exv4w65



 







    Exhibit 4.65



 




    Execution
    version



 



    DATED 17 MAY 2006



 



    (1) AMARIN PHARMACEUTICALS IRELAND LIMITED



 



    AND



 



    (2) DR ANTHONY CLARKE



 





 



    ASSIGNMENT AGREEMENT



 





 



    MATHESON ORMSBY PRENTICE




    30 Herbert Street




    Dublin 2




    Ireland



 












 







    CONTENTS



 


	 	 	 	 	 	 	 
	

    1
    


	
 
	
    Definitions
    
	
 
	
	
    3
    
	

	

    2
    


	
 
	
    Assignment
    
	
 
	
	
    6
    
	

	

    3
    


	
 
	
    Developer  Know-How/Developer
    Improvements
    
	
 
	
	
    7
    
	

	

    4
    


	
 
	
    Development Work
    
	
 
	
	
    7
    
	

	

    5
    


	
 
	
    Payments
    
	
 
	
	
    7
    
	

	

    6
    


	
 
	
    Developer Licence Agreements
    
	
 
	
	
    9
    
	

	

    7
    


	
 
	
    Warranties
    
	
 
	
	
    9
    
	

	

    8
    


	
 
	
    Indemnification
    
	
 
	
	
    9
    
	

	

    9
    


	
 
	
    Patent Prosecution and Maintenance
    
	
 
	
	
    10
    
	

	

    10
    


	
 
	
    Regulatory Matters
    
	
 
	
	
    11
    
	

	

    11
    


	
 
	
    Simbec Study Agreement
    
	
 
	
	
    11
    
	

	

    12
    


	
 
	
    Confidential
    Information/Announcements
    
	
 
	
	
    11
    
	

	

    13
    


	
 
	
    Payments, Reports and Audits
    
	
 
	
	
    12
    
	

	

    14
    


	
 
	
    Change of Control
    
	
 
	
	
    13
    
	

	

    15
    


	
 
	
    Miscellaneous
    
	
 
	
	
    14
    
	

	
 
	
 
	
	
 
	 
	

    Schedule 1 — Developer
    Patents
    


	
 
	
	
    18
    
	










    

    2








 





 




    THIS
    ASSIGNMENT AGREEMENT
    (this
    “Agreement”) dated 17 May 2006
    



 




    BETWEEN:



 


		
	    (1) 
	    AMARIN PHARMACEUTICALS IRELAND LIMITED, a company
    incorporated under the laws of Ireland having its principal
    place of business at 50 Pembroke Road, Ballsbridge, Dublin 4
    (“Amarin”); and

	 
	    (2) 
	    DR ANTHONY CLARKE of Scots Grove House, Uxmore Road,
    Checkendon, Oxfordshire RG8 0TD (“Developer”).




 




    RECITALS



 


		
	    A. 	
    The parties have entered into an Option Agreement dated
    23 February 2006 and a Development and Option Agreement
    dated 21 April 2006 whereby, inter alia, Developer granted
    Amarin an exclusive option to conclude this Agreement.




 


		
	    B. 	
    Developer and Amarin have agreed that Developer will assign and
    transfer to Amarin the Developer Intellectual Property.




 




    NOW, IT
    IS HEREBY AGREED AS
    FOLLOWS
    in consideration of the mutual covenants contained herein:
    



 




    1     DEFINITIONS



 



    “Affiliate” shall mean a corporation or entity
    controlling, controlled by, or under the common control with
    Amarin or Developer, as the case may be. For the purposes of
    this Agreement, “control” shall mean the direct or
    indirect ownership of more than 50% of the issued voting shares
    or other voting rights of the subject entity to elect directors,
    or if not meeting the preceding criteria, any entity owned or
    controlled by or owning or controlling at the maximum control or
    ownership right permitted in the country where such entity
    exists.



 



    “Amarin Milestone Payments” shall mean the
    milestone payments payable by Amarin to the Developer in
    accordance with Clause 5.3.



 



    “Change of Control of Amarin” shall mean with
    respect to either Amarin or Amarin Corporation plc (a) a
    sale, transfer or disposal of all or substantially all of such
    company’s assets or business to a third party which is not
    a direct or indirect subsidiary of Amarin Corporation plc or
    (b) a change in voting control of 50% or more of the
    outstanding voting securities of such company to a third party
    which is not a direct or indirect subsidiary of Amarin
    Corporation plc.



 



    “Claims” shall mean all and any claims (whether
    successful or otherwise), loss, liability, damages and expenses,
    including reasonable attorneys’ fees and expenses and legal
    costs.



 



    “Compound” shall mean apomorphine
    and/or all
    derivatives of apomorphine.



 



    “Confidential Information” shall mean know-how,
    trade secrets, inventions (including patent applications
    covering such inventions), data, information, and any
    improvements, modifications, derivations, or compilations
    thereto that is owned, licensed by or controlled by the
    disclosing party, provided however, that Confidential
    Information shall not include any information which is:



 


			
	 	    (i) 
	
    already known to the receiving party at the time of disclosure,
    as evidenced by such party’s written records, provided such
    information was not obtained directly or indirectly by the
    receiving party from the disclosing party pursuant to a
    confidentiality agreement;




 


			
	 	    (ii) 
	
    publicly known prior to or after disclosure, through no default
    of the receiving party;




 


			
	 	    (iii) 
	
    disclosed in good faith to the receiving party by a third party,
    lawfully and contractually entitled to make such
    disclosure; or




 


			
	 	    (iv) 
	
    is independently discovered without the aid or application of
    the Confidential Information as shall be evidenced by the
    written records of the receiving party.




 



    “Consideration” shall mean the Initial
    Consideration, the Amarin Milestone Payments and the Royalties.




