Document:

Exhibit 4.34

 

Date:  4th
August 2003

 

 

ELAN PHARMACEUTICALS INC.

 

AND

 

AMARIN CORPORATION PLC.

 

 

DEED OF VARIATION NO. 2

RELATING TO

AMENDED AND RESTATED

DISTRIBUTION, MARKETING AND OPTION AGREEMENT

DATED 28 SEPTEMBER 2001

(PERMAX®)

 

 

INDEX

 

	
  1.

  	
  DEFINITIONS AND
  INTERPRETATION

  	
   

  
	
   

  	
   

  	
   

  
	
  2.

  	
  INTRODUCTION

  	
   

  
	
   

  	
   

  	
   

  
	
  3.

  	
  VARIATIONS

  	
   

  
	
   

  	
   

  	
   

  
	
  4.

  	
  CONFIRMATION OF THE AGREEMENT

  	
   

  
	
   

  	
   

  	
   

  
	
  5.

  	
  EXECUTION
  AND DELIVERY

  	
   

  
	
   

  	
   

  	
   

  
	
  6.

  	
  MISCELLANEOUS

  	
   

  

 

 

THIS DEED OF
VARIATION NO. 2 is made the 4th August 2003

 

BETWEEN:

 

(1)                                 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 (“Elan”);
and

 

(2)                                 AMARIN CORPORATION PLC, a company incorporated in
England and Wales (registered no. 002353920), whose registered office is 7
Curzon Street, London, W1J 5HG England (“Amarin”).

 

WHEREAS:

 

(A)                              Elan and Amarin entered into
an Amended and Restated Distribution, Marketing and Option Agreement between
Elan and Amarin dated 28 September 2001 (“Original Agreement”).

 

(B)                                Elan and Amarin entered into a
Waiver and Amendment dated 8 August 2002. 
A condition therein not having been fulfilled, such Waiver and Amendment
was not effective, as Elan and Amarin hereby acknowledge.

 

(C)                                Elan and Amarin also entered
into an assignment and assumption Agreement effective as of 29 March, 2002 as a
part of the consummation of Amarin’s exercise of its option right for Permax.

 

(D)                               Elan and Amarin further
entered into a Deed of Variation dated 27 January 2003.  The Original Agreement as amended by that
Deed of Variation is referred to herein as the “Agreement”.

 

(E)                                 Elan Corporation, plc., Elan
Pharma International Limited, Elan International Services Limited, Elan,
Monksland Holdings BV and Amarin have entered into an Amended and Restated
Master Agreement of even date herewith (the “Master Agreement”).

 

(F)                                 Pursuant to the Master
Agreement, Amarin and Elan have agreed to amend the Agreement by and upon the
terms of this Deed.

 

NOW
THIS DEED WITNESSES AS FOLLOWS:

 

1.                                           DEFINITIONS AND INTERPRETATION

 

1.1.                                   Unless the context otherwise
requires, all other words and expressions defined in the Agreement shall have
the same meaning in this Deed.

 

1.2.                                   Reference to articles,
sections, clauses and paragraphs herein are to articles, sections, clauses and
paragraphs in the Agreement.

 

2.                                           INTRODUCTION

 

This
Deed is supplemental to the Agreement.

 

1

 

3.                                           VARIATIONS

 

The
parties to this Deed agree that with effect from the date hereof the Agreement
shall be varied as follows:

 

3.1.                                   by the insertion into
Section 1.01 of the following additional definitions:

 

“ “Elan Agreement(s)” shall have the same
meaning as in the Master Agreement.”

 

“ “Master Agreement” shall mean that certain
Amended and Restated Master Agreement dated • July 2003 between Elan
Corporation, plc., Elan Pharma International Limited, Elan International
Services Limited, Elan, Monksland Holdings B.V. and Amarin.”

 

3.2.                                   by the deletion of
Section 3.01(c)(ii) in its entirety and the substitution therefor of the
following:

 

“(ii)                       thereafter, subject to Clauses
5, 7 and 8 of the Master Agreement, at quarterly intervals (the first being
three calendar months after the Purchase Closing), successive payments of Two
Million Five Hundred Thousand Dollars ($2,500,000.00) until such time as the
entire Total Divestiture Amount has been paid.”

 

3.3.                                   by the insertion into
Section 3.01 of the following new Section 3.01(dd):

 

“(dd)               Acceleration (Demand).  Further, notwithstanding paragraph (c) above, upon written demand
by Elan made either (a) on or after the Demandable Date, as that expression is
defined in the Master Agreement, or (b) if Amarin breaches any Elan Agreement
and does not remedy it within thirty (30) days of written notice of such breach
from Elan specifying in reasonable detail the nature of the breach and
requesting the same to be remedied, on or after the expiry of such thirty (30)
day period – the entire balance of the Total Divestiture Amount then
undischarged shall become immediately due and payable.”;

 

3.4.                                   by the insertion into
Section 3.01(e) immediately before the words “Amarin shall pay ...” of the
words “subject to Section 3.01(ee),”; and

