
4.56
|
Amendment
(Change Order Number 2), dated June 8, 2006 to Services Agreement dated
June 16, 2005 between Icon Clinical Research Limited and Amarin
Neuroscience Limited.(23)
|
4.57
|
Securities
Purchase Agreement dated October 18, 2006 between the Company and the
purchasers named therein. The Company entered into 32 separate Securities
Purchase Agreements on October 18, 2006 and in total issued 8,965,600
ordinary shares to institutional and accredited investors. The purchase
price was $2.09 per ordinary share(17)
|
4.58
|
Master
Services Agreement dated November 15, 2006 between Amarin Pharmaceuticals
Ireland Limited and Icon Clinical Research (U.K.) Limited. Pursuant to
this agreement, Icon Clinical Research (U.K.) Limited agreed to provide
due diligence services to Amarin Pharmaceuticals Ireland Limited on
ongoing licensing opportunities on an ongoing
basis.(17)
|
4.59
|
Agreement
dated January 18, 2007 between Neurostat Pharmaceuticals Inc.
(“Neurostat”), Amarin Pharmaceuticals Ireland Limited, Amarin Corporation
plc and Mr. Tim Lynch whereby the Company agreed to pay Neurostat a
finder’s fee relating to a potential licensing transaction and similar
payments comprising upfront and contingent milestones totaling $565,000
and warrants to purchase 175,000 ordinary shares with an exercise price of
$1.79 per ordinary share.(23)
|
4.60
|
Lease
Agreement dated January 22, 2007 between the Company, Amarin
Pharmaceuticals Ireland Limited and Mr. David Colgan, Mr. Philip Monaghan,
Mr. Finian McDonnell and Mr. Patrick Ryan. Pursuant to this agreement,
Amarin Pharmaceuticals Ireland Limited took a lease of a premises at The
First Floor, Block 2, The Oval, Shelbourne Road, Dublin 4, Ireland
(17)
|
4.61
|
Amendment
(Change Order Number 4), dated February 15, 2007 to Services Agreement
dated June 16, 2005 between Icon Clinical Research Limited and Amarin
Neuroscience Limited. (17)
|
4.62
|
Employment
Agreement Amendment with Alan Cooke, dated February 21, 2007.
(17)
|
4.63
|
Amendment
(Change Order Number 3), dated March 1, 2007 to Services Agreement dated
June 16, 2005 between Icon Clinical Research Limited and Amarin
Neuroscience Limited. (17)
|
4.64
|
Development
and License Agreement dated March 6, 2007 between Amarin Pharmaceuticals
Ireland Limited and Elan Pharma International Limited. Pursuant to this
agreement, Amarin Pharmaceuticals Ireland Limited acquired global rights
to a novel nasal lorazepam formulation for the treatment of emergency
seizures in epilepsy patients.(23)†
|
4.65
|
Consultancy
Agreement dated March 9, 2007 between Amarin Corporation plc and Dalriada
Limited. Under the Consultancy Agreement, Amarin Corporation plc will pay
Dalriada Limited a fee of £240,000 per annum for the provision of the
consultancy services. Dalriada Limited is owned by a family trust, the
beneficiaries of which include our Chairman and Chief Executive Officer,
Mr. Thomas Lynch, and members of his family.(23)
|
4.66
|
Form
of Securities Purchase Agreement dated June 1, 2007 between Amarin
Corporation plc and the Purchasers named therein. Amarin Corporation plc
entered into 11 separate Securities Purchase Agreements on June 1, 2007
all substantially similar in form and content to this Securities Purchase
Agreement pursuant to which we issued an aggregate of 6,156,406 ordinary
shares to such Purchasers, including management. The purchase price was
$0.60 per ordinary share.(23)
|
4.67
|
Equity
Credit Agreement dated June 1, 2007 between Amarin Corporation plc and
Brittany Capital Management. Pursuant to this agreement, Amarin has an
option to draw up to $15,000,000 of funding at any time over a three year
period solely at Amarin Corporation plc’s
discretion.(18)
|
4.68
|
Form
of Equity Securities Purchase Agreement dated December 4, 2007 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 19 separate Equity Securities Purchase
Agreements on December 4, 2007 all substantially similar in form and
content to this Equity Securities Purchase Agreement pursuant to which we
issued an aggregate of 16,290,900 ordinary shares to such Purchasers,
including management. The purchase price was $0.33 per ordinary
share.(19)
|
4.69
|
Form
of Debt Securities Purchase Agreement dated December 4, 2007 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 2 separate Debt Securities Purchase
Agreements on December 4, 2007 both substantially similar in form and
content to this Debt Securities Purchase Agreement pursuant to which we
issued an aggregate of $2,750,000 of 3 year convertible loan notes to such
Purchasers including management. The conversion price to convert the loan
notes into ordinary shares of Amarin Corporation plc is $0.48 per ordinary
share.(19)
|
4.70
|
Stock
Purchase Agreement dated December 5, 2007 between Amarin Corporation plc,
the selling shareholders of Ester Neurosciences Limited (“Ester”), Ester,
and Medica II Management L.P. pursuant to which Amarin Corporation plc
acquired the entire issued share capital of Ester. Pursuant to this
agreement, Amarin Corporation plc paid initial consideration of
$15,000,000, of which $5,000,000 was paid in cash and $10,000,000 was paid
through the issuance of shares of Amarin Corporation plc. Additional
contingent payments, valued at an aggregate of $17,000,000 are payable in
the event that certain development-based milestones are successfully
completed.(21)
|
4.71
|
Letter
Agreement dated December 6, 2007 between Amarin Corporation plc and the
Seller’s Representatives of the selling shareholders of Ester pursuant to
which the definition of “Closing Date Average Buyer Stock Price” in the
Stock Purchase Agreement dated December 5, 2007 described above was
amended.(22)
|
4.72
|
Senior
Indenture dated December 6, 2007 between Amarin Corporation plc and
Wilmington Trust Company. Under this Indenture, Amarin Corporation plc may
issue one or more series of senior debt securities from time to
time.(19)
|
4.73
|
First
Supplemental Senior Indenture Dated December 6, 2007 between Amarin
Corporation plc and Wilmington Trust Company. Under this
Supplemental Senior Indenture, together with the senior debt indenture
dated December 6, 2007 described above, Amarin Corporation plc issued its
8% Convertible Debentures due 2010.(19)
|
4.74
|
Compromise
Agreement dated December 19, 2007 between Amarin Corporation plc and
Richard Stewart.(20)
|
4.75
|
Collaboration
Agreement dated January 8, 2008 between Amarin Pharmaceuticals Ireland
Limited and ProSeed Capital Holdings (“ProSeed”). Pursuant to
this agreement, 975,000 ordinary shares in Amarin Corporation plc were
issued in the form of ADSs to ProSeed in respect of fees due for
investment banking advice provided to Amarin Corporation plc and Amarin
Pharmaceuticals Ireland Limited on the acquisition of Ester.
(20)†
|
4.76
|
Amendment
No. 1 to Stock Purchase Agreement dated April 7, 2008 between Amarin
Corporation plc and Medica II Management L.P. pursuant to which the
definition of “Milestone II Time Limit Date” in the Stock Purchase
Agreement dated December 5, 2007 described above was
amended.(23)
|
4.77
|
Employment
Agreement dated April 28, 2008 with Dr Declan
Doogan.(20)
|
4.78
|
Form
of Equity Securities Purchase Agreement dated May 13, 2008 between Amarin
Corporation plc and the Purchasers named therein. Amarin Corporation plc
entered into 9 separate Equity Securities Purchase Agreements on May 13,
2008 all substantially similar in form and content to this Securities
Purchase Agreement pursuant to which we issued an aggregate of 12,173,914
Ordinary Shares and 8 Preference Shares to such Purchasers. The purchase
price was $2.30 per Ordinary Share.(20)†
|
4.79
|
Termination
and Separation Agreement and Release Agreement, dated August 7, 2008,
between Mr. Paul Duffy and Amarin Corporation plc.(23)
|
4.80
|
Directors
Securities Purchase Agreement dated May 13, 2008 Sunninghill Ltd, Simon
Kukes, Michael Walsh and Amarin Corporation plc.(23)
|
4.81
|
Change
Order for Additional Biostatistics & Medical Writing Work dated June
04, 2008, between Icon Clinical Research Limited and Amarin Neuroscience
Limited.(23)
|
4.82
|
Consultancy
Agreement, dated August 16, 2008, between Decisionability Inc and Amarin
Neuroscience Limited.(23)
|
4.83
|
Master
Services Agreement, dated August 22, 2008, between Charles River
Laboratories Preclinical Services Edinburgh Limited, Amarin Neuroscience
Limited and Amarin Pharmaceuticals Ireland Ltd.(23)
|
4.84
|
Work
Order, dated September 3, 2008, between Charles River Laboratories
Preclinical Services Edinburgh Limited, Amarin Neuroscience Limited and
Amarin Pharmaceuticals Ireland Ltd.(23)
|
4.85
|
Consultancy
Agreement, dated October 10, 2008, between Icon Clinical Research Limited
and Amarin Corporation plc.(23)
|
4.86
|
Supply
Agreement, dated February 23, 2009, between Nisshin Pharma Inc and Amarin
Pharmaceuticals Ireland Ltd*
†
|
4.87
|
Trial
A Letter Agreement dated February 24, 2009 between Medpace Inc and Amarin
Pharma Inc and Amarin Pharmaceuticals Ireland Ltd.(23)
|
4.88
|
Amendment
and Waiver Agreement, dated May 25, 2009 between Ester Neurosciences Ltd.
Medica II Management L.P. and Amarin Corporation plc.*
†
|
4.89
|
Amendment
number 2 to the Letter Agreement for certain initial services for certain
initial services for the Ethyl-EPA Hypertriglyceridemia Studies between
Medpace Inc and Amarin Pharma Inc and Amarin Pharmaceuticals Ireland Ltd
dated February 24, 2009, as amended on 5 May, 2009.(23)
|
4.90
|
Termination
and Assignment Agreement, dated 21 July, 2009 between Elan Pharma
International Limited and Amarin Pharmaceuticals Ireland Ltd.(23)
†
|
4.91
|
Amendment
number 5 to the Letter Agreement for certain initial services for certain
initial services for the Ethyl-EPA Hypertriglyceridemia Studies between
Medpace Inc and Amarin Pharma Inc and Amarin Pharmaceuticals Ireland Ltd
dated 1 December, 2008, as amended on 19 January, 2009, as further amended
30 January 2009, 5 May, 2009 and 3 August, 2009.(23)
|
4.92
|
Master
Services Agreement, dated September 29, 2009, between Medpace Inc and
Amarin Pharma Inc and Amarin Pharmaceuticals Ireland
Ltd.(23)
|
4.93
|
Bridge
Loan Agreement, dated July 31, 2009 between Sunninghill Ltd, Thomas G.