    

    3








 





 



    “Consideration Period” shall mean the period
    commencing on the Effective Date and expiring on a product by
    product and country by country basis:



 


			
	 	    (i)  
	
    on the 20th anniversary of the date of the launch of the
    Developer Invention in the country concerned; or

	 
	 	    (ii) 
	
    in any country upon the expiry of the life of the last to expire
    patent included in the Developer Intellectual Property which
    covers the Developer Invention in that country;




 



    whichever date is the later to occur.



 



    “Developer” shall mean Dr Anthony Clarke and
    any of his Affiliates.



 



    “Delivery Kit” shall mean a two compartment
    device where one compartment contains an acidic solution of the
    Compound and the second compartment contains an alkaline
    solution, as described in the Developer Patents.



 



    “Developer Intellectual Property” shall mean
    the Developer Patents, Developer Know-How, Developer Patent
    Improvements and Developer Improvements.



 



    “Developer Improvements” shall mean any and all
    improvements to the Developer Know-How
    and/or
    Developer Invention
    and/or the
    Compound
    and/or any
    Other Apomorphine Product that have been conceived, created,
    developed
    and/or
    otherwise invented solely by, or by a third party on behalf of,
    the Developer at any time after the Effective Date.



 



    “Developer Invention” shall mean an invention
    relating to a pharmaceutical formulation of the Compound for
    buccal administration comprising a Delivery Kit, the Compound
    and a buffered solvent, as more fully described in the
    Developer’s Patents.



 



    “Developer Know-How” shall mean any and all
    rights owned, licensed or controlled by the Developer to any
    scientific, pharmaceutical or technical information, data,
    discovery, invention (whether patentable or not), know-how,
    substances, techniques, processes, systems, formulations,
    designs and expertise relating to the Developer Invention
    and/or the
    Compound
    and/or any
    Other Apomorphine Product which is not generally known to the
    public.



 



    “Developer Patents” shall mean any and all
    rights under any and all patent applications
    and/or
    patents, now existing, currently pending or hereafter filed or
    obtained or licensed by Developer relating to the Developer
    Invention
    and/or the
    Compound
    and/or any
    Other Apomorphine Product, including but not limited to those
    set forth in Schedule 1, and any foreign counterparts
    thereof and ail divisionals, continuations,
    continuations-in-part,
    any foreign counterparts thereof and all patents issuing on any
    of the foregoing, and any foreign counterparts thereof, together
    with all registrations, reissues, re-examinations, supplemental
    protection certificates, or extensions thereof, and any foreign
    counterparts thereof.



 



    “Developer Patent Improvements” shall mean any
    and all improvements to the Developer Patents that have been
    conceived, created, developed
    and/or
    otherwise invented solely by, or by a third party on behalf of,
    the Developer at any time after the Effective Date.



 



    “Effective Date” shall mean the date of this
    Agreement.



 



    “EU” shall mean the Member States of the
    European Union, as same may change from time to time in terms of
    Member States.



 



    “EU Regulatory Application” shall mean any
    regulatory application or any other application for approval to
    market the Developer Invention in any Member State of the EU,
    which Amarin may file in any Member State of the EU, including
    any supplements or amendments thereto which Amarin may file.



 



    “EU Regulatory Approval” shall mean the final
    approval to market the Developer Invention in any Member State
    of the EU, including pricing and reimbursement approval and any
    other approval which is required to launch the Developer
    Invention in the normal course of business.



 



    “Field” shall mean all indications of any
    nature.




    

    4








 





 



    “FDA” shall mean the United States Food and
    Drug Administration or any other successor agency whose approval
    is necessary to market the Developer Invention in the USA.



 



    “In Market” means the sale of a Developer
    Invention by Amarin to an unaffiliated third party, such as a
    wholesaler, managed care organisation, hospital or pharmacy.



 



    “Initial Consideration” shall mean the initial
    consideration payable by Amarin to the Developer in accordance
    with Clause 5.2.



 



    “Intellectual Property Rights” shall mean all
    patents, patent applications, copyrights, copyright
    applications, trademarks, trade secrets, know-how and other
    intellectual property rights.



 



    “Licence Agreement” shall mean any licence
    agreement or
    sub-licence
    agreement entered into by Amarin with a third party whereby a
    licensee or a
    sub-licensee,
    as applicable, will sell the Developer Invention in the
    Territory in the Field.



 



    “Major EU Country” shall mean any one of UK,
    France, Germany, Italy and Spain.



 



    “NDA” shall mean a New Drug Application filed
    with the FDA, including any supplements or amendments thereto
    which may be filed.



 



    “NDA Approval” shall mean the final approval of
    an NDA by the FDA to market a product in the USA.



 



    “Net Sales” means aggregate sales amounts
    recognised by Amarin from sales by Amarin of the Developer
    Invention in Market in accordance with the prevailing
    consistently applied generally accepted accounting principles
    applicable to Amarin (“GAAP”), less reasonable
    and customary deductions from such gross amounts as actually
    paid or accrued for by Amarin including, without limitation the
    following:



 


			
	 	    (a) 
	
    trade, cash and quantity discounts allowed, or provided for, and
    taken directly with respect to such sales;




 


			
	 	    (b) 
	
    amounts repaid, credits or allowances granted, or provided for,
    for damaged goods, defects, recalls, returns or rejections of
    the Developer Invention and retroactive price reductions;




 


			
	 	    (c) 
	
    sales or similar taxes paid by or charged to the account of
    Amarin, or provided for, without offset (including, without
    limitation, duties or other governmental charges levied on,
    absorbed or otherwise imposed on the sale of the Developer
    Invention, value added taxes or other governmental charges
    otherwise measured by the billing amount, when included in
    billing, but not including national, state or local taxes based
    on income);




 


			
	 	    (d) 
	
    charge back payments and rebates granted, or provided for, to
    (i) managed health care organizations, (ii) federal,
    state and/or
    local governments or their agencies, (iii) purchasers and
    reimbursers, or (iv) trade customers, including, without
    limitation, wholesalers and chain and pharmacy buying groups;




 


			
	 	    (e) 
	
    freight, postage, shipping, customs duties and insurance charges
    to the extent included in the proceeds received from the
    customer; and




 


			
	 	    (f) 
	
    a deduction in respect of the costs of the Delivery Kit in an
    amount equal to the lesser of:




 


			
	 	    (i) 
	
    the amount payable by Amarin to a third party manufacturer in
    respect of the manufacture of the Delivery Kit for commercial
    sale (whether comprised of royalties or unit manufacturing
    costs); and




 


			
	 	    (ii) 
	
    5% of Net Sales,




 



    provided however that any payments by Amarin to a third party
    manufacturer which relate to the development of the Delivery Kit
    prior to the launch of the Developer Invention shall not be
    included in calculating this deduction hereunder.