 

3.5.                                   by the deletion of
Section 3.01(ee) in its entirety and the substitution therefor of the
following:

 

“(ee)                 Right To Redeem.  At any time after • July 2003, Amarin may
terminate its obligation to pay the Royalty set out in
Section 3.01(e).  Such option may
be exercised by giving Elan written notice and by paying to Elan the sum of
seven hundred thousand Dollars ($700,000) by wire transfer in immediately
available funds, and will not be considered validly exercised until both such
notice is given and such payment is duly made (“Royalty Termination Date”).  Termination of the Royalty obligation under
this Section 3.01(ee) will not affect Amarin’s obligations in respect of
Net Sales of the Product in the Territory up to and including the Royalty
Termination Date, and Amarin shall not be entitled to any credit of Royalty
paid

 

2

 

before the Royalty Termination Date against
the sum of One Million Dollars or any other amount.”

 

4.                                           CONFIRMATION OF THE AGREEMENT

 

Save as
varied by this Deed, the parties hereto confirm that the Agreement shall
continue in full force and effect in all respects.

 

5.                                           EXECUTION AND DELIVERY

 

5.1.                                   Each of the parties to this
document intends it to be a Deed and agrees that upon it being dated it shall
be treated as having been delivered as a Deed.

 

5.2.                                   The signing of this Deed by or
on behalf of the parties hereto shall constitute an authority to their
respective solicitors (or any of them) or any agent or an employee of them to
date it as a Deed on behalf of the parties.

 

6.                                           MISCELLANEOUS

 

The
provisions of Article 13 (Miscellaneous) of the Agreement shall be
incorporated into this Deed mutatis mutandis.

 

IN WITNESS whereof the parties have
executed and delivered this Deed the date first above written.

 

3

 

[Signature Page: Permax
Amendment No. 2]

 

 

	
  EXECUTED as a DEED by

  	
  )

  	
   

  
	
  AMARIN CORPORATION PLC

  	
  )

  	
   

  
	
  acting by:-

  	
  )

  	
   

  
	
   

  	
   

  
	
  Director

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Director/Secretary

  	
   

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  EXECUTED as a DEED by

  	
  )

  	
   

  
	
  ELAN PHARMACEUTICALS, INC.

  	
  )

  	
   

  
	
  acting by:-

  	
  )

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  
								

 

4Exhibit 4.35

 

EXECUTION COPY

 

Date: 4 August 2003

 

 

AMARIN CORPORATION PLC.

 

AND

 

ELAN PHARMA INTERNATIONAL LIMITED

 

 

DEED OF VARIATION NO. 4

RELATING TO

LOAN AGREEMENT DATED 28 SEPTEMBER 2001 AS AMENDED

 

 

INDEX

 

	
  1.

  	
  DEFINITIONS AND
  INTERPRETATION

  	
   

  
	
   

  	
   

  	
   

  
	
  2.

  	
  INTRODUCTION

  	
   

  
	
   

  	
   

  	
   

  
	
  3.

  	
  VARIATIONS

  	
   

  
	
   

  	
   

  	
   

  
	
  4.

  	
  CONFIRMATION OF THE
  AGREEMENT

  	
   

  
	
   

  	
   

  	
   

  
	
  5.

  	
  EXECUTION
  AND DELIVERY

  	
   

  
	
   

  	
   

  	
   

  
	
  6.

  	
  MISCELLANEOUS

  	
   

  

 

 

THIS DEED OF
VARIATION NO. 4 is made the 4th August 2003

 

BETWEEN:

 

(1)                                 AMARIN CORPORATION PLC, a company incorporated in
England and Wales (registered no. 002353920), whose registered office is 7
Curzon Street, London, W1J 5HG England (“Amarin”); and

 

(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 (“Elan Pharma”).

 

WHEREAS:

 

(A)                              Amarin and Elan Pharma entered
into a Loan Agreement dated 28 September 2001.

 

(B)                                The said Loan Agreement was
amended by a Deed of Variation dated 19 July 2002, a Deed of Variation No.
2 dated 23 December 2002 and a Deed of Variation No. 3 dated 27
January 2003.

 

(C)                                Elan Corporation, plc., Elan
Pharma, Elan International Services Limited, Elan Pharmaceuticals, Inc.,
Monksland Holdings BV and Amarin have entered into an Amended and Restated
Master Agreement of even date herewith (the “Master Agreement”).

 

(D)                               Pursuant to the Master
Agreement, Amarin and Elan Pharma have agreed to amend the Agreement by and
upon the terms of this Deed.

 

NOW
THIS DEED WITNESSES AS FOLLOWS:

 

1.                                           DEFINITIONS AND INTERPRETATION

 

1.1.                                   In this Deed, the “Agreement”
shall mean the Loan Agreement between Amarin and Elan Pharma dated 28
September 2001, as amended by the Deed of Variation dated 19
July 2002 and further amended by the Deed of Variation No. 2 dated 23
December 2002 and the Deed of Variation No. 3 dated 27 January 2003.

