Document:

Exhibit 4.26

 

Date
25TH FEBRUARY 2004

 

 

AMARIN
CORPORATION PLC,

 

 

AND

 

 

VALEANT
PHARMACEUTICALS INTERNATIONAL,

 

 

DEVELOPMENT
AGREEMENT

 

 

INDEX

 

	
  1.

  	
  DEFINITIONS AND INTERPRETATION

  	
   

  
	
   

  	
   

  	
   

  
	
  2.

  	
  PURSUIT OF PRODUCT APPROVAL WITH FDA

  	
   

  
	
   

  	
   

  	
   

  
	
  3.

  	
  UTILIZATION OF CRO

  	
   

  
	
   

  	
   

  	
   

  
	
  4.

  	
  DEVELOPMENT STEERING COMMITTEE

  	
   

  
	
   

  	
   

  	
   

  
	
  5.

  	
  MONITORING
  THE IMPLEMENTATION OF THE DEVELOPMENT PLAN

  	
   

  
	
   

  	
   

  	
   

  
	
  6.

  	
  COSTS AND EXPENSES

  	
   

  
	
   

  	
   

  	
   

  
	
  7.

  	
  CONFIDENTIALITY

  	
   

  
	
   

  	
   

  	
   

  
	
  8.

  	
  MISCELLANEOUS.

  	
   

  

 

 

DATE               25
 FEBRUARY 2004

 

PARTIES:

 

(1)                                 AMARIN CORPORATION PLC (registered in England and Wales under company number
2353920) whose registered office is at 7 Curzon Street, London W1J 5HG (“Amarin”);
and

 

(2)                                 VALEANT PHARMACEUTICALS INTERNATIONAL, a Delaware corporation having its
headquarters at 3300 Hyland Avenue, Costa Mesa, California 92626 (“Valeant”).

 

RECITALS:

 

(A)                              R P Scherer Corporation (“Scherer”)
and Elan Pharma International Limited (“Elan”) entered into a License and
Supply Agreement, dated February 25, 1999, as amended (the “Scherer
Agreement”) pursuant to which, among other things, Scherer granted Elan a
license to use and sell (but not manufacture) a formulation of selegiline
hydrochloride using certain patented Zydis® technology (the “Product”) in a
territory including the United States.

 

(B)                                With Scherer’s consent, Elan and
Amarin entered into an option agreement (as amended, the Amended and Restated
Option Agreement, dated August 4, 2003 and the letter agreement dated 23rd
December 2003 (the “Option Agreement”) pursuant to which, among other
things, Elan granted Amarin the option (the “Option”) to obtain the exclusive
transfer and assignment of the rights under the Scherer Agreement to use and
sell (but not manufacture) the Product (presently known as ZelaparTM) in the
United States (the “Territory”), together with certain related information,
data, and know-how (collectively, the “Rights”).

 

(C)                                Amarin and Valeant have entered into
an Asset Purchase Agreement, dated February11, 2004 (the “Asset Purchase
Agreement”) pursuant to which, among other things, Amarin has agreed to (i)
exercise the Option under the Option Agreement, and (ii) then to convey
the Rights on to Valeant.

 

(D)                               The closing of the Asset Purchase
Agreement is conditioned upon, among other things, (i) the receipt from
Cardinal Health, Inc. (as successor-in-interest by merger to Scherer under the
License Agreement) (“Cardinal”) of Cardinal’s consent to Elan’s assignment of
the Rights to Assignee, and (ii) the acknowledgment by the parties hereto of
the satisfaction and/or the assumption and continuation of certain obligations
by the parties under the License Agreement and the Option Agreement, as amended
hereby.

 

(E)                                 Upon Amarin’s exercise of the
Option, in accordance with the terms of the Option Agreement, Amarin shall pay
to Elan Corporation plc (or such other party as it shall direct) the sum of
seventeen million dollars ($17,000,000) which, among other items,

 

1

 

includes the
consideration for the conveyance of the Rights and any other rights it may have
in Product, as defined in the Option Agreement.

 

(F)                                 This Agreement sets out the parties’
obligations and rights relating to the development and registration of the
Product in the Territory and is being entered into in light of the foregoing,
is contingent upon and will be delivered at the closing of the transactions
above as a part of consummating such transaction.

 

NOW
IT IS AGREED in consideration of the mutual
promises and undertakings set out herein as follows:

 

1.                                       DEFINITIONS
AND INTERPRETATION

 

1.1                                 Definitions:

 

In this
Agreement:

 

“Assignment
Agreement” shall mean the assignment and assumption
agreement of today’s date between Amarin, Valeant and Elan;

 

“Commercially
Reasonable Efforts” shall mean efforts consistent with
the exercise of prudent business judgment as applied to other clinical,
regulatory and/or commercialization efforts for products of similar performance
and potential as would be undertaken in the pharmaceutical industry, but not
less than those efforts applied by that party to other similar products of its
own product line;

 

“Development Plan” shall mean the Project
Plan, Timeline and Protocol for the Zelapar Study set out in the
Schedule to this Agreement, as they may be amended from time to time in
accordance herewith;

 

“DSC”
the Development Steering Committee which shall be
appointed and shall operate in accordance with the provisions of Clause 4;

 

“FDA”
the  Food and Drug Administration of the United
States Government or any successor thereto;

 

“NDA”
shall mean a New Drug Application and all supplements
filed pursuant to the requirements of the FDA, including all documents, data
and other information concerning the Product which are necessary for, or
included in, FDA approval to market the Product in the United States of
America;

 

“Successful
Completion” shall mean the earlier of (i) the date of
completion, to the reasonable satisfaction of the DSC, of all of the individual
phases or aspects of the Zelapar Study as prescribed in the Development Plan,
or (ii) the date of a submission to the FDA which seeks FDA approval of the
Product in the Territory.

 

2

 

“Zelapar
Study” shall mean such study or studies as are
identified in the Development Plan as necessary to achieve approval of the NDA
by the FDA in Parkinson’s disease.