 



    Any Developer Invention provided by Amarin free of charge, for
    administration to patients enrolled in clinical trials or
    distributed through a
    not-for-profit
    foundation at no charge to eligible patients




    

    5








 






    would not be included in Net Sales, provided that Amarin
    receives no cash consideration from such
    not-for-profit
    foundation or from such clinical trials or such use of the
    Developer Invention.



 



    Net Sales and any factors used in determining Net Sales shall be
    determined by Amarin in accordance with GAAP.



 



    “Other Apomorphine Product” shall mean any
    product incorporating the Compound, other than the Developer
    Invention.



 



    “Proof of Concept Study Data” shall mean all
    and any data generated pursuant to the Simbec Study Agreement.



 



    “Regulatory Application” shall mean any EU
    Regulatory Application, NDA,
    and/or any
    other regulatory application or other application for approval
    to market the Developer Invention
    and/or any
    Other Apomorphine Product in any country of the Territory, which
    Amarin may file in any country of the Territory, including any
    supplements or amendments thereto which Amarin may file.



 



    “Regulatory Approval” shall mean any EU
    Regulatory Approval, NDA Approval,
    and/or any
    other final approval to market the Developer Invention
    and/or any
    Other Apomorphine Product in any country of the Territory,
    including pricing and reimbursement approval and any other
    approval which is required to launch the Developer Invention
    and/or any
    Other Apomorphine Product in any country of the Territory in the
    normal course of business.



 



    “RHA” shall mean any relevant government health
    authority (or successor agency thereof) in any country of the
    Territory whose approval is necessary to market the Developer
    Invention
    and/or the
    Other Apomorphine Products in the relevant country of the
    Territory.



 



    “Royalty” or “Royalties” shall mean
    the royalties payable by Amarin to the Developer in accordance
    with Clause 5.4.



 



    “Simbec Study Agreement” shall mean the
    Clinical Research Agreement dated 5 April 2006 between
    Amarin, Amarin Neuroscience Ltd. and Simbec Research Ltd.



 



    “Territory” shall mean all countries of the
    world.



 



    “Third Party Royalties” shall mean all
    royalties received by Amarin pursuant to a Licence Agreement in
    respect of sales by a licensee or
    sub-licensee
    of the Developer Invention, having taken account of deductions
    in respect of any customs and excise duties or other sales taxes
    that are actually paid by Amarin (but, for the avoidance of
    doubt, not income or corporation tax), directly related to the
    receipt of such royalties by Amarin.



 



    “Third Party Milestone Payments” shall mean all
    upfront or milestone payments received by Amarin pursuant to a
    Licence Agreement in respect of the Developer Invention, having
    taken account of deductions in respect of any customs and excise
    duties or other sales taxes that are actually paid by Amarin
    (but, for the avoidance of doubt, not income or corporation
    tax), directly related to the receipt of such revenues by Amarin.



 



    ‘‘£” shall mean Pounds Sterling.



 



    “US” or “USA” shall mean the
    United States of America.



 



    “Valid Claim” means a claim of any issued,
    unexpired Developer Patent that has not been revoked or held
    unenforceable or invalid by a decision of a court or
    governmental agency of competent jurisdiction from which no
    appeal can be taken, or with respect to which an appeal is not
    taken within the time allowed for appeal, and that has not been
    disclaimed or otherwise rendered unenforceable.



 




    2   ASSIGNMENT



 


			
	 	    2.1  
	
    In consideration of the payment by Amarin to the Developer of
    the Consideration in accordance with the terms of this
    Agreement, the Developer as legal and beneficial owner, assigns
    to Amarin, its successors





    

    6








 





			
	 	
	
    and assigns, all its right, title and interest in and to the
    Developer Intellectual Property, together with all the rights of
    action, powers and benefits belonging to the same, including the
    right to sue for and obtain damages and other relief in respect
    of any infringement
    and/or any
    violation of any common law rights (whether past, present or
    future) of the Developer Intellectual Property and for Amarin,
    its successors and assigns, to hold, use, exercise and enjoy the
    same unto Amarin absolutely for the whole period of such rights
    for the time being capable of being assigned by the Developer
    together with any and all renewals, reversions and extensions
    throughout the world.




 


			
	 	    2.2  
	
    Without prejudice to the generality of Clause 15.10, the
    Developer will, upon the written request of Amarin, execute all
    such further assignments, transfers, deeds, documents or other
    assurances and do all further acts and things as Amarin may
    require in order to enable Amarin to become registered as the
    proprietor of the Developer Intellectual Property and otherwise
    to secure the benefit of the Developer Intellectual Property
    assigned under this Agreement.




 




    3   DEVELOPER
    KNOW-HOW / DEVELOPER IMPROVEMENTS



 


			
	 	    3.1  
	
    To the extent that the Developer is prohibited by statute or
    otherwise from assigning all current and future rights, title
    and interest in the Developer Know-How and the Developer
    Improvements to Amarin, the Developer hereby grants Amarin an
    exclusive, worldwide, perpetual, fully-paid, royalty-free,
    irrevocable licence (with the right to grant sublicenses) to the
    Developer Know-How and the Developer Improvements, and any
    Intellectual Property Rights therein for all purposes in the
    Field.