Lynch, Simon Kukes, Michael Walsh, Midsummer Investments Limited,
Midsummer Ventures LP, David Hurley, David Brabazon, Pram Lachman and
Amarin Corporation plc. as amended by Amendment No.1 dated September 30,
2009.(23)
|
4.94
|
Securities
Purchase Agreement dated October 12, 2009 between Amarin Corporation plc
and the Purchasers named therein.(23)
|
4.95
|
Compromise
Agreement dated October 16, 2009 with Alan Cooke.(23)
|
4.96
|
Warrant
agreement for Thomas G. Lynch to subscribe for and purchase 500,000
Ordinary Shares of £0.50 each in Amarin Corporation plc with an exercise
price of $1.50.(23)
|
4.97
|
Amendment
Agreement dated October 12, 2009, to the Form of Equity Securities
Purchase Agreement dated May 13, 2008 between Amarin Corporation plc and
the Purchasers named therein.(23)
|
8.1
|
Subsidiaries
of the Group.(23)
|
11.1
|
Code
of Ethics(17)
|
12.1
|
Certification
of Thomas G. Lynch required by R1 15d-14(a) of the Securities Exchange Act
of 1934, as adopted pursuant to Section 302 of the Sarbanes–Oxley Act of
2002.(23)
|
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.(23)
|
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.(23)
|
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.(23)
|
(1)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F–1, File No. 33–58160, filed with the Securities and
Exchange Commission on February 11, 1993.
|
(2)
|
Incorporated
herein by reference to Exhibit (a)(i) to the Group’s Registration
Statement on Post–Effective Amendment No. 1 to Form F–6, File No.
333–5946, filed with the Securities and Exchange Commission on October 8,
1998.
|
(3)
|
Incorporated
herein by reference to Exhibit (a)(ii) to the Group’s Registration
Statement on Post–Effective Amendment No. 2 to Form F–6, File No.
333–5946, filed with the Securities and Exchange commission on September
26, 2002.
|
(4)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20–F for the year ended December 31, 1999, filed with the Securities
and Exchange Commission on June 30, 2000.
|
(5)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F–3, File No. 333–13200, filed with the Securities and
Exchange Commission on February 22, 2001.
|
(6)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20–F for the year ended December 31, 2000, filed with the Securities
and Exchange Commission on July 2, 2001.
|
(7)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20–F for the year ended December 31, 2001, filed with the Securities
and Exchange Commission on May 9, 2002.
|
(8)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Pre-Effective Amendment No. 2 to Form F–3, File No.
333–13200, filed with the Securities and Exchange Commission on November
19, 2001.
|
(9)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on form S-8, File No. 333-101775, filed with the Securities and
Exchange Commission on December 11, 2002.
|
(10)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 21, 2002, filed with the Securities
and Exchange Commission on April 24, 2003.
|
(11)
|
These
agreements are not longer in effect as a result of superseding agreements
entered into by the Group.
|
(12)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2003, filed with the Securities
and Exchange Commission on March 31, 2004.
|
(13)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F-3, File No. 333–121421, filed with the securities and
Exchange Commission on December 20, 2004.
|
(14)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2004, filed with the Securities
and Exchange Commission on April 1, 2005.
|
(15)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F-3, File No. 333–131479, filed with the Securities and
Exchange Commission on February 2, 2006.
|
(16)
|
Incorporated
by reference herein to certain exhibits in the Group’s Annual Report on
Form 20–F for year ended December 31, 2005, filed with the Securities and
Exchange Commission on March 30, 2006 as amended on From 20–F/A filed
October 13, 2006.
|
(17)
|
Incorporated
by reference herein to certain Exhibits in the Group’s Annual Report on
Form 20–F for the year ended December 31, 2006, filed with the Securities
and Exchange Commission on March 5, 2007.
|
(18)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on June 1, 2007.
|
(19)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on December 17, 2007.
|
(20)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on December 19, 2007, as amended on Form 20-F/A filed September
24, 2008
|
(21)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on January 28, 2008.
|
(22)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on February 1, 2008.
|
(23) | Incorporated herein by reference to certain exhibits to the Group's Annual Report on Form 20-F for the year ended December 31, 2008, filed with the Securities and Exchange Commission on October 22, 2009. |
|
*
Filed herewith
|
|
†
confidential treatment requested (the confidential potions of such
exhibits have been omitted and filed separately with the Securities and
Exchange
Commission).
|
1
|
DEFINITIONS
|
2
|
2
|
DUTIES
|
3
|
3
|
ORDER,
ACCEPTANCE AND DELIVERY
|
4
|
4
|
ROLLING
FORECAST
|
5
|
5
|
PRICE
AND MILESTONE PAYMENTS
|
6
|
6
|
WORKING
GROUP
|
7
|
7
|
TECHNICAL
AGREEMENT
|
7
|
8
|
LONG-TERM
SUPPLY AGREEMENT
|
7
|
9
|
TECHNOLOGY
TRANSFER
|
7
|
10
|
WARRANTIES
|
8
|
11
|
SHIPPING
TERM / TITLE AND RISK
|
9
|
12
|
CONFIDENTIAL
INFORMATION
|
9
|
13
|
FORCE
MAJEURE
|
11
|
14
|
TERM
|
11
|
15
|
TERMINATION
|
11
|
16
|
CONSEQUENCES
OF TERMINATION
|
12
|
17
|
ASSIGNMENT
|
12
|
18
|
MISCELLANEOUS
|
12
|
1
|
DEFINITIONS
|
1.1
|
In
this Agreement the following definitions shall apply, unless the context
requires otherwise:
|
(i)
|
in
relation to either Nisshin or Amarin, to a change in ownership or control
of more than 40% of the voting rights in Nisshin or Amarin;
and
|
(ii)
|
in
relation to Nisshin, to any other change in the ownership or control of
the business of Nisshin related to the manufacture of the Products or any
change in the ownership or control of the manufacturing site(s) of Nisshin
at which the Products are
manufactured.
|
2
|
DUTIES
|
2.1
|
During
the term of this Agreement, Nisshin shall manufacture at its manufacturing
plant, and supply to Amarin its requirements of the Products pursuant to
the terms and
|
2.2
|
Nisshin
shall not knowingly export, sell or distribute the Products to any company
who sell or distribute E-EPA in the
Territory.
|
2.3
|
This
Agreement does not impose any restriction of any nature on Amarin
obtaining a supply of E-EPA from suppliers other than Nisshin or from
itself manufacturing E-EPA.
|
2.4
|
Nisshin
shall ensure that the Products meet the
Specifications.
|
2.5
|
Amarin
shall purchase the Minimum Purchase Requirements of the Products from
Nisshin as specified in Schedule
One.
|
2.6
|
Amarin
shall make sure that all payments for these purchases are made without
delay.
|
2.7
|
Nisshin
shall provide reasonable assistance to Amarin for the purpose of Amarin's
import clearances in respect of the
Products.
|
2.8
|
Regulatory
|
2.8.1
|
Save
as otherwise agreed in writing with Amarin, Nisshin shall maintain the US
DMF and the EU DMF currently in
place.
|
2.8.2
|
Each
party shall promptly notify the other party of any notification received
from a regulatory agency, such as a relevant government health authority,
to conduct an inspection of the manufacturing site(s) or other facilities
used by Nisshin in the development, manufacturing, packaging, storage or
handling of the Product. Copies of all applicable
correspondence with the regulatory agency will be provided to the other
party.
|
2.8.3
|
Nisshin
shall make that portion of its facility where the Products are
manufactured, tested or stored, including related record and reference
samples, available for:
|
2.8.4
|
Following
full consultation with Amarin, Nisshin will be responsible for responding
to any notifications or inspections concerning the supply of the Product
by the FDA or EMEA.
|
3
|
ORDER,
ACCEPTANCE AND DELIVERY
|
3.1
|
Amarin
may, at any time, but no later than ninety (90) days before the specified
date of shipment of the Products, issue to Nisshin individual purchase
orders ("Order") for the Products to be delivered to
Amarin. Each Order, upon acceptance by Nishhin, shall
constitute a definitive individual contract for the sale and delivery of
Products. Nisshin shall issue an acceptance or rejection of the Order
within two (2) weeks from Nisshin’s receipt of the
Order.
|
3.2
|
Nisshin
and Amarin shall perform its respective obligations under the individual
contracts.
|
3.3
|
Amarin
shall inspect the Products within fifteen (15) days of receipt of the
Product and may reject any Products that fail to meet the Specifications,
have defects or are damaged in any way. Any Product not
rejected within fifteen (15) days shall be deemed to have been accepted by
Amarin ("Acceptance"). For the avoidance of doubt, Nisshin
shall also be responsible for latent defects in the Products which become
apparent after Acceptance, provided that such defect shall be notified to
Nisshin in writing without delay and not later than three (3) months from
the receipt of the Products by
Amarin.
|
3.4
|
Notwithstanding
the provisions of the above Clause, Amarin may, at its own discretion,
have a third party conduct the inspection of the Product. Under such
circumstances, Amarin will have thirty (30) days from receipt of the
Product to reject any Products that fail to meet the Specifications, have
defects or are damaged in any way.
|
3.5
|
Claims
for latent defects, not discovered during the aforementioned inspections
protocols in Clauses 3.3 and 3.4, shall be made in writing within 3 days
of discovery. Failure to make a timely claim in the aforementioned manner
shall constitute and shall be deemed to be Acceptance of the delivery by
Amarin and a waiver of right to claim by
Amarin.
|
4
|
ROLLING
FORECAST
|
4.1
|
Prior
to the first Marketing Approval, but not later than thirty (30) days
following the Commencement Date, Amarin shall provide Nisshin with a
twelve (12) month demand forecast. Thereafter, until Amarin’s submission
of a regulatory filing for Marketing Approval, Amarin shall provide
Nishhin with twelve (12) month demand forecasts on an annual
basis.