 

1.2                                 Interpretation

 

1.2.1                        any reference to “Amarin”
or the “Valeant” shall be construed so as to include its and any subsequent
successors and any permitted transferees in accordance with their respective
interests;

 

1.2.2                        references in this
Agreement to any Clause or Schedule shall be to a clause or
schedule contained in this Agreement;

 

1.2.3                        the expressions
“include”, “includes”, “including”, “in particular” and similar expressions
shall be construed without limitation; and

 

1.2.4                        unless the context
otherwise requires, a reference to a statute or any provision thereof is to be
construed as a reference to that statute or such provision thereof as it may be
amended, modified, extended, consolidated, re-enacted or replaced from time to
time and shall also include all bye-laws, instruments, orders and regulations
for the time being made thereunder or otherwise deriving validity therefrom.

 

2.                                       PURSUIT OF
PRODUCT APPROVAL WITH
FDA

 

During the term of this Agreement, Amarin
shall be responsible for the implementation of the Zelapar Study as more
particularly provided herein and Valeant shall be responsible for (i) the
preparation, submission and prosecution of the NDA for the Product, and (ii)
corresponding and communicating with the FDA; taking its instruction from the
DSC. Amarin and Valeant shall at all times use Commercially Reasonable Efforts
in discharging their respective duties and responsibilities hereunder.  Notwithstanding the foregoing, Amarin has
not guaranteed, and does not guarantee, final FDA approval of the Product. For
the avoidance of doubt, Amarin shall have no duties or obligations with respect
to the Zelapar Study other than those specifically set out in this Agreement.
It is understood that (i) the timelines shown in the attached Development Plan
have been changed, and an updated Development Plan will be provided to the DSC
promptly following execution of this Agreement; and (ii) any changes to the
Protocol could further affect the timing, cost, or both, of the Zelapar Study.

 

3.                                       UTILIZATION OF
CRO

 

3.1                                 Purpose of CRO.  Consistent with the obligations set forth in
Section 2, but in recognition of the fact that following the closing of
the Asset Purchase Agreement, Amarin will not have any meaningful operations,
staff or facilities in the United States, promptly following the execution
hereof, Amarin shall engage the services of a qualified contract research
organization (“CRO”) to serve as Amarin’s agent for purposes of discharging its
duties and responsibilities under this Agreement.  Subject to oversight and direction by the DSC as provided in
Section 4 hereof, Amarin shall be responsible for selection, management
and control of the CRO.  Anything herein
to the contrary notwithstanding, however, Amarin shall not be liable to Valeant
for any

 

3

 

losses or damages
suffered by Valeant as a result of any actions or inactions of the CRO,
including but not limited to any losses or damages resulting from the CRO’s
failure to properly or successfully design or implement the Zelapar Study or
the CRO’s failure to obtain final FDA approval of the Product, unless and to
the extent only that such losses or damages are the direct result of Amarin’s
gross negligence or willful misconduct.

 

3.2                                 Selection of CRO.  Amarin shall be responsible for identifying
and selecting the CRO; however, the CRO must be reasonably acceptable to
Valeant.  The CRO may be removed and
replaced by Amarin from time to time with Valeant’s prior written consent which
shall not be unreasonably withheld or delayed.

 

3.3                                 CRO Agreement.  Amarin shall enter into a project agreement
(the “CRO Agreement”) with the CRO as promptly as possible after the execution
hereof.  The CRO Agreement shall, among
other things, set forth the CRO’s duties and responsibilities relative to
designing and implementing the Zelapar Study. 
The CRO Agreement shall be reasonably acceptable to Valeant in form and
substance.

 

4.                                       DEVELOPMENT
STEERING COMMITTEE

 

4.1                                 Formation and Purpose of
DSC.  Promptly following the execution hereof,
Amarin and Valeant shall organize a development steering committee (the
“DSC”).  The purpose of the DSC shall be
to implement the Development Plan and to obtain final FDA approval for the
Product.  The DSC shall have three (3)
members, two of whom shall be appointed by Amarin.  The third member shall be appointed by Valeant.  One of the members appointed by Amarin shall
serve as the chairperson of the DSC.

 

4.2                                 Responsibilities of the
DSC.  The DSC shall initially be responsible for
monitoring the Development Plan.  In
that regard, the DSC shall coordinate closely with the CRO.

 

4.3                                 Meetings of the DSC.  The DSC shall hold regular meetings as often
as necessary to discharge its responsibilities hereunder.  Such meetings may be held in person or by
conference call, and minutes of all such meetings shall be recorded and
retained.  Any member of the DSC may
call a meeting at any time upon 3 business days’ notice to the other
members.  Two members shall constitute a
quorum for a meeting of the DSC.

 

4.4                                 Formal Action by the DSC.  Each member of the DSC shall have one vote
on any matter brought before the DSC for a vote.  In any matter voted on by the DSC, a majority vote of the members
shall be required to approve such matter; provided, however, that
notwithstanding the foregoing, the affirmative vote of the DSC member appointed
by Valeant shall be required in order to approve, or take any action relative
to:  (i) the termination of the
Development Plan, (ii) the modification, waiver or enforcement of any
material term or provision of the Development Plan, (iii) the appointment,
removal, or replacement of the CRO, (iv) the negotiation and settlement

 

4

 

of any dispute
with the CRO under the CRO Agreement, (v) the design, implementation or
modification of the Zelapar Study, and (vi) the preparation, submission,
and prosecution of the request for final FDA approval of the Product.

 

5.                                       MONITORING THE IMPLEMENTATION OF THE DEVELOPMENT PLAN

 

5.1                                 DSC Oversight.  Consistent with Section 4.2 hereof, the
DSC shall be responsible for monitoring the implementation of the Development
Plan by the CRO.  To that end, the DSC
shall have full and complete access to (and Amarin shall require the CRO to
provide the DSC with full and complete access to) all books, records, and
materials maintained by the CRO that are relative to the CRO’s involvement in
the Development Plan.  The DSC shall
also be afforded regular and reasonable access, upon reasonable notice, to all
CRO personnel working on the Development Plan.