	 
	 	    3.2  
	
    With effect from the Effective Date, the Developer shall not
    research, develop, market or otherwise commercialise the
    Developer Know-How
    and/or the
    Developer Improvements in the Territory except on behalf of
    Amarin (whether as an employee of Amarin or otherwise).




 




    4   DEVELOPMENT
    WORK



 


			
	 	    4.1  
	
    Amarin shall be responsible for, and have full discretion in
    relation to, the design and implementation of a development plan
    for the Developer Intellectual Property.

	 
	 	    4.2  
	
    For the avoidance of doubt, the cost of conducting all
    development work in relation to the Developer Intellectual
    Property and all costs arising under Clause 9.1 shall be
    borne by Amarin.




 




    5   PAYMENTS



 


			
	 	    5.1  
	
    The Consideration shall be payable by Amarin to the Developer in
    accordance with this Clause 5 during the Consideration
    Period.




 



    5.2  Initial Consideration



 



    Upon the Effective Date, Amarin shall pay to the Developer
    £42,000.



 



    5.3  Amarin Milestone Payments



 



    During the Consideration Period, Amarin shall be liable to pay
    to the Developer the Amarin Milestone Payments in respect of the
    Developer Invention as follows:



 


			
	 	    5.3.1 
	
    upon the final selection by Amarin, at its sole discretion
    having taken advice from its Scientific Advisory Board, of the
    first formulation of the Compound for clinical development of
    the Developer Invention, Amarin shall pay to the Developer
    £42,000;

	 
	 	    5.3.2 
	
    upon the successful completion by Amarin of the first Pivotal
    Bioequivalence Study on the Developer Invention which Amarin is
    satisfied, at its sole discretion having taken advice from its
    Scientific Advisory Board, will enable it to file an NDA on the
    Developer Invention; or upon successful completion of the first
    Phase II clinical trial on the Developer Invention which
    Amarin is satisfied, at its sole discretion having taken advice
    from its Scientific Advisory Board, will enable it to commence a
    Phase III clinical trial on the Developer Invention, Amarin
    shall pay to the Developer £28,000;





    

    7








 





 


			
	 	    5.3.3 
	
    upon the filing and acceptance of the first EU Regulatory
    Application on the Developer Invention in a Major EU Country, or
    under the EMEA centralized procedure, or in any EU country under
    the mutual recognition procedure with the objective of EU
    Regulatory Approval in a Major EU Country, Amarin shall pay to
    the Developer £56,000;

	 
	 	    5.3.4 
	
    upon the filing and acceptance of the first NDA on the Developer
    Invention, Amarin shall pay to the Developer £56,000;

	 
	 	    5.3.5 
	
    upon obtaining the first EU Regulatory Approval on the Developer
    Invention in a Major EU Country, Amarin shall pay to the
    Developer £280,000; and

	 
	 	    5.3.6 
	
    upon obtaining the first NDA Approval on the Developer
    Invention, Amarin shall pay to the Developer £280,000.




 



    For the avoidance of doubt, any one of the Amarin Milestone
    Payments above shall become payable by Amarin upon the first
    achievement of the relevant milestone in relation to the
    Developer Invention, and upon payment of such Amarin Milestone
    Payments by Amarin, all of Amarin’s obligations hereunder
    to pay such Amarin Milestone Payment shall be satisfied in full.



 



    In the event that any one of the milestones set forth above
    should be achieved on more than one occasion in relation to the
    Developer Invention (for example, in relation to two separate
    therapeutic indications), Amarin shall have no obligation to pay
    any Amarin Milestone Payment in relation thereto save the
    obligation to pay the Amarin Milestone Payment which arose on
    the first achievement of the relevant milestone.



 



    5.4  Royalties on Net Sales / Third Party Royalties
    / Third Party Milestone Payments



 



    During the Consideration Period, Amarin shall be liable to pay
    Royalties to the Developer as follows:



 


			
	 	    5.4.1 
	
    if Amarin sells the Developer Invention In Market in the
    Territory, then on a country by country and product by product
    basis:




 


			
	 	    (a) 
	
    where the Developer Invention is covered by a Valid Claim that
    confers market exclusivity for such Developer Invention, or
    where Amarin has market exclusivity for the Developer Invention
    by virtue of having orphan drug status for such Developer
    Invention, payments would be made by Amarin to the Developer as
    follows:




 


	 	 	 
	
    Annual Amount of Net Sales

    
	
 
	
 

	

    in the Territory


	
 
	

    Percentage Payable



	 

	

    less than $17.5 million
    


	
 
	
    5%
    

	

    $17.5 million to
    $87.5 million
    


	
 
	
    2%
    

	

    over $87.5 million
    


	
 
	
    1%
    









 



    or



 


			
	 	    (b) 
	
    where the Developer Invention is not covered by a Valid Claim
    that confers market exclusivity for such Developer Invention or
    where Amarin does not have market exclusivity for the Developer
    Invention by virtue of having orphan drug status for such
    Developer Invention, Amarin shall pay to the Developer, 1% of
    Net Sales;




 


			
	 	    5.4.2 
	
    Amarin enters into a Licence Agreement then, on a country by
    country and product by product basis, Amarin shall pay to the
    Developer:




 



    (a) 7.5% of Third Party Royalties; and



 



    (b) 7.5% of Third Party Milestone Payments.



 


			
	 	    5.4.3 
	
    During the Consideration Period, payment of Royalties shall
    become due at the end of each calendar quarter following first
    commercial sale of the Developer Invention.