|
4.2
|
Within
two hundred and ten (210) days following Amarin's submission of a
regulatory filing for Marketing Approval in the US or EU, Amarin shall
provide Nisshin with a binding order for its launch stocks
requirements. Thereafter, Amarin shall, on a monthly basis,
provide Nisshin with a written rolling forecast for the following 12-month
period.
|
4.3
|
The
forecast amount for the first three months of the rolling forecast
stipulated in the Clause immediately above shall constitute binding
orders. The forecast amounts for the remaining nine months of
such rolling forecast, i.e., months 4-12, shall be non-fixed forecast
amounts. Amarin has the right to vary the forecast amounts for
months 4, 5 and 6 by +/-25%. Amarin may vary the forecast
amounts for months 7-12 without limitation. Nisshin shall not be obligated
to supply Products in excess of the binding forecast amounts contained in
the rolling forecasts.
|
5
|
PRICE
AND MILESTONE PAYMENTS
|
5.1
|
The
Price and Milestone Payments shall be as set forth in Schedule
One.
|
5.2
|
Nisshin
shall issue the invoice for the Product supplied in each shipment to
Amarin within 10 days from the date of each shipment. Amarin
shall pay the invoice amount for the Products delivered to it in
accordance with this Agreement into an account designated by Nisshin
within 30 days from the date of the corresponding invoice issued by
Nisshin.
|
5.3
|
In
the event Amarin fails to pay the Price of any of its purchases by the due
date provided in Clause 5.2 above, Nisshin is entitled, at its own
discretion, to suspend dispatching the Products or to withhold from
accepting Amarin’s Order until Amarin makes full payment with interest
from the due date to the date of payment calculated using an annual
interest rate of 6% per annum.
|
5.4
|
Amarin
shall reimburse Nisshin's reasonable costs for preparing and maintaining
the DMF prior to Amarin's receipt of each relevant Marketing Approval in
both US and EU.
|
5.5
|
Amarin
will reimburse to Nisshin all reasonable costs specifically related to
preparing for an inspection of any facility by a regulatory authority and
audit of any facility by any consultant with regard to cGMP, including but
not limited to interpreter’s fees for the inspection and
audit.
|
6
|
WORKING
GROUP
|
6.1
|
The
Parties shall form a joint working group (the "Working Group") to address
issues related to their future relationship for long term supply after
April 2012, including: (a) Long-Term Supply Agreement; (b) pricing; (c)
supply chain structure; (d) capacity expansion; (e) investment
requirements; (f) third party agreements (g) technology transfer; and (h)
the possible formation of a new business entity to supply Product to
Amarin. As more fully described in Clause 8, the Working Group
will make all reasonable efforts to review and discuss feasibility of such
long term supply relationship between the Parties by addressing the issues
outlined above by June 30, 2010 whether or not it is feasible for the
Parties to agree a long-term plan for supplying the
Product.
|
6.2
|
The
Working Group shall consist of the appropriate representatives from each
party having requisite authority to speak on behalf of each respective
company, provided, however, that the Working Group is not responsible nor
is it entrusted to establish business policy or to make decisions on
behalf of either Party. The number of representatives can be expanded with
the mutual agreement of both Parties. Each Party bears its own costs in
acting as part of the Working
Group.
|
6.3
|
The
Working Group shall meet in person as soon as practicable after the
Commencement Date and on a regular basis thereafter. The
Working Group shall hold discussions via meetings, teleconferences and
e-mail as appropriate and necessary to discuss in good faith the issues
set forth in Clause 6.1 of this Agreement. In the first
meeting, the Working Group will set the specific agenda and timing/venue
for the second meeting. The second meeting will set the specific agenda
and timing/venue for the third meeting, and so forth, provided, however,
that any meeting can be re-scheduled flexibly taking into account either
Party’s situation.
|
6.4
|
The
Working Group shall have no power or authority to enter into any binding
agreements on behalf of either
Party.
|
7
|
TECHNICAL
AGREEMENT
|
7.1
|
After
the Commencement Date, the Parties will initiate the negotiation for the
Technical Agreement, which is necessary for any review by any regulatory
authority in advance of approval of the Drug for marketing, to identify
their respective responsibilities in accordance with accepted GMP during
the term of this Agreement.
|
8
|
LONG-TERM
SUPPLY AGREEMENT
|
8.1
|
Pursuant
to Clause 6.1, the Parties shall conclude discussions no later than June
30, 2010 with regard to the Long-Term Supply Agreement for the supply of
the Products by Nisshin to Amarin. If the Parties agree to the
future supply scheme, the Parties will in good faith negotiate for the
terms of the Long-Term Supply Agreement. The Long-Term Supply
Agreement will determine how the Products are supplied after April 1,
2012.
|
9
|
TECHNOLOGY
TRANSFER
|
9.1
|
If
this Agreement has not been terminated by Nisshin in accordance with
Clause 15.1 of this Agreement (where Amarin has committed a material
breach of the terms of this Agreement and has failed to remedy such breach
within 60 days of receiving the
relevant
|
9.2
|
Nisshin
shall also be obliged to transfer the technology stipulated in Clause 9.1
upon the request of Amarin, to Amarin or to an entity established or
designated by Amarin if Amarin gives Nisshin notice of termination of the
Agreement under Clause 15.1 or 15.2, or if Nisshin gives Amarin notice of
termination of the Agreement under Clause
15.4.
|
9.3
|
Amarin
will be responsible for any and all costs associated with the
aforementioned transfer of technology. The other terms and
conditions of the transfer of technology will be discussed
separately. When the transfer of technology process is being
conducted, except for where the transfer of technology is triggered by
Nisshin giving Amarin notice of termination of the Agreement under Clause
15.4, Nisshin will work with Amarin to use best efforts to try to ensure
that there is no interruption in the supply of the Products to Amarin. If
the transfer of technology would not be completed during the term of this
Agreement, the Parties will consult each other in good faith on how
to deal with the case, including an extension of this Agreement
for a period of time which the Parties consider necessary to complete the
transfer of technology.
|
9.4
|
Amarin
agrees and confirms that the technology transfer provided in this Clause 9
will be Nisshin’s sole obligation in case the Long-Term Supply Agreement
is not executed on or before December 31,
2010.
|
10
|
WARRANTIES
|
10.1
|
Nisshin
hereby warrants that any Products manufactured pursuant to this Agreement
shall comply with the Specifications and all requirements of
cGMP.
|
10.2
|
Amarin
and Nisshin hereby represent and warrant to each other, as of the date of
this Agreement, as follows:
|
10.2.1
|
Each
Party has the right to enter into this
Agreement.
|
10.2.2
|
There
are no agreements between either Amarin or Nisshin and any third party
that conflict with this Agreement in the
Territory.
|
10.3
|
Nisshin
does not make and hereby disclaims any warranty with respect to the
Products other than the warranty set forth in Clauses 10.1 and 10.2,
whether expressed or implied.
|
10.4
|
Each
Party shall promptly notify the other Party of any breach of warranties
set forth in Clauses 10.1 to 10. 2.
|
10.5
|
If
any Products are not manufactured in accordance with the Specifications,
Nisshin at its sole option shall:
|
10.5.1
|
at
Nisshin’s cost, supply replacement of the Products conforming with Clause
10.1; or
|
10.5.2
|
refund
the Price or any part of the Price corresponding to the Products that does
not
|
11
|
SHIPPING
TERM / TITLE AND RISK
|
11.1
|
Nisshin
shall ship the Products FOB Tokyo, as defined in Incoterms
2000.
|
11.2
|
Title
to the Products shall pass from Nisshin to Amarin upon the delivery of the
Products to the Destination in accordance with the
Order.
|
11.3
|
Nisshin
will be responsible for organizing the transport by air and insurance
arrangements for the delivery of the Products from the site of manufacture
to the Destination. Amarin will reimburse Nisshin for the costs of the
transport and insurance arrangements for the said delivery of the Products
from the site of manufacture to the
Destination.
|
12
|
CONFIDENTIAL
INFORMATION
|
12.1
|
The
Parties shall keep Confidential Information strictly confidential, shall
not disclose it to any third party other than Bizen Chemical Ltd., and
Nisshin Seifun Group Inc., the current parent company of Nisshin. Save as
otherwise specifically provided herein, the Parties shall only disclose
Confidential Information to those of its employees, representatives and
agents requiring knowledge thereof in connection with fulfilling that
Party's obligations under this
Agreement.
|
12.2
|
The
Parties further agree to inform all such employees, representatives and
agents of confidential nature of the Confidential Information and their
duties hereunder and make reasonable measures to make employees,
representatives and agent comply with the duties
hereunder.
|
12.3
|
Notwithstanding
the provisions of this Clause 12, if one of the Parties (“Disclosing
Party”) or any person who received the Confidential Information in
accordance with Clause 12.1 is requested or required by any court of
competent jurisdiction, any competent judicial, governmental or regulatory
body, pursuant to any relevant law or regulation to disclose any of the
Confidential Information, the Disclosing Party will make reasonable effort
to provide the other Party with a notice so as to afford the other Party
the opportunity, at the other Party's expense, to pursue a protective
order or other remedy and the Disclosing Party shall reasonably cooperate
with the other Party in such efforts to the extent practical and permitted
under applicable laws and regulations. In no event shall the
Disclosing Party be liable for any damages resulting from disclosure of
the Confidential Information pursuant to this
Clause. Disclosure of Confidential Information by a
Disclosing Party in accordance with this Clause shall not be a breach of
this Agreement.
|
12.4
|
The
Parties shall use the Confidential Information exclusively for performance
of this Agreement and for no other
purpose.
|
12.5
|
Upon
termination or expiration of this Agreement, each Party shall promptly,
upon request of the other Party, return all documents and any copies
thereof containing Confidential Information belonging to, or disclosed by,
such other Party.
|
12.6
|
The
Parties agree that the obligations of this Clause 12 are necessary and
reasonable in order to protect the Parties' respective
businesses.
|
12.7
|
The
Parties agree that any such violation or threatened violation may cause
irreparable injury to a Party and that, in addition to any other remedies
that may be available, each Party shall be entitled to seek injunctive
relief against the threatened breach of the provisions of this Clause 12,
or a continuation of any such breach by the other Party, specific
performance and other such relief to redress such breach together with
damages and reasonable counsel fees and expenses to enforce its rights
hereunder.
|
12.8
|
Subject
to Clause 12.3, no announcement or public statement concerning the
existence, subject matter or any term of this Agreement shall be made by
or on behalf of any Party without the prior written approval of the other
Party.
|
12.9
|
Amarin
shall obtain Nisshin’s prior written consent if Amarin needs to disclose
this Agreement to a potential third party purchaser or commercialisation
partner or current or future Amarin investor (collectively “Potential
Partner”), provided that the relevant third party has entered into a
confidentiality agreement on terms no less protective than the terms of
this Clause 12. When Amarin wishes to obtain such Nisshin’s consent,
Amarin will provide advance written notification to Nisshin of identity of
such third party with the relevant information of the third party. Nisshin
will make response to the notification as soon as practicable.