 

1.2.                                   Unless the context otherwise
requires, all other words and expressions defined in the Agreement shall have
the same meaning in this Deed.

 

1.3.                                   Reference to clauses herein
are to clauses in the Agreement.

 

2.                                           INTRODUCTION

 

This
Deed is supplemental to the Agreement.

 

1

 

3.                                           VARIATIONS

 

The
parties to this Deed agree that with effect from the date hereof the Agreement
shall be varied as follows:

 

3.1.                                   Clause 1 (Definitions and
Interpretation) shall be varied by the addition of the following definitions:

 

“ “Demandable Date” shall have the same
meaning as in the Master Agreement.”

 

“ “Elan Agreement(s)” shall have the same
meaning as in the Master Agreement.”

 

“ “Master Agreement” shall mean that certain
Amended and Restated Master Agreement dated 4 August 2003 between Elan
Corporation, plc., Elan Pharma, Elan International Services, Ltd., Elan
Pharmaceuticals, Inc., Monksland Holdings B.V. and Amarin.”

 

3.2.                                   Clause 2.3 (Interest) shall be
varied by the deletion of the final sentence and the substitution therefor of
the following:

 

“Subject to Clause 5 of the Master
Agreement, such interest shall be payable in arrears on the last day of each
Interest Period without any set-off, counterclaim, withholding or deduction for
any reason whatsoever except as required by law.”

 

3.3.                                   Clause 2.4 (Repayment) shall
be varied so it reads:

 

“Repayment

 

Subject to Clauses 7 and 8 of the Master
Agreement, the Loan shall be repaid by Amarin to Elan Pharma (or as it may
direct) in the following amounts on the following dates:

 

2.4.1                   US$2,500,000 on 22 July 2002 (together
with all interest thereon as calculated pursuant to clause 2.3);

 

2.4.2                   US$17,500,000 (together with all interest
thereon as calculated pursuant to clause 2.3) on 30 September 2002;

 

2.4.3                   US$10,000,000 (together with all interest
thereon as calculated pursuant to clause 2.3) on the sooner of (a) 30
September 2004 and (b) written demand made by Elan Pharma at any time on
or after the Demandable Date;

 

2.4.4                   US$15,000,000 (together with all interest
thereon as calculated pursuant to clause 2.3) on the sooner of (a) 30
September 2005 and (b) written demand made by Elan Pharma at any time on
or after the Demandable Date.

 

in each case without any set-off,
counterclaim, withholding or deduction for any reason whatsoever except as
required by law.”

 

3.4.                                   Clause 4 shall be varied by:

 

2

 

3.4.1                             the replacement of the reference
to Clause 4.5A with a reference to Clause 4.5B; and

 

3.4.2                             the addition of the following
Clause 4.5B between clauses 4.5A and 4.6:

 

“4.5B         Default
on Other Agreement

 

Amarin materially breaches any Elan
Agreement, which breach is not remedied within 30 (thirty) days of Elan Pharma
giving written notice to Amarin of such breach.”

 

4.                                           CONFIRMATION OF THE AGREEMENT

 

Save as
varied by this Deed, the parties hereto confirm that the Agreement shall
continue in full force and effect in all respects.

 

5.                                           EXECUTION AND DELIVERY

 

5.1.                                   Each of the parties to this
document intends it to be a Deed and agrees that upon it being dated it shall
be treated as having been delivered as a Deed.

 

5.2.                                   The signing of this Deed by or
on behalf of the parties hereto shall constitute an authority to their
respective solicitors (or any of them) or any agent or an employee of them to
date it as a Deed on behalf of the parties.

 

6.                                           MISCELLANEOUS

 

6.1.                                   This Deed may be executed in
several counterparts and upon due execution of all such counterparts by one or
more parties, each counterpart shall be deemed to be an original hereof.

 

6.2.                                   The provisions of Clauses 5
(Further Assurance), 6 (General), 7 (Assignment), 8 (Notices) and 9 (Governing
Law, Jurisdiction) of the Agreement shall be incorporated into this Deed
mutatis mutandis.

 

IN WITNESS whereof the parties have
executed and delivered this Deed the date first above written.

 

3

 

[Signature Page: Loan
Amendment No. 4]

 

	
  EXECUTED as a DEED by

  	
  )

  	
   

  	
   

  
	
  AMARIN CORPORATION PLC

  	
  )

  	
   

  	
   

  
	
  acting by:-

  	
  )

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Director

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Director/Secretary

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SIGNED AND DELIVERED AS
  A DEED

  	
   

  	
   

  
	
  by ELAN
  PHARMA INTERNATIONAL

  	
   

  	
   

  	
   

  
	
  LIMITED a company incorporated in
  Ireland acting

  by

  	
   

  	
   

  	
   

  
	
  (being
  [a person] [persons] who, in accordance with the laws of that country,
  [is/are] acting under the authority of the company) in the presence of:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Witness:

  	
   

  	
   

  	
   

  
	
  Signature

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Address

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Occupation

  	
   

  	
   

  	
   

  
							

 

4

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