Exhibit 4.40


 


 


	
  Attn: Mr. R.
  Stewart

  Chief Executive Officer

  Amarin Corporation plc

  7 Curzon Street

  London W1J 5HG

  England

  	
  23 December
  2003

  



 


Dear Rick


 


ZelaparTM


 


Amended and
Restated Option Agreement between Elan Pharma International Limited (“Elan”)
and Amarin Corporation plc. (“Amarin”), 4 August 2003 (the “Zelapar Agreement”)


 


This letter
sets out the terms on which Elan and Amarin have agreed to amend the Zelapar
Agreement and to conduct their respective business in relation to Zelapar (the
“Product”).


 


1.                                           Interpretation


 


In this
letter:


 


1.1.                                   “Amarin Development Period” shall have the meaning in Clause 5
of this letter.


 


1.2.                                   “Amendment Date” shall mean 23 December 2003.


 


1.3.                                   Other expressions used shall have the same meaning as in the Zelapar
Agreement, and this letter is to be interpreted in the same manner as the
Zelapar Agreement.


 


1.4.                                   Except as expressly stated, references to section numbers are to
those of the Zelapar Agreement.


 


2.                                           Amendments To The Zelapar Agreement


 


The Zelapar
Agreement is hereby amended with effect from the Amendment Date, as follows:


 


2.1.                                   Each reference to the “Master Agreement” is deemed to mean the
Master Agreement as amended by the Amendment Agreement between Elan
Corporation, plc., Elan, Elan International Services, Ltd., Elan
Pharmaceuticals, Inc., Monksland Holdings BV and Amarin made on the Amendment
Date.


 


2.2.                                   The following new Section 1.1.4A is inserted:


 

















 


“1.1.4A                                                   “Letter Agreement” shall mean the letter agreement between Elan
and Amarin relating to the Product, dated 23 December 2003.”


 


2.3.                                   Section 3.2 (Option Period) is deleted and the following substituted
therefor:


 


“3.2                      Option Period.  The “Option Period” shall mean the period
commencing on the date of this Agreement and ending on the sooner of:


 


(a)                             the date on which Elan or any of its Affiliates which are a party to
the Master Agreement have received a total between them of:


 


(i)             US$30,000,000 (thirty million dollars) if before 31 December 2003;
or


 


(ii)          US$31,500,000 (thirty one million five hundred thousand dollars) if
thereafter —


 


pursuant to
Clauses 7 and 8 of the Master Agreement or otherwise expressed to be in
discharge of the Outstanding Amounts (as defined in the Master Agreement);and


 


(b)                            31 March 2004.”


 


2.4.                                   Each of Sections 3.5 (Pursuit of New Drug Application), 4.3 (Project
Team) and 4.4 (Expenses) is amended by the insertion immediately after their
respective caption of the words:


 


“Subject to
the Letter Agreement, “


 


2.5.                                   Section 4.2 is amended by the insertion at the end of the following
sentence:


 


“Each
provision of this Section 4.2 is subject to any contrary provision of the
Letter Agreement.”


 


2.6.                                   Section 4.5(a) is amended by the deletion of the words “Out Of
Pocket Expenses of Elan” and the substitution therefor of the words “Out Of
Pocket Costs of Elan”, it being acknowledged that the existing language was a
typographical error.


 


2.7.                                   In Section 8.2 (Termination), the date “31 December 2003” is amended
to read “31 March 2004”.


 


2.8.                                   Section 10.3 (Assignment) is deleted in its entirety and the
following substituted therefor:


 

















 


“10.3                Assignment. Subject to Elan’s rights of
termination in Section 8.4 and Section 9, neither party shall assign its
rights or obligations under the Agreement without the prior written consent of
the other party hereto; provided, however, that:


 


10.3.1                         Elan may, without such consent, assign the Agreement and its rights
and obligations hereunder to an affiliate or in connection with the sale of
substantially all of its assets or business relating to the Product (without
prejudice to any other right to assign specific rights hereunder;


 


10.3.2                         either party may, without such consent, assign the Agreement and its
rights and obligations hereunder in connection with its merger or consolidation
or change in control or similar transaction (again subject to Elan’s right in
the event of an Amarin Change of Control); and


 


10.3.3                         Amarin may not assign the Agreement on a sale of substantially all
of its assets or business, but in such circumstances, at Amarin’s option, Elan
may enter into good faith negotiations with the intended purchaser with a view
to the Assignment Agreement being executed in favour of such purchaser.  In such circumstances, the milestone payment
referred to in Section 7.1 shall be payable in cash instead of ordinary shares,
and the other terms of the Assignment Agreement shall be determined in
accordance with Section 3.1.


 


Provided
further in each case that any permitted
assignee assumes in writing all obligations of its assignor under this
Agreement, and that any assignment is subject to the Scherer Agreement and any
consent that may be required thereunder.”


 


3.                                           Amarin To Conduct Development


 


During the
Amarin Development Period:


 


3.1.                                   As between Elan and Amarin, Amarin shall be solely responsible for
the further development of the Product.


 


3.2.                                   Amarin shall use Commercially Reasonable Efforts to diligently
pursue the preparation, submission, acceptance for filing and substantive
review, and approval of an NDA for the Product with the FDA, including interaction
with the FDA.


