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


 


10