    

    8








 





 



    5.5  Royalties on non-cash Third Party Milestone
    Payments under a Licence Agreement



 



    With reference to Clause 5.4.2(b), if Amarin enters into a
    Licence Agreement where all or part of a Third Party Milestone
    Payment payable to Amarin thereunder is in the form of non-cash
    consideration (including without limitation, product rights to a
    third party product) (“Quid”), Amarin’s
    obligations to the Developer shall be as follows:



 


			
	 	    5.5.1 
	
    Amarin shall promptly notify the Developer in writing of the
    non-cash consideration received or receivable by Amarin and the
    financial value that has been assigned thereto by Amarin
    (“Quid Value”); and

	 
	 	    5.5.2 
	
    Amarin shall be obliged to pay the Developer 7.5% of the Quid
    Value by means of a payment to the Developer at the end of each
    calendar quarter following the execution of the Licence
    Agreement of 10% of the quarterly revenues generated by Amarin
    from the Quid until such time as Amarin’s cumulative
    payments to the Developer have reached 7.5% of the Quid Value,
    whereupon such obligation shall be satisfied in full and shall
    terminate.




 


			
	 	    5.6  
	
    For the avoidance of doubt, all of Amarin’s obligations to
    pay Consideration to the Developer under this Agreement shall
    cease upon the expiry of the Consideration Period
    (“Consideration Expiry Date”), save any accrued
    obligations of Amarin to pay any amounts of Consideration which
    remain due to the Developer on the Consideration Expiry Date.




 




    6   DEVELOPER
    LICENCE AGREEMENTS



 


			
	 	    6.1  
	
    Developer shall be responsible for all payments related to the
    financial provisions and obligations of any third party
    agreement with respect to the Developer Intellectual Property to
    which Developer is a party on the Effective Date (including
    amendments thereto) (the “Developer Effective Date
    Agreements”), including without limitation, any
    royalty, milestone or other compensation obligations triggered
    thereunder on the Effective Date, or triggered thereunder after
    the Effective Date.

	 
	 	    6.2  
	
    For the avoidance of doubt, any royalties, milestone or other
    compensation obligations which arise under any Developer
    Effective Date Agreement from the process of the
    commercialisation or exploitation of the Developer Invention,
    the Developer Intellectual Property or any products that
    incorporate the same shall be payments for which Developer will
    be responsible under this Clause 6.




 




    7   WARRANTIES



 



    7.1  Developer represents and warrants to Amarin as of
    the Effective Date, as follows:



 



    7.1.1 Developer has the right to enter into this Agreement;



 


			
	 	    7.1.2 
	
    Developer has obtained all and any other consents required to
    enter into this Agreement and perform all its obligations set
    forth herein;

	 
	 	    7.1.3 
	
    there are no agreements between Developer and any third party
    that conflict with this Agreement;

	 
	 	    7.1.4 
	
    Developer has provided Amarin with copies of any Developer
    Effective Date Agreements; and

	 
	 	    7.1.5 
	
    there are no proceedings threatened or pending against Developer
    in connection with the Developer Intellectual Property.




 




    8    INDEMNIFICATION



 


			
	 	    8.1  
	
    In addition to any other indemnities provided for in this
    Agreement, and subject to Clause 8.3, Developer shall
    indemnify and hold harmless Amarin and its Affiliates and their
    respective employees, agents, officers and directors from and
    against any Claims incurred or sustained by Amarin arising out
    of or in connection with any:




 


			
	 	    8.1.1 
	
    breach of any representation, covenant, warranty or obligation
    by Developer hereunder; or





    

    9








 





 


			
	 	    8.1.2 
	
    negligent or wilful act or omission or failure to comply with
    applicable laws and regulations on the part of Developer or any
    of its respective employees, agents, officers and directors in
    the performance of this Agreement;




 



    in each case save to the relative extent that such Claim is
    subject to Amarin’s indemnity under Clause 8.2.



 


			
	 	    8.2  
	
    In addition to any other indemnities provided for herein, and
    subject to Clause 8.3, Amarin shall indemnify and hold
    harmless Developer and its Affiliates and their respective
    employees, agents, officers and directors from and against any
    Claims incurred or sustained by Developer arising out of or in
    connection with any:




 


			
	 	    8.2.1 
	
    breach of any representation, covenant, warranty or obligation
    by Amarin hereunder; or

	 
	 	    8.2.2 
	
    negligent or wilful act or omission or failure to comply with
    applicable laws and regulations on the part of Amarin or any of
    its agents or employees in the performance of this Agreement;




 



    in each case save to the relative extent that such Claim is
    subject to the Developer’s indemnity under Clause 8.1.



 



    8.3 The party seeking an indemnity shall:



 


			
	 	    8.3.1 
	
    fully and promptly notify the other party of any claim or
    proceedings, or threatened claim or proceedings;

	 
	 	    8.3.2 
	
    permit the indemnifying party to take full control of such claim
    or proceedings, with counsel of the indemnifying party’s
    choice, provided that the indemnifying party shall reasonably
    and regularly consult with the indemnified party in relation to
    the progress and status of such claim or proceedings;

	 
	 	    8.3.3 
	
    co-operate in the investigation and defence of such claim or
    proceedings; and

	 
	 	    8.3.4 
	
    take all reasonable steps to mitigate any loss or liability in
    respect of any such claim or proceedings.




 



    Save as aforesaid, neither the indemnifying party nor the party
    to be indemnified shall acknowledge the validity of, compromise
    or otherwise settle any Claim without the prior written consent
    of the other, which shall not be unreasonably withheld.



 


			
	 	    8.4 
	
    NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT,
    AMARIN AND DEVELOPER SHALL NOT BE LIABLE TO THE OTHER BY REASON
    OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR
    ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS
    AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR
    PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE
    PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER
    OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR
    EMPLOYEES OR AGENTS OR OTHERWISE.

	 
	 	    8.5 
	
    Nothing in this Agreement shall limit the liability of either
    party for fraud, or limit the liability of either party to any
    third party under applicable laws where any act or omission of
    either party results in death or personal injury.