 

5.2                                 Specific Access.  Without in any way diminishing the general
scope of Section 5.1, in connection with and in furtherance of the DSC’s
oversight role as described in Section 5.1, the DSC and each of its
members shall have full and complete access to, and Amarin shall require the
CRO to provide the DSC with full and complete access to, all documents,
materials and reports related to the design, initiation, and conduct of the
Zelapar Study, including but not limited to the Zelapar Study timeline and
protocol, the case report form, the statistical analysis plan, data tables and
listings, adverse event reports, the clinical trial report, data
interpretations, and study summaries, presentations, publications and
regulatory documents, together with all raw data and source documents related
thereto.

 

6.                                       COSTS AND
EXPENSES

 

Amarin shall be responsible for paying and
shall pay directly, the first U.S. $2.5 million of costs and expenses incurred
by Amarin under, in furtherance of, or in connection with this Agreement,
including but not limited to all costs and expenses due to the CRO and any
other third party contractors and consultants approved by the DSC; provided,
however, that only actual third party costs and expenses incurred by Amarin and
contemplated in the Development Plan budget approved by the DSC, as such budget
may be amended from time to time, shall be credited toward Amarin’s U.S. $2.5
million commitment hereunder.  Valeant
shall be responsible for paying, and shall pay directly, all costs and expenses
incurred by Amarin hereunder in excess of Amarin’s U.S. $2.5 million
commitment, and shall indemnify and hold harmless Amarin against any such costs
and expenses. After Amarin has satisfied its $2.5 million commitment, Amarin
shall not be required to expend any further funds whatsoever, and Valeant shall
upon Amarin’s reasonable request acknowledge in writing to relevant third
parties its obligation to pay, or otherwise provide assurances with respect to
the payment by Valeant of, any further costs or expenses contemplated by the Development
Plan budget or otherwise arising under, in furtherance of or in connection with
this Agreement.  In no event shall
Amarin be required to expend more than a total of $2.5 million in costs and
expenses in connection with its performance of this Agreement and the CRO
Agreement, and any failure or refusal by Amarin to pay costs or expenses in
excess of such amount shall not constitute a breach or default by Amarin under
this Agreement or the CRO Agreement.

 

5

 

7.                                       CONFIDENTIALITY

 

7.1                                 Confidential Information.  Each party shall maintain in confidence all
information of the other party (including any Product samples) disclosed by the
other party under the Agreement (the “Confidential Information”), and shall not
use, disclose or grant the use of the Confidential Information of the other
party, except to its and its affiliates’ directors, officers, employees,
permitted assignees, agents, consultants, clinical investigators and
contractors or Representatives (including in the case of Amarin the CRO), to
the extent such disclosure is reasonably necessary in connection with such
party’s activities as expressly authorized by the Agreement.  To the extent that disclosure is authorized
by the Agreement, prior to disclosure, each party hereto shall obtain agreement
of any such person or entity of its obligation, to hold in confidence and not
make use of the Confidential Information for any purpose other than those
permitted by the Agreement.  Each party
shall notify the other promptly of any unauthorized use or disclosure of the
other party’s Confidential Information.

 

7.2                                 Permitted Disclosures.  The confidentiality obligations contained in
Section 6.1 above shall not apply to the extent that (a) the receiving
party (the “Recipient”) is required to disclose Confidential Information
by law, order or regulation of a governmental agency or a court of competent
jurisdiction, provided that the Recipient shall provide to the disclosing party
written notice and sufficient opportunity to object to such disclosure or to
request confidential treatment thereof; or (b) the Recipient can demonstrate
that (i) the Confidential Information was public knowledge at the time of such
disclosure by the Recipient, or thereafter became public knowledge, other than
as a result of actions of the Recipient, its affiliates and licensees in
violation hereof; (ii) the Confidential Information was rightfully known to or
independently developed by the Recipient, its affiliates or licensees (as shown
by its written records) prior to the date of disclosure to the Recipient by the
other party hereunder; or (iii) the Confidential Information was received by
the Recipient, its affiliates or licensees on an unrestricted basis from a
source unrelated to any party to the Agreement and not under a duty of
confidentiality to the other party.

 

7.3                                 Terms of the Agreement.  Except as otherwise provided in this
Agreement, Valeant and Amarin shall not disclose any terms or conditions of the
Agreement to any third party without the prior consent of the other party, not
to be unreasonably withheld.

 

8.                                       MISCELLANEOUS.

 

8.1                                 Valeant covenants and
agrees to reimburse, indemnify and hold Amarin harmless from and against any
and all claims, actions, judgments, damages, losses, liabilities, costs and
expenses (including without limitation reasonable attorney’s fees and expenses)
(each, a “Loss”) which may be paid, incurred or suffered by Amarin, or to which
Amarin may become subject, arising out of or incident to this Agreement or the
performance of its duties hereunder, or as a result of defending itself against
any claim or liability resulting from its actions under this Agreement,
including any claims based on product liability, strict liability or similar
grounds; provided,

 

6

 

however that Amarin shall not be
entitled to indemnification for any Loss arising out of its gross negligence or
willful misconduct.  The covenants and
agreements of Valeant in this Section 8.1 shall survive the expiration or
termination of this Agreement for any reason. In no event shall Amarin or any
of its affiliates be liable for any indirect, special, punitive or
consequential damages. Notwithstanding anything to the contrary contained
herein, the aggregate liability of Amarin with respect to, arising from or
arising in connection with this Agreement or from all services provided or
omitted to be provided hereunder, whether in contract, tort or otherwise, is
limited to, and shall not exceed, $2,000,000.

 

8.2                                 Notices. Any consent, notice or
report required or permitted to be given or made under the Agreement by  one
of the parties hereto to the other party shall be in writing, delivered
personally or by facsimile (and promptly confirmed by personal delivery, U.S.
first class mail or courier), U.S. first class mail or courier, postage prepaid
(where applicable), addressed to such other party at its address indicated
below, or to such other address as either party may notify the other in
accordance with this Section, and (unless otherwise provided in this Agreement)
shall be effective upon receipt by the addressee.