If Nisshin decides not to agree to provide its consent, Nisshin
will provide Amarin with a written reason why such consent was
withheld. Notwithstanding the foregoing, Nisshin will not
withhold, condition or delay its consent hereunder if the Potential
Partner’s primary line of business is in the area of pharmaceuticals or
biotechnology.
|
12.10
|
Amarin
shall indemnify Nisshin against any claims, costs (including legal costs,
expenses), liabilities, losses (including loss of profit), damages or
expenses arising out of, or in connection with the disclosure of this
Agreement pursuant to Clause
12.9.
|
13
|
FORCE
MAJEURE
|
13.1
|
If
either Party is prevented or delayed in the performance of any of its
obligations under this Agreement as a result of acts of God, war, fire,
earthquake, or other natural disaster beyond the reasonable control of a
Party that has not occurred as a result of its act, omission or negligence
and which was not reasonably foreseeable ("Force Majeure Event"), it shall
notify the other Party, in writing, of the same as soon as
practicable. The affected Party shall use its reasonable
endeavours to remove or overcome such Force Majeure Event as quickly as
possible and shall also use its reasonable endeavours to mitigate the
impact of such Force Majeure Event of the other Party. Subject
to Clause 13.3, if a Party shall have fully complied with its obligations
under this Clause 13.1, it shall be excused from performance of its
unfulfilled obligations under this Agreement from the date of such notice
until such Force Majeure Event no longer
pertains.
|
13.2
|
A
Force Majeure Event will include any issue either Party has with its
subcontractors or suppliers of raw materials, intermediates and packaging
components, which were caused by one of the Force Majeure Events described
in Clause 13.1.
|
13.3
|
If
a Force Majeure Event prevents the performance by a Party of any
obligations hereunder for a continuous period in excess of 12 weeks, the
other Party shall be entitled to terminate this Agreement by written
notice at any time after such 12 week period provided the relevant Force
Majeure Event is continuing at the time such notice is
given.
|
14
|
TERM
|
14.1
|
This
Agreement shall be effective from the Commencement Date until March 31,
2012.
|
15
|
TERMINATION
|
15.1
|
This
Agreement may be terminated by either Party by giving to the other Party a
notice in writing if the other Party commits a material breach of the
terms of this Agreement and (where such breach is capable of remedy) fails
to remedy such breach within 60 days of receiving a written notice from
the terminating Party specifying the breach and requiring its
remedy.
|
15.2
|
This
Agreement may be terminated by either Party immediately by giving a
written notice to the other, if:
|
15.2.1
|
a
petition is filed by or against the other Party for commencement of
bankruptcy proceeding (hasan-tetsuzuki-kaishi), commencement of corporate
reorganization proceeding (kaishakousei-tetsuzuki-kaishi), commencement of
civil rehabilitation proceeding
(minjisaisei-tetsuzuki-kaishi), or any other insolvency
proceeding;
|
15.2.2
|
the
other Party is subject to seizure (sashiosae), sequestration
(kari-sashiosae), preservative attachment (hozen-sashiosae), commencement
of public auction
(keibai),
or other compulsory execution (kyousei-shikkou) or foreclosure
(tanpoken-jikkou) proceeding against material assets of the other
Party;
|
15.2.3
|
the
other Party is unable to pay its debts in the normal course of business;
or
|
15.2.4
|
there
is a Change of Control of the other
Party.
|
15.3
|
Notwithstanding
the provisions of Clause 15.1, this Agreement may be terminated by Nisshin
by giving Amarin 30 days notice in writing, if Amarin fails to perform its
duty as set forth in Clause 2.5, unless, within such 30 days, Amarin pays
to Nisshin the amount corresponding to the unfulfilled purchases according
to the minimum purchase quantities at the Price stated in Schedule
One.
|
15.4
|
This
Agreement may be terminated by Nisshin by giving Amarin notice in writing
without Nisshin incurring any liability or obligation whatsoever (except
the obligations under Clause 9), if Nisshin is unable to continue
manufacturing and supplying the Products to Amarin in accordance with its
requirement due to disruption of supplies of raw materials or
intermediates, which disruption cannot be recovered within reasonable
time, provided that Nisshin shall without delay inform Amarin of
occurrence of such event in order to give Amarin an opportunity to seek
alternative sources.
|
16
|
CONSEQUENCES
OF TERMINATION
|
16.1
|
In
the event that this Agreement is terminated, neither Party shall be
entitled to compensation of damages for lost profits arising out of the
termination of this Agreement.
|
16.2
|
Notwithstanding
any provisions herein to the contrary, in the event that this Agreement is
terminated for any reason, Amarin shall purchase and take delivery of all
the Products manufactured by Nisshin according to Orders placed by Amarin
at the Price stipulated herein, and shall purchase, at cost, all stocks of
the Products either manufactured or in the process of being manufactured
for Amarin, including unused intermediates that Nisshin
stores.
|
17
|
ASSIGNMENT
|
17.1.
|
either
Party may assign this Agreement, in whole or in part, to an affiliate of
the assigning Party; provided, that the assigning Party guarantees the
performance of such affiliate hereunder;
and
|
17.2
|
Amarin
may assign this Agreement, in whole, to the Potential Partner disclosed
under this Agreement pursuant to Clause 12.9 who acquires, by merger, sale
of assets or otherwise, all or substantially all of the business of the
assigning Party in which the subject matter of this Agreement is
included.
|
18
|
MISCELLANEOUS
|
18.1
|
All
notices, consents, approvals or other communications hereunder shall be in
writing and shall be delivered personally or by registered or certified
mail, postage prepaid, or sent by fax, addressed to the authorised
personnel at relevant Party and at such address as each Party shall from
time to time notify the other in writing. Any such notice,
consent,
|
18.2
|
Nothing
in this Agreement shall constitute or be deemed to constitute the creation
of a partnership, agency, or employer/employee relationship between the
parties.
|
18.3
|
This
Agreement, together with the Specifications and the Schedules attached
hereto, constitutes the entire agreement and understanding of the parties
and supersedes any previous agreement between Nisshin and Amarin in
relation to the subject matter of this Agreement.
This Agreement,
the Specification, and the Schedules attached hereto or any order may only
be modified only by a written document signed on behalf of each of the
parties. If there are any inconsistencies between the terms and
conditions of this Agreement and the terms and conditions set forth in any
quotation, order, acknowledgement or invoice, the terms and conditions of
this Agreement shall prevail.
|
18.4
|
If
any provision of this Agreement is held by any court or other competent
authority to be invalid or unenforceable in whole or in part, it shall be
deemed severed from this Agreement and the validity of the other
provisions and the remainder of the provision in question shall not be
affected.
|
18.5
|
This
Agreement shall be governed by and construed in accordance with the laws
of Japan.
|
18.6
|
The
parties hereto shall submit to the exclusive jurisdiction of the Tokyo
District Court of Japan with respect to any dispute arising from this
Agreement.
|
NISSHIN
PHARMA, INC.
|
|
By:__________________________________
|
Date:
____________________,
2009
|
Name:
Toshinori Shiragami
|
|
Title: President
|
|
AMARIN
PHARMACEUTICALS IRELAND LTD.
|
|
By:__________________________________
|
Date:
____________________,
2009
|
Name:
Alan Cooke
|
|
Title: Director
|
a)
|
2008-2009
|
1.62
metric tons
|
|
b)
|
2009-2010
|
1.08
metric tons
|
|
c)
|
2010-2011
|
3.24
metric tons
|
|
d)
|
2011-2012
|
3.24
metric tons
|
Ethyl
(5Z,8Z,11Z,14Z,17Z)-5,8,11,14,17-icosapentaenoate
|
EPA-E
|
Ethyl
eicosapentaenoate
|
73310-10-8
|
Shareholder
|
Shares
|
Basic
%
|
Sofinnova
Venture Partners VII, LP
|
3,586,957
|
13.26%
|
Orbimed
Advisors LLC
|
3,260,870
|
12.06%
|
Thomas,
McNerney & Partners LLC
|
2,173,913
|
8.04%
|
Panorama
Capital LP
|
1,847,826
|
6.83%
|
Sunninghill
Limited
|
1,465,755
|
5.42%
|
Simon
Kukes
|
1,277,695
|
4.72%
|
Longitude
Venture Partners, LP
|
1,086,957
|
4.02%
|
Amarin
Investment Holding Limited
|
1,072,906
|
3.97%
|
Fountain
Healthcare Partners Fund
|
217,391
|
0.80%
|
Michael
Walsh
|
74,828
|
0.28%
|
Total
|
16,065,098
|
59.40%
|
AMARIN
CORPORATION, PLC
ESTER
NEUROSCIENCES LTD.
MEDICA
II MANAGEMENT L.P.
(AS
THE SELLERS’ REPRESENTATIVE)
|
(1)
|
AMARIN CORPORATION, PLC
,
a public limited company incorporated under the laws of England and Wales
(the “
Buyer
”);
|
(2)
|
ESTER NEUROSCIENCES LTD., an
Israeli company (the “
Company
”);
and
|
(3)
|
MEDICA II MANAGEMENT
L.P.,
a Cayman Islands limited partnership, in its capacity as the
Sellers’ Representative appointed pursuant to Section 13 of that certain
Stock Purchase Agreement dated December 5, 2007 between Buyer, the
Security Holders (each a “
Seller
” and collectively
the “
Sellers
”) of
the Company,
the Company, and
the Sellers' Representative.
|
A.
|
The
Buyer, the Sellers,
the Company and
the Sellers' Representative entered into a Stock Purchase Agreement dated
December 5, 2007, as subsequently amended by Amendment No. 1 (“
Amendment No.