 




    9   PATENT
    PROSECUTION AND MAINTENANCE



 


			
	 	    9.1  
	
    For the avoidance of doubt, with effect from the Effective Date,
    Amarin, at its sole discretion and expense, may:




 


			
	 	    9.1.1 
	
    secure the grant of any patent applications within the Developer
    Intellectual Property in the Territory;

	 
	 	    9.1.2 
	
    file and prosecute patent applications on patentable inventions
    and discoveries relating to the same in the Territory;





    

    10








 





 


			
	 	    9.1.3 
	
    defend all such applications against third party oppositions in
    the Territory; and

	 
	 	    9.1.4 
	
    maintain in force any issued letters patent relating to the same
    in the Territory.




 


			
	 	    9.2  
	
    The Developer shall provide Amarin with reasonable support in
    the filing and prosecution of any patent applications under this
    Clause 9 and shall provide all information
    and/or data
    in the Developer’s possession that is necessary to support
    any such patent applications.

	 
	 	    9.3  
	
    Developer shall promptly notify Amarin in writing of the
    following:




 


			
	 	    9.3.1 
	
    any actual or alleged unauthorized use of the Developer
    Intellectual Property by a third party of which it becomes aware
    and provide Amarin with any available evidence of such
    unauthorized use;

	 
	 	    9.3.2 
	
    any claim or proceedings alleging infringement or other
    unauthorised use of the proprietary rights of a third party
    arising from the performance of this Agreement and the conduct
    by Amarin of development work in relation to the Developer
    Intellectual Property.




 



    For the avoidance of doubt, Amarin shall, at its sole
    discretion, determine the strategy to be adopted and actions to
    be taken in relation to any enforcement or defence action
    necessary in relation to the matters set forth above.



 




    10   REGULATORY
    MATTERS



 


			
	 	    10.1  
	
    For the avoidance of doubt, Amarin shall, at its expense, be
    responsible for the filing and maintaining all Regulatory
    Applications and Regulatory Approvals with the RHAs in relation
    to the Developer Invention and Other Apomorphine Products.

	 
	 	    10.2  
	
    For the further avoidance of doubt Amarin shall own all
    Regulatory Applications filed, and Regulatory Approvals obtained
    in respect of the Developer Invention and Other Apomorphine
    Products.




 




    11   SIMBEC
    STUDY AGREEMENT



 


			
	 	    11.1  
	
    The parties acknowledge that pursuant to the Simbec Study
    Agreement, Amarin owns the Proof of Concept Study Data.




 




    12   CONFIDENTIAL
    INFORMATION/ANNOUNCEMENTS



 


			
	 	    12.1  
	
    Upon execution of this Agreement, and thereafter during the term
    hereof, at such times as the parties shall mutually agree, each
    party may disclose to the others, in confidence Confidential
    Information necessary or useful to the activities contemplated
    by this Agreement.




 



    Except as specifically authorised or permitted by this
    Agreement, each party shall, for the term of this Agreement and
    for 7 years after its expiration or termination keep
    confidential and not disclose to others (except its Affiliates),
    and use only as permitted hereunder, all of the Confidential
    Information owned by the other parties.



 



    For the avoidance of doubt, the parties acknowledge that all
    Confidential Information relating to the Developer Intellectual
    Property shall upon execution of this Agreement be the absolute
    property of Amarin.



 


			
	 	    12.2  
	
    Save as otherwise specifically provided herein, each party shall
    disclose Confidential Information of the other parties only to
    those employees, representatives and agents requiring knowledge
    thereof in connection with fulfilling the party’s
    obligations under this Agreement. Each party further agrees to
    (i) inform all such employees, representatives and agents
    of the terms and provisions of this Agreement relating to
    Confidential Information and their duties hereunder, and
    (ii) obtain their agreement hereto as a condition of
    receiving Confidential Information, provided that such agreement
    shall be deemed given in respect of such employees,
    representatives and agents that, at the time of disclosure, are
    under existing obligations of confidentiality no less onerous
    than those contained herein covering such





    

    11








 





			
	 	
	
    disclosure. Each party shall exercise the same standard of care
    as it would itself exercise in relation to its own confidential
    information (but in no event less than a reasonable standard of
    care) to protect and preserve the proprietary and confidential
    nature of the Confidential Information disclosed to it by the
    other parties.




 



    12.3  Notwithstanding the provisions of this
    Clause 12, Confidential Information may be:



 


			
	 	    12.3.1 
	
    published if and to the extent such publication has been
    approved in writing by each of the parties; or

	 
	 	    12.3.2 
	
    disclosed to the extent required by applicable laws or
    regulations or as ordered by a court or other regulatory body
    having competent jurisdiction, provided that if a party becomes
    legally required to disclose any Confidential Information of the
    other party hereunder, the receiving party shall give the
    disclosing party prompt notice of such requirement to enable the
    disclosing party to seek a protective order or other appropriate
    remedy concerning any such disclosure. The receiving party shall
    fully co-operate with the disclosing party in connection with
    the disclosing party’s efforts to obtain any such order or
    other remedy. If any such order or other remedy does not fully
    preclude disclosure, the receiving party shall make such
    disclosure only to the extent that such disclosure is legally
    required.




 


			
	 	    12.4  
	
    The parties agree that the obligations of this Clause 12
    are necessary and reasonable in order to protect the
    parties’ respective businesses, and each party agrees that
    monetary damages would be inadequate to compensate a party for
    any breach by the other party of its covenants and agreements
    set forth herein.




 



    The parties agree that any such violation or threatened
    violation shall cause irreparable injury to a party and that, in
    addition to any other remedies that may be available, in law and
    equity or otherwise, each party shall be entitled to seek
    injunctive relief against the threatened breach of the
    provisions of this Clause 12, or a continuation of any such
    breach by the other party, specific performance and other
    equitable relief to redress such breach together with damages
    and reasonable counsel fees and expenses to enforce its rights
    hereunder.



 


			
	 	    12.5  
	
    Subject to Clause 12.2 and Clause 12.3.2 and 12.6,
    neither party shall have the right to disclose to third parties
    the existence of this Agreement or any of the terms and
    conditions hereof without the prior written consent of the other
    party. In the event that either party wishes to make an
    announcement concerning the Agreement, that party will seek the
    consent of the other party, which consent shall not be
    unreasonably withheld or delayed. The terms of any such
    announcement shall be agreed in good faith.