 

















 


3.3.                                   To the extent that Elan’s obligations in respect of the development
of the Product pursuant to the Scherer Agreement exceed those of Amarin under
the Zelapar Agreement and this letter, Amarin shall on Elan’s behalf do such
acts and exercise such diligence as is required by the Scherer Agreement.


 


3.4.                                   No meetings of the Steering Committee shall take place.


 


3.5.                                   The Plan may be amended by Amarin with Elan’s consent, which shall
not be unreasonably withheld.  For the
avoidance of doubt, Amarin will perform and manage the day to day execution and
operations of the Plan.


 


3.6.                                   Amarin will keep Elan reasonably appraised of its activities in
relation to the Product.  Amarin will
provide to Elan all materials provided to Amarin’s Project Team for Zelapar.


 


3.7.                                   All development work in relation to the Product shall be at Amarin’s
sole cost and expense.


 


4.                                               Exclusions


 


Notwithstanding
Clause 3 of this letter, Amarin shall not:


 


4.1.                                   commence any clinical study; or


 


4.2.                                   enter into any binding commitment pursuant to which Elan may, by
reason of law and/or good ethical practice, become compelled to honor any part
of such commitment after the Amarin Development Period —


 


without the
prior written consent of Elan.


 


5.                                           Amarin Development Period


 


5.1.                                   The Amarin Development Period shall begin on 1 January 2004 and end
on 31 January 2004.


 


5.2.                                   The Amarin Development Period shall be automatically extended to 29
February 2004 and 31 March 2004 unless either Amarin or Elan give written
notice not less than three (3) business days before each such date to the
contrary.  The Amarin Development Period
shall not be extended beyond 31 March 2004.


 


5.3.                                   Notwithstanding Clauses 5.1 and 5.2 of this letter, the Amarin
Development Period shall automatically terminate on the termination of the
Option, and no extensions shall apply.


 

















 


5.4.                                   Following the end of the Amarin Development Period, the parties
shall revert to their status as it would have been under the Zelapar Agreement
as amended by Clause 2 of this letter.


 


6.                                           Warranties, Indemnities and Liability


 


6.1.                                   Amarin represents and warrants to Elan that:


 


6.1.1                             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 letter and any ancillary
documents pertaining thereto (together “Transaction Documents”), and its
obligations under the Transaction Documents are valid, legally binding and
enforceable according to their terms, including obtaining all necessary
approvals and consents from its shareholders and any third parties;


 


6.1.2                             there are no agreements between Amarin and any third party that
conflict with the Transaction Documents;


 


6.1.3                             it does not require any further consents or approvals to consummate
the transaction contemplated by the Transaction Documents including:


 


6.1.3.1                           approval of its shareholders; or


 


6.1.3.2                           approval of NASDAQ.


 


6.2.                                   Default by Amarin under any of the provisions of this letter shall
be deemed a default under the Zelapar Agreement and shall have the consequences
set out in the Zelapar Agreement.


 


6.3.                                   Amarin and Elan shall indemnify and hold harmless the other from and
against all costs, claims, loss, damage and expense incurred or arising out of
any breach by the indemnifying party of its obligations under this letter or
negligence after the Amendment Date. 
Without prejudice to the generality of the foregoing, Amarin shall
indemnify and hold harmless Elan against all such costs, claims, loss, damage
and expense by reason of any default of Elan under the Scherer Agreement to the
extent attributable to Amarin’s default or negligence after the Amendment Date.


 


6.4.                                   Amarin acknowledges that as of the Amendment Date, it is not aware
of any breach by Elan of the Zelapar Agreement.  Each extension of the Amarin Development Period shall be deemed
an acknowledgement by Amarin as of the last day on which Amarin could give
notice not to extend the Amarin Development Period, that it is not


 

















 


aware of any
breach by Elan of the Zelapar Agreement including any breach of the provisions
of this letter.


 


7.                                           Miscellaneous Provisions


 


7.1.                                   Assignment:


 


7.1.1                             Elan may assign its rights and obligations under this letter to a
valid assignee of the Zelapar Agreement.


 


7.1.2                             Amarin may not assign its rights or obligations under this letter,
but without prejudice to the amendments to the Zelapar Agreement effected by
Clause 2 of this letter.


 


7.2.                                   Scherer Consent:


 


To the extent
that the consent of RP Scherer Corporation may be needed to this letter, and/or
to effect the transaction hereby contemplated, the parties shall reasonably
cooperate with each other with a view to securing such consent and further (at
Elan’s option) Amarin shall use its best efforts to secure such consent.


 


7.3.                                   Application of Provisions:


 


Sections 5
(Confidentiality) and 10 (Miscellaneous) of the Zelapar Agreement shall apply
to this letter mutatis mutandis.


 


***


 

















 


Please have a
duplicate of this letter executed by a duly authorised representative of Amarin
to indicate that you are in agreement with the proposed terms.


 


 


Yours
sincerely


 


 


Duly
authorised for and on behalf of


Elan Pharma
International Limited


 


 


	
   

  	
  Accepted and
  agreed to by:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Duly
  authorised for and on behalf of

  
	
   

  	
  Amarin Corporation plc.

  
	
   

  	
   

  
	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
  Date:

  	
   

  	
   

  
					



 


 


[Signature
Page to Zelapar Letter]