1
”) to Stock Purchase Agreement dated April 7, 2008
(together the “
SPA
”).
|
B.
|
The
Buyer is continuing various activities to conclude its auditing and
reporting of the Phase IIa Clinical
Study.
|
C.
|
The
Buyer announced in September 2008 that following a change in strategic
direction, the Buyer would seek partnerships for its CNS pipeline,
including Monarsen in MG. At the date of this Agreement, the
Buyer does not intend to conduct any new development work on Monarsen but
intends to seek to enter into an agreement with a third party partner
whereby such third party partner would conduct any such development work
in the future.
|
D.
|
The
parties hereto acknowledge that it is necessary to agree a number of
amendments to, and waivers under, the SPA to reflect the circumstances
described in Recitals C and E and to facilitate the Buyer’s intention to
seek a future partnership for Monarsen in
MG.
|
E.
|
The
Buyer has agreed to make a settlement payment to the Sellers in the form
of Buyer Ordinary Shares and to amend certain provisions of the SPA
relating to the Escrow Fund in consideration of the Sellers’
Representative and each of the Sellers agreeing to the amendments and
waivers referred to herein and to terminate and extinguish any obligations
of the Buyer to pay the Milestone Ia Consideration to the Sellers pursuant
to the SPA (all of the foregoing as set forth in detail under Section
2).
|
F.
|
The
parties hereto have also agreed certain terms which supplement the SPA and
which are also set forth in this
Agreement.
|
1
|
DEFINITIONS
/ REPRESENTATIONS AND
WARRANTIES
|
1.1
|
Definitions:
|
1.2
|
Representations and
Warranties of Sellers’
Representative:
|
|
1.2.1
|
the
Sellers’ Representative continues to hold all the authorities and powers
granted by the Sellers to the Sellers’ Representative under Section 13 of
the SPA;
|
1.2.2
|
the
Sellers’ Representative has full authority and power to enter into this
Agreement on behalf of each Seller and has all necessary authority and
power to bind each Seller to each of the provisions of this
Agreement;
|
1.2.3
|
all
necessary corporate, shareholder and other legal action has been taken by
the Sellers’ Representative to authorize the execution, delivery and
performance by it of this Agreement. The Sellers’
Representative has duly executed and delivered this Agreement. This
Agreement is the legal, valid and binding obligation of the Sellers’
Representative, enforceable against it in accordance with its respective
terms, except as enforceability of such objections may be limited by
bankruptcy, insolvency, reorganization, moratorium and other similar laws
now or hereafter in effect relating to or limiting creditors’ rights
generally and general principles of equity relating to the availability of
specific performance and injunctive and other forms of equitable
relief;
|
|
1.2.4
|
the
Sellers’ Representative will execute this Agreement in its capacity as the
Sellers’ Representative and, based on its authority as such, as agent and
attorney-in-fact of each Seller (so appointed under Section 13 of the
SPA); and
|
|
1.2.5
|
the
Sellers’ Representative acknowledges that the Buyer is entering into this
Agreement with each of the Sellers in reliance on the provisions of
Section 13 of the SPA (including, without limitation, Section 13(g) of the
SPA) and the representations and warranties of the Sellers’ Representative
set forth in this Section 1.2.
|
1.3
|
Representations
and Warranties of Buyer
:
|
|
1.3.1
|
Organization
and Good Standing
:
The Buyer
has been duly incorporated and is validly existing as a public limited
company under the laws of England and Wales and has all necessary
corporate power and authority to perform all of its obligations under this
Agreement.
|
|
|
1.3.2
|
Power
and Authorization
:
The
Buyer has all requisite power and authority to execute and deliver this
Agreement, to perform its obligations hereunder and to carry out the
transactions contemplated hereby. All necessary corporate, shareholder and
other legal action has been taken by the Buyer to authorize the execution,
delivery and performance by it of this Agreement. The Buyer has
duly executed and delivered this Agreement. This Agreement is the legal,
valid and binding obligation of the Buyer, enforceable against it in
accordance with its respective terms, except as enforceability of such
objections may be limited by bankruptcy, insolvency, reorganization,
moratorium and other similar laws now or hereafter in effect relating to
or limiting creditors’ rights generally and general principles of equity
relating to the availability of specific performance and injunctive and
other forms of equitable relief.
|
|
1.3.3
|
Buyer
Ordinary Shares:
As of the Effective Date, subject to
Section 2.1.1, upon issuance and delivery of the Buyer Ordinary Shares
comprising the Settlement Payment: (a) such Buyer Ordinary Shares will
have been duly authorized and validly issued and will be fully paid and
non-assessable, will have been issued in compliance with all applicable
English laws and the ADSs representing Amarin Shares will have been issued
in compliance with all applicable U.S. securities laws, and will not have
been issued in violation of any preemptive right, resale right, right of
first refusal or similar right, (b) such delivery will convey to the
Sellers good, valid and
|
1.4
|
Representations
and Warranties of each
Seller:
|
|
1.4.1
|
Organization
and Good Standing
:
Such Seller
is duly organized, validly existing and in good standing under the laws of
its jurisdiction of incorporation, formation or organization, as
applicable, and has (as applicable) all necessary corporate, partnership
or limited liability company power and authority, as the case may be, to
perform all of its obligations under this
Agreement.
|
|
1.4.2
|
Power
and Authorization
:
Such Seller
has all legal right, power, authority and legal capacity to execute and
deliver this Agreement, to perform its obligations hereunder and to carry
out the transactions contemplated
hereby.
|
|
1.4.3
|
Status
of Shareholder
:
Such
Seller is not a “U.S. Person” as defined by Rule 902 of Regulation S
promulgated under the Securities Act, was not formed (if an entity) by a
“U.S. Person” as defined by United States jurisdiction, and was not formed
(if an entity) for the purpose of investing in securities not registered
under the Securities Act. Such Seller is not acquiring the
Buyer Ordinary Shares for the benefit of a “U.S. Person” as defined by
Rule 902 of Regulation S. Such Seller is outside the United
States. Such Seller acknowledges, agrees and covenants that it
will not engage in hedging transactions with regard to Buyer Ordinary
Shares prior to the expiration of the distribution compliance period
specified in Rule 903 of Regulation S promulgated under the Securities
Act, unless in compliance with the Securities Act. Absent
another exemption from registration, such Seller will not resell Buyer
Ordinary Shares to “U.S. Persons” or within the United States, unless
pursuant to registration of such Buyer Ordinary Shares under the
Securities Act.
|
|
1.4.4
|
Reliance
Upon Seller’s Representations
:
Such
Seller understands that the issuance and sale thereto of Buyer Ordinary
Shares will not be registered under the Securities Act on the ground that
such issuance and sale will be exempt from registration under the
Securities Act pursuant to Regulation S promulgated under the Securities
Act and that Buyer’s reliance on such exemption is based on each Seller’s
representations set forth herein.
|
|
1.4.5
|
Receipt
of Information
:
Such
Seller has had an opportunity to ask questions and receive answers from
Buyer regarding the terms and conditions of the issuance and sale of the
Buyer Securities and the business, properties, prospects and financial
condition of Buyer and to obtain any additional information requested, and
has received and considered all information such Seller deems relevant to
make an informed decision to purchase Buyer Securities. Neither
such inquiries nor any other investigation conducted by or on behalf of
such Seller or its representatives or counsel shall modify, amend or
affect such Seller’s right to rely the Buyer’s representations and
warranties contained in this
Agreement.
|
|
1.4.6
|
Restricted
Securities
:
Such
Seller understands that the Buyer Ordinary Shares have not been registered
under the Securities Act and such Seller will not sell, offer to sell,
assign, pledge, hypothecate or otherwise transfer any of the Buyer
Ordinary Shares during the 40 days following the Effective
Date. Such Seller agrees that Buyer may place stop transfer
orders with Citibank N.A. (the “
Transfer
Agent
”) (or any other transfer agent) with respect to the Buyer
Ordinary Shares in order to implement the restrictions on transfer set
forth in this Agreement.
|
|
1.4.7
|
Independent
Investment
:
Such
Seller acknowledges that it is aware of its obligations as a beneficial
owner of Buyer Ordinary Shares pursuant to Section 12(d) of the Exchange
Act.
|
1.5
|
No
other
Representations
and Warranties:
|
2
|
SETTLEMENT PAYMENT / RELEASE OF
ESCROW FUND
|
2.1
|
The
Buyer has agreed with the Sellers’ Representative and the Sellers to make
a settlement payment (the “
Settlement Payment
”) to
the Tax Trustee for the Sellers in the form of 1,315,789 Buyer Ordinary
Shares in consideration of the agreement of the Sellers’ Representative
and of each Seller to the amendment, termination and waiver of certain
provisions of the SPA (as set forth in this Agreement) and subject to the
following additional terms:
|
|
2.1.1
|
as
soon as practicable following the date hereof, taking into account the
then relevant issues arising under U.S. securities laws, but not later
than 60 days hereafter, the Buyer shall issue to the Tax
Trustee (the date of such issuance, the "
Effective Date
")
1,315,789 Buyer Ordinary Shares that are freely tradeable on Nasdaq
(pursuant to an effective Buyer registration statement, Regulation S or
other applicable exemption from registration under the Securities Act) in
discharge of the obligation to pay the Settlement Payment under Section
2.1;
|
|
2.1.2
|
for
the avoidance of doubt, and as a consequence of the amendment to the SPA
set forth in Section 2.2, no amount of the Settlement Payment will be paid
by the Buyer to the Escrow Agent for deposit to the Escrow
Fund;
|
|
2.1.3
|
all
and any obligations of the Buyer to pay to the Sellers the Milestone Ia
Consideration pursuant to Section 2.1(d) and Section 9.2 of the SPA shall
be extinguished in full and, with effect from the Effective Date and at
all times thereafter, the Buyer shall have no liability of any nature to
any Seller under Section 2.1(d) and/or Section 9.2 of the SPA or otherwise
in respect of the Milestone Ia Consideration;
and
|
|
2.1.4
|
subject
to Section 3.4.1 and Section 3.5.5, the Sellers’ Representative on behalf
of each Seller (pursuant to Section 14.5 of the SPA), and each Seller,
hereby fully waives all of its rights of any nature whatsoever, on a
perpetual basis, to require or enforce performance by the Buyer of the
requirements of Section 2.1(h), Section 2.1(e) and/or Section 2.1(f) of
the SPA (“
SPA Future
Waiver
”) and the Buyer shall have no liability of any nature to the
Sellers following the Effective Date for breach of, or absence of
performance of, any of the provisions of Section 2.1(h), Section 2.1(e)
and/or Section 2.1(f) of the SPA.
