exv4w62



 







    Exhibit 4.62



 



    Certain portions of this Exhibit have been omitted pursuant to a
    request for “Confidential Treatment” under
    Rule 24b-2
    of the Securities and Exchange Commission. Such portions have
    been redacted and bracketed in the request and appear as [*] in
    the text of this Exhibit. The omitted confidential information
    has been filed with the Securities and Exchange Commission.



 




    Agreement



 



    This Agreement made this 15th day of November 2005 by and
    between Nisshin Pharma Inc., a Japanese corporation having its
    principal office at 25, Kanda-Nishikicho 1-chome, Chiyoda-ku,
    Tokyo, Japan (hereinafter referred to as “Nisshin”)
    and Amarin Pharmaceuticals Ireland Limited, an Irish Company
    (which is wholly owned by Amarin Corporation plc) having its
    principal office at 50 Pembroke Road, Dublin 2,
    (hereinafter referred to as “Amarin”) and Amarin
    Neuroscience limited, a Scottish company having its principle
    office at King Park House, Laurelhill Business Park, Polmaise
    Road, Stirling, UK,FK7 9JQ, in connection with the Agreement
    made on the 27th October 1999 between Nisshin Flour Milling
    Co., Ltd., a Japanese corporation, the parent company of
    Nisshin, and Laxdale Limited, a Scottish company now known as
    Amarin Neuroscience Limited due to the corporate take-over
    closed on the 8th October 2004 by Amarin Corporation plc,
    which was assigned on the 2nd July 2001 by Nisshin Flour
    Milling Co., Ltd. to Nisshin; and is to be assigned by Amarin
    Neuroscience Limited to Amarin in accordance with Article 7
    together with all its rights and obligations having arisen or
    arising thereunder (such agreement hereinafter referred to as
    “the Original Agreement”).



 




    Witnesseth:



 



    Whereas, by the Original Agreement Nisshin Flour Milling Co.,
    Ltd. agreed to supply ethyl-eicosapentaenoate (EPA-E) in bulk
    style (hereinafter referred to as “the Products”) to
    Laxdale Limited to be used by Laxdale Limited in its research
    and development of a drug which will be made from the Products
    and also clinical trials (hereinafter such drug referred to as
    “the Drug”);



 



    Whereas, Nisshin has been waiting for Amarin to obtain an drug
    approval for Huntington’s Disease (HD) treatment and now
    has taken the decision to inform Amarin that Nisshin cannot be
    the supplier of the Products to Amarin in the future because,
    due to Amarin’s unexpected delay in securing the regulatory
    authorities’ approval of its manufacturing and sale of the
    Drug for HD, Nisshin cannot foresee a situation of being able to
    guarantee to maintain its manufacturing facilities and its
    control system for the production of the Products without any
    manufacturing opportunity for another two years or more;



 



    Whereas, Amarin understands that Nisshin wants to discontinue
    the supply of the Products but wishes Nisshin to continue to
    supply of the Products for the clinical trials until an
    alternative supplier can be found,; and



 



    Whereas, Nisshin understands the foregoing conditions of Amarin
    and agrees to continue the supply of the Products to Amarin and
    to cooperate with Amarin, including but not limited to, for the
    dealing with the Inspection by FDA (Food and Drug
    Administration) for Amarin until Amarin obtains the approval for
    HD from FDA, only in parallel to Amarin’s finding an
    alternative supplier only for no more than three years after
    June 6, 2005.



 



    It is therefore agreed between the parties hereto as follows.



 




    Article 1.
    (Extension of Term)



 



    Notwithstanding the provisions of Article 10 of the
    Original Agreement, the said Agreement shall be extended to
    June 6, 2008 on the conditions hereinafter stipulated. It
    is agreed by Amarin that there shall be no further extension of
    the term of the Original Agreement other than the extension
    above for any reason whatsoever.