 

If to Amarin:

 

Amarin Corporation, plc

7 Curzon Street

London W1Y 7FL, UK

Facsimile: 
+44-207-499-9004

Attention: General Counsel & Company Secretary

 

If to Valeant:

 

Valeant Pharmaceuticals International

3300 Hyland Avenue,

Costa Mesa,

California 92626

Facsimile:     
+1 714 641-7265

Attention:  
     General Counsel

 

8.3                                 Governing Law.  The Agreement shall be governed by and
construed in accordance with the laws of California, without regard to the
conflicts of law principles thereof.

 

8.4                                 Assignment.  Neither party shall assign its rights or
obligations under the Agreement without the prior written consent of the other
party hereto (such consent not to be unreasonable withheld or delayed); provided,
however, that either party may, without such consent, assign the
Agreement and its rights and obligations hereunder to an affiliate, or in
connection with the transfer or sale of all or substantially all of its assets
or business, or in the event of its merger or consolidation or change in
control

 

7

 

or similar
transaction and provided further that any permitted assignee assumes in
writing all obligations of its assignor under this Agreement.

 

8.5                                 Waivers and Amendments.  No change, modification, extension,
termination or waiver of this Agreement shall be valid unless made in writing
and signed by duly authorized representatives of the parties.

 

8.6                                 Entire Agreement.  This Agreement (together with the
Schedule hereto), the Asset Purchase Agreement and the Assignment
Agreement embody the entire understanding between the parties and supersedes
any prior understanding and agreements between and among them respecting the
subject matter. There are no representations, agreements, arrangements or
understandings, oral or written, between the parties relating to the subject
matter of the Agreement which are not fully expressed herein.

 

8.7                                 Counterparts.  The Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

 

8.8                                 Further Assurances.  The parties shall take any other actions,
including without limitation the execution and delivery of documents, as may be
reasonably, necessary or appropriate to carry out the intent of this Agreement.

 

8

 

IN
WITNESS WHEREOF, this Agreement has been duly executed
by the parties hereto, and is effective as of, the date first written above.

 

	
   

  	
  AMARIN CORPORATION PLC

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  VALEANT PHARMACEUTICALS

  
	
   

  	
  INTERNATIONAL

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  	
   

  

 

9

 

SCHEDULE 1

 

DEVELOPMENT PLAN SUMMARY
SCHEDULE

 

10Exhibit 4.27

 

EXECUTION
COPY

 

DATED                                                                      2004

 

 

ELAN CORPORATION PLC

 

ELAN PHARMA INTERNATIONAL LIMITED

 

ELAN INTERNATIONAL SERVICES, LTD

 

ELAN PHARMACEUTICALS, INC.

 

MONKSLAND HOLDINGS BV

 

AND

 

AMARIN CORPORATION PLC

 

SETTLEMENT AGREEMENT

 

NICHOLSON GRAHAM
& JONES

110 CANNON STREET LONDON EC4N 6AR

TEL: 020 7648 9000

FAX: 020 7648 9001

REF: OEW/E327-Elan

 

 

THIS DEED is made on • February 2004

 

BETWEEN:

 

(1)                                 ELAN CORPORATION PLC,  (a public limited company registered in
Ireland) whose registered office is at Lincoln House, Lincoln Place, Dublin 2 (“Elan Corp”);

 

(2)                                 ELAN PHARMA INTERNATIONAL LIMITED,  a
company incorporated in  the Republic of Ireland, whose registered
office is at WIL House, Shannon Business Park, Shannon, Co Clare, Ireland (“EPIL”)

 

(3)                                 ELAN INTERNATIONAL SERVICES, LTD., a Bermuda exempted limited liability company
incorporated under the laws of Bermuda and having its registered office at
Clarendon House, 2 Church Street, Hamilton, Bermuda (“EIS”)

 

(4)                                 ELAN PHARMACEUTICALS, INC.,  a
corporation duly organized and existing under the applicable laws of the State
of Delaware, having a principal place of business in South San Francisco,
California (“EP Inc”); and

 

(5)                                 MONKSLAND HOLDINGS BV, a private company limited by shares
incorporated in the Netherlands under registered number 33265127, whose
registered office is at Amsteldijk 166, 1079 Amsterdam, Netherlands (“Monksland”)

 

(6)                                 AMARIN CORPORATION PLC (registered in
England under number 2353920) whose registered office is at 7 Curzon Street
London W1J 5HG (the “Amarin”).

 

WHEREAS:

 

(A)                              Pursuant to an agreement dated 11 February 2004 and made
between Amarin and Valeant Pharmaceuticals International (“Valeant”), Amarin has agreed
to sell to Valeant certain of its product rights relating to Zelapar, Permax
and its PCP line of products together with the entire issued share capital of
Amarin Pharmaceuticals, Inc.(together the “US Business”).  Completion of the Valeant Agreement is
conditional on the satisfaction of certain conditions as provided for in the
Valeant Agreement.

 

(B)                                EIS and Monksland are together the registered holders of 4,653,819
ordinary shares in the capital of Amarin.

 

(C)                                Amarin is indebted to Elan pursuant to the Elan Debt Agreements.

 

1

 

(D)                               In connection with the previous restructuring of the Elan Debt
Agreements Amarin and Elan entered into the Elan Charge to secure the
obligations of Amarin under the Elan Debt Agreements.

 

(E)                                 In consideration of the undertakings and obligations mutually
exchanged in this Deed, the parties have agreed to enter into the arrangements
contemplated by this Deed in order that the indebtedness owing to Elan may be
rescheduled, the Elan Charge may be released as respects the assets to be sold
and the option in the Zelapar Agreement exercised and the rights and
obligations of Amarin thereunder transferred to Valeant.