|
2.2
|
The
Buyer and the Sellers’ Representative agree that on the expiry
of the Escrow Period as such term has been originally defined in the SPA,
i.e., on June 6, 2009, the parties shall execute and deliver the Final
Instruction to Escrow Agent, in the form of
Exhibit
2.2
hereto, informing the Escrow Agent that the parties irrevocably
instruct the Escrow Agent to pay to the Sellers on such date all of the
Remaining Escrow Fund in the manner set forth in the Escrow
Agreement.
|
|
2.2.1
|
any
and all of Buyer's rights and remedies for any Damages incurred as set
forth in the Terminated Section 12 Provisions ("
Covered Liabilities
")
shall terminate, and neither Buyer nor any Buyer Indemnified Party shall
have any other claims, rights or remedies against any of the Sellers after
the Effective Date, whether under the SPA or under any applicable law or
otherwise, for such Covered
Liabilities.
|
|
2.2.2
|
any
and all of Sellers’ rights and remedies for any Damages incurred as set
forth in the Terminated Section 12 Provisions ("
Covered Liabilities
")
shall terminate, and none of the Sellers nor any Seller Indemnified Party
shall have any other claims, rights or remedies against the Buyer after
the Effective Date, whether under the SPA or under any applicable law or
otherwise, for such Covered
Liabilities.
|
3
|
FUTURE DEVELOPMENT OF MONARSEN
/ INTENTION TO PARTNER
MONARSEN
|
3.1
|
It
is acknowledged by the Sellers’ Representative and each Seller that the
intentions of the Buyer as at the date hereof and the Effective Date as
regards any future development and/or commercialization activities in
respect of Monarsen are as follows:
|
|
3.1.1
|
the
Buyer is currently completing certain activities to finalise the Buyer’s
auditing and reporting of the Phase IIa Clinical Study and, save the
completion of such activities and the activities described in Section
3.1.3 below, the Buyer does not intend to conduct any additional
development and/or commercialization activities on Monarsen, (including,
without limitation, any MG Phase II Development Program, US Phase III
Clinical Study or Phase III Clinical
Study);
|
|
3.1.2
|
as
a result of the Buyer’s cessation of all development activities on
Monarsen as described in Section 3.1.1 above, and save in the
circumstances outlined in Section 3.5.5 below where the Buyer would
re-commence development activities on Monarsen in MG, Milestone Ib and
Milestone II will not be achieved by the Buyer in the future and the
potential for future payment to the Sellers of such milestones will be as
set forth in Section 3.3;
|
|
3.1.3
|
as
more fully described in Section 3.3, the Buyer intends to seek to enter
into an agreement (the “
Proposed Partnership
Agreement
”) with a third party partner whereby such third party
partner would conduct future development and/or commercialization
activities on Monarsen in MG
PROVIDED
HOWEVER
that the parties hereto agree that the provisions of this
first paragraph of Section 3.1.3 and the provisions of Section 3.3 are
only expressions of the Buyer’s intentions and no such provision comprises
or contains any legally binding obligation on the
Buyer.
|
3.2
|
Upon
agreement with the Sellers’ Representative, the Sellers’ Representative
will make available to the Buyer a certain portion of the
business time of Prof. Eli Hazum as may be reasonably required
by the Buyer to enable the Buyer to conclude the Buyer’s auditing and
reporting of the Phase IIa Clinical Study and to make any reports to, or
respond to any queries of, or in relation to any inspections or
investigations of, any regulatory authority in Europe, the USA or any
other jurisdiction in relation to the Phase IIa Clinical
Study.
|
3.3
|
The
Buyer intends to seek to negotiate with any potential third party partner
which is an experienced company in the business of developing drugs
(“
Third Party
Partner
”) to include the following terms in the Proposed
Partnership Agreement:
|
|
3.3.1
|
the
Third Party Partner would have direct obligations to the Sellers,
including diligence obligations as regards future development activities
relating to Monarsen in MG identical to the Diligence Obligation set forth
in Section 2.1(h) of the SPA, and including reporting and audit
obligations (provided, however, that if the Third Party Partner is not a
publicly traded company, then its reporting and audit obligations shall be
broadened as required to provide Sellers' Representative reasonable
comfort in such circumstances);
|
|
3.3.2
|
the
Third Party Partner would have an obligation to pay to the Sellers a
milestone payment of
[********]
2
in cash within 14
days after the Milestone Ib Date (the "
First Payment Date
") and
would assume the obligations to the Sellers as regards Milestone II set
forth in Section 2.1(f) of the SPA (other than Section 2.1(f)(iv) of the
SPA, which is hereby terminated);
|
|
3.3.3
|
if
in the negotiation of the matters described in Section 3.3.2, the Third
Party Partner is not agreeable to pay to the Sellers a milestone payment
of
[********]
in
cash on the First Payment Date, and is only agreeable to pay a cash
milestone that is less than
[********]
(“
Reduced Milestone Ib
Payment
”) resulting in a shortfall amount (the “
Milestone Ib Shortfall
Amount
”), without prejudice to the provisions of Section 3.4.2, the
Buyer intends to seek to negotiate with the Third Party Partner an
addition to the Milestone II Consideration whereby the Third Party Partner
would assume the obligations to the Sellers as regards Milestone II set
forth in Section 2.1(f) of the SPA (other than Section 2.1(f)(iv) of the
SPA, which is hereby terminated) and agree to pay an additional cash
payment to the Sellers within 14 days after the Milestone II Date, in
addition to the Milestone II Consideration, equal to the Milestone Ib
Shortfall Amount (“
Additional Milestone II
Consideration
”); and
|
|
3.3.4
|
the
Third Party Partner would have direct obligations to the Buyer, separate
and distinct from the Third Party Partner’s obligations described in
Section 3.3.1 above, including diligence obligations and payment
obligations.
|
3.4
|
If
the Buyer executes a Proposed Partnership Agreement, the following
additional provisions shall apply as between the Buyer and the
Sellers:
|
|
3.4.1
|
without
prejudice to Section 2.1.4, all and any obligations of the Buyer to pay to
the Sellers the Milestone Ib Consideration pursuant to Section 2.1(e) and
Section 9.2 of the SPA; and/or the Milestone II Consideration pursuant to
Section 2.1(f) of the SPA; and the provisions of Section 2.1(h), shall be
terminated and extinguished in full and, with effect from the effective
date of the Proposed Partnership Agreement and at all times thereafter,
the Buyer shall have no liability of any nature to any Seller under
Section 2.1(e) and Section 9.2 of the SPA in respect of the Milestone Ib
Consideration, or under Section 2.1(f) of the SPA in respect of the
Milestone II Consideration, or under any of the provisions of Section
2.1(h);
|
3.4.2
|
in
the event that, under the Proposed Partnership Agreement, the Third Party
Partner does not agree to pay to the Sellers a milestone payment of
[********]
in cash on
the First Payment Date, or to assume the obligations to the Sellers as
regards Milestone II set forth in Section 2.1(f) of the SPA (other than
Section 2.1(f)(iv) of the SPA, which is hereby terminated), then Buyer
agrees to make advance payments (“
Shortfall Advance
Payment(s)
”) to each Seller equal to its portion (as set forth on
the Shortfall Advance Payment
Allocation
Schedule) in cash, of the following
amounts:
|
|
(1)
|
the
amount that reflects the difference between
[********]
and the
aggregate amount actually paid to the Sellers by the Third Party Partner
on the First Payment Date; and
|
|
(2)
|
the
amount that reflects the difference between
[********]
(or
[********]
, as may be
applicable under Section 2.1(f)(ii) of the SPA) and the aggregate amount
actually paid to the Sellers by the Third Party Partner on the Milestone
II Date (or the other
|
|
CONFIDENTIAL INFORMATION
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS [*] DENOTE SUCH
OMISSIONS.
|
|
applicable
payment date), as applicable, plus the Additional Milestone II
Consideration (“
Actual
Milestone II
Consideration
”);
|
|
3.4.3
|
in
addition, the Buyer shall pay to each Seller a payment (the “
Accelerated Payment
”)
equal to its portion (as set forth on the Accelerated Payment Allocation
Schedule) in cash, of
[**]
of any MG Phase II
Third Party Partner Consideration actually received from the Third Party
Partner within 10 Business Days after such MG Phase II Third Party Partner
Consideration has been actually received by the Buyer or its
Affiliates;
|
|
3.4.4
|
if
the Buyer is paid milestone or license payments by the Third Party Partner
under the Proposed Partnership Agreement that are not in the form of cash,
save in the case of Non-MG Sub-license Fees (which are governed by Section
2.1(g) of the SPA), the parties hereto will negotiate in good faith to
agree terms as to how to value such payments under this
Agreement.
|
3.5
|
Subject
to the provisions of Sections 3.5.1 to 3.5.5, if the Buyer has not
executed the Proposed Partnership Agreement on the date which is 21 months
following the date hereof (the “
21 Month Trigger Date
”),
within 30 days of the such date (the “
Ultimate Transfer
Date
”), the Seller's Representative may, but is not bound to,
request in writing that, in accordance with the termination agreement
described in Sections 3.5.1 and 3.5.2, the Buyer shall transfer to the
Sellers’ Representative (or such persons as directed by the Sellers’
Representative) all of its right, title and interest in the entire issued
share capital of the Company:
|
|
3.5.1
|
prior
to any transfer of the share capital of the Company by the Buyer to the
Sellers’ Representative (or such persons as directed by the Sellers’
Representative), the parties hereto shall enter into a termination
agreement (the “
Termination Agreement
”)
, whereby the shares will be transferred by the Buyer to the Sellers’
Representative (or such persons as directed by the Sellers’
Representative), without consideration, subject to the representations and
warranties of the Buyer set forth in Section 3.5.2 and otherwise on an “as
is” basis; the SPA will be terminated in full and the parties hereto will
agree mutual, full and perpetual waivers and releases under the SPA
(pursuant to provisions in identical form to the waivers and releases set
forth in Section 4); and, subject to Section 3.5.2, the Sellers’
Representative and each Seller
|
|
CONFIDENTIAL INFORMATION
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS [*] DENOTE SUCH
OMISSIONS.