	 
	 	    12.6  
	
    Amarin shall be entitled to provide a copy of this Agreement
    (and any related agreements or documents) to a potential third
    party licensee,
    sub-licensee,
    acquirer or other party interested in the research, development
    or commercialization of the Developer Intellectual Property
    provided that the relevant third party has entered into a
    confidentiality agreement on terms to be agreed between Amarin
    and such relevant third party.




 




    13   PAYMENTS,
    REPORTS AND AUDITS



 


			
	 	    13.1  
	
    With reference to Clause 5, Amarin shall keep true and
    accurate records of Net Sales (and any deductibles made in
    calculating same), Third Party Royalties and Third Party
    Milestone Payments.

	 
	 	    13.2  
	
    Any income or other taxes which Amarin is required by law to pay
    or withhold on behalf of the Developer with respect to any
    monies payable to the Developer under this Agreement shall be
    deducted from the amount of such monies due. Any such tax
    required to be paid or withheld shall be an expense of and borne
    solely by the Developer. Amarin shall promptly provide the
    Developer with a certificate or other documentary evidence to
    enable the Developer to support a claim for a refund or a
    foreign tax credit with respect to any such tax so withheld or
    deducted by Amarin.

	 
	 	    13.3  
	
    For the 90 day period following the close of each financial
    year, Amarin will, in the event that the Developer reasonably
    requests such access, provide the Developer’s independent
    certified accountants





    

    12








 





			
	 	
	
    (reasonably acceptable to Amarin) with access, during regular
    business hours and subject to the confidentiality provisions as
    contained in this Agreement, to Amarin’s books and records
    relating to the Developer Invention, solely for the purpose of
    verifying the accuracy and reasonable composition of the
    calculations hereunder for the financial year then ended.




 


			
	 	    13.4  
	
    In the event of a discovery of a discrepancy which exceeds five
    per cent (5%) of the amount due for any period, the cost of such
    audit shall be borne by Amarin; otherwise, such cost shall be
    borne by the Developer.

	 
	 	    13.5  
	
    Payment of monies due under this Agreement shall be made by
    Amarin to the Developer within 30 days of becoming due.

	 
	 	    13.6  
	
    All sums payable by Amarin to the Developer shall be paid in
    pounds sterling by wire transfer to the Developer’s
    designated account. Where a sum is calculated according to
    payments received by Amarin in one or more other currencies, the
    pound sterling amount payable shall be calculated by reference
    to the average mid-price exchange rate between the local
    currencies and the pound sterling over the calendar quarter
    during which such payment becomes due by reference to the
    applicable rates published in The Financial Times.




 


			
	 	    13.7 
	
    Amarin shall pay interest to the Developer on sums not paid to
    the Developer on the date on which payment should have been made
    pursuant to the applicable provisions of this Agreement
    (“Due Date”) over the period from the Due Date
    until the date of actual payment (both before and after
    judgement) at a rate per annum equal to 1% over the 1 year
    LIBOR rate (London Interbank Offer Rate), such interest to
    payable on demand from time to time and compounded quarterly.




 




    14   CHANGE
    OF CONTROL



 



    In the event of a Change of Control of Amarin, the following
    obligations upon Amarin shall arise with effect from the date
    the Change of Control of Amarin takes effect:



 


			
	 	    14.1  
	
    In the event that the board of directors of Amarin makes a final
    determination that Amarin will terminate all further development
    and commercialization activities relating to the Developer
    Invention in both the EU and the US, Amarin shall notify the
    Developer in writing of such determination with 90 days
    (“Notification Date”).

	 
	 	    14.2  
	
    For a period of 30 days from the Notification Date (the
    “Developer Option Period”), Amarin shall grant
    the Developer an exclusive option to negotiate an agreement for
    the commercialisation by the Developer of the Developer
    Intellectual Property in the EU and the US upon terms to be
    negotiated, including the consideration to be paid by the
    Developer to Amarin based on the market value of the opportunity
    (at a minimum) (“Developer Terms”).

	 
	 	    14.3  
	
    For the avoidance of doubt, during the Developer Option Period,
    Amarin will not negotiate in any form, directly or indirectly,
    with any other corporation, entity or person in relation to the
    subject matter of Clause 14.2, nor provide any information
    relating thereto to third parties, save with the prior consent
    in writing of the Developer.

	 
	 	    14.4  
	
    If, despite the above negotiations, Amarin and the Developer do
    not reach agreement within the Developer Option Period, then
    Amarin shall be free to enter into negotiations with third
    parties to agree terms (“Third Party Terms”)
    upon which a third party would commercialise the Developer
    Intellectual Property in the EU
    and/or the
    US as follows:




 


			
	 	    14.4.1 
	
    at any time following the expiry of the Developer Option Period,
    without any reference to the Developer, Amarin shall be free to
    conclude and execute an agreement with a third party to
    commercialise the Developer Intellectual Property in the EU
    and/or the
    US where the Third Party Terms are more favourable to Amarin
    than the Developer Terms; and

	 
	 	    14.4.2 
	
    during a period of 6 months from the expiry of the
    Developer Option Period, Amarin shall provide prior notice in
    writing to the Developer if Amarin proposes to enter into an
    agreement





    

    13








 





			
	 	
	
    with a third party to commercialise the Developer Intellectual
    Property in the EU
    and/or the
    US where the Third Party Terms are not more favourable to Amarin
    than the Developer Terms (such notice to include full disclosure
    of the relevant Third Party Terms) and the Developer shall have
    the right, within 30 days of receipt of such notice, to
    elect to enter into an agreement with Amarin upon the same terms
    and conditions contained in Amarin’s notice to the
    Developer.