 

THIS DEED WITNESSES as
follows:

 

1.                                       DEFINITIONS
AND INTERPRETATION

 

1.1                                 In this Deed unless the context requires otherwise:

 

“Clinical
Trials” means the clinical trials carried out by Elan relating to
its filing of an NDA with the FDA for Zelapar more particularly described as
Z/SEL/97/025 and Z/ZEL/97-026.

 

“Condition” means the
condition set out in Clause 2;

 

“Deed of Release” means the deed of release
relating to the Elan Charge in the Agreed Form;

 

“Elan” means collectively
Elan Corp, EPIL, EIS, EP Inc and Monksland.

 

“Elan Charge” means the
debenture made on 4 August 2003 (as amended) between Amarin and Elan Corp
pursuant to which Amarin granted security to Elan Corp as trustee for the Elan
Group;

 

“Elan Debt Agreements” means
together;

 

(a)                                  the Amended and Restated Master Agreement between Elan Corp, EPIL,
EIS, EP Inc, Monksland and Amarin dated 4 August 2003, as amended by
Amendment Agreement between the same parties dated 23 December 2003 (the
latter, “Dec
03 Amendment”) (together “Master Agreement”);

 

(b)                                 the Amended and Restated Asset Purchase Agreement dated as of 29
September 1999 (which agreement concerned certain products known as the
“Carnrick

 

2

 

products”) by
and between EP Inc and Amarin, as varied inter alia by an Amendment Agreement
No. 1 dated 4 August 2003 and the Amendment Agreement (together “Carnrick
Agreement”);

 

(c)                                  the Loan Agreement dated 28 September 2001 between Amarin and
EPIL, as varied by (i) a Deed of Variation dated 19 August 2002, (ii)
a Deed of Variation No. 2 dated 23 December 2002; (iii) a Deed of
Variation No. 3 dated 27 January 2003; (iv) a Deed of Variation No. 4
dated 4 August 2003 and (v) the Amendment Agreement (together “Loan
Agreement”);

 

(d)                                 the Amended and Restated Distribution, Marketing and Option
Agreement dated 28 September 2001 (which agreement concerned Permax) by
and between EP Inc and Amarin, as varied by (i) Deed of Variation dated 27
January 2003, (ii) Deed of Variation No. 2 dated 4 August 2003 and
(iii) the Amendment Agreement (together “Permax Agreement”); and

 

(e)                                  the Bridging Loan Agreement between EP Inc and Amarin dated
23 December 2003 (“Bridging Loan Agreement”).

 

“Elan Shares” means the 4,653,819 ordinary
shares in the capital of Amarin held by Elan’s subsidiaries;

 

“Governmental Body”  means any:

 

(a)                                  nation, state, county, city, town, borough, village, district or
other jurisdiction;

 

(b)                                 federal, state, local, municipal, foreign or other government;

 

(c)                                  governmental or quasi-governmental authority of any nature
(including any agency, branch, department, board, commission, court, tribunal
or other entity exercising governmental or quasi-governmental powers),
including specifically the FDA;

 

(d)                                 body exercising, or entitled or purporting to exercise, any
administrative, executive, judicial, legislative, police, regulatory or taxing
authority or power; or

 

(e)                                  official of any of the foregoing.

 

“Loan Instrument” means the instrument
constituting up to $5,000,000 8% Secured Loan Notes 2009 entered into by way of
deed poll by the Company on [   ] 2004;

 

3

 

“Proceding(s)” means any claim, action,
arbitration, audit, hearing, investigation, litigation or suit (whether civil,
criminal, administrative, judicial or investigative, whether formal or
informal, whether public or private) commenced, brought, conducted or heard by
or before, or otherwise involving, any Governmental Body or arbitrator.

 

“Valeant Agreement” means the
asset purchase agreement dated 11 February 2004 and made between Amarin,
Amarin Pharmaceutical Company Limited and Valeant relating to the sale of the
US Business referred to in recital (A);

 

“Warrant Instrument” means the instrument
granting warrants to subscribe for 500,000 ordinary shares in the capital of
Amarin on [   ] 2004;

 

“Zelapar Agreement” means the
Amended and Restated Option Agreement (Zelapar), between EPIL and Amarin dated
4 August 2003, as amended by a letter agreement between the same parties
dated 23 December 2003.

 

“Zelapar Milestone” means the
payment referred to in Clause 6.1 below.

 

1.2                                 In this Deed unless the context requires otherwise:

 

(a)                                  references to Clauses are references to clauses of this Deed and
references within a sub-clause to “this Clause” shall refer to the whole Clause
and not merely to the sub-clause in which it appears;

 

(b)                                 the Recitals form part of and are incorporated in this Deed;

 

(c)                                  headings are included for ease of reference only and shall not
affect the interpretation of this Deed;

 

(d)                                 the singular shall include the plural and vice versa, and references
to any gender shall include references to the other genders;

 

(e)                                  the expression “person” shall include individuals,
corporations (wherever incorporated), unincorporated associations and
partnerships;

 

(f)                                    any reference to a party shall mean any party to this Agreement; and

 

(g)                                 any reference to a document as being “in the Agreed Form” means
that document in a form agreed between the parties such agreement being
signified by

 

4

 

the signature
or initialling of a draft for the purposes of identification by or on behalf of
each of the parties;

 

(h)                                 the expressions “include”, “includes”, “including”, “in particular”
and similar expressions shall be construed without limitation.

 

2.                                       COMPLETION

 

This Deed
shall have no effect unless and until Amarin delivers to Elan certification
from a company officer of Amarin, in a form reasonably acceptable to Elan Corp,
that:

 

(a)                                  the Warrant Instrument has been executed, is effective and the
warrant contemplated thereby has been issued to Elan or a person specified by
Elan;

 

(b)                                 the Loan Instrument has been executed, is effective and all of the
Notes contemplated thereby have been issued to Elan or a person specified by
Elan for value received, namely the Elan Releases contemplated by this Deed;

 

(c)                                  Amarin has issued to its UK or US clearing bank irrevocable and
valid instructions to transfer, or has procured that a third party has issued
to its UK or US clearing bank irrevocable and valid instructions to transfer
without recourse to EP Inc, the sum of US$ 17,000,000 (seventeen million
dollars) by electronic bank transfer in immediately available funds to EP Inc
into the following bank account (the “Elan Bank Account”) –

 

Bank of America

335 Madison Ave

New York, NY. 10017

 

Elan Pharmaceuticals, Inc.