|
|
will
fully indemnify the Buyer in relation to any claims taken by any third
party against the Buyer at any time following the Ultimate Transfer Date
relating to any activities of the Company, past, present or
future;
|
|
3.5.2
|
in
addition, the Buyer shall confirm to the Sellers’ Representative and the
Sellers in the Termination Agreement (and provide any documentation
reasonably required by the Sellers’ Representative to support such
confirmations) that as of the Ultimate Transfer Date, (a) the shares of
the Company being transferred to the Sellers’ Representative or to another
person on its behalf are free and clear of any Encumbrances; (b) the
Company owns the patents listed in Exhibit 3.5.2 and has no other assets;
(c) such patents are owned free and clear of any Encumbrances and (d) the
Company owes no monies to any third party; and the Buyer shall also
confirm to the Sellers’ Representative whether any claims or proceedings
are pending or threatened against the Company on the Ultimate Transfer
Date or whether the Buyer has any other liability to any third party of
which the Buyer is actually aware;
|
|
3.5.3
|
notwithstanding
the aforesaid, prior to the 21
Month Trigger
Date, the Buyer shall be entitled to notify the
Sellers’ Representative (such written notice to be accompanied
by supporting evidence), of its desire to extend the 21
Month Trigger Date
to the date which is 6 months thereafter (the “
27 Month Trigger Date
”)
which extension shall be approved by the Sellers’ Representative (such
approval not to be unreasonably withheld or delayed) in circumstances
where the Buyer can demonstrate to the Sellers' Representative’s
satisfaction that it has made substantial progress towards the execution
of the Proposed Partnership Agreement and that execution of such Proposed
Partnership Agreement is reasonably likely within such 6-month period; if
such extension is approved, the Ultimate Transfer Date shall be
similarly extended;
|
|
3.5.4
|
notwithstanding
the aforesaid, prior to the 27 Month Trigger Date, the Buyer shall be
entitled, to notify the Sellers’ Representative in writing (such written
notice to be accompanied by supporting evidence) of its desire to extend
the 27 Month Trigger Date to the date which is 3 months thereafter (the
“
30 Month Trigger
Date
”), which extension shall be approved by the Sellers’
Representative (such approval not to be unreasonably withheld or delayed)
in circumstances where the Buyer can demonstrate to the Sellers'
Representative’s satisfaction, that the execution of the Proposed
Partnership Agreement is reasonably likely within such 3-month period; if
such extension is approved, the Ultimate Transfer Date shall be similarly
extended;
|
|
3.5.5
|
if
prior to the 27
Month Trigger Date
the Buyer notifies the Seller in writing that it has determined that it
will re-commence development activities on Monarsen in MG, then, subject
to the Sellers’ Representative consenting in writing to the Buyer
re-commencing development activities on Monarsen in MG (such consent not
to be unreasonably withheld or delayed), such development activities will
re-commence and all of the provisions of this Clause 3.5, save this
Section 3.5.5, and the SPA Future Waiver shall forthwith terminate, no
transfer of the share capital as described above will occur thereafter,
and with effect from the date of the afore-mentioned consent of the
Sellers’ Representative, the Buyer shall be fully bound by, and liable for
any breach of, the provisions of Sections 2.1(h), Section 2.1(e) and
Section 2.1(f) of the SPA, without any change. For the
avoidance of doubt, the re-commencement of development activities by the
Buyer under this Section 3.5.5 shall not in itself trigger any payment by
the Buyer to the Sellers.
|
3.6
|
From
the date hereof until the earlier of (i) the execution of the Proposed
Partnership Agreement, or (ii) the execution of the Termination Agreement,
or (iii) the notice of Buyer to the Sellers' Representative as set forth
in Section 3.5.5, the Buyer shall report in writing to the Sellers’
Representative, on a six monthly basis, providing an update of the
progress of its activities in that period in relation to the negotiation
and execution of a Proposed Partnership Agreement. Such reports shall be
provided to the Sellers’ Representative not later than the 15th day
following June 30, 2009 and the end of each six month period thereafter.
Further, a full and complete copy of any Proposed Partnership Agreement,
if executed, shall be delivered to the Sellers’ Representative, together
with a summary of the financial terms of any agreement entered into by the
Buyer and the Third Party Partner contemporaneously with, or within 3
months prior to or following the date of the Proposed
Partnership Agreement.
|
4
|
WAIVER OF ACCRUED RIGHTS /
MUTUAL RELEASES
UNDER SPA
|
4.1
|
With
effect from the Effective Date, each party to the SPA and each of its
Affiliates (each a “
Releasor
”)
hereby:
|
|
4.1.1
|
waives
any accrued rights that Releasor may have accrued against the other
parties to the SPA and each of its Affiliates, officers, directors,
representative, agents and employees and the assigns and successors in
interest of any of the foregoing entities (“
Releasees
”), whether
known or unknown, foreseen or unforeseen, fixed or contingent, of any
nature whatsoever from the beginning of time to the Effective Date under
the SPA or otherwise; and
|
|
4.1.2
|
fully
and finally releases and discharges the Releasees from any and all manner
of actions, claims, promises, debts, sums of money, demands, obligations,
in law or in equity, directly or indirectly, whether known or unknown,
foreseen or unforeseen, fixed or contingent, of any nature whatsoever that
Releasor may have by reason of any act, omission, matter, provision, cause
or thing whatsoever from the beginning of time to the Effective Date under
the SPA or otherwise.
|
|
For
the avoidance of doubt, all shares, monies and other consideration due to
the Sellers hereunder shall be issued or paid by the Buyer, when due, to
the Tax Trustee in accordance with Section 13(h) of the
SPA.
|
6
|
NO OTHER AMENDMENT
S
|
IN WITNESS WHEREOF
the
parties hereto have executed this Agreement.
|
SIGNED
|
By:
/s/ Thomas Lynch
|
for and on behalf of
|
AMARIN CORPORATION, PLC
|
SIGNED
|
By:
/s/ Alan Cooke
|
for
and on behalf of
|
ESTER
NEUROSCIENCES LTD.
|
SIGNED
|
By:
/s/ Ehud Geller
|
for and on behalf of
|
MEDICA II MANAGEMENT L.P
|
(AS THE SELLERS’ REPRESENTATIVE)
|
Amarin
Corporation plc
|
Medica
II Management L.P., as
Sellers’
Representative
|
SIGNED
|
By:
|
for
and on behalf of
|
AMARIN
CORPORATION, PLC
|
SIGNED
|
By:
|
for
and on behalf of
|
MEDICA
II MANAGEMENT L.P
|
(AS
THE SELLERS’ REPRESENTATIVE)
|
Family:
1961
|
Title:
Genetically
Engineered Human Cholinesterases
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1390
|
Zakut
Haim
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
1961-00
|
Priority
|
Abandoned
|
Israel
|
21/03/1989
|
89703
|
31/10/2001
|
Aug-01
|
02/03/2002
|
89703
|
||
1961-00
|
Priority
|
Abandoned
|
Israel
|
21/03/1989
|
89703
|
31/10/2001
|
Aug-01
|
02/03/2002
|
89703
|
||
1961-01
|
Abandoned
|
Canada
|
21/03/1990
|
2,012,720-1
|
20/09/1990
|
||||||
1961-02
|
Abandoned
|
US
|
20/03/1990
|
07/496,554
|
|||||||
1961-03
|
Abandoned
|
Europe
|
20/03/1990
|
90105274
|
14/06/1995
|
388906
|
|||||
1961-04
|
Abandoned
|
France
|
20/03/1990
|
90105274
|
14/06/1995
|
388906
|
|||||
1961-05
|
Abandoned
|
Switzerland
|
20/03/1990
|
90105274
|
14/06/1995
|
388906
|
|||||
1961-06
|
Abandoned
|
Great
Britain
|
20/03/1990
|
90105274.6
|
14/06/1995
|
388906
|
|||||
1961-07
|
Abandoned
|
Germany
|
20/03/1990
|
90105274.6
|
14/06/1995
|
69020019
|
|||||
1961-08
|
CIP
|
Granted
|
US
|
08/02/1993
|
08/111,314
|
21/01/1997
|
5,595,903
|
Family:
2042
|
Title:
|
Synthetic
Antisense Deoxyoligonucleotide an
d Pharmaceutical Compositions
Containing the Same
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1513
|
Eckstein
Fritz
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2042-00
|
Priority
|
Granted
|
Israel
|
15/04/1992
|
101600
|
29/02/2000
|
JOURNAL
11/99
|
30/05/2000
|
101600
|
||
2042-01
|
PCT
|
Exhausted
|
PCT
|
15/04/1993
|
PCT/EP93/00911
|
28/10/1993
|
WO
93/21202
|
||||
2042-02
|
