Agreement
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 00, Xxxxx-Xxxxxxxxxx 0-xxxxx, Xxxxxxx-xx,
Xxxxx, Xxxxx (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 00 Xxxxxxxx Xxxx, Xxxxxx 0,
(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.
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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.
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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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