ABA: 121000358

Account:
12330-05275

 

and there are
sufficient funds in the transferor’s account to honour such instruction.  The parties described as “Elan” may
apportion such monies as between the Elan Debt Agreements as may be agreed
between those parties in their absolute discretion, but for the avoidance of
doubt payment to EP Inc into the Elan Bank Account shall constitute receipt on
behalf of all of them sufficient for the purposes of this paragraph (c).

 

5

 

3.                                       RELEASE

 

3.1                                 This deed is in full and final settlement of

 

(a)                                  subject to Clauses 3.2, 3.3, 3.4 and 3.5 all sums owing or which may
become owing, all and/or any actions, claims, rights, demands, whether or not
presently known or suspected, and whether actual or contingent, from the
beginning of time up to and including the date of this Deed, that Amarin, on
behalf of itself and/or any of its predecessors, successors, parents,
subsidiaries, affiliates, related entities, and the assigns, transferees,
representatives, principals, agents, officers, directors and shareholders of
any of them, acting in such capacity (collectively the “Amarin Releasing
Parties”) ever had, may have or hereafter can, shall or may have against Elan,
all of Elan’s predecessors, successors, parents, subsidiaries, affiliates,
related entities, and the assigns, transferees, representatives, principals,
agents, officers, directors and shareholders of any of them, acting in such
capacity (collectively the “Elan Released Parties”) arising in connection with
or related to the Elan Debt Agreements, the Elan Charge and the Zelapar
Agreement (the “Amarin Released Claims”)

 

and of:

 

(b)                                 subject to Clauses 3.2, 3.3, 3.4 and 3.5 all sums owing or which may
become owing, all and/or any actions, claims, rights, demands, whether or not
presently known or suspected, and whether actual or contingent, from the
beginning of time up to and including the date of this Deed, that Elan, on
behalf of itself and/or any of its predecessors, successors, parents,
subsidiaries, affiliates, related entities, and the assigns, transferees,
representatives, principals, agents, officers, directors and shareholders of
any of them, acting in such capacity (collectively the “Elan Releasing
Parties”) ever had, may have or hereafter can, shall or may have against
Amarin, all of Amarin’s predecessors, successors, parents, subsidiaries,
affiliates, related entities, and the assigns, transferees, representatives,
principals, agents, officers, directors and shareholders of any of them, acting
in such capacity (collectively the “Amarin Released Parties”) arising in
connection with or related to the Elan Debt Agreements, the Elan Charge and the
Zelapar Agreement (the “Elan Released Claims”).

 

3.2                                 Nothing in this Deed shall prevent either party making any clams or
demands in respect of the Warrant Instrument, the Loan Instrument, the Elan
Charge (as amended by the Debenture Amendment Agreement No. 2) or any other
agreement of even date herewith to include for the avoidance of doubt any other
Restructuring Document or other document described in the “Escrow Letter” of
today’s date entered into by Amarin and Elan Corp, in respect of claims arising
solely in connection with matters on or after the date of this Deed

 

6

 

or any other
agreement or arrangement entered into between the parties and/or their
respective subsidiary companies subsequent to the parties entering into this
Deed

 

3.3                                 Nothing in this Deed shall be deemed a release of or otherwise
prejudice or affect:

 

(a)                                  EIS’ or Monksland’s rights as ordinary shareholders of Amarin,
except to the extent of the releases provided by the Amarin Releasing Parties
to the Elan Released Parties on their behalf, nor their rights under the
Registration Rights Agreement dated as of 21 October 1998 and amended by
Amendment No. 1 and Waiver dated 27 January 2003 between Amarin, EIS and
Monksland;

 

(b)                                 any right of any party to enforce the provisions of this Deed;

 

(c)                                  without prejudice to the generality of the foregoing, any right the
Elan Releasing Parties or the Amarin Released Parties may have against the Elan
Releasing Parties, the Amarin Released Parties and/or Valeant under (i) the
Permax Assignment and Assumption Agreement between EP Inc., Amarin and Valeant
Pharmaceuticals International; (ii) the Zelapar Assignment and Assumption
Agreement between EPIL and Amarin; (iii) the Zelapar Assignment and Assumption
Agreement between Amarin, EPIL and Valeant Pharmaceuticals International;

 

and
in particular the rights to indemnification provided thereunder;

 

(d)                                 any provision of any agreement requiring confidential information of
a party to be kept confidential and/or not misused by the other party;

 

(e)                                  the provisions relating to product liability set out in Clauses 3.4
and 3.5 below;

 

and
accordingly, the Elan Debt Agreements and the Zelapar Agreement are deemed
terminated with effect from the date of this Deed if not already terminated, so
that only the post-termination restrictions on confidentiality shall apply.

 

3.4                                 EP Inc and Amarin retain their respective rights and are subject to
such obligations as are set out in Clause 4 of the Assignment and Assumption
Agreement relating to Permax with effective date 29th
March 2002.

 

3.5                                 Elan Corp represents and warrants to Amarin that to Elan’s knowledge
there are no Proceedings or pending Proceedings that have been commenced
against Elan or any of its subsidiaries relating to the use of the product
Zelapar in the Clinical Trials. Additionally, to

 

7

 

Elan’s knowledge,
no such Proceeding has been threatened nor to Elan’s knowledge is Elan aware of
any circumstances which are likely to give rise to any Claim (as defined
below).