NP
|
Abandoned
|
Japan
|
15/04/1993
|
517984/93
|
||||||
2042-03
|
NP
|
Granted
|
Europe
|
15/04/1993
|
93911467.4
|
05/04/1997
|
EP
0636137 B1
|
||||
2042-04
|
NP
|
Abandoned
|
Australia
|
15/04/1993
|
40399/93
|
14/12/1995
|
665087
|
||||
2042-05
|
NP
|
Abandoned
|
US
|
12/01/1994
|
08/318,826
|
04/06/1999
|
5,891,725
|
||||
2042-06
|
NP
|
Granted
|
Canada
|
15/04/1993
|
2,118,235
|
15/7/2008
|
2118235
|
||||
2042-07
|
CIP
|
Granted
|
US
|
05/02/1998
|
08/850,347
|
29/08/2000
|
6,110,742
|
||||
2042-08
|
NP
|
Granted
|
France
|
15/04/1993
|
03/12/1997
|
636137
|
|||||
2042-09
|
NP
|
Granted
|
Great
Britain
|
15/04/1993
|
93911467.4
|
02/01/1995
|
03/12/1997
|
636137
|
|||
2042-10
|
NP
|
Granted
|
Germany
|
15/10/1994
|
93
911467.4
|
02/01/1995
|
03/12/1997
|
693
08 833.8-08
|
|
Family:
2098
|
Title:
|
Transgenic
Animal Assay System for Anticholinesterases
Substances
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1777
|
Shani
Moshe
|
|
1390
|
Zakut
Haim
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2098-00
|
Priority
|
Abandoned
|
US
|
28/02/1994
|
08/202,755
|
||||||
2098-01
|
CIP
|
Abandoned
|
US
|
09/01/1995
|
08/370,156
|
03/08/1999
|
5,932,780
|
||||
2098-02
|
PCT
|
Exhausted
|
PCT
|
28/02/1995
|
PCT/US95/02806
|
31/08/1995
|
WO
95/23158
|
||||
2098-03
|
NP
|
Abandoned
|
Europe
|
28/02/1995
|
95913580.7
|
||||||
2098-04
|
CIP
|
Granted
|
US
|
06/03/1997
|
08/814,095
|
15/02/2000
|
6,025,183
|
Family:
2151
|
Title:
|
A
Method and Composition for Enabling Passage Through
BBB
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1882
|
Friedman
Alon
|
|
1881
|
Kaufer
Daniela
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2151-00
|
Priority
|
Expired
|
US
|
20/11/1996
|
60/031,194
|
||||||
2151-01
|
Priority2
|
Expired
|
US
|
12/12/1996
|
60/035,266
|
||||||
2151-02
|
PCT
|
Exhausted
|
PCT
|
20/11/1997
|
PCT/US97/21696
|
28/05/1998
|
WO
98/22132
|
||||
2151-03
|
From
Priority
|
Granted
|
US
|
20/11/1997
|
08/975,084
|
07/10/2001
|
6,258,780
|
||||
2151-04
|
NP
|
Granted
|
Israel
|
20/11/1997
|
129990
|
24/01/2005
|
Pat
Journal 11/2004
|
25/04/2005
|
129990
|
||
2151-05
|
NP
|
Abandoned
|
Australia
|
20/11/1997
|
53642/98
|
06/10/1998
|
04/12/2001
|
732043
|
|||
2151-06
|
NP
|
Abandoned
|
Canada
|
20/11/1997
|
2,272,280
|
||||||
2151-07
|
NP
|
Abandoned
|
Europe
|
20/11/1997
|
97950711.8
|
||||||
2151-08
|
NP
|
Filed
|
Japan
|
20/11/1997
|
10-523989
|
Family:
2304
|
Title:
|
Synthetic
Antisense Oligodeoxynucleotides and Pharmaceutical Compositions Containing
them
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1513
|
Eckstein
Fritz
|
|
1882
|
Friedman
Alon
|
|
1881
|
Kaufer
Daniela
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2304-00
|
Priority
|
Expired
|
US
|
12/12/1996
|
60/035,266
|
||||||
2304-01
|
PCT
|
Exhausted
|
PCT
|
12/12/1997
|
PCT/US97/23598
|
18/06/1998
|
WO
98/26062
|
||||
2304-02
|
CIP
|
Granted
|
US
|
12/12/1997
|
08/990,065
|
19/09/2000
|
6,121,046
|
||||
2304-03
|
NP
|
Allowed
|
Israel
|
12/12/1997
|
130162
|
||||||
2304-04
|
NP
|
Granted
|
Australia
|
12/12/1997
|
53856/98
|
14/12/2000
|
727611
|
||||
2304-05
|
NP
|
Examination
|
Canada
|
12/12/1997
|
2,274,985
|
||||||
2304-06
|
NP
|
Granted
|
Europe*
|
12/12/1997
|
97950993.2
|
15/09/1999
|
951536
|
24/1/2007
|
EP0951536
|
||
2304-07
|
NP
|
Filed
|
Japan
|
12/12/1997
|
10-527069
|
||||||
2304-08
|
CIP
|
Abandoned
|
US
|
09/572,630
|
Family:
2325
|
Title:
|
Antisense
and Non-Catalytic Properties
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1118
|
Soreq
Hermona
|
v
|
Licensee
|
|||||||||||
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2325-00
|
Priority
|
Expired
|
US
|
03/06/1997
|
60/040,203
|
||||||
2325-01
|
PCT
|
Exhausted
|
PCT
|
03/06/1998
|
PCT/US98/04503
|
09/11/1998
|
WO
98/39486
|
||||
2325-02
|
NP
|
Abandoned
|
Australia
|
03/06/1998
|
64521/98
|
AB
|
|||||
2325-03
|
NP
|
Abandoned
|
Canada
|
03/06/1998
|
2,283,068
|
||||||
2325-04
|
NP
|
Granted
|
US
|
03/06/1998
|
09/380,532
|
11/05/2002
|
6,475,998
|
||||
2325-05
|
NP
|
Abandoned
|
Europe
|
98910229.8
|
Abandoned
|
Family:
2356
|
Title:
|
Use
of A Specific AChE Peptide (I4) As A Growth
Factor
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1969
|
Deutch
Varda
|
|
1382
|
Eldor
Amiram
|
|
1970
|
Grisaru
Dan
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2356-00
|
Priority
|
Granted
|
Israel
|
31/05/1999
|
130224
|
19/02/2004
|
Pat
Journal 12/2003
|
20/05/2004
|
130224
|
||
2356-01
|
From
Priority
|
Abandoned
|
Israel
|
09/02/1999
|
131707
|
||||||
2356-02
|
PCT
|
Exhausted
|
PCT
|
31/05/2000
|
PCT/IL00/00311
|
12/07/2000
|
WO
00/73427
|
||||
2356-03
|
CIP
|
Granted
|
US
|
30/11/2001
|
09/998,042
|
20/02/2003
|
US-2003-0036632-A1
|
27/06/2006
|
7,067,486
|
||
2356-04
|
CIP
of CIP
|
Published
|
US
|
04/11/2006
|
11/401,670
|
22/03/2007
|
US-2007-0065882-A1
|
Family:
2463
|
Title:
|
Novel
Uses of Antibodies Against Ache and Peptides
thereof
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1882
|
Friedman
Alon
|
|
1881
|
Kaufer
Daniela
|
|
1118
|
Soreq
Hermona
|
v
|
Family:
2584
|
Title:
|
Antisense
Oligonucleotide Against Human Ache and Uses thereof AS3
(EN101)
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2584-00
|
Priority
|
Filed
|
Israel
|
24/05/2001
|
143379
|
||||||
2584-01
|
PCT
|
Exhausted
|
PCT
|
24/05/2002
|
PCT/IL02/00411
|
01/09/2003
|
WO
03002739
|
||||
2584-02
|
CIP
of NP
|
Granted
|
US
|
27/03/2003
|
10/402,016
|
20/11/2003
|
US-2003-0216344-A1
|
07/11/2006
|
7,074,915
|
||
2584-03
|
NP
|
Examination
|
Europe
|
24/05/2002
|
2726406.8
|
25/02/2004
|
1390493
|
||||
2584-04
|
NP
|
Filed
|
Canada
|
24/05/2002
|
2,458,806
|
||||||
2584-05
|
NP
|
Allowed
|
Australia
|
24/05/2002
|
20002256873
|
18/10/2007
|
20002256873
|
||||
2584-06
|
NP
|
Filed
|
Japan
|
24/05/2002
|
2003-509100
|
||||||
2584-07
|
NP
|
Examination
|
India
|
24/05/2002
|
01497/KOLNP/2003
|
||||||
2584-08
|
NP
|
Examination
|
New
Zealand
|
24/05/2002
|
529549
|
||||||
2584-09
|
DIV
of CIP
|
Published
|
US
|
02/01/2006
|
11/346,145
|
08/10/2006
|
US-2006-0178333-A1
|
Family:
2806
|
Title:
|
Ache
Antisense Deoxyoligonucleotide As Anti-Inflammatory
Agent
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
3170
|
Yirmiya
Raz
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2806-00
|
Priority
|
Filed
|
Israel
|
26/10/2003
|
158600
|
||||||
2806-01
|
PCT
|
Exhausted
|
PCT
|
26/10/2004
|
PCT/IL2004/000978
|
||||||
2806-02
|
CIP
|
Abandoned
|
US
|
26/10/2004
|
11/187,719
|
||||||
CON
|
Filed
|
US
|
18/4/2007
|
11/788,321
|
|||||||
2806-03
|
NP
|
Published
|
Europe
|
23/10/2004
|
4791840.4
|
26/07/2006
|
1682072
|
||||
2806-04
|
NP
|
Examination
|
Canada
|
26/10/2004
|
2,543,305
|
||||||
2806-05
|
NP
|
Filed
|
Japan
|
26/10/2004
|
2006-537550
|
Family:
2816
|
Title:
|
ARP
As an Inducer of Granulocytopoiesis, Uses and Methods thereof
(Hematopoietic Stem Cells)
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
1969
|
Deutch
Varda
|
|
1970
|
Grisaru
Dan
|
|
2637
|
Perry
Chava
|
|
2638
|
Pick
Marjorie
|
|
1118
|
Soreq
Hermona
|
v
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
2816-00
|
Priority
|
Filed
|
Israel
|
02/12/2004
|
160376
|
Tel-Aviv
Sourasky Medical Center
|
50
|
||||
2816-01
|
PCT
|
Exhausted
|
PCT
|
02/10/2005
|
PCT/IL2005/000185
|
Tel-Aviv
Sourasky Medical Center
|
50
|
||||
2816-02
|
NP
|
Filed
|
US
|
02/10/2005
|
10/589,116
|
27/9/2007
|
2007/0224181A1
|
Tel-Aviv
Sourasky Medical Center
|
50
|
Family
:
|
Title:
|
ANTISENSE
OLIGONUCLEOTIDES AGAINST ACETYLCHOLINESTERASE FOR TREATING INFLAMMATORY
DISEASES
|
Inventors
|
||
Inventor
ID
|
Inventor
Name
|
Main
|
Eli
Hazum
|
Application
|
Publication
|
Patent
|
Co-Applicant
|
||||||||
Patent
ID
|
Continuity
|
Status
|
Country
|
Date
|
Number
|
Date
|
Number
|
Date
|
Number
|
Name
|
%
|
Priority
|
Filed
|
US
|
04/10/2006
|
60/790,546
|
|||||||
PCT
|
Exhausted
|
PCT
|
29/3/2007
|
PCT/IL2007/000413
|
18/10/2007
|
WO2007/116395
|
|||||
NP
|
Filed
|
US
|
10/08/2008
|
12/296,455
|
|||||||
NP
|
Filed
|
Australia
|
29/3/2007
|
2007237059
|
|||||||
NP
|
Filed
|
New
Zealand
|
29/3/2007
|
571861
|
|||||||
NP
|
Filed
|
Europe
|
29/3/2007
|
PCT/IL2007/000413
|
|||||||
NP
|
Filed
|
Canada
|
29/3/2007
|
PCT/IL2007/000413
|
|||||||
NP
|
Filed
|
Israel
|
29/3/2007
|
194431
|
|||||||
NP
|
Filed
|
Japan
|
29/3/2007
|
PCT/IL2007/000413
|