    

    1








 







    Article 2.
    (Continued Cooperation)



 



    During the term of the Original Agreement set out in
    Article 1 above, Nisshin shall maintain DMF (Drug Master
    File) of EPA-E and deal with the Inspection by FDA until Amarin
    obtains the approval of the Drug for HD from FDA but no later
    than June 6, 2008, provided, however, Nisshin shall not be
    liable for failure to obtain the said approval by Amarin for any
    reason whatsoever. Nisshin shall, on behalf of Amarin, pay the
    costs for the DMF renewal and changes and for the FDA inspection
    including the related expenses. The repayment of such costs
    shall be made to Nisshin by Amarin based on the Invoices sent by
    Nisshin to Amarin Nisshin shall attach a copy of each invoice in
    evidence for such disbursement together with the Invoices to
    Amarin. It is stated by Nisshin and agreed by Amarin that
    Nisshin shall not guarantee to clear the Inspection of FDA
    smoothly because there is a further absence of any manufacturing
    opportunity for two years or more.



 




    Article 3.
    (Stock Inventory and Continued Supply)



 



    Amarin shall commit itself to complete by the end of December
    2005 the purchase of one batch of the Products (180 kg) now
    remaining in the stock of Nisshin. Amarin shall also commit
    itself the purchase of the Products which will be manufactured
    by Nisshin using the 1.7 tons of the intermediate materials
    currently in the stock of Nisshin regardless of the result of
    the clinical trials which are now conducted for HD and will be
    completed by the end of the year 2006. The order for the
    Products which will be manufactured from the foregoing 1.7 tons
    intermediate shall be sent to Nisshin from Amarin by the end of
    October 2006. Nisshin will notify Amarin a proposed date of
    shipment of the Products after receiving the order from Amarin.



 



    The price of all the Products purchased under this Agreement
    shall be [*] Japanese yen (¥[*]) per kilogram, FOB Japan.
    The conditions of the shipment are the same as specified in the
    Original Agreement.



 



    The supplying schedule for the foregoing Products shall
    separately be agreed upon by the parties hereto and payment of
    the price of the foregoing Products shall be made within one
    month after the receipt of an invoice from Nisshin which will be
    sent by Nisshin to Amarin soon after the shipment of the
    Products, notwithstanding the provision of Article 2 and 4
    of the Original Agreement.



 




    Article 4.
    (Advance)



 



    In order to guarantee the full performance of its obligations
    under the provisions of the preceding Article 3 and in
    consideration of Nisshin’s grant of extension of the term
    of the Original Agreement, Amarin shall pay a down payment of
    [*] yen (¥[*]) to Nisshin by the end of 2005 to be fully
    credited (without set off, deduction or counterclaim) against
    any sums due to Nisshin in respect of the Products purchased
    pursuant to Article 3. It is understood by Amarin that the
    advance money in the amount of [*] yen (¥[*]) set out in
    Article 4 of this Agreement shall not be returned to Amarin
    for any reason whatsoever provided Nisshin is prepared, willing
    and able to make the supplies set out in Article 3.



 




    Article 5.
    (Continued Effect of Provisions of Original Agreement)



 



    Except Article 12. and the provisions of the Original
    Agreement which shall be superceded and hereby deleted by the
    provisions of this Agreement, all the provisions of the Original
    Agreement shall continue effective until the extended term set
    out in Article 1 expires. In the event of any ambiguity or
    inconsistency between the terms of this Agreement and the terms
    of the Original Agreement then the terms of this Agreement shall
    prevail and take precedence.



 




    Article 6.
    (Mutual Discussion)



 



    Any matter not specifically stipulated in this Agreement
    regarding the extension of the Original Agreement or its related
    matters, where necessity happens, shall be agreed between the
    parties hereto through amicable discussion.




    

    2








 







    Article 7.
    (Assignment)



 



    Amarin Neuroscience Limited hereby assigns to Amarin with full
    title guarantee all rights, claims and liberties the full
    benefit and the burden and obligations of the Original Agreement
    to hold the same absolutely and Nisshin hereby consents to such
    assignment to take effect from the date hereof.



 



    In witness whereof, the parties hereto have caused their
    authorized representatives to execute this Agreement on the date
    first written above.



 



    




    

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