 

3.6                                 Amarin shall indemnify Elan from and against any claim, damage or
loss, including reasonable attorneys’ fees (a “Claim”), to the extent that such
Claim is related to the use of Zelapar in the Clinical Trials save that the
foregoing indemnity shall not apply:

 

(a)                                  to the extent a Claim is attributable to an act or omission of Elan
constituting negligence, recklessness, wilful misconduct or fraud by Elan;
and/or

 

(b)                                 where Elan is breach of the warranty and representation set out in
Clause 3.5 Claim has been commenced as of the date of this Deed or, to the
actual knowledge of Elan, is threatened as of the date of this Deed.

 

4.                                       COVENANTS
NOT TO SUE

 

The Amarin
Releasing Parties agree not to sue, commence, voluntarily aid in any way,
prosecute or cause to be commenced or prosecuted against any one or more of the
Elan Released parties any action suit or proceedings concerning the Elan Debt
Agreement, the Elan Charge and or in connection with the Zelapar Agreement or
any other arrangements or agreement in place as at the date of this deed save
in respect of those matters referred to in Clauses 3.2, 3.3, 3.4 and  3.5 above. The Elan Releasing Parties agree not to
sue, commence, voluntarily aid in any way, prosecute or cause to be commenced
or prosecuted against any one or more of the Amarin Released parties any action
suit or proceedings concerning the Elan Debt Agreement, the Elan Charge and or
in connection with the Zelapar Agreement or any other arrangements or agreement
in place as at the date of this deed save in respect of those matters referred
to in Clauses 3.2, 3.3, 3.4 and 3.5 above .

 

5.                                       THE
ELAN SHARES

 

The parties
agree that Amarin may if it desires (but shall not be obliged to) procure
persons willing to purchase all or some of the Elan Shares from Elan. If any
such potential purchasers are identified and brought to the attention of Elan,
Elan shall give consideration to the sale of all or some of the Elan shares (as
the case may be) to such purchaser(s) but shall not in any event be obliged to
sell all or any of the Elan Shares to such potential purchasers.

 

8

 

6.                                       OUTSTANDING
PAYMENTS

 

6.1                                 Amarin shall pay to EPIL the one time sum of US$ 1,000,000 (one
million dollars) upon the receipt from Valeant of the sum of $3,000,000 (three
million dollars) payable by Valeant to Amarin pursuant to the Valeant Agreement
in respect of the Successful Completion of the Zelapar safety studies.

 

6.2                                 Amarin shall further pay to EP Inc the sum of US$ 195,000 (one
hundred and ninety five thousand) upon receipt of the sum due from Watson
Pharmaceuticals Inc. in respect of the Swedish Sale (as defined in the Master
Agreement) in respect of the completion balance sheet adjustment as payable by
Watson to Amarin , if not already paid prior to the date of this Deed.  Such payment shall fully discharge Amarin’s
obligations to Elan in respect of the proceeds of the Swedish Sale.

 

6.3                                 The payment referred to in Clauses 6.1 and 6.2 are in additional
consideration of Elan entering into the transaction constituted by this Deed
and associated documents.  Each such
payment is non-refundable, may not be applied against any other obligations
from Amarin to any Elan Released Party whatsoever, is not subject to any future
performance obligation by any Elan Released Party and is independent and
distinct from any other provision of this Deed.

 

7.                                       WARRANTIES

 

7.1                                 Amarin represents and warrants to Elan that:

 

(a)                                  it has the right, power, capacity and authority and has taken all
action necessary to authorise it to execute and deliver and to exercise its
rights and perform its obligations under this Deed and its obligations under
this Deed are valid, legally binding and enforceable according to their terms,
including obtaining all necessary approvals and consents from its shareholders
and any third parties;

 

(b)                                 there are no agreements between Amarin and any third party that
conflict with this Deed;

 

(c)                                  it does not require any further consents or approvals to consummate
the transaction contemplated by this Deed including:

 

(i)                                     approval of its shareholders; or

 

(ii)                                  approval of NASDAQ.

 

9

 

7.2                                 Elan represents and warrants to Amarin that:

 

(a)                                  it has the right, power, capacity and authority and has taken all
action necessary to authorise it to execute and deliver and to exercise its
rights and perform its obligations under this Deed and its obligations under
this Deed are valid, legally binding and enforceable according to their terms,
including obtaining all necessary approvals and consents from its shareholders
and any third parties;

 

(b)                                 there are no agreements between Amarin and any third party that
conflict with this Deed;

 

(c)                                  it does not require any further consents or approvals to consummate
the transaction contemplated by this Deed including:

 

(i)                                     approval of its shareholders; or

 

(ii)                                  approval of NYSE.

 

8.                                       COSTS.

 

Except as
otherwise provided in this Deed, the parties shall pay their own costs in
connection with this Deed.

 

9.                                       CONFIDENTIALITY

 

Except
as provided in or anticipated by this Deed, each party shall at all times
during the continuance of this Deed use its respective best endeavours to keep
the contents of this Deed confidential and accordingly shall not disclose
details of the contents of this Deed to any other person other than on a
confidential basis.

 

10                                  ANNOUNCEMENTS:

 

10.1                              Subject to Clause 10.2. 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 hereto without the prior written approval of
the other party (Elan Corp in the case of Elan).

 

The terms of any
such announcement shall be agreed in good faith by the parties.

 

10

 

10.2                           Required Disclosures:

 

A party (the “Disclosing Party”) will be
entitled to make an announcement or public statement concerning the existence,
subject matter or any term of this Amendment Agreement, or to disclose
Confidential Information that the Disclosing Party is required to make or
disclose pursuant to:

 

(a)                                  a valid order of a court or Governmental Body; or

 

(b)                                 any other requirement of law, regulation or any securities market or
stock exchange;

 

PROVIDED THAT if the
Disclosing Party becomes legally required to make such announcement, public
statement or disclosure hereunder, the Disclosing Party shall give the other
party or parties hereto prompt notice of such fact to enable the other party or
parties hereto to seek a protective order or other appropriate remedy
concerning any such announcement, public statement or disclosure.