 




    15   MISCELLANEOUS



 


			
	 	    15.1  
	
    This Agreement shall be governed by and construed in accordance
    with the laws of England and the parties submit to the
    non-exclusive jurisdiction of the English courts.

	 
	 	    15.2  
	
    No waiver of any right under this Agreement shall be deemed
    effective unless contained in a written document signed by the
    party charged with such waiver, and no waiver of any breach or
    failure to perform shall be deemed to be a waiver of any future
    breach or failure to perform or of any other right arising under
    this Agreement.

	 
	 	    15.3  
	
    Neither party to this Agreement shall be liable for delay or
    failure in the performance of any of its obligations hereunder
    to the extent such delay or failure results from causes beyond
    its reasonable control, including, without limitation, acts of
    God, fires, strikes, acts of war, or intervention of a
    government authority, non-availability of raw materials, but any
    such delay or failure shall be remedied by such party as soon as
    practicable.




 



    15.4  The following provisions shall apply to the
    assignment of this Agreement:



 


			
	 	    15.4.1 
	
    each party may assign this Agreement in whole or in part and
    delegate its duties hereunder to its Affiliate or Affiliates
    without consent provided that such assignment or delegation has
    no material adverse tax implications for the other
    parties; and

	 
	 	    15.4.2 
	
    Amarin may assign this Agreement to a third party without the
    consent of the Developer.




 


			
	 	    15.5  
	
    Nothing contained in this Agreement is intended or is to be
    construed to constitute Developer and Amarin as partners or
    members of a joint venture. None of the parties hereto shall
    have any express or implied right or authority to assume or
    create any obligations on behalf of or in the name of the other
    parties or to bind the other parties to any contract, agreement
    or undertaking with any third party.

	 
	 	    15.6  
	
    No amendment, modification or addition hereto shall be effective
    or binding on any party unless set forth in writing and executed
    by a duly authorised representative of each of the parties.

	 
	 	    15.7  
	
    Any notice to be given under this Agreement shall be sent in
    writing in English by overnight courier, registered airmail or
    telecopied to:




 



    Amarin at:



 



    50 Pembroke Road,




    Ballsbrdge,




    Dublin 4.



 



    Telephone: 353 1 6699020



 



    Telefax:    353 1 6699028



 



    

    14








 






    Developer at:



 



    Scots Grove House,




    Uxmore Road,




    Checkendon,




    Oxfordshire,



 



    RG8 0TD.



 



    Telephone: +44 1491 680949



 



    Telefax:    +44 1491 680949



 



    or to such other address(es) and telecopier numbers as may from
    time to time be notified by any of the parties to the others
    hereunder.



 



    Any notice sent by overnight courier, registered mail or
    telecopier shall be deemed to have been delivered upon receipt
    by the addressee.



 


			
	 	    15.8  
	
    If any provision in this Agreement is agreed by the parties to
    be, or is deemed to be, or becomes invalid, illegal, void or
    unenforceable under any law that is applicable hereto:-




 


			
	 	    15.8.1 
	
    such provision will be deemed amended to conform to applicable
    laws so as to be valid and enforceable or, if it cannot be so
    amended without materially altering the intention of the
    parties, it will be deleted, with effect from the date of such
    agreement or such earlier date as the parties may agree; and

	 
	 	    15.8.2 
	
    the validity, legality and enforceability of the remaining
    provisions of this Agreement shall not be impaired or affected
    in any way.




 


			
	 	    15.9  
	
    This Agreement sets forth all of the agreements and
    understandings between the parties with respect to the subject
    matter hereof, and supersedes and terminates all prior
    agreements and understandings between the parties with respect
    to the subject matter hereof.

	 
	 	    15.10 
	
    At the request of any of the party, the other parties shall (and
    shall use reasonable efforts to procure that any other necessary
    third parties shall) execute and do all such documents, acts and
    things as may reasonably be required subsequent to the signing
    of this Agreement for assuring to or vesting in the requesting
    party the full benefit of the terms hereof.

	 
	 	    15.11 
	
    Each party shall pay its own legal costs in relation to the
    negotiation and conclusion of this Agreement.

	 
	 	    15.12 
	
    A person who is not a party to this Agreement has no right under
    the Contracts (Rights of Third parties) Act 1999 to enforce any
    term of this Agreement, but this does not affect any right or
    remedy of a third party which exists or is available apart from
    that Act.





    15








 






    IN WITNESS WHEREOF, the parties hereto have executed this
    Agreement.



 



    SIGNED




    for and on behalf of




    AMARIN PHARMACEUTICALS IRELAND LIMITED



 



    ALAN COOKE






 



    SIGNED




    by




    DR ANTHONY CLARKE



 



    ANTHONY CLARKE






 



    

    16








 






    IN WITNESS WHEREOF, the parties hereto have executed this
    Agreement.



 



    SIGNED




    for and on behalf of




    AMARIN PHARMACEUTICALS IRELAND LIMITED



 



    ALAN COOKE






 



    SIGNED




    by




    DR ANTHONY CLARKE



 



    ANTHONY CLARKE







    

    17








 







    SCHEDULE 1

    



 




    Developer
    Patents



 


	 	 	 
	

    British Patent Application:
    


	
 
	
    “Pharmaceutical formulation
    of Apomorphine”
    

	
 
	
 
	
 

	

    Name of Inventor:
    


	
 
	
    Anthony Clarke, Scots Grove House,
    Checkendon, OxfordshireRG8 0TD, UK.
    

	
 
	
 
	
 

	

    British Application No.:
    


	
 
	
    0509317.4
    

	
 
	
 
	
 

	

    Date of submission:
    


	
 
	
    6 May 2005
    










    

    18








 






    (1) AMARIN PHARMACEUTICALS IRELAND LIMITED



 



    AND



 



    (2) DR ANTHONY CLARKE



 





 



    ASSIGNMENT AGREEMENT



 





 



    MATHESON ORMSBY PRENTICE




    30 Herbert Street




    Dublin 2




    Ireland