 

The Disclosing Party shall fully co-operate
with the other party or parties hereto in connection with that other party’s or
parties’ efforts to obtain any such order or other remedy.

 

If any such order or other remedy does not
fully preclude announcement, public statement or disclosure, the Disclosing
Party shall make such announcement, public statement or disclosure only to the
extent that the same is legally required.

 

11.                               FURTHER ASSURANCES

 

Each party
shall do or procure to be done all such further acts and things, and execute or
procure the execution of all such other documents, as the other party may from
time to time reasonably require for the purpose of giving to the other party
the full benefit of all of the provisions of this Deed

 

12                                  WHOLE AGREEMENT

 

12.1                           In this Clause 12:

 

the “Associated Documents” means the documents
to be entered into by the parties in connection with the subject matter of this
Deed as expressly provided for in this Deed and any other documents entered
into by the parties contemporaneously with or after this Deed which expressly
refer to this Deed; and

 

“pre-contractual statement”
means any statement, representation, warranty, undertaking or promise (whether
in writing or not) made by or on behalf of any party to this Deed prior

 

11

 

to entering into this Deed except to the
extent expressly repeated in this Deed or the Associated Documents.

 

12.2                           This Deed, together with the Associated Documents, represents the
whole agreement and understanding between the parties and supersedes all other
agreements and understandings between the parties or any of them relating to
the subject matter of this Deed.

 

12.3                           This Deed supersedes and extinguishes all pre-contractual
statements.

 

12.4                           Without prejudice to Clause 12.3, each party warrants to the others
that, in entering into this Deed and the Associated Documents, it has not
relied on any pre-contractual statement.

 

12.5                           Nothing in this Clause 12 shall exclude or restrict any liability to
which any of the parties may be subject by reason of any fraudulent
misrepresentation or any remedy available to any of the parties by reason of
such fraudulent misrepresentation.

 

13                                  VARIATION

 

No modification, variation or amendment of
this Deed shall be effective unless such modification, variation or amendment
is in writing and has been signed as a deed by or on behalf of both of the
parties.

 

14                                  ASSIGNMENT

 

Elan may
assign the Zelapar Milestone.

 

Subject to the
foregoing, neither of the parties shall, without the prior written consent of
the other, assign, transfer, charge or deal in any other manner with this Deed
or any rights under it nor subcontract any of its obligations under this Deed
in whole or in part.

 

15                                  GOVERNING LAW AND JURISDICTION

 

This Deed shall be governed by and construed
in accordance with English law PROVIDED THAT to the extent that any of the
releases given by the parties in Clause 3 would, if governed by the laws
of the state of Delaware, release claims arising in connection with or related
to the Carnrick Agreement and/or the Permax Agreement and/or the Zelapar
Agreement which would not be so released under English law, the interpretation
of this Deed under Delaware law shall apply in respect of such claims.

 

12

 

Each of the parties submits to the
non-exclusive jurisdiction of the Courts of England.

 

16                                  CONTRACTS (RIGHTS OF THIRD PARTIES) ACT 1999

 

A person who is not a party to this Deed
shall have no right under the Contracts (Rights of Third Parties) Act 1999 to
enforce any term of this Agreement but this shall not affect any right or
remedy of a third party which exists or is available apart from that Act.

 

17                                  INVALIDITY

 

If at any time
any provision of this Deed is or becomes illegal, invalid or unenforceable in
any respect under the law of any jurisdiction, that shall not affect or impair
the legality, validity or enforceability in that jurisdiction of any other
provision of the Deed nor the legality, validity or enforceability in any other
jurisdiction of that or any other provision of this Deed.

 

18                                  COUNTERPARTS

 

This Deed may be signed in any number of
counterparts, each of which, when executed and delivered, shall be an original
and all of which together evidence the same agreement/deed.

 

IN WITNESS whereof this deed has been duly executed and is intended to be and
is delivered on the date first above written.

 

13

 

	
  SIGNED and delivered as a Deed

  	
  )

  	
   

  
	
  by

  	
  )

  	
   

  
	
  as attorney
  for

  	
  )

  	
   

  
	
  ELAN CORPORATION, PLC.

  	
  )

  	
   

  
	
  in the
  presence of:

  	
  )

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Signature of
  witness

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SIGNED and delivered as a Deed

  	
  )

  	
   

  
	
  by

  	
  )

  	
   

  
	
  as attorney
  for

  	
  )

  	
   

  
	
  ELAN PHARMA INTERNATIONAL

  	
  )

  	
   

  
	
  LIMITED

  	
  )

  	
   

  
	
  in the
  presence of:

  	
  )

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Signature of
  witness

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  The Common
  Seal of

  	
  )

  	
   

  
	
  ELAN INTERNATIONAL

  	
  )

  	
   

  
	
  SERVICES, LTD.

  	
  )

  	
   

  
	
  was hereunto
  affixed in the presence of:

  	
  )

  	
   

  
	
   

  	
   

  	
   

  
	
  Director      

  	
   

  
	
   

  	
   

  
	
  Director / Secretary      

  	
   

  

 

14

 

	
  EXECUTED and delivered as a Deed by:

  
	
  ELAN PHARMACEUTICALS, INC.

  
	
   

  
	
   

  	
   

  
	
  Name:

  
	
  Title:

  
	
   

  
	
   

  
	
  SIGNED and delivered as a Deed

  	
  )

  	
   

  
	
  by

  	
  )

  	
   

  
	
  as attorney
  for

  	
  )

  	
   

  
	
  MONKSLAND HOLDINGS BV

  	
  )

  	
   

  
	
  in the
  presence of:

  	
  )

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Signature of
  witness

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  EXECUTED AND DELIVERED

  
	
  AS A DEED by AMARIN
  CORPORATION PLC

  
	
  acting by:

  
	
   

  
	
   

  
	
  Signature of Director

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Print name of Director

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Signature of Director/Secretary

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Print name of Director/Secretary

  	
   

  	
   

  
							

 

15

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